Dual antihypertensive strategies: A real-world comparative study of efficacy and safety of fixed-dose combinations in a tertiary care setting

Abstract

Aim: The aim of this study was to evaluate the comparative efficacy and safety of fixed-dose combinations of amlodipine 5 mg + hydrochlorothiazide 12.5 mg (A+H) (Group 1), telmisartan 40 mg + hydrochlorothiazide 12.5 mg (T+H) (Group 2), and ramipril 5 mg + hydrochlorothiazide 12.5 mg (R+H) (Group 3) in patients of essential hypertension.

Materials and methods: A prospective, randomized, open-labeled study was conducted for a period of 12 months (April 2023-March 2024), at a single tertiary care center involving 327 patients that were newly diagnosed with essential hypertension without any comorbid conditions. Patients were assessed at baseline, 15 days, 1 month, and then followed up at monthly intervals up to 6 months.

Results: In the study, significant reductions in systolic blood pressure (SBP) were noted for A+H with R+H at 3 and 4 months and for T+H with R+H from 3 to 6 months. Diastolic blood pressure (DBP) reductions were significant for A+H with R+H at 15 days and 1 month. T+H was significantly more effective than A+H and R+H in reducing SBP, while all groups showed comparable efficacy in reducing DBP over 6 months. Adverse drug reactions (ADRs) were highest in the A+H group at 29.4% and lowest in the T+H group at 19.8%.

Conclusion: This real-world clinical study provided valuable insights into the comparative efficacy of different antihypertensive drug combinations, with T+H being most effective in reducing SBP; in terms of DBP, all the groups were equally efficacious.

Keywords: Amlodipine; hydrochlorothiazide; hypertension; ramipril; telmisartan.

Figure 1

Study design flowchart: Patient enrolment, randomization, and follow-up