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Continuous positive airway pressure as treatment for systemic hypertension in people with obstructive sleep apnoea: randomised controlled trial

BMJ 2010; 341 doi: https://doi.org/10.1136/bmj.c5991 (Published 24 November 2010) Cite this as: BMJ 2010;341:c5991
  1. Joaquín Durán-Cantolla, respiratory physician12,
  2. Felipe Aizpuru, epidemiologist34,
  3. Jose María Montserrat, respiratory physician56,
  4. Eugeni Ballester, respiratory physician56,
  5. Joaquín Terán-Santos, respiratory physician67,
  6. Jose Ignacio Aguirregomoscorta, respiratory physician8,
  7. Mónica Gonzalez, respiratory physician9,
  8. Patricia Lloberes, respiratory physician610,
  9. Juan Fernando Masa, respiratory physician611,
  10. Mónica De La Peña, respiratory physician612,
  11. Santiago Carrizo, respiratory physician613,
  12. Mercedes Mayos, respiratory physician14,
  13. Ferrán Barbé, respiratory physician26
  14. Spanish Sleep and Breathing Group
  1. 1Sleep Unit, Hospital Universitario Txagorritxu, Facultad de Medicina, Universidad del País Vasco, Vitoria 01009, Spain
  2. 2Department of Respiratory Medicine, IRBlleida, Lleida 25198, Spain
  3. 3Araba Research Unit, Hospital Universitario Txagorritxu
  4. 4Ciber de Epidemiología y Salud Pública (CiberEsp), Instituto de la Salud Carlos III, Madrid, Spain
  5. 5Sleep Unit, Department of Respiratory Medicine, Hospital Clínic de Barcelona, Barcelona 08036, Spain
  6. 6Ciber de Enfermedades Respiratorias (CibeRes), Instituto de la Salud Carlos III, Madrid
  7. 7Department of Respiratory and Sleep Medicine, Hospital General Yagüe, Burgos 09005, Spain
  8. 8Sleep Unit, Department of Respiratory Medicine, Hospital de Galdakano, Vizcaya 48960, Spain
  9. 9Department of Respiratory and Sleep Medicine, Hospital Universitario Marqués de Valdecilla, Santander 39008, Spain
  10. 10Sleep Unit. Department of Respiratory Medicine, Hospital Valle de Hebrón, Barcelona 08035
  11. 11Sleep Unit, Department of Respiratory Medicine, Hospital San Pedro de Alcántara, Cáceres 10003, Spain
  12. 12Sleep Unit, Department of Respiratory Medicine, Hospital Son Dureta, Palma de Mallorca 07014, Spain
  13. 13Sleep Unit, Department of Respiratory Medicine, Hospital Universitario Miguel Server, Zaragoza 50009, Spain
  14. 14Sleep Unit, Department of Respiratory Medicine, Hospital de San Pablo, Barcelona 08030
  1. Correspondence to: J Duran-Cantolla joaquin.durancantolla{at}gmail.com
  • Accepted 7 September 2010

Abstract

Objective To assess the effect of continuous positive airway pressure (CPAP) on 24 hour ambulatory blood pressure monitoring values in a large number of patients with untreated systemic hypertension of new onset and obstructive sleep apnoea.

Design Multicentre, double blind, randomised, placebo controlled trial.

Setting Eleven general hospitals in Spain between 2004 and 2007.

Participants 340 patients recently diagnosed as having systemic hypertension by a general practitioner (systolic blood pressure ≥140 mm Hg, diastolic blood pressure ≥90 mm Hg, or both) and an apnoea-hypopnoea index per hour of sleep of >15 events/hour.

Intervention Patients were assigned to CPAP (n=169) or sham CPAP (n=171) for three months.

Main outcome measurements Net changes in the different 24 hour ambulatory blood pressure monitoring values from baseline to three months of optimal or sham CPAP.

Results 277 (81%) of the 340 patients randomised were men; the patients had a mean age of 52.4 (SD 10.5) years, a body mass index of 31.9 (5.7), an Epworth sleepiness scale score of 10.1 (4.3), an apnoea-hypopnoea index of 43.5 (24.5). No differences between groups were seen at baseline. Compared with placebo and analysed by intention to treat, the mean 24 hour ambulatory blood pressure of the CPAP group decreased by 1.5 (95% confidence interval: 0.4 to 2.7) mm Hg (P=0.01). The mean 24 hour ambulatory blood pressure monitoring measures decreased by 2.1 mm Hg (0.4 to 3.7) mm Hg (P=0.01) for systolic pressure and 1.3 (0.2 to 2.3) mm Hg (P=0.02) for diastolic blood pressure. Mean nocturnal blood pressure decreased by 2.1 (0.5 to 3.6) mm Hg (P=0.01).

Conclusions CPAP produced a statistically significant reduction in blood pressure in patients with systemic hypertension and obstructive sleep apnoea. This reduction is small and did not achieve the 3 mm Hg drop in mean 24 hour ambulatory blood pressure that the trial was powered to detect. Consequently, these results may have uncertain clinical relevance. However, taking into account the prevalence of hypertension and the likelihood of comorbidities, the decrease in blood pressure, although minimal, may be beneficial.

Trial registration Clinical trials NCT00202527.

Footnotes

  • We thank Naiara Parraza and Patricia Amezua of Research Unit of Alava for advice on data analysis and preparation of the report.

  • Spanish Sleep and Breathing Group: Amanda López-Picado, pharmacist, Araba Research Unit, Hospital Universitario Txagorritxu, Vitoria; Erika Miranda-Serrano, statistician, Araba Research Unit, Hospital Universitario Txagorritxu; Cristina Martinez-Null, biologist, Sleep Unit, Hospital Universitario, Vitoria and Ciber de Enfermedades Respiratorias (CibeRes); Ramón Rubio, neurologist, Hospital Universitario Txagorritxu, Vitoria and CibeRes; Maria Luz Alonso, respiratory physician, Hospital General Yagüe, Burgos and CibeRes; José Cordero, epidemiologist, Hospital General Yagüe, Burgos; Cristobal Esteban, respiratory physician, Hospital de Galdakano, Vizcaya; Antonio Jiménez, respiratory physician, Hospital Universitario Marqués de Valdecilla, Santander; Maria Rosario Carpizo, neurophysiologist, Hospital Universitario Marqués de Valdecilla, Santander; Gabriel Sanpol, respiratory physician, Hospital Valle de Hebrón, Barcelona and CibeRes; Jaime Corral, respiratory physician, Hospital San Pedro de Alcántara, Cáceres and CibeRes; Manola Rubio, respiratory physician, Hospital San Pedro de Alcántara, Cáceres; Antonia Barceló, clinical analyst, Hospital Son Dureta, Palma de Mallorca and CibeRes; Javier Piérola, biologist, Hospital Son Dureta, Palma de Mallorca and CibeRes; José María Marín, respiratory physician, Hospital Universitario Miguel Servert, Zaragoza and CibeRes.

  • Contributors: JD-C coordinated the study and, with FA, Amanda López-Picado, Erika Miranda-Serrano, JMM, EB, and FB, collected, processed, and analysed the data. JD-C, FA, FB, and JMM designed the study and obtained funding. FA prepared the randomisation code. JD-C, FA, JMM, Erika Miranda-Serrano, JT-S, JIA, MG, PL, JFM, MDLP, SC, MM, and FB supervised the study. All authors contributed to the recruitment of patients and writing of the report. All authors drafted the manuscript, revised it critically for important intellectual content, and gave final approval of the version to be published. JD-C is the guarantor.

  • Funding: The study was sponsored by the Spanish Ministry of Health (PI041110), the Basque Government’s Department of Health (20031103), and the Spanish Respiratory Society (SEPAR 2005). The sponsors had no role in the design and conduct of the study; in the collection, analysis, and interpretation of the data; or in the preparation, review, and approval of the manuscript. The opinions, results, and conclusions are those of the authors.

  • Competing interests: All authors have completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare (1) No associations with any commercial entities that provided support for the work reported in the submitted manuscript; (2) No financial relationships with commercial entities that might have an interest in the submitted work; (3) No spouses, partners, or children under 18 years with relationships with commercial entities that might have an interest in the submitted work; (4) No non-financial interests that may be relevant to the submitted work.

  • Ethical approval: The human ethics committee of each hospital approved the study protocol, and all patients gave written informed consent.

  • Data sharing: No additional data available

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