Data may lead to new FDA-approved treatment for IBS
Pinaverium offers quick and effective relief of irritable bowel syndrome (IBS) symptoms, according to clinical trial results published in Clinical Gastroenterology and Hepatology, the official clinical practice journal of the American Gastroenterological Association.
Pinaverium bromide (pinaverium), an antispasmodic, is used widely in many countries around the world, including European countries, Canada and Mexico. However, original clinical studies on pinaverium are scarce and there has been no convincing evidence for its effectiveness and safety. As such, the U.S. Food and Drug Administration (FDA) has not approved this treatment for use in the U.S.
"There is no cure for IBS, and no gold standard of treatment. To help our patients suffering from this disorder, we need to gather reliable data to evaluate the effectiveness and safety profile of new treatment options," said lead study author Liang Zheng from the department of gastroenterology, the Second Jiangsu Provincial Hospital of Chinese Medicine, Nanjing University of Chinese Medicine. "This study confirms that pinaverium is an effective and safe option for IBS patients, making it a viable first-line therapy for patients. Hopefully, our findings will help FDA in its evaluation of pinaverium to potentially bring this drug to patients in the U.S."
Researchers conducted a double-blind, randomized, placebo-controlled clinical trial to evaluate the safety and efficacy of pinaverium. Patients with IBS, based on Rome III criteria, were assigned randomly to groups given pinaverium or placebo at four hospitals in China, from August 2012 through December 2013. A significantly higher percentage of patients receiving pinaverium reported that their IBS symptoms improved (60 percent) than in the placebo group (34 percent). In the pinaverium group, 29 percent of patients believed that their IBS symptoms stayed the same and 11 percent said they worsened.
Pinaverium was not associated with severe adverse effects; common side effects included nausea (3.7 percent), dizziness (3.2 percent), increased blood pressure (2.3 percent) and abdominal discomfort (2.3 percent).
Pinaverium is a type of antispasmodic, an agent that improves IBS symptoms (abdominal pain, bloating and disturbed defecation) by directly relaxing the colonic smooth muscle cells or antagonizing the excitatory neuromuscular neurotransmission. Antispasmodics remain one of the most commonly prescribed groups of medications for the treatment of IBS, with few adverse effects.
There are currently five approved treatments for IBS in the U.S. Most recently, FDA approved Viberzi and Xifaxan for diarrhea-predominant IBS in May 2015.
IBS is the most common chronic (life-long in some patients) and highly recurrent gastrointestinal disorder, with an estimated worldwide prevalence of 10 to 15 percent.