Randomized Placebo-Controlled Crossover Trial of Tadalafil in Raynaud’s Phenomenon Secondary to Systemic Sclerosis

Article Figures & Data

Table 1.

Baseline characteristics of the study patients.

Demographic and Clinical Variables
Patients, n	39
Age, yrs	52.9 ± 10.6
Ethnicity, n (%)
Caucasian	36 (92.3)
African	1 (2.6)
Other	2 (5.2)
Disease classification, n (%)
Limited SSc	29 (74.4)
Diffuse SSc	10 (25.6)
RP duration, yrs	11.8 ± 10
Average RP attacks/wk, baseline	20.7 ± 12.3
Average RCS in cm, baseline	3.76 ± 1.83

SSc: systemic sclerosis; RP: Raynaud’s phenomenon; RCS: Raynaud Condition Score.

Table 2.

Concomitant medications.

CCB: calcium channel blockers; ACEI: angiotensin converting enzyme inhibitor; ARB: angiotensin receptor blocker; ERT: estrogen replacement therapy; SSRI: selective serotonin reuptake inhibitor.

Table 3.

Results of the mean RCS, mean RP frequency, and mean RP duration in a crossover trial of tadalafil in RP secondary to SSc.

	Baseline	Tadalafil (change from baseline)	Placebo (change from baseline)	p
RCS, cm	3.76 ± 1.83	2.43 ± 2.01 (− 1.33)	2.53 ± 2.22 (−1.23)	NS
RP frequency, per day	2.93 ± 1.67	2.08 ± 1.72 (−0.85)	2.1 ± 1.78 (−0.83)	NS
RP duration, min	53.42 ± 56.38	40.61 ± 63.81 (−12.81)	47.0 ± 77.60 (−6.42)	NS