Abstract P099: Fixed-dose Combination Therapy-based Protocol Compared With Nigeria’S National Hypertension Treatment Protocol: Results Of A Cluster Randomized Trial

Abstract

Abstract Importance: Out of the >1.2 billion adults with elevated blood pressure globally, treatment (42.5%) and control (20.5%) rates are very low, including in Nigeria, the most populous country in Africa. A treatment protocol that includes fixed-dose combination (FDC) therapy may improve hypertension control rates more efficiently and with no increase in adverse events compared with a standard treatment protocol. Objective: To determine the efficacy and safety of a treatment protocol that uses FDC therapy for hypertension control compared with Nigeria’s 2019 National Hypertension Treatment protocol from baseline to 6 months. Design, setting, and participants: Cluster randomized (1:1) trial among 60 primary health centers in Abuja, Nigeria, stratified by median case load and control rate. Eligible patients were adults ( > 18 years) who had a history of hypertension, persistently elevated blood pressure (SBP ≥140 mmHg or DBP ≥90 mmHg),or use of blood pressure lowering medications. Interventions: Sites were randomized to a protocol that started with and utilized 2- and 3-drug FDC therapy (Step 1: amlodipine 5 mg + losartan 50 mg) to a protocol that started with monotherapy (Step 1: amlodipine 5 mg) and added individuals medications. Results: Sixty sites, including 5,576 patients (mean [SD] age=49.2 [12.4] years; 70% female; mean [SD] baseline systolic/diastolic BP=155[SD]/96 [SD] mm Hg), were randomized. At 6-month follow-up, the rates of hypertension control for the FDC therapy and Nigeria’s 2019 National Hypertension Treatment protocol were 54.7% and 48.3%, respectively ( Figure 1 ). The final results will be added at a later date. Conclusion and relevance: A hypertension treatment protocol that used FDC therapy led to a higher hypertension control rate compared with a standard treatment protocol in Nigeria. These results may have relevance to protocols used in other large-scale hypertension control programs.