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

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

          The purpose of this study was to assess the efficacy and safety of beraprost sodium, an orally active prostacyclin analogue, in New York Heart Association (NYHA) functional class II and III patients with pulmonary arterial hypertension (PAH). Pulmonary arterial hypertension is a life-threatening disease for which continuous intravenous infusion of prostacyclin has been proven effective. However, this treatment is associated with serious complications arising from the complex delivery system. In this double-blind, placebo-controlled study, 130 patients with PAH were randomized to the maximal tolerated dose of beraprost (median dose 80 microg four times a day) or to placebo for 12 weeks. The primary end point was the change in exercise capacity assessed by the 6-min walk test. Secondary end points included changes in Borg dyspnea index, cardiopulmonary hemodynamics and NYHA functional class. Patients treated with beraprost improved exercise capacity and symptoms. The difference between treatment groups in the mean change of 6-min walking distance at week 12 was 25.1 m (95% confidence interval [CI]: 1.8 to 48.3, p = 0.036). The difference in the mean change of Borg dyspnea index was -0.94 (95% CI: -1.63 to -0.24, p = 0.009). In the sub-group of patients with primary pulmonary hypertension, the difference in the mean change of 6-min walking distance was 46.1 m (95% CI: 3.0 to 89.3, p = 0.035). Cardiopulmonary hemodynamics and NYHA functional class had no statistically significant changes. Drug-related adverse events were common in the titration phase and decreased in the maintenance period. 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.
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            Beraprost therapy for pulmonary arterial hypertension.

            The purpose of this study was to assess the safety and efficacy of the oral prostacyclin analogue beraprost sodium during a 12-month double-blind, randomized, placebo-controlled trial in patients with pulmonary arterial hypertension (PAH). Pulmonary arterial hypertension is a progressive disease that ultimately causes right heart failure and death. Despite the risks from its delivery system, continuous intravenous epoprostenol remains the most efficacious treatment currently available. A total of 116 patients with World Health Organization (WHO) functional class II or III primary pulmonary hypertension or PAH related to either collagen vascular diseases or congenital systemic to pulmonary shunts were enrolled. Patients were randomized to receive the maximal tolerated dose of beraprost sodium (median dose 120 microg four times a day) or placebo for 12 months. The primary end point was disease progression; i.e., death, transplantation, epoprostenol rescue, or >25% decrease in peak oxygen consumption (VO(2)). Secondary end points included exercise capacity assessed by 6-min walk test and peak VO(2), Borg dyspnea score, hemodynamics, symptoms of PAH, and quality of life. Patients treated with beraprost exhibited less evidence of disease progression at six months (p = 0.002), but this effect was not evident at either shorter or longer follow-up intervals. Similarly, beraprost-treated patients had improved 6-min walk distance at 3 months by 22 m from baseline and at 6 months by 31 m (p = 0.010 and 0.016, respectively) compared with placebo, but not at either 9 or 12 months. Drug-related adverse events were common and were related to the disease and/or expected prostacyclin adverse events. These data suggest that beneficial effects may occur during early phases of treatment with beraprost in WHO functional class II or III patients but that this effect attenuates with time.
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              How should we measure function in patients with chronic heart and lung disease?


                Author and article information

                S. Karger AG
                September 2006
                29 September 2006
                : 106
                : 3
                : 168-173
                Department of Cardiovascular and Respiratory Sciences, University La Sapienza, Rome, Italy
                92920 Cardiology 2006;106:168–173
                © 2006 S. Karger AG, Basel

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                Figures: 3, Tables: 3, References: 20, Pages: 6
                Original Research


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