Prucalopride, marketed under the name Resolor in Europe and Resotran in Canada, can safely manage mild to severe gastrointestinal (GI) symptoms associated with systemic sclerosis (SSc), including bowel movement and transit, reflux disease, and bloating, finds a study published in the journal Arthritis Research and Therapy.
Doctors have proposed using medicines to improve prokinetics, or motility of the GI tract, in treating SSc patients. But the lack of proper clinical trials demonstrating the therapeutic potential of such drugs in the SSc population discouraged their use in clinics.
Few studies in small cohorts have shown that Propulsid (cisapride), a prokinetic approved by the U.S. Food and Drug Administration, could help manage upper GI symptoms and improve colonic transit in SSc patients. However, Propulsid can provoke severe cardiac side effects, leading to its withdrawal from the market in several countries.
Meanwhile, scientists have developed novel prokinetic medicines with fewer adverse cardiac side effects, but these drugs have not yet explored as a therapy for SSc-associated GI tract dysfunction.
In the study, “Preliminary safety and efficacy profile of prucalopride in the treatment of systemic sclerosis (SSc)-related intestinal involvement: results from the open label cross-over PROGASS study,” Italian researchers assessed the potential of the prokinetic drug prucalopride to manage GI tract symptoms in a small cohort of SSc patients.
The PROGASS trial (EudraCT2012-005348-92) included 40 SSc patients with self-reported mild to moderately severe GI symptoms. Researchers randomly assigned them to receive 2 mg per day of prucalopride or placebo treatment. After one month, all participants underwent a two-week washout period, after which they switched treatment regimens with the other group.
Seven participants withdrew due to persistent side effects such as headache, abdominal pain, dizziness and the sensation of feeling sick, while four patients were excluded from the study for not following protocols.
“About 70 percent of study participants ranked the efficacy of the treatment as very/extremely effective,” researchers wrote. “The proportion of patients achieving more than three defecations per week, which is the threshold to define normal colonic function, was much higher in the treatment arm than in the non-treatment arm.”
Patients on prucalopride also reported a significantly reduced sensation of bloating, and slashed by 65.9 minutes the time for a complete bowel movement during treatment period compared to placebo.
Overall, researchers concluded that “prucalopride seems to be well-tolerated and effective in patients with SSc with mild to moderately severe constipation, favoring defecation, reducing bloating and ameliorating GERD.”
Further studies with a larger cohort are still necessary to evaluate prucalopride’s efficacy in a wider scleroderma population — and for a longer treatment period — in order to identify those who may benefit the most from the drug.