Mayo Clinic researchers investigate drug's possible link to valvular heart disease

December 10, 2002

ROCHESTER, Minn. -- Mayo Clinic researchers are raising concerns about the potential association between the drug pergolide and valvular heart disease.

Pergolide mesylate is used to treat patients with Parkinson's disease and restless legs syndrome. To date, valvular heart disease has not been linked to patients using pergolide. However, in the current issue of Mayo Clinic Proceedings researchers describe three patients who were diagnosed as having valvular heart disease while receiving long-term pergolide therapy. The observations are similar to the findings in 1997 that were detected with fenfluramine and phentermine (fen-phen).

The physicians recommend that patients should discontinue taking pergolide if valvular disease is detected and no other cause identified. More studies are needed to determine the incidence of valvular disease and the spectrum of abnormalities seen with pergolide treatment.

"The clinical, echocardiographic and pathologic findings in our three patients suggest that pergolide treatment may cause valvular disease," said Raul Espinosa, M.D., of the Mayo Clinic Division of Cardiovascular Diseases and Internal Medicine and the principal author of the article.

In an accompanying editorial in Mayo Clinic Proceedings, Shahbudin Rahimtoola, M.B, FRCP, Distinguished Professor at the University of Southern California and professor of medicine at the Keck School of Medicine, outlines a potential study to ascertain the findings of the Mayo Clinic researchers. He said a well-designed prospective study should be conducted at three to four medical centers with experienced cardiologists and advanced laboratories and equipment. Ideally, Dr. Rahimtoola said the patients should undergo clinical cardiac evaluation (history, physical examination, electrocardiography, chest radiography) and two-dimensional echocardiographic and Doppler studies.

And although he said that further study is needed, the findings, thus far, are important. "Is the association with use of the drug real? Yes, until proven otherwise," said Dr. Rahimtoola. "One could argue that this is a report of only three patients and that we should wait for more cases; however, try telling that to patients and families of those who subsequently develop valvular heart disease that requires valve replacement."

The three patients that Mayo physicians examined had leaking or backward flow in the tricuspid valve in the heart. The tricuspid valve separates the right atrium from the right ventricle and prevents blood from flowing back into the right atrium during contraction of the ventricle. The patients were examined from September 2000 to April 2002 at Mayo Clinic in Rochester, Minn. The patients -- all women, ages 61, 72 and 74 -- were not taking any other drugs that have been found to produce similar valvular disease. And all three were taking pergolide. The first two patients also had moderate aortic and mitral regurgitation.
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Other physicians who assisted Dr. Espinosa in the article are: Allison Pritchett, M.D., John Morrison, M.D., and Heidi Connolly, M.D., of the Mayo Clinic Division of Cardiovascular Diseases and Internal Medicine; William Edwards, M.D., of the Mayo Clinic Division of Anatomic Pathology; and Hartzell Schaff, M.D., of the Mayo Clinic Division of Cardiovascular Surgery.

Mayo Clinic Proceedings is a peer-reviewed and indexed general internal medicine journal, published for more than 75 years by Mayo Foundation, with a circulation of 130,000 nationally and internationally.

To obtain the latest news releases from Mayo Clinic, go to www.mayoclinic.org/news. MayoClinic.com (www.mayoclinic.com) is available as a resource for your health stories.

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