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
Open accessAbstract
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.
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Some RCTs that selectively recruited non-sleepy participants demonstrated no benefits in blood pressure or cardiovascular risk reduction with CPAP.
“some RCTs that selectively recruited non-sleepy participants demonstrated no benefits in BP 63,86,106 or cardiovascular risk reduction 106,108 with CPAP.”
From Treatment of Adult Obstructive Sleep Apnea With Positive Airway Pressure: An American Academy of Sleep Medicine Systematic Review, Meta-Analysis, and GRADE Assessment (2019) · cites this paper as [106]
The COMMENT conclusion reports no statistically significant reduction in incident hypertension or cardiovascular events with CPAP in patients without daytime sleepiness, supporting the cardiovascular portion of the claim. The trial’s reported outcome was new-onset hypertension, not a demonstrated absence of benefit in blood-pressure levels; the authors also caution that limited power may have prevented detection of a difference. (LLM, conf=0.82)
Experimental — accuracy not yet measuredSeveral other classifications, based on pathophysiology, comorbid conditions, and clinical outcomes, have also been described.
“Several other classifications, based on pathophysiology,36 comorbid conditions,37 and clinical outcomes,38 have also been described.”
From International Consensus Statement on Obstructive Sleep Apnea (2023) · cites this paper as [38]
Citation 38 is attached to the claim about classifications based on clinical outcomes. The Outcomes and Follow-up section measures hypertension and cardiovascular events, while the Statistical Analysis section divides patients by disease severity and CPAP adherence; neither describes a classification based on clinical outcomes. I searched for outcome-based classification and risk stratification in our copy. (LLM, conf=0.76)
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Research works printed but not linked: 1
- [1]1. Sant Pau, Barcelona (Dr Mayos); Hospital de Bell- vitge, Barcelona (Dr Monasterio); Hospital Rio Hortega, Valladolid (Dr del Campo); Hospital Clinic, Barcelona (Dr Montserrat and Herna ´ndez); CIBERes, Madrid (Drs Barbe ´, Dura ´n-Cantolla, Sa ´nchez-de-la-Torre, Barcelo ´, Masa, Marı ´n, Tera ´n, Mayos, de la Pen ˜a, Monasterio, and Montserrat), Spain. Author Contributions: Dr Barbe ´had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Barbe ´, Dura ´n-Cantolla, Chiner, Masa, Marı ´n, Garcı ´a-Rı ´o, Dı ´az-De-Atauri, Mayos, Monasterio, del Campo, Montserrat. Acquisition of data: Barbe ´, Dura ´n-Cantolla, Sa ´nchez- de-la-Torre, Carmona, Chiner, Masa, Gonzalez, Garcı ´a-Rı ´o, Dı ´az de Atauri, Mayos, Monasterio, del Campo, Montserrat. Analysis and interpretation of data: Barbe ´, Dura ´n- Cantolla, Sa ´nchez-de-la-Torre, Martı ´nez-Alonso, Barcelo ´, Masa, Marı ´n, Garcı ´a-Rı ´o, Tera ´n, de la Pen ˜a, Monasterio, del Campo, Montserrat. Drafting of the manuscript: Barbe ´, Martı ´nez-Alonso, Chiner. Critical revision of the manuscript for important in- tellectual content: Barbe ´, Dura ´n-Cantolla, Sa ´nchez- de-la-Torre, Martı ´nez-Alonso, Carmona, Barcelo ´, Chiner, Masa, Gonzalez, Marı ´n, Garcı ´a-Rı ´o, Dı ´az de Atauri, Tera ´n, Mayos, de la Pen ˜a, Monasterio, del Campo, Montserrat. Statistical analysis: Barbe ´, Martı ´nez-Alonso. Obtained funding: Barbe ´, Dura ´n-Cantolla, Sa ´nchez- de-la-Torre, Masa, Marı ´n, del Campo, Montserrat. Administrative, technical, or material support: Barbe ´, Sa ´nchez-de-la-Torre, Carmona, Barcelo ´, de la Pen ˜a, Monasterio. Study supervision: Barbe ´, Dura ´n-Cantolla, Sa ´nchez- de-la-Torre, Chiner, Masa, Marı ´n, Tera ´n, Monasterio, del Campo, Montserrat. Conflict of Interest Disclosures: All authors have com- pleted and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were re- ported. Funding/Support: This study was funded by the In- stituto de Salud Carlos III (PI 04/0165) (Fondo de In- vestigaciones Sanitarios, Ministerio de Sanidad y Con- sumo, Spain), Spanish Respiratory Society (SEPAR) (Barcelona), Resmed (Bella Vista, Australia), Air Products-Carburos Metalicos (Barcelona), Respiron- ics (Murrysville, Pennsylvania), and Breas Medical (Ma- drid, Spain). Role of the Sponsors: The funding agencies had no role in the design and conduct of the study; the col- lection, management, analysis, and interpretation of the data; or the preparation, review, or approval of the manuscript. Members of the Spanish Sleep and Breathing Net- work: Coordinator Centre, IRB Lleida, Lleida: Marina Lumbierres, Silvia Gomez, Cristina Esquinas. Hospital Universitario de Álava, Vitoria: Ramo ´n Rubio, Ger- ma ´n de la Torre, Cristina Martinez-Null. Hospital Virgen del Rocı ´o, Sevilla: Francisco Capote, Angeles Sa ´nchez- Armengol. Hospital Sant Joan, Alacant: Monica Llom- bart. Hospital San Pedro de Alca ´ntara Hospital, Ca ´- ceres: Fa ´tima Morante, Manuela Rubio, Jaime Corral. Hospital Marqués de Valdecilla, Santander: M. A ´nge- les Martinez. Hospital Miguel Servet, Zaragoza: San- tiago Carrizo. Hospital Universitario La Paz-IdiPAZ, Ma- drid: Olga Mediano, Vanesa Lores. Hospital General Yagu ¨e, Burgos: M. L. Alonso A ´lvarez. Hospital de Bellvitge, Barcelona: Neus Salord. Hospital Clinic, Bar- celona: Lourdes Herna ´ndez. CIBERes, Madrid: Neus Salord, Cristina Esquinas. Online-Only Material: The eAppendix, eFigures 1 and 2, eTables 1-7, and the Author Video Interview are available at http://www.jama.com. REFERENCES
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- Authors
- Barbé, F., Durán-Cantolla, J., Sánchez-de-la-Torre, M., Martínez-Alonso, M., Carmona, C., Barceló, A., Chiner, E., Masa, J. F., Gonzalez, M., Marín, J. M., Garcia-Rio, F., Diaz de Atauri, J., Terán, J., Mayos, M., de la Peña, M., Monasterio, C., del Campo, F., Montserrat, J. M., & Spanish Sleep and Breathing Network, F. T.
- Affiliations
- Hospital Universitari Arnau de Vilanova (ES)
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2012-05-23
- Volume
- 307
- Issue
- 20
- Pages
- 2161-8
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- OpenAlex
- W2160629168
- Cited by
- 792
- References
- 42
- Citations by year
- 2026: 20 · 2025: 37 · 2024: 42 · 2023: 46 · 2022: 65 · 2021: 48 · 2020: 58 · 2019: 66 · 2018: 89 · 2017: 75 · 2016: 65 · 2015: 53 · 2014: 61 · 2013: 49 · 2012: 15
- FWCI
- 38.15
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA (publishedVersion)
- PubMed (publishedVersion)
- Repositori ObertUDL (University of Lleida) (publishedVersion)
- UCrea (University of Cantabria) (submittedVersion, cc-by)
- LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (submittedVersion)
- Docusalut (Conselleria de Salut i Consum del Govern de les Illes Balears) (submittedVersion)
- Hispana (submittedVersion)
- RUIdeRA - Institutional University Repository (University of Castilla-La Mancha) (submittedVersion, other-oa)
- Topics
- Health Sciences › Medicine › Physiology › Obstructive Sleep Apnea Research
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Respiratory Support and Mechanisms
- Keywords
- continuous positive airway pressure, obstructive sleep apnea, hypertension incidence, cardiovascular events, cardiovascular risk, daytime sleepiness, apnea-hypopnea index, Epworth Sleepiness Scale, heart failure, myocardial infarction, stroke, cardiac arrhythmias, unstable angina, cardiovascular mortality, sleep-disordered breathing, nutrition counseling, sleep hygiene
- MeSH terms
- Adult, Cardiovascular Diseases, Fatigue, Female, Humans, Hypertension, Male, Middle Aged, Severity of Illness Index, Incidence, Treatment Outcome, Sleep Apnea, Obstructive, Continuous Positive Airway Pressure
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