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OP0058 Efficacy of Sildenafil on Ischaemic Digital Ulcer Healing in Systemic Sclerosis: The Placebo-Controlled Seduce Study
  1. E. Hachulla1,
  2. P.-Y. Hatron2,
  3. P. Carpentier3,
  4. C. Agard4,
  5. E. Chatelus5,
  6. P. Jego6,
  7. L. Mouthon7,
  8. V. Queyrel8,
  9. A.-L. Fauchais9,
  10. U. Michon-Pasturel10,
  11. R. Jaussaud11,
  12. A. Mathian12,
  13. B. Granel13,
  14. E. Diot14,
  15. D. Farge-Bancel15,
  16. A. Mekinian16,
  17. J. Avouac17,
  18. H. Desmur-Clavel18,
  19. P. Clerson19
  20. on behalf of the SEDUCE Study Group
  1. 1Médecine Interne
  2. 2CHRu Claude Huriez, Lille
  3. 3Médecine Vasculaire, CHU Grenoble, Grenoble
  4. 4Médecine Interne, Hôpital Hôtel Dieu, Nantes
  5. 5Service de Rhumatologie, Hôpital Hautepierre, Strasbourg
  6. 6Médecine Interne, CHR Rennes Sud, Rennes
  7. 7Médecine Interne, Hôpital Cochin, Paris
  8. 8Médecine Interne, Hôpital de l'Archet 1, Nice
  9. 9Médecine Interne, Hôpital Dupuytren, Limoges
  10. 10Médecine Vasculaire, Hôpital Saint Joseph, Paris
  11. 11Médecine Interne, Hôpital Robert Debré, Reims
  12. 12Médecine Interne 2, Hôpital Pitié-Salpêtrière, Paris
  13. 13Médecine Interne, Hôpital Nord, Aix Marseille Université, Maseille
  14. 14Médecine Interne, Hôpital Bretonneau, Tours
  15. 15Médecine Interne, Hôpital Saint Louis, Paris
  16. 16Médecine Interne, Hôpital Jean Verdier, Bondy
  17. 17Rhumatologie A, Hôpital Cochin, Paris
  18. 18Médecine Interne, Hôpital Edouard Herriot, Lyon
  19. 19Orgamétrie Biostatistiques, Roubaix, France


Background Previous data suggested an effect of sildenafil on digital ulcer (DU) healing in Scleroderma (SSc) patients, which needed to be validated in a large randomized controlled study.

Objectives To assess the effect of sildenafil, a PDE-5 inhibitor, on DU healing in SSc.

Methods Randomised, placebo-controlled study in SSc patients to assess the effect of sildenafil 20 mg or placebo, 3 times daily for 12 weeks on ischaemic DU healing. The primary endpoint 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 (ITT) analysis involved 83 patients with a total of 192 DUs (89 in the sildenafil group and 103 in the placebo group). The hazard ratio (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 (PP) 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 to the placebo group at week (W) 8 (1.23±1.61 versus 1.79±2.40 p=0.04) and W12 (0.86±1.62 versus 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 endpoint was not reached in ITT, 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 to placebo at W8 and W12, confirming a sildenafil benefit.

Acknowledgements We gratefully acknowledge the Groupe Francophone de Recherche sur la Sclérodermie (GFRS), and the French Scleroderma Patients' Association (Association des Sclérodermiques de France [(ASF]) which helped to distribute the study protocol to its members.

This study was supported by an unrestricted research grant from PFIZER. The sponsor had no role in the design of the study, the collection and analysis of the data, or in the preparation of the manuscript.

Disclosure of Interest E. Hachulla Grant/research support from: PFIZER, P.-Y. HATRON: None declared, P. CARPENTIER: None declared, C. AGARD: None declared, E. CHATELUS: None declared, P. JEGO: None declared, L. MOUTHON: None declared, V. QUEYREL: None declared, A.-L. FAUCHAIS: None declared, U. MICHON-PASTUREL: None declared, R. JAUSSAUD: None declared, A. MATHIAN: None declared, B. GRANEL: None declared, E. DIOT: None declared, D. FARGE-BANCEL: None declared, A. MEKINIAN: None declared, J. AVOUAC: None declared, H. DESMUR-CLAVEL: None declared, P. CLERSON: None declared

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