Solriamfetol for the Treatment of Excessive Sleepiness in OSA: A Placebo-Controlled Randomized Withdrawal Study.

Abstract:

BACKGROUND:Excessive sleepiness (ES) is a common symptom of OSA, which often persists despite primary OSA therapy. This phase III randomized withdrawal trial evaluated solriamfetol (JZP-110) for the treatment of ES in adults with OSA. METHODS:After 2 weeks of clinical titration (n = 174) and 2 weeks of stable dose administration (n = 148), participants who reported improvement on the Patient Global Impression of Change (PGI-C) and had numerical improvements on the Maintenance of Wakefulness Test (MWT) and Epworth Sleepiness Scale (ESS) were randomly assigned to placebo (n = 62) or solriamfetol (n = 62) for 2 additional weeks. Coprimary end points were change from weeks 4 to 6 in MWT and ESS. RESULTS:In the modified intention-to-treat population (n = 122), MWT mean sleep latencies and ESS scores improved from baseline to week 4 (from 12.3-13.1 to 29.0-31.7 minutes and from 15.3-16.0 to 5.9-6.4, respectively). From weeks 4 to 6, participants treated with solriamfetol maintained improvements (least squares [LS] mean [SE] changes of -1.0 [1.4] minutes on MWT and -0.1 [0.7] on ESS), whereas participants treated with placebo worsened (LS mean [SE] change of -12.1 [1.3] minutes on MWT and 4.5 [0.7] on ESS); LS mean differences between treatments were 11.2 minutes (95% CI, 7.8-14.6) and -4.6 (95% CI, -6.4 to -2.8) on MWT and ESS, respectively. Fewer participants treated with solriamfetol reported worsening on the PGI-C from weeks 4 to 6 (20% vs 50%; P = .0005). Common adverse events included headache, dry mouth, nausea, dizziness, and insomnia. CONCLUSIONS:This study demonstrated maintenance of solriamfetol efficacy and safety over 6 weeks. TRIAL REGISTRY:ClinicalTrials.gov; No.: NCT02348619; URL: www.clinicaltrials.gov; EudraCT No.: 2014-005515-16.

journal_name

Chest

journal_title

Chest

authors

Strollo PJ Jr,Hedner J,Collop N,Lorch DG Jr,Chen D,Carter LP,Lu Y,Lee L,Black J,Pépin JL,Redline S,Tones 4 Study Investigators.

doi

10.1016/j.chest.2018.11.005

subject

Has Abstract

pub_date

2019-02-01 00:00:00

pages

364-374

issue

2

eissn

0012-3692

issn

1931-3543

pii

S0012-3692(18)32732-6

journal_volume

155

pub_type

杂志文章,随机对照试验

相关文献

CHEST文献大全
  • Heightened cough sensitivity secondary to latanoprost.

    abstract::Chronic cough is a common symptom with significant morbidity. We report a case of a 51-year-old woman who presented with chronic cough. She recently had received a diagnosis of glaucoma and had started receiving therapy with topical latanoprost. The onset of cough coincided with the use of latanoprost. We performed a ...

    journal_title:Chest

    pub_type: 杂志文章

    doi:10.1378/chest.09-0070

    authors: Fahim A,Morice AH

    更新日期:2009-11-01 00:00:00

  • A 3-month-old infant with recurrent apparent life-threatening events in a car seat.

    abstract::A 3-month-old infant was brought to clinic for evaluation of recurrent apparent life-threatening events (ALTEs). Two ALTE episodes occurred while the infant was sleeping in a safety car seat. The first one occurred when he was 4 weeks old. His mother noticed that he was not breathing; he appeared limp with full body c...

    journal_title:Chest

    pub_type: 杂志文章

    doi:10.1378/chest.14-1595

    authors: DelRosso LM

    更新日期:2015-04-01 00:00:00

  • Conventional vs endobronchial ultrasound-guided transbronchial needle aspiration: a randomized trial.

    abstract:STUDY OBJECTIVE:Our group performed a randomized trial to assess whether the addition of endobronchial ultrasound (EBUS) guidance will lead to better results than standard transbronchial needle aspiration (TBNS). EBUS guidance seems to be beneficial in increasing the yield of TBNA but has not been proven to be superior...

    journal_title:Chest

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1378/chest.125.1.322

    authors: Herth F,Becker HD,Ernst A

    更新日期:2004-01-01 00:00:00

  • The controversy of combination vs monotherapy in the treatment of hospitalized community-acquired pneumonia.

    abstract:BACKGROUND:The majority of community-acquired pneumonia (CAP) patients (about 80%) will be treated as outpatients, because therapy with a single agent will work. For the remaining 20% of patients requiring hospitalization, there is some growing debate regarding the efficacy of different management approaches. For hospi...

    journal_title:Chest

    pub_type: 杂志文章,评审

    doi:10.1378/chest.128.2.940

    authors: Weiss K,Tillotson GS

    更新日期:2005-08-01 00:00:00

  • Radiation exposure in standard and high-resolution chest CT scans.

    abstract::It has been suggested that radiation doses due to high-resolution computed tomography (HRCT) of the chest are considerably higher than those from conventional CT. We compared the effective dose (E, mSv) in conventional chest CT (10-mm contiguous slices) and HRCT (1.5-mm slices, gap 10 mm). In our study, the effective ...

    journal_title:Chest

    pub_type: 杂志文章

    doi:10.1378/chest.107.1.113

    authors: van der Bruggen-Bogaarts BA,Broerse JJ,Lammers JW,van Waes PF,Geleijns J

    更新日期:1995-01-01 00:00:00

  • Advanced emphysema in African-American and white patients: do differences exist?

    abstract:BACKGROUND:Emphysema is the only smoking-related disease in which white patients have higher prevalence and higher attributable mortality rates than African-American patients. Epidemiologic studies have not addressed, nor explained, the observed racial differences in emphysema. STUDY OBJECTIVES:To determine whether wh...

    journal_title:Chest

    pub_type: 杂志文章

    doi:10.1378/chest.130.1.108

    authors: Chatila WM,Hoffman EA,Gaughan J,Robinswood GB,Criner GJ,National Emphysema Treatment Trial Research Group.

    更新日期:2006-07-01 00:00:00

  • Results of long-term follow-up of photodynamic therapy for roentgenographically occult bronchogenic squamous cell carcinoma.

    abstract:BACKGROUND:Photodynamic therapy (PDT) is considered a useful and minimally invasive modality for treating centrally located early lung cancer. To date, there has been limited information on the long-term outcome of patients treated with PDT, especially those who are medically operable. METHODS:Beginning in 1994, patie...

    journal_title:Chest

    pub_type: 杂志文章

    doi:10.1378/chest.08-2237

    authors: Endo C,Miyamoto A,Sakurada A,Aikawa H,Sagawa M,Sato M,Saito Y,Kondo T

    更新日期:2009-08-01 00:00:00

  • The effect of pulmonary impairment on all-cause mortality in a national cohort.

    abstract::The association between pulmonary impairment and all-cause mortality was investigated among white subjects in a follow-up study of a large national cohort. Pulmonary function was measured during the National Health and Nutrition Examination Survey (NHANESI) (1971 to 1975); subsequent mortality information was obtained...

    journal_title:Chest

    pub_type: 杂志文章

    doi:10.1378/chest.103.2.536

    authors: Bang KM,Gergen PJ,Kramer R,Cohen B

    更新日期:1993-02-01 00:00:00

  • Pulmonary embolism among patients with a nearly normal ventilation/perfusion lung scan.

    abstract:BACKGROUND:Among patients with nearly normal ventilation/perfusion (V/Q) lung scans in the Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED), pulmonary embolism (PE) was diagnosed more frequently in those who underwent pulmonary angiography than in those in whom PE was diagnosed on the basis of an adve...

    journal_title:Chest

    pub_type: 杂志文章,多中心研究

    doi:10.1378/chest.110.2.395

    authors: Henry JW,Stein PD,Gottschalk A,Raskob GE

    更新日期:1996-08-01 00:00:00

  • Combined operations for lung volume reduction surgery and lung cancer.

    abstract::Fifty-three lung masses were found in 51 (16%) of 325 patients who underwent lung volume reduction surgery. This included 11 non-small cell lung cancers and 42 benign lung masses. Eleven patients (mean age, 69.4 years) underwent a combined lung volume reduction surgery and resection of clinical stage I lung cancers (l...

    journal_title:Chest

    pub_type: 杂志文章

    doi:10.1378/chest.110.4.885

    authors: McKenna RJ Jr,Fischel RJ,Brenner M,Gelb AF

    更新日期:1996-10-01 00:00:00

  • Early sepsis treatment with immunoglobulins after cardiac surgery in score-identified high-risk patients.

    abstract::In patients at risk for sepsis after cardiac surgery, the efficacy of intravenous immunoglobulin (Ig) treatment was compared with a historical control population, equivalent in patient characteristics and disease severity. Using APACHE II scores, especially in the high-risk group (IgG), we could discriminate between l...

    journal_title:Chest

    pub_type: 临床试验,杂志文章

    doi:10.1378/chest.105.1.76

    authors: Pilz G,Kreuzer E,Kääb S,Appel R,Werdan K

    更新日期:1994-01-01 00:00:00

  • A 78-Year-Old Man With Repeated Dyspnea and Neutrophilia in Peripheral Blood and BAL.

    abstract:CASE PRESENTATION:A 78-year-old man with asthma and COPD presented with shortness of breath, cough, and severe malaise for 4 days. Upon arrival, the patient was conscious and body temperature was 37.5°C. Arterial oxygen saturation (Spo2) was 80% on room air. Laboratory data demonstrated a WBC count of 17,400/μL (89.5% ...

    journal_title:Chest

    pub_type: 杂志文章

    doi:10.1016/j.chest.2019.07.034

    authors: Nakamatsu E,Morita T,Morishima A,Tagawa H,Furukawa M,Matsushita M,Yamane H

    更新日期:2020-01-01 00:00:00

  • A novel form of manually assisted ventilation.

    abstract::We report an individual with limb-girdle muscular dystrophy who has devised a way to assist her respiration by using her hands braced against the tray of her wheelchair. Utilizing this method, she was able to increase her tidal volume (VT) and lower her respiratory rate compared to unassisted spontaneous breathing, th...

    journal_title:Chest

    pub_type: 杂志文章

    doi:10.1378/chest.123.3.949

    authors: Stone AC,Nolan S,Abu-Hijleh M,McCool D,Hill NS

    更新日期:2003-03-01 00:00:00

  • Persistence of airway obstruction and hyperresponsiveness in subjects with asthma remission.

    abstract::This study was designed to determine if there is residual airflow obstruction and/or airway hyperresponsiveness in adults with symptomatic asthma remission, and if age at remission or its duration influence these parameters. We studied 30 subjects, (20 men, 10 women, 28 atopics, aged 18 to 61 years; mean, 32 years) wi...

    journal_title:Chest

    pub_type: 杂志文章

    doi:10.1378/chest.105.4.1024

    authors: Boulet LP,Turcotte H,Brochu A

    更新日期:1994-04-01 00:00:00

  • A 26-Year-Old Woman With a Small Right Lung and a Right-Sided Heart.

    abstract::A 26-year-old woman presented with abnormal findings on a chest radiograph. She had no significant history other than a fever 4 months prior to presentation that had resolved without a definite cause identified. She denied cough, shortness of breath, chest pain, history of smoking, environmental exposures, or prior pr...

    journal_title:Chest

    pub_type: 杂志文章

    doi:10.1016/j.chest.2015.08.023

    authors: Albores J,Smith MI

    更新日期:2016-03-01 00:00:00

  • Aerosol delivery during continuous nebulization.

    abstract:BACKGROUND AND OBJECTIVES:Continuous administration of aerosolized beta 2-agonists has been suggested as an effective treatment for severe reversible airways disease. To facilitate continuous therapy and avoid a feed system for small-volume nebulizers (SVNs), a large-volume medication nebulizer (Vortran HEART) was deve...

    journal_title:Chest

    pub_type: 杂志文章

    doi:10.1378/chest.111.5.1200

    authors: McPeck M,Tandon R,Hughes K,Smaldone GC

    更新日期:1997-05-01 00:00:00

  • Lung health in sawmill workers exposed to pine and spruce.

    abstract::Workers exposed to a variety of wood dusts have been shown to exhibit occupational asthma, lung function deficits, and elevated levels of respiratory symptoms. Despite the popularity of pine and spruce, the health effects of exposures to these woods have not been extensively investigated. A study was undertaken to inv...

    journal_title:Chest

    pub_type: 杂志文章

    doi:10.1378/chest.108.3.642

    authors: Hessel PA,Herbert FA,Melenka LS,Yoshida K,Michaelchuk D,Nakaza M

    更新日期:1995-09-01 00:00:00

  • Pleural effusion in Churg-Strauss syndrome.

    abstract::A 33-year-old man with a two-year history of asthma and sinusitis presented with wheezing, pleuritis, bilateral pleural effusions, and patchy basilar infiltrates on chest roentgenogram. Laboratory studies revealed peripheral blood eosinophilia, and pulmonary function studies showed an obstructive pattern which was bro...

    journal_title:Chest

    pub_type: 杂志文章

    doi:10.1378/chest.95.6.1357

    authors: Erzurum SC,Underwood GA,Hamilos DL,Waldron JA

    更新日期:1989-06-01 00:00:00

  • Crosslinking and carbohydrate studies on the hydroxylated glycopeptides which accumulate in alveoli and lamellar bodies.

    abstract::These data suggest that the alveolar lining layer and lamellar body membranes contain the same saline-insoluble proteins, two of which are unusual in that they contain hydroxyproline and large amounts of glycine. Neither the function nor the origin of these glycopeptides has been established, and we are currently eval...

    journal_title:Chest

    pub_type: 杂志文章

    doi:10.1378/chest.67.2_supplement.28s

    authors: Passero MA,Bhattacharyya SN,Sahu S,Lynn WS

    更新日期:1975-02-01 00:00:00

  • The acute effects of nasal positive pressure ventilation in patients with advanced cystic fibrosis.

    abstract:OBJECTIVE:To evaluate the acute effects of noninvasive positive pressure ventilation (NPPV) in patients with stable chronic respiratory failure secondary to cystic fibrosis. PATIENTS:Eight patients (29+/-5 years of age) with severe airflow limitation (mean FEV1, 24+/-3% predicted) and chronic respiratory failure (PaO2...

    journal_title:Chest

    pub_type: 杂志文章

    doi:10.1378/chest.113.4.1013

    authors: Granton JT,Kesten S

    更新日期:1998-04-01 00:00:00

  • Trends in the incidence and outcomes of disseminated intravascular coagulation in critically ill patients (2004-2010): a population-based study.

    abstract:BACKGROUND:The incidence and outcomes of disseminated intravascular coagulation (DIC) are incompletely defined. Therefore, we aimed to evaluate the trends in incidence and outcomes of critically ill patients with DIC. METHODS:We conducted a population-based, retrospective cohort study evaluating consecutively admitted...

    journal_title:Chest

    pub_type: 杂志文章

    doi:10.1378/chest.12-2112

    authors: Singh B,Hanson AC,Alhurani R,Wang S,Herasevich V,Cartin-Ceba R,Kor DJ,Gangat N,Li G

    更新日期:2013-05-01 00:00:00

  • Transbronchial fine needle aspiration of bronchogenic cysts.

    abstract::Transbronchial fine needle aspiration (TBFNA) was used to confirm the diagnosis of bronchogenic cyst in two asymptomatic patients with mediastinal masses who declined surgical exploration. Both masses were located subcarinally but differed in computed tomographic density (7 and 59 Hounsfield units). Aspirate cytology ...

    journal_title:Chest

    pub_type: 杂志文章

    doi:10.1378/chest.88.4.573

    authors: Schwartz DB,Beals TF,Wimbish KJ,Hammersley JR

    更新日期:1985-10-01 00:00:00

  • Determination of bronchodilation in the clinical pulmonary function laboratory. Role of changes in static lung volumes.

    abstract::Improved airway resistance following bronchodilator inhalation is not always accompanied by improvement in forced expiratory flow. We studied 241 patients with airways obstruction to learn whether changes in static lung volumes (vital capacity and function residual capacity measured by body plethysmography [FRCB]) wou...

    journal_title:Chest

    pub_type: 杂志文章

    doi:10.1378/chest.76.6.622

    authors: Ramsdell JW,Tisi GM

    更新日期:1979-12-01 00:00:00

  • Portable monitors in the diagnosis of obstructive sleep apnea.

    abstract::The use of portable monitors (PM) devices has been demonstrated in a wide variety of investigational settings with varying results. While most devices correlate very well with in-laboratory polysomnography, some still misclassify a significant numbers of patients and have lower sensitivity. In addition, the failure ra...

    journal_title:Chest

    pub_type: 杂志文章,评审

    doi:10.1378/chest.06-2793

    authors: Ahmed M,Patel NP,Rosen I

    更新日期:2007-11-01 00:00:00

  • Interpreting periodic lung function tests in individuals: the relationship between 1- to 5-year and long-term FEV1 changes.

    abstract:STUDY OBJECTIVE:Spirometry is performed to monitor lung health, but variability between tests can hinder recognition of excessive FEV(1) declines. We sought to describe the relationship between FEV(1) changes over 1 to 5 years and FEV(1) declines over longer terms, using 21,821 test results from 1,884 workers who parti...

    journal_title:Chest

    pub_type: 杂志文章

    doi:10.1378/chest.130.2.493

    authors: Wang ML,Avashia BH,Petsonk EL

    更新日期:2006-08-01 00:00:00

  • Improved left ventricular relaxation during short-term right ventricular outflow tract compared to apical pacing.

    abstract:STUDY OBJECTIVES:Pacing-induced asynchrony may deteriorate left ventricular function; however, limited data exists in humans. The aim of our study was to compare left ventricular hemodynamics during short-term atrioventricular sequential pacing from the right ventricular apex and from the outflow tract of the right ven...

    journal_title:Chest

    pub_type: 杂志文章

    doi:10.1378/chest.117.1.60

    authors: Kolettis TM,Kyriakides ZS,Tsiapras D,Popov T,Paraskevaides IA,Kremastinos DT

    更新日期:2000-01-01 00:00:00

  • Discontinuing mechanical ventilatory support.

    abstract::The ventilator discontinuation process is a critical component of ICU care. Ongoing ventilator dependency is caused by both disease factors (eg, respiratory, cardiac, metabolic, and neuromuscular) and clinician management factors (eg, failing to recognize discontinuation potential and inappropriate ventilator settings...

    journal_title:Chest

    pub_type: 杂志文章,评审

    doi:10.1378/chest.06-2862

    authors: MacIntyre N

    更新日期:2007-09-01 00:00:00

  • Coronary artery bypass performed without the use of cardiopulmonary bypass is associated with reduced cerebral microemboli and improved clinical results.

    abstract:STUDY OBJECTIVES:Strokes and neurocognitive dysfunction have been correlated with cerebral microemboli produced during cardiopulmonary bypass (CPB). The purpose of this study was to determine whether, and to what extent, off-pump coronary artery bypass (OPCAB) reduces the occurrence of cerebral microemboli compared wit...

    journal_title:Chest

    pub_type: 杂志文章

    doi:10.1378/chest.119.1.25

    authors: Bowles BJ,Lee JD,Dang CR,Taoka SN,Johnson EW,Lau EM,Nekomoto K

    更新日期:2001-01-01 00:00:00

  • Sputum cathelicidin, urokinase plasminogen activation system components, and cytokines discriminate cystic fibrosis, COPD, and asthma inflammation.

    abstract:BACKGROUND:Interest in airways inflammatory disease has increasingly focused on innate immunity. We investigated several components of innate immunity in induced sputum of patients with cystic fibrosis (CF), COPD, and asthma, and healthy control subjects. METHODS:Twenty eight patients with mild CF lung disease (age > ...

    journal_title:Chest

    pub_type: 杂志文章

    doi:10.1378/chest.128.4.2316

    authors: Xiao W,Hsu YP,Ishizaka A,Kirikae T,Moss RB

    更新日期:2005-10-01 00:00:00

  • Admission hyperglycemia and other risk factors as predictors of hospital mortality in a medical ICU population.

    abstract:BACKGROUND:Tight glycemic control is recommended for patients in the ICU, as hyperglycemia is associated with increased morbidity and mortality. DESIGN:Observational cohort of patients admitted to a 12-bed, inner-city, medical ICU (MICU). SUBJECTS:A total of 1,185 of 1,506 patients from July 1, 1999, to December 31, ...

    journal_title:Chest

    pub_type: 杂志文章

    doi:10.1378/chest.128.5.3109

    authors: Freire AX,Bridges L,Umpierrez GE,Kuhl D,Kitabchi AE

    更新日期:2005-11-01 00:00:00