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Researchers see link between heart valve damage and Parkinson's drugs

Research finds that the Parkinsonís disease drugs Permax and Dostinex/ Cabaser may cause heart valve damage

Research published in the New England Journal of Medicine (NEJM) has found that the ergot-derived dopamine receptor agonists used to treat Parkinson's disease (PD), Permax (pergolide) and Dostinex/ Cabaser (cabergolide), may cause heart valve damage.

Both drugs reduce PD symptoms by mimicking the effects of dopamine, a neurotransmitter lacking in PD patients due to neuronal deterioration. The gradual destruction of dopamine-producing neurons eventually leads to the jerky movements seen in patients with the disease.

Valeant Pharmaceuticalís Permax is approved for the treatment of PD in the US, while Pfizerís Dostinex/ Cabaser is only approved for the treatment of the hormonal disorder, hyperprolectinaemia, but has been approved in other countries for the treatment of PD and is sometimes prescribed off-label in the region.

Dr Renzo Zanettini and fellow researchers from the Instituti Clinici di Perfezionamento in Milan, Italy, looked at the medical records of 11,417 patients aged between 40 and 80 who had received any PD medication between 1988 and 2005.

In the sample, 31 patients were diagnosed with cardiac-valve regurgitation, where blood leaks back across the valve and reduces the heart's ability to pump blood around the body. Of those with the condition, 12 had been taking either pergolide or cabergolide for up to a year before diagnosis. Patients on other PD meds did not have any increased risk of developing valve regurgitation.

Zanettini found that pergolide and cabergolide increase risk for a heart valve condition by seven and five times, respectively, compared with patients on a different drug.

Permax already has a black-box warning label about the increased risk of heart-valve problems, based on a small number of patients who were diagnosed with this problem. A milder warning was recently placed on Dostinex. It remains unclear if the recent data will change either label.

Zanettini said: "Our findings suggest that follow-up monitoring is advisable in all patients with PD who are treated with dopamine agonists."

According to Wolters Kluwer Health, FY06 US sales of Permax were approximately USD 2m, while those of generic equivalents reached around USD 12m. Dostinex sales in the same time period were USD 20m.

15th August 2007

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