Effects of beraprost sodium, an oral prostacyclin analogue, in patients with pulmonary arterial hypertension: a randomized, double-blind, placebo-controlled trial

Galiè, Nazzareno; Humbert, Marc; Vachiéry, Jean‐Luc; Vizza, Carmine Dario; Kneußl, Meinhard; Manes, Alessandra; Sitbon, Olivier; Torbicki, Adam; Delcroix, Marion; Naeije, Robert; Hoeper, Marius M.; Chaouat, Ari; Morand, Sophie; Besse, B.; Simonneau, Gérald

doi:10.1016/s0735-1097(02)01786-2

Cited by 568 publications

(277 citation statements)

References 25 publications

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“…Following these studies and our initial experience [19] with beraprost regarding a group of patients with severe pulmonary hypertension – including 3 patients with distal CTEPH – we performed this prospective, case-controlled study to clarify whether beraprost produces clinical beneficial effect in distal CTEPH patients, comparable to what is seen in PAH patients [9, 20]. …”

Section: Discussionmentioning

confidence: 99%

“…The ALPHABET study [9] demonstrated that a 3-month treatment with beraprost improved exercise capacity in patients with PAH, mainly in idiopathic PAH (treatment effect +44 m), with a small, non-significant increase of cardiac index and no significant decrease in mean PAP. Similar results in effort tolerance were observed in the early phase (6 months) of a study in the US in which the median difference in the distance walked during 6 min was 31 m [20], but during the subsequent follow-up (9–12 months) the effort capacity declined close to the baseline in the beraprost group while in the placebo group continued to deteriorate over time.…”

Section: Discussionmentioning

confidence: 99%

“…Thus, the search for alternative ways of administrating prostacyclin has led to the synthesis of analog molecules, more stable and with improved pharmacokinetic. Recently, beraprost, an orally active prostacyclin analog, has been shown to be effective in improving clinical status and effort tolerance in PAH [9] after a 12-week treatment period. Small uncontrolled studies suggest its short- and long-term efficacy even in CTEPH [10, 11].…”

Section: Introductionmentioning

confidence: 99%

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Mid-Term Efficacy of Beraprost, an Oral Prostacyclin Analog, in the Treatment of Distal CTEPH: A Case Control Study

Vizza¹,

Badagliacca²,

Sciomer³

et al. 2006

Cardiology

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Background: Prostanoids are a well-established therapy for pulmonary arterial hypertension (PAH), and observational studies suggest their efficacy even in chronic thromboembolic pulmonary hypertension (CTEPH) patients. Objective: To compare the effects of 6 months of treatment with beraprost, an orally-active prostacyclin analog, in patients with distal CTEPH and PAH. Design: Case-control study. Population: Sixteen patients with severe pulmonary hypertension (NYHA II–IV), eight with distal CTEPH matched with eight patients with idiopathic PAH for similar effort tolerance. Methods: All patients were in stable clinical and hemodynamic condition for 3 months with maximal standard therapy. During the titration phase (4 weeks) beraprost was increased to maximal tolerated dose (mean daily dosage: CTEPH 275 ± 47 µg, PAH 277 ± 47 µg) in adjunction of standard therapy, patients were followed-up for 6 months. Main Outcome Measures: World Heart Organization (WHO) functional class, exercise capacity measured by distance walked in 6 min, and systolic pulmonary pressure (echocardiography), were evaluated at baseline, and at 1-, 3- and 6-month interval. Results: At 6 months WHO class decreased significantly in both groups (CTEPH from 2.7 ± 0.6 to 2.0 ± 0.24, p < 0.05; PAH from 3.0 ± 0.26 to 2.1 ± 0.25, p < 0.05), similarly the 6-min walk distance increased significantly from baseline (CTEPH from 312 ± 31 to 373 ± 29 m, p < 0.003; PAH from 303 ± 31 to 347 ± 29, p < 0.0003). Systolic pulmonary artery pressure showed a trend toward lower value (CTEPH from 85 ± 7 m to 81 ± 6 mm Hg, p = NS; PAH from 89 ± 7 to 82 ± 5, p = NS). During the observation period we did not have any death. The drug was well-tolerated with minor side-effects. Conclusion: In patients with CTEPH beraprost had similar mid-term clinical and hemodynamic improvements than in patients with PAH.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Mid-Term Efficacy of Beraprost, an Oral Prostacyclin Analog, in the Treatment of Distal CTEPH: A Case Control Study

Vizza¹,

Badagliacca²,

Sciomer³

et al. 2006

Cardiology

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“…Seitdem sind große Fortschritte in der PAH-Therapie erzielt worden; in einer Reihe gut aufgebauter und durchgeführter klinischer Studien wurde die anhaltende Wirksamkeit verschiedener Therapien nachgewiesen, die bei verschiedenen PAH-spezifischen Anomalien ansetzen [13,14,15,16]. Zugleich sind die Behandlungen im Hinblick auf die Art der Anwendung einfacher geworden - an Stelle der kontinuierlichen intravenösen Gabe sind orale Einnahme und Inhalation getreten.…”

Section: Therapie Der Pulmonal-arteriellen Hypertonieunclassified

Zukunftsperspektiven auf dem Gebiet der pulmonal-arteriellen Hypertonie

Rubin¹

2016

Kompass Pneumol

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In einem bemerkenswert kurzen Zeitraum hat sich die pulmonal-arteriellen Hypertonie (PAH) von einer Krankheit unbekannter Pathogenese ohne wirksame Therapie zu einem pathologischen Zustand entwickelt, dessen zelluläre und molekulare Grundlagen immer besser bekannt sind und für den mittlerweile drei Therapieklassen zur Verfügung stehen. Dennoch bleibt die PAH unheilbar und ist oft refraktär gegenüber medikamentöser Therapie, was die Notwendigkeit weiterer Forschung unterstreicht. In diesem Bei- trag werden einige der meistbeachteten Forschungsansätze zur Pathogenese, Diagnose und Überwachung sowie neue Therapieansätze vorgestellt, die hoffentlich künftig Einzug in die klinische Praxis halten.

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“…It provides improved exercise capacity and symptom relief, such as dyspnea at rest. Beraprost is associated with frequent side effects, such as headache, flushing, and diarrhea [26], which limit high-dose administration.…”

Section: Therapymentioning

confidence: 99%

Pulmonary Hypertension and Right Heart Failure in Chronic Kidney Disease: New Challenge for 21st-Century Cardionephrologists

et al. 2013

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Pulmonary hypertension is defined as an increased systolic pulmonary pressure of >30 mm Hg, and it shows a 40% prevalence in hemodialysis patients due to vascular access (both central venous catheter and arteriovenous fistula). Secondary pulmonary hypertension in chronic kidney disease patients is strictly related to pulmonary circulation impairment together with chronic volume overload and increased levels of cytokines and growth factors, such as FGF, PDGF, and TGF-β, leading to fibrosis. Endothelial dysfunction, together with lower activation of NOS, increased levels of serum endothelin and fibrin storages, involves an extensive growth of endothelial cells leading to complete obliteration of pulmonary vessels. Pulmonary hypertension has no pathognomonic and distinctive symptoms and signs; standard transthoracic echocardiography allows easy assessment of compliance of the right heart chambers. The therapeutic approach is based on traditional drugs such as digitalis-derived drugs, vasodilatory agents (calcium channel blockers), and oral anticoagulants. New pharmacological agents are under investigation, such as prostaglandin analogues, endothelin receptor blockers, and phosphodiesterase-5 inhibitors.

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Effects of beraprost sodium, an oral prostacyclin analogue, in patients with pulmonary arterial hypertension: a randomized, double-blind, placebo-controlled trial

Abstract: Beraprost improves exercise capacity and symptoms in NYHA functional class II and III patients with PAH and, in particular, in those with primary pulmonary hypertension.

Cited by 568 publications

References 25 publications

Mid-Term Efficacy of Beraprost, an Oral Prostacyclin Analog, in the Treatment of Distal CTEPH: A Case Control Study

Mid-Term Efficacy of Beraprost, an Oral Prostacyclin Analog, in the Treatment of Distal CTEPH: A Case Control Study

Zukunftsperspektiven auf dem Gebiet der pulmonal-arteriellen Hypertonie

Pulmonary Hypertension and Right Heart Failure in Chronic Kidney Disease: New Challenge for 21st-Century Cardionephrologists

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