Clinically relevant reductions in HbA1c without hypoglycaemia: results across four studies of saxagliptin.
Bottom Line: Data from these studies were analysed to compare the proportions of patients who achieved specific reductions from baseline in glycated haemoglobin [HbA(1c); reductions of ≥ 0.5% and ≥ 0.7% in all studies (prespecified); reductions ≥ 1.0% in the add-on studies and ≥ 1.0% to ≥ 2.5% in the initial combination study (post hoc)] for saxagliptin vs. comparator at week 24.Analysis of several demographic and baseline clinical variables revealed no consistent correlations with response to saxagliptin.Whether receiving saxagliptin as an add-on therapy to glyburide, a thiazolidinedione, or metformin or in initial combination with metformin, a greater percentage of patients achieve clinically relevant large reductions in HbA(1c) vs. comparator, with a low incidence of hypoglycaemia.
Affiliation: Bristol-Myers Squibb, Princeton, NJ, USA. email@example.comShow MeSH
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Mentions: In the analysis of initial combination therapy with saxagliptin 5 mg and metformin in drug-naive patients (Table 4, Figure 2), rates of response defined by HbA1c reduction ≥ 2.0% were 68.3% with saxagliptin plus metformin vs. 49.8% with metformin monotherapy [difference from metformin 18.5% (10.7%, 26.0%)]; rates of response defined by HbA1c reduction ≥ 2.5% were 51.3% vs. 33.9% [difference from metformin 17.4% (9.6%, 25.1%)]. Not counting patients who experienced one or more events of hypoglycaemia (3.4% in the saxagliptin plus metformin group vs. 4.0% in the placebo plus metformin group), the rates of response defined by HbA1c reduction ≥ 2.0% were 65.7% with saxagliptin plus metformin vs. 47.3% with metformin monotherapy [difference from metformin 18.4% (10.6%, 26.0%)]. Excluding hypoglycaemia, rates of response defined by HbA1c reduction ≥ 2.5% were 49.3% vs. 31.6% [difference from metformin 17.7% (10.0%, 25.2%)].
Affiliation: Bristol-Myers Squibb, Princeton, NJ, USA. firstname.lastname@example.org