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Sex differences in the efficacy of antihypertensive treatment in preventing cardiovascular outcomes and reducing blood pressure: protocol for a systematic review and meta-analysis.

ABSTRACT: INTRODUCTION:Hypertension is a leading cause of mortality worldwide and its prevalence is expected to rise over the next decade. Sex differences exist in the epidemiology and pathophysiology of hypertension. It is well established that antihypertensive treatment can significantly reduce the risk for stroke and other cardiovascular disease events. However, it remains unclear whether this effect is dependent on sex. In this protocol, we outlined a systematic review and meta-analysis to evaluate the effects of antihypertensive therapy in (1) reducing blood pressure and (2) preventing cardiovascular morbidity and mortality outcomes for each sex separately. METHODS AND ANALYSIS:The following electronic databases will be searched: Medline, Embase, The Cochrane Library, PubMed, Cumulative Index of Nursing and Allied Health Literature Plus, Web of Science, grey literature (Google Scholar) and several trial registries. Search strategies will be designed to identify human adult (?18) randomised (and non-randomised) controlled trials, prospective and retrospective cohort studies, and case-control studies concerning 'sex-specific differences associated with the efficacy of antihypertensive treatment'. A preliminary search strategy was developed for Medline (1946-16 September 2019). Two investigators will independently review each article included in the final analysis. Primary outcomes investigated are cardiovascular morbidity and mortality and systolic and diastolic blood pressure. Pooled analyses will be conducted using the random-effects model. Publication bias will be assessed by visual inspection of funnel plots and by Begg's and Egger's statistical tests. Between-studies heterogeneity will be measured using the I2 test (p<0.10). Sources of heterogeneity will be explored by sensitivity, subgroup and metaregression analyses. ETHICS AND DISSEMINATION:This is the first meta-analysis that will comprehensively compare the efficacy of antihypertensive treatment regimens between men and women. Findings will be shared through scientific conferences and societies, social media and consumer advocacy groups. Results will be used to inform the current guidelines for management of hypertension in men and women by demonstrating the importance of implementing sex-specific recommendations. Ethical considerations are not applicable for this protocol.

SUBMITTER: Gasbarrino K

PROVIDER: S-EPMC7069325 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Sex differences in the efficacy of antihypertensive treatment in preventing cardiovascular outcomes and reducing blood pressure: protocol for a systematic review and meta-analysis.

Gasbarrino Karina K Labos Christopher C Mastropietro Victoria V Hales Lindsay L Khan Nadia N Rabi Doreen D Daskalopoulou Stella S SS

BMJ open 20200312 3

<h4>Introduction</h4>Hypertension is a leading cause of mortality worldwide and its prevalence is expected to rise over the next decade. Sex differences exist in the epidemiology and pathophysiology of hypertension. It is well established that antihypertensive treatment can significantly reduce the risk for stroke and other cardiovascular disease events. However, it remains unclear whether this effect is dependent on sex. In this protocol, we outlined a systematic review and meta-analysis to eva ...[more]

PMID: 32169929

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Project description:ImportanceIf we assume that women and men exhibit variations of the same fundamental vascular physiology, then conventional analyses of subclinical measures would suggest that women catch up to men by midlife in the extent of potentially important vascular disease. Alternatively, under the assumption that vascular physiology may fundamentally differ between women and men, a sex-specific analysis of existing data could offer new insights and augment our understanding of sex differences in cardiovascular diseases.ObjectiveTo evaluate whether longitudinal patterns of blood pressure (BP) elevation differ between women and men during the life course when considering baseline BP levels as the reference.Design, setting, and participantsWe conducted sex-specific analyses of longitudinal BP measures (144 599 observations) collected for a period of 43 years (1971 to 2014) in 4 community-based US cohort studies. The combined total included 32 833 participants (54% female) spanning ages 5 to 98 years. Data were analyzed between May 4, 2019, and August 5, 2019.ExposuresAge and serially assessed longitudinal BP measures: systolic BP, diastolic BP, mean arterial pressure (MAP), and pulse pressure (PP).Main outcomes and measuresSex-specific change in each primary BP measure compared with baseline BP levels, derived from multilevel longitudinal models fitted over the age span, and new-onset cardiovascular disease events.ResultsOf the 32 833 participants, 17 733 were women (54%). Women compared with men exhibited a steeper increase in BP that began as early as in the third decade and continued through the life course (likelihood ratio test χ2 = 531 for systolic BP; χ2 = 123 for diastolic BP; χ2 = 325 for MAP; and χ2 = 572 for PP; P for all <.001). After adjustment for multiple cardiovascular disease risk factors, these between-sex differences in all BP trajectories persisted (likelihood ratio test χ2 = 314 for systolic BP; χ2 = 31 for diastolic BP; χ2 = 129 for MAP; and χ2 = 485 for PP; P for all <.001).Conclusions and relevanceIn contrast with the notion that important vascular disease processes in women lag behind men by 10 to 20 years, sex-specific analyses indicate that BP measures actually progress more rapidly in women than in men, beginning early in life. This early-onset sexual dimorphism may set the stage for later-life cardiovascular diseases that tend to present differently, not simply later, in women compared with men.

Project description:Interface pressure is a key risk factor in the development of pressure ulcers. Visual feedback of continuous interface pressure between the body and support surface could inform clinicians on repositioning strategies and play a key role in an overall strategy for the prevention and management of pressure ulcers.A parallel two-group randomized controlled clinical trial will be conducted to study the effect of continuous pressure imaging on reducing interface pressure and on the incidence of pressure ulcers in vulnerable hospital patients. A total of 678 eligible consenting inpatients at risk of pressure ulcer development in a tertiary acute care institution will be randomly allocated to either having the ForeSite PT™ system with the liquid-crystal display monitor turned on to provide visual feedback to the clinicians while also collecting continuous interface pressure data (intervention group) or to having the ForeSite PT™ system with monitor turned off (that is, not providing visual feedback) but still collecting continuous interface pressure data (control group), in a ratio of 1:1. Continuous interface pressure data will be collected in both groups for 3 days (72 h). Data collection will continue until discharge for a subset of approximately 60 patients. The primary outcome will be the differences in the two groups' interface pressure analysis. Interface pressure readings will be collected through hourly samplings of continuous interface pressure recordings. Secondary outcomes will be the differences between the two groups in pressure-related skin and soft tissue changes in areas at risk of pressure ulcer (obtained at baseline within 24 h of admission) and on the third day of the trial or at discharge and perceptions of the intervention by patients and clinicians (obtained on the third day or at discharge).This will be the first randomized controlled trial to investigate the effect of visual feedback with continuous interface pressure of vulnerable hospital patients across different care settings, and the association between interface pressure and development of pressure-related skin and soft tissue changes. The results could provide important information to guide clinical practice in the prevention and management of pressure ulcers.ClinicalTrials.gov NCT02325388 (date of registration: 24 December 2014).

Dataset Information

Sex differences in the efficacy of antihypertensive treatment in preventing cardiovascular outcomes and reducing blood pressure: protocol for a systematic review and meta-analysis.

Publications

Sex differences in the efficacy of antihypertensive treatment in preventing cardiovascular outcomes and reducing blood pressure: protocol for a systematic review and meta-analysis.

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