Glibenclamide-associated hypoglycaemia: A report on 57 cases

Abstract

In the largest series of patients with glibenclamide-associated hypoglycaemia reported so far, 51 cases reported to the Swedish Adverse Drug Reactions Advisory Committee and six additional cases are reviewed and related to sales and prescription data of glibenclamide. Median age of the patients with hypoglycaemia was 75 years and 21% were 85 years or above. For comparison, the median age of a random sample (1 in 288 of all patients prescribed glibenclamide) was 70 years and only 5% were 85 years or older. In eight out of 40 cases where duration of glibenclamide treatment was recorded, the hypoglycaemic event occurred during the first month of treatment. The median daily dose of glibenclamide prescribed was 10 mg both in the hypoglycaemic cases and in the prescription sample. Coma or disturbed consciousness was the most common clinical presentation in this series and the minimum blood glucose value was 1.3 mmol/l (median). Twenty-two patients responded immediately to treatment, 24 had protracted hypoglycaemia of 12-72 h duration and 10 died. Fatal outcome was observed even with small doses of glibenclamide (2.5-5 mg/day). Previous strokes and cardiac disorders were isolated as two independent determinants of a serious course of the hypoglycaemia. Other contributing factors included impaired renal function, low food intake, diarrhoea, alcohol intake and interaction with other drugs. Thus, it is not uncommon for glibenclamide, like the first-generation sulphonylureas, to cause serious, protracted and even fatal hypoglycaemic events.

Glibenclamide-induced profound hypoglycaemic crisis: a case report

“…However, in our case the patient had no past medication history of such kind. The presentation of our patient is consistent with the results of a report on 57 cases by Asplund and colleagues in which a fatal outcome was observed even with small doses of glibenclamide (2.5-5 mg/day) [Asplund et al 1983]. The contributing factors, including impaired renal function, poor intake and diarrhoea were present in the current case.…”

A Systematic Review and Meta-Analysis of Hypoglycemia and Cardiovascular Events

“…The UK Prospective Diabetes Study (UKPDS) showed that improving glycemic control reduced longterm microvascular complications (2). However, intensive therapy increases the risk for severe hypoglycemia, which is associated with mortality and morbidity (3,4).…”

“…Glyburide (called glibenclamide in Europe), the most widely used sulfonylurea (7), has a relatively long terminal half-life in chronic dosing compared with other sulfonylureas, owing to its high affinity for the ␤-cell sulfonylurea receptor and the accumulation of active metabolites that are excreted through the kidney (7). Several observational studies have reported increased rates of hypoglycemia with the use of glyburide compared with other sulfonylureas (3,4). A systematic review of randomized controlled trials (RCTs) evaluating the risk for hypoglycemia associated with the use of glyburide has not, to our knowledge, been previously conducted.…”

True

“…10 A high mean age also characterised a series of glibenclamide-treated patients with Type 2 diabetes in whom severe hypoglycaemia was reported to the Swedish Adverse Drug Reactions Advisory Committee. 14 In this study, 24 of the 57 patients reviewed had protracted hypoglycaemia, and 10 patients died. In some cases, fatal outcomes occurred when doses were as low as 2.5 ± 5 mgaday.…”