Efficacy and safety profile of co-administered ER niacin/laropiprant and simvastatin in dyslipidaemia

Co-administered niacin and statin may offer additional lipid management; however, niacin is underutilised due to flushing, mediated primarily by prostaglandin D 2 (PGD 2 ). A combination tablet containing 1 g extended-release niacin and 20 mg laropiprant (ERN/LRPT), a PGD 2 -receptor (DPI) antagonist, offers improved tolerability. To assess the efficacy and safety of ERN/LRPT + simvastatin versus ERN/LRPT and simvastatin alone in dyslipidaemic patients, in this 12-week study, 1,398 patients were randomised equally to ERN/LRPT 1 g/20 mg, simvastatin (10, 20 or 40 mg), or ERN/ LRPT 1 g/20 mg + simvastatin (10, 20 or 40 mg) once-daily for four weeks. At week five, doses were doubled in all groups except simvastatin 40 mg (unchanged) and ERN/LRPT 1 g/20 mg + simvastatin 40 mg (switched to ERN/LRPT 2 g/40 mg + simvastatin 40 mg). ERN/LRPT + simvastatin (pooled across simvastatin doses) significantly improved key lipid parameters versus ERN/LRPT and pooled simvastatin: mean percentage changes from baseline to week 12 for low-density lipoprotein cholesterol were -47.9%, -17.0% and -37.0%, respectively, and for high-density lipoprotein cholesterol were 27.5%, 23.4% and 6.0%, respectively. ERN/LRPT + simvastatin was generally well tolerated, with a low incidence of serious treatment-related adverse experiences (0.2%, 0.5% and 0.2% for ERN/LRPT + simvastatin, ERN/ LRPT and simvastatin, respectively). In conclusion, ERN/LRPT + simvastatin significantly improved the lipid profile compared with ERN/LRPT and simvastatin alone and was generally well tolerated in dyslipidaemic patients.