Glucovance Side Effects & Drug Interactions - Glyburide/Metformin

[Glyburide/Metformin]

ADVERSE REACTIONS

In double-blind clinical trials involving GLUCOVANCE as initial therapy or as second-line therapy, a total of 642 patients received GLUCOVANCE, 312 received metformin therapy, 324 received glyburide therapy, and 161 received placebo. The percent of patients reporting events and types of adverse events reported in clinical trials of GLUCOVANCE (all strengths) as initial therapy and second-line therapy are listed in Table 5.

In a controlled clinical trial of rosiglitazone versus placebo in patients treated with GLUCOVANCE (n= 365), 181 patients received GLUCOVANCE with rosiglitazone and 184 received GLUCOVANCE with placebo. Edema was reported in 7.7% (14/ 181) of patients treated with rosiglitazone compared to 2.2% (4/ 184) of patients treated with placebo. A mean weight gain of 3 kg was observed in rosiglitazone-treated patients. Disulfiram-like reactions have very rarely been reported in patients treated with glyburide tablets.

In controlled clinical trials of GLUCOVANCE (Glyburide and Metformin HCl Tablets) there were no hypoglycemic episodes requiring medical intervention and/ or pharmacologic therapy; all events were managed by the patients. The incidence of reported symptoms of hypoglycemia (such as dizziness, shakiness, sweating, and hunger), in the initial therapy trial of GLUCOVANCE are summarized in Table 6. The frequency of hypoglycemic symptoms in patients treated with GLUCOVANCE 1.25 mg/ 250 mg was highest in patients with a baseline HbA 1c <7%, lower in those with a baseline HbA 1c of between 7 and 8%, and was comparable to placebo and metformin in those with a baseline HbA 1c >8%. For patients with a baseline HbA 1c of between 8% and 11% treat-ed with GLUCOVANCE 2.5 mg/ 500 mg as initial therapy, the frequency of hypoglycemic symptoms was 30-35%.

As second-line therapy in patients inadequately controlled on sulfonylurea alone, approximately 6.8% of all patients treated with GLUCOVANCE experienced hypoglycemic symp-toms. When rosiglitazone was added to GLUCOVANCE therapy, 22% of patients reported one or more fingerstick glucose measurements 50 mg/ dL compared to 3.3% of placebo-treated patients. All hypoglycemic events were managed by the patients and only one patient discontinued for hypo-glycemia. (See PRECAUTIONS: General; Addition of Thiazolidinediones to GLUCOVANCE Therapy.)