Effect of cilostazol on walking distances in patients with intermittent claudication caused by peripheral vascular disease

Money, Samuel R.; Herd, J. Alan; Isaacsohn, Jonathan L.; Davidson, Michael; Cutler, Bruce S.; Heckman, Jeffrey; Forbes, William

doi:10.1016/s0741-5214(98)70357-x

Cited by 307 publications

(187 citation statements)

References 19 publications

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“…11,19,20 In 1 study of cilostazol, however, the increase in walking distance was accompanied by a small but significant increase in the ABI compared with placebo. 18 BPS had no significant effect on blood pressure and heart rate. This posed, once more, the problem of the mechanism of action of BPS in particular and prostanoids in general in the treatment of intermittent claudication.…”

Section: Discussionmentioning

confidence: 78%

“…In another 16-week study of cilostazol, the difference between the active and placebo groups was 28 m for the increase in pain-free walking distance and 62 m for the increase in absolute walking distance. 18 In this latter study, however, a variablegrade, constant-speed treadmill exercise protocol was used, which makes the results difficult to compare with those of BERCI-2.…”

Section: Discussionmentioning

confidence: 99%

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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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Section: Discussionmentioning

confidence: 78%

Section: Discussionmentioning

confidence: 99%

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

et al. 2000

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“…A hat hónapos kezelés során a boka/kar index (BKI) szignifikáns javulását is igazoltuk. A BKI változását kevés tanulmányban vizsgálták, egy vizsgálatban hasonló javulást találtak [15], másik két vizsgálatban a BKI csökkent vagy nem változott [14]. A hat hónapos kezelés során észlelt javulásban a cilostazol ismert vasodilatator és érfa-li pleiotrop hatása szerepet játszhat.…”

Section: Megbeszélésunclassified

A cilostazol hatékony és biztonságos lehetőség a claudicatio intermittens kezelésére. A NOCLAUD vizsgálat eredményei

Farkas

Járai

2017

Orvosi Hetilap

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A perifériás verőérbetegség gyakori megjelenési formája a claudicatio intermittens, amely jelentősen rontja a betegek életminőségét. A cilostazol 2014-ben került Magyarországon forgalomba. A vizsgálat célkitűzése a cilostazol haté-konyságának és biztonságosságának értékelése volt claudicatio intermittensben szenvedő betegekben. A multicentrikus, beavatkozással nem járó vizsgálatba 1405 beteg került beválasztásra, akik hat hónapig cilostazolkezelést kaptak. A vizsgálatot befejező 1331 betegből 674 beteg adatai kerültek hatékonysági elemzésre. A fájdalommentes és abszolút járástávolság, valamint a hatperces sétateszt szignifikánsan nőtt a harmadik hónapra (78,65%, 65,23%, 56,09%; p<0,0001), és további növekedés volt megfigyelhető a hat hónapos kezelést követően (129,74%, 107,2%, 80,38%; p<0,0001). Mellékhatás a betegek 7,26%-ában fordult elő. A leggyakoribb mellékhatások a fejfájás, hasmenés, szédü-lés, tachycardia és palpitatio voltak. A cilostazolkezelés leállítására 24 beteg (1,7%) esetében került sor mellékhatás miatt. A hat hónapos cilostazolkezelés szignifikánsan növelte a claudicatio intermittensben szenvedő betegek járástá-volságát, jelentős biztonságossági probléma nélkül. Orv. Hetil., 2017, 158(4), 123-128.

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“…In two studies it was necessary to interrupt the use of cilostazol due to headaches in 1.7% of the patients in relation to 1.3% in those treated with placebo, while suspension for other causes was similar between the groups 16,17 . In the case of chronic liver disease, Child-Pugh classes B and C, it should be used with caution 18 .…”

Section: Pharmacological Properties Of Cilostazolmentioning

confidence: 99%

Cilostazol, um inibidor da fosfodiesterase III: perspectivas futuras na aterosclerose

Rosa¹,

Baroni²,

Portal³

2006

Arq. Bras. Cardiol.

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Effect of cilostazol on walking distances in patients with intermittent claudication caused by peripheral vascular disease

Abstract: Cilostazol significantly increased ACD at all measured time points and initial claudication distances at most time points. This agent may represent a new treatment option for patients with intermittent claudication.

Cited by 307 publications

References 19 publications

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

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

A cilostazol hatékony és biztonságos lehetőség a claudicatio intermittens kezelésére. A NOCLAUD vizsgálat eredményei

Cilostazol, um inibidor da fosfodiesterase III: perspectivas futuras na aterosclerose

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Effect of cilostazol on walking distances in patients with intermittent claudication caused by peripheral vascular disease

Abstract: Cilostazol significantly increased ACD at all measured time points and initial claudication distances at most time points. This agent may represent a new treatment option for patients with intermittent claudication.

Cited by 307 publications

References 19 publications

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

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

A cilostazol hatékony és biztonságos lehetőség a claudicatio intermittens kezelésére. A NOCLAUD vizsgálat eredményei

Cilostazol, um inibidor da fosfodiesterase III: perspectivas futuras na aterosclerose

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

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