000148095 001__ 148095
000148095 005__ 20250114155432.0
000148095 0247_ $$2doi$$a10.1016/j.chest.2020.03.068
000148095 0248_ $$2sideral$$a119729
000148095 037__ $$aART-2020-119729
000148095 041__ $$aeng
000148095 100__ $$aQuiroga, M.S.
000148095 245__ $$aLong-Term Noninvasive Ventilation in Obesity Hypoventilation Syndrome Without Severe Obstructive Sleep Apnoea. The Pickwick Randomised Controlled Trial
000148095 260__ $$c2020
000148095 5060_ $$aAccess copy available to the general public$$fUnrestricted
000148095 5203_ $$aBackground: Noninvasive ventilation (NIV) is an effective form of treatment in obesity hypoventilation syndrome (OHS) with severe OSA. However, there is paucity of evidence in patients with OHS without severe OSA phenotype. Research question: Is NIV effective in OHS without severe OSA phenotype? Study design and methods: In this multicenter, open-label parallel group clinical trial performed at 16 sites in Spain, we randomly assigned 98 stable ambulatory patients with untreated OHS and apnea-hypopnea index < 30 events/h (ie, no severe OSA) to NIV or lifestyle modification (control group) using simple randomization through an electronic database. The primary end point was hospitalization days per year. Secondary end points included other hospital resource utilization, incident cardiovascular events, mortality, respiratory functional tests, BP, quality of life, sleepiness, and other clinical symptoms. Both investigators and patients were aware of the treatment allocation; however, treating physicians from the routine care team were not aware of patients'' enrollment in the clinical trial. The study was stopped early in its eighth year because of difficulty identifying patients with OHS without severe OSA. The analysis was performed according to intention-to-treat and per-protocol principles and by adherence subgroups. Results: Forty-nine patients in the NIV group and 49 in the control group were randomized, and 48 patients in each group were analyzed. During a median follow-up of 4.98 years (interquartile range, 2.98-6.62), the mean hospitalization days per year ± SD was 2.60 ± 5.31 in the control group and 2.71 ± 4.52 in the NIV group (adjusted rate ratio, 1.07; 95% CI, 0.44-2.59; P = .882). NIV therapy, in contrast with the control group, produced significant longitudinal improvement in Paco2, pH, bicarbonate, quality of life (Medical Outcome Survey Short Form 36 physical component), and daytime sleepiness. Moreover, per-protocol analysis showed a statistically significant difference for the time until the first ED visit favoring NIV. In the subgroup with high NIV adherence, the time until the first event of hospital admission, ED visit, and mortality was longer than in the low adherence subgroup. Adverse events were similar between arms. Interpretation: In stable ambulatory patients with OHS without severe OSA, NIV and lifestyle modification had similar long-term hospitalization days per year. A more intensive program aimed at improving NIV adherence may lead to better outcomes. Larger studies are necessary to better determine the long-term benefit of NIV in this subgroup of OHS.
000148095 540__ $$9info:eu-repo/semantics/openAccess$$aby-nc-nd$$uhttp://creativecommons.org/licenses/by-nc-nd/3.0/es/
000148095 590__ $$a21.405$$b2020
000148095 591__ $$aCRITICAL CARE MEDICINE$$b2 / 36 = 0.056$$c2020$$dQ1$$eT1
000148095 591__ $$aRESPIRATORY SYSTEM$$b2 / 64 = 0.031$$c2020$$dQ1$$eT1
000148095 592__ $$a6.272$$b2020
000148095 593__ $$aPulmonary and Respiratory Medicine$$c2020$$dQ1
000148095 593__ $$aCritical Care and Intensive Care Medicine$$c2020$$dQ1
000148095 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion
000148095 700__ $$aMasa, J.F.
000148095 700__ $$aBenitez, I.
000148095 700__ $$ade Terreros, F.G.
000148095 700__ $$aPenafiel, J.C.
000148095 700__ $$aRomero, A.
000148095 700__ $$aEraso, C.C.
000148095 700__ $$aAlvarez, M.A.
000148095 700__ $$aOrdax, E.
000148095 700__ $$aGarcia, T.G.
000148095 700__ $$aGonzalez, M.
000148095 700__ $$aMartin, S.L.
000148095 700__ $$0(orcid)0000-0001-9096-2294$$aMarin, J.M.$$uUniversidad de Zaragoza
000148095 700__ $$aMarti, S.
000148095 700__ $$aCambriles, T.D.
000148095 700__ $$aChiner, E.
000148095 700__ $$aSantaolalla, C.E.
000148095 700__ $$aBarca, J.
000148095 700__ $$aPolo, F.V.
000148095 700__ $$aNegrin, M.
000148095 700__ $$aEscobar, M.M.
000148095 700__ $$aBarbe, F.
000148095 700__ $$aMokhlesi, B.
000148095 7102_ $$11007$$2610$$aUniversidad de Zaragoza$$bDpto. Medicina, Psiqu. y Derm.$$cArea Medicina
000148095 773__ $$g158, 3 (2020), 1176-1186$$pAm. j. respir. crit. care med.$$tAmerican Journal of Respiratory and Critical Care Medicine$$x1073-449X
000148095 8564_ $$s450113$$uhttps://zaguan.unizar.es/record/148095/files/texto_completo.pdf$$yVersión publicada
000148095 8564_ $$s2218935$$uhttps://zaguan.unizar.es/record/148095/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada
000148095 909CO $$ooai:zaguan.unizar.es:148095$$particulos$$pdriver
000148095 951__ $$a2025-01-13-14:27:43
000148095 980__ $$aARTICLE