Metabolic and Clinical Outcomes of Combined Pitavastatin and Valsartan Therapy in Patients With Acute Myocardial Infarction: A Multicenter Prospective Observational Study.

Abstract

Objective: We evaluated the efficacy and safety of combined pitavastatin and valsartan therapy in patients with acute myocardial infarction.

Methods: This non-interventional, multicenter, prospective observational study included 836 patients receiving combined pitavastatin and valsartan (80 mg) with 48 weeks of follow-up. Co-primary outcomes were major adverse cardiovascular events (MACEs) and changes in metabolic profiles.

Results: Among 698 patients (mean age 61.8±12.1 years; 81.4% male) treated with pitavastatin/valsartan 2/80 mg or 4/80 mg, 15 MACEs occurred at 48 weeks (15/698, 2.1%). The mean (standard deviation) changes in fasting blood glucose and glycated hemoglobin from baseline to 48 weeks were -11.4±45.0 mg/dL (p=0.467) and -0.17±0.29% (p=0.165) for the 2/80 mg group, and -7.9±46.2 mg/dL (p=0.043) and -0.06±1.07% (p=0.181) for the 4/80 mg group, respectively. The mean (standard deviation) reductions in low-density lipoprotein cholesterol from baseline to 48 weeks were -27.9±24.7 mg/dL (p=0.006) for 2/80 mg and -29.9±38.1 mg/dL (p<0.001) for 4/80 mg. No serious adverse drug reactions were observed except for one case of chest pain in one patient.

Conclusion: This multicenter, prospective observational study of 836 patients with acute myocardial infarction and 48-week follow-up demonstrated that combined pitavastatin and valsartan therapy was associated with a low incidence of MACEs and was not associated with unfavorable metabolic profiles, although it should be cautiously interpreted due to the lack of a control arm and missing substantial follow-up data.