A European, Observational, 3‐Year Cohort Comparative Study on the Safety of the Fixed Dose Combination Pravastatin 40 mg/Fenofibrate 160 mg vs. Statin Alone in Real Clinical Practice: The POSE Study

• Published in: Pharmacoepidemiology and drug safety 2024-11, Vol.33 (11), p.e70047-n/a
• Main Authors: Papadopoulos, Nikolaos, Arvaniti, Eleni, Angelopoulos, Theodoros, Tziomalos, Konstantinos, Tembra, Manuel Suarez, Diaz, Jose Luis, De Niet, Sophie, Da Silva, Stéphanie, Doupis, John
• Format: Article
• Language: English
• Subjects: Aged; Cardiovascular Diseases - chemically induced; Cardiovascular Diseases - epidemiology; Cardiovascular Diseases - prevention & control; Cohort Studies; Drug Combinations; dyslipidaemia; Dyslipidemias - drug therapy; Dyslipidemias - epidemiology; Europe - epidemiology; Female; Fenofibrate - administration & dosage; Fenofibrate - adverse effects; fixed dose combination; Follow-Up Studies; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration & dosage; Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects; Hypolipidemic Agents - administration & dosage; Hypolipidemic Agents - adverse effects; Male; Middle Aged; Pravastatin - administration & dosage; Pravastatin - adverse effects; pravastatin 40 mg/fenofibrate 160 mg; real‐life; safety
• ISSN: 1053-8569; 1099-1557; 1099-1557
• DOI: 10.1002/pds.70047

ABSTRACT Background and Purpose The aim of the study was to provide valuable real‐world long‐term safety data of the fixed pravastatin 40 mg/fenofibrate 160 mg combination in comparison of monotherapy with statins of moderate intensity. Materials and Methods POSE study was an observational, comparative study conducted in three European countries. Patients treated or planned to be treated with pravastatin 40 mg/fenofibrate 160 mg or with a moderate‐intensity statin in monotherapy were assessed over 3 years. The main safety endpoints included the incidence of renal or urinary disorder, musculoskeletal or connective tissue disorder, hepatobiliary disorder and cardiovascular events. Results The study included 3075 patients treated for dyslipidaemia, with diabetes mellitus (47%), hypertension (56%) and/or established cardiovascular disease (61%). Over the 3 years of follow‐up, the difference in incidence rate of safety events between the pravastatin 40 mg/fenofibrate 160 mg group and the statin group was not statistically significant (RR = 1.366 [95% CI = 0.967–1.929]). The most frequently occurring events were musculoskeletal and connective tissue disorders (AR = 0.030 in the pravastatin 40 mg/fenofibrate 160 mg group and 0.024 in the statin group), renal and urinary disorders (AR = 0.019 vs. 0.016, respectively) and aggravated diabetes mellitus (0.021 vs. 0.014). Most events occurred during the first year, then incidence decreased over the 3‐year period. No statistically significant difference was observed between treatment groups regarding the cardiovascular events (RR = 1.209 [95% CI = 0.596–2.453]) and no new signal emerged from the long‐term follow‐up. Conclusions This study demonstrates a reassuring long‐term safety profile of the fixed pravastatin 40 mg/fenofibrate 160 mg combination in routine clinical practice, with low and similar incidence of events over the 3 years follow‐up compared to a monotherapy with statins of moderate intensity.