Efficacy and Safety of Combination therapy of Amlodipine along with Rosuvastatin versus Amlodipine Monotherapy in Hypertensive Patients with Dyslipidaemia: A Randomised Controlled Trial

Abstract

Background: Even with the success of antihypertensive and lipid‐lowering medications in reaching target values, the percentage of patients having blood pressure under control is still low. Patients with both ailments typically have low compliance since many require continuous treatment and take a long time to receive a diagnosis before the implications of both diseases manifest. The purpose of this study was to evaluate the safety and effectiveness of amlodipine monotherapy against combination therapy with amlodipine along with rosuvastatin in hypertensive patients with dyslipidaemia. Methods: 120 hypertensive patients with dyslipidaemia were randomised into Group MT (monotherapy with Amlodipine 10 mg once daily) and Group CT (recombination therapy with rosuvastatin 20 mg along with amlodipine 10 mg once daily). At one and three months after randomization, all patients were asked to visit the institution in order to assess the safety and effectiveness. The unpaired t‐test was used to evaluate end‐points like mean SBP, DBP, LDL‐C, total cholesterol (TC), triglyceride (TG), and HDL from baseline to one month as well as three months. Results: SBP in CT group was significantly lesser (132.83 ± 8.26) as compared to MT group (137.2 ± 8.46) (p=0.005). There was significantly greater improvement in lipid profile in CT group as compared to MT group. However, there was also some slight improvement in lipid profile in patients receiving monotherapy with amlodipine. There was no significant difference between CT group and MT group with respect to ADRs. Conclusion: The single‐pill FDC "Rosuvastatin‐Amlodipine" constitutes a sensible combination of two safe, well‐tolerated, evidence‐based, and effective medications to treat two major risk factors, such as hypertension and hypercholesterolemia.