Dr. Padmanabha Shenoy, from the department of immunology, says that when used in addition to other treatments, tadalafil is effective and well tolerated in the treatment of secondary Raynaud's phenomenon, in which blood vessels narrow abnormally when exposed to cold and blood supply to the hands and feet decreases as a result.
During the study, the research team studied the effectiveness and tolerability of tadalafil as an additional therapy to treat patients with secondary Raynaud's phenomenon, who had not successfully responded to treatment with vasodilators-a common treatment that relaxes the smooth muscles in blood vessels.
Twenty-five patients, mostly females with an average age of 37, were randomly selected to receive either tadalafil or placebo for six weeks as an add-on treatment to their usual vasodilator therapy.
After the initial six weeks, patients received a seven-day break, and then those initially administered tadalafil began taking placebo, and vice versa.
The researchers recorded the frequency and duration of Raynaud's episodes.
They also watched for the healing of existing and the appearance of new fingertip ulcers, and performed physician and patient assessments of the overall severity of Raynaud's phenomenon.
Twenty-four of the 25 patients completed the study.
It was found that when taking tadalafil, the average daily frequency and duration of Raynaud's episodes experienced by patients were less: 2.23 episodes versus 3.36, and 31.5 minutes versus 53.9 minutes respectively.
All the 24 ulcers present at the start of treatment healed while on tadalfil, compared to only three out of 13 while on placebo. One new fingertip ulcer was reported while taking tadalafil; 13 new ulcers were reported while on placebo.
The researchers also said that patients' overall assessments, as well as physicians' overall assessments of Raynaud's phenomenon, significantly improved while patients were taking tadalafil, without any serious side effects.
"This research has proven the excellent efficacy of tadalafil in the treatment of the Raynaud's phenomenon and ischemic ulcers secondary to it. This study also generates a new hope in the treatment of scleroderma, which is currently incurable.
It has to be seen in further studies whether tadalafil can improve survival in scleroderma patients," says Padmanabha Shenoy.
The findings of the study were presented at the American College of Rheumatology Annual Scientific Meeting in San Francisco, California.