Abstract
Fixed-dose combination (FDC) therapy is recommended for hypertension management in Nigeria based on randomized trials at the individual level. This cluster-randomized trial evaluates effectiveness and safety of a treatment protocol that used two-drug FDC therapy as the second and third steps for hypertension control compared with a protocol that used free pill combinations. From January 2021 to June 2021, 60 primary healthcare centers in the Federal Capital Territory of Nigeria were randomized to a protocol using FDC therapy as second and third steps compared with a protocol that used the same medications in free pill combination therapy for these steps. Eligible patients were adults (≥18 years) with hypertension. The primary outcome was the odds of a patient being controlled at their last visit between baseline to 6-month follow-up in the FDC group compared to the free pill group. 4427 patients (mean [SD] age: 49.0 [12.4] years, 70.5% female) were registered with mean (SD) baseline systolic/diastolic blood pressure 155 (20.6)/96 (13.1) mm Hg. Baseline characteristics of groups were similar. After 6-months, hypertension control rate improved in the two treatment protocols, but there were no differences between the groups after adjustment (FDC = 53.9% versus free pill combination = 47.9%, cluster-adjusted p =.29). Adverse events were similarly low (<1%) in both groups. Both protocols improved hypertension control rates at 6-months in comparison to baseline, though no differences were observed between groups. Further work is needed to determine if upfront FDC therapy is more effective and efficient to improve hypertension control rates.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 127-136 |
| Number of pages | 10 |
| Journal | Journal of Clinical Hypertension |
| Volume | 25 |
| Issue number | 2 |
| DOIs | |
| State | Published - Feb 2023 |
Funding
The study is supported by the National Heart, Lung, and Blood Institute (R01HL144708), Northwestern Robert J. Havey MD Institute for Global Health, and Resolve to Save Lives. The funders were not involved in the development of the study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication. The program officer representing the National Heart, Lung, and Blood Institute participated in Data and Safety Monitoring Board activities. The Northwestern Robert J. Havey MD Institute for Global Health and Resolve to Save Lives contributed support for projects embedded within the overall HTN Program. We acknowledge the patients and teams at each of the 60 participating public primary health centers. We would like to thank members of the HTN Program investigators and advisory board who contributed to the planning and execution of this study, including: Dr Morenika Alex-Okoh, Dr Oyinlola Sanni, Dr. Mangai Toma, Dr. Nina Ezeigwe, Dr. Saddiq Abdurrahman, Dr. Isah Y. Vatsa, Dr. Mary Dewan, Mr. Michael Uwazie, Dr. Sunday Goji, PharmD Innocent Uche Nnubia, Dr. Ibrahim Katibi, and Dr. Emmanuel Agogo. We would like to thank members of the Data and Safety Monitoring Board who have overseen the conduct of this study, including: Dr. Brian Rayner (chair), Dr. Amam Mbakwem, Dr. Justine Davies, Dr. James Sheppard, Dr. Patricia Ojiah, Dr. Amanda Thrift, and Dr. Adeloye Davies.
Keywords
- Nigeria
- cluster-randomized trial
- fixed-dose combination
- free pill combination
- hypertension
ASJC Scopus subject areas
- Internal Medicine
- Endocrinology, Diabetes and Metabolism
- Cardiology and Cardiovascular Medicine
