1. Outcome of pitavastatin versus atorvastatin therapy in patients with hypercholesterolemia at high risk for atherosclerotic cardiovascular disease
- Author
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Shuki Usui, Yasuo Iwasaki, Masao Moroi, Daiji Nagayama, Tatsuo Chiba, Kazuhiro Shimizu, Toshiki Fujioka, Mao Takahashi, Ichiro Tatsuno, Junichi Yamasaki, Kohji Shirai, Kosuke Nishizawa, Hideki Sugimoto, Teruo Shiba, Kaoru Sugi, Naoko Sato, Fumihiko Hara, Atsuhito Saiki, and Shigeo Yamamura
- Subjects
Male ,medicine.medical_specialty ,Atorvastatin ,Hypercholesterolemia ,030204 cardiovascular system & hematology ,Sudden death ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,Clinical endpoint ,Medicine ,Humans ,Pyrroles ,030212 general & internal medicine ,Myocardial infarction ,Pitavastatin ,Adverse effect ,Aged ,business.industry ,Proportional hazards model ,medicine.disease ,Treatment Outcome ,Cardiovascular Diseases ,Heart failure ,Cardiology ,Quinolines ,lipids (amino acids, peptides, and proteins) ,Female ,Hydroxymethylglutaryl-CoA Reductase Inhibitors ,Cardiology and Cardiovascular Medicine ,business ,medicine.drug - Abstract
Background There has been no report about outcome of pitavastatin versus atorvastatin therapy in high-risk patients with hypercholesterolemia. Methods Hypercholesterolemic patients with one or more risk factors for atherosclerotic diseases (n = 664, age = 65, male = 54%, diabetes = 76%, primary prevention = 74%) were randomized to receive pitavastatin 2 mg/day (n = 332) or atorvastatin 10 mg/day (n = 332). Follow-up period was 240 weeks. The primary end point was a composite of cardiovascular death, sudden death of unknown origin, nonfatal myocardial infarction, nonfatal stroke, transient ischemic attack, or heart failure requiring hospitalization. The secondary end point was a composite of the primary end point plus clinically indicated coronary revascularization for stable angina. Results The mean low-density lipoprotein cholesterol (LDL-C) level at baseline was 149 mg/dL. The mean LDL-C levels at 1 year were 95 mg/dL in the pitavastatin group and 94 mg/dL in the atorvastatin group. There were no differences in LDL-C levels between both groups, however, pitavastatin significantly reduced the risk of the primary end point, compared to atorvastatin (pitavastatin = 2.9% and atorvastatin = 8.1%, HR, 0.366; 95% CI 0.170–0.787; P = 0.01 by multivariate Cox regression) as well as the risk of the secondary end point (pitavastatin = 4.5% and atorvastatin = 12.9%, HR = 0.350; 95%CI = 0.189–0.645, P = 0.001). The results for the primary and secondary end points were consistent across several prespecified subgroups. There were no differences in incidence of adverse events between the statins. Conclusion Pitavastatin therapy compared with atorvastatin more may prevent cardiovascular events in hypercholesterolemic patients with one or more risk factors for atherosclerotic diseases despite similar effects on LDL-C levels.
- Published
- 2019