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Avandia

Clinical Pharmacology
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Clinical Pharmacology

Avandia

In a second 26-week study, patients with type 2 diabetes inadequately controlled on 2.5 grams/day of metformin who were randomized to receive the combination of AVANDIA 4 mg twice daily and metformin (N = 105) showed a statistically significant improvement in glycemic control with a mean treatment effect for FPG of -56 mg/dL and a mean treatment effect for HbA1c of -0.8% over metformin alone. The combination of metformin and AVANDIA resulted in lower levels of FPG and HbA1c than either agent alone.

Patients who were inadequately controlled on a maximum dose (2.5 grams/day) of metformin and who were switched to monotherapy with AVANDIA demonstrated loss of glycemic control, as evidenced by increases in FPG and HbA1c. In this group, increases in LDL and VLDL were also seen.

Combination With a Sulfonylurea: A total of 3,457 patients with type 2 diabetes participated in ten 24- to 26-week randomized, double-blind, placebo/active-controlled studies and one 2-year double-blind, active-controlled study in elderly patients designed to assess the efficacy and safety of AVANDIA in combination with a sulfonylurea. AVANDIA 2 mg, 4 mg, or 8 mg daily, was administered either once daily (3 studies) or in divided doses twice daily (7 studies), to patients inadequately controlled on a submaximal or maximal dose of sulfonylurea.

In these studies, the combination of AVANDIA 4 mg or 8 mg daily (administered as single or twice daily divided doses) and a sulfonylurea significantly reduced FPG and HbA1c compared to placebo plus sulfonylurea or further up-titration of the sulfonylurea. Table 10 shows pooled data for 8 studies in which AVANDIA added to sulfonylurea was compared to placebo plus sulfonylurea.

Table 10. Glycemic Parameters in 24- to 26-Week Combination Studies of AVANDIA Plus Sulfonylurea

Twice Daily Divided Dosing (5 Studies) Sulfonylurea AVANDIA 2 mg twice daily + sulfonylurea Sulfonylurea AVANDIA 4 mg twice daily + sulfonylurea
N = 397 N = 497 N = 248 N = 346
FPG (mg/dL)
Baseline (mean) 204 198 188 187
Change from baseline (mean) 11 -29 8 -43
Difference from sulfonylurea alone (adjusted mean) – -42* – -53*
% of patients with ≥ 30 mg/dL decrease from baseline 17% 49% 15% 61%
HbA1c (%)
Baseline (mean) 9.4 9.5 9.3 9.6
Change from baseline (mean) 0.2 -1.0 0.0 -1.6
Difference from sulfonylurea alone (adjusted mean) – -1.1* – -1.4*
% of patients with ≥ 0.7% decrease from baseline 21% 60% 23% 75%
Once Daily Dosing (3 Studies) Sulfonylurea AVANDIA 4 mg once daily + sulfonylurea Sulfonylurea AVANDIA 8 mg once daily + sulfonylurea
  N = 172 N = 172 N = 173 N = 176
FPG (mg/dL)
Baseline (mean) 198 206 188 192
Change from baseline (mean) 17 -25 17 -43
Difference from sulfonylurea alone (adjusted mean) – -47* – -66*
% of patients with ≥ 30 mg/dL decrease from baseline 17% 48% 19% 55%
HbA1c (%)
Baseline (mean) 8.6 8.8 8.9 8.9
Change from baseline (mean) 0.4 -0.5 0.1 -1.2
Difference from sulfonylurea alone (adjusted mean) – -0.9* – -1.4*
% of patients with ≥ 0.7% decrease from baseline 11% 36% 20% 68%
* p < 0.0001 compared to sulfonylurea alone.
Brand Name: Avandia
Generic Name: Rosiglitazone Maleate
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