058. REPOSITIONING SILDENAFIL IN RAYNAUD’S: A REAL-WORLD EXPERIENCE

Abstract

Background: Recent studies of phosphodiesterase type 5 (PDE5) inhibitors have shown varied clinical benefit in patients with Raynaud's phenomenon. This audit aimed to examine the use of the PDE5 inhibitor sildenafil following its off-patent availability and to investigate whether its repositioning in the management of patients with digital vasculopathy will maximize efficiency and reduce costs in treating digital vasculopathy. Methods: Patients with Raynaud's phenomenon, critical digital ischaemia or digital ulceration were identified using medical records at Aintree University Hospital Trust. Patients who received a prescription of iloprost or sildenafil from 1 April 2012 to 31 December 2015 for the management of Raynaud's phenomenon, critical digital ischaemia or digital ulceration were included. A sub-population was selected from these patients; those who were prescribed sildenafil between 1 October 2014 and 31 March 2015. Patients under 16 years of age and patients with pulmonary artery hypertension were excluded. Outcome measures used were: the number of iloprost prescriptions before and after generic availability of sildenafil and the outcome of sildenafil treatment on Raynaud's symptoms, digital ulcer healing and iloprost requirement. Results: There was a 27% decrease in the number of prescriptions of iloprost when comparing the 2 years pre and post generic sildenafil adoption on the treatment pathway. A sub-population of 34 patients who received sildenafil as a new prescription between 1 October 2014 and 31 March 2015 were identified: these subjects' clinical records were reviewed in detail to 31 December 2015. 68% of these patients reported that the number and duration of Raynaud's attacks were slightly or significantly better within 8-12 weeks of commencing sildenafil. 64% of patients with digital ulcers experienced healing of their ulcers while taking sildenafil. Approximately 50% of patients experienced some side effects on sildenafil, with headache and dizziness most commonly reported; most of these side effects were acceptable to the patients and sildenafil was continued in the majority. Conclusion: There has been a reduction in use of iloprost since sildenafil became generically available that has led to a significant cost saving. Most patients noticed improvements in Raynaud's severity and digital ulcer healing following sildenafil use. A prospective study is recommended which uses a validated measurement instrument for digital vasculopathy severity before and after sildenafil use. A high quality study would help to set national guidelines on the use of sildenafil in digital vasculopathy.