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Thorax ; 71(10): 899-906, 2016 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-27406165

RESUMO

BACKGROUND: Non-invasive ventilation (NIV) is an effective form of treatment in patients with obesity hypoventilation syndrome (OHS) who have concomitant severe obstructive sleep apnoea (OSA). However, there is a paucity of evidence on the efficacy of NIV in patients with OHS without severe OSA. We performed a multicentre randomised clinical trial to determine the comparative efficacy of NIV versus lifestyle modification (control group) using daytime arterial carbon dioxide tension (PaCO2) as the main outcome measure. METHODS: Between May 2009 and December 2014 we sequentially screened patients with OHS without severe OSA. Participants were randomised to NIV versus lifestyle modification and were followed for 2 months. Arterial blood gas parameters, clinical symptoms, health-related quality of life assessments, polysomnography, spirometry, 6-min walk distance test, blood pressure measurements and healthcare resource utilisation were evaluated. Statistical analysis was performed using intention-to-treat analysis. RESULTS: A total of 365 patients were screened of whom 58 were excluded. Severe OSA was present in 221 and the remaining 86 patients without severe OSA were randomised. NIV led to a significantly larger improvement in PaCO2 of -6 (95% CI -7.7 to -4.2) mm Hg versus -2.8 (95% CI -4.3 to -1.3) mm Hg, (p<0.001) and serum bicarbonate of -3.4 (95% CI -4.5 to -2.3) versus -1 (95% CI -1.7 to -0.2 95% CI)  mmol/L (p<0.001). PaCO2 change adjusted for NIV compliance did not further improve the inter-group statistical significance. Sleepiness, some health-related quality of life assessments and polysomnographic parameters improved significantly more with NIV than with lifestyle modification. Additionally, there was a tendency towards lower healthcare resource utilisation in the NIV group. CONCLUSIONS: NIV is more effective than lifestyle modification in improving daytime PaCO2, sleepiness and polysomnographic parameters. Long-term prospective studies are necessary to determine whether NIV reduces healthcare resource utilisation, cardiovascular events and mortality. TRIAL REGISTRATION NUMBER: NCT01405976; results.


Assuntos
Ventilação não Invasiva/métodos , Síndrome de Hipoventilação por Obesidade/terapia , Idoso , Idoso de 80 Anos ou mais , Pressão Sanguínea/fisiologia , Dióxido de Carbono/sangue , Feminino , Volume Expiratório Forçado/fisiologia , Humanos , Estilo de Vida , Masculino , Pessoa de Meia-Idade , Síndrome de Hipoventilação por Obesidade/complicações , Síndrome de Hipoventilação por Obesidade/fisiopatologia , Pressão Parcial , Polissonografia , Testes de Função Respiratória/métodos , Apneia Obstrutiva do Sono/complicações , Resultado do Tratamento , Capacidade Vital/fisiologia
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