Effect of continuous positive airway pressure on the incidence of hypertension and cardiovascular events in nonsleepy patients with obstructive sleep apnea: a randomized controlled trial.
Abstract
CONTEXT
Continuous positive airway pressure (CPAP) is the first-line treatment for patients with symptomatic obstructive sleep apnea
(OSA). However, its indication for all patients with sleep-disordered breathing, regardless of daytime symptoms, is unclear.
OBJECTIVE
To evaluate the effect of CPAP treatment on the incidence of hypertension or cardiovascular events in a cohort of nonsleepy
patients with OSA.
DESIGN, SETTING, AND PATIENTS
Multicenter, parallel-group, randomized controlled trial in 14 teaching hospitals in Spain. Between May 2004 and May 2006,
725 consecutive patients were enrolled who had an apnea-hypopnea index of 20 h(-1) or greater and an Epworth Sleepiness Scale
score of 10 or less (scores range from 0-24, with values <10 suggesting no daytime sleepiness). Exclusion criteria were previous
cardiovascular event, physical or psychological incapacity, chronic disease, or drug or alcohol addiction. Follow-up ended
in May 2009.
INTERVENTION
Patients were allocated to receive CPAP treatment or no active intervention. All participants received dietary counseling
and sleep hygiene advice.
MAIN OUTCOME MEASURES
Incidence of either systemic hypertension (taking antihypertensive medication or blood pressure greater than 140/90 mm Hg)
or cardiovascular event (nonfatal myocardial infarction, nonfatal stroke, transient ischemic attack, hospitalization for unstable
angina or arrhythmia, heart failure, or cardiovascular death).
RESULTS
Seven hundred twenty-three patients underwent follow-up for a median of 4 (interquartile range, 2.7-4.4) years (1 patient
from each group did not receive allocated treatment); 357 in the CPAP group and 366 in the control group were included in
the analysis. In the CPAP group there were 68 patients with new hypertension and 28 cardiovascular events (17 unstable angina
or arrhythmia, 3 nonfatal stroke, 3 heart failure, 2 nonfatal myocardial infarction, 2 transient ischemic attack, 1 cardiovascular
death). In the control group there were 79 patients with new hypertension and 31 cardiovascular events (11 unstable angina
or arrhythmia, 8 nonfatal myocardial infarction, 5 transient ischemic attack, 5 heart failure, 2 nonfatal stroke). The hypertension
or cardiovascular event incidence density rate was 9.20 per 100 person-years (95% CI, 7.36-11.04) in the CPAP group and 11.02
per 100 person-years (95% CI, 8.96-13.08) in the control group. The incidence density ratio was 0.83 (95% CI, 0.63-1.1; P
= .20).
CONCLUSIONS
In patients with OSA without daytime sleepiness, the prescription of CPAP compared with usual care did not result in a statistically
significant reduction in the incidence of hypertension or cardiovascular events. However, the study may have had limited power
to detect a significant difference.
TRIAL REGISTRATION
clinicaltrials.gov Identifier: NCT00127348.
Links
Authors
Barbé F, Durán-Cantolla J, Sánchez-de-la-Torre M, Martínez-Alonso M, Carmona C, Barceló A, Chiner E, Masa JF, Gonzalez M, Marín JM, Garcia-Rio F, Diaz de Atauri J, Terán J, Mayos M, de la Peña M, Monasterio C, del Campo F, Montserrat JM, Spanish Sleep And Breathing Network
Institution
Coordinator Centre, IRB Lleida, Lleida, Spain. fbarbe@arnau.scs.es
Source
JAMA : the journal of the American Medical Association 307:20 2012 May 23 pg 2161-8MeSH
AdultCardiovascular Diseases
Continuous Positive Airway Pressure
Fatigue
Female
Humans
Hypertension
Incidence
Male
Middle Aged
Severity of Illness Index
Sleep Apnea, Obstructive
Treatment Outcome
Pub Type(s)
Journal ArticleMulticenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Language
eng
PubMed ID
22618923
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