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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 (

Abstract Improved understanding of the current burden of hypertension, including awareness, treatment, and control, is needed to guide relevant preventative measures in Nigeria. A systematic search of studies on the epidemiology of hypertension in Nigeria, published on or after January 1990, was conducted. The authors employed random‐effects meta‐analysis on extracted crude hypertension prevalence, and awareness, treatment, and control rates. Using a meta‐regression model, overall hypertension cases in Nigeria in 1995 and 2020 were estimated. Fifty‐three studies (n = 78 949) met our selection criteria. Estimated crude prevalence of pre‐hypertension (120‐139/80‐89 mmHg) in Nigeria was 30.9% (95% confidence interval [CI]: 22.0%‐39.7%), and the crude prevalence of hypertension (≥140/90 mmHg) was 30.6% (95% CI: 27.3%‐34.0%). When adjusted for age, study period, and sample, absolute cases of hypertension increased by 540% among individuals aged ≥20 years from approximately 4.3 million individuals in 1995 (age‐adjusted prevalence 8.6%, 95% CI: 6.5‐10.7) to 27.5 million individuals with hypertension in 2020 (age‐adjusted prevalence 32.5%, 95% CI: 29.8‐35.3). The age‐adjusted prevalence was only significantly higher among men in 1995, with the gap between both sexes considerably narrowed in 2020. Only 29.0% of cases (95% CI: 19.7‐38.3) were aware of their hypertension, 12.0% (95% CI: 2.7‐21.2) were on treatment, and 2.8% (95% CI: 0.1‐5.7) had at‐goal blood pressure in 2020. Our study suggests that hypertension prevalence has substantially increased in Nigeria over the last two decades. Although more persons are aware of their hypertension status, clinical treatment and control rates, however, remain low. These estimates are relevant for clinical care, population, and policy response in Nigeria and across Africa.