ACC: Valsartan, Nateglinide Do Not Reduce Cardio Events
Research looks at drugs' effectiveness in patients with impaired glucose tolerance
MONDAY, March 15 (HealthDay News) -- In patients with impaired glucose tolerance and cardiovascular disease or cardiovascular risk factors, neither valsartan nor nateglinide reduces the incidence of cardiovascular outcome measures, but valsartan does lead to a modest reduction in the incidence of diabetes, according to the results of two analyses from the Nateglinide and Valsartan in Impaired Glucose Tolerance Outcomes Research (NAVIGATOR) study group. The findings were published online March 14 in the New England Journal of Medicine to coincide with the Annual Scientific Session of the American College of Cardiology, held from March 14 to 16 in Atlanta.
Rury R. Holman, of the University of Oxford in the United Kingdom, and colleagues randomized 9,306 individuals to receive nateglinide or placebo, in a two-by-two factorial design with valsartan or placebo, coupled with participation in a lifestyle modification program. After five years of follow-up and adjustment for multiple testing, the researchers found that nateglinide did not significantly reduce either the cumulative incidence of diabetes, the core composite cardiovascular outcome (death from cardiovascular causes, nonfatal heart attack or stroke, or hospitalization due to heart failure), or the extended composite cardiovascular outcome (individual components of the core composite outcome, hospitalization due to unstable angina, or arterial revascularization).
In another analysis performed by the NAVIGATOR study group, the researchers evaluated the effects of valsartan on the incidence of diabetes and cardiovascular events. The investigators found that patients in the valsartan group had a modestly lower incidence of diabetes than those in the placebo group, but that valsartan did not significantly reduce the incidence of the core composite or the extended composite cardiovascular outcome measures.
"The results of the NAVIGATOR study are largely negative. Neither drug (nor the combination, keeping in mind that one quarter of the study cohort took both drugs) reduced the two coprimary cardiovascular-disease outcomes. The only positive result was a weak, albeit statistically significant, reduction in the incidence of diabetes with valsartan," writes the author of an accompanying editorial.
The research was supported by Novartis; several authors reported financial relationships with the company.