Journal Article > ResearchFull Text
BMJ Open. 25 January 2023; Volume 13 (Issue 1); e063668.; DOI:10.1136/bmjopen-2022-063668
Ansbro É, Masri S, Prieto-Merino D, Willis R, Aoun Bahous S, et al.
BMJ Open. 25 January 2023; Volume 13 (Issue 1); e063668.; DOI:10.1136/bmjopen-2022-063668
OBJECTIVES
This pre–post implementation study evaluated the introduction of fixed dose combination (FDC) medications for atherosclerotic cardiovascular disease (ASCVD) secondary prevention into routine care in a humanitarian setting.
SETTING
Two Médecins sans Frontières (MSF) primary care clinics serving Syrian refugee and host populations in north Lebanon.
PARTICIPANTS
Consenting patients ≥18 years with existing ASCVD requiring secondary prevention medication were eligible for study enrolment. Those with FDC contraindication(s) or planning to move were excluded. Of 521 enrolled patients, 460 (88.3%) were retained at 6 months, and 418 (80.2%) switched to FDC. Of these, 84% remained on FDC (n=351), 8.1% (n=34) discontinued and 7.9% (n=33) were lost to follow-up by month 12.
INTERVENTIONS
Eligible patients, enrolled February–May 2019, were switched to Trinomia FDC (atorvastatin 20 mg, aspirin 100 mg, ramipril 2.5/5/10 mg) after 6 months’ usual care. During the study, the COVID-19 pandemic, an economic crisis and clinic closures occurred.
OUTCOME MEASURES
Descriptive and regression analyses compared key outcomes at 6 and 12 months: medication adherence, non-high density lipoprotein cholesterol (non-HDL-C) and systolic blood pressure (SBP) control. We performed per-protocol, intention-to-treat and secondary analyses of non-switchers.
RESULTS
Among 385 switchers remaining at 12 months, total adherence improved 23%, from 63% (95% CI 58 to 68) at month 6, to 86% (95% CI 82 to 90) at month 12; mean non-HDL-C levels dropped 0.28 mmol/L (95% CI −0.38 to −0.18; p<0.0001), from 2.39 (95% CI 2.26 to 2.51) to 2.11 mmol/L (95% CI 2.00 to 2.22); mean SBP dropped 2.89 mm Hg (95% CI −4.49 to −1.28; p=0.0005) from 132.7 (95% CI 130.8 to 134.6) to 129.7 mm Hg (95% CI 127.9 to 131.5). Non-switchers had smaller improvements in adherence and clinical outcomes.
CONCLUSION
Implementing an ASCVD secondary prevention FDC improved adherence and CVD risk factors in MSF clinics in Lebanon, with potential for wider implementation by humanitarian actors and host health systems.
This pre–post implementation study evaluated the introduction of fixed dose combination (FDC) medications for atherosclerotic cardiovascular disease (ASCVD) secondary prevention into routine care in a humanitarian setting.
SETTING
Two Médecins sans Frontières (MSF) primary care clinics serving Syrian refugee and host populations in north Lebanon.
PARTICIPANTS
Consenting patients ≥18 years with existing ASCVD requiring secondary prevention medication were eligible for study enrolment. Those with FDC contraindication(s) or planning to move were excluded. Of 521 enrolled patients, 460 (88.3%) were retained at 6 months, and 418 (80.2%) switched to FDC. Of these, 84% remained on FDC (n=351), 8.1% (n=34) discontinued and 7.9% (n=33) were lost to follow-up by month 12.
INTERVENTIONS
Eligible patients, enrolled February–May 2019, were switched to Trinomia FDC (atorvastatin 20 mg, aspirin 100 mg, ramipril 2.5/5/10 mg) after 6 months’ usual care. During the study, the COVID-19 pandemic, an economic crisis and clinic closures occurred.
OUTCOME MEASURES
Descriptive and regression analyses compared key outcomes at 6 and 12 months: medication adherence, non-high density lipoprotein cholesterol (non-HDL-C) and systolic blood pressure (SBP) control. We performed per-protocol, intention-to-treat and secondary analyses of non-switchers.
RESULTS
Among 385 switchers remaining at 12 months, total adherence improved 23%, from 63% (95% CI 58 to 68) at month 6, to 86% (95% CI 82 to 90) at month 12; mean non-HDL-C levels dropped 0.28 mmol/L (95% CI −0.38 to −0.18; p<0.0001), from 2.39 (95% CI 2.26 to 2.51) to 2.11 mmol/L (95% CI 2.00 to 2.22); mean SBP dropped 2.89 mm Hg (95% CI −4.49 to −1.28; p=0.0005) from 132.7 (95% CI 130.8 to 134.6) to 129.7 mm Hg (95% CI 127.9 to 131.5). Non-switchers had smaller improvements in adherence and clinical outcomes.
CONCLUSION
Implementing an ASCVD secondary prevention FDC improved adherence and CVD risk factors in MSF clinics in Lebanon, with potential for wider implementation by humanitarian actors and host health systems.
Conference Material > Slide Presentation
Ansbro E, Masri S, Prieto-Merino D, Bahous SA, Molfino L, et al.
MSF Scientific Days International 2022. 11 May 2022; DOI:10.57740/mzsh-8t29
Conference Material > Abstract
Ansbro E, Masri S, Prieto-Merino D, Bahous SA, Molfino L, et al.
MSF Scientific Days International 2022. 11 May 2022; DOI:10.57740/8697-vn33
INTRODUCTION
Cardiovascular disease (CVD) is the leading cause of death and disability globally, including in humanitarian contexts. Fixed-dose combination (FDC) drugs are cost-effective for primary and secondary prevention of CVD. From 2012 until the end of 2020, MSF provided care for CVD patients from Syrian refugee and host populations in primary care clinics in Tripoli, north Lebanon. In this implementation study, we assessed whether FDC use is linked with adherence to CVD medications and treatment simplification in a humanitarian setting.
METHODS
Our prospective, before-and-after cohort study followed CVD patients in MSF clinics in Lebanon during two consecutive six month periods. Eligible patients, enrolled February-May 2019, were switched to Trinomia® FDC (atorvastatin 20mg, aspirin 100 mg, ramipril 2.5/5/10/mg) after six months’ usual care. During the study, the Covid-19 pandemic, an economic crisis, and clinic closures occurred. Descriptive and regression analyses compared key outcomes: medication adherence, non-high density lipoprotein cholesterol (non-HDL-C) levels, and systolic blood pressure (SBP) control, at six and twelve months. We performed intention-to-treat analyses and secondary analyses of non-switchers.
ETHICS
This study was approved by the MSF Ethics Review Board, the LSHTM Research Ethics Committee, and the Lebanese American University’s Institutional Review Board.
RESULTS
Of 521 enrolled patients, 460 (88.3%) were retained at six months and 418 (80.3%) switched to FDC. By month 12, 84% of switched patients remained on FDC (n=351), 8.1% (n=34) discontinued, and 7.9% (n=33) were lost to follow-up. Among the 385 who initially switched and remained in the study at 12 months, total adherence improved by 23% from 63% (95% confidence intervals (CI) 0.58-0.68) at month six to 86% (95% CI 0.82-0.90) at month 12. Mean non-HDL-C levels dropped 0.28 millimoles/litre (mmol/L; 95% CI -0.38 to -0.1; p=0.000) from 2.39 (95% CI 2.26 - 2.51) to 2.11 mmol/L (95% CI 2.00 - 2.22); mean SBP dropped 3.07 mmHg (95% CI -4.76 to -1.38; p= 0004) from 132.7 (95% CI 130.8 - 134.6) to 129.7 mmHg (95% CI 127.9 - 131.5). Among non-switchers, total adherence was lower and improvements in clinical outcomes were less pronounced.
CONCLUSION
Implementing a CVD secondary prevention FDC was associated with better adherence and intermediate clinical outcomes inan MSF primary care clinic in Lebanon. Further operational experience is needed to ascertain how best to integrate and sustain CVD FDC’s in humanitarian operations. MSF could advocate for their broader use with other humanitarian actors and within public health systems of crisis-affected countries.
CONFLICTS OF INTEREST
None declared.
Cardiovascular disease (CVD) is the leading cause of death and disability globally, including in humanitarian contexts. Fixed-dose combination (FDC) drugs are cost-effective for primary and secondary prevention of CVD. From 2012 until the end of 2020, MSF provided care for CVD patients from Syrian refugee and host populations in primary care clinics in Tripoli, north Lebanon. In this implementation study, we assessed whether FDC use is linked with adherence to CVD medications and treatment simplification in a humanitarian setting.
METHODS
Our prospective, before-and-after cohort study followed CVD patients in MSF clinics in Lebanon during two consecutive six month periods. Eligible patients, enrolled February-May 2019, were switched to Trinomia® FDC (atorvastatin 20mg, aspirin 100 mg, ramipril 2.5/5/10/mg) after six months’ usual care. During the study, the Covid-19 pandemic, an economic crisis, and clinic closures occurred. Descriptive and regression analyses compared key outcomes: medication adherence, non-high density lipoprotein cholesterol (non-HDL-C) levels, and systolic blood pressure (SBP) control, at six and twelve months. We performed intention-to-treat analyses and secondary analyses of non-switchers.
ETHICS
This study was approved by the MSF Ethics Review Board, the LSHTM Research Ethics Committee, and the Lebanese American University’s Institutional Review Board.
RESULTS
Of 521 enrolled patients, 460 (88.3%) were retained at six months and 418 (80.3%) switched to FDC. By month 12, 84% of switched patients remained on FDC (n=351), 8.1% (n=34) discontinued, and 7.9% (n=33) were lost to follow-up. Among the 385 who initially switched and remained in the study at 12 months, total adherence improved by 23% from 63% (95% confidence intervals (CI) 0.58-0.68) at month six to 86% (95% CI 0.82-0.90) at month 12. Mean non-HDL-C levels dropped 0.28 millimoles/litre (mmol/L; 95% CI -0.38 to -0.1; p=0.000) from 2.39 (95% CI 2.26 - 2.51) to 2.11 mmol/L (95% CI 2.00 - 2.22); mean SBP dropped 3.07 mmHg (95% CI -4.76 to -1.38; p= 0004) from 132.7 (95% CI 130.8 - 134.6) to 129.7 mmHg (95% CI 127.9 - 131.5). Among non-switchers, total adherence was lower and improvements in clinical outcomes were less pronounced.
CONCLUSION
Implementing a CVD secondary prevention FDC was associated with better adherence and intermediate clinical outcomes inan MSF primary care clinic in Lebanon. Further operational experience is needed to ascertain how best to integrate and sustain CVD FDC’s in humanitarian operations. MSF could advocate for their broader use with other humanitarian actors and within public health systems of crisis-affected countries.
CONFLICTS OF INTEREST
None declared.
Journal Article > ResearchFull Text
BMJ Open. 24 November 2019; Volume 9 (Issue 11); DOI:10.1136/bmjopen-2019-030176
Ansbro É, Biringanine M, Caleo GNC, Prieto-Merino D, Sadique Z, et al.
BMJ Open. 24 November 2019; Volume 9 (Issue 11); DOI:10.1136/bmjopen-2019-030176