| Autor: |
Yoon, K.H., Shockey, G.R., Teng, R., Golm, G.T., Thakkar, P.R., Meehan, A.G., Williams-Herman, D.E., Kaufman, K.D., Amatruda, J.M., Steinberg, H. |
| Zdroj: |
International Journal of Clinical Practice; Feb2011, Vol. 65 Issue 2, p154-164, 11p |
| Abstrakt: |
Aim/hypothesis: To assess the safety and efficacy of initial combination therapy with sitagliptin and pioglitazone compared with pioglitazone monotherapy in drug-naïve patients with type 2 diabetes. Methods: A total of 520 patients were randomised to initial combination therapy with sitagliptin 100 mg q.d. and pioglitazone 30 mg q.d. or pioglitazone 30 mg q.d. monotherapy for 24 weeks. Results: Initial combination therapy with sitagliptin and pioglitazone led to a mean reduction from baseline in A1C of -2.4% compared with -1.5% for pioglitazone monotherapy (p < 0.001). Mean reductions from baseline were greater in patients with a baseline A1C greater than or equal to 10% (-3.0% with combination therapy vs. -2.1% with pioglitazone monotherapy) compared with patients with a baseline A1C < 10% (-2.0% with combination therapy vs. -1.1% with pioglitazone monotherapy). Sixty percent f patients in the combination therapy group vs. 28% in the pioglitazone monotherapy group had an A1C of < 7% at week 24 (p < 0.001). Fasting plasma glucose decreased by -63.0 mg/dl (-3.5 mmol/l) in the combination therapy group compared with -40.2 mg/dl (-2.2 mmol/l) for pioglitazone monotherapy (p < 0.001), and 2-h post meal glucose decreased by -113.6 mg/dl (-6.3 mmol/) with combination therapy compared with -68.9 mg/dl (-3.8 mmol/l) for pioglitazone monotherapy (p < 0.001). Measures related to b-cell function also improved significantly with combination therapy compared with pioglitazone monotherapy. Combination therapy was generally well-tolerated compared with pioglitazone monotherapy, with similar incidences of hypoglycemia (1.1% and 0.8%, respectively), gastrointestinal adverse events (5.7% and 6.9%, respectively), and oedema (2.7% and 3.5%, respectively). Conclusion/interpretation: Initial combination therapy with sitagliptin and pioglitazone substantially improved glycemic control and was generally well-tolerated compared with pioglitazone monotherapy. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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