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| |  Saxagliptin Combination Therapy Shows Better Glycaemic Control Over Monotherapy: Presented at ESC By Ed Susman BARCELONA, Spain -- September 2, 2009 -- Combination therapy with saxagliptin improved glycaemic control among patients with type 2 diabetes, whether used as an add-on to metformin therapy or as an initial treatment when compared with monotherapy, researchers stated here at the 2009 Congress of the European Society of Cardiology (ESC). “Significantly more patients achieved target glycosylated haemoglobin A1C levels of less than 7% at week 24 with saxagliptin add-on therapy to metformin or with saxagliptin initial combination therapy with metformin compared with placebo and monotherapy, respectively,” said Irina Gurieva, MD, Federal Bureau of Medical and Social Expertise, Moscow, Russia. Dr. Gurieva and colleagues examined 2 phase 3 clinical trials and determined that use of saxagliptin, at 3 different doses, had significant impact on the ability of patients with diabetes to achieve glycaemic control. In the add-on study, patients were treated with metformin. If they failed to achieve glycaemic control, patients were assigned to placebo (n = 79), saxagliptin 2.5 mg/day (n = 192), saxagliptin 5 mg/day (n = 191), or saxagliptin 10 mg/day (n = 181). About 16.6% of patients on placebo achieved glycaemic control, Dr. Gurieva reported in a poster presentation on August 30. About 37.1% of patients receiving saxagliptin 2.5 mg achieved glycaemic control as did 43.5% of those on saxagliptin 5 mg and 44.4% of those on saxagliptin 10 mg (P < .0001 vs placebo for all doses). In the second trial in which combinations of saxagliptin 5 and 10 mg in initial combination with metformin were compared with metformin and saxagliptin monotherapy, the researchers found a similar pattern. About 32.2% of the 335 saxagliptin monotherapy patients achieved glycaemic control and 41.1% of the 328 metformin monotherapy patients achieved glycaemic control. That compared with glycaemic control achieved among 60.3% of the 320 patients taking saxagliptin 5 mg and metformin and among 59.7% of the 323 patients taking saxagliptin 10 mg and metformin. The differences between the monotherapies when compared with the combination therapies were statistically significant (P < .0001). “By providing incremental benefits in glycaemic control, saxagliptin as add-on therapy to metformin or as initial combination therapy with metformin may contribute towards reducing the attendant risks associated with hyperglycaemia in patients with diabetes,” Dr. Gurieva said. Funding for this study was provided by Bristol-Myers Squibb. [Presentation title: Saxagliptin Improves Glycaemic Control Either as Add-On Therapy to Metformin or as Initial Combination Therapy With Metformin in Patients With Type 2 Diabetes]
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