Saxagliptin Could be Big

July 21st, 2009 | Sources: MedPageToday


Ever since a 2007 trial of Avandia raised concern that newer generation diabetes-fighters raised cardiovascular risk, sales of the drugs have crashed and investigators have scurried to provide follow-up data one way or the other.

omgNow, Bristol Meyers Squibb scientists have raised hope that a diabetes drug in the pipeline may actually cut cardiovascular risk.

The drug is saxagliptin, a dipeptidyl peptidase-4 (DPP4) inhibitor.

At the ADA meetings last month, Robert Wolf and colleagues reported the results of a meta-analysis, in which they pooled results from 8 phase II and III trials of the drug.

They found major adverse cardiovascular events to be 55% less common in saxagliptin-treated patients than in those receiving either placebo or metformin.

If confirmed with prospective trials, this cardioprotective effect “would be a very important advance,” Wolf told MedPageToday.

The meta-analysis combined 4,607 adverse events reported during 3,758 patient-years of study in 8 randomized, double-blind trials of saxagliptin in type 2 diabetes.

The incidence of major adverse cardiovascular events, which include cardiovascular death, nonfatal MI, and nonfatal stroke was 0.7% in saxagliptin-treated patients and 1.4% in the other groups.

Saxagliptin was found to cut CV risk in high-risk subsets as well. For example, among those with a prior history of cardiovascular disease, the incidence of major adverse CV events was 9.2% in saxagliptin-treated patients versus 46.3% in other groups.

Equally impressive reductions were seen in populations with at least one CV risk factor beyond diabetes, at least 2 risk factors in addition to diabetes, in men, and in those at least 65 years old.

The drug’s codevelopers, BMS and AZ, have submitted an NDA to the FDA, which is expected to rule on the matter later this month.


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