Efficacy of a new prostaglandin E1 regimen in outpatients with severe intermittent claudication: Results of a multicenter placebo-controlled double-blind trial

Diehm, Curt; Balzer, K.; Bisler, H; Bulling, B; Camcı, Mehmet; Creutzig, A; Gruss, J; Hörsch, S.; Odemar, Frank; Piehler, U.; Rogatti, W.; Scheffler, P; Spengel, F. A.; Treese, N; Turowski, A; Waldhausen, P.; Weber, Bernhard; Weiss, Th.

doi:10.1016/s0741-5214(97)70265-9

Cited by 62 publications

(33 citation statements)

References 15 publications

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“…[21][22][23] The largest published study 21 evaluated 213 patients with a maximum walking distance of 50 to 200 m at treadmill exercise. PGE 1 was infused 5 days a week for 4 weeks.…”

Section: Discussionmentioning

confidence: 99%

Oral Beraprost Sodium, a Prostaglandin I ₂ Analogue, for Intermittent Claudication

et al. 2000

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Background-Beraprost sodium (BPS) is a new stable, orally active prostaglandin I 2 analogue with antiplatelet and vasodilating properties. We report the results of a phase III clinical trial of BPS in patients with intermittent claudication. Methods and Results-Patients (nϭ549) with a pain-free walking distance of between 50 and 300 m were entered into a 4-week single-blind placebo run-in phase. Patients whose pain-free walking distance had changed by Ͻ25% were then randomized to receive either BPS (40 g TID, nϭ209) or placebo (nϭ213) in a double-blind manner for 6 months. Pain-free and maximum walking distances were measured on the occasion of treadmill exercise tests performed at baseline and 1.5, 3, 4.5, and 6 months after randomization. Success was defined as an improvement of Ͼ50% in pain-free walking distance at month 6 and in Ն1 earlier treadmill exercise test in the absence of critical cardiovascular events. Success was observed more frequently in the BPS group (43.5%) than in the placebo group (33.3%, Pϭ0.036). Pain-free walking distances increased by 81.5% and 52.5%, respectively, in the BPS and placebo groups (Pϭ0.001) and maximum walking distances by 60.1% and 35.0%, respectively (Pϭ0.004). The incidence of critical cardiovascular events was 4.8% in the BPS group and 8.9% in the placebo group. Conclusions-These results show that BPS is an effective symptomatic treatment of patients with intermittent claudication.The beneficial effects of BPS on critical cardiovascular events should be confirmed in appropriate clinical trials. Key Words: claudication Ⅲ beraprost sodium Ⅲ prostaglandins I ntermittent claudication is a common presentation of lower-limb arterial disease, with a prevalence of 1% to 7% in men 50 to 75 years old. 1,2 Medical therapy for patients with intermittent claudication has 2 goals: improvement of symptoms and prevention of cardiovascular events. Many agents, including vasodilators, have been tried for the relief of symptoms, although their effectiveness is still subject to debate. The antiplatelet and vasodilating properties of epoprostenol (prostaglandin [PG] I 2 ) make it a theoretically interesting agent in the treatment of peripheral vascular disease. 3 Although promising results were reported for its use in the treatment of intermittent claudication, 4 its very short half-life and high chemical instability precluded its use as a therapeutic agent and led to the development of more stable synthetic analogues. Iloprost, to date the most extensively studied of these analogues, has been shown to provide pain relief and to accelerate ulcer healing in patients with stage III or IV critical leg ischemia 5 and has been licensed in some countries for the treatment of thromboangiitis obliterans. The need for an intravenous infusion of iloprost, although acceptable for the treatment of critical ischemia, makes it unacceptable for the long-term treatment of intermittent claudication.Beraprost sodium (BPS) is a new stable, orally active PGI 2 analogue with antiplatelet and vasodilating prope...

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“…[21][22][23] The largest published study 21 evaluated 213 patients with a maximum walking distance of 50 to 200 m at treadmill exercise. PGE 1 was infused 5 days a week for 4 weeks.…”

Section: Discussionmentioning

confidence: 99%

Oral Beraprost Sodium, a Prostaglandin I ₂ Analogue, for Intermittent Claudication

et al. 2000

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“…31 Likewise, prostaglandin E 1 , when given intravenously for 5 days per week for 4 weeks and then twice weekly for 4 additional weeks, resulted in a 37% increase in walking distance over the placebo group. 32 Finally, Brevetti and colleagues have performed a number of studies examining the clinical effect of propionyl l-carnitine in patients with intermittent claudication. In the largest of these studies, these investigators found no difference in walking distances from placebo over the course of the study until 180 days of intervention.…”

Section: Discussionmentioning

confidence: 99%

Nutritional therapy for peripheral arterial disease: a double-blind, placebo-controlled, randomized trial of HeartBar®

2000

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Abstract:We investigated the clinical effects of a food bar enriched with l-arginine and a combination of other nutrients known to enhance the activity of endothelium-derived nitric oxide (EDNO) in individuals with claudication from atherosclerotic peripheral arterial disease. The study was a 2-week, double-blind, placebo-controlled trial of subjects randomized to three groups (two active bars, one active and one placebo bar, and two placebo bars per day) followed by an 8-week open-label period. Subjects (n = 41) were outpatient volunteers with intermittent claudication. Pain-free and total walking distances were measured by variable-grade, treadmill exercise testing. Quality of life was assessed using the Medical Outcome Survey (SF-36). After 2 weeks of treatment, the pain-free walking distance increased 66% while the total walking distance increased 23% in the group taking two active bars/day. The general and emotional/social functioning components of the SF-36 also improved. These effects were not observed in the one active bar/day and placebo groups. The effects were maintained after 10 weeks and, in addition, an improvement in walking distance was observed in the group taking one active bar. These findings reveal that use of a nutrient bar designed to enhance EDNO activity improves pain-free and total walking distance as well as quality of life in individuals with intermittent claudication.

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“…Nevertheless, quite a few patients are unsuitable for operation. Despite technical progress, the treatment of patients with inoperable chronic CLI is still challenging; most of the patients have to undergo amputation: [6][7][8][9] 33% at 6 months and 51% at 2 years. [10] SCS has been recommended to treat ischemic pain and prevent amputation in patients with inoperable CLI.…”

Section: Introductionmentioning

confidence: 99%

Spinal cord stimulation for patients with inoperable chronic critical leg ischemia

Chen

2011

World Journal of Emergency Medicine

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Efficacy of a new prostaglandin E1 regimen in outpatients with severe intermittent claudication: Results of a multicenter placebo-controlled double-blind trial

Cited by 62 publications

References 15 publications

Oral Beraprost Sodium, a Prostaglandin I ₂ Analogue, for Intermittent Claudication

Oral Beraprost Sodium, a Prostaglandin I ₂ Analogue, for Intermittent Claudication

Nutritional therapy for peripheral arterial disease: a double-blind, placebo-controlled, randomized trial of HeartBar®

Spinal cord stimulation for patients with inoperable chronic critical leg ischemia

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Efficacy of a new prostaglandin E1 regimen in outpatients with severe intermittent claudication: Results of a multicenter placebo-controlled double-blind trial

Cited by 62 publications

References 15 publications

Oral Beraprost Sodium, a Prostaglandin I 2 Analogue, for Intermittent Claudication

Oral Beraprost Sodium, a Prostaglandin I 2 Analogue, for Intermittent Claudication

Nutritional therapy for peripheral arterial disease: a double-blind, placebo-controlled, randomized trial of HeartBar®

Spinal cord stimulation for patients with inoperable chronic critical leg ischemia

Contact Info

Product

Resources

About

Oral Beraprost Sodium, a Prostaglandin I ₂ Analogue, for Intermittent Claudication

Oral Beraprost Sodium, a Prostaglandin I ₂ Analogue, for Intermittent Claudication