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N Engl J Med. 2010 Sep 2;363(10):905-17. doi: 10.1056/NEJMoa1003114.

Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects.

Collaborators (389)

James WP, Caterson ID, Coutinho W, Finer N, Van Gaal LF, Maggioni AP, Sharma AM, Torp-Pedersen C, Pepine C, Pocock S, Drexler H, Swedberg K, Sleight P, Armstrong P, Kerr D, Dagenais G, Brophy J, Avezum A, Bogaty P, Fabbri G, Galli M, Hildebrandt P, Mann J, Ostergren J, Sherman D, Zannad F, Colquhoun D, Hollanders G, Costa e Forti A, Cifkova R, Toubro S, Ziegler O, Scherbaum WA, Jordan J, Halmy L, Ferrannini E, Santini F, Gonzalez C, Narkiewicz K, Hancu N, Payer J, Pascual J, Wilding J, Campbell L, Carey D, Colquhoun D, Gerstman M, Karrasch J, Lefkovits J, Marks J, Marks S, Moses R, Phillips P, Proietto J, Roberts D, Roberts-Thomson P, Shaw J, Simpson R, Singh B, Singleton Jeffries W, Stuckey B, Boland J, Brohet C, Coucke F, Dendale P, Hollanders G, Jouret G, Kolanowski J, Kutnowski M, Martens F, Muls E, Peiffer F, Penninckx H, Scheen A, Schoors D, Vaerenberg M, Van Cleemput J, Van Crombrugge P, Van Kuyk M, Verhaegen A, Wollaert B, de Albuquerque DC, Appolinario J, Costa e Forti A, de Godoy Matos AF, Gross JL, Halpern A, Kerr Saraiva JF, Milagres R, Repetto G, Suplicy HL, Zanella MT, Bednarova J, Cepelak V, Cerny P, Cifkova R, Hainer V, Havranek P, Homza M, Jansa P, Karlicek M, Kolesar J, Kotik I, Kucera D, Kuchar J, Kunc M, Kvapil M, Linhart A, Machova V, Matuska J, Oral I, Pavlas J, Pesatova S, Povolny J, Semrad B, Smetana K, Soucek M, Svacina S, Tesinsky P, Urbanek R, Wasserburger B, Zachoval R, Zahumensky E, Zidkova E, Astrup A, Dominguez H, Faber J, Hilderbrant P, Kober L, Perrild H, Richelsen B, Sogaard P, Svendsen OL, Toubro S, Urhammer S, Archambeaud F, Basdevant A, Borys JM, Bringer J, Brunetiere C, Charpentier G, Cocaul-André M, Dabadie H, Dubreuil A, Estour B, Gautier JF, Gibault T, Halimi S, Hespel JP, Issa Sayegh M, Krempf M, Laville M, Lecerf JM, Louvet JP, Penfornis A, Ritz P, Schlienger JL, Schmitt B, Valensi P, Ziegler O, Baar M, Beermann J, Bock M, Boenner G, Dammann HG, Diehm C, Ditschuneit H, Gadow J, Gehlhar S, Gessner S, Guthersohn A, Hamann A, Hanefeld M, Hasenfuss G, Herzner A, Heun KC, Heufelder AE, Hohensee H, Jacob S, Jordan J, Krings P, Krätzig B, Krosse B, Lehmann RT, Mindt-Prüfert S, Maisch B, Pfeiffer AF, Richard F, Rose B, Scherbaum WA, Schmidt E, Scholze J, Schreckenberg A, Stuebler P, Walter J, Wirth A, Wunderlich J, Abraham G, Altorjay A, Augusztin G, Csaszar A, Czuriga I, Dinnyes J, Gero L, Gyimesi A, Halmy L, Janosi A, Kovacs I, Kucera D, Liziczai I, Majtenyi A, Medvegy M, Nadhazi Z, Pados G, Polak G, Ronaszeki A, Sido Z, Simon K, Anzà C, Bevilacqua M, Bosello O, Chiariello M, Cordera R, Ferrari E, Ferrannini E, Frittitta L, Giorgino R, Liuzzi A, Malinverni C, Di Mario U, Melchionda N, Occhi G, Perticone F, Pinchera A, Pinelli G, Rovera G, Santeusanio F, Urbinati S, Alpizar-Salazar M, Carrillo-Ortega E, Fanghanel Salmon G, Gonzalez C, Laviada-Molina HA, Madero MA, Rodriguez G, Saldate C, Sanchez-Castillo CP, Violante RM, Wacher N, Zayas-Jaime FJ, Zuniga-Guajardo S, Adamiec R, Banasiak W, Chrusciel P, Derlaga B, Gebala A, Gessek J, Janik K, Janion M, Kalina Z, Kozlowski A, Kusnierz B, Majcher Z, Miekus P, Narkiewicz K, Niegowska J, Okopien B, Ostrowska L, Pasowicz M, Piepiorka M, Pluta W, Polaszewska-Muszynska M, Ponikowski P, Pupek-Musialik D, Sawicki A, Sobocik H, Stankiewicz A, Szpajer M, Trojnar R, Tykarski A, Wrabec K, Wyrzkowski B, Zahorska-Markiewicz B, Zalewski M, Carrageta M, Mendes Pedro MM, Parente Martins LM, dos Santos L, Babes A, Creteanu G, Dan GA, Dragulescu SI, Graur M, Hancu N, Tirgoviste CI, Morosanu M, Mota M, Paveliu FS, Radoi M, Ranetti A, Totoian I, Andre I, Bugan V, Cencarik J, Csala L, Farsky S, Gonsorcik J, Kamensky G, Kmec J, Krahulec B, Kurian R, Macek V, Majercak I, Micko K, Mokan M, Riecansky I, Sojka G, Uhliar R, Urgeova L, Vancik J, Baro FM, Barrios Merino A, Borras JL, Caixas A, Cuatrecasas Cambra G, Dominguez Escribano JR, Duran Garcia S, Escobar-Jimenez L, Esteva de Antonio I, Formiguera Sala X, Garcia-Luna PP, Garcia Robles R, Gonzalez Albarran O, Hernandez-Mijares A, Martin Hidalgo A, Masmiquel Comas L, Morales Perez F, Moreno Esteban B, Pascual Izuel JM, Redon Mas J, Ricart W, Rubio MA, Ruilope LM, Salas-Salvado J, Terroba Larumbe M, Tinahones F, de la Torre Casares ML, Vidal Cortada J, Zuniga-Perez Lemaur M, Abdulhakim EE, Adler A, Barnett AH, Bodmer C, Campbell IW, Chowdhury T, Cleland J, Cook RC, Dinneen S, Donnachie H, Haslam DW, Hillis GS, Horne M, Howarth DJ, Hughes E, Jackson S, Jones SC, Jones TH, Kumar S, Lean M, Maroni J, McInnes G, Middleton A, Morris A, Newcombe G, O'Kane KP, Pavel IC, Pawa R, Perry C, Pitts C, Raja A, Reckless J, Robinson J, Sarmiento R, Soo SC, Taylor S, Thomas HO, Thomson MA, Wilding J, Wilkins M.

Author information

  • 1London School of Hygiene and Tropical Medicine, London, England. jeanhjames@aol.com

Abstract

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.)

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PMID:
20818901
[PubMed - indexed for MEDLINE]
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