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1. Tenosynovial Giant Cell Tumor Observational Platform Project (TOPP) Registry: A 2-Year Analysis of Patient-Reported Outcomes and Treatment Strategies

Author

Palmerini, Emanuela, Healey, John H, Bernthal, Nicholas M, Bauer, Sebastian, Schreuder, Hendrik, Leithner, Andreas, Martin-Broto, Javier, Gouin, Francois, Lopez-Bastida, Julio, Gelderblom, Hans, Staals, Eric L, Mercier, Florence, Laeis, Petra, Ye, Xin, and van de Sande, Michiel

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Pain Research, Chronic Pain, 7.1 Individual care needs, Management of diseases and conditions, Good Health and Well Being, Humans, Adult, Quality of Life, Prospective Studies, Giant Cell Tumor of Tendon Sheath, Pain, Patient Reported Outcome Measures, diffuse-TGCT, pexidartinib, patient-reported outcome, prospective, quality of life, tenosynovial giant cell tumor observational platform project, Oncology and Carcinogenesis, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

BackgroundThe Tenosynovial giant cell tumor Observational Platform Project (TOPP) registry is an international prospective study that -previously described the impact of diffuse-type tenosynovial giant cell tumour (D-TGCT) on patient-reported outcomes (PROs) from a baseline snapshot. This analysis describes the impact of D-TGCT at 2-year follow-up based on treatment strategies.Material and methodsTOPP was conducted at 12 sites (EU: 10; US: 2). Captured PRO measurements assessed at baseline, 1-year, and 2-year follow-ups were Brief Pain Inventory (BPI), Pain Interference, BPI Pain Severity, Worst Pain, EQ-5D-5L, Worst Stiffness, and -Patient-Reported Outcomes Measurement Information System. Treatment interventions were no current/planned treatment (Off-Treatment) and systemic treatment/surgery (On-Treatment).ResultsA total of 176 patients (mean age: 43.5 years) were included in the full analysis set. For patients without active treatment strategy -(Off-Treatment) at baseline (n = 79), BPI Pain Interference (1.00 vs. 2.86) and BPI Pain Severity scores (1.50 vs. 3.00) were numerically favorable in patients remaining Off-Treatment compared with those who switched to an active treatment strategy at year 1. From 1-year to 2-year -follow-ups, patients who remained Off-Treatment had better BPI Pain Interference (0.57 vs. 2.57) and Worst Pain (2.0 vs. 4.5) scores compared with patients who switched to an alternative treatment strategy. In addition, EQ-5D VAS scores (80.0 vs. 65.0) were higher in patients who remained -Off-Treatment between 1-year and 2-year follow-ups compared with patients who changed treatment strategy. For patients receiving systemic treatment at baseline, numerically favorable scores were seen in patients remaining on systemic therapy at 1-year follow-up: BPI Pain Interference (2.79 vs. 5.93), BPI Pain Severity (3.63 vs. 6.38), Worst Pain (4.5 vs. 7.5), and Worst Stiffness (4.0 vs. 7.5). From 1-year to 2-year follow-up, EQ-5D VAS scores (77.5 vs. 65.0) were higher in patients who changed from systemic treatment to a different treatment strategy.ConclusionThese findings highlight the impact D-TGCT has on patient quality of life, and how treatment strategies may be influenced by these outcome measures. (ClinicalTrials.gov number: NCT02948088).

Published
2023

2. A prospective real‐world study of the diffuse‐type tenosynovial giant cell tumor patient journey: A 2‐year observational analysis

Author

Bernthal, Nicholas M, Healey, John H, Palmerini, Emanuela, Bauer, Sebastian, Schreuder, Hendrik, Leithner, Andreas, Martin‐Broto, Javier, Gouin, Francois, Lopez‐Bastida, Julio, Gelderblom, Hans, Staals, Eric L, Burke, Zachary D, Geiger, Erik J, Spierenburg, Geert, Laeis, Petra, Beyerlein, Elisabeth, Ye, Xin, and van de Sande, Michiel

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Rare Diseases, Cancer, Clinical Research, Humans, Adult, Prospective Studies, Synovitis, Pigmented Villonodular, Giant Cell Tumor of Tendon Sheath, Knee Joint, Soft Tissue Neoplasms, diffuse-tenosynovial giant cell tumor, pexidartinib, prospective, real-world, TGCT observational platform project, Oncology and Carcinogenesis, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

Background and objectivesDiffuse-tenosynovial giant cell tumor (D-TGCT) is a rare, locally aggressive, typically benign neoplasm affecting mainly large joints, representing a wide clinical spectrum. We provide a picture of the treatment journey of D-TGCT patients as a 2-year observational follow-up.MethodsThe TGCT Observational Platform Project registry was a multinational, multicenter, prospective observational study at tertiary sarcoma centers spanning seven European countries and two US sites. Histologically confirmed D-TGCT patients were categorized as either those who remained on initial treatment strategy (determined at baseline visit) or those who changed treatment strategy with specific changes documented (e.g., systemic treatment to surgery) at the 1-year and/or 2-year follow-up visits.ResultsA total of 176 patients were assessed, mean diagnosis age was 38.4 (SD ± 14.6) years; most patients had a knee tumor (120/176, 68.2%). For the 2-year observation period, most patients (75.5%) remained on the baseline treatment strategy throughout, 54/79 patients (68.4%) remained no treatment, 30/45 patients (66.7%) remained systemic treatment, 39/39 patients (100%) remained surgery. Those who changed treatment strategy utilized multimodal treatment options.ConclusionsThis is the first prospectively collected analysis to describe D-TGCT patient treatments over an extended follow-up and demonstrates the need for multidisciplinary teams to determine an optimal treatment strategy.

Published
2022

3. The diffuse-type tenosynovial giant cell tumor (dt-TGCT) patient journey: a prospective multicenter study

Author

Bernthal, Nicholas M, Spierenburg, Geert, Healey, John H, Palmerini, Emanuela, Bauer, Sebastian, Gelderblom, Hans, Staals, Eric L, Lopez-Bastida, Julio, Fronk, Eva-Maria, Ye, Xin, Laeis, Petra, and van de Sande, Michiel AJ

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Trials and Supportive Activities, Rare Diseases, Pediatric, Clinical Research, Cancer, Good Health and Well Being, Adolescent, Adult, Europe, Giant Cell Tumor of Tendon Sheath, Humans, Neoplasm Recurrence, Local, Prospective Studies, Quality of Life, Retrospective Studies, Arthroscopy, Diagnosis, Patient journey, Surgery, Synovectomy, Systemic therapies, Diffuse TGCT, TOPP registry, TOPP Study Group, Other Medical and Health Sciences, Genetics & Heredity, Genetics, Clinical sciences
Abstract

BackgroundTenosynovial giant cell tumor (TGCT) is a rare, locally aggressive neoplasm arising from the synovium of joints, bursae, and tendon sheaths affecting small and large joints. It represents a wide spectrum ranging from minimally symptomatic to massively debilitating. Most findings to date are mainly from small, retrospective case series, and thus the morbidity and actual impact of this rare disease remain to be elucidated. This study prospectively explores the management of TGCT in tertiary sarcoma centers.MethodsThe TGCT Observational Platform Project registry was a multinational, multicenter, prospective observational study involving 12 tertiary sarcoma centers in 7 European countries, and 2 US sites. This study enrolled for 2 years all consecutive ≥ 18 years old patients, with histologically diagnosed primary or recurrent cases of diffuse-type TGCT. Patient demographic and clinical characteristics were collected at baseline and every 6 months for 24 months. Quality of life questionnaires (PROMIS-PF and EQ-5D) were also administered at the same time-points. Here we report baseline patient characteristics.Results166 patients were enrolled between November 2016 and March 2019. Baseline characteristics were: mean age 44 years (mean age at disease onset: 39 years), 139/166 (83.7%) had prior treatment, 71/166 patients (42.8%) had ≥ 1 recurrence after treatment of their primary tumor, 76/136 (55.9%) visited a medical specialist ≥ 5 times, 66/116 (56.9%) missed work in the 24 months prior to baseline, and 17/166 (11.6%) changed employment status or retired prematurely due to disease burden. Prior treatment consisted of surgery (i.e., arthroscopic, open synovectomy) (128/166; 77.1%) and systemic treatments (52/166; 31.3%) with imatinib (19/52; 36.5%) or pexidartinib (27/52; 51.9%). Treatment strategies at baseline visits consisted mainly of watchful waiting (81/166; 48.8%), surgery (41/166; 24.7%), or targeted systemic therapy (37/166; 22.3%). Patients indicated for treatment reported more impairment compared to patients indicated for watchful waiting: worst stiffness NRS 5.16/3.44, worst pain NRS 6.13/5.03, PROMIS-PF 39.48/43.85, and EQ-5D VAS 66.54/71.85.ConclusionThis study confirms that diffuse-type TGCT can highly impact quality of life. A prospective observational registry in rare disease is feasible and can be a tool to collect curated-population reflective data in orphan diseases. Name of registry: Tenosynovial Giant Cell Tumors (TGCT) Observational Platform Project (TOPP).Trial registration numberNCT02948088. Date of registration: 10 October 2016. URL of Trial registry record: https://clinicaltrials.gov/ct2/show/NCT02948088?term=NCT02948088&draw=2 .

Published
2021

4. Economic burden and health-related quality of life in tenosynovial giant-cell tumour patients in Europe: an observational disease registry

Author

J. Lopez-Bastida, I. Aranda-Reneo, B. Rodríguez-Sánchez, L. M. Peña-Longobardo, X. Ye, P. Laeis, E. M. Fronk, E. Palmerini, A. Leithner, and M. A. J. Van de Sande

Subjects
Tenosynovial giant-cell tumour (TGCT), Cost-of-illness, Health-related quality of life, Economic burden, Productivity loss, Informal care, Medicine
Abstract

Abstract Background Tenosynovial Giant-Cell Tumour (TGCT) is a benign clonal neoplastic proliferation arising from the synovium, causing a variety of symptoms and often requiring repetitive surgery. This study aims to define the economic burden—from a societal perspective—associated with TGCT patients and their health-related quality of life (HRQOL) in six European countries. Methods This article analyses data from a multinational, multicentre, prospective observational registry, the TGCT Observational Platform Project (TOPP), involving hospitals and tertiary sarcoma centres from six European countries (Austria, France, Germany, Italy, the Netherlands, and Spain). It includes information on TGCT patients’ health-related quality of life and healthcare and non-healthcare resources used at baseline (the 12-month period prior to the patients entering the registry) and after 12 months of follow-up. Results 146 TGCT patients enrolled for the study, of which 137 fulfilled the inclusion criteria. Their mean age was 44.5 years, and 62% were female. The annual average total costs associated with TGCT were €4866 at baseline and €5160 at the 12-month follow-up visit. The annual average healthcare costs associated with TGCT were €4620 at baseline, of which 67% and 18% corresponded to surgery and medical visits, respectively. At the 12-month follow-up, the mean healthcare costs amounted to €5094, with surgery representing 70% of total costs. Loss of productivity represented, on average, 5% of the total cost at baseline and 1.3% at follow-up. The most-affected HRQOL dimensions, measured with the EQ-5D-5L instrument, were pain or discomfort, mobility, and the performance of usual activities, both at baseline and at the follow-up visit. Regarding HRQOL, patients declared a mean index score of 0.75 at baseline and 0.76 at the 12-month follow-up. Conclusion The results suggest that TGCT places a heavy burden on its sufferers, which increases after one year of follow-up, mainly due to the healthcare resources required—in particular, surgical procedures. As a result, this condition has a high economic impact on healthcare budgets, while the HRQOL of TGCT patients substantially deteriorates over time.

Published
2021
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5. The diffuse-type tenosynovial giant cell tumor (dt-TGCT) patient journey: a prospective multicenter study

Author

Nicholas M. Bernthal, Geert Spierenburg, John H. Healey, Emanuela Palmerini, Sebastian Bauer, TOPP Study Group, Hans Gelderblom, Eric L. Staals, Julio Lopez-Bastida, Eva-Maria Fronk, Xin Ye, Petra Laeis, and Michiel A. J. van de Sande

Subjects
Arthroscopy, Diagnosis, Patient journey, Surgery, Synovectomy, Systemic therapies, Medicine
Abstract

Abstract Background Tenosynovial giant cell tumor (TGCT) is a rare, locally aggressive neoplasm arising from the synovium of joints, bursae, and tendon sheaths affecting small and large joints. It represents a wide spectrum ranging from minimally symptomatic to massively debilitating. Most findings to date are mainly from small, retrospective case series, and thus the morbidity and actual impact of this rare disease remain to be elucidated. This study prospectively explores the management of TGCT in tertiary sarcoma centers. Methods The TGCT Observational Platform Project registry was a multinational, multicenter, prospective observational study involving 12 tertiary sarcoma centers in 7 European countries, and 2 US sites. This study enrolled for 2 years all consecutive ≥ 18 years old patients, with histologically diagnosed primary or recurrent cases of diffuse-type TGCT. Patient demographic and clinical characteristics were collected at baseline and every 6 months for 24 months. Quality of life questionnaires (PROMIS-PF and EQ-5D) were also administered at the same time-points. Here we report baseline patient characteristics. Results 166 patients were enrolled between November 2016 and March 2019. Baseline characteristics were: mean age 44 years (mean age at disease onset: 39 years), 139/166 (83.7%) had prior treatment, 71/166 patients (42.8%) had ≥ 1 recurrence after treatment of their primary tumor, 76/136 (55.9%) visited a medical specialist ≥ 5 times, 66/116 (56.9%) missed work in the 24 months prior to baseline, and 17/166 (11.6%) changed employment status or retired prematurely due to disease burden. Prior treatment consisted of surgery (i.e., arthroscopic, open synovectomy) (128/166; 77.1%) and systemic treatments (52/166; 31.3%) with imatinib (19/52; 36.5%) or pexidartinib (27/52; 51.9%). Treatment strategies at baseline visits consisted mainly of watchful waiting (81/166; 48.8%), surgery (41/166; 24.7%), or targeted systemic therapy (37/166; 22.3%). Patients indicated for treatment reported more impairment compared to patients indicated for watchful waiting: worst stiffness NRS 5.16/3.44, worst pain NRS 6.13/5.03, PROMIS-PF 39.48/43.85, and EQ-5D VAS 66.54/71.85. Conclusion This study confirms that diffuse-type TGCT can highly impact quality of life. A prospective observational registry in rare disease is feasible and can be a tool to collect curated-population reflective data in orphan diseases. Name of registry: Tenosynovial Giant Cell Tumors (TGCT) Observational Platform Project (TOPP). Trial registration number: NCT02948088. Date of registration: 10 October 2016. URL of Trial registry record: https://clinicaltrials.gov/ct2/show/NCT02948088?term=NCT02948088&draw=2 .

Published
2021
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6. Elderly patients with atrial fibrillation in routine clinical practice—peri-procedural management of edoxaban oral anticoagulation therapy is associated with a low risk of bleeding and thromboembolic complications: a subset analysis of the prospective, observational, multinational EMIT-AF study

Author

M. Unverdorben, C. von Heymann, A. Santamaria, M. Saxena, T. Vanassche, J. Jin, P. Laeis, R. Wilkins, C. Chen, and P. Colonna

Subjects
Age, Bleeding, Systemic thromboembolism, Atrial fibrillation, Edoxaban, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Abstract Background Annually > 10% of patients with atrial fibrillation on oral anticoagulation undergo invasive procedures. Optimal peri-procedural management of anticoagulation, as judged by major bleeding and thromboembolic events, especially in the elderly, is still debated. Methods Procedures from 1442 patients were evaluated. Peri-procedural edoxaban management was guided only by the experience of the attending physician. The primary safety outcome was the rate of major bleeding. Secondary outcomes included the peri-procedural administration of edoxaban, other bleeding events, and the main efficacy outcome, a composite of acute coronary syndrome, non-hemorrhagic stroke, transient ischemic attack, systemic embolic events, deep vein thrombosis, pulmonary embolism, and mortality. Results Of the 1442 patients, 280 (19%) were 65, and seven in patients aged > 75 years. Conclusion Despite increased bleeding risk factors in the elderly, bleeding rates were small and similar across all age groups. However, there was a trend toward more thromboembolic complications with advancing age. Further efforts to identify the optimal management to reduce ischemic complications are needed. Trial registration: NCT# 02950168, October 31, 2016

Published
2020
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7. Correction to: Elderly patients with atrial fibrillation in routine clinical practice: peri-procedural management of edoxaban oral anticoagulation therapy is associated with a low risk of bleeding and thromboembolic complications: a subset analysis of the prospective, observational, multinational EMIT-AF study

Author

Unverdorben, M., von Heymann, C., Santamaria, A., Saxena, M., Vanassche, T., Jin, J., Laeis, P., Wilkins, R., Chen, C., and Colonna, P.

Published
2021
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8. Local food and tourism in the Global South

Author

Gabriel CM Laeis

Subjects
agriculture–tourism linkages, cuisine, fiji, global south, local food, south africa, sustainable tourism, Hospitality industry. Hotels, clubs, restaurants, etc. Food service, TX901-946.5
Abstract

Many countries in the Global South import a significant share of the food served to tourists. For decades, closer linkages of local food producer and the resort industry have been heralded as an antidote to this unsustainable circumstance, further encouraged by the current consumer trend around local food. Reflections on two qualitative research projects in resorts in South Africa and Fiji challenge the notion that tourists move out of their comfort zone to eat local dishes to any greater extent. Large-scale, internationally branded and managed resorts serve predominantly what their tourists from the Global North like to eat: a Western cuisine. If farmers want to benefit from this resort industry, they have to grow food according to the Western palate, which in turn has questionable impacts on biodiversity levels and environmental health in general. The discussion around localising tourism-related food chains in countries of the Global South needs to acknowledge for whose agenda food is being produced. “Corporate resorts” endorse neither a very sustainable nor a locally adaptable culinary agenda.

Published
2019
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9. Characteristics of patients initiated on edoxaban in Europe: baseline data from edoxaban treatment in routine clinical practice for patients with atrial fibrillation (AF) in Europe (ETNA-AF-Europe)

Author

Raffaele De Caterina, Peter Kelly, Pedro Monteiro, Jean Claude Deharo, Carlo de Asmundis, Esteban López-de-Sá, Thomas W. Weiss, Johannes Waltenberger, Jan Steffel, Joris R. de Groot, Pierre Levy, Ameet Bakhai, Wolfgang Zierhut, Petra Laeis, Michael Kerschnitzki, Paul-Egbert Reimitz, Paulus Kirchhof, and on behalf of the ETNA-AF-Europe investigators

Subjects
Non-vitamin K antagonist oral anticoagulants, Real-world, Registry, Stroke prevention, Major bleeding, Safety outcomes, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Abstract Background Non-vitamin K antagonist (VKA) oral anticoagulants (NOACs) have substantially improved anticoagulation therapy for prevention of stroke and systemic embolism in patients with atrial fibrillation (AF). The available routine care data have demonstrated the safety of different NOACs; however, such data for edoxaban are scarce. Here, we report baseline characteristics of 13,638 edoxaban-treated patients with AF enrolled between November 2016 and February 2018. Methods ETNA-AF-Europe is a multinational, multi-centre, post-authorisation, observational study conducted in 825 sites in 10 European countries. Patients will be followed up for four years. Results Overall, 13,980 patients were enrolled of which 342 patients were excluded from the analysis. Mean patient age was 73.6 years with an average creatinine clearance of 69.4 mL/min. 56.6% were male. The calculated CHA2DS2-VASc and HAS-BLED mean scores were 3.1 and 2.6, respectively. Overall, 3.3, 14.6 and 82.0% of patients had low (CHA2DS2-VASc = 0), intermediate (CHA2DS2-VASc = 1) and high (CHA2DS2-VASc≥2) risks of stroke, respectively. High-risk patients (those with prior stroke, prior major bleeding, prior intracranial bleed or CHA2DS2-VASc ≥4) comprised 38.4% of the overall population. For 75.1% of patients edoxaban was their first anticoagulant prescription, whilst 16.9% switched from a VKA and 8.0% from another NOAC. A total of 23.4% of patients in ETNA-AF-Europe received the reduced dose of edoxaban 30 mg. Overall, 83.8% of patients received an edoxaban dose in line with the criteria outlined in the label. Conclusion Edoxaban was predominantly initiated in older, often anticoagulation-naïve, unselected European patients with AF, with a good overall adherence to the approved label. Trial registration NCT02944019; Date of registration: October 24, 2016.

Published
2019
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11. Design and rationale of the non-interventional, edoxaban treatment in routiNe clinical prActice in patients with venous ThromboEmbolism in Europe (ETNA-VTE-Europe) study

Author

Alexander T. Cohen, Cihan Ay, Philippe Hainaut, Hervé Décousus, Ulrich Hoffmann, Sean Gaine, Michiel Coppens, Pedro Marques da Silva, David Jiménez, Beatrice Amann-Vesti, Bernd Brüggenjürgen, Pierre Levy, Julio Lopez Bastida, Eric Vicaut, Petra Laeis, Eva-Maria Fronk, Wolfgang Zierhut, Thomas Malzer, Peter Bramlage, Giancarlo Agnelli, and on behalf of the ETNA-VTE-Europe investigators

Subjects
Venous thromboembolism (VTE), Edoxaban, Direct oral anticoagulant (DOAC/NOAC), Anticoagulation, Registry, Diseases of the blood and blood-forming organs, RC633-647.5
Abstract

Abstract Background Venous thromboembolism (VTE, including deep vein thrombosis [DVT] and pulmonary embolism [PE]) has an annual incidence rate of 104–183 per 100,000 person-years. After a VTE episode, the two-year recurrence rate is about 17%. Consequently, effective and safe anticoagulation is paramount. Edoxaban is a direct oral anticoagulant (DOAC) approved VTE treatment. Current safety and efficacy data are derived from clinical trials, and information about treatment durations beyond 12 months are not available. Methods ETNA-VTE-Europe is an 18-month prospective, single-arm, non-interventional, multinational post-authorisation safety study. Approximately 310 sites across eight European countries (Austria, Belgium, Germany, Ireland, Italy, the Netherlands, Switzerland and the United Kingdom) will participate in the study, with the intention to represent the regional distributions of centres, healthcare settings and specialties. An estimated cohort of 2700 patients will be recruited, the only enrolment criteria being acute symptomatic VTE, no participation in an interventional study, and treating physician decision to prescribe edoxaban independently from the registry. Data from patient medical records and/or telephone interviews will be collected at baseline, 1, 3, 6, 12 and 18 months. The primary objective is to evaluate the 18-month rate of symptomatic VTE recurrence in patients with VTE treated with edoxaban outside a clinical trial. The co-primary objective is to evaluate the real-world rates of bleeding and adverse drug reactions. Secondary outcomes include rates of other patient-relevant safety events, adherence to and discontinuation of edoxaban. Furthermore, 12-month ETNA-VTE-Europe data will be considered in the context of those for patients receiving different anticoagulants in the PREFER in VTE registry and Hokusai-VTE clinical trial. Conclusions ETNA-VTE-Europe will allow the safety and effectiveness of edoxaban to be evaluated over an extended period in acute symptomatic VTE patients encountered in routine clinical practice. Findings will be informative for European practitioners prescribing edoxaban as part of real-world VTE treatment/prevention. Trial registration ClinicalTrials.gov Identifier: NCT02943993.

Published
2018
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12. Correction to: Elderly patients with atrial fibrillation in routine clinical practice: peri-procedural management of edoxaban oral anticoagulation therapy is associated with a low risk of bleeding and thromboembolic complications: a subset analysis of the prospective, observational, multinational EMIT-AF study

Author

M. Unverdorben, C. von Heymann, A. Santamaria, M. Saxena, T. Vanassche, J. Jin, P. Laeis, R. Wilkins, C. Chen, and P. Colonna

Subjects
Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

An amendment to this paper has been published and can be accessed via the original article.

Published
2021
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13. Characteristics of patients initiated on edoxaban in Europe: baseline data from edoxaban treatment in routine clinical practice for patients with atrial fibrillation (AF) in Europe (ETNA-AF-Europe)

Author

De Caterina, Raffaele, Kelly, Peter, Monteiro, Pedro, Deharo, Jean Claude, de Asmundis, Carlo, López-de-Sá, Esteban, Weiss, Thomas W., Waltenberger, Johannes, Steffel, Jan, de Groot, Joris R., Levy, Pierre, Bakhai, Ameet, Zierhut, Wolfgang, Laeis, Petra, Kerschnitzki, Michael, Reimitz, Paul-Egbert, Kirchhof, Paulus, and on behalf of the ETNA-AF-Europe investigators

Published
2019
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14. Correction to: Design and rationale of the non-interventional, edoxaban treatment in routiNe clinical prActice in patients with venous ThromboEmbolism in Europe (ETNA-VTE-Europe) study

Author

Cohen, Alexander T., Ay, Cihan, Hainaut, Philippe, Décousus, Hervé, Hoffmann, Ulrich, Gaine, Sean, Coppens, Michiel, da Silva, Pedro Marques, Jimenez, David, Amann-Vesti, Beatrice, Brüggenjürgen, Bernd, Levy, Pierre, Bastida, Julio Lopez, Vicaut, Eric, Laeis, Petra, Fronk, Eva-Maria, Zierhut, Wolfgang, Malzer, Thomas, Bramlage, Peter, Agnelli, Giancarlo, and on behalf of the ETNA-VTE-Europe investigators

Published
2018
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15. Design and rationale of the non-interventional, edoxaban treatment in routiNe clinical prActice in patients with venous ThromboEmbolism in Europe (ETNA-VTE-Europe) study

Author

Cohen, Alexander T., Ay, Cihan, Hainaut, Philippe, Décousus, Hervé, Hoffmann, Ulrich, Gaine, Sean, Coppens, Michiel, da Silva, Pedro Marques, Jiménez, David, Amann-Vesti, Beatrice, Brüggenjürgen, Bernd, Levy, Pierre, Bastida, Julio Lopez, Vicaut, Eric, Laeis, Petra, Fronk, Eva-Maria, Zierhut, Wolfgang, Malzer, Thomas, Bramlage, Peter, Agnelli, Giancarlo, and on behalf of the ETNA-VTE-Europe investigators

Published
2018
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16. A prospective real-world study of the diffuse-type tenosynovial giant cell tumor patient journey: A 2-year observational analysis.

Author

Bernthal, N.M., Healey, J.H., Palmerini, E., Bauer, S., Schreuder, H.W.B., Leithner, A., Martin-Broto, J., Gouin, F., Lopez-Bastida, J., Gelderblom, H., Staals, E.L., Burke, Z.D., Geiger, E.J., Spierenburg, G., Laeis, P., Beyerlein, E., Ye, X., Sande, Michiel van de, Bernthal, N.M., Healey, J.H., Palmerini, E., Bauer, S., Schreuder, H.W.B., Leithner, A., Martin-Broto, J., Gouin, F., Lopez-Bastida, J., Gelderblom, H., Staals, E.L., Burke, Z.D., Geiger, E.J., Spierenburg, G., Laeis, P., Beyerlein, E., Ye, X., and Sande, Michiel van de

Abstract

01 december 2022, Item does not contain fulltext, BACKGROUND AND OBJECTIVES: Diffuse-tenosynovial giant cell tumor (D-TGCT) is a rare, locally aggressive, typically benign neoplasm affecting mainly large joints, representing a wide clinical spectrum. We provide a picture of the treatment journey of D-TGCT patients as a 2-year observational follow-up. METHODS: The TGCT Observational Platform Project registry was a multinational, multicenter, prospective observational study at tertiary sarcoma centers spanning seven European countries and two US sites. Histologically confirmed D-TGCT patients were categorized as either those who remained on initial treatment strategy (determined at baseline visit) or those who changed treatment strategy with specific changes documented (e.g., systemic treatment to surgery) at the 1-year and/or 2-year follow-up visits. RESULTS: A total of 176 patients were assessed, mean diagnosis age was 38.4 (SD ± 14.6) years; most patients had a knee tumor (120/176, 68.2%). For the 2-year observation period, most patients (75.5%) remained on the baseline treatment strategy throughout, 54/79 patients (68.4%) remained no treatment, 30/45 patients (66.7%) remained systemic treatment, 39/39 patients (100%) remained surgery. Those who changed treatment strategy utilized multimodal treatment options. CONCLUSIONS: This is the first prospectively collected analysis to describe D-TGCT patient treatments over an extended follow-up and demonstrates the need for multidisciplinary teams to determine an optimal treatment strategy.

Published
2022

17. Correction to: Design and rationale of the non-interventional, edoxaban treatment in routiNe clinical prActice in patients with venous ThromboEmbolism in Europe (ETNA-VTE-Europe) study

Author

Alexander T. Cohen, Cihan Ay, Philippe Hainaut, Hervé Décousus, Ulrich Hoffmann, Sean Gaine, Michiel Coppens, Pedro Marques da Silva, David Jimenez, Beatrice Amann-Vesti, Bernd Brüggenjürgen, Pierre Levy, Julio Lopez Bastida, Eric Vicaut, Petra Laeis, Eva-Maria Fronk, Wolfgang Zierhut, Thomas Malzer, Peter Bramlage, Giancarlo Agnelli, and on behalf of the ETNA-VTE-Europe investigators

Subjects
Diseases of the blood and blood-forming organs, RC633-647.5
Abstract

Correction to: Thrombosis Journal (2018) 16:9 DOI 10.1186/s12959-018-0163-7

Published
2018
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18. Design and rationale of the Edoxaban Treatment in routiNe clinical prActice for patients with Atrial Fibrillation in Europe (ETNA-AF-Europe) study

Author

De Caterina, R., Kelly, P., Monteiro, P., Deharo, J. C., de Asmundis, C., López-de-Sá, E., Weiss, T. W., Waltenberger, J., Steffel, J., de Groot, J. R., Levy, P., Bakhai, A., Zierhut, W., Laeis, P., Reimitz, P. -E., Kirchhof, P., on behalf of the ETNA-AF-Europe investigators, Clinical sciences, Heartrhythmmanagement, Institute of Clinical Physiology, National Council of Research, NS Research, Novartis Institutes for BioMedical Research (NIBR), Division of Medicine, University College of London [London] (UCL), Neurovascular Clinical Science Unit, Catherine McAuley Centre, Mater Misericordiae University Hospital, Département de Cardiologie [Hôpital de la Timone - APHM], Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE), Laboratoire d'Economie de Dauphine (LEDa), Université Paris Dauphine-PSL, Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL), Laboratoire d'Economie et de Gestion des Organisations de Santé (Legos), Department of Medicine, Royal Free (DEPARTMENT OF MEDICINE, ROYAL FREE), Royal Free and University College London School of Medicine, Daiichi Sankyo Inc., Daiichi Sankyo Co., ACS - Heart failure & arrhythmias, Cardiology, University of Zurich, and De Caterina, Raffaele

Subjects
Research design, Time Factors, medicine.drug_mechanism_of_action, Pyridines, Administration, Oral, Major bleeding, 030204 cardiovascular system & hematology, chemistry.chemical_compound, 0302 clinical medicine, Edoxaban, Stroke prevention, Atrial Fibrillation, Epidemiology, Routine clinical practice, Prospective Studies, Registries, 030212 general & internal medicine, Prospective cohort study, Stroke, [QFIN]Quantitative Finance [q-fin], Atrial fibrillation, General Medicine, 3. Good health, Europe, JEL: I - Health, Education, and Welfare/I.I1 - Health/I.I1.I11 - Analysis of Health Care Markets, Treatment Outcome, ETNA-AF-Europe study, Research Design, 10209 Clinic for Cardiology, epidemiology, Cardiology and Cardiovascular Medicine, Registry, medicine.medical_specialty, Factor Xa Inhibitor, 610 Medicine & health, Hemorrhage, 2705 Cardiology and Cardiovascular Medicine, 03 medical and health sciences, Nonvitamin K antagonist oral anticoagulants, Internal medicine, medicine, Humans, cardiovascular diseases, Safety outcomes, business.industry, PREFER in AF, medicine.disease, JEL: I - Health, Education, and Welfare/I.I1 - Health/I.I1.I12 - Health Behavior, Thiazoles, Real-world, chemistry, business, Factor Xa Inhibitors
Abstract

AIM: Edoxaban, a nonvitamin K antagonist oral anticoagulant, is an oral factor Xa inhibitor approved for the prevention of stroke and systemic embolism in adult patients with atrial fibrillation and for the treatment and secondary prevention in adult patients with venous thromboembolism (VTE). This study details the design of the Edoxaban Treatment in routiNe clinical prActice for patients with Atrial Fibrillation in Europe (ETNA-AF-Europe) study - a postauthorization observational study, which is part of the postapproval plan for edoxaban agreed with the European Medicines Agency. METHODS: The ETNA-AF-Europe study (Clinicaltrials.gov: NCT02944019) is a multicenter, prospective, observational study that enrolled 13 980 patients with atrial fibrillation treated with edoxaban from 852 sites across 10 European countries (Austria, Belgium, Germany, Ireland, Italy, the Netherlands, Portugal, Spain, Switzerland, and the United Kingdom). Patients treated with edoxaban were prospectively enrolled and will be followed up for 4 years with yearly follow-up visits. ASSESSMENTS: The primary objective of the ETNA-AF-Europe study is to assess the real-world safety of edoxaban by evaluating bleeding events, including intracranial hemorrhage; drug-related adverse events, such as hepatic events; and cardiovascular and all-cause mortality. In addition, efficacy will be assessed by recording major adverse cardiovascular events including stroke, systemic embolic events, transient ischemic attacks, and also VTE episodes, acute coronary syndromes, and hospitalizations related to cardiovascular condition. Event rates will be compared with event rates reported in the PREvention oF thromboembolic events-European Registry in Atrial Fibrillation in atrial fibrillation (PREFER in AF) and PREFER in AF Prolongation registries, and in the Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation - Thrombolysis in Myocardial Infarction 48 study datasets.

Published
2019

19. The diffuse-type tenosynovial giant cell tumor (dt-TGCT) patient journey

Author

Bernthal, N.M., Spierenburg, G., Healey, J.H., Palmerini, E., Bauer, S., Gelderblom, H., Staals, E.L., Lopez-Bastida, J., Fronk, E.M., Ye, X., Laeis, P., Sande, M.A.J. van de, TOPP Study Grp, Daiichi-Sankyo, National Institutes of Health (US), and National Cancer Institute (US)

Subjects
Patient journey, medicine.medical_treatment, Medizin, Synovectomy, Arthroscopy, 0302 clinical medicine, Quality of life, Diagnosis, Pharmacology (medical), 030212 general & internal medicine, Prospective Studies, Genetics (clinical), Cancer, Pediatric, Genetics & Heredity, Systemic therapies, General Medicine, Primary tumor, Europe, Local, 030220 oncology & carcinogenesis, Medicine, Sarcoma, TOPP registry, Diffuse TGCT, musculoskeletal diseases, Adult, medicine.medical_specialty, Adolescent, Clinical Trials and Supportive Activities, Pexidartinib, Giant Cell Tumor of Tendon Sheath, 03 medical and health sciences, Rare Diseases, Clinical Research, Internal medicine, medicine, Humans, TOPP Study Group, Retrospective Studies, Other Medical and Health Sciences, business.industry, Research, medicine.disease, Neoplasm Recurrence, Good Health and Well Being, Quality of Life, Observational study, Surgery, Neoplasm Recurrence, Local, business, Watchful waiting, Rare disease
Abstract

[Background] Tenosynovial giant cell tumor (TGCT) is a rare, locally aggressive neoplasm arising from the synovium of joints, bursae, and tendon sheaths affecting small and large joints. It represents a wide spectrum ranging from minimally symptomatic to massively debilitating. Most findings to date are mainly from small, retrospective case series, and thus the morbidity and actual impact of this rare disease remain to be elucidated. This study prospectively explores the management of TGCT in tertiary sarcoma centers., [Methods] The TGCT Observational Platform Project registry was a multinational, multicenter, prospective observational study involving 12 tertiary sarcoma centers in 7 European countries, and 2 US sites. This study enrolled for 2 years all consecutive ≥ 18 years old patients, with histologically diagnosed primary or recurrent cases of diffuse-type TGCT. Patient demographic and clinical characteristics were collected at baseline and every 6 months for 24 months. Quality of life questionnaires (PROMIS-PF and EQ-5D) were also administered at the same time-points. Here we report baseline patient characteristics., [Results] 166 patients were enrolled between November 2016 and March 2019. Baseline characteristics were: mean age 44 years (mean age at disease onset: 39 years), 139/166 (83.7%) had prior treatment, 71/166 patients (42.8%) had ≥ 1 recurrence after treatment of their primary tumor, 76/136 (55.9%) visited a medical specialist ≥ 5 times, 66/116 (56.9%) missed work in the 24 months prior to baseline, and 17/166 (11.6%) changed employment status or retired prematurely due to disease burden. Prior treatment consisted of surgery (i.e., arthroscopic, open synovectomy) (128/166; 77.1%) and systemic treatments (52/166; 31.3%) with imatinib (19/52; 36.5%) or pexidartinib (27/52; 51.9%). Treatment strategies at baseline visits consisted mainly of watchful waiting (81/166; 48.8%), surgery (41/166; 24.7%), or targeted systemic therapy (37/166; 22.3%). Patients indicated for treatment reported more impairment compared to patients indicated for watchful waiting: worst stiffness NRS 5.16/3.44, worst pain NRS 6.13/5.03, PROMIS-PF 39.48/43.85, and EQ-5D VAS 66.54/71.85., [Conclusion] This study confirms that diffuse-type TGCT can highly impact quality of life. A prospective observational registry in rare disease is feasible and can be a tool to collect curated-population reflective data in orphan diseases., [Name of registry] Tenosynovial Giant Cell Tumors (TGCT) Observational Platform Project (TOPP)., [Trial registration number] NCT02948088., [Date of registration] 10 October 2016., [URL of Trial registry record] https://clinicaltrials.gov/ct2/show/NCT02948088?term=NCT02948088&draw=2., Sponsored by Daiichi Sankyo, Co., Ltd; ClinicalTrials.gov Number NCT02948088. The Department of Orthopaedics of the Leiden University Medical Center receives research funding from Daiichi Sankyo. All research funding for Memorial Sloan Kettering is supported in part by a grant from the National Institutes of Health/National Cancer Institute (#P30 CA008748).

Published
2021

20. P1.24 DOSE-DEPENDENT INWARD ARTERIAL REMODELLING AND DE STIFFENING AFTER OLMESARTAN IN HYPERSENTSIVES WITH METABOLIC SYNDROME: THE VASCULAR MECHANISM STUDY

Author

S. Laurent, P. Laeis, H. Rauer, and P. Boutouyrie

Subjects
Specialties of internal medicine, RC581-951, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Background: Whether angiotensin receptor blockers can dose-dependently remodel the arterial wall during long-term treatment has only been rarely studied. Olmesartan (OM) has previously shown a favourable pharmacodynamic profile for such an action. Methods: In this phase 3, multi-centre, double-blind, randomized, parallel-group study, 133 subjects with hypertension and metabolic syndrome were assigned to three treatment groups and received either OM 20 mg (n=44), OM 40 mg (n=42), or OM 80 mg (n=47) once a day according to a force-titration design during a 1 year period. Office blood pressure (BP), 24hABPM, aortic stiffness (carotid-femoral pulse wave velocity-PWV) and carotid parameters (diameter, intima-media thickness, and stiffness) were measured at baseline, 24 weeks (W24) and 52 weeks (W52). A mixed-model was used for statistical analysis. Results: PWV significantly decreased (P

Published
2013
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22. Edoxaban versus Vitamin K Antagonist for Atrial Fibrillation after TAVR

Author

Van Mieghem, NM, Unverdorben, M, Hengstenberg, C, Mollmann, H, Mehran, R, Lopez-Otero, D, Nombela-Franco, L, Moreno, R, Nordbeck, P, Thiele, H, Lang, IE, Zamorano, JL, Shawl, F, Yamamoto, M, Watanabe, Y, Hayashida, K, Hambrecht, R, Meincke, F, Vranckx, P, Jin, JM, Boersma, E, Rodes-Cabau, J, Ohlmann, P, Capranzano, P, Kim, HS, Pilgrim, T, Anderson, R, Baber, U, Duggal, A, Laeis, P, Lanz, H, Chen, C, Valgimigli, M, Veltkamp, R, Saito, S, Dangas, GD, Asmarats L., and ENVISAGE TAVI AF Investigators

Abstract

Background The role of direct oral anticoagulants as compared with vitamin K antagonists for atrial fibrillation after successful transcatheter aortic-valve replacement (TAVR) has not been well studied. Methods We conducted a multicenter, prospective, randomized, open-label, adjudicator-masked trial comparing edoxaban with vitamin K antagonists in patients with prevalent or incident atrial fibrillation as the indication for oral anticoagulation after successful TAVR. The primary efficacy outcome was a composite of adverse events consisting of death from any cause, myocardial infarction, ischemic stroke, systemic thromboembolism, valve thrombosis, or major bleeding. The primary safety outcome was major bleeding. On the basis of a hierarchical testing plan, the primary efficacy and safety outcomes were tested sequentially for noninferiority, with noninferiority of edoxaban established if the upper boundary of the 95% confidence interval for the hazard ratio did not exceed 1.38. Superiority testing of edoxaban for efficacy would follow if noninferiority and superiority were established for major bleeding. Results A total of 1426 patients were enrolled (713 in each group). The mean age of the patients was 82.1 years, and 47.5% of the patients were women. Almost all the patients had atrial fibrillation before TAVR. The rate of the composite primary efficacy outcome was 17.3 per 100 person-years in the edoxaban group and 16.5 per 100 person-years in the vitamin K antagonist group (hazard ratio, 1.05; 95% confidence interval [CI], 0.85 to 1.31; P=0.01 for noninferiority). Rates of major bleeding were 9.7 per 100 person-years and 7.0 per 100 person-years, respectively (hazard ratio, 1.40; 95% CI, 1.03 to 1.91; P=0.93 for noninferiority); the difference between groups was mainly due to more gastrointestinal bleeding with edoxaban. Rates of death from any cause or stroke were 10.0 per 100 person-years in the edoxaban group and 11.7 per 100 person-years in the vitamin K antagonist group (hazard ratio, 0.85; 95% CI, 0.66 to 1.11). Conclusions In patients with mainly prevalent atrial fibrillation who underwent successful TAVR, edoxaban was noninferior to vitamin K antagonists as determined by a hazard ratio margin of 38% for a composite primary outcome of adverse clinical events. The incidence of major bleeding was higher with edoxaban than with vitamin K antagonists. (Funded by Daiichi Sankyo; ENVISAGE-TAVI AF ClinicalTrials.gov number, .) Edoxaban for Atrial Fibrillation with TAVR In a randomized trial involving patients who had atrial fibrillation after TAVR, edoxaban was noninferior to vitamin K antagonists with respect to a composite outcome of death, MI, stroke, thromboembolism, valve thrombosis, or major bleeding but was associated with a higher incidence of major bleeding.

Published
2021

23. Additional file 1 of Economic burden and health-related quality of life in tenosynovial giant-cell tumour patients in Europe: an observational disease registry

Author

Lopez-Bastida, J., Aranda-Reneo, I., Rodríguez-Sánchez, B., Peña-Longobardo, L. M., Ye, X., Laeis, P., Fronk, E. M., Palmerini, E., Leithner, A., and Van de Sande, M. A. J.

Subjects
macromolecular substances, health care economics and organizations
Abstract

Additional file 1. Unit costs, health-related quality of life by country and average annual costs per patient by tumour severity.

Published
2021
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24. Routine clinical practice in the periprocedural management of edoxaban therapy is associated with low risk of bleeding and thromboembolic complications: The prospective, observational, and multinational EMIT-AF/VTE study

Author

Colonna P, von Heymann C, Santamaria A, Saxena M, Vanassche T, Wolpert D, Laeis P, Wilkins R, Chen C, and Unverdorben M

Subjects
edoxaban, periprocedural management, venous thromboembolism, atrial fibrillation, NOAC, bleeding
Abstract

Background Guidance for periprocedural anticoagulant management is mainly based on limited data from Phase III or observational studies and expert opinion. Hypothesis EMIT-AF/VTE was designed to document the risks of bleeding and thromboembolic events in more than 1000 patients on edoxaban undergoing diagnostic and therapeutic procedures in clinical practice. Methods Routine care in a multinational multicenter, prospective observational study. Participants were adult patients with atrial fibrillation and/or venous thromboembolism treated with edoxaban for stroke prevention or for secondary prevention in venous thromboembolic disease, undergoing a wide range of diagnostic and therapeutic procedures. Edoxaban therapy was interrupted periprocedurally at the treating physician's discretion. Patients were evaluated from 5 days pre- until 30 days postprocedure. Primary outcome was the incidence of International Society on Thrombosis and Haemostasis defined major bleeding; secondary outcomes included incidence of clinically relevant non-major bleeding, acute coronary syndrome, and acute thromboembolic events. Results Outcomes and management are reported for the first procedures in 1155 unselected patients. Five cases of major bleeding (0.4%) and eight of clinically relevant non-major bleeding (0.7%) were documented, five (38%) of which occurred outside the period of likely edoxaban effect (last edoxaban dose >= 3 days prior to bleeding). Five (0.4%) deaths from any cause, seven acute thromboembolic events (0.6%) including two cardiac deaths (0.2%) in six patients, and one acute coronary event (0.1%) occurred. Conclusions The periprocedural bleeding and acute thromboembolic event risks for patients treated with edoxaban were low. This can help inform both clinical routine and guidelines for the periprocedural management of edoxaban.

Published
2020

26. PRO134 HEALTH-RELATED QUALITY OF LIFE IN TENOSYNOVIAL GIANT CELL TUMOR (TGCT) PATIENTS IN EUROPE AND US: AN OBSERVATIONAL DISEASE REGISTRY

Author

Lopez Bastida, J., primary, Ye, X., additional, Laeis, P., additional, Fronk, E.M., additional, Healey, J.H., additional, Stacchiotti, S., additional, Palmerini, E., additional, Bauer, S., additional, Bernthal, N.M., additional, Schreuder, B., additional, Leithner, A., additional, and Van de Sande, M., additional

Published
2019
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28. The management of acute venous thromboembolism in clinical practice - study rationale and protocol of the European PREFER in VTE Registry

Author

Agnelli, G., Gitt, A. K., Bauersachs, R., Fronk, E. -M., Laeis, P., Mismetti, P., Monreal, M., Willich, S. N., Wolf, W. -P., Cohen, A. T., Brodmann, M., Rief, P., Eischer, L., Stoshikj, S., Hirschl, M., Weinmann, S., Marschang, P., Abbadie, F., Achkar, A., Addala, A., Adnet, F., Alexandra, J. -F., Aquilanti, S., Belhassane, A., Benaroya, A., Berremili, T., Grenot, M. C., Birr, V., Holtea, D., Bonnin, C., Bosler, F., Durand, M. -G. B., Brisot, D., Brousse, C., De La Fuente, T., Cayman, R., Cazaubon, M., Champion, O., Chanut, M., Chevalet, P., Connault, J., Durant, C., Constans, J., Cordeanu, M., Couturaud, F., Lacut, K., De Dedker, L., Decoulx, E., Derrien, B., Diamand, J. -M., Diard, A., Douadi, Y., Dupas, S., Remond, S. S. M., Sevestre, M. -A., Edhery, S., Falvo, N., Taralunga, C. F., Ferrari, E., Gaillard, C., Garrigues, D., Gillet, J. L., Giordana, P., Grange, C., Vital-Durand, D., Grare, F., Henni, A. H., Heuser, S., Schmidt, J., Hidden-Henic, V., Hottin, D., Imbert, B., Pernod, G., Jakob, D., Jacquinandi, V., Jurus, C., Lacoste, A., Laroche, J. -P., Martin, M., Mazollier, C., Mersel, T., Miserey, G., Nedey, C., Nou, M., Quere, I., Ouvry, P., Peuch, B., Pichot, O., Poulain, V., Ray, P., Rifai, A., Roy, P. -M., Saby, J. -C., Simon, F., Simonot-Lalandec, E., Stephan, D., Tissot, A., Vodoungnon, H., Adamczyk, A., Schnabl, S., Ahmad, W. A., Weber, H., Axthelm, C., Bergmann, K., Beschorner, U., Knittel, M., Binias, K. -H., Pasligh, M., Boral, M., Friederike, G., Bratsch, H., Brauer, G., Burghard, S., Demann, C., Rennebaum, C., Demmig, A., Eberlein, U., Enger, F., Eschenburg, J., Forkmann, L., Frank, J., Freischmidt, H., Gassauer, M., Fritsche, I., Kubicek-Hofmann, C., Goebels, M. -C., Guggenbichler, S., Hartel, D., Hartmann, K., Heilberger, P., Heinsius, A., Held, M., Schnupp, S., Herman, G., Herold, J., Hertrich, F., Hommel, H., Hutte, G., Kalka, C., Jungandreas, K., Ramthor, M., Karcher, J., Werner, N., Karl-Wollweber, S., Keilhau, D. -A., Kittel, K., Knolinski, T., Kohler, C., Werth, S., Kopplin, U., Korner, I., Wittig, K., Kroger, K., Moysidis, T., Kroschel, U., Leschke, M., zur Nieden, T., Lubbert, G., Lutz, A., Wucherpfennig, P., Marencke, G. -H., Mortensen, K., Reppel, M., Nelles, H., Nestler, K., Neumeister, A., Schlosser, A., Oettler, W., Ott, I., Otto, A., Pertermann, A., Pfister, R., Pindur, L., Pourhassan, S., Predel, D., Pudollek, T., Reimer, D., Richter, C., Rieker, E., Rothenbucher, G., Rothhagen, B., Rudolff, S., Stucker, M., Schafer, A., Sonnenschein, K., Schafnitzl, W., Schellong, S., Voigts, B., Schiller, M., Schmeink, T., Schneider, H., Schon, N., Schulze, M., Sechtem, U., Sedl, S., Werno, H. S., Stachowitz, J., Thieme, M., Tiefenbacher, C., Tsantilas, D., Vieth, P., vom Dahl, J., Grun-Himmelmann, K., von Bilderling, P., von Maltik, T., Weinrich, K., Weyer, M., Koln, E. K., Wirtz, P., Wittig, I., Zierock, P., Ageno, W., Caprioli, M., Rancan, E., Guercini, F., Mommi, V., Amitrano, M., Cannavacciuolo, F., Amore, M., D'Antoni, S., Angelini, E., Forgia, S. L., Antignani, P. L., Calandra, G., Arone, A., Perticone, F., Sciacqua, A., Asaro, G., Bellisi, M., Attanzio, M. T., Pinto, A., Attinasi, V., Cillari, E., Sorvillo, S., Balbarini, A., Santini, C., Violo, C., Banfi, E., Lodigiani, C., Barcellona, D., Delpin, S., Marongiu, S., Barillari, G., Pasca, S, Bartolini, C., Verdecchia, P., Bartone, M., Mancuso, G., Bellanuova, I., Felis, S., Bellizzi, A., Masotti, L., Bianchi, M., Carugati, A., Bianchini, G., Guarnera, G., Boari, B., Gallerani, M., Pasin, M., Bortoluzzi, C., Parisi, R., Brucoli, C., Palasciano, G., Camporese, G., Tonello, C., Canafoglia, L., Rupoli, S., Cancellieri, E., Paoletti, O., Testa, S., Carlizza, A., Carnovali, M., Sada, S., Samaden, A., Casarsa, C., Mearelli, F., Pivetti, G., Catalini, R., Zingaretti, O., Vascolare, M., Cavazza, S., Cosmi, B., Cenci, C., Prisco, D., Silvestri, E., Ceresa, F., Patane, F., Ciampa, A., Siniscalchi, V., Ciarambino, T., De Bartolomeo, G., Clemente, M., Conti, F., Paiella, L., D'Avino, M., D'Alessandro, A., Placentino, M., Sollazzo, V., D'Angelo, A., Vigano, S., De Campora, P., Sangiuolo, R., De Franciscis, S., Serra, R., De Gaudenzi, E., De Santis, F., Piccinni, G. C., De Tommaso, I. D., Di Francesco, L., Vincentelli, G. M., Di Maggio, R., Saccullo, G., Siragusa, S., Di Micco, P., Fontanella, A., Di Michele, D., Di Minno, G., Tufano, A., Di Nisio, M., Porreca, E., Donadio, F., Imberti, D., Enea, I., Fabbian, F., Manfredini, R., Pala, M., Falanga, A., Milesi, V., Fiore, V., Franco, E., Giudice, G., Frausini, G., Rovinelli, M., Fuorlo, M., Landolfi, R., Morretti, T., Gamberini, S., Salmi, R., Ghirarduzzi, A., Veropalumbo, M. R., Ghizzi, M., Pepe, C., Gianniello, F., Martinelli, I., Iosub, D. I., Piovella, F., Iozzi, E., Talerico, A., Regina, M. L., Orlandini, F., Marconi, L., Palla, A., Marcucci, R., Poli, D., Margheriti, R., Sala, G., Marra, A., Marrocco, F., Montagna, E. S., Silvestris, F., Vallarelli, S., Mos, L., Rossetto, V., Mugno, F., Di Salvo, M., Nitti, C., Pennacchioni, M., Salvi, A., Olivieri, O., Tosi, F., Zorzi, F., Onesta, M., Pagliara, V., Villalta, S., Paolucci, G., Severino, S., Pierri, F., Russo, V., Pizzini, A. M., Quintavalla, R., Rubino, P., Ria, L., Schenone, A., Strafino, C., Tropeano, P., Vetrano, A., Zanatta, N., Cansino, M. D. A., Gutierrez, J. A., de las Revillas, F. A., Fernandez, C. A., Mijares, N. C., Blanco-Molina, M. A., Garcia, M. A., Seijo, D. J., Blazquez, R. A., Lopez-Saez, J. -B., Rodrigo, E. A., Blanch, J. V., Arxe, A. A., Dalmau, F. G. -B., Quincoces, A. B., Loizaga, A. G., Perez, J. L. B., Diaz, P. B., Loaiza, A. Q., Castellote, M. C., Alcantara, I. C., Padierna, M. L., Exposito, M. C., Mas, A. C., Castro, F. C., Sanz, R. C., de Saracho, J. O., de la Fuente, E. C., de Ancos Aracil, C., Ruiz, J. R., de Daborenea Gonzalez, M. D., Iglesias, A. F., de la Fuente Aguado, J., Gonzalez, L. G., del Carmen Fernandez-Capitan, M., Hernandez, A. L., del Toro Cervera, J., Rus, G. P., Bregel, J. L. D., Fernandez, F. D., Teresa Elias Hernandez, Palomares, L. J., Bataler, R. F., Rodriguez, J. A. N., Garcia, J. M. G., Porras, J. R. G., Garcia, M. G., Lopez, E. H., Lazaro, A. R., Jaras, M. J., Castro, D. J., Madridejos, R. J. -R., Navas, J. M. P., Lecumberri, R., Martinez, N., Castellanos, G. T. L., Espinosa, L. M., Jimenez, L. L., Cobo, O. M., Saiz, C. M., Pizarro, Y. R., Yglesias, P. J. M., Martin del Pozo, M., Melibovsky, L., Altarriba, E. S., Bosch, M. M., Secades, R. M., Lujan, J. M. M., Mestre, A. R., Moral, P. M., Parra, J. A. T., Flores, A. M., Munoz-Torrero, J. F. S., Rodriguez, F. J. M., Fernandez, M. J. N., Sibajas, E. O., de Sedas, M. V., Caballero, P. P., del Campo, I. P. M., Sanchez, J. P., Gallego, A. R., Alvarez, I. V., Beltran, E. M. R., Fuentes, D. S., Schilling, V. R., Alvarez, J. S., Lopez, G. T., Caralt, J. M. S., Miranda, R. T., de Antonio, E. U., Banyai, M., Frank, U., Gian Reto Jorg, Jeanneret, C., Staub, D., Ackroyd, S., Agarwal, G., Mearns, B., Alikhan, R., Allameddine, A., Al-Refaie, F., Arden, C., Austin, A., Bakhai, A., Barton, T., Ewad, H., Body, R., Thachil, J., Chacko, J., Chandra, D., Charters, F., Church, A., Mcgrane, F., Clements, J., Clifford, P., Cox, D., Crouch, M., Crowther, M., Davies, E., Davies, M., Dimitri, S., Drebes, A., Franklin, S., George, J., Irvine, N., Gerofke, H., Gibbs, C., Goh, T., Gupta, S., Holmes, J., Jackson-Voyzey, E., Jones, N., Kallat, A., Kerr, P., Kesteven, P., Lench, T., Lester, W., Lowe, G., Lewis, M., Mccormack, T., Mccoye, A., Moriarty, A., Morris, W., Myers, B., Narayanan, M., Oo, N., Reed, M., Rose, P., Saja, K., Sivakumaran, M., Sohal, M., Solomons, G., Sultanzadeh, S. J., Venton, T., Wakeling, J., Walby, C., Waldron, M., Watt, S., Willcock, W., Agnelli, G., Gitt, A. K., Bauersachs, R., Fronk, E. -M., Laeis, P., Mismetti, P., Monreal, M., Willich, S. N., Wolf, W. -P., Cohen, A. T., Brodmann, M., Rief, P., Eischer, L., Stoshikj, S., Hirschl, M., Weinmann, S., Marschang, P., Abbadie, F., Achkar, A., Addala, A., Adnet, F., Alexandra, J. -F., Aquilanti, S., Belhassane, A., Benaroya, A., Berremili, T., Grenot, M. C., Birr, V., Holtea, D., Bonnin, C., Bosler, F., Durand, M. -G. B., Brisot, D., Brousse, C., De La Fuente, T., Cayman, R., Cazaubon, M., Champion, O., Chanut, M., Chevalet, P., Connault, J., Durant, C., Constans, J., Cordeanu, M., Couturaud, F., Lacut, K., De Dedker, L., Decoulx, E., Derrien, B., Diamand, J. -M., Diard, A., Douadi, Y., Dupas, S., Remond, S. S. M., Sevestre, M. -A., Edhery, S., Falvo, N., Taralunga, C. F., Ferrari, E., Gaillard, C., Garrigues, D., Gillet, J. L., Giordana, P., Grange, C., Vital-Durand, D., Grare, F., Henni, A. 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S., Stachowitz, J., Thieme, M., Tiefenbacher, C., Tsantilas, D., Vieth, P., vom Dahl, J., Grun-Himmelmann, K., von Bilderling, P., von Maltik, T., Weinrich, K., Weyer, M., Koln, E. K., Wirtz, P., Wittig, I., Zierock, P., Ageno, W., Caprioli, M., Rancan, E., Guercini, F., Mommi, V., Amitrano, M., Cannavacciuolo, F., Amore, M., D'Antoni, S., Angelini, E., Forgia, S. L., Antignani, P. L., Calandra, G., Arone, A., Perticone, F., Sciacqua, A., Asaro, G., Bellisi, M., Attanzio, M. 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R., Jaras, M. J., Castro, D. J., Madridejos, R. J. -R., Navas, J. M. P., Lecumberri, R., Martinez, N., Castellanos, G. T. L., Espinosa, L. M., Jimenez, L. L., Cobo, O. M., Saiz, C. M., Pizarro, Y. R., Yglesias, P. J. M., Martin del Pozo, M., Melibovsky, L., Altarriba, E. S., Bosch, M. M., Secades, R. M., Lujan, J. M. M., Mestre, A. R., Moral, P. M., Parra, J. A. T., Flores, A. M., Munoz-Torrero, J. F. S., Rodriguez, F. J. M., Fernandez, M. J. N., Sibajas, E. O., de Sedas, M. V., Caballero, P. P., del Campo, I. P. M., Sanchez, J. P., Gallego, A. R., Alvarez, I. V., Beltran, E. M. R., Fuentes, D. S., Schilling, V. R., Alvarez, J. S., Lopez, G. T., Caralt, J. M. S., Miranda, R. T., de Antonio, E. 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J., Venton, T., Wakeling, J., Walby, C., Waldron, M., Watt, S., Willcock, W., Zafar, A., Agnelli, G, Gitt, A, Bauersachs, R, Fronk, E, Laeis, P, Mismetti, P, Monreal, M, Willich, S, Wolf, W, Cohen, A, Brodmann, M, Rief, P, Eischer, L, Stoshikj, S, Hirschl, M, Weinmann, S, Marschang, P, Abbadie, F, Achkar, A, Addala, A, Adnet, F, Alexandra, J, Aquilanti, S, Belhassane, A, Benaroya, A, Berremili, T, Grenot, M, Birr, V, Holtea, D, Bonnin, C, Bosler, F, Durand, M, Brisot, D, Brousse, C, De La Fuente, T, Cayman, R, Cazaubon, M, Champion, O, Chanut, M, Chevalet, P, Connault, J, Durant, C, Constans, J, Cordeanu, M, Couturaud, F, Lacut, K, De Dedker, L, Decoulx, E, Derrien, B, Diamand, J, Diard, A, Douadi, Y, Dupas, S, Remond, S, Sevestre, M, Edhery, S, Falvo, N, Taralunga, C, Ferrari, E, Gaillard, C, Garrigues, D, Gillet, J, Giordana, P, Grange, C, Vital-Durand, D, Grare, F, Henni, A, Heuser, S, Schmidt, J, Hidden-Henic, V, Hottin, D, Imbert, B, Pernod, G, Jakob, D, Jacquinandi, V, Jurus, C, 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A, Wucherpfennig, P, Marencke, G, Mortensen, K, Reppel, M, Nelles, H, Nestler, K, Neumeister, A, Schlosser, A, Oettler, W, Ott, I, Otto, A, Pertermann, A, Pfister, R, Pindur, L, Pourhassan, S, Predel, D, Pudollek, T, Reimer, D, Richter, C, Rieker, E, Rothenbucher, G, Rothhagen, B, Rudolff, S, Stucker, M, Schafer, A, Sonnenschein, K, Schafnitzl, W, Schellong, S, Voigts, B, Schiller, M, Schmeink, T, Schneider, H, Schon, N, Schulze, M, Sechtem, U, Sedl, S, Werno, H, Stachowitz, J, Thieme, M, Tiefenbacher, C, Tsantilas, D, Vieth, P, vom Dahl, J, Grun-Himmelmann, K, von Bilderling, P, von Maltik, T, Weinrich, K, Weyer, M, Koln, E, Wirtz, P, Wittig, I, Zierock, P, Ageno, W, Caprioli, M, Rancan, E, Guercini, F, Mommi, V, Amitrano, M, Cannavacciuolo, F, Amore, M, D'Antoni, S, Angelini, E, Forgia, S, Antignani, P, Calandra, G, Arone, A, Perticone, F, Sciacqua, A, Asaro, G, Bellisi, M, Attanzio, M, Pinto, A, Attinasi, V, Cillari, E, Sorvillo, S, Balbarini, A, Santini, C, Violo, C, Banfi, E, Lodigiani, C, Barcellona, D, Delpin, S, Marongiu, S, Barillari, G, Pasca, S, Bartolini, C, Verdecchia, P, Bartone, M, Mancuso, G, Bellanuova, I, Felis, S, Bellizzi, A, Masotti, L, Bianchi, M, Carugati, A, Bianchini, G, Guarnera, G, Boari, B, Gallerani, M, Pasin, M, Bortoluzzi, C, Parisi, R, Brucoli, C, Palasciano, G, Camporese, G, Tonello, C, Canafoglia, L, Rupoli, S, Cancellieri, E, Paoletti, O, Testa, S, Carlizza, A, Carnovali, M, Sada, S, Samaden, A, Casarsa, C, Mearelli, F, Pivetti, G, Catalini, R, Zingaretti, O, Vascolare, M, Cavazza, S, Cosmi, B, Cenci, C, Prisco, D, Silvestri, E, Ceresa, F, Patane, F, Ciampa, A, Siniscalchi, V, Ciarambino, T, De Bartolomeo, G, Clemente, M, Conti, F, Paiella, L, D'Avino, M, D'Alessandro, A, Placentino, M, Sollazzo, V, D'Angelo, A, Vigano, S, De Campora, P, Sangiuolo, R, De Franciscis, S, Serra, R, De Gaudenzi, E, De Santis, F, Piccinni, G, De Tommaso, I, Di Francesco, L, Vincentelli, G, Di Maggio, R, Saccullo, G, Siragusa, S, Di Micco, P, 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V, Alvarez, J, Lopez, G, Caralt, J, Miranda, R, de Antonio, E, Banyai, M, Frank, U, Gian Reto, J, Jeanneret, C, Staub, D, Ackroyd, S, Agarwal, G, Mearns, B, Alikhan, R, Allameddine, A, Al-Refaie, F, Arden, C, Austin, A, Bakhai, A, Barton, T, Ewad, H, Body, R, Thachil, J, Chacko, J, Chandra, D, Charters, F, Church, A, Mcgrane, F, Clements, J, Clifford, P, Cox, D, Crouch, M, Crowther, M, Davies, E, Davies, M, Dimitri, S, Drebes, A, Franklin, S, George, J, Irvine, N, Gerofke, H, Gibbs, C, Goh, T, Gupta, S, Holmes, J, Jackson-Voyzey, E, Jones, N, Kallat, A, Kerr, P, Kesteven, P, Lench, T, Lester, W, Lowe, G, Lewis, M, Mccormack, T, Mccoye, A, Moriarty, A, Morris, W, Myers, B, Narayanan, M, Oo, N, Reed, M, Rose, P, Saja, K, Sivakumaran, M, Sohal, M, Solomons, G, Sultanzadeh, S, Venton, T, Wakeling, J, Walby, C, Waldron, M, Watt, S, Willcock, W, and Zafar, A

Subjects
Drug Utilization, Pediatrics, medicine.medical_specialty, Novel Oral Anticoagulants, Registry, Deep vein, Alternative medicine, Anticoagulation, Patient satisfaction, Quality of life, Health care, medicine, Anticoagulation, Novel Oral Anticoagulants, Prevention, Registry, Venous Thromboembolism, Vitamin K antagonists, cardiovascular diseases, business.industry, Prevention, Venous Thromboembolism, Vitamin K antagonists, Hematology, Novel Oral Anticoagulant, medicine.disease, equipment and supplies, Pulmonary embolism, medicine.anatomical_structure, Emergency medicine, Original Clinical Investigation, Observational study, business
Abstract

Background: Venous thromboembolism (VTE) is a major health problem, with over one million events every year in Europe. However, there is a paucity of data on the current management in real life, including factors influencing treatment pathways, patient satisfaction, quality of life (QoL), and utilization of health care resources and the corresponding costs. The PREFER in VTE registry has been designed to address this and to understand medical care and needs as well as potential gaps for improvement. Methods/design: The PREFER in VTE registry was a prospective, observational, multicenter study conducted in seven European countries including Austria, France Germany, Italy, Spain, Switzerland, and the UK to assess the characteristics and the management of patients with VTE, the use of health care resources, and to provide data to estimate the costs for 12 months treatment following a first-time and/or recurrent VTE diagnosed in hospitals or specialized or primary care centers. In addition, existing anticoagulant treatment patterns, patient pathways, clinical outcomes, treatment satisfaction, and health related QoL were documented. The centers were chosen to reflect the care environment in which patients with VTE are managed in each of the participating countries. Patients were eligible to be enrolled into the registry if they were at least 18 years old, had a symptomatic, objectively confirmed first time or recurrent acute VTE defined as either distal or proximal deep vein thrombosis, pulmonary embolism or both. After the baseline visit at the time of the acute VTE event, further follow-up documentations occurred at 1, 3, 6 and 12 months. Follow-up data was collected by either routinely scheduled visits or by telephone calls. Results: Overall, 381 centers participated, which enrolled 3,545 patients during an observational period of 1 year. Conclusion: The PREFER in VTE registry will provide valuable insights into the characteristics of patients with VTE and their acute and mid-term management, as well as into drug utilization and the use of health care resources in acute first-time and/or recurrent VTE across Europe in clinical practice. Trial registration: Registered in DRKS register, ID number: DRKS00004795

Published
2015

30. The management of acute venous thromboembolism in clinical practice - study rationale and protocol of the European PREFER in VTE Registry

Author

Agnelli, G, Gitt, A, Bauersachs, R, Fronk, E, Laeis, P, Mismetti, P, Monreal, M, Willich, S, Wolf, W, Cohen, A, Brodmann, M, Rief, P, Eischer, L, Stoshikj, S, Hirschl, M, Weinmann, S, Marschang, P, Abbadie, F, Achkar, A, Addala, A, Adnet, F, Alexandra, J, Aquilanti, S, Belhassane, A, Benaroya, A, Berremili, T, Grenot, M, Birr, V, Holtea, D, Bonnin, C, Bosler, F, Durand, M, Brisot, D, Brousse, C, De La Fuente, T, Cayman, R, Cazaubon, M, Champion, O, Chanut, M, Chevalet, P, Connault, J, Durant, C, Constans, J, Cordeanu, M, Couturaud, F, Lacut, K, De Dedker, L, Decoulx, E, Derrien, B, Diamand, J, Diard, A, Douadi, Y, Dupas, S, Remond, S, Sevestre, M, Edhery, S, Falvo, N, Taralunga, C, Ferrari, E, Gaillard, C, Garrigues, D, Gillet, J, Giordana, P, Grange, C, Vital-Durand, D, Grare, F, Henni, A, Heuser, S, Schmidt, J, Hidden-Henic, V, Hottin, D, Imbert, B, Pernod, G, Jakob, D, Jacquinandi, V, Jurus, C, Lacoste, A, Laroche, J, Martin, M, Mazollier, C, Mersel, T, Miserey, G, Nedey, C, Nou, M, Quere, I, Ouvry, P, Peuch, B, Pichot, O, Poulain, V, Ray, P, Rifai, A, Roy, P, Saby, J, Simon, F, Simonot-Lalandec, E, Stephan, D, Tissot, A, Vodoungnon, H, Adamczyk, A, Schnabl, S, Ahmad, W, Weber, H, Axthelm, C, Bergmann, K, Beschorner, U, Knittel, M, Binias, K, Pasligh, M, Boral, M, Friederike, G, Bratsch, H, Brauer, G, Burghard, S, Demann, C, Rennebaum, C, Demmig, A, Eberlein, U, Enger, F, Eschenburg, J, Forkmann, L, Frank, J, Freischmidt, H, Gassauer, M, Fritsche, I, Kubicek-Hofmann, C, Goebels, M, Guggenbichler, S, Hartel, D, Hartmann, K, Heilberger, P, Heinsius, A, Held, M, Schnupp, S, Herman, G, Herold, J, Hertrich, F, Hommel, H, Hutte, G, Kalka, C, Jungandreas, K, Ramthor, M, Karcher, J, Werner, N, Karl-Wollweber, S, Keilhau, D, Kittel, K, Knolinski, T, Kohler, C, Werth, S, Kopplin, U, Korner, I, Wittig, K, Kroger, K, Moysidis, T, Kroschel, U, Leschke, M, zur Nieden, T, Lubbert, G, Lutz, A, Wucherpfennig, P, Marencke, G, Mortensen, K, Reppel, M, Nelles, H, Nestler, K, Neumeister, A, Schlosser, A, Oettler, W, Ott, I, Otto, A, Pertermann, A, Pfister, R, Pindur, L, Pourhassan, S, Predel, D, Pudollek, T, Reimer, D, Richter, C, Rieker, E, Rothenbucher, G, Rothhagen, B, Rudolff, S, Stucker, M, Schafer, A, Sonnenschein, K, Schafnitzl, W, Schellong, S, Voigts, B, Schiller, M, Schmeink, T, Schneider, H, Schon, N, Schulze, M, Sechtem, U, Sedl, S, Werno, H, Stachowitz, J, Thieme, M, Tiefenbacher, C, Tsantilas, D, Vieth, P, vom Dahl, J, Grun-Himmelmann, K, von Bilderling, P, von Maltik, T, Weinrich, K, Weyer, M, Koln, E, Wirtz, P, Wittig, I, Zierock, P, Ageno, W, Caprioli, M, Rancan, E, Guercini, F, Mommi, V, Amitrano, M, Cannavacciuolo, F, Amore, M, D'Antoni, S, Angelini, E, Forgia, S, Antignani, P, Calandra, G, Arone, A, Perticone, F, Sciacqua, A, Asaro, G, Bellisi, M, Attanzio, M, Pinto, A, Attinasi, V, Cillari, E, Sorvillo, S, Balbarini, A, Santini, C, Violo, C, Banfi, E, Lodigiani, C, Barcellona, D, Delpin, S, Marongiu, S, Barillari, G, Pasca, S, Bartolini, C, Verdecchia, P, Bartone, M, Mancuso, G, Bellanuova, I, Felis, S, Bellizzi, A, Masotti, L, Bianchi, M, Carugati, A, Bianchini, G, Guarnera, G, Boari, B, Gallerani, M, Pasin, M, Bortoluzzi, C, Parisi, R, Brucoli, C, Palasciano, G, Camporese, G, Tonello, C, Canafoglia, L, Rupoli, S, Cancellieri, E, Paoletti, O, Testa, S, Carlizza, A, Carnovali, M, Sada, S, Samaden, A, Casarsa, C, Mearelli, F, Pivetti, G, Catalini, R, Zingaretti, O, Vascolare, M, Cavazza, S, Cosmi, B, Cenci, C, Prisco, D, Silvestri, E, Ceresa, F, Patane, F, Ciampa, A, Siniscalchi, V, Ciarambino, T, De Bartolomeo, G, Clemente, M, Conti, F, Paiella, L, D'Avino, M, D'Alessandro, A, Placentino, M, Sollazzo, V, D'Angelo, A, Vigano, S, De Campora, P, Sangiuolo, R, De Franciscis, S, Serra, R, De Gaudenzi, E, De Santis, F, Piccinni, G, De Tommaso, I, Di Francesco, L, Vincentelli, G, Di Maggio, R, Saccullo, G, Siragusa, S, Di Micco, P, Fontanella, A, Di Michele, D, Di Minno, G, Tufano, A, Di Nisio, M, Porreca, E, Donadio, F, Imberti, D, Enea, I, Fabbian, F, Manfredini, R, Pala, M, Falanga, A, Milesi, V, Fiore, V, Franco, E, Giudice, G, Frausini, G, Rovinelli, M, Fuorlo, M, Landolfi, R, Morretti, T, Gamberini, S, Salmi, R, Ghirarduzzi, A, Veropalumbo, M, Ghizzi, M, Pepe, C, Gianniello, F, Martinelli, I, Iosub, D, Piovella, F, Iozzi, E, Talerico, A, Regina, M, Orlandini, F, Marconi, L, Palla, A, Marcucci, R, Poli, D, Margheriti, R, Sala, G, Marra, A, Marrocco, F, Montagna, E, Silvestris, F, Vallarelli, S, Mos, L, Rossetto, V, Mugno, F, Di Salvo, M, Nitti, C, Pennacchioni, M, Salvi, A, Olivieri, O, Tosi, F, Zorzi, F, Onesta, M, Pagliara, V, Villalta, S, Paolucci, G, Severino, S, Pierri, F, Russo, V, Pizzini, A, Quintavalla, R, Rubino, P, Ria, L, Schenone, A, Strafino, C, Tropeano, P, Vetrano, A, Zanatta, N, Cansino, M, Gutierrez, J, de las Revillas, F, Fernandez, C, Mijares, N, Blanco-Molina, M, Garcia, M, Seijo, D, Blazquez, R, Lopez-Saez, J, Rodrigo, E, Blanch, J, Arxe, A, Dalmau, F, Quincoces, A, Loizaga, A, Perez, J, Diaz, P, Loaiza, A, Castellote, M, Alcantara, I, Padierna, M, Exposito, M, Mas, A, Castro, F, Sanz, R, de Saracho, J, de la Fuente, E, de Ancos Aracil, C, Ruiz, J, de Daborenea Gonzalez, M, Iglesias, A, de la Fuente Aguado, J, Gonzalez, L, del Carmen Fernandez-Capitan, M, Hernandez, A, del Toro Cervera, J, Rus, G, Bregel, J, Fernandez, F, Teresa Elias, H, Palomares, L, Bataler, R, Rodriguez, J, Garcia, J, Porras, J, Lopez, E, Lazaro, A, Jaras, M, Castro, D, Madridejos, R, Navas, J, Lecumberri, R, Martinez, N, Castellanos, G, Espinosa, L, Jimenez, L, Cobo, O, Saiz, C, Pizarro, Y, Yglesias, P, Martin del Pozo, M, Melibovsky, L, Altarriba, E, Bosch, M, Secades, R, Lujan, J, Mestre, A, Moral, P, Parra, J, Flores, A, Munoz-Torrero, J, Rodriguez, F, Fernandez, M, Sibajas, E, de Sedas, M, Caballero, P, del Campo, I, Sanchez, J, Gallego, A, Alvarez, I, Beltran, E, Fuentes, D, Schilling, V, Alvarez, J, Lopez, G, Caralt, J, Miranda, R, de Antonio, E, Banyai, M, Frank, U, Gian Reto, J, Jeanneret, C, Staub, D, Ackroyd, S, Agarwal, G, Mearns, B, Alikhan, R, Allameddine, A, Al-Refaie, F, Arden, C, Austin, A, Bakhai, A, Barton, T, Ewad, H, Body, R, Thachil, J, Chacko, J, Chandra, D, Charters, F, Church, A, Mcgrane, F, Clements, J, Clifford, P, Cox, D, Crouch, M, Crowther, M, Davies, E, Davies, M, Dimitri, S, Drebes, A, Franklin, S, George, J, Irvine, N, Gerofke, H, Gibbs, C, Goh, T, Gupta, S, Holmes, J, Jackson-Voyzey, E, Jones, N, Kallat, A, Kerr, P, Kesteven, P, Lench, T, Lester, W, Lowe, G, Lewis, M, Mccormack, T, Mccoye, A, Moriarty, A, Morris, W, Myers, B, Narayanan, M, Oo, N, Reed, M, Rose, P, Saja, K, Sivakumaran, M, Sohal, M, Solomons, G, Sultanzadeh, S, Venton, T, Wakeling, J, Walby, C, Waldron, M, Watt, S, Willcock, W, Zafar, A, Agnelli G., Gitt A. K., Bauersachs R., Fronk E. -M., Laeis P., Mismetti P., Monreal M., Willich S. N., Wolf W. -P., Cohen A. T., Brodmann M., Rief P., Eischer L., Stoshikj S., Hirschl M., Weinmann S., Marschang P., Abbadie F., Achkar A., Addala A., Adnet F., Alexandra J. -F., Aquilanti S., Belhassane A., Benaroya A., Berremili T., Grenot M. C., Birr V., Holtea D., Bonnin C., Bosler F., Durand M. -G. B., Brisot D., Brousse C., De La Fuente T., Cayman R., Cazaubon M., Champion O., Chanut M., Chevalet P., Connault J., Durant C., Constans J., Cordeanu M., Couturaud F., Lacut K., De Dedker L., Decoulx E., Derrien B., Diamand J. -M., Diard A., Douadi Y., Dupas S., Remond S. S. M., Sevestre M. -A., Edhery S., Falvo N., Taralunga C. F., Ferrari E., Gaillard C., Garrigues D., Gillet J. L., Giordana P., Grange C., Vital-Durand D., Grare F., Henni A. H., Heuser S., Schmidt J., Hidden-Henic V., Hottin D., Imbert B., Pernod G., Jakob D., Jacquinandi V., Jurus C., Lacoste A., Laroche J. -P., Martin M., Mazollier C., Mersel T., Miserey G., Nedey C., Nou M., Quere I., Ouvry P., Peuch B., Pichot O., Poulain V., Ray P., Rifai A., Roy P. -M., Saby J. -C., Simon F., Simonot-Lalandec E., Stephan D., Tissot A., Vodoungnon H., Adamczyk A., Schnabl S., Ahmad W. A., Weber H., Axthelm C., Bergmann K., Beschorner U., Knittel M., Binias K. -H., Pasligh M., Boral M., Friederike G., Bratsch H., Brauer G., Burghard S., Demann C., Rennebaum C., Demmig A., Eberlein U., Enger F., Eschenburg J., Forkmann L., Frank J., Freischmidt H., Gassauer M., Fritsche I., Kubicek-Hofmann C., Goebels M. -C., Guggenbichler S., Hartel D., Hartmann K., Heilberger P., Heinsius A., Held M., Schnupp S., Herman G., Herold J., Hertrich F., Hommel H., Hutte G., Kalka C., Jungandreas K., Ramthor M., Karcher J., Werner N., Karl-Wollweber S., Keilhau D. -A., Kittel K., Knolinski T., Kohler C., Werth S., Kopplin U., Korner I., Wittig K., Kroger K., Moysidis T., Kroschel U., Leschke M., zur Nieden T., Lubbert G., Lutz A., Wucherpfennig P., Marencke G. -H., Mortensen K., Reppel M., Nelles H., Nestler K., Neumeister A., Schlosser A., Oettler W., Ott I., Otto A., Pertermann A., Pfister R., Pindur L., Pourhassan S., Predel D., Pudollek T., Reimer D., Richter C., Rieker E., Rothenbucher G., Rothhagen B., Rudolff S., Stucker M., Schafer A., Sonnenschein K., Schafnitzl W., Schellong S., Voigts B., Schiller M., Schmeink T., Schneider H., Schon N., Schulze M., Sechtem U., Sedl S., Werno H. S., Stachowitz J., Thieme M., Tiefenbacher C., Tsantilas D., Vieth P., vom Dahl J., Grun-Himmelmann K., von Bilderling P., von Maltik T., Weinrich K., Weyer M., Koln E. K., Wirtz P., Wittig I., Zierock P., Ageno W., Caprioli M., Rancan E., Guercini F., Mommi V., Amitrano M., Cannavacciuolo F., Amore M., D'Antoni S., Angelini E., Forgia S. L., Antignani P. L., Calandra G., Arone A., Perticone F., Sciacqua A., Asaro G., Bellisi M., Attanzio M. T., Pinto A., Attinasi V., Cillari E., Sorvillo S., Balbarini A., Santini C., Violo C., Banfi E., Lodigiani C., Barcellona D., Delpin S., Marongiu S., Barillari G., Pasca S., Bartolini C., Verdecchia P., Bartone M., Mancuso G., Bellanuova I., Felis S., Bellizzi A., Masotti L., Bianchi M., Carugati A., Bianchini G., Guarnera G., Boari B., Gallerani M., Pasin M., Bortoluzzi C., Parisi R., Brucoli C., Palasciano G., Camporese G., Tonello C., Canafoglia L., Rupoli S., Cancellieri E., Paoletti O., Testa S., Carlizza A., Carnovali M., Sada S., Samaden A., Casarsa C., Mearelli F., Pivetti G., Catalini R., Zingaretti O., Vascolare M., Cavazza S., Cosmi B., Cenci C., Prisco D., Silvestri E., Ceresa F., Patane F., Ciampa A., Siniscalchi V., Ciarambino T., De Bartolomeo G., Clemente M., Conti F., Paiella L., D'Avino M., D'Alessandro A., Placentino M., Sollazzo V., D'Angelo A., Vigano S., De Campora P., Sangiuolo R., De Franciscis S., Serra R., De Gaudenzi E., De Santis F., Piccinni G. C., De Tommaso I. D., Di Francesco L., Vincentelli G. M., Di Maggio R., Saccullo G., Siragusa S., Di Micco P., Fontanella A., Di Michele D., Di Minno G., Tufano A., Di Nisio M., Porreca E., Donadio F., Imberti D., Enea I., Fabbian F., Manfredini R., Pala M., Falanga A., Milesi V., Fiore V., Franco E., Giudice G., Frausini G., Rovinelli M., Fuorlo M., Landolfi R., Morretti T., Gamberini S., Salmi R., Ghirarduzzi A., Veropalumbo M. R., Ghizzi M., Pepe C., Gianniello F., Martinelli I., Iosub D. I., Piovella F., Iozzi E., Talerico A., Regina M. L., Orlandini F., Marconi L., Palla A., Marcucci R., Poli D., Margheriti R., Sala G., Marra A., Marrocco F., Montagna E. S., Silvestris F., Vallarelli S., Mos L., Rossetto V., Mugno F., Di Salvo M., Nitti C., Pennacchioni M., Salvi A., Olivieri O., Tosi F., Zorzi F., Onesta M., Pagliara V., Villalta S., Paolucci G., Severino S., Pierri F., Russo V., Pizzini A. M., Quintavalla R., Rubino P., Ria L., Schenone A., Strafino C., Tropeano P., Vetrano A., Zanatta N., Cansino M. D. A., Gutierrez J. A., de las Revillas F. A., Fernandez C. A., Mijares N. C., Blanco-Molina M. A., Garcia M. A., Seijo D. J., Blazquez R. A., Lopez-Saez J. -B., Rodrigo E. A., Blanch J. V., Arxe A. A., Dalmau F. G. -B., Quincoces A. B., Loizaga A. G., Perez J. L. B., Diaz P. B., Loaiza A. Q., Castellote M. C., Alcantara I. C., Padierna M. L., Exposito M. C., Mas A. C., Castro F. C., Sanz R. C., de Saracho J. O., de la Fuente E. C., de Ancos Aracil C., Ruiz J. R., de Daborenea Gonzalez M. D., Iglesias A. F., de la Fuente Aguado J., Gonzalez L. G., del Carmen Fernandez-Capitan M., Hernandez A. L., del Toro Cervera J., Rus G. P., Bregel J. L. D., Fernandez F. D., Teresa Elias Hernandez, Palomares L. J., Bataler R. F., Rodriguez J. A. N., Garcia J. M. G., Porras J. R. G., Garcia M. G., Lopez E. H., Lazaro A. R., Jaras M. J., Castro D. J., Madridejos R. J. -R., Navas J. M. P., Lecumberri R., Martinez N., Castellanos G. T. L., Espinosa L. M., Jimenez L. L., Cobo O. M., Saiz C. M., Pizarro Y. R., Yglesias P. J. M., Martin del Pozo M., Melibovsky L., Altarriba E. S., Bosch M. M., Secades R. M., Lujan J. M. M., Mestre A. R., Moral P. M., Parra J. A. T., Flores A. M., Munoz-Torrero J. F. S., Rodriguez F. J. M., Fernandez M. J. N., Sibajas E. O., de Sedas M. V., Caballero P. P., del Campo I. P. M., Sanchez J. P., Gallego A. R., alvarez I. V., Beltran E. M. R., Fuentes D. S., Schilling V. R., alvarez J. S., Lopez G. T., Caralt J. M. S., Miranda R. T., de Antonio E. U., Banyai M., Frank U., Gian Reto Jorg, Jeanneret C., Staub D., Ackroyd S., Agarwal G., Mearns B., Alikhan R., Allameddine A., Al-Refaie F., Arden C., Austin A., Bakhai A., Barton T., Ewad H., Body R., Thachil J., Chacko J., Chandra D., Charters F., Church A., McGrane F., Clements J., Clifford P., Cox D., Crouch M., Crowther M., Davies E., Davies M., Dimitri S., Drebes A., Franklin S., George J., Irvine N., Gerofke H., Gibbs C., Goh T., Gupta S., Holmes J., Jackson-Voyzey E., Jones N., Kallat A., Kerr P., Kesteven P., Lench T., Lester W., Lowe G., Lewis M., McCormack T., McCoye A., Moriarty A., Morris W., Myers B., Narayanan M., Oo N., Reed M., Rose P., Saja K., Sivakumaran M., Sohal M., Solomons G., Sultanzadeh S. J., Venton T., Wakeling J., Walby C., Waldron M., Watt S., Willcock W., Zafar A., Agnelli, G, Gitt, A, Bauersachs, R, Fronk, E, Laeis, P, Mismetti, P, Monreal, M, Willich, S, Wolf, W, Cohen, A, Brodmann, M, Rief, P, Eischer, L, Stoshikj, S, Hirschl, M, Weinmann, S, Marschang, P, Abbadie, F, Achkar, A, Addala, A, Adnet, F, Alexandra, J, Aquilanti, S, Belhassane, A, Benaroya, A, Berremili, T, Grenot, M, Birr, V, Holtea, D, Bonnin, C, Bosler, F, Durand, M, Brisot, D, Brousse, C, De La Fuente, T, Cayman, R, Cazaubon, M, Champion, O, Chanut, M, Chevalet, P, Connault, J, Durant, C, Constans, J, Cordeanu, M, Couturaud, F, Lacut, K, De Dedker, L, Decoulx, E, Derrien, B, Diamand, J, Diard, A, Douadi, Y, Dupas, S, Remond, S, Sevestre, M, Edhery, S, Falvo, N, Taralunga, C, Ferrari, E, Gaillard, C, Garrigues, D, Gillet, J, Giordana, P, Grange, C, Vital-Durand, D, Grare, F, Henni, A, Heuser, S, Schmidt, J, Hidden-Henic, V, Hottin, D, Imbert, B, Pernod, G, Jakob, D, Jacquinandi, V, Jurus, C, Lacoste, A, Laroche, J, Martin, M, Mazollier, C, Mersel, T, Miserey, G, Nedey, C, Nou, M, Quere, I, Ouvry, P, Peuch, B, Pichot, O, Poulain, V, Ray, P, Rifai, A, Roy, P, Saby, J, Simon, F, Simonot-Lalandec, E, Stephan, D, Tissot, A, Vodoungnon, H, Adamczyk, A, Schnabl, S, Ahmad, W, Weber, H, Axthelm, C, Bergmann, K, Beschorner, U, Knittel, M, Binias, K, Pasligh, M, Boral, M, Friederike, G, Bratsch, H, Brauer, G, Burghard, S, Demann, C, Rennebaum, C, Demmig, A, Eberlein, U, Enger, F, Eschenburg, J, Forkmann, L, Frank, J, Freischmidt, H, Gassauer, M, Fritsche, I, Kubicek-Hofmann, C, Goebels, M, Guggenbichler, S, Hartel, D, Hartmann, K, Heilberger, P, Heinsius, A, Held, M, Schnupp, S, Herman, G, Herold, J, Hertrich, F, Hommel, H, Hutte, G, Kalka, C, Jungandreas, K, Ramthor, M, Karcher, J, Werner, N, Karl-Wollweber, S, Keilhau, D, Kittel, K, Knolinski, T, Kohler, C, Werth, S, Kopplin, U, Korner, I, Wittig, K, Kroger, K, Moysidis, T, Kroschel, U, Leschke, M, zur Nieden, T, Lubbert, G, Lutz, A, Wucherpfennig, P, Marencke, G, Mortensen, K, Reppel, M, Nelles, H, Nestler, K, Neumeister, A, Schlosser, A, Oettler, W, Ott, I, Otto, A, Pertermann, A, Pfister, R, Pindur, L, Pourhassan, S, Predel, D, Pudollek, T, Reimer, D, Richter, C, Rieker, E, Rothenbucher, G, Rothhagen, B, Rudolff, S, Stucker, M, Schafer, A, Sonnenschein, K, Schafnitzl, W, Schellong, S, Voigts, B, Schiller, M, Schmeink, T, Schneider, H, Schon, N, Schulze, M, Sechtem, U, Sedl, S, Werno, H, Stachowitz, J, Thieme, M, Tiefenbacher, C, Tsantilas, D, Vieth, P, vom Dahl, J, Grun-Himmelmann, K, von Bilderling, P, von Maltik, T, Weinrich, K, Weyer, M, Koln, E, Wirtz, P, Wittig, I, Zierock, P, Ageno, W, Caprioli, M, Rancan, E, Guercini, F, Mommi, V, Amitrano, M, Cannavacciuolo, F, Amore, M, D'Antoni, S, Angelini, E, Forgia, S, Antignani, P, Calandra, G, Arone, A, Perticone, F, Sciacqua, A, Asaro, G, Bellisi, M, Attanzio, M, Pinto, A, Attinasi, V, Cillari, E, Sorvillo, S, Balbarini, A, Santini, C, Violo, C, Banfi, E, Lodigiani, C, Barcellona, D, Delpin, S, Marongiu, S, Barillari, G, Pasca, S, Bartolini, C, Verdecchia, P, Bartone, M, Mancuso, G, Bellanuova, I, Felis, S, Bellizzi, A, Masotti, L, Bianchi, M, Carugati, A, Bianchini, G, Guarnera, G, Boari, B, Gallerani, M, Pasin, M, Bortoluzzi, C, Parisi, R, Brucoli, C, Palasciano, G, Camporese, G, Tonello, C, Canafoglia, L, Rupoli, S, Cancellieri, E, Paoletti, O, Testa, S, Carlizza, A, Carnovali, M, Sada, S, Samaden, A, Casarsa, C, Mearelli, F, Pivetti, G, Catalini, R, Zingaretti, O, Vascolare, M, Cavazza, S, Cosmi, B, Cenci, C, Prisco, D, Silvestri, E, Ceresa, F, Patane, F, Ciampa, A, Siniscalchi, V, Ciarambino, T, De Bartolomeo, G, Clemente, M, Conti, F, Paiella, L, D'Avino, M, D'Alessandro, A, Placentino, M, Sollazzo, V, D'Angelo, A, Vigano, S, De Campora, P, Sangiuolo, R, De Franciscis, S, Serra, R, De Gaudenzi, E, De Santis, F, Piccinni, G, De Tommaso, I, Di Francesco, L, Vincentelli, G, Di Maggio, R, Saccullo, G, Siragusa, S, Di Micco, P, 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V, Alvarez, J, Lopez, G, Caralt, J, Miranda, R, de Antonio, E, Banyai, M, Frank, U, Gian Reto, J, Jeanneret, C, Staub, D, Ackroyd, S, Agarwal, G, Mearns, B, Alikhan, R, Allameddine, A, Al-Refaie, F, Arden, C, Austin, A, Bakhai, A, Barton, T, Ewad, H, Body, R, Thachil, J, Chacko, J, Chandra, D, Charters, F, Church, A, Mcgrane, F, Clements, J, Clifford, P, Cox, D, Crouch, M, Crowther, M, Davies, E, Davies, M, Dimitri, S, Drebes, A, Franklin, S, George, J, Irvine, N, Gerofke, H, Gibbs, C, Goh, T, Gupta, S, Holmes, J, Jackson-Voyzey, E, Jones, N, Kallat, A, Kerr, P, Kesteven, P, Lench, T, Lester, W, Lowe, G, Lewis, M, Mccormack, T, Mccoye, A, Moriarty, A, Morris, W, Myers, B, Narayanan, M, Oo, N, Reed, M, Rose, P, Saja, K, Sivakumaran, M, Sohal, M, Solomons, G, Sultanzadeh, S, Venton, T, Wakeling, J, Walby, C, Waldron, M, Watt, S, Willcock, W, Zafar, A, Agnelli G., Gitt A. 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S., Stachowitz J., Thieme M., Tiefenbacher C., Tsantilas D., Vieth P., vom Dahl J., Grun-Himmelmann K., von Bilderling P., von Maltik T., Weinrich K., Weyer M., Koln E. K., Wirtz P., Wittig I., Zierock P., Ageno W., Caprioli M., Rancan E., Guercini F., Mommi V., Amitrano M., Cannavacciuolo F., Amore M., D'Antoni S., Angelini E., Forgia S. L., Antignani P. L., Calandra G., Arone A., Perticone F., Sciacqua A., Asaro G., Bellisi M., Attanzio M. 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Abstract

Background: Venous thromboembolism (VTE) is a major health problem, with over one million events every year in Europe. However, there is a paucity of data on the current management in real life, including factors influencing treatment pathways, patient satisfaction, quality of life (QoL), and utilization of health care resources and the corresponding costs. The PREFER in VTE registry has been designed to address this and to understand medical care and needs as well as potential gaps for improvement. Methods/design: The PREFER in VTE registry was a prospective, observational, multicenter study conducted in seven European countries including Austria, France Germany, Italy, Spain, Switzerland, and the UK to assess the characteristics and the management of patients with VTE, the use of health care resources, and to provide data to estimate the costs for 12 months treatment following a first-time and/or recurrent VTE diagnosed in hospitals or specialized or primary care centers. In addition, existing anticoagulant treatment patterns, patient pathways, clinical outcomes, treatment satisfaction, and health related QoL were documented. The centers were chosen to reflect the care environment in which patients with VTE are managed in each of the participating countries. Patients were eligible to be enrolled into the registry if they were at least 18 years old, had a symptomatic, objectively confirmed first time or recurrent acute VTE defined as either distal or proximal deep vein thrombosis, pulmonary embolism or both. After the baseline visit at the time of the acute VTE event, further follow-up documentations occurred at 1, 3, 6 and 12 months. Follow-up data was collected by either routinely scheduled visits or by telephone calls. Results: Overall, 381 centers participated, which enrolled 3,545 patients during an observational period of 1 year. Conclusion: The PREFER in VTE registry will provide valuable insights into the characteristics of patients with VTE and their acute

Published
2015

31. The management of acute venous thromboembolism in clinical practice. Results from the European PREFER in VTE Registry

Author

Cohen, At, Gitt, Ak, Bauersachs, R, Fronk, Em, Laeis, P, Mismetti, P, Monreal, M, Willich, Sn, Bramlage, P, Agnelli, G, Brodmann, M, Rief, P, Eischer, L, Stoshikj, S, Hirschl, M, Weinmann, S, Peter Marschang, P, Abbadie, F, Achkar, A, Addala, A, Reynaldo, P, Adnet, F, Alexandra, Jf, Aquilanti, S, Belhassane, A, Benaroya, B, Berremili, T, Grenot, Mc, Birr, V, Holtea, D, Bonnin, C, Bosler, F, Bresin Durand MG, Brisot, D, Brousse, C, De La Fuente, T, Cayman, C, Cazaubon, M, Champion, O, Chanut, M, Chevalet, P, Connault, J, Durant, C, Constans, J, Cordeanu, M, Couturaud, F, Lacut, K, De Dedker, L, Piloquet, Fx, Decoulx, E, Derrien, B, Diamand, Jm, Diard, A, Douadi, Y, Dupas, S, Modeliar Remond SS, Sevestre, Ma, Edhery, S, Falvo, N, Farcas Taralunga, C, Ferrari, E, Gaillard, C, Garrigues, D, Gillet, Jl, Giordana, P, Grange, C, Vital-Durand, D, Grare, F, Hadj Henni, A, Heuser, S, Schmidt, J, Hidden-Henic, V, Hottin, D, Imbert, B, Pernod, G, Jakob, D, Jacquinandi, V, Jurus, C, Lacoste, A, Laroche, Jp, Martin, M, Mazollier, C, Mersel, T, Miserey, G, Nedey, C, Nou, M, Quere, I, Ouvry, P, Peuch, B, Pichot, O, Poulain, V, Ray, P, Rifai, A, Roy, Pm, Saby, Jc, Simon, F, Simonot-Lalandec, E, Stephan, D, Tissot, A, Vodoungnon, H, Adamczyk, A, Schnabl, S, Al Ahmad, W, Weber, H, Axthelm, C, Axthelm, P, Bergmann, K, Beschorner, U, Knittel, M, Binias, Kh, Pasligh, M, Boral, M, Girke, F, Bratsch, H, Brauer, G, Burghard, S, Demann, C, Rennebaum, C, Emter, E, Demmig, A, Eberlein, U, Enger, F, Eschenburg, J, Eschenburg, Ju, Forkmann, L, Frank, J, Freischmidt, H, Gassauer, M, Fritsche, I, Kubicek–hofmann, C, Goebels, Mc, Guggenbichler, S, Härtel, D, Hartmann, K, Heilberger, P, Heinsius, A, Held, M, Schnupp, S, Herman, G, Herold, J, Hertrich, F, Hommel, H, Hütte, G, Kalka, C, Jungandreas, K, Ramthor, M, Karcher, J, Werner, N, Karl-Wollweber, S, Keilhau, Da, Kittel, K, Knolinski, T, Köhler, C, Werth, S, Kopplin, U, Körner, I, Wittig, K, Dres, P, Kröger, K, Moysidis, T, Kroschel, U, 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Sorvillo, S, Balbarini, A, Santini, C, Violo, C, Banfi, E, Lodigiani, C, Barcellona, D, Delpin, S, Marongiu, S, Barillari, G, Pasca, S, Bartolini, C, Verdecchia, P, Bartone, M, Mancuso, G, Bellanuova, I, Felis, S, Bellizzi, A, Masotti, L, Bianchi, M, Carugati, A, Bianchini, G, Guarnera, G, Boari, B, Gallerani, M, Pasin, M, Bortoluzzi, C, Parisi, R, Brucoli, C, Palasciano, G, Camporese, G, Tonello, C, Canafoglia, L, Rupoli, S, Cancellieri, E, Paoletti, O, Testa, S, Carlizza, A, Carnovali, M, Sada, S, Samaden, A, Casarsa, C, Mearelli, F, Pivetti, G, Catalini, R, Zingaretti, O, Cavazza, S, Cosmi, B, Cenci, C, Prisco, D, Silvestri, E, Ceresa, F, Patanè, F, Ciampa, A, Siniscalchi, V, Ciarambino, T, De Bartolomeo, G, Clemente, M, Conti, F, Paiella, L, D’Avino, M, D'Alessandro, A, Placentino, M, Sollazzo, V, D'Angelo, A, Viganò, S, De Campora, P, Sangiuolo, R, De Franciscis, S, Serra, R, De Gaudenzi, E, De Santis, F, Piccinni, Gc, De Tommaso, I, Di Francesco, L, Vincentelli, Gm, Di Maggio, R, Saccullo, G, Siragusa, S, Di Micco, P, Fontanella, A, Di Michele, D, Di Minno, G, Tufano, A, Di Nisio, M, Porreca, E, Donadio, F, Imberti, D, Enea, I, Fabbian, F, Manfredini, R, Pala, P, Falanga, A, Milesi, V, Fiore, V, Signorelli, Ss, Franco, E, Giudice, G, Frausini, G, Rovinelli, M, Fuorlo, M, Landolfi, R, Morretti, T, Gamberini, S, Salmi, R, Ghirarduzzi, A, Ghizzi, G, Pepe, C, Gianniello, F, Martinelli, I, Iosub, Di, Piovella, F, Iozzi, E, Talerico, A, La Regina, M, Orlandini, F, Marconi, L, Palla, A, Marcucci, R, Poli, D, Margheriti, R, Sala, G, Marra, A, Marrocco, F, Montagna, Es, Silvestris, F, Vallarelli, S, Mos, L, Rossetto, V, Mugno, F, Di Salvo, M, Nitti, C, Pennacchioni, M, Salvi, A, Olivieri, O, Tosi, F, Zorzi, F, Onesta, M, Pagliara, V, Villalta, S, Paolucci, G, Severino, S, Pierri, F, Russo, V, Pizzini, Am, Quintavalla, R, Rubino, P, Ria, L, Schenone, A, Strafino, C, Tropeano, P, Vetrano, V, Zanatta, N, Adarraga Cansino MD, Gutierrez, Ja, de las Revillas FA, Amado Fernández, C, Calvo Mijares, N, Blanco-Molina, Ma, Garcia, Ma, Joya Seijo, D, Aranda Blazquez, R, López-Sáez, Jb, Arellano Rodrigo, E, Villalta Blanch, J, Armengou Arxe, A, García-Bragado Dalmau, F, Ballaz Quincoces, A, García Loizaga, A, Beato Pérez JL, Bedate Díaz, P, Quezada Loaiza, A, Castellote, Mc, Cañas Alcántara, I, Lluís Padierna, M, Carrasco Expósito, M, Millón Caño JA, Carrasco Mas, A, Cereto Castro, F, Castrodeza Sanz, R, Ortiz de Saracho, J, Cisneros de la Fuente, E, de Ancos Aracil, C, Ruiz, J, de Daborenea González MD, Fernández Iglesias, A, de la Fuente Aguado, J, González, Lg, del Carmen Fernández-Capitán, M, Lorenzo Hernández, A, del Toro Cervera, J, Pérez Rus, G, Delgado Bregel JL, Díez Fernández, F, Santalla Valle EA, Elias Hernández, T, Jara Palomares, L, Ferri Bataler, R, Nieto Rodríguez JA, García García JM, Villanueva Montes MA, González Porras JR, Guil García, M, San Román Terán CM, Hernando López, E, Roncero Lázaro, A, Jaras, Mj, Jiménez Castro, D, Jiménez-Rodríguez Madridejos, R, Pedrajas Navas JM, Lecumberri, R, Martínez, N, López Castellanos GT, Manzano Espinosa, L, López Jiménez, L, Madridano Cobo, O, Mainez Saiz, C, Romero Pizarro, Y, Marchena Yglesias PJ, Martín del Pozo, M, Melibovsky, L, Altarriba, Es, Monreal Bosch, M, Monte Secades, R, Mora Luján JM, Riera Mestre, A, Moral Moral, P, Todolí Parra JA, Moreno Flores, A, Sánchez Muñoz-Torrero JF, Muñoz Rodríguez FJ, Núñez Fernández MJ, Oncala Sibajas, E, Vaquero de Sedas, M, Parra Caballero, P, Pons Martín del Campo, I, Portillo Sánchez, J, Rivera Gallego, A, Villaverde Álvarez, I, Rodríguez Beltrán EM, Sánchez Fuentes, D, Roldán Schilling, V, Sánchez Álvarez, J, López, Gt, Suriñach Caralt JM, Tirado Miranda, R, Usandizaga de Antonio, E, Banyai, M, Frank, U, Jörg, Gr, Jeanneret, C, Staub, D, Ackroyd, A, Agarwal, G, Mearns, B, Alikhan, R, Allameddine, A, Al-Refaie, F, Arden, C, Austin, A, Bakhai, A, Barton, T, Ewad, H, Body, R, Thachil, J, Chacko, J, Chandra, D, Charters, F, Church, A, Mcgrane, F, Clements, J, Clifford, P, Cox, D, Crouch, M, Crowther, M, Davies, E, Davies, M, Dimitri, S, Drebes, A, Franklin, S, George, J, Irvine, N, Gerofke, H, Gibbs, C, Goh, T, Gupta, S, Holmes, J, Jackson-Voyzey, E, Jones, N, Kallat, A, Kerr, P, Kesteven, P, Lench, T, Lester, W, Lowe, G, Lewis, M, Mccormack, T, Mccoye, A, Moriarty, A, Morris, W, Narayanan, M, Oo, N, Reed, M, Rose, P, Saja, K, Sivakumaran, M, Sohal, M, Solomons, G, Sultanzadeh, Sj, Venton, T, Wakeling, J, Walby, C, Waldron, M, Watt, S, Willcock, W, and Zafar, A.

Subjects
Male, Time Factors, Databases, Factual, Administration, Oral, Disease, Comorbidity, 030204 cardiovascular system & hematology, registry, Direct oral anticoagulants, 0302 clinical medicine, Recurrence, Risk Factors, Epidemiology, 030212 general & internal medicine, Prospective Studies, Registries, anticoagulation, LS4_7, Venous Thrombosis, Hematology, Venous Thromboembolism, Vitamin K antagonist, Middle Aged, Thrombosis, Pulmonary embolism, Europe, vitamin K antagonists, Treatment Outcome, Administration, Female, Coagulation and Fibrinolysis, Venous thromboembolism, Oral, Adult, medicine.medical_specialty, Registry, medicine.drug_class, Socio-culturale, Hemorrhage, direct oral anticoagulants, Venous thromboembolism, anticoagulation, direct oral anticoagulants, registry, vitamin K antagonists, Anticoagulation, Vitamin K antagonists, Aged, Anticoagulants, Humans, Pulmonary Embolism, 03 medical and health sciences, Databases, Disease registry, Internal medicine, medicine, cardiovascular diseases, Intensive care medicine, Factual, business.industry, medicine.disease, equipment and supplies, Clinical trial, business
Abstract

SummaryVenous thromboembolism (VTE) is a significant cause of morbidity and mortality in Europe. Data from real-world registries are necessary, as clinical trials do not represent the full spectrum of VTE patients seen in clinical practice. We aimed to document the epidemiology, management and outcomes of VTE using data from a large, observational database. PREFER in VTE was an international, non-interventional disease registry conducted between January 2013 and July 2015 in primary and secondary care across seven European countries. Consecutive patients with acute VTE were documented and followed up over 12 months. PREFER in VTE included 3,455 patients with a mean age of 60.8 ± 17.0 years. Overall, 53.0% were male. The majority of patients were assessed in the hospital setting as inpatients or outpatients (78.5%). The diagnosis was deep-vein thrombosis (DVT) in 59.5% and pulmonary embolism (PE) in 40.5%. The most common comorbidities were the various types of cardiovascular disease (excluding hypertension; 45.5%), hypertension (42.3%) and dyslipidaemia (21.1%). Following the index VTE, a large proportion of patients received initial therapy with heparin (73.2%), almost half received a vitamin K antagonist (48.7%) and nearly a quarter received a DOAC (24.5%). Almost a quarter of all presentations were for recurrent VTE, with >80% of previous episodes having occurred more than 12 months prior to baseline. In conclusion, PREFER in VTE has provided contemporary insights into VTE patients and their real-world management, including their baseline characteristics, risk factors, disease history, symptoms and signs, initial therapy and outcomes.

Published
2016

32. Carotid intima-media thickness and plaque volume changes following 2-year angiotensin II-receptor blockade. The Multicentre Olmesartan atherosclerosis Regression Evaluation (MORE) study

Author

Kl. O. Stumpe, E. Agabiti-Rosei, T. Zielinski, D. Schremmer, J. Scholze, P. Laeis, P. Schwandt, and M. Ludwig

Subjects
сarotid arteries, atherosclerosis, hypertension, olmesartan, atenolol, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Aim. The Multicentre Olmesartan atherosclerosis Regression Evaluation (MORE) study was a double-blind trial in patients with hypertension at increased cardiovascular risk with carotid wall thickening and a defined atherosclerotic plaque that used non-invasive 2- and 3-dimensional (D) ultrasound (US), to compare the effects of a 2-year treatment based on either olmesartan medoxomil or atenolol on common carotid (CC) intima-media thickness (IMT) and plaque volume (PV). Methods. A total of 165 patients (with systolic/diastolic blood pressure 140–180/90–105 mm Hg) were randomized to receive either olmesartan (20–40 mg/day) or atenolol (50–100 mg/day). US was performed at baseline and 28, 52 and 104 weeks. The primary efficacy outcome was the change from baseline (Δ) in CC-IMT assessed by 2D US. Secondary outcomes included ΔPV assessed by 3D US and blood pressure (BP). Results. Olmesartan and atenolol produced comparable significant reductions in CC-IMT; mean ΔIMT (SEM) was −0,090 (0,015) mm for olmesartan and −0,082 (0,014) mm for atenolol. Mean ΔPV was −4,4 (2,3) μl and 0,1 (1,5) μl in the olmesartan and atenolol treated subjects, respectively, without significant between-treatment differences. In the subgroup of patients with baseline PV ≥ median (33,7 μl), significant between-treatment differences existed in ΔPV (p=0,023), because PV regressed significantly with olmesartan (ΔPV: −11,5 (4,4) μl) but not with atenolol (ΔPV: 0,6 (2,5) μl). In these patients BP reductions were comparable. Conclusion. Carotid IMT and BP decreased similarly with olmesartan and atenolol, but only olmesartan reduced the volume of larger atherosclerotic plaques.

Published
1970

33. Local food and tourism in the Global South

Author

Laeis, Gabriel CM

Abstract

ABSTRACTMany countries in the Global South import a significant share of the food served to tourists. For decades, closer linkages of local food producer and the resort industry have been heralded as an antidote to this unsustainable circumstance, further encouraged by the current consumer trend around local food. Reflections on two qualitative research projects in resorts in South Africa and Fiji challenge the notion that tourists move out of their comfort zone to eat local dishes to any greater extent. Large-scale, internationally branded and managed resorts serve predominantly what their tourists from the Global North like to eat: a Western cuisine. If farmers want to benefit from this resort industry, they have to grow food according to the Western palate, which in turn has questionable impacts on biodiversity levels and environmental health in general. The discussion around localising tourism-related food chains in countries of the Global South needs to acknowledge for whose agenda food is being produced. “Corporate resorts” endorse neither a very sustainable nor a locally adaptable culinary agenda.

Published
2019
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40. Edoxaban in atrial fibrillation patients with percutaneous coronary intervention by acute or chronic coronary syndrome presentation: a pre-specified analysis of the ENTRUST-AF PCI trial.

Author

Vranckx P, Valgimigli M, Eckardt L, Lewalter T, Unikas R, Marin F, Schiele F, Laeis P, Reimitz PE, Smolnik R, Zierhut W, Tijssen J, and Goette A

Subjects
Anticoagulants therapeutic use, Fibrinolytic Agents therapeutic use, Humans, Platelet Aggregation Inhibitors adverse effects, Pyridines, Thiazoles, Treatment Outcome, Acute Coronary Syndrome drug therapy, Atrial Fibrillation complications, Atrial Fibrillation drug therapy, Percutaneous Coronary Intervention, Stroke drug therapy, Stroke etiology, Stroke prevention & control
Abstract

Aims: To compare the safety and efficacy of edoxaban combined with P2Y12 inhibition following percutaneous coronary intervention (PCI) in patients with atrial fibrillation (AF) presenting with an acute coronary syndrome (ACS) or chronic coronary syndrome (CCS)., Methods and Results: In this pre-specified sub-analysis of the ENTRUST-AF PCI trial, participants were randomly assigned 1:1 to edoxaban- or vitamin K antagonist (VKA)-based strategy and randomization was stratified by ACS (edoxaban n = 388, VKA n = 389) vs. CCS (edoxaban n = 363, VKA = 366). Participants received edoxaban 60 mg once-daily plus a P2Y12 inhibitor for 12 months, or VKA combined with a P2Y12 inhibitor and aspirin 100 mg (for 1-12 months). The primary bleeding endpoint at 12 months occurred in 59 (15.2%) vs. 79 (20.3%) ACS patients [hazard ratio (HR): 0.73, 95% confidence interval (CI): 0.59-1.02, P = 0.063], and in 69 (19.0%) vs. 73 (19.9%) CCS patients (HR: 0.94, 95%CI: 0.68-1.31, P = 0.708) with edoxaban- and VKA-based therapy, respectively [P for interaction (P-int) = 0.2741]. The main secondary endpoint (composite of CV death, myocardial infarction, stroke, systemic embolic events, or definite stent thrombosis) in ACS patients was 33 (8.5%) vs. 28 (7.2%) (HR: 1.16, 95%CI: 0.70-1.92), compared with 16 (4.4%) vs. 18 (4.9%) (HR: 0.91, 95%CI: 0.47-1.78) CCS patients with edoxaban and VKA-based therapy, respectively (P-int = 0.5573)., Conclusions: In patients with AF who underwent PCI, the edoxaban-based regimen, as compared with VKA-based regimen, provides consistent safety and similar efficacy for ischaemic events in patients with AF regardless of their clinical presentation., (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Published
2020
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41. The global Edoxaban Treatment in routine cliNical prActice (ETNA) noninterventional study program: rationale and design.

Author

De Caterina R, Agnelli G, Laeis P, Unverdorben M, Rauer H, Wang CC, Nakamura M, Chiu KM, Reimitz PE, Koretsune Y, Chen C, Thee U, Kaburagi J, Kim YH, Choi WI, Yamashita T, Cohen A, and Kirchhof P

Subjects
Databases, Factual, Humans, Venous Thromboembolism etiology, Atrial Fibrillation complications, Factor Xa Inhibitors therapeutic use, Pyridines therapeutic use, Thiazoles therapeutic use, Venous Thromboembolism prevention & control
Abstract

Background: Randomized controlled trials showed the nonvitamin K oral anticoagulant (NOAC) edoxaban was effective and safe for stroke and systemic embolism prevention in nonvalvular atrial fibrillation (AF) and for the prevention and treatment of venous thromboembolism (VTE; including pulmonary embolism and deep vein thrombosis). Additional research is needed to evaluate the effects of edoxaban in routine clinical practice. Therefore, the Edoxaban Treatment in routine cliNical prActice (ETNA) program is being conducted to provide routine clinical care data on characteristics and outcomes in patients with AF or VTE receiving edoxaban., Methods: The Global ETNA program integrates prospectively collected data from edoxaban patients in regional ETNA noninterventional studies across Europe, Japan, and East and Southeast Asia into indication-specific databases for AF and VTE. Targeted enrollment is >31 000 patients (AF >26 000; VTE >4500), with a follow-up of 2 years for AF and 1 year for VTE. Data integration will be possible using consistent terminology, parameter definitions, and data collection across the regional noninterventional studies. Safety and effectiveness data will be assessed. Crude rates of outcomes including bleeding and thromboembolic events will be reported., Results: Globally, enrollment began in early 2015 and is ongoing., Conclusions: Global ETNA will generate the largest integrated prospective repository of routine clinical care data for a single NOAC in patients with AF or VTE. It will provide important information on the safety of edoxaban in routine clinical care and gather further information on its effectiveness., (© 2019 The Authors. Clinical Cardiology published by Wiley Periodicals, Inc.)

Published
2019
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42. Adding Hydrochlorothiazide to Olmesartan/Amlodipine Increases Efficacy in Patients With Inadequate Blood Pressure Control on Dual-Combination Therapy.

Author

Rump LC, Ammentorp B, Laeis P, and Scholze J

Subjects
Adult, Aged, Blood Pressure drug effects, Blood Pressure physiology, Blood Pressure Monitoring, Ambulatory methods, Drug Synergism, Drug Therapy, Combination, Female, Humans, Hypertension physiopathology, Male, Middle Aged, Amlodipine administration & dosage, Angiotensin II Type 1 Receptor Blockers administration & dosage, Calcium Channel Blockers administration & dosage, Diuretics administration & dosage, Hydrochlorothiazide administration & dosage, Hypertension drug therapy, Olmesartan Medoxomil administration & dosage
Abstract

This randomized, parallel-group study in patients inadequately controlled on olmesartan medoxomil/amlodipine (OLM/AML) 40/10 mg assessed the effects of adding hydrochlorothiazide (HCTZ) 12.5 mg and 25 mg, using seated blood pressure (SeBP) measurements and ambulatory blood pressure (BP) monitoring. Enrolled patients were screened and tapered off of therapy if required. All patients received OLM/AML 40/10 mg and those with mean seated BP (SeBP) ≥140/90 mm Hg after 8 weeks (n=808) were randomized (1:1:1) to continue with OLM/AML 40/10 mg or receive OLM/AML/HCTZ 40/10/12.5 or 40/10/25 mg for a further 8 weeks. The primary endpoint was the change in seated diastolic BP (SeDBP) from the start to the end of the randomized treatment period. The addition of HCTZ 25 mg significantly reduced SeDBP (-2.8 mm Hg; P<.0001), lowered seated systolic BP (SeSBP) and ambulatory DBP and SBP, and improved BP goal rates. In patients uncontrolled on OLM/AML 40/10 mg, adding HCTZ led to further BP reductions, particularly in ambulatory BP., (© 2015 The Authors. The Journal of Clinical Hypertension Published by Wiley Periodicals, Inc.)

Published
2016
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43. The management of acute venous thromboembolism in clinical practice - study rationale and protocol of the European PREFER in VTE Registry.

Author

Agnelli G, Gitt AK, Bauersachs R, Fronk EM, Laeis P, Mismetti P, Monreal M, Willich SN, Wolf WP, and Cohen AT

Abstract

Background: Venous thromboembolism (VTE) is a major health problem, with over one million events every year in Europe. However, there is a paucity of data on the current management in real life, including factors influencing treatment pathways, patient satisfaction, quality of life (QoL), and utilization of health care resources and the corresponding costs. The PREFER in VTE registry has been designed to address this and to understand medical care and needs as well as potential gaps for improvement., Methods/design: The PREFER in VTE registry was a prospective, observational, multicenter study conducted in seven European countries including Austria, France Germany, Italy, Spain, Switzerland, and the UK to assess the characteristics and the management of patients with VTE, the use of health care resources, and to provide data to estimate the costs for 12 months treatment following a first-time and/or recurrent VTE diagnosed in hospitals or specialized or primary care centers. In addition, existing anticoagulant treatment patterns, patient pathways, clinical outcomes, treatment satisfaction, and health related QoL were documented. The centers were chosen to reflect the care environment in which patients with VTE are managed in each of the participating countries. Patients were eligible to be enrolled into the registry if they were at least 18 years old, had a symptomatic, objectively confirmed first time or recurrent acute VTE defined as either distal or proximal deep vein thrombosis, pulmonary embolism or both. After the baseline visit at the time of the acute VTE event, further follow-up documentations occurred at 1, 3, 6 and 12 months. Follow-up data was collected by either routinely scheduled visits or by telephone calls., Results: Overall, 381 centers participated, which enrolled 3,545 patients during an observational period of 1 year., Conclusion: The PREFER in VTE registry will provide valuable insights into the characteristics of patients with VTE and their acute and mid-term management, as well as into drug utilization and the use of health care resources in acute first-time and/or recurrent VTE across Europe in clinical practice., Trial Registration: Registered in DRKS register, ID number: DRKS00004795.

Published
2015
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44. Efficacy and tolerability of triple-combination therapy with olmesartan, amlodipine, and hydrochlorothiazide: a subgroup analysis of patients stratified by hypertension severity, age, sex, and obesity.

Author

Kreutz R, Ammentorp B, Laeis P, and de la Sierra A

Subjects
Adult, Age Factors, Aged, Amlodipine adverse effects, Blood Pressure drug effects, Body Mass Index, Dose-Response Relationship, Drug, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Hydrochlorothiazide administration & dosage, Imidazoles adverse effects, Male, Middle Aged, Obesity classification, Sex Factors, Tetrazoles adverse effects, Amlodipine therapeutic use, Hydrochlorothiazide therapeutic use, Hypertension classification, Hypertension drug therapy, Imidazoles therapeutic use, Obesity complications, Tetrazoles therapeutic use
Abstract

This prespecified subgroup analysis of a phase III study examined the effect of adding hydrochlorothiazide (HCTZ) to olmesartan (OLM)/amlodipine (AML) in patients with moderate to severe hypertension stratified by age, sex, body mass index, and hypertension severity. A total of 2690 patients, aged 18 years and older, with seated blood pressure (SeBP) ≥160/100 mm Hg received placebo or OLM/AML 20/5 mg, 40/5 mg, or 40/10 mg during a 2-week, double-blind, run-in period, after which they were allocated to one of eight treatment groups with the same OLM/AML dose or with HCTZ 12.5 mg or 25 mg added for 8 weeks. By week 10, greater reductions in SeBP were observed in each OLM/AML/HCTZ group (P<.05, respectively) compared with the corresponding dual dose. Adding HCTZ increased blood pressure-lowering efficacy in all subgroups, with a higher proportion of blood pressure goal achievement vs dual therapy. OLM/AML/HCTZ reduced SeBP to a greater extent than OLM/AML in patients with moderate to severe hypertensive; this was unaffected by baseline hypertension severity, age, sex, and obesity., (©2014 Wiley Periodicals, Inc.)

Published
2014
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