Hachulla E1Hatron PY1Carpentier P2Agard C3Chatelus E4Jego P5Mouthon L6Queyrel V7Fauchais AL8Michon-Pasturel U9Jaussaud R10Mathian A11Granel B12Diot E13Farge-Bancel D14Mekinian A15Avouac J16Desmurs-Clavel H17Clerson P18SEDUCE study group.

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.

Suscribe to our newsletter

By clicking on the link below, you will be redirected to Youtube. Third-party cookies may then be installed on your browser. These cookies are not implemented directly by the Soladis Clinical Studies site but by the site to which you connect.
Important: these cookies are subject to their own privacy policies and are in no way the responsibility of Soladis.
You can view Youtube's cookie policy by clicking on the following link: Google – Privacy & terms

  Follow Soladis on Youtube

By clicking on the link below, you will be redirected to LinkedIn. Third-party cookies may then be installed on your browser. These cookies are not implemented directly by the Soladis Clinical Studies site but by the social network site to which you connect.
These cookies are subject to their own privacy policies and are in no way the responsibility of Soladis.
You can view LinkedIn's cookie policy by clicking on the following link :  LinkedIn – Cookie Policy

Follow Soladis on LinkedIn

En cliquant sur le lien ci-dessous, vous allez être redirigé vers Youtube. Des cookies tiers peuvent alors être installés sur votre navigateur. Ces cookies ne sont pas implémentés directement par le site Soladis Clinical Studies mais par le site auquel vous vous connectez.
Important : ces cookies sont soumis à leurs propres politiques de confidentialité et ne relèvent en aucun cas de la responsabilité de Soladis.
Vous pouvez consulter la politique de Youtube en matière de cookies en cliquant sur le lien suivant : Google – Règles de confidentialité et conditions d’utilisation

  Suivre Soladis sur Youtube

En cliquant sur le lien ci-dessous, vous allez être redirigé vers LinkedIn. Des cookies tiers peuvent alors être installés sur votre navigateur. Ces cookies ne sont pas implémentés directement par le site Soladis Clinical Studies mais par le site de réseau social auquel vous vous connectez.
Ces cookies sont soumis à leurs propres politiques de confidentialité et ne relèvent en aucun cas de la responsabilité de Soladis.
Vous pouvez consulter la politique de LinkedIn en matière de cookies en cliquant sur le lien suivant : LinkedIn – Politique relative aux cookies

  Suivre Soladis sur LinkedIn