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Combination Therapy...
Combination Therapy with Oral Treprostinil for Pulmonary Arterial Hypertension. A Double-Blind Placebo-controlled Clinical Trial.
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White, R James (author)
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Jerjes-Sanchez, Carlos (author)
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Bohns Meyer, Gisela Martina (author)
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Pulido, Tomas (author)
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Sepulveda, Pablo (author)
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Wang, Kuo Yang (author)
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Grünig, Ekkehard (author)
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Hiremath, Shirish (author)
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Yu, Zaixin (author)
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Gangcheng, Zhang (author)
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Yip, Wei Luen James (author)
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Zhang, Shuyang (author)
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Khan, Akram (author)
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Deng, C Q (author)
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Grover, Rob (author)
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Tapson, Victor F (author)
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- Hjalmarsson, Clara, 1969 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för molekylär och klinisk medicin,Institute of Medicine, Department of Molecular and Clinical Medicine
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- 2020
- 2020
- English.
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In: American journal of respiratory and critical care medicine. - 1535-4970. ; 201:6, s. 707-717
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https://doi.org/10.1...
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Abstract
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- Rationale: Oral treprostinil improves exercise capacity in patients with pulmonary arterial hypertension (PAH), but the effect on clinical outcomes was unknown.Objectives: To evaluate the effect of oral treprostinil compared with placebo on time to first adjudicated clinical worsening event in participants with PAH who recently began approved oral monotherapy.Methods: In this event-driven, double-blind study, we randomly allocated 690 participants (1:1 ratio) with PAH to receive placebo or oral treprostinil extended-release tablets three times daily. Eligible participants were using approved oral monotherapy for over 30 days before randomization and had a 6-minute-walk distance 150 m or greater. The primary endpoint was the time to first adjudicated clinical worsening event: death; hospitalization due to worsening PAH; initiation of inhaled or parenteral prostacyclin therapy; disease progression; or unsatisfactory long-term clinical response.Measurements and Main Results: Clinical worsening occurred in 26% of the oral treprostinil group compared with 36% of placebo participants (hazard ratio, 0.74; 95% confidence interval, 0.56-0.97; P = 0.028). Key measures of disease status, including functional class, Borg dyspnea score, and N-terminal pro-brain natriuretic peptide, all favored oral treprostinil treatment at Week 24 and beyond. A noninvasive risk stratification analysis demonstrated that oral treprostinil-assigned participants had a substantially higher mortality risk at baseline but achieved a lower risk profile from Study Weeks 12-60. The most common adverse events in the oral treprostinil group were headache, diarrhea, flushing, nausea, and vomiting.Conclusions: In participants with PAH, addition of oral treprostinil to approved oral monotherapy reduced the risk of clinical worsening.Clinical trial registered with www.clinicaltrials.gov (NCT01560624).
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine (hsv//eng)
Keyword
- clinical study
- combination therapy
- oral treprostinil
- pulmonary arterial hypertension
- sequential therapy
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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White, R James
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Jerjes-Sanchez, ...
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Bohns Meyer, Gis ...
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Pulido, Tomas
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Sepulveda, Pablo
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Wang, Kuo Yang
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show more...
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Grünig, Ekkehard
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Hiremath, Shiris ...
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Yu, Zaixin
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Gangcheng, Zhang
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Yip, Wei Luen Ja ...
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Zhang, Shuyang
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Khan, Akram
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Deng, C Q
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Grover, Rob
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Tapson, Victor F
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Hjalmarsson, Cla ...
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show less...
- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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American journal ...
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University of Gothenburg