PDE5 Inhibitors Beneficial in Raynaud's Phenomenon

SAN FRANCISCO, CA—Phosphodiesterase 5 (PDE5) inhibitors appear to be effective in treating Raynaud's phenomenon secondary to scleroderma, investigators concluded at the 2015 ACR/ARHP Annual Meeting.

Janet E. Pope, MD, of the University of Western Ontario in London, Ontario, Canada, and colleagues searched the Cochrane library, MEDLINE, EMBASE, and ClinicalTrials.gov for randomized controlled trials of the treatment of Raynaud's phenomenon with PDE5 inhibitors.

They specifically focused on the following outcomes for Raynaud's phenomenon: frequency, duration and severity of attacks; pain, patient global assessments, treatment withdrawals, and serious adverse events. Secondary outcomes included Raynaud's Condition Score (RCS), function, general improvement, physician global assessment of Raynaud's phenomenon, change in digital ulceration, and side effects.

A total of seven trials were identified comprising 255 subjects, 97% of whom had Raynaud's phenomenon secondary to systemic sclerosis; 4 with tadalafil, 2 with sildenafil, and 1 with vardenafil. Average duration of treatment was 5 weeks.

“Trial quality ranged from low to moderate,” Dr. Pope stated. “Many individual trials were not significantly different from placebo.”

They found that from a baseline of 26 attacks per week, the PDE5 inhibitors reduced frequency of these attacks by 4.2 per week (95% confidence interval [CI]: 2.01, 6.38), a relative reduction of 22% (95% CI: 10, 33).

In addition, duration of attacks decreased by 6 minutes (95% CI: 0.5, 11), a relative reduction of 24% (95% CI: 2, 47%).

One trial assessed the severity of the Raynaud's phenomenon attack. In this trial, the Raynaud's Condition Score (RCS) improved by 0.49cm (95% CI: 0.02, 0.95); in addition, pain improved by 1.06 (VAS 0–10) (95% CI: 0.09, 2.03), a 25% relative decrease. Use of PDE5 inhibitors resulted in more improvements in physician global assessment (RR -2.85, 95% CI: -4.73, -0.97) compared to placebo. Healing of existing (RR 3.95, 95% CI: 2.20, 7.19) and prevention of new (RR 0.11, 95% CI: 0.03, 0.45) were better with use of PDE5 inhibitors. 

“The number needed for an additional harmful outcome (NNTH) was 32 (95%: CI 7, 717),” Dr. Pope noted. However, “samples were too small to detect differences between PDE5 drugs.”

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