Fixed-dose combination therapy-based protocol compared with free pill combination protocol: Results of a cluster randomized trial.

Autor: Sanuade OA; Department of Population Health Sciences, Spencer Fox Eccles, School of Medicine at the University of Utah, Salt Lake City, Utah, USA.; Department of Medical Social Sciences and Robert J Havey Institute for Global Health, Northwestern University Feinberg School of medicine, Chicago, Illinois, USA., Ale BM; Cardiovascular Research Unit, University of Abuja and University of Abuja Teaching Hospital, Gwagwalada, Abuja, Nigeria.; Holo Healthcare, Nairobi, Kenya., Baldridge AS; Department of Medical Social Sciences and Robert J Havey Institute for Global Health, Northwestern University Feinberg School of medicine, Chicago, Illinois, USA.; Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA., Orji IA; Cardiovascular Research Unit, University of Abuja and University of Abuja Teaching Hospital, Gwagwalada, Abuja, Nigeria., Shedul GL; Cardiovascular Research Unit, University of Abuja and University of Abuja Teaching Hospital, Gwagwalada, Abuja, Nigeria., Ojo TM; Cardiovascular Research Unit, University of Abuja and University of Abuja Teaching Hospital, Gwagwalada, Abuja, Nigeria.; Department of Public Health, Federal Ministry of Health, Abuja, Nigeria., Shedul G; Cardiovascular Research Unit, University of Abuja and University of Abuja Teaching Hospital, Gwagwalada, Abuja, Nigeria., Ugwuneji EN; Cardiovascular Research Unit, University of Abuja and University of Abuja Teaching Hospital, Gwagwalada, Abuja, Nigeria., Egenti N; College of Health Sciences, University of Abuja, Abuja, Nigeria., Omitiran K; Cardiovascular Research Unit, University of Abuja and University of Abuja Teaching Hospital, Gwagwalada, Abuja, Nigeria., Okoli R; University of Nigeria, Nsukka, Nigeria., Eze H; Cardiovascular Research Unit, University of Abuja and University of Abuja Teaching Hospital, Gwagwalada, Abuja, Nigeria., Nwankwo A; Cardiovascular Research Unit, University of Abuja and University of Abuja Teaching Hospital, Gwagwalada, Abuja, Nigeria., Hirschhorn LR; Department of Medical Social Sciences and Robert J Havey Institute for Global Health, Northwestern University Feinberg School of medicine, Chicago, Illinois, USA.; Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA., Chopra A; Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA., Ye J; Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA., Tripathi P; Stanley Manne Children's Research Institute, Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, USA., Banigbe B; Boston University School of Public Health, Boston, Massachusetts, USA., Kandula NR; Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA., Huffman MD; Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.; Cardiovascular Division and Global Health Center, Washington University in St. Louis, St. Louis, Missouri, USA.; The George Institute for Global Health, University of New South Wales, Sydney, Australia., Ojji DB; Cardiovascular Research Unit, University of Abuja and University of Abuja Teaching Hospital, Gwagwalada, Abuja, Nigeria.; Department of Internal Medicine, Faculty of Clinical Sciences, University of Abuja, Abuja, Nigeria.
Jazyk: angličtina
Zdroj: Journal of clinical hypertension (Greenwich, Conn.) [J Clin Hypertens (Greenwich)] 2023 Feb; Vol. 25 (2), pp. 127-136. Date of Electronic Publication: 2023 Jan 20.
DOI: 10.1111/jch.14632
Abstrakt: 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.
(© 2023 The Authors. The Journal of Clinical Hypertension published by Wiley Periodicals LLC.)
Databáze: MEDLINE
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