Abstract:
INTRODUCTION:Pulmonary arterial hypertension (PAH) is associated with poor prognosis despite significant recent advances in its treatment. An intravenous formulation of epoprostenol sodium containing glycine and mannitol (epoprostenol GM; GlaxoSmithKline, London, UK) is widely used to treat PAH. A new formulation of epoprostenol sodium containing arginine and sucrose excipients (epoprostenol AS; Actelion Pharmaceuticals Japan Ltd., Tokyo, Japan) shows better stability at room temperature after preparing diluted solutions. The primary objective of this study was to evaluate the safety and tolerability of switching from epoprostenol GM to epoprostenol AS in Japanese patients with PAH. The authors also evaluated the efficacy and treatment satisfaction after switching formulations. METHODS:This was a two-site, open-label, single-arm, Phase 3b study. Eight adult Japanese PAH patients (seven females) treated with a stable dose of epoprostenol GM for ≥30 days were switched to epoprostenol AS and followed for 12 weeks. Outcomes included safety, changes from baseline to 12 weeks in pulmonary hemodynamic factors (pulmonary vascular resistance, mean pulmonary arterial pressure, and cardiac output), and treatment satisfaction, assessed using the Treatment Satisfaction Questionnaire for Medication (TSQM-9). RESULTS:The mean (range) age and time since diagnosis of PAH were 48 (25-69) years and 6.2 (0.6-13.9) years, respectively. There were no unexpected safety or tolerability concerns after switching formulations. The epoprostenol dose was maintained after switching formulations. There were no significant changes in pulmonary hemodynamic factors from baseline to week 12. Regarding treatment satisfaction, there was a significant improvement in convenience, which is demonstrated in the score of the domain increased from 51.40 ± 10.19 at baseline to 58.33 ± 12.96 at week 12 (P < 0.05). CONCLUSIONS:Switching from epoprostenol GM to the same dose of epoprostenol AS was well tolerated over 12 weeks of treatment, and pulmonary hemodynamics were maintained. Switching to epoprostenol AS was also associated with improvements in treatment satisfaction (convenience). Clinical Trials: JapicCTI-122017.
journal_name
Adv Therjournal_title
Advances in therapyauthors
Tamura Y,Ono T,Fukuda K,Satoh T,Sasayama Sdoi
10.1007/s12325-013-0029-0subject
Has Abstractpub_date
2013-05-01 00:00:00pages
459-71issue
5eissn
0741-238Xissn
1865-8652journal_volume
30pub_type
杂志文章,多中心研究abstract:INTRODUCTION:This study aimed to demonstrate the clinical utility of non-invasive multigene Cxbladder urine tests in reducing the overall number of diagnostic tests and invasive procedures used in the clinical evaluation of patients presenting with microhematuria, a key symptom of urothelial carcinoma (UC). There is a ...
journal_title:Advances in therapy
pub_type: 杂志文章
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journal_title:Advances in therapy
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journal_title:Advances in therapy
pub_type: 杂志文章
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abstract::Life expectancy has increased substantially over the last few decades, leading to a worldwide increase in the prevalence and burden of aging-associated diseases. Recent evidence has proven that cellular senescence contributes substantially to the development of these disorders. Cellular senescence is a state of cell c...
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journal_title:Advances in therapy
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pub_type: 杂志文章,随机对照试验
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journal_title:Advances in therapy
pub_type: 杂志文章,评审
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journal_title:Advances in therapy
pub_type: 杂志文章,多中心研究
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abstract:INTRODUCTION:Most cases of small cell lung cancer (SCLC) are diagnosed at an advanced stage. The objective of this study was to investigate patient characteristics, survival, chemotherapy treatments, and health care use after a diagnosis of advanced SCLC in subjects enrolled in a health system network. METHODS:This wa...
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journal_title:Advances in therapy
pub_type: 杂志文章,评审
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pub_type: 杂志文章,meta分析
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journal_title:Advances in therapy
pub_type: 杂志文章
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abstract:INTRODUCTION:The European Medicines Agency (EMA) requires vaccine manufacturers to conduct enhanced safety surveillance (ESS) of seasonal influenza vaccines including a near real-time evaluation of collected data. The objective was to identify whether the use of passive surveillance or active surveillance provides diff...
journal_title:Advances in therapy
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更新日期:2018-08-01 00:00:00
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journal_title:Advances in therapy
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journal_title:Advances in therapy
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:
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journal_title:Advances in therapy
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pub_type: 杂志文章,meta分析
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journal_title:Advances in therapy
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