Erectile Dysfunction Treatment May Also Treat Blood Vessel Narrowing in Rheumatic Diseases

When used in addition to other treatments, tadalafil is effective and well tolerated in the treatment of secondary Raynaud’s phenomenon, according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in San Francisco, Calif.

In Raynaud's phenomenon blood vessels narrow abnormally when exposed to cold. This leads on to decreased blood supply to the hands and feet. Typically, Raynaud’s phenomenon results in episodic attacks where the fingers turn white and blue—sometimes accompanied by fingertip ulcers—and burn, tingle, turn red, throb, go numb, or swell. Raynaud’s phenomenon can exist alone (primary), or as a secondary condition to other diseases, such as scleroderma and lupus. Primary Raynaud’s phenomenon affects up to 5 percent of the general population. Secondary Raynaud’s phenomenon is less common than primary, but is considered more serious because the constriction of blood vessels occurs also in the internal organs.

Researchers recently studied the effectiveness and tolerability of tadalafil (Cialis®) 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—the majority of whom were females with an average age of 37—were randomly selected to receive either tadalafil (20 mg every-other-day) or placebo for six weeks as an add-on treatment to their usual vasodilator therapy. After the initial six weeks, patients were given a seven-day break from the tadalafil and placebo and then switched treatment: those initially receiving tadalafil began taking placebo and vice versa. Researchers recorded the frequency and duration of Raynaud’s episodes. In addition, they 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 who began the study completed it. Researchers 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.

In addition, patients’ overall assessments, as well as physicians’ overall assessments of Raynaud’s phenomenon, significantly improved while patients were taking tadalafil, and no serious side effects were reported.

“This research has proven the excellent efficacy of tadalafil in the treatment of the Raynaud’s phenomenon and ischemic ulcers secondary to it,” explains Padmanabha Shenoy, MBBS, MD; senior resident; SGPGIMS, department of immunology, Lucknow, India, and lead investigator in the study. “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.”