Actos Clinical Pharmacology

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Actos - Clinical Pharmacology [Pioglitazone]

Table 1 Lipids in a 26-Week Placebo-Controlled Dose-Ranging Study
ACTOS ACTOS ACTOS Placebo 15 mg 30 mg 45 mg
Once Daily Once Daily Once Daily
Triglycerides (mg/ dL) N= 79 N= 79 N= 84 N= 77 Baseline (mean) 262.8% 283.8% 261.1% 259.7%

Percent change from 4.8% -9.0% -9.6% -9.3% baseline (mean)
HDL Cholesterol (mg/ dL) N= 79 N= 79 N= 83 N= 77 Baseline (mean) 41.7% 40.4% 40.8% 40.7%
Percent change from 8.1% 14.1% 12.2% 19.1% baseline (mean)
LDL Cholesterol (mg/ dL) N= 65 N= 63 N= 74 N= 62 Baseline (mean) 138.8% 131.9% 135.6% 126.8%
Percent change from 4.8% 7.2% 5.2% 6.0% baseline (mean)
Total Cholesterol (mg/ dL) N= 79 N= 79 N= 84 N= 77 Baseline (mean) 224.6% 220.0% 222.7% 213.7%
Percent change from 4.4% 4.6% 3.3% 6.4% baseline (mean)

In the two other monotherapy studies (24 weeks and 16 weeks) and in combination therapy studies with sulfonylurea (16 weeks) and metformin (16 weeks), the results were generally consistent with the data above. For patients treated with ACTOS, the corrected mean changes from baseline decreased 5% to 26% for triglycerides and increased 6% to 13% for HDL cholesterol. In the combination therapy study with insulin (16 weeks), the placebo-corrected mean percent change from baseline in triglyceride values for patients treated with ACTOS was also decreased. A placebo-corrected mean change from baseline in LDL cholesterol of 7% was observed for the 15 mg dose group. Similar results to those noted above for HDL and total cholesterol were observed.

Clinical Studies

Monotherapy

In the U. S., three randomized, double-blind, placebo-controlled trials with durations from 16 to 26 weeks were conducted to evaluate the use of ACTOS as monotherapy in patients with type 2 diabetes. These studies examined ACTOS at doses up to 45 mg or placebo once daily in 865 patients.