Study finds diabetes drugs do not ease heart disease risk

9/16/2009

NEW YORK In patients with recent onset Type 2 diabetes, treatment with insulin or the diabetes drug metformin did not reduce such inflammatory biomarkers as high-sensitivity C-reactive protein, although the treatment did improve glucose control, according to a new study.

The study, which was published in the Sept. 16 issue of the Journal of the American Medical Association, was led by Aruna D. Pradhan, M.D., M.P.H. and colleagues, of Brigham and Women's Hospital and Harvard Medical School in Boston. The goal was to determine whether insulin alone or combined with metformin lowers levels of hsCRP, IL-6, and sTNFr2 in patients with recent-onset type 2 diabetes mellitus. The study included 500 adults (median [midpoint] time from diabetes diagnosis, 2.0 years), with suboptimal glycemic control and elevated hsCRP levels. Participants were randomized to one of four treatments: placebo metformin only; placebo metformin and insulin; active metformin only; or active metformin and insulin. The researchers noted the change in the measurement of the inflammatory biomarkers from the beginning of the trial to 14 weeks.

The authors wrote that "no consistent association was found between glucose reduction and improvement in inflammatory status ascertained by change in levels of hsCRP, IL-6, or sTNFr2. Despite substantially improving glucose control, neither insulin nor metformin reduced inflammatory biomarker levels for the main effects evaluated or in comparisons between the individual treatment groups. An interaction between interventions was observed such that, compared with no pharmacologic intervention, those allocated to insulin alone had a significant attenuation of inflammation reduction, an effect not observed among those allocated to metformin and insulin or to metformin alone."

The authors also added that the data underscore the need of improved therapy adherence by patients to reduce heart disease risks, including exercise and weight management, and statin therapy.

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