Journal
BMJ OPEN
Volume 2, Issue 6, Pages -Publisher
BMJ PUBLISHING GROUP
DOI: 10.1136/bmjopen-2012-001972
Keywords
-
Categories
Funding
- Bayer HealthCare Pharmaceuticals
- Bayer-Schering Pharma
- Merck-Serono
- Teva Pharmaceuticals
- Novartis
- Abbott Laboratories
- American Medical Association
- Astra Merck
- Athena Neurosciences
- Aventis Pharma
- Bayer Schering Pharma
- Berlex Laboratories
- Biogen and Biogen Idec
- BioMS Medical Corp.
- Blue Cross
- Blue Shield
- Boehringer Ingelheim Pharmaceuticals Inc.
- Caremark Rx
- Centocor, Inc.
- Cephalon, Inc.
- Connectics/Connective Therapeutics
- CroMedica Global Inc.
- Elan Pharmaceuticals, Inc.
- Eli Lilly and Company
- Genentech
- Genzyme Corporation
- GlaxoSmithKline
- Hoechst Marion Roussel Canada Research, Inc.
- Hoffman-LaRoche
- Idec
- Immunex
- Institute for Health Care Quality
- Johnson & Johnson Pharmaceutical Research & Development, LLC
- Kalobios
- S NARCOMS
- Yale University
- Barrow Neurological Institute
- National Multiple Sclerosis Society & Paralyzed Veterans of America
- Pain Panel
- Neurocrine Biosciences
- Novartis Corporation
- Parke-Davis
- Pfizer Inc
- Pharmacia Upjohn
- Protein Design Labs, Inc
- Quantum Biotechnologies, Inc.
- Questcor Pharmaceuticals Inc.
- Quintiles, Inc.
- Sention, Inc.
- Serono
- Shering AG
- Smith Kline-Beecham
- Berlipharm, Inc.
- Takeda Pharmaceuticals
- Teva-Marion
- Triton Biosciences
- Roche
- Biopartners
- EISAI
- MVM Life Science Partners
- Antisense Therapeutics Limited
- Sanofi-Aventis
- Bayhill Pharmaceuticals
- BioMS Pharmaceuticals
- Daichi-Sankyo
- Genmab Biopharmaceuticals
- Glaxo Smith Klein
- PTC Therapeutics
- Medivation
- Eli Lilly
- Teva
- Vivus
- University of Pennsylvania
- NHLBI
- NINDS
- NMSS
- Ono Pharmaceuticals
- Alexion Inc.
- Accentia
- Bayer
- Bayhill
- Barofold
- CibaVision
- Diagenix
- Consortium of MS Centers
- Klein-Buendel Incorporated
- Enzo Pharmaceuticals
- Peptimmune
- Somnus Pharmaceuticals
- UTSouthwestern
- Visioneering Technologies
- Sandoz
- Nuron Biotech, Inc
- Biogen Idec
- Teva Neurosciences
- EMD Serono
- Aspreva
- Aventis
- Schering
- Talecris
Ask authors/readers for more resources
Objectives: Compared with controls, multiple sclerosis (MS) patients die, on average, 7-14 years prematurely. Previously, we reported that, 21 years after their participation in the pivotal randomised, controlled trial (RCT) of interferon beta-1b, mortality was reduced by 46-47% in the two groups who received active therapy during the RCT. To determine whether the excessive deaths observed in placebo-treated patients was due to MS-related causes, we analysed the causes-of-death (CODs) in these three, randomised, patient cohorts. Design: Long-term follow-up (LTF) of the pivotal RCT of interferon beta-1b. Setting: Eleven North American MS-centres participated. Participants: In the original RCT, 372 patients participated, of whom 366 (98.4%) were identified after a median of 21.1 years from RCT enrolment. Interventions: Using multiple information sources, we attempted to establish COD and its relationship to MS in deceased patients. Primary outcome: An independent adjudication committee, masked to treatment assignment and using prespecified criteria, determined the likely CODs and their MS relationships. Results: Among the 366 MS patients included in this LTF study, 81 deaths were recorded. Mean age-at-death was 51.7 (+/-8.7) years. COD, MS relationship, or both were determined for 88% of deaths (71/81). Patients were assigned to one of nine COD categories: cardiovascular disease/stroke; cancer; pulmonary infections; sepsis; accidents; suicide; death due to MS; other known CODs; and unknown COD. Of the 69 patients for whom information on the relationship of death to MS was available, 78.3% (54/69) were adjudicated to be MS related. Patients randomised to receive placebo during the RCT (compared with patients receiving active treatment) experienced an excessive number of MS-related deaths. Conclusions: In this long-term, randomised, cohort study, MS patients receiving placebo during the RCT experienced greater all-cause mortality compared to those on active treatment. The excessive mortality in the original placebo group was largely from MS-related causes, especially, MS-related pulmonary infections.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available