RT Journal Article
T1 Long-term Noninvasive Ventilation in Obesity Hypoventilation Syndrome Without Severe OSA: The Pickwick Randomized Controlled Trial.
A1 Masa, Juan F
A1 Benítez, Iván
A1 Sánchez-Quiroga, Maria Á
A1 Gomez de Terreros, Francisco J
A1 Corral, Jaime
A1 Romero, Auxiliadora
A1 Caballero-Eraso, Candela
A1 Alonso-Álvarez, Maria L
A1 Ordax-Carbajo, Estrella
A1 Gomez-Garcia, Teresa
A1 González, Mónica
A1 López-Martín, Soledad
A1 Marin, José M
A1 Martí, Sergi
A1 Díaz-Cambriles, Trinidad
A1 Chiner, Eusebi
A1 Egea, Carlos
A1 Barca, Javier
A1 Vázquez-Polo, Francisco J
A1 Negrín, Miguel A
A1 Martel-Escobar, María
A1 Barbé, Ferrán
A1 Mokhlesi, Babak
A1 Spanish Sleep Network, 
K1 CPAP
K1 noninvasive ventilation
K1 obesity hypoventilation syndrome
K1 sleep apnea
AB 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. Is NIV effective in OHS without severe OSA phenotype? 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  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. 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. ClinicalTrials.gov; No.: NCT01405976; URL: www.clinicaltrials.gov.
YR 2020
FD 2020-04-25
LK http://hdl.handle.net/10668/15452
UL http://hdl.handle.net/10668/15452
LA en
DS RISalud
RD Apr 19, 2025