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


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; No.: NCT02348619; URL:; EudraCT No.: 2014-005515-16.






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.




Has Abstract


2019-02-01 00:00:00
















  • The role of hypovolemic stress in the production of fat embolism in rabbits. 1. Morphologic alterations of the lungs.

    abstract::In rabbits, an experimental model of fat embolism was produced that simulates the course of events in the clinical situation. Small doses of fat-cell suspension (0.075 ml/kg of body weight), prepared by collagenase treatment of homologous adipose tissue, were injected intravenously. Concomitantly, hypovolemia was prod...


    pub_type: 杂志文章


    authors: Cotev S,Rosenmann E,Eyal Z,Weinberg H,Shafrir E,Davidson JT

    更新日期:1976-04-01 00:00:00

  • A test of the practical value of estimating breath sound intensity. Breath sounds related to measured ventilatory function.

    abstract::Each of four examiners performed standardized physical examinations on a group of patients who had just undergone tests of ventilatory function. The intensity of breath sounds heard with deep inspiration was graded on a rating scale of 0 to 4; the grades in six areas of the chest were added to give a total score, with...


    pub_type: 杂志文章


    authors: Pardee NE,Martin CJ,Morgan EH

    更新日期:1976-09-01 00:00:00

  • Successful pulmonary thromboendarterectomy in a patient with Klippel-Trenaunay syndrome.

    abstract::Klippel-Trenaunay syndrome (KTS) is a congenital disorder characterized by a triad of cutaneous vascular nevi, soft tissue or bony hypertrophy, and varicose veins or venous malformations involving one or more extremities. An incidence of venous thromboembolism of up to 22% has been reported in this disorder. Also repo...


    pub_type: 杂志文章


    authors: Walder B,Kapelanski DP,Auger WR,Fedullo PF

    更新日期:2000-05-01 00:00:00

  • Perceptions of prognosis, treatment, and treatment impact on prognosis in non-small cell lung cancer.

    abstract:STUDY OBJECTIVES:We designed and performed a survey to assess the roles and knowledge level of physicians, by specialty, in the management of non-small cell lung cancer (NSCLC). The primary objective was to evaluate the potential variability of physician perceptions of prognosis, recommended treatments, and the impact ...


    pub_type: 杂志文章


    authors: Perez EA

    更新日期:1998-08-01 00:00:00

  • A new treatment strategy for advanced idiopathic interstitial pneumonia: living-donor lobar lung transplantation.

    abstract:BACKGROUND:Among patients awaiting cadaveric lung transplantation, patients with idiopathic interstitial pneumonia (IIP) have been demonstrated to have the highest mortality rate. Contraindications to cadaveric lung transplantation include current high-dose systemic corticosteroid therapy because it may increase airway...


    pub_type: 杂志文章


    authors: Date H,Tanimoto Y,Goto K,Yamadori I,Aoe M,Sano Y,Shimizu N

    更新日期:2005-09-01 00:00:00

  • Surfactant replacement therapy.

    abstract::Surfactant replacement therapy (SRT) has a proven role in the treatment of neonatal respiratory distress syndrome and severe meconium aspiration syndrome in infants, and may have a role in the treatment of pediatric patients with ARDS. Although newer delivery mechanisms and strategies are being studied, the classic su...


    pub_type: 杂志文章,评审


    authors: Stevens TP,Sinkin RA

    更新日期:2007-05-01 00:00:00

  • The effects of helium-hyperoxia on 6-min walking distance in COPD: a randomized, controlled trial.

    abstract:BACKGROUND:We hypothesized that breathing helium-hyperoxia (HeO2) would significantly improve 6-min walking test (6MWT) distance in COPD subjects. METHODS:This was a blinded, randomized crossover study. At visit 1, we assessed pulmonary function, exercise capacity, and 6MWT distance. Visits 2 and 3 consisted of four 6...


    pub_type: 杂志文章,随机对照试验


    authors: Marciniuk DD,Butcher SJ,Reid JK,MacDonald GF,Eves ND,Clemens R,Jones RL

    更新日期:2007-06-01 00:00:00

  • Does delayed correction interfere with pulmonary functions and exercise tolerance in patients with tetralogy of fallot?

    abstract:STUDY OBJECTIVES:To assess exercise tolerance and determine the distinct role of cardiac, respiratory, or peripheral factors on it after delayed surgical repair in patients with tetralogy of Fallot. DESIGN:The aerobic exercise capacity of 15 adult patients (mean [+/- SD] age, 21 +/- 6; age range, 9 to 30 years) underg...


    pub_type: 杂志文章


    authors: Ercisli M,Vural KM,Gokkaya KN,Koseoglu F,Tufekcioglu O,Sener E,Tasdemir O

    更新日期:2005-08-01 00:00:00

  • The clinical utility of flexible bronchoscopy in the evaluation of chronic cough.

    abstract:STUDY OBJECTIVES:To assess the clinical utility of flexible bronchoscopy (FB) in the evaluation of patients with chronic cough and normal or nonlocalizing chest radiographic findings. DESIGN:Retrospective chart review. SETTING:Tertiary referral center. PATIENTS:Forty-eight patients with chronic cough and no other cl...


    pub_type: 杂志文章


    authors: Barnes TW,Afessa B,Swanson KL,Lim KG

    更新日期:2004-07-01 00:00:00

  • Prevalence of physician-diagnosed COPD and its association with smoking among urban and rural residents in regional mainland China.

    abstract:OBJECTIVES:To investigate the prevalence of physician-diagnosed COPD and to explore the relationship between the total amount of cigarettes smoked (TACS) and COPD among urban and rural adults in Nanjing, China. DESIGN:Population-based, cross-sectional study conducted between October 2000 and March 2001. SETTING:Admin...


    pub_type: 杂志文章


    authors: Xu F,Yin X,Zhang M,Shen H,Lu L,Xu Y

    更新日期:2005-10-01 00:00:00

  • Patent ductus arteriosus with hypoplastic lung.

    abstract::A median sternotomy approach was used for closure of patent ductus arteriosus associated with a hypoplastic right lung. The anterior approach to the left ductus is indicated if left thoracotomy is contraindicated. ...


    pub_type: 杂志文章


    authors: Rao B,Gootman N,Silbert D,Wisoff BG

    更新日期:1976-06-01 00:00:00

  • Pleural Myiasis Associated With Pleural Angiosarcoma.

    abstract::Myiasis refers to a parasitic infestation of vertebrate mammals by dipterous larvae (maggots) of higher flies. Infections in humans typically occur in tropical and subtropical regions, regions with limited medical access, and areas with poor hygiene and living conditions. Infestations in humans have been described in ...


    pub_type: 杂志文章


    authors: Patel MB,Munzer K,Dougherty M,Williams P,Loiselle A

    更新日期:2016-06-01 00:00:00

  • The laboratory-clinical interface: point-of-care testing.

    abstract::POC testing provides an opportunity for clinicians and laboratorians to work together to consider how best to serve the patients within an individual institution. Each health system has unique characteristics relative to patient population, as well as a unique laboratory structure. If physicians, nurses, laboratorians...


    pub_type: 杂志文章


    authors: Kost GJ,Ehrmeyer SS,Chernow B,Winkelman JW,Zaloga GP,Dellinger RP,Shirey T

    更新日期:1999-04-01 00:00:00

  • Immediate operative treatment for massive hemoptysis.

    abstract::A series of 15 patients with life threatening, massive hemoptysis is reported. Thirteen of these patients underwent immediate operative treatment with only three deaths. One died after bronchoscopic identification of the bleeding site while awaiting elective thoracotomy. The other patient left the hospital against med...


    pub_type: 杂志文章


    authors: McCollun WB,Mattox KL,Guinn GA,Beall AC Jr

    更新日期:1975-02-01 00:00:00

  • Assessment of Intervention Fidelity and Recommendations for Researchers Conducting Studies on the Diagnosis and Treatment of Chronic Cough in the Adult: CHEST Guideline and Expert Panel Report.

    abstract:BACKGROUND:Successful management of chronic cough has varied in the primary research studies in the reported literature. One of the potential reasons relates to a lack of intervention fidelity to the core elements of the diagnostic and/or therapeutic interventions that were meant to be used by the investigators. METHO...


    pub_type: 杂志文章,评审


    authors: French CT,Diekemper RL,Irwin RS,Adams TM,Altman KW,Barker AF,Birring SS,Blackhall F,Bolser DC,Boulet LP,Braman SS,Brightling C,Callahan-Lyon P,Canning BJ,Chang AB,Coeytaux R,Cowley T,Davenport P,Diekemper RL,Ebihara

    更新日期:2015-07-01 00:00:00

  • Successful treatment of juvenile laryngeal papillomatosis-related multicystic lung disease with cidofovir: case report and review of the literature.

    abstract::Cidofovir, a nucleoside analog antiviral agent, has been used with moderate success in the treatment of juvenile laryngeal papillomatosis (JLP) by direct intralesional injection. We report the first case where IV cidofovir was used successfully to treat a rare but lethal multicystic lung disease complicating JLP. A 35...


    pub_type: 杂志文章,评审


    authors: Dancey DR,Chamberlain DW,Krajden M,Palefsky J,Alberti PW,Downey GP

    更新日期:2000-10-01 00:00:00

  • Variation in Patient Smoking Cessation Rates Among Health-Care Providers: An Observational Study.

    abstract:BACKGROUND:Physicians play a crucial role in providing smoking cessation counseling and medications. However, it is unknown whether individual physicians' approaches affect whether patients quit. RESEARCH QUESTION:This study assessed patient quit rates within a national quality-improvement learning collaborative to do...


    pub_type: 杂志文章


    authors: Almaaitah S,Ciemins EL,Joshi V,Arora A,Meskow C,Rothberg MB

    更新日期:2020-11-01 00:00:00

  • Clinical correlation with changing radiographic appearance during partial liquid ventilation.

    abstract:STUDY OBJECTIVES:To evaluate the chest radiographic filling pattern associated with partial liquid ventilation (PLV) with the perfluorochemical perflubron (LiquiVent; Alliance Pharmaceutical Corp; San Diego CA) as a function of dose and timing. DESIGN:Post hoc review of chest radiographs by three independent observers...


    pub_type: 临床试验,杂志文章,多中心研究,随机对照试验


    authors: Schuster DP,Lange NR,Tutuncu A,Wedel M,LiquiVent Study Group.

    更新日期:2001-05-01 00:00:00

  • Lipid mediator dysregulation in primary pulmonary hypertension.

    abstract::The characteristic arteriopathy of primary pulmonary hypertension (PPH) with attendant endothelial dysfunction provides an opportunity for enhanced cellular activation in the lung. Data from many laboratories support the concept of altered eicosanoid metabolism in PPH. Rigorously quantitative measurements of the excre...


    pub_type: 杂志文章,评审


    authors: Christman BW

    更新日期:1998-09-01 00:00:00

  • Regulation of breathing and perception of dyspnea in healthy pregnant women.

    abstract:STUDY OBJECTIVE:To examine if the perception of dyspnea during normal pregnancy may be related to an inappropriate ventilatory response to the increased metabolic rate, due to a higher chemosensitivity. PATIENTS AND INTERVENTIONS:At weeks 12, 24, and 36 of gestation and 4 months after delivery, 11 healthy pregnant wom...


    pub_type: 杂志文章


    authors: García-Rio F,Pino JM,Gómez L,Alvarez-Sala R,Villasante C,Villamor J

    更新日期:1996-08-01 00:00:00

  • Treatment of warfarin-associated coagulopathy: a physician survey.

    abstract:STUDY OBJECTIVES:(1) To determine physician preferences in the management of warfarin-induced excessive anticoagulation (AC); and (2) to assess compliance with the American College of Chest Physicians (ACCP) guidelines for the reversal of excessive AC. DESIGN:Cross-sectional physician survey. PARTICIPANTS:Members of ...


    pub_type: 杂志文章


    authors: Wilson SE,Douketis JD,Crowther MA

    更新日期:2001-12-01 00:00:00

  • Peak flow lability: association with asthma and spirometry in an older cohort.

    abstract:OBJECTIVE:To determine the success rate and correlates of ambulatory peak expiratory flow (PEF) monitoring in an epidemiologic study. DESIGN:An observational survey. SETTING:Several communities in California. PARTICIPANTS:We studied 1,223 nonsmoking men and women (mean age, 66 years) from an established cohort. OUT...


    pub_type: 杂志文章


    authors: Enright PL,Burchette RJ,Peters JA,Lebowitz MD,McDonnell WF,Abbey DE

    更新日期:1997-10-01 00:00:00

  • Vasodilator therapy-induced pacemaker syndrome.

    abstract::Disabling presyncopal attacks were provoked in a patient with a sinus nodal disorder and cardiac pacemaker by treatment with antianginal vasodilators. At cardiac catheterization a severe fall in aortic pressure was documented during ventricular pacing, when desynchronized atrial contractions coincided with ventricular...


    pub_type: 杂志文章


    authors: Toivonen LK,Pohjola-Sintonen S

    更新日期:1987-06-01 00:00:00

  • Heart rate pattern during sleep in an infant with congenital prolongation of the Q-T interval (Romano-Ward syndrome).

    abstract::Heart rate and the variability of the heart rate, indices of autonomic control, were studied during sleep in an infant with prolonged Q-T interval (Romano-Ward syndrome) and were compared to the heart rate and variability of heart rate in 18 normal infants studied at monthly intervals during the first four months of l...


    pub_type: 杂志文章


    authors: Leistner HL,Haddad GG,Lai TL,Mellins RB

    更新日期:1983-08-01 00:00:00

  • The timing of tracheotomy in critically ill patients undergoing mechanical ventilation: a systematic review and meta-analysis of randomized controlled trials.

    abstract:BACKGROUND:The objective of this study was to systematically review and quantitatively synthesize all randomized controlled trials (RCTs), comparing important outcomes in ventilated critically ill patients who received an early or late tracheotomy. METHODS:A systematic literature search of PubMed, Cumulative Index to ...


    pub_type: 杂志文章,meta分析,评审


    authors: Wang F,Wu Y,Bo L,Lou J,Zhu J,Chen F,Li J,Deng X

    更新日期:2011-12-01 00:00:00

  • Cost-effectiveness of fluticasone propionate administered via metered-dose inhaler plus babyhaler spacer in the treatment of asthma in preschool-aged children.

    abstract:STUDY OBJECTIVES:To evaluate the cost-effectiveness of inhaled fluticasone propionate (FP) in children aged 12 to 47 months with asthma symptoms. DESIGN:A retrospective economic analysis conducted from the perspective of the Danish health-care system, based on clinical data from a 12-week study. SETTING:Thirty-three ...


    pub_type: 临床试验,杂志文章,多中心研究,随机对照试验


    authors: Bisgaard H,Price MJ,Maden C,Olsen NA

    更新日期:2001-12-01 00:00:00

  • Effects of omega-3 polyunsaturated fatty acids on inflammatory markers in COPD.

    abstract:BACKGROUND:COPD, the fifth-leading cause of death worldwide, is characterized by chronic inflammation. However, no available agent can effectively cure this inflammation. A dietary supplement containing omega-3 polyunsaturated fatty acids (PUFAs) has anti-inflammatory effects. In this study, we hypothesized that nutrit...


    pub_type: 杂志文章,随机对照试验,收录出版


    authors: Matsuyama W,Mitsuyama H,Watanabe M,Oonakahara K,Higashimoto I,Osame M,Arimura K

    更新日期:2005-12-01 00:00:00

  • Significance of T-wave pseudonormalization during exercise. A radionuclide angiographic study.

    abstract::In 84 consecutive patients with resting T-wave inversion, radionuclide angiography revealed significant new wall motion abnormalities in 13 (28 percent) of the 47 patients with persistent T-wave inversion and in 23 (62 percent) of the 37 patients with T-wave pseudonormalization during exercise (p less than 0.01). The ...


    pub_type: 杂志文章


    authors: Lavie CJ,Oh JK,Mankin HT,Clements IP,Giuliani ER,Gibbons RJ

    更新日期:1988-09-01 00:00:00

  • Noninvasive pressure support ventilation in patients with acute respiratory failure. A randomized comparison with conventional therapy.

    abstract::The benefit of noninvasive pressure support ventilation (NIPSV) in avoiding the need for endotracheal intubation and reducing morbidity and mortality associated with endotracheal intubation was evaluated in 41 patients who presented with acute respiratory failure not related to chronic obstructive pulmonary disease (C...


    pub_type: 临床试验,杂志文章,随机对照试验


    authors: Wysocki M,Tric L,Wolff MA,Millet H,Herman B

    更新日期:1995-03-01 00:00:00

  • Oral Low-dose Theophylline on Top of Inhaled Fluticasone-Salmeterol Does Not Reduce Exacerbations in Patients With Severe COPD: A Pilot Clinical Trial.

    abstract:BACKGROUND:COPD is characterized by chronic inflammation. In vitro and ex vivo observations suggest that this inflammatory response is partially resistant to the effect of corticosteroids and that low-dose theophylline can restore this response via enhancement of histone deacetylase (HDAC) activity. Whether this occurs...


    pub_type: 杂志文章,随机对照试验


    authors: Cosío BG,Shafiek H,Iglesias A,Yanez A,Córdova R,Palou A,Rodriguez-Roisin R,Peces-Barba G,Pascual S,Gea J,Sibila O,Barnes PJ,Agusti A

    更新日期:2016-07-01 00:00:00