• Cardiometabolic Disorder
• Cardiology Clinical Trials
• Hypertensive Disease

• Cardiometabolic Disorder
• Cardiology Clinical Trials
• Hypertensive Disease
• Cardiology

Fimasartan reduced blood pressure (BP) and albumin-creatinine ratio (ACR) in patients with or without metabolic syndrome; however, patients with metabolic syndrome at baseline and 3 months were at a greater risk of elevated ACR at 1 year. Jeong Bae Park, MD, Cheil General Hospital, Kwandong, Korea, presented-3-month and 1-year data from a 3-year multicenter study designed to evaluate the effect of early correction of metabolic syndrome on organ damage for patients with hypertension [K-METS]. The design of this study has been published [Kim C et al. Pulse 2013].

The antihypertensive agent fimasartan is derived from losartan and is expected to have greater efficacy and potency [Kim TW et al. Bioorg Med Chem Lett 2012]. In clinical trials of fimasartan, risk of cardiovascular disease was reduced with the correction of metabolic risk factors in addition to BP control. The purpose of the observational K-METS study was to determine the effect of the early correction of metabolic syndrome on organ damage, as well as the future development of diabetes and cardiovascular disease, for patients with hypertension.

In the prospective single-arm K-METS study, 5481 patients with hypertension received open-label fimasartan and are being followed for 3 years. At baseline, 17% of patients had diabetes, mean weight was 67.3 kg, mean body mass index was 25.3 kg/m², and the mean number of years taking an antihypertensive agent was 3.58. Baseline systolic and diastolic BPs (SBP and DBP, respectively) were 144 and 88 mm Hg, respectively. Metabolic syndrome was present in 57% of the study population.

The primary end point of the K-METS study is cardiovascular mortality, stroke, myocardial infarction, hospitalization for heart failure, and the development of diabetes at 3 years. At 3 months, patients with hypertension or metabolic syndrome received therapy for correction. At 1 year, BP, insulin resistance, diabetes, and cardiovascular events were assessed. At 3 years, incidence of diabetes and cardiovascular disease will be evaluated. Patients were categorized into 4 groups according to the presence of metabolic syndrome:

1. Group 1: metabolic syndrome at baseline and 3 months

2. Group 2: metabolic syndrome at baseline but not at 3 months

3. Group 3: no metabolic syndrome at baseline but metabolic syndrome developed by 3 months

4. Group 4: no metabolic syndrome at baseline or 3 months

At 1 year, SBP and DBP significantly decreased to 127 and 79 mm Hg, respectively (p<0.0001), as well as ACR from 41.2 to 26.6 mg/g (p<0.0001). The proportion of patients with metabolic syndrome also decreased to 44% (p<0.0001). Although all groups experienced a decrease in ACR, patients in Group 1 or 2 experienced the greatest decrease in ACR. Patients in Group 1 had the highest ACR rates compared with Groups 2, 3, and 4. In addition, patients in Group 1 were at a greater risk of ACR ≥30 mg/g compared with Groups 2, 3, and 4 (odds ratio, 1.62; 95% CI, 1.33 to 1.97).

Dr. Park stated that data from the K-METS trial suggest that fimasartan treatment results in a substantial decrease in BP and ACR at 3 months and 1 year.

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