Prospective, open-label, uncontrolled pilot study to study safety and efficacy of sildenafil in systemic sclerosis-related pulmonary artery hypertension and cutaneous vascular complications
Rheumatology International, 08/01/2012
Kumar U et al. – Sildenafil is highly efficacious cheaper and safe alternative to other available therapies for systemic sclerosis–associated pulmonary artery hypertension, Raynaud’s phenomenon, and digital infarcts/ulcers.Methods
- A prospective, open-label, uncontrolled pilot study was done at a tertiary care centre in India to study the safety and efficacy of oral sildenafil in PAH, Raynaud’s phenomenon, digital infarcts, and ulcers in SSc.
- Seventeen patients fulfilling ACR classification criteria for scleroderma and having PAH were recruited.
- Six-minute walk test, WHO class of dyspnoea, severity of Raynaud’s phenomenon, and 2D ECHO were performed in all the study subjects at baseline and at 3 months post-treatment.
- All patients were treated with oral sildenafil 25 mg three times a day for a period of 3 months.
- The pre- and post-treatment values of mean pulmonary artery pressure (PAP), 6-min walk test, WHO class of dyspnoea, and severity of Raynaud’s phenomenon were compared to look for any significant change.
- Sixteen patients who completed 3-month follow-up had shown statistically significant improvement in 6-min walk test, WHO class of dyspnoea, severity of Raynaud’s phenomenon, and mPAP.
- Also, there was no occurrence of new digital infarcts or ulcers, and existing ulcers showed signs of healing.