AIM: These analyses were undertaken to evaluate the efficacy of the insulin sensitizer rosiglitazone (RSG) when added to the therapy of obese type 2 diabetes mellitus patients (T2DM) taking near-maximal doses (2.5 g/day) of metformin (MET). In obese, insulin-resistant patients with T2DM who are inadequately controlled on MET, the addition of an agent that reduces insulin resistance may be a more rational and innovative approach than the addition of an insulin secretagogue. METHODS: Data were pooled from two double-blind studies of RSG added to 2.5 g/day MET, involving a total of 550 T2DM patients. Patients were categorized as non-overweight, overweight and obese according to their baseline BMI using WHO criteria (<25 kgm(-2), 25-30 kgm(-2), >30 kgm(-2) respectively). RESULTS:RSG improved glycaemia (HbA1c) and fasting plasma glucose (FPG) to a clinically significant extent in all three subgroups but the effect was most pronounced in the obese patients. Improvements in HOMA estimates of insulin resistance and beta-cell function were also greatest in the obese patients (4 mg: -16% and +19%; 8 mg: -37% and + 33% respectively), as were reductions in fasting insulin. The profile of adverse events was not demonstrably different in obese patients from the non-obese. CONCLUSIONS: In obese type 2 diabetic patients inadequately controlled on MET alone, addition of rosiglitazone improves glycaemic control, insulin sensitivity and beta-cell function to a clinically important extent.
RCT Entities:
AIM: These analyses were undertaken to evaluate the efficacy of the insulin sensitizer rosiglitazone (RSG) when added to the therapy of obese type 2 diabetes mellituspatients (T2DM) taking near-maximal doses (2.5 g/day) of metformin (MET). In obese, insulin-resistant patients with T2DM who are inadequately controlled on MET, the addition of an agent that reduces insulin resistance may be a more rational and innovative approach than the addition of an insulin secretagogue. METHODS: Data were pooled from two double-blind studies of RSG added to 2.5 g/day MET, involving a total of 550 T2DM patients. Patients were categorized as non-overweight, overweight and obese according to their baseline BMI using WHO criteria (<25 kgm(-2), 25-30 kgm(-2), >30 kgm(-2) respectively). RESULTS:RSG improved glycaemia (HbA1c) and fasting plasma glucose (FPG) to a clinically significant extent in all three subgroups but the effect was most pronounced in the obesepatients. Improvements in HOMA estimates of insulin resistance and beta-cell function were also greatest in the obesepatients (4 mg: -16% and +19%; 8 mg: -37% and + 33% respectively), as were reductions in fasting insulin. The profile of adverse events was not demonstrably different in obesepatients from the non-obese. CONCLUSIONS: In obese type 2 diabeticpatients inadequately controlled on MET alone, addition of rosiglitazone improves glycaemic control, insulin sensitivity and beta-cell function to a clinically important extent.
Authors: Wendy L Bennett; Nisa M Maruthur; Sonal Singh; Jodi B Segal; Lisa M Wilson; Ranee Chatterjee; Spyridon S Marinopoulos; Milo A Puhan; Padmini Ranasinghe; Lauren Block; Wanda K Nicholson; Susan Hutfless; Eric B Bass; Shari Bolen Journal: Ann Intern Med Date: 2011-03-14 Impact factor: 25.391
Authors: James H Flory; Dylan S Small; Patricia A Cassano; David J Brillon; Alvin I Mushlin; Sean Hennessy Journal: J Comp Eff Res Date: 2014-01 Impact factor: 1.744
Authors: Mi Young Lee; Jang Hyun Koh; Soo Min Nam; Pil Moon Jung; Joong Kyung Sung; Song Yi Kim; Jang Yel Shin; Young Goo Shin; Choon Hee Chung Journal: Yonsei Med J Date: 2008-12-31 Impact factor: 2.759