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Marrakesh, Morocco

Valeyre D.,Hospital Avicenne | Albera C.,University of Turin | Bradford W.Z.,InterMune Inc. | Costabel U.,University of Duisburg - Essen | And 5 more authors.

Background and objective Pirfenidone is an oral antifibrotic agent that is approved in several countries for the treatment of idiopathic pulmonary fibrosis (IPF). We performed a comprehensive analysis of safety across four clinical trials evaluating pirfenidone in patients with IPF. Methods All patients receiving pirfenidone 2403 mg/day in the Phase 3 CAPACITY studies (Studies 004 and 006) and all patients receiving at least one dose of pirfenidone in one of two ongoing open-label studies in patients with IPF (Studies 002 and 012) were selected for inclusion. Safety outcomes were evaluated from baseline until 28 days after the last dose of study drug. Results A total of 789 patients were included in the analysis. The median duration of exposure to pirfenidone was 2.6 years (range, 1 week-7.7 years), and the cumulative total exposure was 2059 person exposure years (PEY). Gastrointestinal and skin-related events were the most commonly reported adverse events; these were almost always mild to moderate in severity, and rarely led to treatment discontinuation. Elevations (>3× upper limit of normal) in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) occurred in 21/789 (2.7%) patients; the adjusted incidence of AST/ALT elevations was 1.7 per 100 PEY. Conclusions This comprehensive analysis of safety in a large cohort of IPF patients receiving pirfenidone for a total of 2059 PEY demonstrates that long-term treatment with pirfenidone is safe and generally well tolerated. Comprehensive analysis of safety outcomes in a large cohort of patients with IPF demonstrated that treatment with pirfenidone for up to 7.7 years (median, 2.6 years; range, 1 week-7.7 years) was safe and generally well tolerated. © 2014 The Authors. Respirology published by Wiley Publishing Asia Pty Ltd on behalf of Asian Pacific Society of Respirology. Source

Valeyre D.,Hospital Avicenne
European Respiratory Review

Idiopathic pulmonary fibrosis (IPF) is the most common of the idiopathic interstitial pneumonias, and poses significant clinical challenges. IPF diagnosis is based on clear-cut computed tomography (CT) and histopathological criteria, in an appropriate clinical context. The diagnostic criteria include: 1) exclusion of known causes of interstitial lung disease (including connective tissue disease); 2) usual interstitial pneumonia pattern on high-resolution CT in patients not subjected to surgical lung biopsy; and 3) specific combinations of high-resolution CT with pathological patterns in case of surgical lung biopsy. Improved diagnosis of IPF may help physicians to reduce the delay before an accurate diagnosis is made and increase patient awareness and access to adequate information, follow-up and treatment. © ERS 2011. Source

Eholie S.P.,Treichville University Hospital | Lacombe K.,University Pierre and Marie Curie | Lacombe K.,University Paris Est Creteil | Lacombe K.,Paris-Sorbonne University | And 9 more authors.
AIDS Research and Human Retroviruses

In a cohort of HIV-infected patients of sub-Saharan origin we describe the incidence of metabolic syndrome, insulin resistance, and lipodystrophy after 3 years of combined antiretroviral therapy, and model the 10-year risk of cardiovascular diseases, while taking into account environmental factors. This is a multinational, prospective cohort study conducted in HIV outpatient clinics from four tertiary care centers set in France and Côte d'Ivoire. The participants were HIV-infected, treatment-naive patients eligible to start antiretroviral treatment and were of sub-Saharan African origin. The main outcome measures were the incidence of metabolic syndrome, insulin resistance, and lipodystrophy, and the assessment of the 10-year risk of cardiovascular diseases using Framingham risk prediction, D.A.D. Cardiovascular Disease Risk, and WHO/ISH prediction charts. Of 245 patients followed for up to 3 years, the incidence of metabolic syndrome, insulin resistance, and lipodystrophy was 5.5, 8.5, and 6.8 per 100 person-years of follow-up (cumulative incidence: 14.4%, 19.2%, and 18.1%, respectively). Living in France as well as female gender and being overweight were risk factors for metabolic disorders as whole and only first generation protease inhibitors were marginally associated with metabolic syndrome. Cardiovascular risk as modeled through the three equations was high in all patients with the synergistic and deleterious effect of living in France compared to Côte d'Ivoire. This cohort study shows how the synergy between HIV, antiretroviral (ARV) exposure, and westernization of life style in a cohort of HIV-infected patients of sub-Saharan origin leads to a progressive increase in the risk of lipodystrophy, as well as metabolic syndrome and insulin resistance, all associated with increased cardiovascular risk. © Copyright 2015, Mary Ann Liebert, Inc. 2015. Source

Baughmann R.P.,University of Cincinnati | Drent M.,Maastricht University | Culver D.A.,Cleveland Clinic | Handa T.,Kyoto University | And 10 more authors.
Sarcoidosis Vasculitis and Diffuse Lung Diseases

Over the past few years an increasing number of prospective controlled sarcoidosis treatment trials have been completed. Unfortunately, these studies utilize different endpoints making comparisons between studies difficult. At the recent World Association of Sarcoidosis and other Granulomatous disease (WASOG) meeting, a session was dedicated to the evaluation of clinical endpoints for various disease manifestations. These included pulmonary, pulmonary hypertension, fatigue, cutaneous, and a classification of clinical disease phenotypes. Based on the available literature and our current understanding of the disease, recommendations for clinical evaluation were proposed for each disease category. For example, it was recommended that pulmonary studies should include changes in the forced vital capacity. Additionally, it was recommended that all trials should incorporate measurement of quality of life. © Mattioli 1885. Source

Mechchat A.,Hospital Avicenne
The Pan African medical journal

Aneurysms of the intra-thoracic subclavian artery (SCA) are rare. They are often revealed by complications. Surgical treatment is always indicated. Endovascular treatment is a less invasive alternative. We report a case of a 60 years-old woman admitted for right chest pain and dysphonia. Laryngoscopy noted a right vocal cord palsy. Chest computed tomography and angiography showed a giant aneurysm of the intra-thoracic right SCA. A resection-ligation of the aneurysm was performed by a supra-clavicular approach. Postoperative course was uneventful. The histology defined an atherosclerotic aneurysm. The patient underwent voice reeducation with partial improvement after six months. Source

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