Efficacy of a fixed dose combination of irbesartan and atorvastatin (Rovelito®) in Korean adults with hypertension and hypercholesterolemia.

PURPOSE Coexistence of hypertension (HTN) and hypercholesterolemia is a major synergistic and modifiable risk factor for cardiovascular disease (CVD). Thus, a fixed-dose combination (FDC) of anti-HTN drugs and statins may be useful for treating CVD. This study evaluated the efficacy of an FDC of irbesartan and atorvastatin (Rovelito®) in Korean patients. PATIENTS AND METHODS Patients with HTN and hypercholesterolemia were screened for this prospective, observational, descriptive, multi-center, phase IV study. Eligible patients were administered with Rovelito for 3 months. Dose adjustment was allowed based on the physician's discretion. Blood pressure (BP) goal was <140/90 mmHg, and blood lipid goal was based on Adult Treatment Panel III. Compliance with therapeutic lifestyle modification and safety of the study drugs were evaluated. RESULTS Of the 2,777 patients enrolled in this study, 931 were analyzed for clinical efficacy. BP and low-density lipoprotein cholesterol (LDL-C) goals were achieved in 801 (86.04%) and 797 (85.61%) patients, respectively. For the BP goal, higher baseline BP and higher body mass index were risk factors for treatment failure. For LDL-C goal, baseline LDL-C level, number of concomitant drugs, smoking status, and alcohol consumption were risk factors for treatment failure. Of the 931 participants, 694 (74.54%) achieved the treatment goals for both BP and LDL-C. Smoking status, alcohol consumption, number of concomitant drugs, and higher baseline LDL-C and BP levels were risk factors for treatment failure in both BP and LDL-C goals. Adherence with Rovelito was 97.90%±5.79%, and incidence of adverse events was 4.19% (116). CONCLUSION FDC of irbesartan and atorvastatin (Rovelito) could be extremely helpful in treating patients with both HTN and hypercholesterolemia. Poor metabolic profiles were risk factors for poor treatment response and the reason for choosing Rovelito. Therapeutic lifestyle modification should still be underscored despite the 75% treatment success rate with Rovelito for both conditions.