Dataset Information

Blood pressure, heart rate, and mortality in chronic obstructive pulmonary disease: the SUMMIT trial.

ABSTRACT: Aims:To characterize the relationship between blood pressure (BP) or heart rate and mortality and morbidity in chronic obstructive pulmonary disease (COPD). Methods and results:We performed post hoc analysis of baseline BP or heart rate and all-cause mortality and cardiovascular events in the SUMMIT trial. SUMMIT was a randomized double-blind outcome trial of 16 485 participants (65?±?8?years, 75% male, and 47% active smokers) enrolled at 1368 sites in 43 countries. Participants with moderate COPD with or at risk for cardiovascular disease (CVD) were randomized to placebo, long-acting beta agonist, inhaled corticosteroid, or their combination. All-cause mortality increased in relation to high systolic [?140?mmHg; hazard ratio (HR) 1.27, 95% confidence interval (CI) 1.12-1.45] or diastolic (?90?mmHg; HR 1.35, 95% CI 1.14-1.59) BP and low systolic (<120?mmHg; HR 1.36, 95% CI 1.13-1.63) or diastolic (<80?mmHg; HR 1.15, 95% CI 1.00-1.32) BP. Higher heart rates (?80 per minute; HR 1.39, 95% CI 1.21-1.60) and pulse pressures (?80?mmHg; HR 1.39, 95% CI 1.07-1.80) were more linearly related to increases in all-cause mortality. The risks of cardiovascular events followed similar patterns to all-cause mortality. Similar findings were observed in subgroups of patients without established CVD. Conclusion:A 'U-shaped' relationship between BP and all-cause mortality and cardiovascular events exists in patients with COPD and heightened cardiovascular risk. A linear relationship exists between heart rate and all-cause mortality and cardiovascular events in this population. These findings extend the prognostic importance of BP to this growing group of patients and raise concerns that both high and low BP may pose health risks.

SUBMITTER: Byrd JB

PROVIDER: S-EPMC7263699 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Blood pressure, heart rate, and mortality in chronic obstructive pulmonary disease: the SUMMIT trial.

Byrd James Brian JB Newby David E DE Anderson Julie A JA Calverley Peter M A PMA Celli Bartolome R BR Cowans Nicholas J NJ Crim Courtney C Martinez Fernando J FJ Vestbo Jørgen J Yates Julie J Brook Robert D RD

European heart journal 20180901 33

<h4>Aims</h4>To characterize the relationship between blood pressure (BP) or heart rate and mortality and morbidity in chronic obstructive pulmonary disease (COPD).<h4>Methods and results</h4>We performed post hoc analysis of baseline BP or heart rate and all-cause mortality and cardiovascular events in the SUMMIT trial. SUMMIT was a randomized double-blind outcome trial of 16 485 participants (65 ± 8 years, 75% male, and 47% active smokers) enrolled at 1368 sites in 43 countries. Participants w ...[more]

PMID: 30101300

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Project description:BACKGROUND:Adjudicated cause-specific mortality has been used in major trials of chronic obstructive pulmonary disease. However, there is less experience with adjudicated major adverse cardiovascular events as a key efficacy outcome in chronic obstructive pulmonary disease trials. The Study to Understand Mortality and Morbidity in chronic obstructive pulmonary disease trial required a Clinical Endpoint Committee to adjudicate the outcomes of modified major adverse cardiovascular events and cause-specific mortality. METHODS AND RESULTS:A six-member Clinical Endpoint Committee reviewed adverse event and serious adverse event reports included in a list of 204 Medical Dictionary for Regulatory Activities terms. Adverse events were triaged by one Clinical Endpoint Committee member, and then reviewed by three reviewers (round 1). If these three disagreed on the adjudication, the event was discussed by the full committee to reach a consensus (round 2). Among 16,485 participants, 48,105 adverse events were reported, among which 3314 were reviewed by the Clinical Endpoint Committee. After triage, 1827 were adjudicated in round 1; 338 required committee consensus in round 2, yielding 450 myocardial infarctions, strokes, unstable anginas or transient ischaemic attacks. Only 20/1627 (1%) non-serious adverse events were adjudicated as cardiovascular events. Only 45/204 Medical Dictionary for Regulatory Activities terms reviewed yielded cardiovascular events. A total of 430 deaths were adjudicated in round 1 and 631 in round 2, yielding 459 cardiovascular deaths. Adjudication of chest pain and sudden death often required additional information from site investigators. Site assessment of cardiovascular death was moderately specific (501/602?=?83%) but not sensitive (256/459?=?56%). CONCLUSION:A Clinical Endpoint Committee is useful for adjudication of major adverse cardiovascular events in chronic obstructive pulmonary disease trials but requires considerable resources and effort by investigators. This process can be streamlined by reviewing only serious adverse events and filtering by selected Medical Dictionary for Regulatory Activities terms.

Project description:Objective:Most patients with resistant hypertension (RH) have obstructive sleep apnea (OSA). We aimed to determine the impact of OSA and continuous positive airway pressure (CPAP) treatment on the leptin profile and blood pressure (BP) in patients with RH. Methods:After an initial case-control study (RH with and without OSA), we performed a randomized, single blind study in OSA?+?RH patients receiving either sham CPAP (3?months) followed by active CPAP (6?months) or 6?months of active CPAP. The primary outcome was the comparison of leptin levels between groups of RH patients with or without OSA. Secondary outcomes were the comparison of metabolic parameters, biomarkers of sympathetic activity, and BP indices between the two groups of RH patients with or without OSA. The same outcomes were then evaluated and compared before and after sham and effective CPAP intervention. Results:Sixty-two patients (60?±?10?years; 77% men) with RH (24-h daytime systolic BP (SBP)/diastolic BP: 145?±?13/85?±?10?mmHg, 3.7 antihypertensive drugs) were included. The 37 RH patients exhibiting OSA (60%) were predominantly men (87 vs 64% for non-OSA patients), with a greater prevalence of metabolic syndrome and higher creatininemia. Their leptin concentrations were significantly lower than in non-OSA patients [9 (6; 15) vs 17 (6; 29) ng/mL] but increased after 6?months of CPAP. Three months of effective CPAP significantly decreased night-time SBP by 6.4?mmHg and heart rate (HR) by 6.0?bpm, compared to sham CPAP. Conclusion:The association between OSA and RH corresponds to a specific, predominately male phenotype with a higher burden of metabolic syndrome and higher creatininemia but there was no significant difference between OSA and non-OSA patients regarding BP indices, and the number of antihypertensive drugs used. Active CPAP could be efficient at decreasing night-time BP and HR, but there was no difference between CPAP and sham CPAP groups for all metabolic and SNS markers (NCT00746902 RHOOSAS).

Dataset Information

Blood pressure, heart rate, and mortality in chronic obstructive pulmonary disease: the SUMMIT trial.

Publications

Blood pressure, heart rate, and mortality in chronic obstructive pulmonary disease: the SUMMIT trial.

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