Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.
Efficacy of Tadalafil in Raynaud's Phenomenon Secondary to Systemic Sclerosis: A Double Blind Randomized Placebo Controlled Parallel Group Multicentric Study.
Agarwal8, Vikas, Ghosh6, Parasar, Sharma7, Aman, Bhakuni5, Darshan Singh, Kumar1, Sudeep, Singh1, Upendra Narayan, Vijayvergiya3, Rajesh
To evaluate the efficacy of Tadalafil in Raynaud's phenomenon (RP) secondary to systemic sclerosis (SSc).
Patients with scleroderma (as per ACR criteria) having >=4 Raynaud's attacks/week were randomized to receive either placebo or Tadalafil (20 mg) on alternate days as add-on-therapy to their current vasodilators for eight weeks. Primary end points were improvement in RP parameters (daily frequency, duration and Raynaud's condition score [RCS]) and healing of existing digital ulcers (DU). Secondary outcome measures were appearance of new DU and improvement in scleroderma specific health assessment questionnaire (SHAQ) and quality of life (QoL) indices.
We conducted a multicenter, randomized, placebo-controlled study with a 1-week run-in period to determine baseline severity, followed by a 8-week double-blind treatment phase. Fifty three patients (26 limited, 27 diffuse SSc, 50 females) with mean age 36.8 years and mean disease duration 62.8 months were recruited in the study. All the patients were receiving vasodilators (Calcium channel blockers n=38, angiotensin receptor blockers n=16, angiotensin converting enzyme inhibitors n=8 and a combination of two vasodilators n=13. Twenty six patients were randomized to placebo and 27 to Tadalafil arm. Baseline frequency, duration and severity of RP were not different between the two groups. Improvement in mean daily frequency, mean daily duration of RP and mean daily RCS was significant in the Tadalafil group (p<0.001, <0.001, <0.05, respectively), placebo (p=0.77, 0.821, 0.209, respectively) as compared to the baseline RP parameters. The mean change in daily frequency (p=0.01), duration (p=0.063) and severity (p=0.039) of RP was significantly better in the Tadalafil group as compared to placebo group. Eighteen patients in the Tadalafil group had DU as compared to 13 patients in the placebo group at baseline. Following treatment, DU healed completely in 14/18 patients in the Tadalafil group as compared to 5/13 patients in the placebo group (p=0.026). New DU appeared in one patient in the Tadalafil group as compared to 9 patients in the placebo group (p=0.004). Questions related to dyspnea (Q2), Raynaud's phenomenon (Q4) and digital ulcers (Q5) of SHAQ improved significantly in the Tadalafil group. Adverse events (AE) were similar between the two groups. No serious AE was observed.
Tadalafil as add-on therapy improves symptoms of RP, heals the existing DU and prevent new DU in patients with scleroderma.
Clinicaltrials.gov identifier: NCT01117298
To cite this abstract, please use the following information:
Agarwal, Vikas, Ghosh, Parasar, Sharma, Aman, Bhakuni, Darshan Singh, Kumar, Sudeep, Singh, Upendra Narayan, et al; Efficacy of Tadalafil in Raynaud's Phenomenon Secondary to Systemic Sclerosis: A Double Blind Randomized Placebo Controlled Parallel Group Multicentric Study. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :2086