Effect of Nateglinide on the Incidence of Diabetes and Cardiovascular Events

• DOI: 10.1056/nejmoa1001122
• Publication Date: 2010-03-15T00:12:47Z
• Authors: Rury R. Holman; Steven M. Haffner; John J.V. McMurray; M. Angelyn Bethel; Björn Holzhauer; Tsushung A. Hua; Yuri Belenkov; Mitradev Boolell; John B. Buse; Brendan M. Buckley; Antônio Roberto C...; Fu‐Tien Chiang; B Charbonnel; Chun Chung Chow; Melanie J. Davies; Prakash Deedwania; Peter Diem; Daniel Einhorn; Vivian Fonseca; Gregory Fulcher; Zbigniew Gaciong; Sonia Gaztambide; Thomas D. Giles; Edward S. Horton; Hasan İlkova; Trond Jenssen; Steven E. Kahn; Henry Krum; Markku Laakso; Lawrence A. Leiter; Naomi Levitt; Mareev VIu; Felipe A. Martínez; Chantal Masson; Theodore Mazzone; Eduardo Meaney; Richard W. Nesto; Changyu Pan; Rudolf Prager; S. Raptis; Guy E.H.M. Rutten; Herbert Sandstroem; Frank Schäper; André Scheen; Ole Schmitz; Isaac Sinay; Vladimír Soška; Steen Stender; Gyula Tamás; Gianni Tognoni; Jaako Tuomilehto; Alberto S. Villamil; J Vozár; Robert M. Califf
• Keywords: Nateglinide; Cumulative incidence; Unstable angina; Stroke

The ability of short-acting insulin secretagogues to reduce the risk diabetes or cardiovascular events in people with impaired glucose tolerance is unknown.In a double-blind, randomized clinical trial, we assigned 9306 participants and either disease factors receive nateglinide (up 60 mg three times daily) placebo, 2-by-2 factorial design valsartan addition participation lifestyle modification program. We followed for median 5.0 years incident (and 6.5 vital status). evaluated effect on occurrence coprimary outcomes: development diabetes; core outcome that was composite death from causes, nonfatal myocardial infarction, stroke, hospitalization heart failure; an extended individual components outcome, unstable angina, arterial revascularization.After adjustment multiple testing, nateglinide, as compared did not significantly cumulative incidence (36% 34%, respectively; hazard ratio, 1.07; 95% confidence interval [CI], 1.00 1.15; P=0.05), (7.9% 8.3%, 0.94, CI, 0.82 1.09; P=0.43), (14.2% 15.2%, 0.93, 0.83 1.03; P=0.16). Nateglinide did, however, increase hypoglycemia.Among persons established factors, assignment 5 outcomes. (ClinicalTrials.gov number, NCT00097786.)