Fixed‐dose combination therapy‐based protocol compared with free pill combination protocol: Results of a cluster randomized trial
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 step...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2023-02-01
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| Series: | The Journal of Clinical Hypertension |
| Subjects: | |
| Online Access: | https://doi.org/10.1111/jch.14632 |
| _version_ | 1797645222667091968 |
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| author | Olutobi A. Sanuade Boni M. Ale Abigail S. Baldridge Ikechukwu A. Orji Gabriel L. Shedul Tunde M. Ojo Grace Shedul Eugenia N. Ugwuneji Nonye Egenti Kasarachi Omitiran Rosemary Okoli Helen Eze Ada Nwankwo Lisa R. Hirschhorn Aashima Chopra Jiancheng Ye Priya Tripathi Bolanle Banigbe Namratha R. Kandula Mark D. Huffman Dike B. Ojji the Hypertension Treatment in Nigeria Program Investigators |
| author_facet | Olutobi A. Sanuade Boni M. Ale Abigail S. Baldridge Ikechukwu A. Orji Gabriel L. Shedul Tunde M. Ojo Grace Shedul Eugenia N. Ugwuneji Nonye Egenti Kasarachi Omitiran Rosemary Okoli Helen Eze Ada Nwankwo Lisa R. Hirschhorn Aashima Chopra Jiancheng Ye Priya Tripathi Bolanle Banigbe Namratha R. Kandula Mark D. Huffman Dike B. Ojji the Hypertension Treatment in Nigeria Program Investigators |
| author_sort | Olutobi A. Sanuade |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-11T14:43:14Z |
| format | Article |
| id | doaj.art-4b2d93f5be6d4865b749f2dccdbc94f5 |
| institution | Directory Open Access Journal |
| issn | 1524-6175 1751-7176 |
| language | English |
| last_indexed | 2024-03-11T14:43:14Z |
| publishDate | 2023-02-01 |
| publisher | Wiley |
| record_format | Article |
| series | The Journal of Clinical Hypertension |
| spelling | doaj.art-4b2d93f5be6d4865b749f2dccdbc94f52023-10-30T13:26:13ZengWileyThe Journal of Clinical Hypertension1524-61751751-71762023-02-0125212713610.1111/jch.14632Fixed‐dose combination therapy‐based protocol compared with free pill combination protocol: Results of a cluster randomized trialOlutobi A. Sanuade0Boni M. Ale1Abigail S. Baldridge2Ikechukwu A. Orji3Gabriel L. Shedul4Tunde M. Ojo5Grace Shedul6Eugenia N. Ugwuneji7Nonye Egenti8Kasarachi Omitiran9Rosemary Okoli10Helen Eze11Ada Nwankwo12Lisa R. Hirschhorn13Aashima Chopra14Jiancheng Ye15Priya Tripathi16Bolanle Banigbe17Namratha R. Kandula18Mark D. Huffman19Dike B. Ojji20the Hypertension Treatment in Nigeria Program InvestigatorsDepartment of Population Health Sciences Spencer Fox Eccles School of Medicine at the University of Utah Salt Lake City Utah USACardiovascular Research Unit University of Abuja and University of Abuja Teaching Hospital Gwagwalada Abuja NigeriaDepartment of Medical Social Sciences and Robert J Havey Institute for Global HealthNorthwestern University Feinberg School of medicine Chicago Illinois USACardiovascular Research Unit University of Abuja and University of Abuja Teaching Hospital Gwagwalada Abuja NigeriaCardiovascular Research Unit University of Abuja and University of Abuja Teaching Hospital Gwagwalada Abuja NigeriaCardiovascular Research Unit University of Abuja and University of Abuja Teaching Hospital Gwagwalada Abuja NigeriaCardiovascular Research Unit University of Abuja and University of Abuja Teaching Hospital Gwagwalada Abuja NigeriaCardiovascular Research Unit University of Abuja and University of Abuja Teaching Hospital Gwagwalada Abuja NigeriaCollege of Health Sciences University of Abuja Abuja NigeriaCardiovascular Research Unit University of Abuja and University of Abuja Teaching Hospital Gwagwalada Abuja NigeriaUniversity of Nigeria Nsukka NigeriaCardiovascular Research Unit University of Abuja and University of Abuja Teaching Hospital Gwagwalada Abuja NigeriaCardiovascular Research Unit University of Abuja and University of Abuja Teaching Hospital Gwagwalada Abuja NigeriaDepartment of Medical Social Sciences and Robert J Havey Institute for Global HealthNorthwestern University Feinberg School of medicine Chicago Illinois USANorthwestern University Feinberg School of Medicine Chicago Illinois USANorthwestern University Feinberg School of Medicine Chicago Illinois USAStanley Manne Children's Research Institute Ann and Robert H. Lurie Children's Hospital of Chicago Chicago Illinois USABoston University School of Public Health Boston Massachusetts USANorthwestern University Feinberg School of Medicine Chicago Illinois USANorthwestern University Feinberg School of Medicine Chicago Illinois USACardiovascular Research Unit University of Abuja and University of Abuja Teaching Hospital Gwagwalada Abuja NigeriaAbstract 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.https://doi.org/10.1111/jch.14632cluster‐randomized trialfixed‐dose combinationfree pill combinationhypertensionNigeria |
| spellingShingle | Olutobi A. Sanuade Boni M. Ale Abigail S. Baldridge Ikechukwu A. Orji Gabriel L. Shedul Tunde M. Ojo Grace Shedul Eugenia N. Ugwuneji Nonye Egenti Kasarachi Omitiran Rosemary Okoli Helen Eze Ada Nwankwo Lisa R. Hirschhorn Aashima Chopra Jiancheng Ye Priya Tripathi Bolanle Banigbe Namratha R. Kandula Mark D. Huffman Dike B. Ojji the Hypertension Treatment in Nigeria Program Investigators Fixed‐dose combination therapy‐based protocol compared with free pill combination protocol: Results of a cluster randomized trial The Journal of Clinical Hypertension cluster‐randomized trial fixed‐dose combination free pill combination hypertension Nigeria |
| title | Fixed‐dose combination therapy‐based protocol compared with free pill combination protocol: Results of a cluster randomized trial |
| title_full | Fixed‐dose combination therapy‐based protocol compared with free pill combination protocol: Results of a cluster randomized trial |
| title_fullStr | Fixed‐dose combination therapy‐based protocol compared with free pill combination protocol: Results of a cluster randomized trial |
| title_full_unstemmed | Fixed‐dose combination therapy‐based protocol compared with free pill combination protocol: Results of a cluster randomized trial |
| title_short | Fixed‐dose combination therapy‐based protocol compared with free pill combination protocol: Results of a cluster randomized trial |
| title_sort | fixed dose combination therapy based protocol compared with free pill combination protocol results of a cluster randomized trial |
| topic | cluster‐randomized trial fixed‐dose combination free pill combination hypertension Nigeria |
| url | https://doi.org/10.1111/jch.14632 |
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