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Two randomised and placebo-controlled studies of an oral prostacyclin analogue (Iloprost) in severe leg ischaemia. The Oral Iloprost in severe Leg Ischaemia Study Group.
Eur J Vasc Endovasc Surg. 2000 Oct; 20(4):358-62.EJ

Abstract

Two separate studies are described using the same prostacyclin analogue in a similar group of patients.

OBJECTIVES

to assess the tolerability and efficacy of two dose regimens of oral Iloprost compared with placebo in the treatment of patients with ischaemic ulcers, gangrene or rest pain due to severe arterial disease over a period of 4 weeks (Study A) and one year (Study B).

DESIGN

multicentre, placebo controlled, double-blind, randomized prospective studies.

SUBJECTS & METHODS

178 (study A) and 624 (study B) patients with trophic skin lesions (ulcers or gangrene) or ischaemic rest pain due to severe arterial disease. To confirm severe arterial disease patients were required to have a systolic ankle Doppler pressure of 70 mmHg or less or a toe systolic Doppler pressure of 50 mmHg or less in one leg. In both studies patients were randomly allocated to three treatment groups: placebo, low dose Iloprost (50-100 microgram twice a day) or high dose (150-200 microgram twice a day) In Study A the main outcome measures were tolerability of different doses of Iloprost and death, major amputation, healing of trophic lesions and relief of rest pain at the end of the follow up, which was 5 months after the end of the treatment. In Study B the primary end point was time to major amputation and stroke or death up to 12 months. Secondary pre-defined end points included the combined end point of patients alive without amputation, no trophic skin changes, no rest pain and not on regular analgesics.

RESULTS

the proportion of patients who completed the 4-week treatment period in Study A at the intended dose was 58%, 43%, 45% respectively in the placebo, low dose and high dose Iloprost groups. In an intention to treat analysis the proportion of patients who survived without major amputation, ulcers or gangrene and had no rest pain was 11% in the placebo group, 19% in the low dose iloprost group and 28% in the high dose Iloprost group. The pooled Iloprost groups showed a statistically significantly better result than the placebo group (p=0.04), as did the high dose Iloprost group compared to the placebo (p=0.014). In Study B there was no treatment benefit in terms of a primary end point of amputation and death. However the secondary combined end point of patients who survived without a major amputation, ulcers or gangrene and had no rest pain, nor a need for regular analgesia was favourable for Iloprost, with 18% of patients in the placebo group reaching this optimal secondary end point, compared to 23% in the low dose Iloprost group and 26% in the higher dose Iloprost group (p<0.05).

CONCLUSIONS

oral Iloprost administered for a year showed no clear benefit in patients with advanced severe leg ischaemia (PAOD III and IV). The results obtained with 4 weeks' treatment in Study A and in previous trials of intravenous Iloprost could not be reproduced

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

11038148

Citation

"Two Randomised and Placebo-controlled Studies of an Oral Prostacyclin Analogue (Iloprost) in Severe Leg Ischaemia. the Oral Iloprost in Severe Leg Ischaemia Study Group." European Journal of Vascular and Endovascular Surgery : the Official Journal of the European Society for Vascular Surgery, vol. 20, no. 4, 2000, pp. 358-62.
Two randomised and placebo-controlled studies of an oral prostacyclin analogue (Iloprost) in severe leg ischaemia. The Oral Iloprost in severe Leg Ischaemia Study Group. Eur J Vasc Endovasc Surg. 2000;20(4):358-62.
(2000). Two randomised and placebo-controlled studies of an oral prostacyclin analogue (Iloprost) in severe leg ischaemia. The Oral Iloprost in severe Leg Ischaemia Study Group. European Journal of Vascular and Endovascular Surgery : the Official Journal of the European Society for Vascular Surgery, 20(4), 358-62.
Two Randomised and Placebo-controlled Studies of an Oral Prostacyclin Analogue (Iloprost) in Severe Leg Ischaemia. the Oral Iloprost in Severe Leg Ischaemia Study Group. Eur J Vasc Endovasc Surg. 2000;20(4):358-62. PubMed PMID: 11038148.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Two randomised and placebo-controlled studies of an oral prostacyclin analogue (Iloprost) in severe leg ischaemia. The Oral Iloprost in severe Leg Ischaemia Study Group. PY - 2000/10/19/pubmed PY - 2001/2/28/medline PY - 2000/10/19/entrez SP - 358 EP - 62 JF - European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery JO - Eur J Vasc Endovasc Surg VL - 20 IS - 4 N2 - UNLABELLED: Two separate studies are described using the same prostacyclin analogue in a similar group of patients. OBJECTIVES: to assess the tolerability and efficacy of two dose regimens of oral Iloprost compared with placebo in the treatment of patients with ischaemic ulcers, gangrene or rest pain due to severe arterial disease over a period of 4 weeks (Study A) and one year (Study B). DESIGN: multicentre, placebo controlled, double-blind, randomized prospective studies. SUBJECTS & METHODS: 178 (study A) and 624 (study B) patients with trophic skin lesions (ulcers or gangrene) or ischaemic rest pain due to severe arterial disease. To confirm severe arterial disease patients were required to have a systolic ankle Doppler pressure of 70 mmHg or less or a toe systolic Doppler pressure of 50 mmHg or less in one leg. In both studies patients were randomly allocated to three treatment groups: placebo, low dose Iloprost (50-100 microgram twice a day) or high dose (150-200 microgram twice a day) In Study A the main outcome measures were tolerability of different doses of Iloprost and death, major amputation, healing of trophic lesions and relief of rest pain at the end of the follow up, which was 5 months after the end of the treatment. In Study B the primary end point was time to major amputation and stroke or death up to 12 months. Secondary pre-defined end points included the combined end point of patients alive without amputation, no trophic skin changes, no rest pain and not on regular analgesics. RESULTS: the proportion of patients who completed the 4-week treatment period in Study A at the intended dose was 58%, 43%, 45% respectively in the placebo, low dose and high dose Iloprost groups. In an intention to treat analysis the proportion of patients who survived without major amputation, ulcers or gangrene and had no rest pain was 11% in the placebo group, 19% in the low dose iloprost group and 28% in the high dose Iloprost group. The pooled Iloprost groups showed a statistically significantly better result than the placebo group (p=0.04), as did the high dose Iloprost group compared to the placebo (p=0.014). In Study B there was no treatment benefit in terms of a primary end point of amputation and death. However the secondary combined end point of patients who survived without a major amputation, ulcers or gangrene and had no rest pain, nor a need for regular analgesia was favourable for Iloprost, with 18% of patients in the placebo group reaching this optimal secondary end point, compared to 23% in the low dose Iloprost group and 26% in the higher dose Iloprost group (p<0.05). CONCLUSIONS: oral Iloprost administered for a year showed no clear benefit in patients with advanced severe leg ischaemia (PAOD III and IV). The results obtained with 4 weeks' treatment in Study A and in previous trials of intravenous Iloprost could not be reproduced SN - 1078-5884 UR - https://www.unboundmedicine.com/medline/citation/11038148/Two_randomised_and_placebo_controlled_studies_of_an_oral_prostacyclin_analogue__Iloprost__in_severe_leg_ischaemia__The_Oral_Iloprost_in_severe_Leg_Ischaemia_Study_Group_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1078588400911754 DB - PRIME DP - Unbound Medicine ER -