Efficacy, Safety and Tolerability of Valsartan and Hydrochlorothiazide Compared to Valsartan and Amlodipine in Stage 2 Hypertension

Abstract

Background: Hypertension is a growing medical and public health issue. The United States and European treatment guidelines have been issued to attain smooth control of hypertension in various categories of patients. It is a need of time to unveil safe combination therapies in various populations. Objectives: (i) To determine the efficacy of valsartan and hydrochlorothiazide versus valsartan and amlodipine (ii) To determine the safety and tolerability of both combinations. Materials & Methods: This experimental study was conducted at Shalamar Hospital Lahore. 126 patients with stage 2 hypertension were recruited from the medical outdoor of Shalamar Hospital Lahore after getting informed consent. In group A, 63 patients were given valsartan and hydrochlorothiazide. In group B, 63 patients were given valsartan and amlodipine. Blood pressure (BP) of both study groups was recorded on day zero, 2nd, 4th, and 8th weeks and the readings were entered on a Proforma. The efficacy of drug combinations was accessed in both groups by recording the change in mean systolic blood pressure (MSBP) and mean diastolic blood pressure (MDBP). The safety and tolerability of the drug combinations were assessed in terms of side effects and laboratory findings. Results: In group A, there was a 39±7mmzHg and 18±1mmHg decrease in MSBP and MDBP, respectively, from baseline BP. In group B, there was a 26.7±4mmHg and 14±2 mmHg decrease in MSBP and MDBP, respectively, from baseline BP. Both combinations were safe, and no significant difference in the efficacy of both combinations was observed after 8-week of treatment. Conclusion: Both combinations are effective for control of BP, but the valsartan and hydrochlorothiazide combination (group A) appears to have better tolerability and greater effect in decreasing BP as compared to the combination of valsartan and amlodipine (group B), although this difference is not statistically significant.