Modest weight gain and increase in severe hypoglycemia when compared to standard care
TUESDAY, June 12 (HealthDay News) -- The use of insulin glargine to normalize fasting blood glucose levels is not associated with improvements in cardiovascular outcomes compared with standard care, according to a study published online June 11 in the New England Journal of Medicine to coincide with presentation at the American Diabetes Association's 72nd Scientific Sessions, held from June 8 to 12 in Philadelphia.
Hertzel C. Gerstein, M.D., from McMaster University and Hamilton Health Sciences in Canada, and colleagues from the Outcome Reduction with an Initial Glargine Intervention trial randomized 12,537 adults (mean age, 63.5 years) with cardiovascular risk factors and impaired fasting glucose, impaired glucose tolerance, or type 2 diabetes to receive insulin glargine or standard care. The coprimary outcomes were nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes (first coprimary outcome) and these events plus revascularization or hospitalization for heart failure (second coprimary outcome). The authors also looked at between-group differences in microvascular outcomes, incident diabetes, hypoglycemia, weight, and cancers.
During a median of 6.2 years of follow-up, the researchers found that there were similar rates of incident cardiovascular outcomes for the insulin-glargine and standard-care groups (first coprimary outcome, 2.94 and 2.85 per 100 person-years, respectively [P = 0.63] and second coprimary outcome, 5.52 and 5.28 per 100 person-years, respectively [P = 0.27]). Approximately three months after therapy was stopped, new diabetes was diagnosed in 30 and 35 percent, respectively, of participants without baseline diabetes (odds ratio, 0.80; 95 percent confidence interval, 0.64 to 1.00; P = 0.05). The rates of severe hypoglycemia per 100 person-years were 1.00 and 0.31, respectively. In the insulin-glargine group the median weight increased by 1.6 kg, whereas in the standard-care group weight declined by 0.5 kg. No significant difference was noted in the incidence of cancers between the groups.
"When used to target normal fasting plasma glucose levels for more than six years, insulin glargine had a neutral effect on cardiovascular outcomes and cancers," the authors write. "Although it reduced new-onset diabetes, insulin glargine also increased hypoglycemia and modestly increased weight."
The study was supported by Sanofi; several authors disclosed financial ties to pharmaceutical companies, including Sanofi-Aventis, which manufactures insulin glargine.