Search

Evidence suggests that migraine is associated with decreased productivity. This article describes the results of a systematic literature review of peer-reviewed publications that measured the impact of migraine on workplace [...]

BACKGROUND: Corticosteroids, plasma exchange, and intravenous immunoglobulin (IVIG) have been standard-of-care treatments for chronic inflammatory demyelinating polyneuropathy (CIDP) for more than 2 decades. Despite guideline recommendations for best clinical practices, heterogeneity in patient presentation and the course of treatment for CIDP remains. There is limited literature regarding the real-world treatment patterns of and costs associated with CIDP. OBJECTIVE: To analyze and describe the real-world treatment patterns of and economic burden associated with CIDP. METHODS: This retrospective cohort study evaluated the treatment patterns and CIDP-related healthcare costs over a 2-year follow-up period for patients with newly diagnosed CIDP who had commercial insurance, using claims data from the IMS LifeLink PharMetrics Plus Claims database between 2009 through 2014. Treatment-naïve patients with newly diagnosed CIDP were evaluated for 2 years postdiagnosis, which captured the treatments used and the resource utilization. The patients were defined as receiving active CIDP therapy (ie, IVIG, immunosuppressants, oral or intravenous steroids, or plasma exchange) or active surveillance. RESULTS: Of the 525 patients identified with newly diagnosed CIDP, 55.2% of patients were prescribed only steroid therapy, and 25.3% of patients were prescribed an IVIG therapy during the 2-year follow-up. The median time to the initial treatment was shortest for patients receiving plasma exchange alone (0.03 months) or in combination with a steroid (0.03 months), followed by IVIG plus another therapy (0.53 months), and then IVIG alone (0.71 months). Initiating therapy with steroids alone took the longest mean time (6.51 months) to start the treatment. The median length of time to receive therapy was longest for the steroid plus plasma exchange cohort (21.8 months), followed by the steroid plus immunosuppressant cohort (10.1 months), and the 2 IVIG cohorts (9.04 months for IVIG alone and 9.82 months for IVIG plus another therapy). The mean total CIDP-specific 2-year follow-up costs were highest for the cohort that received IVIG alone ($119,928) or with an additional therapy ($133,334) and lowest for patients who received active surveillance ($3723) or steroids alone ($3101). CONCLUSIONS: Steroid therapy was initiated later and resulted in a shorter duration of treatment than other treatment options for patients with CIDP, which may reflect diagnostic uncertainty, disease severity or remission, therapeutic challenge to determine diagnosis, or the side-effect profile of steroids. The use of steroids alone was the most common prescribed treatment for CIDP. Further research is needed to understand the rationale for treatment decisions in this patient population and their potential impact on patients and health plans. [ABSTRACT FROM AUTHOR]

Background: Alzheimer Management By Albumin Replacement (AMBAR) is a multicenter, randomized, placebo‐controlled, Phase IIb/III clinical trial that evaluated the efficacy and safety of Plasma Exchange with Albumin replacement (PE‐A) in patients with mild‐to‐moderate Alzheimer's disease (Boada et al., Alzheimers Dement. 2020). PE‐A has demonstrated an overall benefit in quality of life as measured by the Quality of Life‐Alzheimer's disease (QoL‐AD) score (Boada et al., Alzheimers Dement. 2021). We evaluated PE‐A treatment benefit for each of 13 individual patient‐rated QoL‐AD items. Method: A cumulative logistic mixed model was applied on the Full Analysis Set (FAS) population. The odds that a patient receiving PE‐A would have a more favorable response (i.e., higher item score) than a similar subject receiving placebo was estimated at final visit for each QoL‐AD item. Age, baseline MMSE score, and baseline individual QoL‐AD item responses were included as covariates. Result: The FAS included 76 placebo patients and 229 PE‐A‐treated patients. A significant PE‐A treatment effect vs. placebo at final visit was observed for QoL‐AD item 4: Living situation ("How do you feel about the place you live now?") [Odds Ratio (OR) = 3.92 (95% CI: 1.38‐11.12), p = 0.010] and for QoL‐AD item 13: Life as a whole ("When you think about your life as a whole, everything together, how do you feel about your life?") [OR = 3.80 (95% CI: 1.32‐10.91), p = 0.013]. Conclusion: The analysis demonstrated that when compared to patients on placebo, patients receiving PE‐A were more likely to have a favorable response for the QoL‐AD items "Living situation" and "Life as a whole", suggesting that the reported benefit of PE‐A vs. placebo on the full QoL‐AD score is also observed in these individual QoL‐AD items. [ABSTRACT FROM AUTHOR]

Objectives To assess the consistency of improved functioning, productivity, and medication satisfaction in migraines treated with a single tablet of sumatriptan 85 mg/naproxen sodium 500 mg ( S/ NS) using an early intervention approach. Methods Two randomized, double-blind, placebo-controlled, 4-period crossover, multi-attack, multi-center, outpatient studies of moderate to severe adult migraineurs were conducted to compare S/ NS with placebo. Participants recorded outcome assessments in a diary during the 24 hours following study medication. Analyses were conducted on the intent-to-treat population who treated at least 1 attack. Statistical significance between treatment groups used analysis of variance repeated measures models and the intent-to-treat population. There were no corrections for multiplicity. Results Almost half (48.5%) of migraineurs treated with S/ NS returned to normal functioning at 2 hours and 73.3% at 4 hours postdose, compared with 28.7% (2 hours) and 43.3% (4 hours) of placebo-treated attacks. Total productivity loss over the 24 hours postdose was significantly reduced following S/ NS treatment (2.5 hours on average) compared with placebo (4.0 hours). Sumatriptan/naproxen treatment resulted in significantly higher medication satisfaction scores on the efficacy, functionality, and total efficacy subscales compared with placebo in all attacks in both studies. Sumatriptan/naproxen treatment also provided significantly greater ease of use in 7 of the 8 attacks. Although tolerability was high in both treatment groups (over 90%), the placebo group was significantly less bothered by side effects in 6 of 8 attacks. Conclusion Results from these 2 randomized, double-blind, placebo-controlled, multi-attack, crossover studies demonstrated the rapid and consistent restoration of patients' functioning, the consistent reduction in productivity loss, and high satisfaction ratings from patients treating multiple migraine attacks with S/ NS using an early intervention approach. [ABSTRACT FROM AUTHOR]

Objective.- The objective of this study is to investigate migraines, both longitudinally and cross-sectionally, to understand the impact that time of treatment has on migraine duration and the patients' return to daily functioning. Background.- Several studies have explored the relationship between migraine treatment and its impact on migraine duration; however, the interrelationship of migraine onset and impact of treatment timing on migraine resolution is not completely understood. Design/Methods.- Five hundred and nine migraineurs completed 1 online baseline survey and a diary survey after each of their next 3 migraines. All subjects were 18 or older and were employed full time. Results.- Migraine episodes treated within 1 hour were significantly shorter on average than those treated after 1 hour (9.1 hours vs 12.3 hours) ( P < .05). Over-the-counter medication was the most frequently reported first-line treatment (44%) followed by an oral triptan (30%), another prescription medication (14%), and combination therapy (4%). Rescue treatment was reported in 57% of attacks. The majority of over-the-counter (69%) and another prescription (55%) treated attacks required rescue whereas only 39% of first-line triptan attacks required rescue. Conclusions.- Treating migraines early with an oral triptan-containing therapy appears to be a very effective method for reducing migraine duration and preventing the need for additional medication. Our findings also suggest that physicians should spend more time educating patients how to identify migraines early. Understanding the relationship between these key factors will provide insight into appropriate treatment and management of migraines, and more importantly, equip patients with the tools necessary to improve their outcomes and overall impact on functioning. ( Headache 2012;52:363-373) [ABSTRACT FROM AUTHOR]

Background: Disease progression in Alzheimer's Dementia (AD) is typically characterized by accelerated cognitive and functional decline, where heterogeneous trajectories can impact the observed treatment response., Methods: We hypothesized that unobserved heterogeneity could obscure treatment benefits in AD. The effect of unobserved heterogeneity was empirically quantified within the Alzheimer's Management By Albumin Replacement (AMBAR) phase 2b trial data. The ADAS-Cog 12 cognition endpoint was reanalyzed in a 2-class latent growth mixture model initially fit to the treatment arm. The model with the best fit was then applied across both treatment arms to a larger (n=1000) simulated dataset that was representative of AMBAR trial cognitive data., Results: Two classes of patients were observed: a stable cognitive trajectory class and a highly variable class. Removal of the latter (n=48, 22%) from the analysis and refitting efficacy models comparing the stable class to full placebo yielded significant treatment efficacy on cognition (p=0.007, Cohen's D=-0.4). Comparison of the stable class of each arm within the simulated dataset revealed a significant difference in treatment efficacy favoring the simulated stable treatment arm., Conclusion: This post hoc exploratory analysis suggests that prespecified strategies for addressing unobserved heterogeneity may yield improved effect detection in AD trials. The generalizability of the analytic strategy is limited by latent stratification in only the treatment arm, a requirement given the small placebo arm in AMBAR. This limitation was partially addressed by the simulation modeling., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

Background: As research continues towards improved treatments for Alzheimer disease (AD), there is growing interest in the views and needs from patients and caregivers on AD treatments., Methods: In this study, we surveyed patients with AD and caregivers to determine the treatment goals that are most important to them. Patients with AD and caregivers were independently recruited in Europe and North America to complete a web-based survey. Eligible participants were ≥18 years old and diagnosed with mild cognitive impairment or mild-to-moderate AD (patient-reported group) or persons involved in the care of patients with AD (caregiver-reported group). A total of 322 patients and 614 caregivers completed the survey., Results: The demographic characteristics of patients in the patient-reported and the caregiver-reported groups were similar. Disease severity of patients was greater in the caregiver-reported group compared with the patient-reported group (72.1% versus 46.9% moderate AD). The most important goal of AD treatment in both groups was maintenance of quality of life (QoL) (patient-reported group 31.1% and caregiver-reported group 38.8%; p =0.01). This was consistent across disease stages or symptom severity except for patients with mild cognitive impairment in the caregiver-reported group where slowing the progression of memory loss was the most important treatment goal., Conclusions: Patient QoL was consistently the most relevant treatment goal for patients with AD and caregivers. In AD clinical trials, patient-relevant outcomes, for example, QoL, should be given high priority to reflect the needs and demands of patients with AD and their caregivers.A preliminary report of this work was presented at the 14th Clinical Trials on Alzheimer's Disease meeting (November 9-12, 2021)., Competing Interests: Disclosure and potential conflicts of interest: DG-U, MCR, WIR, BH, MC and AED are current or former employees of Grifols. PN reports no conflicts of interest. The International Committee of Medical Journal Editors (ICMJE) Potential Conflicts of Interests form for the authors is available for download at: https://www.drugsincontext.com/wp-content/uploads/2024/04/dic.2023-11-6-COI.pdf, (Copyright © 2024 Gómez-Ulloa D, Runken MC, Rodriguez WI, Hernández B, Chivite M, Davis EA, Nisbet P.)

Objective: The purpose of this study was to examine the rates of acute urinary retention (AUR) and surgery after initiating 5-alpha reductase inhibitor (5ARI) therapy and to compare the 2 currently available 5ARIs, dutasteride and finasteride, in a real-world, managed care setting. This study constitutes the first direct comparison of therapeutic outcome between a mono 5ARI (finasteride) and a dual 5ARI (dutasteride)., Methods: This is a retrospective descriptive and comparative analysis of the rates of AUR and prostate surgery in patients with benign prostatic hyperplasia (BPH) treated with 5ARI therapy, either dutasteride or finasteride. Data were obtained from the PharMetrics Integrated Medical and Pharmaceutical Database (PIMPD) (Watertown, Mass) during a 6-year period. The PIMPD is a large national healthcare database that represents a total of 85 managed health plans and covers more than 45 million patients. The data analysis included all patients aged 50 years or older diagnosed with BPH who were treated with 5ARIs (dutasteride 0.5 mg/day or finasteride 5 mg/day) for up to 12 months during the 6-year period of January 1, 1999, to March 1, 2005. Patients meeting the selection criteria were evaluated for a total of 12 months with regard to the likelihood of experiencing AUR or prostate-related surgery., Results: After 5 months of 5ARI therapy, the rate of AUR during months 5 to 12 was found to be significantly lower in the dutasteride group compared with the finasteride group (5.3% vs 8.3%). After controlling for background covariates, dutasteride-treated patients were 49.1% less likely to experience AUR than patients treated with finasteride (P = .0207). Patients treated with dutasteride were also less likely to undergo prostate-related surgery, with 1.4% of dutasteride treated patients and 3.4% of patients receiving finasteride undergoing surgery; differences in surgery rates, however, were not statistically significant (P = .0745), even after controlling for background covariates. CONCLUSTION: Although the 2 drugs, dutasteride and finasteride, belong to the same category of 5ARIs, this large retrospective multivariate analysis potentially indicates differences in therapeutic outcomes. In this study, patients treated with dutasteride were less likely to experience AUR and demonstrated a trend toward being less likely to experience surgery than patients treated with finasteride.

Objective: The objective of this study was to assess the economic differences between dutasteride and finasteride patients within the first year of initiating treatment., Methods: A retrospective analysis using the PharMetrics Integrated Medical and Pharmaceutical Database (Watertown, Mass) was conducted to assess economic differences in patients who were initiated on dutasteride or finasteride. The database is nationally representative, encompassing administrative claims from more than 45 million patients within 85 managed healthcare plans. Male patients aged >50 years with a diagnosis of benign prostatic hyperplasia who began 5-alpha reductase inhibitor (5ARI) treatment (dutasteride or finasteride) between January 1, 1999, and March 1, 2005, were identified. Patients eligible for study inclusion were matched (1 dutasteride: 3 finasteride) on 4 variables (measured during the 6-month period before their first 5ARI prescription): age, presence of acute urinary retention, total amount of enlarged prostate (EP)-specific charges (+/- $1), and the duration of follow-up (measured in months). EP-specific charges were defined as the total amount charged for EP-specific physician visits, inpatient hospitalizations, outpatient hospital care, emergency department visits, and other ancillary services during the follow-up period for each patient, expressed as average monthly costs., Results: Overall, patients incurred $121.04 in EP-specific charges per month, with inpatient hospitalizations making up 39.1% ($47.29) of the total costs of care. Physician office visits constituted 33.6% ($40.66) of monthly charges. When comparing differences among patients taking the two 5ARIs, patients taking dutasteride incurred $20.50 less per month in EP-specific charges than patients taking finasteride ($105.67 vs $126.17, P = .0007). This reduction in overall medical utilization resulted from a lower amount of inpatient hospitalization charges for dutasteride patients., Conclusion: Patients treated with dutasteride incurred $20.50 less per month in medical costs than patients treated with finasteride. Healthcare plans should consider the incremental differences in medical costs along with the difference in pharmaceutical expenditures when evaluating these two 5ARIs.