BACKGROUND: Although some evidence suggests that women may be at greater risk for hypoglycemia, no conclusion has been reached, and female sex has not been taken into account in antidiabetic drug-induced hypoglycemia. This study aimed to determine whether females are at a higher risk of sulfonylurea (SU)-associated hypoglycemia in daily clinical practice. METHODS: The incidence of adverse reactions of SU was investigated in 2119 Japanese patients who participated in the Drug Event Monitoring project of the Japan Pharmaceutical Association, which was conducted in Kumamoto prefecture. A multiple logistic regression analysis was used to determine the association between the incidence of hypoglycemic symptoms and female sex, with adjusted odds ratios (ORs) and 95 % confidence intervals (95 % CIs). RESULTS: Female sex was found to be significantly associated with hypoglycemic symptoms (female vs. male; OR 2.04; 95 % CI 1.22-3.41; p = 0.007). The concomitant use of other antihyperglycemic agents (≥2 vs. 0 concomitant drug; OR 2.80; 95 % CI 1.17-6.67; p = 0.021), a shorter duration of diabetes medication (<3 vs. ≥24 months; OR 4.14; 95 % CI 1.06-16.14; p = 0.041) and a longer follow-up period (OR 1.02; 95 % CI 1.00-1.04; p = 0.041) were identified as risk factors for hypoglycemia that were specific to females. CONCLUSION: To the best of our knowledge, this is the first report to focus on female sex as a potential risk factor for SU-associated hypoglycemia. Our results support the importance of individualized therapy, which may be effective not only for reducing the risk of hypoglycemia in females but also the risk of its consequences, such as cardiovascular disease, dementia and increased mortality.
BACKGROUND: Although some evidence suggests that women may be at greater risk for hypoglycemia, no conclusion has been reached, and female sex has not been taken into account in antidiabetic drug-induced hypoglycemia. This study aimed to determine whether females are at a higher risk of sulfonylurea (SU)-associated hypoglycemia in daily clinical practice. METHODS: The incidence of adverse reactions of SU was investigated in 2119 Japanese patients who participated in the Drug Event Monitoring project of the Japan Pharmaceutical Association, which was conducted in Kumamoto prefecture. A multiple logistic regression analysis was used to determine the association between the incidence of hypoglycemic symptoms and female sex, with adjusted odds ratios (ORs) and 95 % confidence intervals (95 % CIs). RESULTS: Female sex was found to be significantly associated with hypoglycemic symptoms (female vs. male; OR 2.04; 95 % CI 1.22-3.41; p = 0.007). The concomitant use of other antihyperglycemic agents (≥2 vs. 0 concomitant drug; OR 2.80; 95 % CI 1.17-6.67; p = 0.021), a shorter duration of diabetes medication (<3 vs. ≥24 months; OR 4.14; 95 % CI 1.06-16.14; p = 0.041) and a longer follow-up period (OR 1.02; 95 % CI 1.00-1.04; p = 0.041) were identified as risk factors for hypoglycemia that were specific to females. CONCLUSION: To the best of our knowledge, this is the first report to focus on female sex as a potential risk factor for SU-associated hypoglycemia. Our results support the importance of individualized therapy, which may be effective not only for reducing the risk of hypoglycemia in females but also the risk of its consequences, such as cardiovascular disease, dementia and increased mortality.