The effect of ciprostene in patients with peripheral vascular disease (PVD) characterized by ischemic ulcers

Ciprostene Study Group

    Research output: Contribution to journalArticle

    16 Citations (Scopus)

    Abstract

    This randomized, double-blind study investigated the effect of ciprostene, a stable epoprostenol (prostacyclin) analog in patients with peripheral vascular disease (PVD) characterized by ischemic ulcers. A total of 211 patients (106 ciprostene, 105 placebo) received IV infusions of ciprostene (120 ng/kg/min in 8-hour daily infusions for 7 days) or placebo. The two groups were comparable with regard to demographic data. Only 45% of the patients receiving ciprostene and 55% of the placebo patients completed the trial. The groups were similar in frequency of amputations, vascular surgery, and development of new ulcers. Among those who completed the trials an insignificantly higher percentage of patients receiving ciprostene had all ulcers heal completely. The reduction of ulcer size by at least 50% was higher in the ciprostene-treated group at month 4 (P = .005). Both ciprostene and placebo reduced the severity of a patient's rest pain. There was no difference in the ankle brachial index between the groups. Ciprostene induced a higher incidence of headache, nausea, and flushing during infusion when compared with the placebo group. The results confirmed inherent problems with studies in PVD, namely, scarcity of patients with ischemic ulcers, inclusion of severely ill patients leading to a high dropout rate, and a high placebo effect. Good tolerance and safety of ciprostene was documented in this patient population, and the therapeutic benefit was limited to partial reduction of ulcer size. Selection of patients with less advanced disease and a longer infusion of ciprostene may improve the clinical benefit of this agent.

    Original languageEnglish
    Pages (from-to)81-87
    Number of pages7
    JournalJournal of Clinical Pharmacology
    Volume31
    Issue number1
    DOIs
    Publication statusPublished - 1991

    Keywords

    • TOLERANCE
    • OCCLUSIVE DISEASE
    • PGI2
    • CARBACYCLIN
    • TRIAL
    • EPOPROSTENOL PROSTACYCLIN
    • INTERMITTENT CLAUDICATION
    • ANALOG
    • PROSTAGLANDIN-E1

    Cite this

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    title = "The effect of ciprostene in patients with peripheral vascular disease (PVD) characterized by ischemic ulcers",
    abstract = "This randomized, double-blind study investigated the effect of ciprostene, a stable epoprostenol (prostacyclin) analog in patients with peripheral vascular disease (PVD) characterized by ischemic ulcers. A total of 211 patients (106 ciprostene, 105 placebo) received IV infusions of ciprostene (120 ng/kg/min in 8-hour daily infusions for 7 days) or placebo. The two groups were comparable with regard to demographic data. Only 45{\%} of the patients receiving ciprostene and 55{\%} of the placebo patients completed the trial. The groups were similar in frequency of amputations, vascular surgery, and development of new ulcers. Among those who completed the trials an insignificantly higher percentage of patients receiving ciprostene had all ulcers heal completely. The reduction of ulcer size by at least 50{\%} was higher in the ciprostene-treated group at month 4 (P = .005). Both ciprostene and placebo reduced the severity of a patient's rest pain. There was no difference in the ankle brachial index between the groups. Ciprostene induced a higher incidence of headache, nausea, and flushing during infusion when compared with the placebo group. The results confirmed inherent problems with studies in PVD, namely, scarcity of patients with ischemic ulcers, inclusion of severely ill patients leading to a high dropout rate, and a high placebo effect. Good tolerance and safety of ciprostene was documented in this patient population, and the therapeutic benefit was limited to partial reduction of ulcer size. Selection of patients with less advanced disease and a longer infusion of ciprostene may improve the clinical benefit of this agent.",
    keywords = "TOLERANCE, OCCLUSIVE DISEASE, PGI2, CARBACYCLIN, TRIAL, EPOPROSTENOL PROSTACYCLIN, INTERMITTENT CLAUDICATION, ANALOG, PROSTAGLANDIN-E1",
    author = "Linet, {Otto I.} and Jill Belch and {Ciprostene Study Group}",
    year = "1991",
    doi = "10.1002/j.1552-4604.1991.tb01891.x",
    language = "English",
    volume = "31",
    pages = "81--87",
    journal = "Journal of Clinical Pharmacology",
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    }

    The effect of ciprostene in patients with peripheral vascular disease (PVD) characterized by ischemic ulcers. / Ciprostene Study Group.

    In: Journal of Clinical Pharmacology, Vol. 31, No. 1, 1991, p. 81-87.

    Research output: Contribution to journalArticle

    TY - JOUR

    T1 - The effect of ciprostene in patients with peripheral vascular disease (PVD) characterized by ischemic ulcers

    AU - Linet, Otto I.

    AU - Ciprostene Study Group

    A2 - Belch, Jill

    PY - 1991

    Y1 - 1991

    N2 - This randomized, double-blind study investigated the effect of ciprostene, a stable epoprostenol (prostacyclin) analog in patients with peripheral vascular disease (PVD) characterized by ischemic ulcers. A total of 211 patients (106 ciprostene, 105 placebo) received IV infusions of ciprostene (120 ng/kg/min in 8-hour daily infusions for 7 days) or placebo. The two groups were comparable with regard to demographic data. Only 45% of the patients receiving ciprostene and 55% of the placebo patients completed the trial. The groups were similar in frequency of amputations, vascular surgery, and development of new ulcers. Among those who completed the trials an insignificantly higher percentage of patients receiving ciprostene had all ulcers heal completely. The reduction of ulcer size by at least 50% was higher in the ciprostene-treated group at month 4 (P = .005). Both ciprostene and placebo reduced the severity of a patient's rest pain. There was no difference in the ankle brachial index between the groups. Ciprostene induced a higher incidence of headache, nausea, and flushing during infusion when compared with the placebo group. The results confirmed inherent problems with studies in PVD, namely, scarcity of patients with ischemic ulcers, inclusion of severely ill patients leading to a high dropout rate, and a high placebo effect. Good tolerance and safety of ciprostene was documented in this patient population, and the therapeutic benefit was limited to partial reduction of ulcer size. Selection of patients with less advanced disease and a longer infusion of ciprostene may improve the clinical benefit of this agent.

    AB - This randomized, double-blind study investigated the effect of ciprostene, a stable epoprostenol (prostacyclin) analog in patients with peripheral vascular disease (PVD) characterized by ischemic ulcers. A total of 211 patients (106 ciprostene, 105 placebo) received IV infusions of ciprostene (120 ng/kg/min in 8-hour daily infusions for 7 days) or placebo. The two groups were comparable with regard to demographic data. Only 45% of the patients receiving ciprostene and 55% of the placebo patients completed the trial. The groups were similar in frequency of amputations, vascular surgery, and development of new ulcers. Among those who completed the trials an insignificantly higher percentage of patients receiving ciprostene had all ulcers heal completely. The reduction of ulcer size by at least 50% was higher in the ciprostene-treated group at month 4 (P = .005). Both ciprostene and placebo reduced the severity of a patient's rest pain. There was no difference in the ankle brachial index between the groups. Ciprostene induced a higher incidence of headache, nausea, and flushing during infusion when compared with the placebo group. The results confirmed inherent problems with studies in PVD, namely, scarcity of patients with ischemic ulcers, inclusion of severely ill patients leading to a high dropout rate, and a high placebo effect. Good tolerance and safety of ciprostene was documented in this patient population, and the therapeutic benefit was limited to partial reduction of ulcer size. Selection of patients with less advanced disease and a longer infusion of ciprostene may improve the clinical benefit of this agent.

    KW - TOLERANCE

    KW - OCCLUSIVE DISEASE

    KW - PGI2

    KW - CARBACYCLIN

    KW - TRIAL

    KW - EPOPROSTENOL PROSTACYCLIN

    KW - INTERMITTENT CLAUDICATION

    KW - ANALOG

    KW - PROSTAGLANDIN-E1

    U2 - 10.1002/j.1552-4604.1991.tb01891.x

    DO - 10.1002/j.1552-4604.1991.tb01891.x

    M3 - Article

    VL - 31

    SP - 81

    EP - 87

    JO - Journal of Clinical Pharmacology

    JF - Journal of Clinical Pharmacology

    SN - 0091-2700

    IS - 1

    ER -