Long-term Noninvasive Ventilation in Obesity Hypoventilation Syndrome Without Severe OSA The Pickwick Randomized Controlled Trial
Por:
Masa, J, Benitez, I, Sanchez-Quiroga, M, de Terreros, F, Corral, J, Romero, A, Caballero-Eraso, C, Alonso-Alvarez, M, Ordax-Carbajo, E, Gomez-Garcia, T, Gonzalez, M, Lopez-Martin, S, Marin, J, Marti, S, Diaz-Cambriles, T, Chiner, E, Egea, C, Barca, J, Vazquez-Polo, F, Negrin, M, Martel-Escobar, M, Barbe, F, Mokhlesi, B and Spanish Sleep Network
Publicada:
1 sep 2020
Resumen:
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 1/4 .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.
Filiaciones:
Masa, J:
San Pedro Althntara Hosp, Resp Dept, Caceres, Spain
CIBER Enfermedades Resp CIBERES, Madrid, Spain
Inst Univ Invest Biosanitaria Extremadura INUBE, Badajoz, Spain
Benitez, I:
CIBER Enfermedades Resp CIBERES, Madrid, Spain
Inst Recerca Biomed LLeida IRBLLEIDA, Lleida, Spain
Sanchez-Quiroga, M:
CIBER Enfermedades Resp CIBERES, Madrid, Spain
Inst Univ Invest Biosanitaria Extremadura INUBE, Badajoz, Spain
Virgen del Puerto Hosp, Resp Dept, Plasencia, Caceres, Spain
de Terreros, F:
San Pedro Althntara Hosp, Resp Dept, Caceres, Spain
CIBER Enfermedades Resp CIBERES, Madrid, Spain
Inst Univ Invest Biosanitaria Extremadura INUBE, Badajoz, Spain
Corral, J:
San Pedro Althntara Hosp, Resp Dept, Caceres, Spain
CIBER Enfermedades Resp CIBERES, Madrid, Spain
Inst Univ Invest Biosanitaria Extremadura INUBE, Badajoz, Spain
Romero, A:
CIBER Enfermedades Resp CIBERES, Madrid, Spain
Hosp Univ Virgen del Rocio, Inst Biomed Sevilla IBiS, Unidad Med Quirurg Enfermedades Resp, Seville, Spain
Caballero-Eraso, C:
CIBER Enfermedades Resp CIBERES, Madrid, Spain
Hosp Univ Virgen del Rocio, Inst Biomed Sevilla IBiS, Unidad Med Quirurg Enfermedades Resp, Seville, Spain
Alonso-Alvarez, M:
CIBER Enfermedades Resp CIBERES, Madrid, Spain
Univ Hosp, Resp Dept, Burgos, Spain
Ordax-Carbajo, E:
CIBER Enfermedades Resp CIBERES, Madrid, Spain
Univ Hosp, Resp Dept, Burgos, Spain
Gomez-Garcia, T:
CIBER Enfermedades Resp CIBERES, Madrid, Spain
IIS Fdn Jimenez Diaz, Resp Dept, Madrid, Spain
Gonzalez, M:
Valdecilla Hosp, Resp Dept, Santander, Spain
Lopez-Martin, S:
CIBER Enfermedades Resp CIBERES, Madrid, Spain
Gregorio Maranon Hosp, Resp Dept, Madrid, Spain
Marin, J:
CIBER Enfermedades Resp CIBERES, Madrid, Spain
Miguel Servet Hosp, Resp Dept, Zaragoza, Spain
Marti, S:
Vall dHebron Hosp, Resp Dept, Barcelona, Spain
Diaz-Cambriles, T:
CIBER Enfermedades Resp CIBERES, Madrid, Spain
Doce Octubre Hosp, Resp Dept, Madrid, Spain
:
San Juan Hosp, Resp Dept, Alicante, Spain
Egea, C:
CIBER Enfermedades Resp CIBERES, Madrid, Spain
Alava Univ Hosp IRB, Resp Dept, Vitoria, Spain
Barca, J:
Inst Univ Invest Biosanitaria Extremadura INUBE, Badajoz, Spain
Extremadura Univ, Nursing Dept, Caceres, Spain
Vazquez-Polo, F:
Las Palmas de Gran Canaria Univ, Dept Quantitat Methods, Canary Isl, Spain
Negrin, M:
Las Palmas de Gran Canaria Univ, Dept Quantitat Methods, Canary Isl, Spain
Martel-Escobar, M:
Las Palmas de Gran Canaria Univ, Dept Quantitat Methods, Canary Isl, Spain
Barbe, F:
CIBER Enfermedades Resp CIBERES, Madrid, Spain
Inst Recerca Biomed LLeida IRBLLEIDA, Lleida, Spain
Mokhlesi, B:
Univ Chicago, Dept Med Pulm & Crit Care, Chicago, IL 60637 USA
hybrid, Green Published
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