Use of vasoactive/vasodilating drugs for systemic sclerosis (SSc)-related digital ulcers (DUs) in expert tertiary centres: results from the analysis of the observational real-life DeSScipher study
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DeSScipher is the first European multicentre study on management of systemic sclerosis (SSc), and its observational trial 1 (OT1) evaluated the efficacy of different drugs for digital ulcer (DU) prevention and healing. The aim of this study was to assess current use of vasoactive/vasodilating agents for SSc-related DU in the expert centres by analysing the baseline data of the DeSScipher OT1.
Baseline characteristics of patients enrolled in the OT1 and data regarding DU were analysed.
The most commonly used drugs, in both patients with and without DU, were calcium channel blockers (CCBs) (71.6%), followed by intravenous iloprost (20.8%), endothelin receptor antagonists (ERAs) (20.4%) and phosphodiesterase 5 (PDE-5) inhibitors (16.5%). Of patients, 32.6% with DU and 12.8% without DU received two drugs (p < 0.001), while 11.5% with DU and 1.9% without DU were treated with a combination of three or more agents (p < 0.001). Sixty-five percent of the patients with recurrent DU were treated with bosentan and/or sildenafil. However, 64 out of 277 patients with current DU (23.1%) and 101 (23.6%) patients with recurrent DU were on CCBs alone.
Our study shows that CCBs are still the most commonly used agents for DU management in SSc. The proportion of patients on combination therapy was low, even in patients with recurrent DU: almost one out of four patients with current and recurrent DU was on CCBs alone. Prospective analysis is planned to investigate the efficacy of different drugs/drug combinations on DU healing and prevention.
• The analysis of DeSScipher, the first European multicentre study on management of SSc, has shown that the most commonly used vasoactive/vasodilating drugs for DU were CCBs, followed by intravenous Iloprost, ERAs and PDE-5 inhibitors.
• More than half of the patients with recurrent DU received bosentan and/or sildenafil.
• However, the proportion of patients on combination therapy of more than one vasoactive/vasodilating drug was low and almost one out of four patients with current and recurrent DU was on CCBs alone.
KeywordsDigital ulcer Management Systemic sclerosis
This study, as part of the DeSScipher project, was supported by the European Community’s Framework Programme 7 (FP7-HEALTH-2012.2.4.4-2 Observational trials in rare diseases; grant agreement no. 305495). The authors report personal fees and non-financial support (to LV) from the European Union Seventh Framework Program 7 (FP7-HEALTH-2012.2.4.4-2 Observational trials in rare diseases]; grant agreement no. 305495).
Compliance with ethical standards
Ethical approval had been obtained from all participating centres’ local ethics committees, according to the declaration of Helsinki and its later amendments. Each patient signed a written informed consent form.
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