000148687 001__ 148687 000148687 005__ 20250123145735.0 000148687 0247_ $$2doi$$a10.1016/S0140-6736(18)32978-7 000148687 0248_ $$2sideral$$a112226 000148687 037__ $$aART-2019-112226 000148687 041__ $$aeng 000148687 100__ $$aMasa, J.F 000148687 245__ $$aLong-term clinical effectiveness of continuous positive airway pressure therapy versus non-invasive ventilation therapy in patients with obesity hypoventilation syndrome: a multicentre, open-label, randomised controlled trial 000148687 260__ $$c2019 000148687 5060_ $$aAccess copy available to the general public$$fUnrestricted 000148687 5203_ $$aBackground Obesity hypoventilation syndrome is commonly treated with continuous positive airway pressure or noninvasive ventilation during sleep. Non-invasive ventilation is more complex and costly than continuous positive airway pressure but might be advantageous because it provides ventilatory support. To date there have been no longterm trials comparing these treatment modalities. We therefore aimed to determine the long-term comparative effectiveness of both treatment modalities. Methods We did a multicentre, open-label, randomised controlled trial at 16 clinical sites in Spain. We included patients aged 15-80 years with untreated obesity hypoventilation syndrome and an apnoea-hypopnoea index of 30 or more events per h. We randomly assigned patients, using simple randomisation through an electronic database, to receive treatment with either non-invasive ventilation or continuous positive airway pressure. Both investigators and patients were aware of the treatment allocation. The research team was not involved in deciding hospital treatment, duration of treatment in the hospital, and adjustment of medications, as well as adjudicating cardiovascular events or cause of mortality. Treating clinicians from the routine care team were not aware of the treatment allocation. The primary outcome was the number of hospitalisation days per year. The analysis was done according to the intention-to-treat principle. This study is registered with ClinicalTrials. gov, number NCT01405976. Findings From May 4, 2009, to March 25, 2013, 100 patients were randomly assigned to the non-invasive ventilation group and 115 to the continuous positive airway pressure group, of which 97 patients in the non-invasive ventilation group and 107 in the continuous positive airway pressure group were included in the analysis. The median follow-up was 5.44 years (IQR 4.45-6.37) for all patients, 5.37 years (4.36-6.32) in the continuous positive airway pressure group, and 5.55 years (4.53-6.50) in the non-invasive ventilation group. The mean hospitalisation days per patient-year were 1.63 (SD 3.74) in the continuous positive airway pressure group and 1.44 (3.07) in the non-invasive ventilation group (adjusted rate ratio 0.78, 95% CI 0.34-1.77; p= 0.561). Adverse events were similar between both groups. Interpretation In stable patients with obesity hypoventilation syndrome and severe obstructive sleep apnoea, noninvasive ventilation and continuous positive airway pressure have similar long-term effectiveness. Given that continuous positive airway pressure has lower complexity and cost, continuous positive airway pressure might be the preferred first-line positive airway pressure treatment modality until more studies become available. 000148687 536__ $$9info:eu-repo/grantAgreement/ES/ISCIII/PI050402 000148687 540__ $$9info:eu-repo/semantics/openAccess$$aby-nc-nd$$uhttp://creativecommons.org/licenses/by-nc-nd/3.0/es/ 000148687 590__ $$a60.392$$b2019 000148687 591__ $$aMEDICINE, GENERAL & INTERNAL$$b2 / 165 = 0.012$$c2019$$dQ1$$eT1 000148687 592__ $$a14.554$$b2019 000148687 593__ $$aMedicine (miscellaneous)$$c2019$$dQ1 000148687 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/acceptedVersion 000148687 700__ $$aMokhlesi, B 000148687 700__ $$aBenitez, I 000148687 700__ $$ade Terreros, F.J.G 000148687 700__ $$aSanchez-Quiroga, M.A 000148687 700__ $$aRomero, A 000148687 700__ $$aCaballero-Eraso, C 000148687 700__ $$aTeran-Santos, J 000148687 700__ $$aAlonso-Alvarez, M.L 000148687 700__ $$aTroncoso, M.F 000148687 700__ $$aGonzalez, M 000148687 700__ $$aLopez-Martin, S 000148687 700__ $$0(orcid)0000-0001-9096-2294$$aMarin, J.M$$uUniversidad de Zaragoza 000148687 700__ $$aMarti, S 000148687 700__ $$aDiaz-Cambriles, T 000148687 700__ $$aChiner, E 000148687 700__ $$aEgea, C 000148687 700__ $$aBarca, J 000148687 700__ $$aVazquez-Polo, F.J 000148687 700__ $$aNegrin, M.A 000148687 700__ $$aMartel-Escobar, M 000148687 700__ $$aBarbe, F 000148687 700__ $$aCorral, J 000148687 700__ $$aFernandez, G 000148687 700__ $$aOrdax-Carbajo, E 000148687 700__ $$aGonzalez-Mangado, N 000148687 700__ $$aGomez-Garcia, T 000148687 700__ $$aMartinez-Martinez, M.A 000148687 700__ $$aOjeda-Castillejo, E 000148687 700__ $$aPadilla, D.L 000148687 700__ $$aCarrizo, P.J 000148687 700__ $$aGallego, B 000148687 700__ $$aPallero, M 000148687 700__ $$aRomero, O 000148687 700__ $$aRamon, M.A 000148687 700__ $$aArias, E 000148687 700__ $$aMunoz-Mendez, J 000148687 700__ $$aSenent, C 000148687 700__ $$aSancho-Chust, J.N 000148687 700__ $$aSoriano, N.B.N 000148687 700__ $$aBarrot, E 000148687 700__ $$aBenitez, J.M 000148687 700__ $$aSanchez-Gomez, J 000148687 700__ $$aGolpe, R 000148687 700__ $$aSantiago-Recuerda, A 000148687 700__ $$aGomez, S 000148687 700__ $$aBengoa, M. 000148687 7102_ $$11007$$2610$$aUniversidad de Zaragoza$$bDpto. Medicina, Psiqu. y Derm.$$cArea Medicina 000148687 773__ $$g393, 10182 (2019), 1721-1732$$pLancet$$tThe Lancet$$x0140-6736 000148687 8564_ $$s564078$$uhttps://zaguan.unizar.es/record/148687/files/texto_completo.pdf$$yPostprint 000148687 8564_ $$s2487268$$uhttps://zaguan.unizar.es/record/148687/files/texto_completo.jpg?subformat=icon$$xicon$$yPostprint 000148687 909CO $$ooai:zaguan.unizar.es:148687$$particulos$$pdriver 000148687 951__ $$a2025-01-23-14:55:12 000148687 980__ $$aARTICLE