Document Detail


Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects.
MedLine Citation:
PMID:  20818901     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: The long-term effects of sibutramine treatment on the rates of cardiovascular events and cardiovascular death among subjects at high cardiovascular risk have not been established. METHODS: We enrolled in our study 10,744 overweight or obese subjects, 55 years of age or older, with preexisting cardiovascular disease, type 2 diabetes mellitus, or both to assess the cardiovascular consequences of weight management with and without sibutramine in subjects at high risk for cardiovascular events. All the subjects received sibutramine in addition to participating in a weight-management program during a 6-week, single-blind, lead-in period, after which 9804 subjects underwent random assignment in a double-blind fashion to sibutramine (4906 subjects) or placebo (4898 subjects). The primary end point was the time from randomization to the first occurrence of a primary outcome event (nonfatal myocardial infarction, nonfatal stroke, resuscitation after cardiac arrest, or cardiovascular death). RESULTS: The mean duration of treatment was 3.4 years. The mean weight loss during the lead-in period was 2.6 kg; after randomization, the subjects in the sibutramine group achieved and maintained further weight reduction (mean, 1.7 kg). The mean blood pressure decreased in both groups, with greater reductions in the placebo group than in the sibutramine group (mean difference, 1.2/1.4 mm Hg). The risk of a primary outcome event was 11.4% in the sibutramine group as compared with 10.0% in the placebo group (hazard ratio, 1.16; 95% confidence interval [CI], 1.03 to 1.31; P=0.02). The rates of nonfatal myocardial infarction and nonfatal stroke were 4.1% and 2.6% in the sibutramine group and 3.2% and 1.9% in the placebo group, respectively (hazard ratio for nonfatal myocardial infarction, 1.28; 95% CI, 1.04 to 1.57; P=0.02; hazard ratio for nonfatal stroke, 1.36; 95% CI, 1.04 to 1.77; P=0.03). The rates of cardiovascular death and death from any cause were not increased. CONCLUSIONS: Subjects with preexisting cardiovascular conditions who were receiving long-term sibutramine treatment had an increased risk of nonfatal myocardial infarction and nonfatal stroke but not of cardiovascular death or death from any cause. (Funded by Abbott; ClinicalTrials.gov number, NCT00234832.)
Authors:
W Philip T James; Ian D Caterson; Walmir Coutinho; Nick Finer; Luc F Van Gaal; Aldo P Maggioni; Christian Torp-Pedersen; Arya M Sharma; Gillian M Shepherd; Richard A Rode; Cheryl L Renz;
Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The New England journal of medicine     Volume:  363     ISSN:  1533-4406     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2010 Sep 
Date Detail:
Created Date:  2010-09-07     Completed Date:  2010-09-16     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  905-17     Citation Subset:  AIM; IM    
Affiliation:
London School of Hygiene and Tropical Medicine, London, England. jeanhjames@aol.com
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00234832
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MeSH Terms
Descriptor/Qualifier:
Aged
Appetite Depressants / adverse effects*,  therapeutic use
Blood Pressure / drug effects
Cardiovascular Diseases / chemically induced,  complications,  epidemiology*,  mortality
Cyclobutanes / adverse effects*,  therapeutic use
Diabetes Mellitus, Type 2 / complications
Double-Blind Method
Female
Humans
Kaplan-Meiers Estimate
Male
Middle Aged
Myocardial Infarction / chemically induced,  epidemiology
Obesity / complications,  drug therapy*
Overweight / complications,  drug therapy*
Stroke / chemically induced,  epidemiology
Chemical
Reg. No./Substance:
0/Appetite Depressants; 0/Cyclobutanes; 106650-56-0/sibutramine
Investigator
Investigator/Affiliation:
W P T James / ; I D Caterson / ; W Coutinho / ; N Finer / ; L F Van Gaal / ; A P Maggioni / ; A M Sharma / ; C Torp-Pedersen / ; C Pepine / ; S Pocock / ; H Drexler / ; K Swedberg / ; P Sleight / ; P Armstrong / ; D Kerr / ; G Dagenais / ; J Brophy / ; A Avezum / ; P Bogaty / ; G Fabbri / ; M Galli / ; P Hildebrandt / ; J Mann / ; J Ostergren / ; D Sherman / ; F Zannad / ; D Colquhoun / ; G Hollanders / ; A Costa e Forti / ; R Cifkova / ; S Toubro / ; O Ziegler / ; W A Scherbaum / ; J Jordan / ; L Halmy / ; E Ferrannini / ; F Santini / ; C Gonzalez / ; K Narkiewicz / ; N Hancu / ; J Payer / ; J Pascual / ; J Wilding / ; L Campbell / ; D Carey / ; D Colquhoun / ; M Gerstman / ; J Karrasch / ; J Lefkovits / ; J Marks / ; S Marks / ; R Moses / ; P Phillips / ; J Proietto / ; D Roberts / ; P Roberts-Thomson / ; J Shaw / ; R Simpson / ; B Singh / ; W Singleton Jeffries / ; B Stuckey / ; J Boland / ; C Brohet / ; F Coucke / ; P Dendale / ; G Hollanders / ; G Jouret / ; J Kolanowski / ; M Kutnowski / ; F Martens / ; E Muls / ; F Peiffer / ; H Penninckx / ; A Scheen / ; D Schoors / ; M Vaerenberg / ; J Van Cleemput / ; P Van Crombrugge / ; M Van Kuyk / ; A Verhaegen / ; B Wollaert / ; D Campos de Albuquerque / ; J Appolinario / ; A Costa e Forti / ; A Fernando de Godoy Matos / ; J Luiz Gross / ; A Halpern / ; J F Kerr Saraiva / ; R Milagres / ; G Repetto / ; H Lacerda Suplicy / ; M T Zanella / ; J Bednarova / ; V Cepelak / ; P Cerny / ; R Cifkova / ; V Hainer / ; P Havranek / ; M Homza / ; P Jansa / ; M Karlicek / ; J Kolesar / ; I Kotik / ; D Kucera / ; J Kuchar / ; M Kunc / ; M Kvapil / ; A Linhart / ; V Machova / ; J Matuska / ; I Oral / ; J Pavlas / ; S Pesatova / ; J Povolny / ; B Semrad / ; K Smetana / ; M Soucek / ; S Svacina / ; P Tesinsky / ; R Urbanek / ; B Wasserburger / ; R Zachoval / ; E Zahumensky / ; E Zidkova / ; A Astrup / ; H Dominguez / ; J Faber / ; P Hilderbrant / ; L Kober / ; H Perrild / ; B Richelsen / ; P Sogaard / ; O Lander Svendsen / ; S Toubro / ; S Urhammer / ; F Archambeaud / ; A Basdevant / ; J-M Borys / ; J Bringer / ; C Brunetiere / ; G Charpentier / ; M Cocaul-André / ; H Dabadie / ; A Dubreuil / ; B Estour / ; J-F Gautier / ; T Gibault / ; S Halimi / ; J-P Hespel / ; M Issa Sayegh / ; M Krempf / ; M Laville / ; J-M Lecerf / ; J-P Louvet / ; A Penfornis / ; P Ritz / ; J-L Schlienger / ; B Schmitt / ; P Valensi / ; O Ziegler / ; M Baar / ; J Beermann / ; M Bock / ; G Boenner / ; H-G Dammann / ; C Diehm / ; H Ditschuneit / ; J Gadow / ; S Gehlhar / ; S Gessner / ; A Guthersohn / ; A Hamann / ; M Hanefeld / ; G Hasenfuss / ; A Herzner / ; K-C Heun / ; A E Heufelder / ; H Hohensee / ; S Jacob / ; J Jordan / ; P Krings / ; B Krätzig / ; B Krosse / ; R Thorsten Lehmann / ; S Mindt-Prüfert / ; B Maisch / ; A F H Pfeiffer / ; F Richard / ; B Rose / ; W A Scherbaum / ; E Schmidt / ; J Scholze / ; A Schreckenberg / ; P Stuebler / ; J Walter / ; A Wirth / ; J Wunderlich / ; G Abraham / ; A Altorjay / ; G Augusztin / ; A Csaszar / ; I Czuriga / ; J Dinnyes / ; L Gero / ; A Gyimesi / ; L Halmy / ; A Janosi / ; I Kovacs / ; D Kucera / ; I Liziczai / ; A Majtenyi / ; M Medvegy / ; Z Nadhazi / ; G Pados / ; G Polak / ; A Ronaszeki / ; Z Sido / ; K Simon / ; C Anzà / ; M Bevilacqua / ; O Bosello / ; M Chiariello / ; R Cordera / ; E Ferrari / ; E Ferrannini / ; L Frittitta / ; R Giorgino / ; A Liuzzi / ; C Malinverni / ; U Di Mario / ; N Melchionda / ; G Occhi / ; F Perticone / ; A Pinchera / ; G Pinelli / ; G Rovera / ; F Santeusanio / ; S Urbinati / ; M Alpizar-Salazar / ; E Carrillo-Ortega / ; G Fanghanel Salmon / ; C Gonzalez / ; H A Laviada-Molina / ; M Agustin Madero / ; G Rodriguez / ; C Saldate / ; C P Sanchez-Castillo / ; R M Violante / ; N Wacher / ; F J Zayas-Jaime / ; S Zuniga-Guajardo / ; R Adamiec / ; W Banasiak / ; P Chrusciel / ; B Derlaga / ; A Gebala / ; J Gessek / ; K Janik / ; M Janion / ; Z Kalina / ; A Kozlowski / ; B Kusnierz / ; Z Majcher / ; P Miekus / ; K Narkiewicz / ; J Niegowska / ; B Okopien / ; L Ostrowska / ; M Pasowicz / ; M Piepiorka / ; W Pluta / ; M Polaszewska-Muszynska / ; P Ponikowski / ; D Pupek-Musialik / ; A Sawicki / ; H Sobocik / ; A Stankiewicz / ; M Szpajer / ; R Trojnar / ; A Tykarski / ; K Wrabec / ; B Wyrzkowski / ; B Zahorska-Markiewicz / ; M Zalewski / ; M Carrageta / ; M M Mendes Pedro / ; L M Parente Martins / ; L dos Santos / ; A Babes / ; G Creteanu / ; G A Dan / ; S I Dragulescu / ; M Graur / ; N Hancu / ; C I Tirgoviste / ; M Morosanu / ; M Mota / ; F S Paveliu / ; M Radoi / ; A Ranetti / ; I Totoian / ; I Andre / ; V Bugan / ; J Cencarik / ; L Csala / ; S Farsky / ; J Gonsorcik / ; G Kamensky / ; J Kmec / ; B Krahulec / ; R Kurian / ; V Macek / ; I Majercak / ; K Micko / ; M Mokan / ; I Riecansky / ; G Sojka / ; R Uhliar / ; L Urgeova / ; J Vancik / ; F Moreno Baro / ; A Barrios Merino / ; J-L Griera Borras / ; A Caixas / ; G Cuatrecasas Cambra / ; J R Dominguez Escribano / ; S Duran Garcia / ; L Escobar-Jimenez / ; I Esteva de Antonio / ; X Formiguera Sala / ; P-P Garcia-Luna / ; R Garcia Robles / ; O Gonzalez Albarran / ; A Hernandez-Mijares / ; A Martin Hidalgo / ; L Masmiquel Comas / ; F Morales Perez / ; B Moreno Esteban / ; J M Pascual Izuel / ; J Redon Mas / ; W Ricart / ; M-A Rubio / ; L M Ruilope / ; J Salas-Salvado / ; M Terroba Larumbe / ; F Tinahones / ; M Lopez de la Torre Casares / ; J Vidal Cortada / ; M Zuniga-Perez Lemaur / ; E E A Abdulhakim / ; A Adler / ; A H Barnett / ; C Bodmer / ; I W Campbell / ; T Chowdhury / ; J Cleland / ; R C Cook / ; S Dinneen / ; H Donnachie / ; D W Haslam / ; G S Hillis / ; M Horne / ; D J Howarth / ; E Hughes / ; S Jackson / ; S C Jones / ; T H Jones / ; S Kumar / ; M Lean / ; J Maroni / ; G McInnes / ; A Middleton / ; A Morris / ; G Newcombe / ; K P J O'Kane / ; I C Pavel / ; R Pawa / ; C Perry / ; C Pitts / ; A Raja / ; J Reckless / ; J Robinson / ; R Sarmiento / ; S-C Soo / ; S Taylor / ; H O Thomas / ; M A Thomson / ; J Wilding / ; M Wilkins /
Comments/Corrections
Comment In:
N Engl J Med. 2010 Sep 2;363(10):972-4   [PMID:  20818908 ]

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