The Efficacy of Fimasartan for Cardiovascular Events and Metabolic Syndrome (K-MetS Study): Rationale, Design and Participant Characteristics

Fimasartan, the eighth angiotensin receptor blocker, was launched in March 2011 and was found to have an excellent efficacy and safety profile in a large cross-sectional population study [Safety and Efficacy of Fimasartan in Patients with Arterial Hypertension (Safe-KanArb); Park et al.: Am J Cardiovasc Drugs 2013;13:47-56]. However, there is no long-term study to evaluate its efficacy for major adverse cardiovascular events (MACE) and other effects. The purpose of this study (K-MetS study) was to evaluate whether the early reduction of blood pressure (BP) and/or correction of metabolic derangements with fimasartan will affect MACE and the development of diabetes after long-term use in patients with hypertension. A total of 10,734 patients were screened between October 2011 and October 2012. Of these, 10,601 patients from 582 private clinics and 11 university hospitals were enrolled and are currently treated with fimasartan. The primary endpoints are MACE (cardiovascular mortality, stroke, myocardial infarction, and hospitalization for heart failure) and the development of diabetes after 3 years of follow-up. In addition to BP monitoring in the clinic, home BP monitoring is performed in about two thirds of patients. The patients were 56.2 ± 10.9 years old (mean ± SD), with 48.4% being women. The mean clinic and home systolic/diastolic BP at baseline were 145.0 ± 17.0/88.8 ± 11.4 and 138.6 ± 14.8/82.6 ± 9.9 mm Hg, respectively. The metabolic syndrome was found in 56.4%, increased abdominal circumference in 52.8%, elevated fasting glucose in 46.8%, hypertriglyceridemia in 44.7%, and low high-density lipoprotein cholesterol in 33.3% of patients. Further, complicated hypertension with diabetes occurred in 15.1%, ischemic heart disease in 3.3%, stroke in 0.9%, heart failure in 0.7%, and atrial fibrillation in 0.4% of patients. Most participants in this study had a low-to-moderate risk for hypertension. The K-MetS study is expected to provide valuable information about the effects of early BP control and correction of metabolic abnormalities on future cardiovascular outcomes relative to low-risk hypertension.