Glucovance Adverse Reactions

In double-blind clinical trials involving Glucovance, a total of 642 patients received Glucovance, 312 received metformin therapy, 324 received glibenclamide 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 2.


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Disulfiram-like reactions have very rarely been reported in patients treated with glibenclamide tablets.
Hypoglycemia: In controlled clinical trials of Glucovance, 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 (eg, dizziness, shakiness, sweating and hunger) in the initial therapy trial of Glucovance are summarized in Table 3. 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 baseline HbA_1c >8%. For patients with a baseline HbA_1c between 8% and 11% treated 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 symptoms.
Gastrointestinal Reactions: The incidence of GI side effects (diarrhea, nausea/vomiting and abdominal pain) in the initial therapy trial are summarized in Table 3. Across all Glucovance trials, GI symptoms were the most common adverse events with Glucovance and were more frequent at higher dose levels. In controlled trials, <2% of patients discontinued Glucovance therapy due to GI adverse events.


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