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Title: Long-term noninvasive ventilation in obesity hypoventilation Syndrome Without Severe OSA: The pickwick randomized controlled trial
Authors: Masa, Juan F.
Benítez, Iván
Sánchez-Quiroga, Maria
Gomez de Terreros, Francisco J.
Corral, Jaime
Romero, Auxiliadora
Caballero-Eraso, Candela
Alonso-Álvarez, Maria L.
Ordax-Carbajo, Estrella
Gomez-Garcia, Teresa
González, Mónica
López-Martín, Soledad
Marin, José M.
Martí, Sergi
Díaz-Cambriles, Trinidad
Chiner, Eusebi
Egea, Carlos
Barca, Javier
Vázquez Polo, Francisco José 
Negrín Hernández, Miguel Ángel 
Martel Escobar, María Carmen 
Barbé, Ferrán
Mokhlesi, Babak
Riesco, Juan A.
González-Mangado, Nicolás
Troncoso, Maria F.
Martinez-Martinez, Maria A.
Ojeda-Castillejo, Elena
López-Padilla, Daniel
Carrizo, Santiago J.
Gallego, Begoña
Pallero, Mercedes
Romero, Odile
Ramón, Maria A.
Arias, Eva
Muñoz-Méndez, Jesús
Senent, Cristina
Sancho-Chust, Jose N.
Navarro-Soriano, Nieves B.
Barrot, Emilia
Benítez, José M.
Sanchez-Gómez, Jesús
Golpe, Rafael
Gómez-Mendieta, María A.
Gomez, Silvia
Bengoa, Mónica
UNESCO Clasification: 32 Ciencias médicas
Keywords: CPAP
Noninvasive Ventilation
Obesity Hypoventilation Syndrome
Sleep Apnea
Issue Date: 2020
Project: PI050402
Journal: Chest (American College of Chest Physicians) 
Abstract: Background: 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.
ISSN: 0012-3692
DOI: 10.1016/j.chest.2020.03.068
Source: Chest [ISSN 0012-3692], v. 158 (3), p. 1176-1186, (Septiembre 2020)
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