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Per-Protocol Analysis of Chlorthalidone Versus Hydrochlorothiazide for Cardiovascular Event Prevention-Diuretic
Sonia T Anand1, Cynthia Hau1, Michael J Davenport1
1Cooperative Studies Program Coordinating Center, VA Boston Healthcare System Boston MA.
Journal of the American Heart Association
|January 30, 2026
Summary
Per-protocol analysis of the Diuretic Comparison Project suggests hydrochlorothiazide may be more effective than chlorthalidone in preventing cardiovascular events. However, this difference was not statistically significant.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- The Diuretic Comparison Project (DCP) is a pragmatic trial comparing chlorthalidone and hydrochlorothiazide for cardiovascular risk reduction.
- An intent-to-treat analysis showed no significant difference between the two diuretics.
- This study focuses on the per-protocol effect to assess adherence impact.
Purpose of the Study:
- To estimate the per-protocol effect of chlorthalidone versus hydrochlorothiazide in preventing major adverse cardiovascular events.
- To evaluate the impact of treatment adherence on cardiovascular outcomes in hypertensive patients.
Main Methods:
- Assessed treatment adherence by censoring nonadherent participants (defined by gaps, switches, or discontinuation).
- Primary outcome: composite of nonfatal myocardial infarction, stroke, heart failure hospitalization, urgent coronary revascularization, or noncancer-related death.
- Used inverse probability weighting on DCP trial data to evaluate per-protocol effects.
Main Results:
- Nonadherence was observed in 40% of participants.
- Among adherent participants, the estimated 5-year risk ratio for the primary outcome was 1.36 (95% CI, 0.96-2.12) for chlorthalidone compared to hydrochlorothiazide.
- This suggests a trend towards higher risk with chlorthalidone.
Conclusions:
- Per-protocol analysis indicated a potential lower risk of cardiovascular events with hydrochlorothiazide compared to chlorthalidone.
- The observed difference was not statistically significant.
- Dispensation data for adherence identification may have limitations.
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