A Meta-Analysis of Phosphodiesterase 5 Inhibitors for the Treatment of Raynaud's Phenomenon

Janet E. Pope¹, Fadumo Rirash², Paul Tingey³, Sarah Harding⁴, Lara J. Maxwell⁵, Jordi Pardo⁶, Elizabeth Ghogomu⁷, Peter Tugwell⁸ and George A. Wells⁹, ¹University of Western Ontario, London, ON, Canada, ²Medicine/Rheumatology, University of Western Ontario, London, ON, Canada, ³Faculty of Medicine, University of Queensland, Brisbane, Australia, ⁴ERLanger, ERLanger, KY, ⁵Centre for Global Health, Institute of Population Health, University of Ottawa, Ottawa, ON, Canada, ⁶University of Ottawa, Ottawa, ON, Canada, ⁷University of Ottawa, Cochrane Musculoskeletal Group, Ottawa, ON, Canada, ⁸Center For Global Health, Institute of Population Hlth, Ottawa, ON, Canada, ⁹Cardiovascular Research Reference Centre, University of Ottawa Heart Institute, Ottawa, ON, Canada

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: meta-analysis and systemic sclerosis, Raynaud's phenomenon

Session Information

Date: Tuesday, November 10, 2015

Title: Systemic Sclerosis, Fibrosing Syndromes and Raynaud's - Clinical Aspects and Therapeutics Poster III

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose: To assess the
benefits and harms of phosphodiesterase 5 inhibitors (PDE5) for the
treatment of Raynaud’s phenomenon (RP).

Methods: The Cochrane library, MEDLINE,
EMBASE and Clinicaltrials.gov were searched to June 2014 for randomized
controlled trials (RCTs) examining RP with PDE5. Outcomes of interest were: Frequency
of RP attacks, Duration of attacks, Severity of attacks, Pain, Patient global, Withdrawals
and Serious adverse events. Fixed effects models were used to calculate mean
differences (MD) or standardized mean differences (SMD) for continuous outcomes
and pooled risk ratios (RR) for dichotomous outcomes. Heterogeneity was
determined and was considered significant if I²>50%.

Results: Seven trials (4 with
tadalafil, 2 sildenafil, 1 vardenafil) with an average duration of 5 weeks totaling
255 subjects were included; 97% had RP secondary to systemic sclerosis; SSc).
Trial quality ranged from low to moderate. Many individual trials were not
significantly different from placebo. PDE5 reduced the frequency of attacks by 4.2
attacks/week (95% CI 2.01-6.38) from a baseline of 26 attacks/week, or relative
%change in the frequency of attacks of 22% reduction (95% CI 10-33%). Duration
of attacks decreased by 6 minutes (95% CI 0.5-11); relative %reduction of 24%
(95% CI 2-47%). Severity of RP attacks was assessed in one trial. Raynaud’s
Condition Score (RCS) improved by 0.49 cm (95% CI 0.02-0.95). Pain (VAS
0-10) improved by 1.06 (95% CI 0.09-2.03) with 25% decrease in relative %pain.
The relative %reduction in disability was 39% (95% CI 18-60%). The relative
risk of withdrawals was 4.42 (higher in PDE5 group). The number needed for an
additional harmful outcome (NNTH) was 32 (95% CI 7 to 717). Figure shows the
reduction of RP frequency and duration of attacks. Samples were too small to
detect differences between PDE5 drugs.

Conclusion: PDE5 medications seem to be
effective in treating RP associated with SSc.

Disclosure: J. E. Pope, None; F. Rirash, None; P. Tingey, None; S. Harding, None; L. J. Maxwell, None; J. Pardo, None; E. Ghogomu, None; P. Tugwell, None; G. A. Wells, None.

To cite this abstract in AMA style:

Pope JE, Rirash F, Tingey P, Harding S, Maxwell LJ, Pardo J, Ghogomu E, Tugwell P, Wells GA. A Meta-Analysis of Phosphodiesterase 5 Inhibitors for the Treatment of Raynaud’s Phenomenon [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/a-meta-analysis-of-phosphodiesterase-5-inhibitors-for-the-treatment-of-raynauds-phenomenon/. Accessed .

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