37 research outputs found

    Effect of angiotensin-converting enzyme inhibitor and angiotensin receptor blocker initiation on organ support-free days in patients hospitalized with COVID-19

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    IMPORTANCE Overactivation of the renin-angiotensin system (RAS) may contribute to poor clinical outcomes in patients with COVID-19. Objective To determine whether angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) initiation improves outcomes in patients hospitalized for COVID-19. DESIGN, SETTING, AND PARTICIPANTS In an ongoing, adaptive platform randomized clinical trial, 721 critically ill and 58 non–critically ill hospitalized adults were randomized to receive an RAS inhibitor or control between March 16, 2021, and February 25, 2022, at 69 sites in 7 countries (final follow-up on June 1, 2022). INTERVENTIONS Patients were randomized to receive open-label initiation of an ACE inhibitor (n = 257), ARB (n = 248), ARB in combination with DMX-200 (a chemokine receptor-2 inhibitor; n = 10), or no RAS inhibitor (control; n = 264) for up to 10 days. MAIN OUTCOMES AND MEASURES The primary outcome was organ support–free days, a composite of hospital survival and days alive without cardiovascular or respiratory organ support through 21 days. The primary analysis was a bayesian cumulative logistic model. Odds ratios (ORs) greater than 1 represent improved outcomes. RESULTS On February 25, 2022, enrollment was discontinued due to safety concerns. Among 679 critically ill patients with available primary outcome data, the median age was 56 years and 239 participants (35.2%) were women. Median (IQR) organ support–free days among critically ill patients was 10 (–1 to 16) in the ACE inhibitor group (n = 231), 8 (–1 to 17) in the ARB group (n = 217), and 12 (0 to 17) in the control group (n = 231) (median adjusted odds ratios of 0.77 [95% bayesian credible interval, 0.58-1.06] for improvement for ACE inhibitor and 0.76 [95% credible interval, 0.56-1.05] for ARB compared with control). The posterior probabilities that ACE inhibitors and ARBs worsened organ support–free days compared with control were 94.9% and 95.4%, respectively. Hospital survival occurred in 166 of 231 critically ill participants (71.9%) in the ACE inhibitor group, 152 of 217 (70.0%) in the ARB group, and 182 of 231 (78.8%) in the control group (posterior probabilities that ACE inhibitor and ARB worsened hospital survival compared with control were 95.3% and 98.1%, respectively). CONCLUSIONS AND RELEVANCE In this trial, among critically ill adults with COVID-19, initiation of an ACE inhibitor or ARB did not improve, and likely worsened, clinical outcomes. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT0273570

    The impact of group counseling on depression, post-traumatic stress and function outcomes: A prospective comparison study in the Peter C. Alderman trauma clinics in northern Uganda

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    AbstractBackgroundThe effectiveness of group interventions for adults with mental distress in post-conflict settings is less clear in sub-Saharan Africa.AimTo assess the impact of group counseling intervention on depression, post-traumatic stress and function outcomes among adults attending the Peter C. Alderman Foundation (PCAF) trauma clinics in northern Uganda.Methods631 War affected adults were enrolled into PCAF trauma clinics. Using a quasi-experimental design, assessments were conducted at baseline, at 3 and 6 months following initiation of care. Multivariate longitudinal regression models were used to determine change in depression, post-traumatic stress and function scores over time among group counseling participants and non-participants.ResultsIn comparison to non-participants, participants had faster reduction in depression scores during the 6-month follow-up period [β=−1.84, 95%CI (−3.38 to −0.30), p=0.019] and faster reduction in post-traumatic stress scores during the 3-month follow-up period [β=−2.14, 95%CI (−4.21 to −0.10), p=0.042]. At 3-month follow up, participants who attended two or more sessions had faster increase in function scores [β=3.51, 95%CI (0.61–6.40), p=0.018] than participants who attended only one session.LimitationsSelection bias due to the use of non-random samples. Substantial attrition rates and small sample sizes may have resulted in insufficient statistical power to determine meaningful differences.ConclusionThe group counseling intervention offered in the PCAF clinics may have considerable mental health benefits over time. There is need for more research to structure, standardize and test the efficacy of this intervention using a randomized controlled trial

    Low Diastolic Blood Pressure and Mortality in Older Women. Results from the Women\u27s Health Initiative Long Life Study.

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    BACKGROUND: Recommended systolic blood pressure (SBP) targets often do not consider the relationship of low diastolic blood pressure (DBP) levels with cardiovascular disease (CVD) and all-cause mortality risk, which is especially relevant for older people with concurrent comorbidities.We examined the relationship of DBP levels to CVD and all-cause mortality in older women in the Women\u27s Health Initiative Long Life Study (WHI-LLS). METHODS: The study sample included 7,875 women (mean age: 79 years) who underwent a BP measurement at an in-person home visit conducted in 2012-2013. CVD and all-cause mortality were centrally adjudicated. Hazard ratios (HR) were obtained from adjusted Cox proportional hazards models. RESULTS: After 5 years follow-up, all-cause mortality occurred in 18.4% of women. Compared to a DBP of 80 mmHg, the fully adjusted hazards ratio (HR) for mortality was 1.33 (95% CI: 1.04-1.71) for a DBP of 50 mmHg and 1.67 (95% CI: 1.29-2.16) for a DBP of 100 mmHg. The HRs for CVD were 1.14 (95% CI: 0.78-1.67) for a DBP of 50 mmHg and HR 1.50 (95% CI: 1.03-2.17) for a DBP of 100 mmHg. The nadir DBP associated with lowest mortality risk was 72 mmHg overall. CONCLUSIONS: In older women, consideration should be given to the potential adverse effects of low and high DBP. Low DBP may serve as a risk marker. DBP target levels between 68 and 75 mmHg may avoid higher mortality risk
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