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Pinaverium safely reduces IBS symptoms
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Results from a randomized controlled trial showed pinaverium bromide, an antispasmodic commonly used around the world but not currently approved by the FDA, quickly and safely reduces symptoms of irritable bowel syndrome.
“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,” Liang Zheng, MD, from the department of gastroenterology, the Second Jiangsu Provincial Hospital of Chinese Medicine, Nanjing University of Chinese Medicine, said in a press release.
Because clinical studies of pinaverium are limited, Zheng and colleagues performed a multicenter placebo-controlled clinical trial to evaluate its efficacy and safety profile. From August 2012 to December 2013, they randomly assigned 427 patients with IBS from four Chinese hospitals to receive either 50 mg pinaverium 3 times daily (n = 218) or placebo (n = 209). The primary endpoints were reduced abdominal pain and improved stool consistency based on recommendations by the FDA, and secondary endpoints included average weekly frequency of abdominal pain, daily stool, abdominal discomfort and weekly average of daily worst abdominal discomfort.
Intention-to-treat analysis showed 50% of the treatment group met either primary endpoint at week 2 compared with 22% of the placebo group, and 77.5% of the treatment group met either primary endpoint at week 4 compared with 33.5% of the placebo group (both P < .001). Furthermore, 76.1% of the treatment group saw at least one improved secondary endpoint at week 2 and 91.7% did at week 4 (P < .001 for both compared with placebo).
Of the 368 patients who completed an IBS global symptom relief survey at the end of treatment, 60% of the treatment group reported improved symptoms compared with 34% of the placebo group (P < .001). No severe adverse effects occurred, and adverse events were comparable between groups. Common side effects of pinaverium were nausea (3.7%), dizziness (3.2%) increased blood pressure (2.3%) and abdominal discomfort (2.3%).
“This study confirms that pinaverium is an effective and safe option for IBS patients, making it a viable first-line therapy for patients,” Zheng said in the release. “Hopefully, our findings will help FDA in its evaluation of pinaverium to potentially bring this drug to patients in the U.S.” – by Adam Leitenberger
Disclosure: The researchers report no relevant financial disclosures.
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