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Randomized elimination and prolongation of ACE inhibitors and ARBs in coronavirus 2019 (REPLACE COVID) Trial Protocol.

ABSTRACT: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for coronavirus disease 2019 (COVID-19), is associated with high incidence of multiorgan dysfunction and death. Angiotensin-converting enzyme 2 (ACE2), which facilitates SARS-CoV-2 host cell entry, may be impacted by angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs), two commonly used antihypertensive classes. In a multicenter, international randomized controlled trial that began enrollment on March 31, 2020, participants are randomized to continuation vs withdrawal of their long-term outpatient ACEI or ARB upon hospitalization with COVID-19. The primary outcome is a hierarchical global rank score incorporating time to death, duration of mechanical ventilation, duration of renal replacement or vasopressor therapy, and multiorgan dysfunction severity. Approval for the study has been obtained from the Institutional Review Board of each participating institution, and all participants will provide informed consent. A data safety monitoring board has been assembled to provide independent oversight of the project.

SUBMITTER: Cohen JB

PROVIDER: S-EPMC7722152 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Randomized elimination and prolongation of ACE inhibitors and ARBs in coronavirus 2019 (REPLACE COVID) Trial Protocol.

Cohen Jordana B JB Hanff Thomas C TC Corrales-Medina Vicente V William Preethi P Renna Nicolas N Rosado-Santander Nelson R NR Rodriguez-Mori Juan E JE Spaak Jonas J Andrade-Villanueva Jaime J Chang Tara I TI Barbagelata Alejandro A Alfonso Carlos E CE Bernales-Salas Eduardo E Coacalla Johanna J Castro-Callirgos Carlos Augusto CA Tupayachi-Venero Karen E KE Medina Carola C Valdivia Renzo R Villavicencio Mirko M Vasquez Charles R CR Harhay Michael O MO Chittams Jesse J Sharkoski Tiffany T Byrd James Brian JB Edmonston Daniel L DL Sweitzer Nancy N Chirinos Julio A JA

Journal of clinical hypertension (Greenwich, Conn.) 20200916 10

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for coronavirus disease 2019 (COVID-19), is associated with high incidence of multiorgan dysfunction and death. Angiotensin-converting enzyme 2 (ACE2), which facilitates SARS-CoV-2 host cell entry, may be impacted by angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs), two commonly used antihypertensive classes. In a multicenter, international randomized controlled trial that ...[more]

PMID: 32937008

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Project description:BackgroundSacubitril/valsartan (SAV) is crucial for managing heart failure (HF). Randomized clinical trials have shown SAV's superiority over angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs) in reducing N-terminal pro-B-type natriuretic peptide levels. However, results for cardiovascular (CV) mortality, HF rehospitalization, and all-cause mortality have been mixed.ObjectivesThis study aimed to determine hard endpoints among the population with HF treated with SAV vs ACEI/ARBs and conduct a comprehensive risk-benefit analysis of the safety profile for SAV vs ACEI/ARB.MethodsWe queried PubMed, EMBASE, Scopus, and the Cochrane Central Register of Controlled Trials for randomized clinical trials from inception to November 2023. We included studies that compared SAV to ACEI or ARBs and reported hard endpoints, including all-cause mortality, CV mortality, and HF rehospitalizations. Random effect model was used, and categorical values were analyzed using risk ratios (RRs) and 95% CI. The I2 test was used to assess between-study heterogeneity. Publication bias was assessed via funnel plots and the Egger test. This study was registered in PROSPERO (CRD42024497661).ResultsThe study included a total of 14 trials (n = 25,167). SAV reduced all-cause mortality in the population with an ejection fraction (EF) ≤40% (RR: 0.88; 95% CI: 0.81-0.94; P = 0.0006), but not in those with EF >40% (RR: 0.97; 95% 0.85-1.11; P = 0.67). There was no difference in CV mortality across EF spectrums (RR: 0.9; 95% CI: 0.79-1.03; P = 0.13). HF readmission was lower in the SAV-treated group regardless of EF (RR: 0.85; 95% CI: 0.79-0.91; P = 0.00001).ConclusionsThe SAV-treated group, across all EF spectrum, was less likely to be rehospitalized than the ACEI/ARB-treated group. However, all-cause mortality reduction was only noted in the SAV group with EF <40%. No reduction in CV-related mortality was observed across the EF spectrum.

Project description:A 2007 systematic review compared angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) in patients with hypertension. Direct renin inhibitors (DRIs) have since been introduced, and significant new research has been published. We sought to update and expand the 2007 review.We searched MEDLINE and EMBASE (through December 2010) and selected other sources for relevant English-language trials.We included studies that directly compared ACE inhibitors, ARBs, and/or DRIs in at least 20 total adults with essential hypertension; had at least 12 weeks of follow-up; and reported at least one outcome of interest. Ninety-seven (97) studies (36 new since 2007) directly comparing ACE inhibitors versus ARBs and three studies directly comparing DRIs to ACE inhibitor inhibitors or ARBs were included.A standard protocol was used to extract data on study design, interventions, population characteristics, and outcomes; evaluate study quality; and summarize the evidence.In spite of substantial new evidence, none of the conclusions from the 2007 review changed. The level of evidence remains high for equivalence between ACE inhibitors and ARBs for blood pressure lowering and use as single antihypertensive agents, as well as for superiority of ARBs for short-term adverse events (primarily cough). However, the new evidence was insufficient on long-term cardiovascular outcomes, quality of life, progression of renal disease, medication adherence or persistence, rates of angioedema, and differences in key patient subgroups.Included studies were limited by follow-up duration, protocol heterogeneity, and infrequent reporting on patient subgroups.Evidence does not support a meaningful difference between ACE inhibitors and ARBs for any outcome except medication side effects. Few, if any, of the questions that were not answered in the 2007 report have been addressed by the 36 new studies. Future research in this area should consider areas of uncertainty and be prioritized accordingly.

Project description:BackgroundReducing patient cost-sharing and engaging patients in disease management activities have been shown to increase uptake of evidence-based care.ObjectiveTo evaluate the effect of employer purchase of a disease-specific plan with reduced cost-sharing and disease management (the Diabetes Health Plan/DHP) on medication adherence among eligible employees and dependents.DesignEmployer-level "intent to treat" cohort study, including data from eligible employees and their dependents with diabetes, regardless of whether they were enrolled in the DHP.SettingEmployers that contracted with a large national health plan administrator in 2009, 2010, and/or 2011.ParticipantsTen employers that purchased the DHP and 191 employers that did not (controls). Inverse probability weighting (IPW) estimation was used to adjust for inter-group differences.InterventionThe DHP includes free or low-cost medications and physician visits. Enrollment strategies and specific benefit designs are determined by the employer and vary in practice. DHP participants are notified up front that they must engage in their own health care (e.g., receiving diabetes-related screening) in order to remain enrolled.Main outcome measureMean employee adherence to metformin, statins, and ACE/ARBs at the employer level at one year post-DHP implementation, as measured by the proportion of days covered (PDC).ResultsBaseline adherence to the three medications was similar across DHP and control employers, ranging from 64 to 69 %. In the first year after DHP implementation, predicted employer-level adherence for metformin (+4.9 percentage points, p = 0.017), statins (+4.8, p = 0.019), and ACE/ARBs (+4.4, p = 0.02) was higher with DHP purchase.LimitationsNon-randomized, observational study.ConclusionsThe Diabetes Health Plan, an innovative health plan that combines reduced cost-sharing and disease management with an up-front requirement of enrollee participation in his or her own health care, is associated with a modest improvement in medication adherence at 12 months.

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Randomized elimination and prolongation of ACE inhibitors and ARBs in coronavirus 2019 (REPLACE COVID) Trial Protocol.

Publications

Randomized elimination and prolongation of ACE inhibitors and ARBs in coronavirus 2019 (REPLACE COVID) Trial Protocol.

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