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A comparison between diuretics and angiotensin-receptor blocker agents in patients with stage I hypertension
Flávio D Fuchs1, Sandra C Fuchs, Leila B Moreira
1Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil. ffuchs@hcpa.ufrgs.br
Insights
This study compares chlorthalidone/amiloride with losartan for hypertension treatment in Brazil. Results will inform hypertension management strategies and cardiovascular event prevention.
Area of Science:
- Cardiology
- Nephrology
- Pharmacology
Background:
- Cardiovascular disease is the leading cause of death in Brazil, with hypertension as a major risk factor.
- Angiotensin-receptor blockers (ARBs) are preferred for hypertension, but evidence of superiority over older drugs is lacking, and concerns exist regarding renal protection and cancer risk.
- Diuretics are effective, well-tolerated, and inexpensive but rarely compared to ARBs, necessitating further research.
Purpose of the Study:
- To compare the efficacy and safety of a diuretic combination (chlorthalidone and amiloride) versus an Angiotensin-receptor blocker (losartan) as first-line treatment for stage I hypertension.
- To evaluate the impact on blood pressure, adverse events, microalbuminuria, and left ventricular hypertrophy.
- To assess the incidence of fatal and non-fatal cardiovascular events.
Main Methods:
- A randomized, double-blind, clinical trial involving 1200 participants per group, aged 30-70 years, with stage I hypertension.
- Primary outcomes include blood pressure variation, adverse events, and changes in microalbuminuria and left ventricular hypertrophy.
- Secondary outcomes assess cardiovascular events such as myocardial infarction, stroke, heart failure, and sudden death over an 18-month period.
Main Results:
- Data on primary and secondary outcomes are currently being collected.
- The study aims to provide robust evidence on the comparative effectiveness of diuretics and ARBs in hypertension management.
- Analysis will focus on blood pressure control, renal function, cardiac changes, and overall cardiovascular event rates.
Conclusions:
- The study will clarify the comparative benefits and risks of diuretics versus ARBs in treating hypertension, particularly in the Brazilian population.
- Findings will contribute to evidence-based healthcare policy for hypertension management.
- Even null findings will provide valuable information regarding the comparative efficacy and safety of these drug classes.
Background:
Cardiovascular disease is the leading cause of death in Brazil, and hypertension is its major risk factor. The benefit of its drug treatment to prevent major cardiovascular events was consistently demonstrated. Angiotensin-receptor blockers (ARB) have been the preferential drugs in the management of hypertension worldwide, despite the absence of any consistent evidence of advantage over older agents, and the concern that they may be associated with lower renal protection and risk for cancer. Diuretics are as efficacious as other agents, are well tolerated, have longer duration of action and low cost, but have been scarcely compared with ARBs. A study comparing diuretic and ARB is therefore warranted.
Methods/Design:
This is a randomized, double-blind, clinical trial, comparing the association of chlorthalidone and amiloride with losartan as first drug option in patients aged 30 to 70 years, with stage I hypertension. The primary outcomes will be variation of blood pressure by time, adverse events and development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG. The secondary outcomes will be fatal or non-fatal cardiovascular events: myocardial infarction, stroke, heart failure, evidence of new subclinical atherosclerosis and sudden death. The study will last 18 months. The sample size will be of 1200 participants for group in order to confer enough power to test for all primary outcomes. The project was approved by the Ethics committee of each participating institution.
Discussion:
The putative pleiotropic effects of ARB agents, particularly renal protection, have been disputed, and they have been scarcely compared with diuretics in large clinical trials, despite that they have been at least as efficacious as newer agents in managing hypertension. Even if the null hypothesis is not rejected, the information will be useful for health care policy to treat hypertension in Brazil.
Clinical Trials Registration Number:
ClinicalTrials.gov: NCT00971165.
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