Scleroderma

Adding tadalafil (Cialis®; Adcirca®) to the treatment of people with Scleroderma can improve Raynaud’s phenomenon symptoms and heal and prevent hand and finger ulcers associated with it, according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in Atlanta.

Scleroderma (more formally called systemic sclerosis) is a rheumatic disease that results in the thickening and tightening of skin, as well as a build-up of scar tissue and damage to internal organs. Scleroderma is a relatively uncommon problem, affecting only 200 to 300 people per million in the U.S. Some 12 to 20 new cases per million are diagnosed annually. Effective treatments are available for some forms of the disease, although scleroderma is not yet curable.

The majority of patients with scleroderma also suffer from Raynaud's phenomenon – structural damage of the blood vessels that cause them to react abnormally to the cold. Raynaud’s phenomenon is commonly marked by discoloration of the hands, fingers and toes. This occurs due to poor blood flow and, in severe cases, can lead to damage such as finger ulcers, gangrene and scarring. These problems may adversely affect the functioning of the hands and quality of life during winter months.

Researchers recently completed a study to evaluate the effectiveness of adding tadalafil, a drug that can increase arterial blood flow and is commonly used to treat erectile dysfunction, to treat Raynaud's phenomenon in people with scleroderma. They studied 53 patients—of which 50 were women—whose average age was almost 37 years and who had suffered from scleroderma, on average, for almost six years. Twenty-six of the participants had limited scleroderma (which only occurs in the forearms, hands, legs, feet and face) and 27 had diffuse scleroderma (which can affect almost any area of the body). All participants met the American College of Rheumatology’s criteria for scleroderma diagnosis and had at least four Raynaud’s attacks per week.

The participants were monitored for one week to determine the initial severity of their disease and then were placed into two groups. The first group, of 26 participants, received placebo to take every-other-day in addition to their usual vasodilators (medication used to relax and widen blood vessels). The second group, of 27 participants, was given 20mg of tadalafil to take every-other-day in addition to their existing vasodilators. Participants in both groups did not know what treatment they were receiving and followed their treatment assignment for eight weeks.

Researchers then monitored the progress of each participant. They noted the number of daily Raynaud’s attacks and other measures of Raynaud’s, including the length of each individual attack, healing of existing hand and finger ulcers, appearance of new finger ulcers and improvement in scleroderma symptoms based on health and quality of life assessment questionnaires.

Researchers noticed that improvement in the tadalafil group was significantly better than in the placebo group. At the beginning of the study, 18 patients in the tadalafil group had ulcers as compared to 13 patients in the placebo group. Following treatment with tadalafil, 14 out of 18 of those patients healed completely as compared to five out of 13 patients in the placebo group.

Further results revealed that new ulcers appeared in only one patient in the tadalafil group as compared to nine patients in the placebo group. Additionally, other symptoms such as dyspnea (difficulty breathing), Raynaud’s phenomenon and digital ulcers were greatly improved in those taking tadalafil. Finally, researchers noted that side effects were similar in both groups and no serious side effects were observed.

These results led researchers to believe that adding tadalafil to existing Raynaud's phenomenon therapy may be of great benefit to people with scleroderma.

“Tadalafil, in combination with other vasodilators, not only improves the number, duration and severity of Raynaud’s attacks, but also heals the existing digital ulcers as compared to placebo,” explains Vikas Agarwal, MD; associate professor of clinical immunology at the Sanjay Gandhi Postgraduate Institute of Medical Sciences and lead investigator in the study. “In addition to preventing the development of new digital ulcers, tadalafil in combination with other vasodilators marks the beginning of new phase of oral therapeutic options available for severe scleroderma.”

Patients should talk to their rheumatologists to determine their best course of treatment.

Source: Newswise (2010), "Erectile Dysfunction Drug Could Improve Raynaud’s Symptoms Associated with Scleroderma"; full article can be viewed here.