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Dopamine agonists and damage to heart valves PDF Print
Saturday, January 20 2007

How to protect oneself without losing the benefits

Press conference on January, 31 2007

Interview of Prof Pezzoli, AIP president and author of the study that showed that dopamine agonists can damage heart valves.

 

 

The study is well known in the medical field and its message has been repeatedly published and extensively disseminated by the media. Why a press conference?

The study has truly become news. This was to be expected, because it has been published in one of the most famous and most read medical journals of the world, the New England Journal of Medicine (Zanettini e coll, New Engl J Med 2007; 356: 29-46 The objective of the Press Conference was not to disseminate the news any further, but to create an opportunity to reply to the questions of patients, who understandably are worried and confused. The heart is a very important organ and they fear the damage to heart valves due to overgrowth of fibrotic tissue, but they also fear worsening considerably if they discontinue dopamine agonists, which are a class of very effective drugs for the control of the motor symptoms of Parkinson’s disease. It should be borne in mind that this dilemma regards the majority of patients with Parkinson’s disease. For this reason I believe that they should be given the possibility to speak directly to the authors of the study, who are the most competent neurologists to answer their questions When and where will the press conference take place ? The journalists are invited to lunch at the Dulcis in fundo, via Zuretti, 55 in Milano on 31 January 2006. What will the neurologists say to patients ? In essence, that the neurologist must take each case into consideration separately, assessing the risk/benefit ratio in each patient thoroughly. In any case, all the patients who have been treated with an ergot-derived dopamine agonist should undergo an echocardiographic examination to check the status of their heart valves. Should they decide to continue treatment with an ergot-derived dopamine agonist, the echocardiographic examination should be repeated periodically.

How did you have the idea to assess the class of dopamine agonists to see whether they damage heart valves ?

Cases of inexplicable severe heart failure had been observed for some time. I remember several cases amongst my own patients. I recall two typical cases: A young patient of mine, in good general conditions, went swimming, had difficulty in returning to shore and ran the risk of drowning. After having been rescued and brought to shore, he was found to have heart failure due to a pleural and pericardial effusion. Another typical patient was a friend who worked hard for AIP; after having been treated with pergolide for many years, he developed cardiopulmonary fibrosis that was difficult to explain We knew that ergot-derived dopamine agonists could cause pulmonary fibrosis very rarely, but this did not justify the above described cases. In 2003/2004 cases of valvular fibrosis associated with pergolide began to be reported and the dilemma was whether the problem was related only to pergolide as a molecule, to the whole class of dopamine agonists or only to a few of them, e.g. ergot-derivatives. We decided that we had give an answer to this important question.

Was it difficult to carry out the study ?

In truth, it was not easy. Notwithstanding the fact that the centre has more than 10,000 patients in its database, when we checked their files nearly all the patients on treatment with a dopamine agonist had taken more than one and we wanted to compare patients who had taken only one dopamine agonist for at least one year. We set this criterion so that we could carry out a clear-cut comparison. In the end we managed to include 155 patients in the study. Then there was the problem of finding funds. In other countries, such as the United States, there are funds for independent studies i.e. studies conducted without the support of pharmaceutical companies, to which investigators can have access if they have sound projects to submit to the authorities. Here in Italy, at the time when we planned the study, there weren't any. Now AIFA has begun to make announcements for competitions, but in other therapeutic areas. At present there still isn’t anything for Parkinson’s disease.

Did patients co-operate ?

Patients were very co-operative and we wish to thank all the ones who took part in the study and continue to take part in it. What, the study isn’t finished yet !? NO, not yet. Patients are still being followed-up to see whether the valve damage regresses with time after discontinuation of the dopamine agonist.

Does it regress ?

We still don’t know with certainty, but we think so.

Have you other ongoing studies on the side effects of drugs for Parkinson's disease ?

At the moment we haven’t, but we continue to monitor the situation. Many years ago, when I still was a young, inexperienced doctor, my teacher told me about a Chinese custom: When a patient died and the cause was unknown, the doctor put a red candle in front of the house, so that one would remember that there was an unresolved case to bear in mind. I think we should continue such a custom i.e. earmark unresolved cases in the hope to manage to resolve them in the future. Today, things have changed and in the place of a red candle in front of the house, we earmark the electronic file of the patient in red, but the principle is the same.

Interview of prof Pezzoli
 
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