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Ann Rheum Dis. 2016 Jun;75(6):1009-15. doi: 10.1136/annrheumdis-2014-207001. Epub 2015 May 20.

Efficacy of sildenafil on ischaemic digital ulcer healing in systemic sclerosis: the placebo-controlled SEDUCE study.

Author information

1
Médecine Interne, Hopital Huriez, Université de Lille, Lille, France.
2
Médecine Vasculaire, CHU, Grenoble, France.
3
Médecine Interne, Hôpital Hôtel Dieu, Nantes, France.
4
Rhumatologie, Hôpital Hautepierre, Strasbourg, France.
5
Médecine Interne, CHR Rennes Sud, Rennes, France.
6
Médecine Interne, AP-HP, Hôpital Cochin, Université Paris Descartes, Paris, France.
7
Médecine Interne, Hôpital de l'Archet 1, Nice, France.
8
Médecine Interne, Hôpital Dupuytren, Limoges, France.
9
Médecine Vasculaire, Hôpital Saint Joseph, Paris, France.
10
Médecine Interne, Hôpital Robert Debré, Reims, France.
11
Médecine Interne 2, Hôpital Pitié-Salpêtrière, Paris, France.
12
Médecine Interne, Hôpital Nord, Aix Marseille Université, Marseille, France.
13
Médecine Interne, Hôpital Bretonneau, Tours, France.
14
Médecine Interne, Hôpital Saint Louis, Paris, France.
15
Medicine interne and Inflammation-Immunopathology-Biotherapy Department (DHU i2B), AP-HP, Hôpital Saint Antoine, Paris, France.
16
Rhumatologie A, Hôpital Cochin, Paris, France.
17
Médecine Interne, Hôpital Edouard Herriot, Lyon, France.
18
Orgamétrie Biostatistiques, Roubaix, France.

Abstract

OBJECTIVE:

To assess the effect of sildenafil, a phosphodiesterase type 5 inhibitor, on digital ulcer (DU) healing in systemic sclerosis (SSc).

METHODS:

Randomised, placebo-controlled study in patients with SSc to assess the effect of sildenafil 20 mg or placebo, three times daily for 12 weeks, on ischaemic DU healing. The primary end point was the time to healing for each DU. Time to healing was compared between groups using Cox models for clustered data (two-sided tests, p=0.05).

RESULTS:

Intention-to-treat analysis involved 83 patients with a total of 192 DUs (89 in the sildenafil group and 103 in the placebo group). The HR for DU healing was 1.33 (0.88 to 2.00) (p=0.18) and 1.27 (0.85 to 1.89) (p=0.25) when adjusted for the number of DUs at entry, in favour of sildenafil. In the per protocol population, the HRs were 1.49 (0.98 to 2.28) (p=0.06) and 1.43 (0.93 to 2.19) p=0.10. The mean number of DUs per patient was lower in the sildenafil group compared with the placebo group at week (W) 8 (1.23±1.61 vs 1.79±2.40 p=0.04) and W12 (0.86±1.62 vs 1.51±2.68, p=0.01) resulting from a greater healing rate (p=0.01 at W8 and p=0.03 at W12).

CONCLUSIONS:

The primary end point was not reached in intention-to-treat, partly because of an unexpectedly high healing rate in the placebo group. We found a significant decrease in the number of DUs in favour of sildenafil compared with placebo at W8 and W12, confirming a sildenafil benefit.

TRIAL REGISTRATION NUMBER:

NCT01295736.

KEYWORDS:

Autoimmune Diseases; Patient perspective; Treatment

PMID:
25995322
PMCID:
PMC4893100
DOI:
10.1136/annrheumdis-2014-207001
[Indexed for MEDLINE]
Free PMC Article

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