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Anti-hypertensive medication adherence in the REQUIRE trial: post-hoc exploratory evaluation
Kazuomi Kario1, Hisashi Kai2, Shinsuke Nanto3
1Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Tochigi, Japan. kkario@jichi.ac.jp.
Summary
Medication adherence significantly impacts resistant hypertension (RH) treatment outcomes. Poor adherence in the REQUIRE trial confounded results, highlighting the need for monitoring in future RH studies.
Area of Science:
- Cardiology
- Nephrology
- Clinical Trials
Background:
- Medication adherence is critical for managing hypertension, particularly resistant hypertension (RH).
- Variable adherence can significantly confound results in clinical trials evaluating antihypertensive therapies.
- The REQUIRE trial investigated ultrasound renal denervation (uRDN) versus sham in RH patients.
Purpose of the Study:
- To assess the impact of baseline and changing medication adherence on blood pressure outcomes in the REQUIRE trial.
- To compare the efficacy of uRDN versus sham in RH patients with varying adherence levels.
Main Methods:
- Post-hoc analysis of the REQUIRE trial data.
- Evaluation of medication adherence using urine samples at baseline and 3 months.
- Comparison of 24-h ambulatory systolic blood pressure (ASBP) changes between uRDN and sham groups based on adherence.
Main Results:
- 45% of RH patients exhibited poor adherence at baseline.
- In patients with good baseline adherence, uRDN led to ASBP reduction, while sham did not.
- Poorly adherent sham patients showed improved adherence and significant ASBP reduction, unlike uRDN patients.
Conclusions:
- Adherence changes in poorly adherent sham patients may explain the lack of significant between-group differences in the REQUIRE trial.
- Monitoring and ensuring medication adherence are crucial for future interventional studies in resistant hypertension.
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