title: 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: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  Patients were allocated to receive CPAP treatment or no active intervention. All participants received dietary counseling and sleep hygiene advice.
  
  
  METHODS
  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.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00127348.
authors.affiliation: Coordinator Centre, IRB Lleida, Lleida, Spain. fbarbe@arnau.scs.es
authors.forename: Ferran
authors.initials: F
authors.lastname: Barbé
authors.forename: Joaquín
authors.initials: J
authors.lastname: Durán-Cantolla
authors.forename: Manuel
authors.initials: M
authors.lastname: Sánchez-de-la-Torre
authors.forename: Montserrat
authors.initials: M
authors.lastname: Martínez-Alonso
authors.forename: Carmen
authors.initials: C
authors.lastname: Carmona
authors.forename: Antonia
authors.initials: A
authors.lastname: Barceló
authors.forename: Eusebi
authors.initials: E
authors.lastname: Chiner
authors.forename: Juan F
authors.initials: JF
authors.lastname: Masa
authors.forename: Mónica
authors.initials: M
authors.lastname: Gonzalez
authors.forename: Jose M
authors.initials: JM
authors.lastname: Marín
authors.forename: Francisco
authors.initials: F
authors.lastname: Garcia-Rio
authors.forename: Josefa
authors.initials: J
authors.lastname: Diaz de Atauri
authors.forename: Joaquín
authors.initials: J
authors.lastname: Terán
authors.forename: Mercedes
authors.initials: M
authors.lastname: Mayos
authors.forename: Mónica
authors.initials: M
authors.lastname: de la Peña
authors.forename: Carmen
authors.initials: C
authors.lastname: Monasterio
authors.forename: Felix
authors.initials: F
authors.lastname: del Campo
authors.forename: Josep M
authors.initials: JM
authors.lastname: Montserrat
mesh_terms: D000328:Adult; D002318:Cardiovascular Diseases / Q000453:epidemiology* / Q000517:prevention & control; D045422:Continuous Positive Airway Pressure; D005221:Fatigue; D005260:Female; D006801:Humans; D006973:Hypertension / Q000453:epidemiology* / Q000517:prevention & control; D015994:Incidence; D008297:Male; D008875:Middle Aged; D012720:Severity of Illness Index; D020181:Sleep Apnea, Obstructive / Q000150:complications* / Q000628:therapy*; D016896:Treatment Outcome