170 results on '"Emmanouil Rampakakis"'
Search Results
2. Generic orphan drug substitution: a critical analysis of global practices and Saudi Arabia’s perspective
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Yousif S. Alakeel, Emmanouil Rampakakis, Ali AlRumaih, Rana AlRuwaisan, Maha Abushal, Abdullah M. AlDalaan, Majdy M. Idrees, Zaid D. Alanazi, Hanouf AlKoait, Abdulrahman Muaadi, Majed Ali M. AlAfra, Shaya A. AlShaya, and Suliman AlHomida
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generic ,biosimilar ,orphan ,rare ,Middle East ,Therapeutics. Pharmacology ,RM1-950 - Abstract
In an era of cost pressure, substituting generic drugs represents one of the main cost-containment strategies of healthcare systems. Despite the obvious financial benefits, in a minority of cases, substitution may require caution or even be contraindicated. In most jurisdictions, to obtain approval, the bioequivalence of generic products with the brand-name equivalent needs to be shown via bioavailability studies in healthy subjects. Rare diseases, defined as medical conditions with a low prevalence, are a group of heterogenous diseases that are typically severe, disabling, progressive, degenerative, and life-threatening or chronically debilitating, and disproportionally affect the very young and elderly. Despite these unique features of rare diseases, generic bioequivalence studies are typically carried out with single doses and exclude children or the elderly. Furthermore, the excipients and manufacturing processes for generic/biosimilar products can differ from the brand products which may affect the shelf-life of the product, its appearance, smell, taste, bioavailability, safety and potency. This may result in approval of generics/biosimilars which are not bioequivalent/comparable in their target population or that meet bioequivalence but not therapeutic equivalence criteria. Another concern relates to the interchangeability of generics and biosimilars which cannot be guaranteed due to the phenomenon of biocreep. This review summarizes potential concerns with generic substitution of orphan drugs and discusses potentially problematic cases including narrow therapeutic index drugs or critical conditions where therapeutic failure could lead to serious complications or even death. Finally, we put forward the need for refining regulatory frameworks, with emphasis on Saudi Arabia, for generic substitution and recent efforts toward this direction.
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- 2024
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3. Guselkumab provides durable improvement across psoriatic arthritis disease domains: post hoc analysis of a phase 3, randomised, double-blind, placebo-controlled study
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Laure Gossec, Peter Nash, Philip J Mease, Emmanouil Rampakakis, Laura C Coates, Philip S Helliwell, Alexa P Kollmeier, Xie L Xu, May Shawi, Miriam Zimmermann, and Natalie J Shiff
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Medicine - Abstract
Objective Evaluate long-term guselkumab effectiveness across Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-recognised domains/related conditions of psoriatic arthritis (PsA).Methods Post hoc analyses used data from DISCOVER-2 (NCT03158285) biologic/Janus-kinase inhibitor-naïve participants with active PsA (≥5 swollen/≥5 tender joints, C-reactive protein ≥0.6 mg/dL), randomised (1:1:1) to guselkumab every 4 or 8 weeks (Q4W/Q8W) or placebo with crossover to guselkumab. Outcomes aligned with key GRAPPA-recognised domains of overall disease activity, peripheral arthritis, axial disease, enthesitis/dactylitis and skin psoriasis (nail psoriasis was not evaluated). PsA-related conditions (inflammatory bowel disease (IBD)/uveitis) were assessed via adverse events through W112. Least squares mean changes from baseline through W100 in continuous outcomes employed repeated measures mixed-effects models adjusting for baseline scores. Binary measure response rates were determined with non-responder imputation for missing data.Results 442/493 (90%) of guselkumab-randomised patients completed treatment through W100. Following early reductions in disease activity with guselkumab, durable improvements were observed across key PsA domains (swollen/tender joints, psoriasis, spinal pain, enthesitis/dactylitis) through W100. Response rates of therapeutically relevant targets generally increased through W100 with guselkumab Q4W/Q8W: Disease Activity Index for PsA low disease activity (LDA) 62%/59%, enthesitis resolution 61%/70%, dactylitis resolution 72%/83%, 100% improvement in Psoriasis Area and Severity Index 59%/53%, Psoriatic Arthritis Disease Activity Score LDA 51%/49% and minimal disease activity 38%/40%. Through W112, no cases of IBD developed among guselkumab-randomised patients and one case of uveitis was reported.Conclusion In biologic-naïve patients with active PsA, guselkumab provided early and durable improvements in key GRAPPA-recognised domains through 2 years, with substantial proportions achieving important treatment targets.
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- 2024
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4. Effectiveness of a treat-to-target strategy in patients with moderate to severely active rheumatoid arthritis treated with abatacept
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Louis Bessette, Boulos Haraoui, Emmanouil Rampakakis, Joanna Dembowy, Marc-Olivier Trépanier, and Janet Pope
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Abatacept ,Real-world ,Rheumatoid arthritis ,Routine care ,Treat-to-target ,Diseases of the musculoskeletal system ,RC925-935 - Abstract
Abstract Background To compare a treat-to-target (T2T) approach and routine care (RC) in adults with active to severely active rheumatoid arthritis (RA) initiating subcutaneous abatacept. Methods A 12-month cluster-randomized trial in active RA patients treated with abatacept was conducted. Physicians were randomized to RC or T2T with a primary endpoint of achieving sustained Clinical Disease Activity Index (CDAI) low disease activity (LDA) at two consecutive assessments approximately 3 months apart. Additional outcomes included Simple Disease Activity Index (SDAI), Disease Activity Score 28-CRP (DAS28-CRP), Routine Assessment of Patient Index Data 3 (RAPID3), and the Health Assessment Questionnaire-Disability Index (HAQ-DI). Time to achieve therapeutic endpoints was assessed with survival analysis. Results Among the 284 enrolled patients, 130 were in the T2T group and 154 in RC. Primary endpoint was achieved by 36.9% and 40.3% of patients in T2T and RC groups, respectively. No significant between-group differences were observed in the odds of achieving secondary outcomes, except for a higher likelihood of CDAI LDA in the T2T group vs. RC (odds ratio [95% confidence interval]: 1.33 [1.03–1.71], p = 0.0263). Compared with RC, patients in the T2T group achieved SDAI remission significantly faster (Kaplan–Meier-estimated mean [standard error]: 14.0 [0.6] vs. 19.3 [0.8] months, p = 0.0428) with a trend toward faster achievement of CDAI LDA/remission, DAS28-CRP remission, and HAQ-DI minimum clinically important difference. Conclusions Patients managed per T2T and those under RC experienced significant improvements in RA disease activity at 12 months of abatacept treatment. T2T was associated with higher odds of CDAI LDA and a shorter time to achieving therapeutic endpoints. Trial registration Name of the registry: ClinicalTrials.gov. Trial registrations: NCT03274141 . Date of registration: September 6, 2017.
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- 2023
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5. Sustained low functional impairment in axial spondyloarthritis (axSpA): which are the primary outcomes that should be targeted to achieve this?
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Walter P. Maksymowych, Robert D. Inman, Louis Bessette, Proton Rahman, Emmanouil Rampakakis, Odalis Asin-Milan, Meagan Rachich, Anne Marilise Marrache, and Allen J. Lehman
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Spondyloarthritis ,Treat-to-target ,Infliximab ,Golimumab ,TNFi ,Function ,Diseases of the musculoskeletal system ,RC925-935 - Abstract
Abstract Objectives To (i) determine whether sustained disease activity states, as measured by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS), impact function, and (ii) evaluate characteristics predicting sustained low functional impairment in a prospective axial spondyloarthritis (axSpA) cohort. Methods Biologic Treatment Registry Across Canada (BioTRAC) was a multi-center, prospective registry that collected real-world data on axSpA patients receiving infliximab or golimumab between 2006 and 2017. Generalized estimating equations (GEE) were used to test baseline characteristics, treatment, and duration (at 6 and 12 months vs. only at 6 or 12 months vs. neither) of low BASDAI (
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- 2023
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6. COVID-19 Vaccine in Immunosuppressed Adults with Autoimmune rheumatic Diseases (COVIAAD): safety, immunogenicity and antibody persistence at 12 months following Moderna Spikevax primary series
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Emmanouil Rampakakis, Paul R Fortin, Sasha Bernatsky, Louis Bessette, Ines Colmegna, Elizabeth Hazel, Laëtitia Michou, Mary-Ann Fitzcharles, Louis Flamand, Emmanuelle Rollet-Labelle, Marc-André Langlois, Valeria Valerio, Nathalie Amiable, Mariana Useche, Deirdre McCormack, and Pantelis Panopalis
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Medicine - Abstract
Objective To assess the safety, immunogenicity and cellular responses following the Moderna Spikevax primary series in rheumatic disease.Methods We conducted a 12-month, prospective, non-randomised, open-label, comparative trial of adults with either rheumatoid arthritis (RA, n=131) on stable treatment; systemic lupus erythematosus (SLE, n=23) on mycophenolate mofetil (MMF); other rheumatic diseases on prednisone ≥10 mg/day (n=8) or age-matched/sex-matched controls (healthy control, HC, n=58). Adverse events (AEs), humoral immune responses (immunogenicity: IgG positivity for anti-SARS-CoV-2 spike protein and its receptor binding domain, neutralising antibodies (NAbs)), cellular responses (ELISpot) and COVID-19 infection rates were assessed.Results Frequency of solicited self-reported AEs following vaccination was similar across groups (HC 90%, RA 86%, SLE 90%); among them, musculoskeletal AEs were more frequent in RA (HC 48% vs RA 66% (Δ95% CI CI 3 to 32.6)). Disease activity scores did not increase postvaccination. No vaccine-related serious AEs were reported. Postvaccination immunogenicity was reduced in RA and SLE (RA 90.2%, SLE 86.4%; for both, ΔCIs compared with HC excluded the null). Similarly, NAbs were reduced among patients (RA 82.6%, SLE 81.8%). In RA, age >65 (OR 0.3, 95% CI 0.1 to 0.8) and rituximab treatment (OR 0.003, 95% CI 0.001 to 0.02) were negative predictors of immunogenicity. ELISpot was positive in 16/52 tested RA and 17/26 HC (ΔCI 11.2–53.3). During the study, 11 HC, 19 RA and 3 SLE patients self-reported COVID-infection.Conclusion In COVID-19 Vaccine in Immunosuppressed Adults with Autoimmune Diseases, the Moderna Spikevax primary series was safe. MMF, RA age >65 and rituximab were associated with reduced vaccine-induced protection.
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- 2023
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7. Surgical classification for large macular hole: based on different surgical techniques results: the CLOSE study group
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Flavio A. Rezende, Bruna G. Ferreira, Emmanouil Rampakakis, David H. Steel, Michael J. Koss, Zofia A. Nawrocka, Daniela Bacherini, Eduardo B. Rodrigues, Carsten H. Meyer, Tomaso Caporossi, Tamer H. Mahmoud, Stanislao Rizzo, Mark W. Johnson, and Jay S. Duker
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Large macular holes ,Surgical macular hole classification ,Close study group ,Ophthalmology ,RE1-994 - Abstract
Abstract Background The CLOSE study group proposes an updated surgical classification for large macular holes based on a systematic review of new treatments. Recently, many new techniques have been introduced to treat large full-thickness macular holes (FTMH); although the indications are not clear. An updated surgical classification is needed to help surgical decision-making. Methods We gathered published series by the CLOSE Study Group members and from literature search until June 2021. Techniques included: internal limiting membrane peeling (ILM peeling), ILM flaps, macular hydrodissection (macular hydro), human amniotic membrane graft (hAM), and autologous retinal transplantation (ART). Within each technique, chi-square test assessed association between the minimal linear diameter (MLD) (in µm) and closure rate; the postoperative best-corrected visual acuity (BCVA) gains were compared among groups. Results Data extraction included 31 published articles: total of 1135 eyes. Eyes were divided into the following groups: ILM peel (n: 683), ILM Flap (n: 233), macular hydrodissection (n: 64), hAM (n: 59), and ART (n: 96). The initial BCVA and size were heterogenous between the groups. ILM peel showed the best results in large FTMH ≤ 535 µm (closure rate 96.8%); adjusted mean BCVA: 0.49 (LogMAR) with a statistical difference among groups. Large FTMH between 535 and 799 µm: ILM flap technique showed better results (closure rate 99.0%); adjusted mean BCVA: 0.67(LogMAR); also with a statistical difference. For large FTMH ≥ 800 µm more invasive techniques are required. Use of hAM, macular hydrodissection and ART showed higher closure rates for this category (100%, 83.3% and 90.5% respectively), and adjusted mean BCVA varied from 0.76 to 0.89. Although there was no statistical difference between those techniques for this group due to the smaller number of cases. Conclusions The CLOSE study group demonstrated the potential usefulness of a new surgical classification for large FTMHs and propose OCT biomarkers for use in clinical practice and future research. This new classification demonstrated that Large (400–550 µm) and X-Large (550–800 µm) holes can be treated highly successfully with ILM peel and ILM flap techniques, respectively. Further studies are necessary for the larger FTMHs (XX-Large and Giant), using the CLOSE classification, in order to determine which technique is better suited for each hole size and characteristics.
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- 2023
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8. Long-term effectiveness and safety of infliximab and golimumab in ankylosing spondylitis patients from a Canadian prospective observational registry
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Proton Rahman, Michael Starr, Derek Haaland, Louis Bessette, Michelle Teo, Emmanouil Rampakakis, Allen J. Lehman, and Francois Nantel
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Ankylosing spondylitis ,Axial spondyloarthritis ,Registry ,Infliximab ,Golimumab ,Effectiveness ,Diseases of the musculoskeletal system ,RC925-935 - Abstract
Abstract Background The objectives of this study were to describe the profile of ankylosing spondylitis (AS) patients treated with either infliximab (IFX) or subcutaneous golimumab (GLM) treatment in Canadian routine care setting along with assessing long-term effectiveness and safety. Methods AS patients who were eligible for treatment with IFX or subcutaneous GLM as per their respective Canadian product monographs were enrolled into the BioTRAC registry from 2005 to 2017. The study visits occurred at baseline and every 6 months thereafter. Effectiveness was assessed by changes in clinical outcomes and acute phase reactants. Safety was evaluated by assessing the incidence of adverse events (AEs) and drug survival rates. Results A total of 389 IFX- and 421 GLM-treated patients were enrolled. A significant decrease in disease duration at baseline was observed in the IFX cohort, from a median of 8.0 in 2005–2008 to 1.0 years in 2009–2015 (p
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- 2020
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9. Long-term effectiveness and safety of infliximab, golimumab and golimumab-IV in rheumatoid arthritis patients from a Canadian prospective observational registry
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Proton Rahman, Philip Baer, Ed Keystone, Denis Choquette, Carter Thorne, Boulos Haraoui, Andrew Chow, Rafat Faraawi, Wojciech Olszynski, John Kelsall, Emmanouil Rampakakis, Allen J. Lehman, and Francois Nantel
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Rheumatoid arthritis ,Registry ,Infliximab ,Golimumab ,Effectiveness ,Safety ,Diseases of the musculoskeletal system ,RC925-935 - Abstract
Abstract Background Long-term clinical registries are essential tools to evaluate new therapies in a patient population that differs from those in randomized clinical trials. The objectives are to describe the profile of rheumatoid arthritis (RA) patients treated with anti-TNF agents in Canadian routine care. Methods RA patients eligible for treatment with Infliximab (IFX), golimumab (GLM) or intravenous golimumab (GLM-IV) as per their respective Canadian product monographs were enrolled into the BioTRAC registry between 2002 and 2017. Study visits occurred at baseline and every 6 months thereafter. Effectiveness was assessed by changes in disease activity. Safety was evaluated by the incidence of adverse events (AEs) and drug survival. Results Of the 890 IFX-, 530 GLM- and 157 GLM-IV-treated patients, the proportion of females ranged from 77.0–86.6%, the mean ages from 55.8–57.7 and the mean disease duration from 6.5–8.6 years. A significant decrease in baseline disease duration and disease activity parameters (DAS, TJC, SJC, HAQ, AM stiffness, MDGA, PtGA, CRP, ESR) was observed over time. Treatment with IFX, GLM- and GLM-IV significantly improved all disease parameters over time. The incidence of AEs was 105, 113 and 82.6 /100 PYs and the incidence of SAEs was 11.7, 11.2 and 4.68 /100 PYs for IFX, GLM- and GLM-IV-treated patients, respectively. Conclusion Differences in baseline characteristics between patients treated with an anti-TNFs over time shows the evolution of treatment modalities over time. All treatments significantly reduced disease activity and improved functionality in a similar fashion. The incidence of adverse events was consistent with the safety profiles of IFX and GLM. Trial registration ClinicalTrials.gov Identifier: NCT00741793 (Retrospectively registered on August 26, 2008).
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- 2020
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10. Endoscopy-assisted vitrectomy vs. vitrectomy alone: comparative study in complex retinal detachment with proliferative vitreoretinopathy
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Flavio A. Rezende, Natalia Vila, and Emmanouil Rampakakis
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Endoscopy-assisted vitrectomy ,Endoscopy-guided vitrectomy ,Endoscopic vitrectomy ,Proliferative vitreoretinopathy ,Retinal detachment ,Ophthalmology ,RE1-994 - Abstract
Abstract Background Recurrent retinal detachment (RD) is still a widespread event despite the therapeutic options available. Proliferative vitreoretinopoathy (PVR) is one of the main causes of redetachment. Little is known about the use of endoscopy-assisted vitrectomy (E-PPV) in complex recurrent RD with PVR. The purpose of this study was to identify the potential advantages of E-PPV in complex RD with PVR compared with pars plana vitrectomy (PPV) alone. Methods Single-center, retrospective, observational, descriptive study. The medical records of 293 patients were reviewed. Patients who underwent PPV for complex rhegmatogenous RD and associated PVR between 2009 and 2017 were included. Patients with diabetic tractional RD, trauma, uveitis or detachment postendophthalmitis were excluded. After 2013, an endoscopic visualization system was used in a nonrandomized fashion at the surgeon’s discretion. Outcome measures (reattachment rate, number of surgeries, lens status, PVR stage, intraocular pressure, phthisis rate) were compared between the E-PPV and PPV-only groups with independent samples t-tests (continuous variables) and Fisher’s exact test (categorical variables), as well as time-adjusted analyses. Postoperative time to retinal redetachment was assessed with Kaplan–Meier survival analysis. Results One hundred one eyes from 100 patients met the inclusion criteria. The mean participant age was 63.3 years old (95% CI 60.4–66.1 years), without a significant difference between groups. E-PPV was performed in 36.6% (n = 37) of eyes, and 63.4% (n = 64) underwent PPV only. The mean follow-up was significantly longer in the PPV-only group (31.9 vs. 21.1 months; p = 0.021). Upon adjustment for follow-up duration, the mean number of surgeries was significantly lower in the PPV-only group (2.6 vs. 4.3 number of surgeries; p 0.05). Conclusions Compared to PPV alone, endoscopy-assisted vitrectomy seems to be advantageous in achieving better reattachment rates in complex RD with advanced PVR. Endoscopic visualization allows a thorough examination and extensive anterior PVR and vitreous base dissection.
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- 2020
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11. Medical Cannabis Use by Rheumatology Patients Following Recreational Legalization: A Prospective Observational Study of 1000 Patients in Canada
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Mary‐Ann Fitzcharles, Emmanouil Rampakakis, John Sampalis, Yoram Shir, Martin Cohen, Michael Starr, and Winfried Häuser
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Diseases of the musculoskeletal system ,RC925-935 - Abstract
Objective Recreational legalization of cannabis may influence the medical use by patients. When only medical access was legally available in Canada, 4.3% of rheumatology patients reported use. With the current recreational legalization, we have reexamined the prevalence and characteristics of medical cannabis use in this same rheumatology setting. Methods Consecutively attending rheumatology patients participated in an onsite survey comprising the following two questionnaires: 1) demographic and disease information completed by the rheumatologist and 2) patient anonymous questionnaire of health status, cannabis use (recreational and/or medicinal), and characteristics of cannabis use. Results Of 1047 attendees from June to August 2019, with 1000 participating, medical cannabis had been used by 12.6% of patients (95% confidence interval 10.7%‐14.8%), with half continuing use for mostly pain relief. Discontinuation was due to lack of effect in 57% of patients and side effects in 28% of patients. Ever medical users were younger (61.2 vs. 64.9 years; P = 0.006), more likely unemployed/disabled (16.7% vs. 5.9%; P < 0.001), and had more previous (47.6% vs. 25.5%; P < 0.001) and current recreational cannabis use (17.5% vs. 3.1%; P < 0.001) than nonusers. Most patients used multiple methods of administration, including smoking, vaporizing, and using oral oil preparations, but were poorly knowledgeable of product content, which was bought solely via the legal medical route by only 20%, and only one‐third disclosed their use to the rheumatologist. Conclusion Medical cannabis use has tripled for rheumatology patients since recreational legalization, with users being younger, not working, and having recreational cannabis experience. Concerning issues are the poor knowledge of the product being used, access via the nonmedical route, and nondisclosure to the physician.
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- 2020
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12. Continuing Medical Education Improves Physician Communication Skills and Increases Likelihood of Pediatric Vaccination: Findings from the Pediatric Influenza Vaccination Optimization Trial (PIVOT)—II
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William A. Fisher, Vladimir Gilca, Michelle Murti, Alison Orth, Hartley Garfield, Paul Roumeliotis, Emmanouil Rampakakis, Vivien Brown, John Yaremko, Paul Van Buynder, Constantina Boikos, and James A. Mansi
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influenza ,childhood vaccination ,parental acceptance ,vaccine hesitancy ,education ,Medicine - Abstract
This study evaluated the impact of a continuing medical education (CME) program that emphasized actionable information, motivation to act, and skills to strengthen physician recommendations for seasonal influenza vaccination in children 6 through 23 months of age for whom influenza immunization rates are suboptimal. Physicians were randomly assigned to an accredited CME program or to no CME. Participants completed pre- and post-study questionnaires. Influenza immunization rates were compared between groups. A total of 33 physicians in the CME group and 35 in the control group documented 292 and 322 healthy baby visits, respectively. Significantly more parents immunized their children against influenza after interacting with CME-trained physicians than those with no CME training (52.9% vs. 40.7%; p = 0.007). The odds ratio for vaccination after visits with CME-trained physicians was 1.52 (95% confidence interval 1.09 to 2.12; p = 0.014), which was unaffected by the socioeconomic status of parents. Parents who discussed influenza vaccination with CME-trained physicians were 20% more likely to choose an approved but publicly unfunded adjuvanted pediatric influenza vaccine. The percentages of physicians reporting the highest levels of knowledge, ability, and confidence doubled or tripled after the CME intervention. Significantly more parents immunized very young children after interacting with physicians who had undergone CME training.
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- 2022
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13. Clinicians Are Not Able to Infer Parental Intentions to Vaccinate Infants with a Seasonal Influenza Vaccine, and Perhaps They Should Not Try: Findings from the Pediatric Influenza Vaccination Optimization Trial (PIVOT)–IV
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William A. Fisher, Vladimir Gilca, Michelle Murti, Alison Orth, Hartley Garfield, Paul Roumeliotis, Emmanouil Rampakakis, Vivien Brown, John Yaremko, Paul Van Buynder, Constantina Boikos, and James A. Mansi
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influenza ,childhood vaccination ,parental acceptance ,vaccine hesitancy ,education ,Medicine - Abstract
This prospective cohort survey evaluated the concordance of clinicians’ perceptions of parental intentions and parents’ actual intentions to vaccinate their infants against influenza. During a routine healthy baby visit, clinicians provided parents with information about influenza, children’s vulnerability to influenza, and nonadjuvanted and adjuvanted trivalent influenza vaccines (TIV and aTIV, respectively). Before and after the clinician–parent interaction, parents were surveyed about their attitudes, their perceptions of support from significant others, and the intention to vaccinate their infant with aTIV. Clinicians were asked about their perception of parents’ intentions to choose aTIV for their children. These assessments included 24 clinicians at 15 community practices and nine public health clinics, and 207 parents. The correlation coefficients of the clinicians’ assessment of parents’ intention to vaccinate were 0.483 (p < 0.001) if the vaccine was presented as free of cost, 0.266 (p < 0.001) if the cost was $25, and 0.146 (p = 0.036) if the cost was $50, accounting for 23%, 7%, and 2% of the variance in parental intentions, respectively. The clinicians were poor at predicting parental intentions to immunize, particularly when cost was involved. Information on vaccine options and influenza infection should be provided for every eligible patient to allow parents to determine if the vaccine is appropriate for their child.
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- 2022
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14. Parental Attitudes and Perceptions of Support after Brief Clinician Intervention Predict Intentions to Accept the Adjuvanted Seasonal Influenza Vaccination: Findings from the Pediatric Influenza Vaccination Optimization Trial (PIVOT)–I
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William A. Fisher, Vladimir Gilca, Michelle Murti, Alison Orth, Hartley Garfield, Paul Roumeliotis, Emmanouil Rampakakis, Vivien Brown, John Yaremko, Paul Van Buynder, Constantina Boikos, and James A. Mansi
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adjuvanted ,immunization ,influenza ,pediatric ,parental acceptance ,vaccine hesitancy ,Medicine - Abstract
Adjuvanted trivalent influenza vaccine (aTIV) provides enhanced protection against seasonal influenza in children compared with nonadjuvanted trivalent influenza vaccine (TIV). This prospective cohort study assessed parental attitudes, beliefs, and intentions to vaccinate their infants aged 6–23 months with aTIV. Parents were surveyed before and after routine healthy baby visits, and post clinician interaction results were analyzed using multivariable logistic regression. Physicians at 15 community practice clinics and nurses at 3 public health clinics participated; 207 parents were surveyed. After clinician consultation, most parents considered immunization with aTIV to be safe (72.9%), effective (69.6%), and important (69.0%); most perceived support for vaccination from significant others (62.8%) and clinicians (81.6%); and 66.6% intended to vaccinate their infant with aTIV. Parental attitudes toward vaccinating their infant with aTIV were strongly correlated with perceptions of vaccine safety, efficacy, and importance, and these represented the strongest influence on intentions to vaccinate (odds ratio (OR) 79.25; 95% confidence interval (CI) 6.05–1037.50). Parental intentions were further influenced by perceived strength of clinician recommendation (OR 4.55, 95% CI 1.38–15.06) and social support for vaccination (OR 3.46, 95% CI 0.50–24.13). These findings may inform clinician approaches to parental education to ensure optimal seasonal pediatric influenza vaccination.
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- 2022
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15. Understanding the Impact of Approved but Unfunded Vaccine Status on Parental Acceptance of an Adjuvanted Seasonal Influenza Vaccine for Infants: Results from the Pediatric Influenza Vaccination Optimization Trial (PIVOT)–III
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William A. Fisher, Vladimir Gilca, Michelle Murti, Alison Orth, Hartley Garfield, Paul Roumeliotis, Emmanouil Rampakakis, Vivien Brown, John Yaremko, Paul Van Buynder, Constantina Boikos, and James A. Mansi
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approved vaccine ,unfunded vaccine ,parental acceptance ,vaccine hesitancy ,influenza ,Medicine - Abstract
The adjuvanted trivalent influenza vaccine (aTIV) provides enhanced protection against influenza for infants but is not publicly funded (NPF). The objective of this prospective cohort study of parents with children 6 through 23 months of age was to understand how NPF status influences parental perceptions of approved but unfunded vaccines and their intentions to vaccinate. At healthy baby visits, clinicians provided parents with information about influenza and vaccination. Before and after these interactions, a research nurse assessed parents’ intentions to vaccinate their children and their beliefs about the safety, efficacy, and necessity of vaccinating their children with aTIV in both publicly funded (PF) and NPF settings. Overall, 15 community practice clinics (n = 15 physicians) and nine public health clinics (n = 9 nurses) recruited 207 parents. The percentage of parents intending to immunize their children with aTIV decreased from 72% (vaccine PF, free of charge), to 42% (NPF, $25 per dose), to 27% (NPF, $50 per dose). Funding status strongly influenced whether parents perceived immunization with aTIV to be necessary, safe, and effective. Information on influenza and influenza vaccines should be provided to parents routinely to allow for well-informed decisions on the suitability of specific influenza vaccines for their child.
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- 2022
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16. High Frequency of COVID-19 Vaccine Hesitancy among Canadians Immunized for Influenza: A Cross-Sectional Survey
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Valeria Valerio, Emmanouil Rampakakis, Theodoros P. Zanos, Todd J. Levy, Hao Cheng Shen, Emily G. McDonald, Charles Frenette, Sasha Bernatsky, Marie Hudson, Brian J. Ward, and Inés Colmegna
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vaccines ,vaccine hesitancy ,COVID-19 infection ,immunization ,vaccination ,Medicine - Abstract
We assessed the frequency and correlates of COVID-19 vaccine hesitancy before Canada’s vaccine rollout. A cross-sectional vaccine hesitancy survey was completed by consecutive patients/family members/staff who received the influenza vaccine at McGill University affiliated hospitals. Based on the self-reported likelihood of receiving a future vaccine (scale 0–10), the following three groups were defined: non-hesitant (score 10), mildly hesitant (7.1–9.9), and significantly hesitant (0–7). Factors associated with vaccine hesitancy were assessed with multivariate logistic regression analyses and binomial logistic regression machine learning modelling. The survey was completed by 1793 people. Thirty-seven percent of participants (n = 669) were hesitant (mildly: 315 (17.6%); significantly: 354 (19.7%)). Lower education levels, opposition and uncertainty about vaccines being mandatory, feelings of not receiving enough information about COVID-19 prevention, perceived social pressure to get a future vaccine, vaccine safety concerns, uncertainty regarding the vaccine risk-benefit ratio, and distrust towards pharmaceutical companies were factors associated with vaccine hesitancy. Vaccine safety concerns and opposition to mandatory vaccinations were the strongest correlates of vaccine hesitancy in both the logistic regressions and the machine learning model. In conclusion, in this study, over a third of people immunized for influenza before the COVID-19 vaccine rollout expressed some degree of vaccine hesitancy. Effectively addressing COVID-19 vaccine safety concerns may enhance vaccine uptake.
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- 2022
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17. The use of antibiotics in the treatment of pediatric varicella patients: real-world evidence from the multi-country MARVEL study in Latin America & Europe
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Lara J. Wolfson, Marìa Esther Castillo, Norberto Giglio, Zsófia Mészner, Zsuzsanna Molnár, Mirella Vàzquez, Jacek Wysocki, Alexandra Altland, Barbara J. Kuter, Melissa Stutz, Emmanouil Rampakakis, and Craig S. Roberts
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Varicella ,Pediatrics ,Antimicrobial stewardship ,Observation study ,Public aspects of medicine ,RA1-1270 - Abstract
Abstract Background Varicella is a highly contagious childhood disease. Generally benign, serious complications necessitating antibiotic use may occur. The objective of this study was to characterize the rate, appropriateness and patterns of real-world antibiotic prescribing for management of varicella-associated complications, prior to universal varicella vaccination (UVV) implementation. Methods Pooled, post-hoc analysis of 5 international, multicenter, retrospective chart reviews studies (Argentina, Hungary, Mexico, Peru, Poland). Inpatient and outpatient primary pediatric (1–14 years) varicella cases, diagnosed between 2009 and 2016, were eligible. Outcomes, assessed descriptively, included varicella-associated complications and antibiotic use. Three antibiotic prescribing scenarios were defined based on complication profile in chart: evidence of microbiologically confirmed bacterial infection (Scenario A); insufficient evidence confirming microbiological confirmation (Scenario B); no evidence of microbiological confirmation (Scenario C). Stratification was performed by patient status (inpatient vs. outpatient) and country. Results Four hundred one outpatients and 386 inpatients were included. Mean (SD) outpatient age was 3.6 (2.8) years; inpatient age was 3.1 (2.8) years. Male gender was predominant. Overall, 12.2% outpatients reported ≥1 infectious complication, 3.7% ≥1 bacterial infection, and 0.5% ≥1 microbiologically confirmed infection; inpatient complication rates were 78.8, 33.2 and 16.6%, respectively. Antibiotics were prescribed to 12.7% of outpatients and 68.9% of inpatients. Among users, β-lactamases (class), and clindamycin (agent), dominated prescriptions. Scenario A was assigned to 3.9% (outpatients) vs 13.2% (inpatients); Scenario B: 2.0% vs. 6.0%; Scenario C: 94.1% vs. 80.8%. Conclusions High rates of infectious complications and antibiotic use are reported, with low rates of microbiological confirmation suggesting possible antibiotic misuse for management of varicella complications.
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- 2019
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18. Varicella healthcare resource utilization in middle income countries: a pooled analysis of the multi-country MARVEL study in Latin America & Europe
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Lara J. Wolfson, Maria Esther Castillo, Norberto Giglio, Zsofia Meszner, Zsuzsanna Molnar, Mirella Vazquez, Jacek Wysocki, Alexandra Altland, Barbara J. Kuter, Jenaya Rickard, and Emmanouil Rampakakis
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varicella ,pediatrics ,healthcare resource utilization (hcru) ,costs ,multi-country ,Immunologic diseases. Allergy ,RC581-607 ,Therapeutics. Pharmacology ,RM1-950 - Abstract
Varicella is a mild and self-limited illness in children, but can result in significant healthcare resource utilization (HCRU). To quantify/contrast varicella-associated HCRU in five middle-income countries (Hungary, Poland, Argentina, Mexico, and Peru) where universal varicella vaccination was unimplemented, charts were retrospectively reviewed among 1–14 year-olds. Data were obtained on management of primary varicella between 2009–2016, including outpatient/inpatient visits, allied healthcare contacts, tests/procedures, and medications. These results are contrasted across countries, and a regression model is fit to extrapolated country-level costs as a function of gross domestic product (GDP). A total of 401 outpatients and 386 inpatients were included. Significant differences between countries were observed in the number of skin lesions among outpatients, ranging from 5.3% to 25.4% of patients with ≥250 lesions. Among inpatients, results were less variable. Average ambulatory medical visits ranged from 1.1 to 2.2. Average hospital stay ranged from 3.6 to 6.8 days. Use of tests/procedures was infrequent in outpatients, except in Argentina (13.3%); among inpatients, a test/procedure was ordered for 81.3% of patients, without regional variation. Prescription medications were administered in 44.4% of outpatients (range 9.3%–80.0%), and in 86% of inpatients (range 70.4%–94.9%). Total estimated spending on varicella treatment in the absence of vaccination was predicted from income levels (GDP) with an exponential function (R2 = 0.89). This study demonstrates that substantial HCRU is associated with varicella resulting in significant public health burden that could be alleviated through the use of varicella vaccination. Differences observed between countries possibly reflect treatment guidelines, healthcare resource availabilities and physician practices.
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- 2019
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19. Real-life assessment of aripiprazole monthly (Abilify Maintena) in schizophrenia: a Canadian naturalistic non-interventional prospective cohort study
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Sally Mustafa, Joanna Bougie, Maia Miguelez, Guerline Clerzius, Emmanouil Rampakakis, Jean Proulx, and Ashok Malla
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Long acting injectable antipsychotics ,Aripiprazole once-monthly ,Global functioning ,Adherence ,Schizophrenia ,Psychiatry ,RC435-571 - Abstract
Abstract Background With previously established efficacy of aripiprazole once-monthly injectable formulation (AOM) in pre-registration randomized controlled trials, the current study was designed to evaluate its effectiveness in patients treated for schizophrenia in regular clinical settings in Canada. Methods Following their clinicians’ decision to prescribe AOM, 193 patients with a diagnosis of schizophrenia, were recruited from 17 Canadian community or hospital-based settings. The primary outcome of global functioning was assessed with the Global Assessment of Functioning Scale (GAF) at 3-month intervals for 1 year. Secondary outcomes (social and occupational functioning and illness severity) and adverse drug reactions (ADR) were also assessed. Results A majority of the 169 evaluable patients were within the first 5 years of diagnosis (early phase). A linear mixed model analysis showed a significant main effect of time (Type III test p
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- 2019
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20. Post Hoc Analysis of the CONFIDENCE II, PROTECT I, SHAKE THE HABIT I and SHAKE THE HABIT II Observational Studies in Mild to Moderate Hypertensive Patients Treated with Perindopril and Atorvastatin Concomitantly
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John S. Sampalis, Eliofotisti Psaradellis, Melissa Stutz, Jenaya Rickard, and Emmanouil Rampakakis
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Therapeutics. Pharmacology ,RM1-950 - Abstract
Abstract Background and Objectives Management of hypertension and dyslipidemia is important when considering cardiovascular disease risk; however, achievement of optimal lipid and blood pressure (BP) targets in clinical practice remains inadequate. This analysis sought to estimate the frequency, effectiveness, and safety of co-administrated atorvastatin and perindopril in routine care. Methods We conducted a post hoc analysis of four Canadian, prospective, multi-center, observational studies assessing real-life effectiveness and safety of perindopril + atorvastatin in mild-to-moderate hypertensive patients with concomitant dyslipidemia over 16 weeks. The safety population comprised patients receiving one or more doses of free combination perindopril + atorvastatin; the full analysis set (FAS) received perindopril + atorvastatin at baseline, with one or more post-baseline systolic BP measurements while on treatment. Results A total of 3541 and 3172 patients were included in the safety population and FAS, respectively. At the last observation carried forward, significant reductions in mean systolic BP (− 18.0 mmHg; p
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- 2018
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21. Myelination may be impaired in neonates following birth asphyxia
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Bianca Olivieri, Emmanouil Rampakakis, Guillaume Gilbert, Aliona Fezoua, and Pia Wintermark
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Asphyxia ,Brain ,Hypothermia ,Magnetic resonance imaging ,Myelination ,Neonate ,Computer applications to medicine. Medical informatics ,R858-859.7 ,Neurology. Diseases of the nervous system ,RC346-429 - Abstract
Background: Myelination is a developmental process that begins during the end of gestation, intensifies after birth over the first years of life, and continues well into adolescence. Any event leading to brain injury around the time of birth and during the perinatal period, such as birth asphyxia, may impair this critical process. Currently, the impact of such brain injury related to birth asphyxia on the myelination process is unknown. Objective: To assess the myelination pattern over the first month of life in neonates with neonatal encephalopathy (NE) developing brain injury, compared to neonates without injury (i.e., healthy neonates and neonates with NE who do not develop brain injury). Methods: Brain magnetic resonance imaging (MRI) was performed around day of life 2, 10, and 30 in healthy neonates and near-term/term neonates with NE who were treated with hypothermia. We evaluated myelination in various regions of interest using a T2* mapping sequence. In each region of interest, we compared the T2* values of the neonates with NE with brain injury to the values of the neonates without injury, according to the MRI timing, by using a repeated measures generalized linear mixed model. Results: We obtained 74 MRI scans over the first month of life for 6 healthy neonates, 17 neonates with NE who were treated with hypothermia and did not develop brain injury, and 16 neonates with NE who were treated with hypothermia and developed brain injury. The T2* values significantly increased in the neonates with NE who developed injury in the posterior limbs of the internal capsule (day 2: p
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- 2021
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22. Long-term effectiveness and safety of infliximab, golimumab and ustekinumab in patients with psoriatic arthritis from a Canadian prospective observational registry
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Emmanouil Rampakakis, Majed Khraishi, Maqbool Sheriff, Dalton Sholter, Allen J Lehman, François Nantel, and Regan Arendse
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Medicine - Published
- 2020
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23. A phase IIa proof-of-concept, placebo-controlled, randomized, double-blind, crossover, single-dose clinical trial of a new class of bronchodilator for acute asthma
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Veronica Swystun, Francis H. Y. Green, John H. Dennis, Emmanouil Rampakakis, Gurkeet Lalli, Morenike Fadayomi, Andrea Chiu, Grishma Shrestha, Sharif Galal El Shahat, David Evan Nelson, Tamer Y. El Mays, Cora A. Pieron, and Richard Leigh
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Novel bronchodilator ,Asthma ,S1226 ,Carbon dioxide (CO2) ,Perflubron ,Clinical trial ,Medicine (General) ,R5-920 - Abstract
Abstract Background This study evaluates a novel bronchodilator, S1226, for its efficacy in reversing allergen-induced bronchoconstriction in subjects with mild, allergic asthma. S1226 is a new class of bronchodilator that is an aerosol/vapor/gas mixture combining pharmacological and biophysical principles for a novel mode of action. It contains a potent bronchodilator gas (carbon dioxide or CO2) and nebulized perflubron (a synthetic surfactant possessing mucolytic properties). It has demonstrated rapid reversal of allergen-induced bronchoconstriction in an ovine study model. Methods This was a phase IIa proof-of-concept, placebo-controlled, randomized, double-blind, crossover single-dose clinical trial to evaluate the safety, tolerability, and efficacy of S1226 (8% CO2) administered by nebulization following an allergen-induced early asthmatic response in 12 subjects with mild, allergic asthma. Primary safety endpoints were adverse events, vital signs, pulse oximetry, and spirometry. Efficacy endpoints included bronchodilator response (measured as the forced expiratory volume in 1 s or FEV1) over time, the area under the curve of FEV1 for the early asthmatic response over time, and achievement of responder status, defined as a 12% improvement after the allergen challenge. Results No significant safety issues were observed. All adverse events were non-serious, mild, and transient. There was a statistically significant decrease in peripheral blood oxygenation levels over time in the placebo group following allergen inhalation, whereas blood oxygenation was maintained at normal levels in the S1226-treated subjects (P = 0.028). This effect was greatest 5 min after start of treatment (P
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- 2018
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24. Varicella in Poland: economic burden in children 1–12 years of age in Poland, 2010–2015
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Jacek Wysocki, Ilona Malecka, Joanna Stryczynska-Kazubska, Emmanouil Rampakakis, Barbara Kuter, and Lara J. Wolfson
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Varicella ,Burden of illness ,Vaccination ,Retrospective studies ,Pediatric ,Varicella vaccine ,Public aspects of medicine ,RA1-1270 - Abstract
Abstract Background The safety and efficacy of live-attenuated varicella zoster virus (VZV) vaccines in preventing varicella and reducing associated morbidity and mortality in real-world have been previously shown. In Poland, VZV vaccination is only mandatory for certain high-risk individuals. Here, we have conducted an evaluation of the clinical and economic burden of varicella in Poland. Methods Multicenter, retrospective chart review of varicella inpatients and outpatients aged 1–12 years with a primary diagnosis between 2010 and 2015. Varicella-related outcomes included the incidence of complications, the proportion of patients reporting healthcare resource utilization (HCRU), and frequency of HCRU. Direct costs were derived from per patient resource use multiplied by unit costs, and indirect costs were calculated as loss of revenue of caregivers reporting work days missed. The overall annual cost of varicella in Poland was estimated based on the calculated direct and indirect costs per case and the estimated number of varicella cases. All costs are presented in 2015 Polish złoty (PLN) / Euros (€). Results A total of 150 children with varicella were included, of which 75 were outpatients and 75 were inpatients with a mean (± SD) age of 3.9 (±2.6) and 4.2 (±2.3) years, respectively. Complications were experienced by 14.7% of outpatients and 82.7% of inpatients, of which the most common were skin and soft tissue infections and dehydration. The rate of HCRU was as follows: over-the-counter medications (80.0% outpatients, 81.3% inpatients), prescription medications (80.0% outpatients, 93.3% inpatients), tests/procedures (0.0% outpatients, 69.3% inpatients), and allied health professional consults (0.0% outpatients, 24.0% inpatients). Total (direct and indirect) cost per varicella case was 5013.3 PLN (€ 1198.1) for inpatients and 1027.2 PLN (€ 245.5) for outpatients, resulting in an estimated overall annual (2015) cost of varicella in Poland of 178,198,320 PLN (€ 42,588,385) among children aged 1–15 years. Conclusions Significant clinical and economic burden is associated with varicella in Poland. These results may be used to foster discussion related to the implications of implementing routine VZV vaccination in Poland.
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- 2018
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25. Economic Burden of Herpes Zoster ('culebrilla') in Latin America
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Emmanouil Rampakakis, Clare Pollock, Claudia Vujacich, Joao Toniolo Neto, Alejandro Ortiz Covarrubias, Homero Monsanto, and Kelly D. Johnson
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Herpes zoster ,burden of disease ,healthcare cost ,Latin America ,Infectious and parasitic diseases ,RC109-216 - Abstract
Background: Herpes zoster (HZ) is characterized by debilitating pain and blistering dermatomal rash. The most common complication of HZ is postherpetic neuralgia (PHN), a persistent pain that can substantially affect patients’ quality of life. HZ has significant impact on patients’ lives with considerable implications for healthcare systems and society. The purpose of this study was to evaluate the healthcare resource utilization (HCRU) and medical costs associated with HZ in Latin America. Method: We conducted a pooled-analysis of three prospective cohort studies of HZ patients ≥50 years of age in Argentina (n = 96); Brazil (n = 145) and Mexico (n = 142). Patients were recruited at different time-points during their HZ episode and were followed for six months. The incidence of PHN was defined as a worst ZBPI pain score of ≥3, persisting or appearing more than 90 days after the onset of rash. Work effectiveness was measured on a 100-point Likert scale where 100 was described as completely effective (able to work like before HZ began) and 0 as not effective at all. Direct costs included costs due to use of antiviral medications and all medical services used to treat HZ. Indirect cost was based on foregone earnings from patients due to work loss and presenteeism, and work loss by family caretakers. One-way sensitivity analysis was performed to assess the impact on total costs. All costs are reported in 2015 USD currency. Results: 383 HZ patients were included and PHN incidence was 38.6%. The most commonly used resources were visits to the doctor’s office (79.1% of patients), the emergency room (48.8%) and a specialist (37.9%); hospitalization was reported for 5.7% of patients. The overall direct cost per case was $763.19 USD, indirect cost was $701.40, for a total of $1,464.59 per HZ episode in Latin America. Total cost associated with HZ in patients with PHN was markedly higher compared to patients without PHN ($2,001.13 vs. $867.72, respectively) with indirect costs accounting for the most part of this difference. The sensitivity analysis was generally robust to changes in the assumptions made. Conclusion: HZ and its sequelae impose a substantial economic burden in Latin America which is expected to rise as the population ages and the number of HZ cases increases. The results support the need for early intervention, preventative strategies and improved disease management to reduce the HZ-associated disease burden in Latin America.
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- 2017
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26. Measuring herpes zoster disease burden in São Paulo, Brazil: a clinico-epidemiological single-center study
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João Toniolo-Neto, Eliofotisti Psaradellis, Angela Karellis, Emmanouil Rampakakis, Talita Y. Rockett, John S. Sampalis, Kelly D. Johnson, Homero A. Monsanto, and Camilo J. Acosta
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Herpes Zoster ,Observational Study ,Brazil ,Pain ,Medicine (General) ,R5-920 - Abstract
OBJECTIVES: Herpes zoster is characterized by acute neuritis and post-herpetic neuralgia. Currently, data concerning the zoster-associated impact on quality of life and healthcare resource utilization in Brazil are scarce. This study measured the zoster-associated burden in a Brazilian population. METHODS: This was a prospective, observational, single-cohort study conducted in a primary hospital’s emergency room in São Paulo, Brazil. Patients enrolled at various timepoints during a zoster episode were followed over 180 days. The Zoster Brief Pain Inventory and the Initial Zoster Impact Questionnaire assessed zoster-associated pain. The EuroQoL assessed the impact of herpes zoster and/or zoster-associated pain on quality of life. Healthcare resource utilization was assessed by patient-reported questionnaires. RESULTS: One-hundred forty-six zoster patients were enrolled [mean (SD) age of 69.9 (10.9) years]. Mean (SD) worst pain scores decreased from 5.3 (3.5) at baseline to 1.9 (3.0) 180 days following rash onset. Mean (SD) EuroQoL scores significantly decreased from 0.9 (0.2) before rash appearance to 0.7 (0.2) after rash onset (p
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- 2018
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27. Predictors of postherpetic neuralgia in patients with herpes zoster: a pooled analysis of prospective cohort studies from North and Latin America and Asia
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Kosuke Kawai, Emmanouil Rampakakis, Tsen-Fang Tsai, Hee Jin Cheong, Jittima Dhitavat, Alejandro Ortiz Covarrubias, Lin Yang, Miguel Cashat-Cruz, Homero Monsanto, Kelly Johnson, John S. Sampalis, and Camilo J. Acosta
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Herpes zoster ,Postherpetic neuralgia ,Predictors ,North America ,Latin America ,Asia ,Infectious and parasitic diseases ,RC109-216 - Abstract
Objectives: The most common complication of herpes zoster (HZ) is postherpetic neuralgia (PHN), a persistent pain that can substantially affect quality of life (QoL). This analysis aimed to evaluate predictors of PHN in HZ patients. Methods: A pooled analysis of prospective cohort studies of HZ patients aged ≥50 years from North America (Canada), Latin America (Brazil, Mexico, and Argentina), and Asia (Taiwan, South Korea, and Thailand) was performed. Patients within 14 days of rash onset were included. The incidence of PHN was defined as a worst pain score of ≥3, persisting/appearing at >90 days after rash onset. Socio-demographics, HZ disease characteristics, treatment, pain-related interference with activities of daily living, and health-related QoL were assessed. Results: Of 702 patients with HZ, 148 (21.1%) developed PHN. Similar risks of PHN were observed across geographic regions. On multivariate analysis, older age, greater severity of pain at rash onset, employment status, walking problems at enrollment, and pain interference affecting social relationships were significantly associated with the development of PHN. Conclusions: In addition to older age and severe acute pain, this study suggests that impaired physical and social functioning from acute zoster pain may play a role in the development of PHN in this prospective cohort study of HZ patients from North and Latin America and Asia.
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- 2015
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28. Biologic Treatment Registry Across Canada (BioTRAC): a multicentre, prospective, observational study of patients treated with infliximab for ankylosing spondylitis
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Emmanouil Rampakakis, John S Sampalis, Susan Otawa, Proton Rahman, Michel Zummer, Andrew Chow, May Shawi, Majed Khraishi, Denis Choquette, William G Bensen, Saeed Shaikh, Maqbool Sheriff, Sanjay Dixit, Dalton Sholter, Eliofotisti Psaradellis, Vincent Letourneau, Allen J Lehman, and François Nantel
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Medicine - Abstract
Objectives To describe the profile of patients with ankylosing spondylitis (AS) treated with infliximab in Canadian routine care and to assess the effectiveness and safety of infliximab in real world.Setting 46 primary care rheumatology practices across Canada.Participants 303 biological-naïve patients with AS or patients previously treated with a biological for
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- 2016
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29. The McGill University Health Centre Cancer Pain Clinic: A Retrospective Analysis of an Interdisciplinary Approach to Cancer Pain Management
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Jordi Perez, Sara Olivier, Emmanouil Rampakakis, Manuel Borod, and Yoram Shir
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Medicine (General) ,R5-920 - Abstract
Context. The McGill University Health Center (MUHC) Cancer Pain Clinic offers an interdisciplinary approach to cancer pain management for patients. The core team includes a nurse clinician specialist in oncology and palliative care, a palliativist, an anaesthetist, and a radiation oncologist. This tailored approach includes pharmacological and nonpharmacological therapies offered concurrently in an interdisciplinary fashion. Objectives. Description of the interdisciplinary MUHC cancer pain approach and analysis of treatments and outcomes. Methods. A retrospective analysis of new outpatients completing two subsequent visits (baseline and follow-ups: FU1, FU2) was conducted. Variables included (a) symptom severity measured by the Edmonton Symptom Assessment Scale, (b) pain and disability measured with the Brief Pain Inventory, and (c) analgesic plan implementation including pharmacological and nonpharmacological therapies. Results. 71 charts were reviewed. Significant pain relief was achieved consistently at FU1 and FU2. The average pain severity decreased by 2 points between initial assessment and FU2. More than half (53%) of patients responded with a pain reduction greater than 30%. Severity of other symptoms (i.e., fatigue, nausea, depression, and anxiety) and disability also decreased significantly at FU2. The total consumption of opioids remained stable; however, the consumption of short acting preparations decreased by 52% whereas the prescription of nonopioid agents increased. Beyond drug management, 60% of patients received other analgesic therapies, being the most common interventional pain procedures and psychosocial approaches. Conclusion. The MUHC interdisciplinary approach to cancer pain management provides meaningful relief of pain and other cancer-related symptoms and decreases patients’ disability.
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- 2016
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30. Monoallelic chromatin conformation flanking long-range silenced domains in cancer-derived and normal cells.
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Domenic Di Paola, John Raelson, Emmanouil Rampakakis, Mark Basik, Maria Zannis-Hadjopoulos, and W Edward C Bradley
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Medicine ,Science - Abstract
Epigenetic inactivation of chromatin plays an important role in determining cell phenotype in both normal and cancer cells, but our knowledge is still incomplete with respect to any potential monoallelic nature of the phenomenon. We have genotyped DNA isolated from chromatin of two colorectal cancer-derived lines and a culture of normal human intestinal epithelial cells (HIEC), which was immunoprecipitated with antibodies to acetylated vs. methylated histone H3K9, and presented the data as B allele frequency differences over multiple single-nucleotide polymorphism (SNP) moving window averages. [B allele is an arbitrary term defined as one of the two alleles at any given SNP, named A and B]. Three different validation tests confirmed that peaks exhibiting differences represented monoallelic domains. These complementary tests confirmed the following: 1) genes in the regions of high B allele frequency difference were expressed monoallelically; 2) in normal cells all five imprinting control regions which carried heterozygous SNPs were characterized by B allele difference peaks; and 3) the haplotypes in the B allele difference peaks were faithfully maintained in the chromatin immunoprecipitated with the respective antibodies. In both samples most of the monoallelic domains were found at the boundaries between regions of open and closed chromatin. With respect to the cancer line, this supports the established concept of conformation spreading, but the results from the normal cells were unexpected. Since these cells were polyclonal, the monoallelic structures were probably not determined by random choice as occurs in X-inactivation, so we propose that epigenetic inactivation in some domains may be heritable and polymorphic in normal human cells.
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- 2013
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31. A Randomized Trial Assessing the Effectiveness of Ezetimibe in South Asian Canadians with Coronary Artery Disease or Diabetes: The INFINITY Study
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Mina Madan, Tasnim Vira, Emmanouil Rampakakis, Anup Gupta, Anil Khithani, Lyn Balleza, Julie Vaillancourt, Stella Boukas, John Sampalis, and Emidio de Carolis
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Public aspects of medicine ,RA1-1270 - Abstract
Background. There is a paucity of data regarding the effectiveness and safety of lipid-lowering treatments among South-Asian patients. Methods. Sixty-four South-Asian Canadians with coronary artery disease or diabetes and persistent hypercholesterolemia on statin therapy, were randomized to ezetimibe 10 mg/day co-administered with statin therapy (EZE + Statin) or doubling their current statin dose (STAT2). Primary outcome was the proportion of patients achieving target LDL-C (
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- 2012
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32. Pilot, randomized study assessing safety, tolerability and efficacy of simplified LPV/r maintenance therapy in HIV patients on the 1 PI-based regimen.
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Pedro Cahn, Julio Montaner, Patrice Junod, Patricia Patterson, Alejandro Krolewiecki, Jaime Andrade-Villanueva, Isabel Cassetti, Juan Sierra-Madero, Arnaldo David Casiró, Raul Bortolozzi, Sergio Horacio Lupo, Nadia Longo, Emmanouil Rampakakis, Nabil Ackad, and John S Sampalis
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Medicine ,Science - Abstract
To compare the efficacy and safety of an individualized treatment-simplification strategy consisting of switching from a highly-active anti-retroviral treatment (HAART) with a ritonavir-boosted protease inhibitor (PI/r) and 2 nucleoside reverse-transcriptase inhibitors (NRTIs) to lopinavir/ritonavir (LPV/r) monotherapy, with intensification by 2 NRTIs if necessary, to that of continuing their HAART.This is a one-year, randomized, open-label, multi-center study in virologically-suppressed HIV-1-infected adults on their first PI/r-containing treatment, randomized to either LPV/r-monotherapy or continue their current treatment. Treatment efficacy was determined by plasma HIV-1 RNA viral load (VL), time-to-virologic rebound, patient-reported outcomes (PROs) and CD4+T-cell-count changes. Safety was assessed with the incidence of treatment-emergent adverse events (AE).Forty-one patients were randomized to LPV/r and 39 to continue their HAART. No statistically-significant differences between the two study groups in demographics and baseline characteristics were observed. At day-360, 71(39:LPV/r;32:HAART) patients completed treatment, while 9(2:LPV/r;7:HAART) discontinued. In a Last Observation Carried Forward Intent-to-Treat analysis, 40(98%) patients on LPV/r and 37(95%) on HAART had VL
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- 2011
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33. P176 Minimal important difference, minimal detectable change and disease activity thresholds for two novel composite instruments, three visual analogue scale/VAS and four visual analogue scale/VAS, in patients with psoriatic arthritis: pooled analysis of three phase III studies
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William Tillett, Laura Coates, Marijn Vis, Joseph Merola, Enrique Soriano, Michelle Perate, May Shawi, Miriam Zimmermann, Emmanouil Rampakakis, Mohamed Sharaf, Peter Nash, and Philip S Helliwell
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Rheumatology ,Pharmacology (medical) - Abstract
Background/Aims Although continuous composite measures of disease activity for PsA assessment exist, more feasible abbreviated measures are needed for routine screening. The 3VAS and 4VAS scores, developed by abridging the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Composite Exercise (GRACE) measure, are the first short multidimensional composite measures specifically for routine PsA care. 3VAS/4VAS showed superior performance vs. several established composite measures using small datasets. However, GRAPPA members recommended further testing of 3VAS/4VAS in observational and trial datasets. Methods This post hoc analysis used pooled data through W24 from all treatment groups in the DISCOVER 1/2 and COSMOS studies. Correlation of 3VAS/4VAS with DAPSA, PASDAS, PhGA and PtGA was assessed with Pearson’s correlation coefficient, minimal important difference (MID) with four distribution-based methods and minimal detectable change (MDC) with the standard formula (Table 1). Clinically relevant thresholds for low, moderate and high disease activity were estimated with receiver operating characteristic analysis and DAPSA (≤4, >4-≤14, >14-≤28, >28), PASDAS (≤1.9, >1.9-≤3.2, >3.2-1-≤3, >3-≤6, >6 cm) as anchors. Results This analysis included 1405 patients: 51.3% were male, with a mean (sd) age of 47.1 (11.8) and PsA duration of 6.4 (6.5) years. The mean baseline 3VAS, 4VAS, DAPSA, PASDAS, PhGA and PtGA scores reflected high disease activity levels (Table 1). Through W24, 3VAS and 4VAS showed very strong correlation with PtGA (r3VAS=0.92, r4VAS=0.94) and PASDAS (r3VAS=0.81, r4VAS=0.82), strong with PhGA (r3VAS=0.77, r4VAS=0.74) and moderate-to-strong with DAPSA (r3VAS=0.59, r4VAS=0.61). Calculated MIDs were 0.9 for 3VAS and 0.9 for 4VAS; MDCs were 3.3 for 3VAS and 3.2 for 4VAS (Table 1). Cut-off values for low, moderate and high disease activity were 2.0, 3.4 and 4.9 for 3VAS, and 2.1, 3.5 and 5.1 for 4VAS. Conclusion Using a large pooled clinical trial dataset of patients with active PsA, we have calculated clinically relevant thresholds for improvement, as well as disease activity thresholds, for 3VAS and 4VAS. These estimates are generally comparable to those previously reported and may facilitate setting treatment targets and screening disease activity in routine care when resources are limited or in remote patient monitoring. Disclosure W. Tillett: Other; Received research funding, consulting, speaker fees and/or honoraria from AbbVie, Amgen, Celgene, GlaxoSmithKline, Janssen, Lilly, MSD, Novartis, Pfizer and UCB. L. Coates: Consultancies; AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Gilead, Galapagos, Janssen, Novartis, Pfizer and UCB. Member of speakers’ bureau; AbbVie, Amgen, Biogen, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Medac, Novartis, Pfizer and UCB. Grants/research support; AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Novartis, Pfizer and UCB. Other; National Institute for Health Research (NIHR) Clinician Scientist award. The research was supported by the NIHR Oxford Biomedical Research Centre, The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health, We acknowledge the support of the NIHR Clinical Research Network. M. Vis: Other; Received research grants and consulting or speaker fees from AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, UCB and the Dutch Arthritis Foundation. J. Merola: Consultancies; Consultant and/or investigator for AbbVie, Arena, Biogen, Bristol Myers Squibb, Dermavant, Lilly, Janssen, Novartis, Pfizer, Sun Pharma and UCB Pharma. E. Soriano: Consultancies; AbbVie, Janssen, Novartis and Roche. Member of speakers’ bureau; AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer, Roche and UCB. Grants/research support; AbbVie, Janssen, Novartis, Pfizer, Roche and UCB. M. Perate: Shareholder/stock ownership; Employee of Janssen and owns stocks in Johnson & Johnson. M. Shawi: Shareholder/stock ownership; Employee of Janssen and owns stocks in Johnson & Johnson. M. Zimmermann: Shareholder/stock ownership; Employee of Janssen and owns stocks in Johnson & Johnson. E. Rampakakis: Consultancies; Employee of JSS Medical Research; paid consultant of Janssen. M. Sharaf: Shareholder/stock ownership; Employee of Janssen and owns stocks in Johnson & Johnson. P. Nash: Other; Received grants for research and clinical trials and honoraria for advice and lectures on behalf of AbbVie, Boehringer-Ingelheim, Gilead/Galapagos, GSK, Janssen, Lilly, MSD, Novartis, Pfizer, Samsung,. P.S. Helliwell: Consultancies; AbbVie, Amgen, Novartis and Janssen. Other; Fees for educational services from AbbVie, Amgen, Novartis and Janssen.
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- 2023
34. Safety and therapeutic value of radiosynoviorthesis with yttrium-90: a Canadian single-centre experience
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John S. Sampalis, Emmanouil Rampakakis, Nadil Zeiadin, Carter Thorne, Eric Turcotte, and Helena Senta
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Adult ,Male ,musculoskeletal diseases ,Subset Analysis ,Canada ,medicine.medical_specialty ,medicine.medical_treatment ,Arthritis ,Synovectomy ,030204 cardiovascular system & hematology ,030207 dermatology & venereal diseases ,03 medical and health sciences ,0302 clinical medicine ,Rheumatology ,Refractory ,Synovitis ,medicine ,Humans ,Yttrium Radioisotopes ,Pharmacology (medical) ,Adverse effect ,business.industry ,Middle Aged ,medicine.disease ,Surgery ,Treatment Outcome ,Effusion ,Cohort ,Female ,business - Abstract
Background Yttrium-90 (90Y) is approved in several countries as a radiosynoviorthesis agent in the intra-articular treatment of synovitis, however, no such radiopharmaceuticals are approved in Canada. The aim of this Health Canada–approved study was to examine the safety and efficacy of 90Y synovectomy among patients with refractory synovitis. Methods We performed a subset analysis of a prospective, phase III, single-arm, pan-Canadian trial. Large and medium-sized joints of adults with refractory inflammatory mono- or oligo-arthritis and minimal cartilage/bone destruction who failed treatment with two intra-articular corticosteroid injections were eligible. Patient follow-up was at 3, 6 and 12 months. Outcome measures included joint tenderness, swelling, effusion, joint function and bone scans. Results A total of 79 joints were included (90% knees). The underlying diagnosis included SpA (35.2% of patients), RA (26.8%), JIA (8.5%) and other (29.6%). Non-biologic DMARDs were concurrently used in 59.2% of patients and biologic/targeted synthetic DMARDs in 31%. Five adverse events occurred, including one serious radiation burn requiring surgery. All events were non-life-threatening and resolved. Significant improvements in joint tenderness, swelling and effusion were achieved at 3 months (P Conclusion Our results confirm the safety of 90Y radiosynoviorthesis in refractory synovitis and provide preliminary evidence supporting its clinical efficacy with sustained benefit at 12 months, suggesting that it is a safe alternative to surgical synovectomy in such cases. This is the first such study in a Canadian cohort.
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- 2020
35. Long-term effectiveness and safety of infliximab and golimumab in ankylosing spondylitis patients from a Canadian prospective observational registry
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Derek Haaland, M. Teo, Proton Rahman, Francois Nantel, Michael Starr, Allen J. Lehman, Louis Bessette, and Emmanouil Rampakakis
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medicine.medical_specialty ,Registry ,lcsh:Diseases of the musculoskeletal system ,Effectiveness ,Golimumab ,03 medical and health sciences ,0302 clinical medicine ,Rheumatology ,Internal medicine ,Medicine ,030212 general & internal medicine ,Axial spondyloarthritis ,Adverse effect ,030203 arthritis & rheumatology ,Ankylosing spondylitis ,business.industry ,Incidence (epidemiology) ,medicine.disease ,Infliximab ,Cohort ,Safety ,lcsh:RC925-935 ,business ,BASFI ,medicine.drug ,Research Article - Abstract
Background The objectives of this study were to describe the profile of ankylosing spondylitis (AS) patients treated with either infliximab (IFX) or subcutaneous golimumab (GLM) treatment in Canadian routine care setting along with assessing long-term effectiveness and safety. Methods AS patients who were eligible for treatment with IFX or subcutaneous GLM as per their respective Canadian product monographs were enrolled into the BioTRAC registry from 2005 to 2017. The study visits occurred at baseline and every 6 months thereafter. Effectiveness was assessed by changes in clinical outcomes and acute phase reactants. Safety was evaluated by assessing the incidence of adverse events (AEs) and drug survival rates. Results A total of 389 IFX- and 421 GLM-treated patients were enrolled. A significant decrease in disease duration at baseline was observed in the IFX cohort, from a median of 8.0 in 2005–2008 to 1.0 years in 2009–2015 (p p = 0.011) and proportion of patients in ASDAS very high disease activity (p = 0.004) was also observed over time. Meanwhile, in the GLM cohort, most disease parameters remained similar from 2010 to 2017. Treatment with both agents significantly improved all disease parameters over time with similar efficacy between the two agents. The incidence of AEs and SAEs were 136 and 131 events/100 PYs and 10.5 and 8.45 events/100 PYs for IFX- and GLM-treated patients, respectively. Conclusion Both IFX and GLM treatment in AS significantly reduced disease activity in most outcome measures in a similar fashion and were well tolerated in Canadian routine care. Trial registration NCT00741793.
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- 2020
36. Medical cannabis use by rheumatology patients in routine clinical care: results from The Ontario Best Practices Research Initiative
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Emmanouil Rampakakis, Carter Thorne, Angela Cesta, Mohammad Movahedi, XiuYing Li, Carol Mously, Vandana Ahluwalia, Julie Brophy, Patricia Ciaschini, Edward Keystone, Arthur Lau, Gerald Major, Viktoria Pavlova, Janet E. Pope, and Claire Bombardier
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Rheumatology ,Immunology ,Immunology and Allergy - Abstract
Medical cannabis is often used to alleviate common symptoms in patients with chronic conditions. With cannabis legalisation in Canada and easier access, it is important that rheumatologists understand its potential impact on their practice. Among patients attending rheumatology clinics in Ontario we assessed: the prevalence of medical cannabis use; symptoms treated; rheumatologists' perceptions.Eight rheumatology clinics recruited consecutive adult patients in a 3-part medical cannabis survey: the first completed by rheumatologists; the second by all patients; the third by medical cannabis users. Student's t-test and Chi-square test were used to compare medical cannabis users to never users.799 patients participated, 163 (20.4%) currently using medical cannabis or within2 years and 636 never users; most had rheumatoid arthritis (37.8%) or osteoarthritis (34.0%). Compared to never users, current/past-users were younger; more likely to be taking opioids/anti-depressants, have psychiatric/gastrointestinal disorders, and have used recreational cannabis (p0.05); had higher physician (2.9 vs. 2.1) and patient (6.0 vs. 4.2) global scores, and pain (6.2 vs. 4.7) (p0.0001). Pain (95.5%), sleeping (82.3%) and anxiety (58.9%) were the most commonly treated symptoms; 78.2% of current/past-users reported medical cannabis was at least somewhat effective. Most rheumatologists reported being uncomfortable to authorise medical cannabis, primarily due to lack of evidence, knowledge, and product standardisation.Medical cannabis use among rheumatology patients in Ontario was two-fold higher than that reported for the general population of similar age. Use was associated with more severe disease, pain, and prior recreational use. Reported lack of research, knowledge, and product standardisation were barriers for rheumatologist use authorisation.
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- 2022
37. Characterizing pediatric lung ultrasound findings during a chemically induced bronchospasm
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Francois Gagnon, Noah Marzook, Alexandre Deragon, Larry C. Lands, David Zielinski, Adam J. Shapiro, Emmanouil Rampakakis, and Alexander S. Dubrovsky
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Pulmonary and Respiratory Medicine ,Adolescent ,Bronchial Spasm ,Pediatrics, Perinatology and Child Health ,Humans ,Child ,Lung ,Pediatrics ,Bronchial Provocation Tests ,Methacholine Chloride ,Bronchodilator Agents ,Ultrasonography - Abstract
Lung ultrasound (LUS) has been shown to be a useful clinical tool in pediatrics, but very little is known about the LUS findings of asthma in children.The primary objective was to characterize LUS findings of pediatric patients before and after a chemically induced bronchospasm. The secondary objective was to evaluate the effect of bronchodilators on LUS findings.Eligible children 6-17 years old presenting for a methacholine challenge test (MCT) in a pediatric respiratory clinic were recruited. Patients with viral symptoms were excluded. A six-zone LUS protocol was performed before and after the MCT, and after bronchodilator administration; video recordings were analysed by an expert blinded to the patient characteristics and MCT results.Forty-four patients were included in the study. Five patients had positive LUS findings at baseline. Nine patients out of 29 (31%) had new-onset positive LUS following a reactive MCT. There was a significant association between having a chemically induced bronchospasm and a positive LUS post-MCT (odds ratio [95% confidence interval]: 5.3 [1.0-27.7]; p = 0.05). Among patients who developed positive LUS findings post-MCT, four out of nine returned to having a negative LUS postbronchodilator administration.This is the first known report of an association between LUS findings and bronchospasm in pediatric patients. It is also the first documentation of resolution of LUS findings postbronchodilator administration. Most LUS findings observed were small and limited to a few intercostal spaces. Further research is required to quantify these findings and evaluate the effect of salbutamol on LUS.
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- 2022
38. Medical Cannabis Use by Rheumatology Patients Following Recreational Legalization: A Prospective Observational Study of 1000 Patients in Canada
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Martin Cohen, John S. Sampalis, Emmanouil Rampakakis, Mary-Ann Fitzcharles, Yoram Shir, Michael Starr, and Winfried Häuser
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medicine.medical_specialty ,lcsh:Diseases of the musculoskeletal system ,biology ,business.industry ,MEDLINE ,biology.organism_classification ,Rheumatology ,Confidence interval ,Discontinuation ,Internal medicine ,Family medicine ,medicine ,Original Article ,Observational study ,Cannabis ,lcsh:RC925-935 ,business ,Recreation ,Legalization - Abstract
Objective Recreational legalization of cannabis may influence the medical use by patients. When only medical access was legally available in Canada, 4.3% of rheumatology patients reported use. With the current recreational legalization, we have reexamined the prevalence and characteristics of medical cannabis use in this same rheumatology setting. Methods Consecutively attending rheumatology patients participated in an onsite survey comprising the following two questionnaires: 1) demographic and disease information completed by the rheumatologist and 2) patient anonymous questionnaire of health status, cannabis use (recreational and/or medicinal), and characteristics of cannabis use. Results Of 1047 attendees from June to August 2019, with 1000 participating, medical cannabis had been used by 12.6% of patients (95% confidence interval 10.7%‐14.8%), with half continuing use for mostly pain relief. Discontinuation was due to lack of effect in 57% of patients and side effects in 28% of patients. Ever medical users were younger (61.2 vs. 64.9 years; P = 0.006), more likely unemployed/disabled (16.7% vs. 5.9%; P < 0.001), and had more previous (47.6% vs. 25.5%; P < 0.001) and current recreational cannabis use (17.5% vs. 3.1%; P < 0.001) than nonusers. Most patients used multiple methods of administration, including smoking, vaporizing, and using oral oil preparations, but were poorly knowledgeable of product content, which was bought solely via the legal medical route by only 20%, and only one‐third disclosed their use to the rheumatologist. Conclusion Medical cannabis use has tripled for rheumatology patients since recreational legalization, with users being younger, not working, and having recreational cannabis experience. Concerning issues are the poor knowledge of the product being used, access via the nonmedical route, and nondisclosure to the physician.
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- 2020
39. Prospective observational study to evaluate the use of musculoskeletal ultrasonography in rheumatoid arthritis management: the ECHO study
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Julie Vaillancourt, Michael Stein, Emmanouil Rampakakis, and John S. Sampalis
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Male ,Canada ,medicine.medical_specialty ,Non-Randomized Controlled Trials as Topic ,Rate ratio ,Arthritis, Rheumatoid ,03 medical and health sciences ,0302 clinical medicine ,Patient satisfaction ,Rheumatology ,Predictive Value of Tests ,Synovitis ,Internal medicine ,medicine ,Humans ,Pharmacology (medical) ,Patient Reported Outcome Measures ,Prospective Studies ,030212 general & internal medicine ,Disease management (health) ,Musculoskeletal System ,Aged ,Ultrasonography ,Subclinical infection ,Inflammation ,030203 arthritis & rheumatology ,business.industry ,Disease Management ,Middle Aged ,medicine.disease ,Patient Satisfaction ,Antirheumatic Agents ,Rheumatoid arthritis ,Female ,Perception ,Observational study ,business ,Follow-Up Studies - Abstract
Objectives Since the creation of the Canadian Rheumatology Ultrasonography Society, an increasing number of rheumatologists has been trained in the use of musculoskeletal US (MSUS). We compared the effectiveness of MSUS to routine care (RC) as a disease management tool in patients with moderate-to-severe RA requiring a treatment change due to lack of efficacy. The predictive value of MSUS was also assessed. Methods This was a prospective, two-cohort, quasi-experimental study. Patients were managed either with MSUS (within the Canadian Rheumatology Ultrasonography Society) or as per RC for up to 1 year. Main outcomes included Clinical Disease Activity Index low disease activity/remission, DAS28 low disease activity/remission, MSUS scores, patient satisfaction and perception of participation in disease management. Results A total of 383 patients were enrolled (MSUS: n = 171; RC: n = 212). At baseline, a greater proportion of MSUS patients were treated with a biologic DMARD (50.3 vs 36.8%; P = 0.008) while more patients treated per RC received a non-biologic DMARD (84.2 vs 91.5%; P = 0.027). During follow-up, a greater number of RA treatment modifications was applied in the MSUS group compared with RC [adjusted incidence rate ratio (95% CI): 1.4 (1.1, 1.8)], including steroids, non-biologic DMARDs and biologic DMARDs. Regarding clinical and patient-reported outcomes, no remarkable differences were observed between groups. However, throughout the study, 50–80% of MSUS patients in clinical remission has a MSUS synovitis score of ≥1, and 37–73% an erosion score of ≥1. Significant associations were observed between baseline synovitis and joint erosion during follow-up. Conclusion MSUS assessments can be useful in detecting subclinical levels of inflammation and predicting future joint deterioration, thus allowing optimization of RA treatment and patient care.
- Published
- 2020
40. Differential influence of Clinical Disease Activity Index components based on disease state in rheumatoid arthritis patients: real-world results from the Ontario Best Practices Research Initiative
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Edward, Keystone, Mohammad, Movahedi, Angela, Cesta, Claire, Bombardier, John S, Sampalis, and Emmanouil, Rampakakis
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Ontario ,Arthritis, Rheumatoid ,Treatment Outcome ,Rheumatology ,Antirheumatic Agents ,Immunology ,Humans ,Immunology and Allergy ,Registries ,Severity of Illness Index - Abstract
The Clinical Disease Activity Index (CDAI) is routinely used in clinical care when treating-to-target RA patients. Previous validation studies have looked at CDAI's overall performance; this analysis aimed at evaluating its properties by disease state and identifying drivers of variance.RA patients enrolled in the OBRI registry, with available follow-up of ≥6 months were included. Construct validity of CDAI was assessed with principal component analysis; internal consistency with Cronbach's alpha (α); correlational validity with Spearman's rho (ρ); agreement in disease state classification with the kappa statistic. Stratification by disease states was performed.CDAI correlation with DAS28 was strong when CDAI10 (ρ=0.79), moderate when CDAI≤10 (ρ=0.56) or 2.8CDAI≤10 (ρ=0.44), and very weak when CDAI≤2.8 (ρ=0.02). Classification agreement of low disease activity (LDA)/remission between CDAI (≤10) and DAS28 (≤3.2) or HAQ-DI (≤2) was fair-to-moderate, while poor-to-fair for remission. For CDAI10, CDAI was able to be reduced to a single component with patient global assessment (PtGA) having the lowest loading. When CDAI≤10, two distinct components were identified: (1) PtGA and physician global assessment; (2) SJC28 and TJC28. Moderate levels (α=0.71) of internal consistency were observed when CDAI10 but low when CDAI≤10 (α=0.23), 2.8CDAI≤10 (α=-0.42) or CDAI≤2.8 (α=-0.35). PtGA showed lowest correlation with remaining CDAI components.CDAI and DAS28 correlated well in moderate/high disease activity and poorly in LDA/remission. PtGA correlated weakly with other CDAI components and had a stronger influence on CDAI in LDA/remission. Thus, careful interpretation of PtGA is necessary when making treatment decisions, particularly in patients in CDAI LDA who are non-remitters.
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- 2021
41. Estudio observacional prospectivo que evalúa la carga de enfermedad del HZ en Colombia
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Dora Inés Molina de Salazar, Emmanouil Rampakakis, Andrés Zapata-Cárdenas, Melissa Stutz, Kelly D Johnson, Oscar Enrique Pradilla Vesga, Andrés Eduardo Rico Carillo, Gonzalo Mejía-Vélez, and Homero Antonio Monsanto Planadeball
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neuralgia posherpética ,Pediatrics ,medicine.medical_specialty ,business.industry ,Incidence (epidemiology) ,herpes zóster ,herpes zoster ,General Medicine ,Disease ,Colombia ,burden of disease ,medicine.disease ,Rash ,Quality of life ,carga de la enfermedad ,Neuralgia ,Medicine ,Observational study ,medicine.symptom ,Brief Pain Inventory ,business ,postherpetic neuralgia ,Cohort study - Abstract
Resumen Introducción: el herpes zóster (HZ) es una enfermedad debilitante que afecta negativamente la calidad de vida (CV). Este estudio buscó describir la carga de la enfermedad por el HZ en Colombia. Métodos: estudio prospectivo, observacional, de cohorte única realizado en 10 centros clínicos colombianos. Para ser elegibles, los pacientes tenían que ser inmunocompetentes, ≥50 años de edad, y tener un diagnóstico confirmado de HZ en fase aguda o dolor posherpético. Los resultados del estudio incluyeron el inventario breve del dolor por zóster (ZBPI), la CV evaluada con el cuestionario EQ-5D y la utilización de recursos de atención médica (URAM) debido a HZ. El seguimiento fue de 180 días. Resultados: se incluyeron 154 pacientes con una media (DE) de la edad de 64.6 (9.6) años. La media (DE) del peor dolor agudo fue 8.2 (2.1), mientras la neuralgia posherpética (dolor por HZ ≥3 que persistió ≥90 días) fue reportado por 36.5% de los pacientes. Los predictores significativos del aumento de la carga de dolor fueron la edad avanzada y puntuaciones de peor dolor más altas desde el inicio de la erupción. El aumento en el dolor asociado a HZ estuvo acompañado con reducción significativa en CV, la cual duró aproximadamente 60 días. En términos de la URAM, medicamentos para el HZ y que fueron recetados a 98.7% de los pacientes, incluyendo aciclovir en 85.1% de los pacientes, 79.2% tuvieron un seguimiento por un médico general, 38.2% visitó una sala de emergencia y 29.2% visitó un especialista Conclusión: HZ está asociado a carga de enfermedad significativa en Colombia, incluyendo dolor, impacto en la CV y URAM. A medida que la población colombiana envejece, se deben implementar estrategias para manejar y/o prevenir de manera más efectiva la carga asociada al HZ. (Acta Med Colomb 2021; 46. DOI:https://doi.org/10.36104/amc.2021.1636). Abstract Introduction: herpes zoster (HZ) is a debilitating disease with a negative effect on quality of life (QL). This study sought to describe the burden of disease of HZ in Colombia. Methods: this was a prospective, observational single-cohort study in 10 Colombian clinical centers. To be eligible, patients had to be immunocompetent, ≥50 years old, and have a confirmed diagnosis of acute phase HZ or postherpetic pain. The study outcomes included the Zoster Brief Pain Inventory (ZBPI), QL assessed through the EQ-5D questionnaire, and healthcare resource utilization (HCRU) due to HZ. Patients were followed for 180 days. Results: 154 patients were included with a mean (SD) age of 64.6 (9.6) years. The mean (SD) worst acute pain was 8.2 (2.1), while postherpetic neuralgia (HZ pain ≥3 which lasted for ≥90 days) was reported by 36.5% of the patients. The significant predictors of increased pain burden were advanced age and higher worst pain score from the onset of the rash. Increased HZ-related pain was associated with a significant reduction in QL, which lasted approximately 60 days. In terms of HCRU, HZ medications were prescribed for 98.7% of the patients, including acyclovir in 85.1%; 79.2% were followed by a general practitioner; 38.2% were seen in the emergency room and 29.2% consulted a specialist. Conclusion: HZ is associated with a significant burden of disease in Colombia, including pain and an impact on QL and HCRU. As the Colombian population ages, strategies should be implemented to more effectively manage and/or prevent the HZ-related burden. (Acta Med Colomb 2021; 46. DOI:https://doi.org/10.36104/amc.2021.1636).
- Published
- 2021
42. Myelination may be impaired in neonates following birth asphyxia
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Pia Wintermark, Bianca Olivieri, Guillaume Gilbert, Emmanouil Rampakakis, and Aliona Fezoua
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Internal capsule ,qMT, quantitative magnetisation transfer ,Hypothermia ,MWF, myelin water fraction ,FOV, field of view ,Myelination ,0302 clinical medicine ,Neonate ,DTI, diffusion-tensor imaging ,Pregnancy ,MRT, magnetisation transfer ratio ,MCR, multicomponent relaxation ,Asphyxia Neonatorum ,medicine.diagnostic_test ,MWI, myelin water imaging ,05 social sciences ,McDESPOT, multi-component driven equilibrium single pulse observation of T1 and T2 ,NBI, no brain injury ,SAR, specific absorption rate ,Brain ,Regular Article ,SNR, signal-to-noise ratio ,DOL, day of life ,TR, repetition time ,3. Good health ,medicine.anatomical_structure ,Neurology ,Anesthesia ,TSE, turbo spin echo ,Hypoxia-Ischemia, Brain ,Gestation ,Female ,NE, neonatal encephalopathy ,medicine.symptom ,Adolescent ,Cognitive Neuroscience ,Computer applications to medicine. Medical informatics ,R858-859.7 ,Neonatal encephalopathy ,050105 experimental psychology ,MR, magnetic resonance ,White matter ,03 medical and health sciences ,Asphyxia ,Magnetic resonance imaging ,BI, brain injury ,medicine ,Humans ,0501 psychology and cognitive sciences ,Radiology, Nuclear Medicine and imaging ,RC346-429 ,business.industry ,Infant, Newborn ,Repeated measures design ,ihMT, inhomogenous magnetisation transfer ,medicine.disease ,nervous system ,PLIC, posterior limb of the internal capsule ,TE, time to echo ,Neurology. Diseases of the nervous system ,Neurology (clinical) ,business ,SD, standard deviation ,MRI, magnetic resonance imaging ,030217 neurology & neurosurgery - Abstract
Highlights • Myelination is a developmental process that intensifies after birth during the first years of life. • We used a T2* mapping sequence to assess myelination in healthy and critically ill neonates with neonatal encephalopathy. • Birth asphyxia, in addition to causing the previously well-described direct injury to the brain, may impair myelination., Background Myelination is a developmental process that begins during the end of gestation, intensifies after birth over the first years of life, and continues well into adolescence. Any event leading to brain injury around the time of birth and during the perinatal period, such as birth asphyxia, may impair this critical process. Currently, the impact of such brain injury related to birth asphyxia on the myelination process is unknown. Objective To assess the myelination pattern over the first month of life in neonates with neonatal encephalopathy (NE) developing brain injury, compared to neonates without injury (i.e., healthy neonates and neonates with NE who do not develop brain injury). Methods Brain magnetic resonance imaging (MRI) was performed around day of life 2, 10, and 30 in healthy neonates and near-term/term neonates with NE who were treated with hypothermia. We evaluated myelination in various regions of interest using a T2* mapping sequence. In each region of interest, we compared the T2* values of the neonates with NE with brain injury to the values of the neonates without injury, according to the MRI timing, by using a repeated measures generalized linear mixed model. Results We obtained 74 MRI scans over the first month of life for 6 healthy neonates, 17 neonates with NE who were treated with hypothermia and did not develop brain injury, and 16 neonates with NE who were treated with hypothermia and developed brain injury. The T2* values significantly increased in the neonates with NE who developed injury in the posterior limbs of the internal capsule (day 2: p
- Published
- 2021
43. Endoscopy-Assisted Vitrectomy Outcomes During Silicone Oil Removal After Complex Retinal Detachment Repair
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Emmanouil Rampakakis, Flavio A. Rezende, and Natalia Vila
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Pars plana ,Proliferative vitreoretinopathy ,medicine.medical_specialty ,medicine.diagnostic_test ,business.industry ,medicine.medical_treatment ,Retinal detachment repair ,Retinal detachment ,Vitrectomy ,medicine.disease ,Silicone oil ,Endoscopy ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,medicine.anatomical_structure ,chemistry ,Ophthalmology ,030221 ophthalmology & optometry ,medicine ,business ,030217 neurology & neurosurgery - Abstract
Purpose: This retrospective study recorded intraoperative findings during silicone oil removal and postoperative anatomical outcomes comparing endoscopy-assisted pars plana vitrectomy (E-PPV) vs pars plana vitrectomy (PPV) alone after proliferative vitreoretinopathy (PVR)-related retinal detachment (RD) repair. Methods: This single-center retrospective study included patients who underwent PPV for silicone oil removal after RD with PVR from July 2009 to January 2017. Patients with diabetic tractional RD, history of trauma, uveitis, or endophthalmitis were excluded. After 2013, an endoscopic visualization system (E2 MicroProbe; Endo Optiks) was used in a nonrandomized fashion. Data collection included reattachment rate, intraoperative endoscopic findings and phthisis rate. Results: Fifty-four eyes of 54 patients were included. The mean participant age was 58.4 ± 12.9 years and 36 (65.5%) participants were male. The mean (± SD) follow-up duration after oil removal was 24.3 ± 20.1 months. E-PPV combined with wide-angle visualization system was performed in 26 (48.1%) of the patients; the surgical management was modified after endoscopic examination in 17 (65.4%) of the cases. Reattachment rate in the E-PPV group was 96.2% compared with 76.0% in the PPV-alone group ( P = .04). Conclusions: E-PPV for silicone oil removal appears to be advantageous for prevention of RD recurrence, thus achieving better reattachment rates. A thorough examination is facilitated by endoscopic visualization and contributory factors for anterior PVR can be identified and treated.
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- 2019
44. Carga económica de la varicela en niños en Perú, entre 2011 y 2016
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Raul Chuquiyauri-Haro, Raúl de Jesús Gutiérrez, Mao Zeta-Zeta, Alexandra Altland, Veronica Petrozzi, Lara J. Wolfson, Homero Monsanto, MarÃa Eldemira Cruz-Saldarriaga, Maria E. Castillo, and Emmanouil Rampakakis
- Subjects
programas de inmunización, costos y análisis de costo ,chickenpox ,immunization programs ,Niño ,varicela ,costos de la atención en salud ,health care costs ,General Medicine ,gastos en salud ,Child ,costs and cost analysis - Abstract
Objetivo: Describir las complicaciones más frecuentes y la carga económica asociada con la varicela en el Perú. Material y métodos: Estudio multicéntrico de revisión de historias clÃnicas de pacientes de 1 a 14 años con diagnóstico de varicela entre 2011 y 2016. El uso de recursos de atención médica (URAM) asociados con la varicela, los costos unitarios y la pérdida de trabajo se utilizaron para estimar los costos directos e indirectos, presentados en USD ($). Los datos de costos y URAM se combinaron con estimaciones de carga de enfermedad para calcular el costo total anual de la varicela en el Perú. Resultados: Se incluyeron un total de 179 niños con varicela (101 ambulatorios, 78 hospitalizados). Entre los pacientes ambulatorios, el 5,9 % presentó una o más complicaciones, en comparación con 96,2 % de pacientes hospitalizados. El URAM incluyó el uso de medicamentos de venta libre (72,3 % frente a 89,7 % de pacientes ambulatorios y hospitalizados, respectivamente), medicamentos con receta (30,7 % frente a 94,9 %) y análisis y procedimientos (0,0 % frente a 80,8 %). Los costos directos e indirectos por caso ambulatorio fueron $36 y $62 respectivamente y por caso hospitalizado fueron $548 y $222. El costo anual total asociado con la varicela se estimó en $13 907 146. Conclusión: La varicela está asociada con complicaciones clÃnicas importantes y elevado URAM en Perú, lo que respalda la necesidad de implementación de un plan de vacunación universal. Objective: The purpose of this study was to evaluate the clinical and economic burden associated with varicella in Peru. Methods: This was a multicenter, retrospective chart review study of patients aged 1-14 years with a varicella diagnosis between 2011 and 2016. Healthcare resource utilization (HCRU) associated with varicella, unit costs, and work loss were used to estimate direct and indirect costs, presented in USD ($). The cost and HCRU data was combined with estimates of varicella disease burden to estimate the overall annual costs of management of varicella in Peru. Results: A total of 179 children with varicella (101 outpatients, 78 inpatients) were included. Among outpatients, 5.9% experienced ≥1 complication, compared with 96.2% of inpatients. HCRU estimates included use of over-the-counter (OTC) medications (72.3% vs. 89.7% of outpatient and inpatients, respectively), prescription medications (30.7% vs. 94.9%), tests/procedures (0.0% vs. 80.8%). Among outpatients, direct and indirect costs per case were $36 and $62, respectively; among inpatients, respective costs were $548 and $222. The total annual cost associated with varicella was estimated at $ 13 907 146. Conclusion: Varicella is associated with substantial clinical complications and high HCRU in Peru, supporting the need for implementation of a routine childhood varicella vaccination plan.
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- 2019
45. The use of antibiotics in the treatment of pediatric varicella patients: real-world evidence from the multi-country MARVEL study in Latin America & Europe
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Zsófia Mészner, Mirella Vazquez, Alexandra Altland, Emmanouil Rampakakis, Norberto Giglio, Zsuzsanna Molnár, Melissa Stutz, Jacek Wysocki, Lara J. Wolfson, Barbara J. Kuter, Craig S. Roberts, and Maria E. Castillo
- Subjects
health care delivery ,Male ,Pediatrics ,purl.org/pe-repo/ocde/ford#3.03.05 [https] ,retrospective study ,Antibiotics ,Antimicrobial stewardship ,Varicella ,preschool child ,Chickenpox ,0302 clinical medicine ,Outpatients ,Epidemiology ,statistics and numerical data ,Medicine ,030212 general & internal medicine ,Child ,Latin America/epidemiology ,Clindamycin ,lcsh:Public aspects of medicine ,Bacterial Infections ,virology ,Anti-Bacterial Agents ,antiinfective agent ,Europe ,Hospitalization ,hospital patient ,female ,Child, Preschool ,outpatient ,standards ,Observation study ,Female ,Clindamycin/therapeutic use ,Chickenpox/drug therapy/epidemiology/virology ,Research Article ,medicine.drug ,medicine.medical_specialty ,Drug Prescriptions/statistics & numerical data ,Adolescent ,medicine.drug_class ,030209 endocrinology & metabolism ,Drug Prescriptions ,beta-Lactamases ,beta lactamase ,Europe/epidemiology ,South and Central America ,03 medical and health sciences ,Delivery of Health Care/standards ,Humans ,human ,Medical prescription ,beta-Lactamases/therapeutic use ,Retrospective Studies ,prescription ,Inpatients ,business.industry ,Public health ,microbiology ,bacterial infection ,Public Health, Environmental and Occupational Health ,Infant ,Bacterial Infections/drug therapy/microbiology ,lcsh:RA1-1270 ,Antibiotic misuse ,Anti-Bacterial Agents/therapeutic use ,Latin America ,business ,Complication ,Delivery of Health Care - Abstract
Background Varicella is a highly contagious childhood disease. Generally benign, serious complications necessitating antibiotic use may occur. The objective of this study was to characterize the rate, appropriateness and patterns of real-world antibiotic prescribing for management of varicella-associated complications, prior to universal varicella vaccination (UVV) implementation. Methods Pooled, post-hoc analysis of 5 international, multicenter, retrospective chart reviews studies (Argentina, Hungary, Mexico, Peru, Poland). Inpatient and outpatient primary pediatric (1–14 years) varicella cases, diagnosed between 2009 and 2016, were eligible. Outcomes, assessed descriptively, included varicella-associated complications and antibiotic use. Three antibiotic prescribing scenarios were defined based on complication profile in chart: evidence of microbiologically confirmed bacterial infection (Scenario A); insufficient evidence confirming microbiological confirmation (Scenario B); no evidence of microbiological confirmation (Scenario C). Stratification was performed by patient status (inpatient vs. outpatient) and country. Results Four hundred one outpatients and 386 inpatients were included. Mean (SD) outpatient age was 3.6 (2.8) years; inpatient age was 3.1 (2.8) years. Male gender was predominant. Overall, 12.2% outpatients reported ≥1 infectious complication, 3.7% ≥1 bacterial infection, and 0.5% ≥1 microbiologically confirmed infection; inpatient complication rates were 78.8, 33.2 and 16.6%, respectively. Antibiotics were prescribed to 12.7% of outpatients and 68.9% of inpatients. Among users, β-lactamases (class), and clindamycin (agent), dominated prescriptions. Scenario A was assigned to 3.9% (outpatients) vs 13.2% (inpatients); Scenario B: 2.0% vs. 6.0%; Scenario C: 94.1% vs. 80.8%. Conclusions High rates of infectious complications and antibiotic use are reported, with low rates of microbiological confirmation suggesting possible antibiotic misuse for management of varicella complications. Electronic supplementary material The online version of this article (10.1186/s12889-019-7071-z) contains supplementary material, which is available to authorized users.
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- 2019
46. Canadian Treat-and-Extend Analysis Trial with Ranibizumab in Patients with Neovascular Age-Related Macular Disease
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Tom G. Sheidow, Ivan J. Galic, Andrea Scarino, Peter J. Kertes, Emmanouil Rampakakis, R. Geoff Williams, and Mark Greve
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0303 health sciences ,medicine.medical_specialty ,Visual acuity ,genetic structures ,business.industry ,Treat and extend ,Confidence interval ,law.invention ,03 medical and health sciences ,Ophthalmology ,Regimen ,0302 clinical medicine ,Randomized controlled trial ,law ,Internal medicine ,030221 ophthalmology & optometry ,medicine ,Dosing ,Ranibizumab ,medicine.symptom ,business ,Prospective cohort study ,030304 developmental biology ,medicine.drug - Abstract
Purpose To compare the efficacy of ranibizumab using a treat-and-extend (TE monthly, n = 258). At baseline, mean age was 78.8 years (standard deviation [SD], 7.8 years), 60.3% were women, and 94.3% were white. No significant between-group baseline differences were observed. The primary outcome of noninferiority regarding visual acuity was met with mean BCVA improvement of 8.4 letters (SD, 11.9 letters) and 6.0 letters (SD, 11.9 letters; P = 0.017) in the T&E and monthly regimens, respectively, with a between-group mean difference of 2.38 letters (95% confidence interval, 0.32–4.45 letters). Per protocol, a secondary analysis was performed to test for superiority of number of injections received up to month 12. This analysis demonstrated significantly fewer injections with T&E versus monthly dosing (9.4 and 11.8 injections, respectively), with a mean difference of –2.46 injections (95% confidence interval, –2.68 to –2.23 injections). Conclusions The 12-month results of this 2-year study demonstrated that regarding visual outcomes, the T&E regimen was noninferior to a monthly dosing regimen. Similar visual outcomes in the T&E group as in the monthly dosing group were achieved with significantly fewer injections.
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- 2019
47. Effect of Concomitant Disease-modifying Antirheumatic Drugs and Methotrexate Administration Route on Biologic Treatment Durability in Rheumatoid Arthritis: OBRI Cohort Results
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Arthur N, Lau, J Carter, Thorne, Mohammad, Movahedi, Emmanouil, Rampakakis, Angela, Cesta, Xiuying, Li, Sandra, Couto, John, Sampalis, Claire, Bombardier, and Shirley, Chow
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Adult ,Male ,medicine.medical_specialty ,Combination therapy ,medicine.medical_treatment ,Immunology ,Lower risk ,Arthritis, Rheumatoid ,Route of administration ,Rheumatology ,Internal medicine ,medicine ,Humans ,Immunology and Allergy ,Disease-modifying antirheumatic drug ,Adverse effect ,Aged ,Biological Products ,business.industry ,Middle Aged ,medicine.disease ,Discontinuation ,Methotrexate ,Treatment Outcome ,Antirheumatic Agents ,Concomitant ,Rheumatoid arthritis ,Drug Therapy, Combination ,Female ,business - Abstract
Objective.Prior studies have suggested that concurrent conventional synthetic disease-modifying antirheumatic drug (csDMARD) therapy enhances the efficacy of biologic DMARD (bDMARD). Here, we assessed the effect of concomitant csDMARD use and methotrexate (MTX) route of administration on time to bDMARD discontinuation in a large Canadian (Ontario), observational, rheumatoid arthritis (RA) cohort.Methods.Patients from the Ontario Best Practices Research Initiative (OBRI) who initiated bDMARD therapy and had ≥ 1 followup assessment were included. The effect of concomitant csDMARD use (primary analysis) and MTX route of administration (secondary analysis) on bDMARD discontinuation owing to (1) any reason, (2) ineffectiveness, (3) adverse events (AE), and (4) both (2) and (3), were assessed with multivariate Cox regression.Results.Among the 814 patients included, 153 (18.8%) received bDMARD monotherapy and 661 (81.2%) combination csDMARD/bDMARD therapy. Over a mean followup of 1.9 years, bDMARD were discontinued in 38.7% of patients. In multivariate analysis, there was a nonsignificant trend toward lower discontinuation for the csDMARD/bDMARD group compared to bDMARD monotherapy for any reason (HR 0.76, 95% CI 0.55–1.05) and owing to ineffectiveness/AE (HR 0.73, 95% CI 0.50–1.06). Further, patients taking combination therapy had significantly lower risk of bDMARD discontinuation due to AE (HR 0.43, 95% CI 0.24–0.76). In the secondary analysis, no statistical association between MTX dose or route of administration and bDMARD durability was observed.Conclusion.Concomitant csDMARD use was associated with a significantly lower hazard for bDMARD discontinuation due to AE among patients with RA followed in routine clinical practice in Ontario, Canada. Neither MTX route of administration nor dose were significant predictors of bDMARD durability.
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- 2019
48. Impact of restricting fluid and sodium intake in term asphyxiated newborns treated with hypothermia
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Emmanouil Rampakakis, Noémie La Haye-Caty, Michael Zappitelli, Pia Wintermark, Stephanie Barbosa Vargas, and Julie Maluorni
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Hypothermia ,Fluid management ,03 medical and health sciences ,0302 clinical medicine ,Hypothermia, Induced ,030225 pediatrics ,medicine ,Humans ,030212 general & internal medicine ,Retrospective Studies ,Asphyxia Neonatorum ,business.industry ,Neonatal encephalopathy ,Infant, Newborn ,Acute kidney injury ,Obstetrics and Gynecology ,Sodium, Dietary ,Retrospective cohort study ,medicine.disease ,humanities ,Sodium intake ,body regions ,Anesthesia ,Hypoxia-Ischemia, Brain ,Pediatrics, Perinatology and Child Health ,medicine.symptom ,business ,Hyponatremia - Abstract
Aim: To study the consequences of restricting fluid and sodium intake in asphyxiated newborns treated with hypothermia.Methods: We conducted a retrospective cohort study of asphyxiated newborns tre...
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- 2019
49. Varicella healthcare resource utilization in middle income countries: a pooled analysis of the multi-country MARVEL study in Latin America & Europe
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Jacek Wysocki, Barbara J. Kuter, Maria E. Castillo, Zsófia Mészner, Alexandra Altland, Norberto Giglio, Jenaya Rickard, Emmanouil Rampakakis, Lara J. Wolfson, Zsuzsanna Molnár, and Mirella Vazquez
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Male ,Latin Americans ,retrospective study ,viruses ,costs ,intensive care unit ,regression analysis ,0302 clinical medicine ,varicella ,Chickenpox ,Cost of Illness ,Health care ,Outpatients ,Immunology and Allergy ,middle income country ,030212 general & internal medicine ,Socioeconomics ,Child ,chickenpox ,child ,integumentary system ,Vaccination ,food and beverages ,virus diseases ,skin defect ,purl.org/pe-repo/ocde/ford#3.01.03 [https] ,Europe ,female ,Geography ,Pooled analysis ,Child, Preschool ,healthcare resource utilization (HCRU) ,Health Resources ,Female ,post hoc analysis ,hospitalization ,Research Paper ,pediatrics ,Adolescent ,030231 tropical medicine ,Immunology ,Argentina ,Article ,South and Central America ,03 medical and health sciences ,male ,chickenpox vaccine ,health care utilization ,medicine ,Humans ,human ,gross national product ,Developing Countries ,Retrospective Studies ,Pharmacology ,multi-country ,Hungary ,business.industry ,Infant ,Gross national product ,Patient Acceptance of Health Care ,vaccination ,medicine.disease ,major clinical study ,Latin America ,adolescent ,general practitioner ,observational study ,Observational study ,business ,Resource utilization ,Multi country - Abstract
Varicella is a mild and self-limited illness in children, but can result in significant healthcare resource utilization (HCRU). To quantify/contrast varicella-associated HCRU in five middle-income countries (Hungary, Poland, Argentina, Mexico, and Peru) where universal varicella vaccination was unimplemented, charts were retrospectively reviewed among 1–14 year-olds. Data were obtained on management of primary varicella between 2009–2016, including outpatient/inpatient visits, allied healthcare contacts, tests/procedures, and medications. These results are contrasted across countries, and a regression model is fit to extrapolated country-level costs as a function of gross domestic product (GDP). A total of 401 outpatients and 386 inpatients were included. Significant differences between countries were observed in the number of skin lesions among outpatients, ranging from 5.3% to 25.4% of patients with ≥250 lesions. Among inpatients, results were less variable. Average ambulatory medical visits ranged from 1.1 to 2.2. Average hospital stay ranged from 3.6 to 6.8 days. Use of tests/procedures was infrequent in outpatients, except in Argentina (13.3%); among inpatients, a test/procedure was ordered for 81.3% of patients, without regional variation. Prescription medications were administered in 44.4% of outpatients (range 9.3%–80.0%), and in 86% of inpatients (range 70.4%–94.9%). Total estimated spending on varicella treatment in the absence of vaccination was predicted from income levels (GDP) with an exponential function (R2 = 0.89). This study demonstrates that substantial HCRU is associated with varicella resulting in significant public health burden that could be alleviated through the use of varicella vaccination. Differences observed between countries possibly reflect treatment guidelines, healthcare resource availabilities and physician practices.
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- 2019
50. Assessment in Work Productivity and the Relationship with Cognitive Symptoms (AtWoRC): primary analysis from a Canadian open-label study of vortioxetine in patients with major depressive disorder (MDD)
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Joanna Bougie, Pratap Chokka, Jean Proulx, and Emmanouil Rampakakis
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Adult ,Male ,medicine.medical_specialty ,Work Limitations Questionnaire ,vortioxetine ,03 medical and health sciences ,0302 clinical medicine ,Cognition ,Cognitive dysfunction ,real life ,medicine ,Clinical endpoint ,Humans ,Effects of sleep deprivation on cognitive performance ,Major depressive episode ,Work Performance ,Original Research ,Vortioxetine ,Depressive Disorder, Major ,major depressive disorder ,business.industry ,Middle Aged ,medicine.disease ,work productivity ,Antidepressive Agents ,030227 psychiatry ,Psychiatry and Mental health ,functional impairment ,Digit symbol substitution test ,Physical therapy ,Major depressive disorder ,Female ,Neurology (clinical) ,medicine.symptom ,business ,030217 neurology & neurosurgery - Abstract
ObjectiveThe Assessment in Work Productivity and the Relationship with Cognitive Symptoms (AtWoRC) study aimed to assess the association between cognitive symptoms and work productivity in gainfully employed patients receiving vortioxetine for a major depressive episode (MDE).MethodsPatients diagnosed with major depressive disorder (MDD) and treated with vortioxetine independently of study enrollment were assessed over 52 weeks at visits that emulated a real-life setting. Patients were classified as those receiving vortioxetine as the first treatment for their current MDE (first treatment) or having shown inadequate response to a previous antidepressant (switch). The primary endpoint was the correlation between changes in patient-reported cognitive symptoms (20-item Perceived Deficits Questionnaire [PDQ-D-20]) and changes in work productivity loss (Work Limitations Questionnaire [WLQ]) at week 12. Additional assessments included changes in symptom and disease severity, cognitive performance, functioning, work loss, and safety.ResultsIn the week 12 primary analysis, 196 eligible patients at 26 Canadian sites were enrolled, received at least one treatment dose, and attended at least one postbaseline study visit. This analysis demonstrated a significant, strong correlation between PDQ-D-20 and WLQ productivity loss scores (r=0.634; ppr=−0.244; p=0.003).ConclusionAt 12 weeks, improvements in cognitive dysfunction were significantly associated with improvements in workplace productivity in patients with MDD, suggesting a role for vortioxetine in functional recovery in MDD.
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- 2019
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