Efficacy and tolerability of glimepiride in daily practice - A non-interventional observational cohort study

Objective: The aim of the present study was to monitor the efficacy and tolerability of glimepiride in daily practice. Design: An 8-week non-interventional cohort study investigating glimepiride in daily practice. Setting and Data Collection: 4810 general practitioners and hospital physicians were asked to report on demographics and medical history, glimepiride dose, glycated haemoglobin (HbA(1c)) levels, adverse events and causes of discontinuation of therapy. Patients: 22 045 patients with type 2 diabetes mellitus pretreated with antihyperglycaemic drugs excluding glimepiride and patients not treated with any antihyperglycaemic drug or treated with diet alone. Most patients were either overweight (42.2%) or obese (26.1%). Results: A total of 29.3% of patients were treated with glimepiride as a first-time antihyperglycaemic drug, whereas in 70.7% of patients pre-existing oral antiyperglycaemic medication was changed to glimepiride monotherapy (69.6%) or continued as combination therapy with glimepiride (30.4%). The initial and final doses were lower in patients who commenced oral anti hyperglycaemic therapy (initial 1.3mg, final 1.8mg) compared with patients whose therapy was changed (initial 1.7mg, final 2.4mg). The mean reduction of HbA(1c) was more pronounced in newly treated patients (1.8%) compared with patients changed to glimepiride therapy (1.3%). The most marked reduction in HbA(1c) levels (1.9%) was achieved in obese patients (body mass index greater than or equal to 30 kg/m), treated for the first time with an antihyperglycaemic drug using glimepiride. Bodyweight was reduced on therapy with glimepiride in all patients (1.4kg). With a bodyweight reduction of 2.2kg, this effect was particularly outstanding in obese patients. Adverse events and discontinuation of therapy were observed in 2.3 and 4.9% of patients, respectively, including a hypoglycaemia rate of 0.3%. Conclusion: This non-interventional study carried out under daily practice conditions confirmed the good efficacy and tolerability of glimepiride in a large number of patients, as documented in previous clinical trials.