Safety of nateglinide as used in general practice in England: results of a prescription-event monitoring study
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Nateglinide (Starlix®) is licensed for the treatment of Type 2 diabetes in patients inadequately controlled with metformin. The study objective was to monitor the safety and use of nateglinide prescribed by primary care physicians (GPs) in England, using the observational cohort technique, Prescription–Event Monitoring. Exposure data were derived from dispensed nateglinide prescriptions issued October 2001–June 2004; demographic and outcome data, from questionnaires sent to patients’ GPs at least 6 months after patients’ first prescription. Incidence densities (IDs; number of first reports of an event/1,000 patient-months exposure) were calculated for month 1 (ID1), months 2–6 (ID2–6); rate differences [ID1−ID2–6 (+99% CI)] were examined. Cohort comprised 4,557 patients, median age 60 (IQR 51, 68 years); 2,439 (53.5%) male; 3,463 (76.0%) received nateglinide in combination with metformin. GPs reported 1,625 reasons for stopping in 1,474 (32.3%) patients and 80 events as adverse drug reactions in 66 (1.5%) patients. Events associated with starting treatment included nausea/vomiting [ID1−ID2–6 9.6 (99% CI 5.3, 13.9)], malaise/lassitude [ID1−ID2–6 6.03 (99% CI 2.2, 9.9)]. No serious hypersensitivity reactions were reported. Two pregnancies (< 0.1%) and 73 deaths (1.6%) were reported. Nateglinide appeared to be generally well tolerated when used in combination with metformin for the treatment of Type 2 diabetes.
KeywordsNateglinide Type 2 diabetes Drug safety Post-marketing surveillance Prescription-event monitoring
We are grateful to the GPs in England and the Prescription Pricing Division (a part of the NHSBSA) for their co-operation in this study. We also wish to thank Mrs Lesley Flowers for assistance in the preparation of this manuscript and Mr. Shayne Freemantle for IT support. The Drug Safety Research Unit (DSRU) is a registered independent medical charity (No. 327206) associated with the University of Portsmouth. The DSRU receives donations from pharmaceutical companies; the companies have no control on the conduct or the publication of its studies. The DSRU has received such funds from the manufacturer of the product included in this study.
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