Efficacy of sildenafil on ischaemic digital ulcer healing in systemic sclerosis: the placebo-controlled SEDUCE study. Issue 6 (20th May 2015)

• Record Type: Journal Article
• Authors: Hachulla, Eric; Hatron, Pierre-Yves; Carpentier, Patrick; Agard, Christian; Chatelus, Emmanuel; Jego, Patrick; Mouthon, Luc; Queyrel, Viviane; Fauchais, Anne-Laure; Michon-Pasturel, Ulrique; Jaussaud, Roland; Mathian, Alexis; Granel, Brigitte; Diot, Elisabeth; Farge-Bancel, Dominique; Mekinian, Arsène; Avouac, Jérôme; Desmurs-Clavel, Hélène; Clerson, Pierre
• Other Names: author non-byline.; Quemeneur Thomas author non-byline.; Balquet Marie-Hélène author non-byline.; Wojtasik Géraldine author non-byline.; Lambert Marc author non-byline.; Launay David author non-byline.; Maillard Hélène author non-byline.; Morell-Dubois Sandrine author non-byline.; Le Gouellec Noémie author non-byline.; Marie Isabelle author non-byline.; Tieulie Nathalie author non-byline.; Deligny Christophe author non-byline.; Bienvenu Boris author non-byline.; Berezne Alice author non-byline.; Lazareth Isabelle author non-byline.; Khelifa Sondess Hadj author non-byline.; Tiev Kiet author non-byline.; Cabane Jean author non-byline.; Hervier Baptiste author non-byline.; Amoura Zahir author non-byline.; Allanore Yannick author non-byline.; Arnault Jean-Philippe author non-byline.; Berthier Sabine author non-byline.; Cazalets Claire author non-byline.; Ly Kim author non-byline.; Sparsa Agnès author non-byline.; Sibilia Jean author non-byline.; Ninet Jacques author non-byline.
• Is Part Of: Annals of the rheumatic diseases. Volume 75:Issue 6(2016)
• Page Start: 1009
• Page End: 1015
• Publication Date: 2015-05-20
• Subjects: Autoimmune Diseases -- Patient perspective -- Treatment; Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/annrheumdis-2014-207001
• Languages: English
• ISSNs: 0003-4967

Abstract

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.