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Effectiveness of blood pressure-lowering drug treatment by levels of absolute risk: post hoc analysis of the Australian National Blood Pressure Study.

ABSTRACT: OBJECTIVES:In many current guidelines, blood pressure (BP)-lowering drug treatment for primary prevention of cardiovascular disease (CVD) is based on absolute risk. However, in clinical practice, therapeutic decisions are often based on BP levels alone. We sought to investigate which approach was superior by conducting a post hoc analysis of the Australian National Blood Pressure (ANBP) cohort, a seminal study establishing the efficacy of BP lowering in 'mild hypertensive' persons. DESIGN:A post hoc subgroup analysis of the ANBP trial results by baseline absolute risk tertile. SETTING AND PARTICIPANTS:3244 participants aged 35-69 years in a community-based randomised placebo controlled trial of blood pressure-lowering medication. INTERVENTIONS:Chlorothiazide500?mg versus placebo. PRIMARY OUTCOME MEASURES:All-cause mortality and non-fatal events (non-fatal CVD, congestive cardiac failure, renal failure, hypertensive retinopathy or encephalopathy). RESULTS:Treatment effects were assessed by HR, absolute risk reduction and number needed to treat. Participants had an average 5-year CVD risk in the intermediate range (10.5±6.5) with moderately elevated BP (mean 159/103?mmHg) and were middle aged (52±8 years). In a subgroup analysis, the relative effects (HR) and absolute effects (absolute risk reduction and number needed to treat) did not statistically differ across the three risk groups except for the absolute benefit in all-cause mortality (p for heterogeneity=0.04). With respect to absolute benefit, drug treatment significantly reduced the number of events in the high-risk group regarding any event with a number needed to treat of 18 (10 to 64), death from any cause with 45 (25 to 196) and major CVD events with 23 (12 to 193). CONCLUSION:Our analysis confirms that the benefit of treatment was substantial only in the high-risk tertile, reaffirming the rationale of treating elevated blood pressure in the setting of all risk factors rather than in isolation.

SUBMITTER: Ho CLB

PROVIDER: S-EPMC5875665 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Effectiveness of blood pressure-lowering drug treatment by levels of absolute risk: post hoc analysis of the Australian National Blood Pressure Study.

Ho Chau Le Bao CLB Breslin Monique M Doust Jenny J Reid Christopher M CM Nelson Mark R MR

BMJ open 20180319 3

<h4>Objectives</h4>In many current guidelines, blood pressure (BP)-lowering drug treatment for primary prevention of cardiovascular disease (CVD) is based on absolute risk. However, in clinical practice, therapeutic decisions are often based on BP levels alone. We sought to investigate which approach was superior by conducting a post hoc analysis of the Australian National Blood Pressure (ANBP) cohort, a seminal study establishing the efficacy of BP lowering in 'mild hypertensive' persons.<h4>De ...[more]

PMID: 29555790

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Project description:BackgroundCommunication of the benefits and harms of blood pressure lowering strategy is crucial for shared decision-making.ObjectivesTo quantify the effect of intensive versus standard systolic blood pressure lowering in terms of the number of event-free days DESIGN: Post hoc analysis of the Systolic Blood Pressure Intervention Trial PARTICIPANTS: A total of 9361 adults 50 years or older without diabetes or stroke who had a systolic blood pressure of 130-180 mmHg and elevated cardiovascular risk INTERVENTIONS: Intensive (systolic blood pressure goal <120 mmHg) versus standard blood pressure lowering (<140 mmHg) MAIN MEASURES: Days free of major adverse cardiovascular events (MACE), serious adverse events (SAE), and monitored adverse events (hypotension, syncope, bradycardia, electrolyte abnormalities, injurious falls, or acute kidney injury) over a median follow-up of 3.33 years KEY RESULTS: The intensive treatment group gained 14.7 more MACE-free days over 4 years (difference, 14.7 [95% confidence interval: 5.1, 24.4] days) than the standard treatment group. The benefit of the intensive treatment varied by cognitive function (normal: difference, 40.7 [13.0, 68.4] days; moderate-to-severe impairment: difference, -15.0 [-56.5, 26.4] days; p-for-interaction=0.009) and self-rated health (excellent: difference, -22.7 [-51.5, 6.1] days; poor: difference, 156.1 [31.1, 281.2] days; p-for-interaction=0.001). The mean overall SAE-free days were not significantly different between the treatments (difference, -14.8 [-35.3, 5.7] days). However, the intensive treatment group had 28.5 fewer monitored adverse event-free days than the standard treatment group (difference, -28.5 [-40.3, -16.7] days), with significant variations by frailty status (non-frail: difference, 38.8 [8.4, 69.2] days; frail: difference, -15.5 [-46.6, 15.7] days) and self-rated health (excellent: difference, -12.9 [-45.5, 19.7] days; poor: difference, 180.6 [72.9, 288.4] days; p-for-interaction <0.001).ConclusionsOver 4 years, intensive systolic blood pressure lowering provides, on average, 14.7 more MACE-free days than standard treatment, without any difference in SAE-free days. Whether this time-based effect summary improves shared decision-making remains to be elucidated.Trial registrationClinicalTrials.gov Registration: NCT01206062.

Project description:ImportanceHigh blood pressure (BP) is the most important risk factor for death and cardiovascular disease (CVD) worldwide. The optimal cutoff for treatment of high BP is debated.ObjectiveTo assess the association between BP lowering treatment and death and CVD at different BP levels.Data sourcesPrevious systematic reviews were identified from PubMed, the Cochrane Database of Systematic Reviews, and the Database of Abstracts of Reviews of Effect. Reference lists of these reviews were searched for randomized clinical trials. Randomized clinical trials published after November 1, 2015, were also searched for in PubMed and the Cochrane Central Register for Controlled Trials during February 2017.Study selectionRandomized clinical trials with at least 1000 patient-years of follow-up, comparing BP-lowering drugs vs placebo or different BP goals were included.Data extraction and synthesisData were extracted from original publications. Risk of bias was assessed using the Cochrane Collaborations assessment tool. Relative risks (RRs) were pooled in random-effects meta-analyses with Knapp-Hartung modification. Results are reported according to PRISMA guidelines.Main outcomes and measuresPrespecified outcomes of interest were all-cause mortality, cardiovascular mortality, major cardiovascular events, coronary heart disease (CHD), stroke, heart failure, and end-stage renal disease.ResultsSeventy-four unique trials, representing 306 273 unique participants (39.9% women and 60.1% men; mean age, 63.6 years) and 1.2 million person-years, were included in the meta-analyses. In primary prevention, the association of BP-lowering treatment with major cardiovascular events was dependent on baseline systolic BP (SBP). In trials with baseline SBP 160 mm Hg or above, treatment was associated with reduced risk for death (RR, 0.93; 95% CI, 0.87-1.00) and a substantial reduction of major cardiovascular events (RR, 0.78; 95% CI, 0.70-0.87). If baseline SBP ranged from 140 to 159 mm Hg, the association of treatment with mortality was similar (RR, 0.87; 95% CI, 0.75-1.00), but the association with major cardiovascular events was less pronounced (RR, 0.88; 95% CI, 0.80-0.96). In trials with baseline SBP below 140 mm Hg, treatment was not associated with mortality (RR, 0.98; 95% CI, 0.90-1.06) and major cardiovascular events (RR, 0.97; 95% CI, 0.90-1.04). In trials including people with previous CHD and mean baseline SBP of 138 mm Hg, treatment was associated with reduced risk for major cardiovascular events (RR, 0.90; 95% CI, 0.84-0.97), but was not associated with survival (RR, 0.98; 95% CI, 0.89-1.07).Conclusions and relevancePrimary preventive BP lowering is associated with reduced risk for death and CVD if baseline SBP is 140 mm Hg or higher. At lower BP levels, treatment is not associated with any benefit in primary prevention but might offer additional protection in patients with CHD.

Project description:Background: Poor cognitive function can predict poor clinical outcomes. Intensive blood pressure control can reduce the risk of cardiovascular diseases and all-cause mortality. In this study, we assessed whether intensive blood pressure control in older patients can reduce the risk of stroke, composite cardiovascular outcomes and all-cause mortality for participants in the Systolic Blood Pressure Intervention Trial (SPRINT) with lower or higher cognitive function based on the Montreal Cognitive Assessment (MoCA) cut-off scores. Methods: The SPRINT evaluated the impact of intensive blood pressure control (systolic blood pressure <120 mmHg) compared with standard blood pressure control (systolic blood pressure <140 mmHg). We defined MoCA score below education specific 25th percentile as lower cognitive function. And SPRINT participants with a MoCA score below 21 (<12 years of education) or 22 (≥12 years of education) were having lower cognitive function, and all others were having higher cognitive function. The Cox proportional risk regression was used to investigate the association of treatment arms with clinical outcomes and serious adverse effects in different cognitive status. Additional interaction and stratified analyses were performed to evaluate the robustness of the association between treatment arm and stroke in patients with lower cognitive function. Results: Of the participants, 1,873 were having lower cognitive function at baseline. The median follow-up period was 3.26 years. After fully adjusting for age, sex, ethnicity, body mass index, smoking, systolic blood pressure, Framingham 10-year CVD risk score, aspirin use, statin use, previous cardiovascular disease, previous chronic kidney disease and frailty status, intensive blood pressure control increased the risk of stroke [hazard ratio (HR) = 1.93, 95% confidence interval (CI): 1.04-3.60, P = 0.038)] in patients with lower cognitive function. Intensive blood pressure control could not reduce the risk of composite cardiovascular outcomes (HR = 0.81, 95%CI: 0.59-1.12, P = 0.201) and all-cause mortality (HR = 0.93, 95%CI: 0.64-1.35, P = 0.710) in lower cognitive function group. In patients with higher cognitive function, intensive blood pressure control led to significant reduction in the risk of stroke (HR = 0.55, 95%CI: 0.35-0.85, P = 0.008), composite cardiovascular outcomes (HR = 0.68, 95%CI: 0.56-0.83, P < 0.001) and all-cause mortality (HR = 0.62, 95%CI: 0.48-0.80, P < 0.001) in the fully adjusted model. Additionally, after the full adjustment, intensive blood pressure control increased the risk of hypotension and syncope in patients with lower cognitive function. Rates of hypotension, electrolyte abnormality and acute kidney injury were increased in the higher cognitive function patients undergoing intensive blood pressure control. Conclusion: Intensive blood pressure control might not reduce the risk of stroke, composite cardiovascular outcomes and all-cause mortality in patients with lower cognitive function.

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Effectiveness of blood pressure-lowering drug treatment by levels of absolute risk: post hoc analysis of the Australian National Blood Pressure Study.

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Effectiveness of blood pressure-lowering drug treatment by levels of absolute risk: post hoc analysis of the Australian National Blood Pressure Study.

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