アブストラクト | PURPOSE: While statins and antiplatelet therapies are largely prescribed together worldwide, limited information is available on the safety of their association regarding rhabdomyolysis occurrence. We aimed to assess the reporting of rhabdomyolysis in patients treated with a combination of statin and antiplatelet therapy, compared to statin alone. METHODS: We used the World Health Organization pharmacovigilance database (VigiBase(R)) to compare the rhabdomyolysis reporting between statin (atorvastatin, fluvastatin, pravastatin, rosuvastatin, and simvastatin) plus antiplatelet therapy (acetylsalicylic acid, clopidogrel, prasugrel and ticagrelor) groups versus statin alone groups, for each statin and antiplatelet therapy. Study setting was restricted to patients aged 45 or older, including reports up until 1(st) September, 2021. We computed reporting Odds-Ratio (ROR) and their 95% confidence interval (CI) to quantify the disproportionality between groups, adjusted on age and sex. RESULTS: Among the 11,431,708 reports of adverse reactions, we extracted 9,489 cases of rhabdomyolysis in patients treated with statins, of whom 2,464 (26%) were also treated with antiplatelet therapy. The reporting of rhabdomyolysis was increased when ticagrelor was associated with atorvastatin (ROR 1.30 [1.02-1.65]) or rosuvastatin (ROR 1.90 [1.42-2.54]) compared to the respective statin alone but did not change when aspirin, clopidogrel or prasugrel were considered. CONCLUSION: Rhabdomyolysis reporting was increased when ticagrelor -but not other antiplatelet agents- was notified with the most prescribed statins in practice. This finding needs to be considered by physicians especially in high-risk patients. |
ジャーナル名 | Cardiovascular drugs and therapy |
Pubmed追加日 | 2023/4/28 |
投稿者 | Roule, Vincent; Alexandre, Joachim; Lemaitre, Adrien; Chretien, Basile; Sassier, Marion; Fedrizzi, Sophie; Beygui, Farzin; Dolladille, Charles |
組織名 | Service de Cardiologie, CHU de Caen Normandie, 14000, Caen, France.;roule-v@chu-caen.fr.;UMRS 1237, INSERM, GIP Cyceron, 14000, Caen, France. roule-v@chu-caen.fr.;Cardiology department, Caen University Hospital, Avenue Cote de Nacre, 14033,;Caen, France. roule-v@chu-caen.fr.;Service de Pharmacologie, CHU de Caen Normandie, PICARO Cardio-Oncology Program,;14000, Caen, France.;UMRS 1237, INSERM, GIP Cyceron, 14000, Caen, France.;ACTION Study Group, Pitie-Salpetriere University Hospital, Cardiology Department,;Paris, France. |
Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/37115431/ |