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Pergolide and cabergoline have same effect as now-banned Fen-phen, studies find
By Steven Reinberg HealthDay Reporter
WEDNESDAY, Jan. 3 (HealthDay News) -- Two drugs commonly used to treat Parkinson's disease can cause harm to heart valves, according to two studies in the Jan. 4 New England Journal of Medicine.
The drugs, pergolide and cabergoline, are both from a class of medications called "ergot-derived dopamine receptor agonists." Ergot is a fungus, and ergot-derived drugs are used not only in the treatment of Parkinson's but also for restless leg syndrome and migraine headaches.
Ergot-derived dopamine receptor agonists were also in the now banned diet drug Fen-phen -- also associated with heart valve disease.
"We uncovered the biomedical reason why Fen-phen had particular side effects on the heart," said Dr. Bryan L. Roth, of the Department of Pharmacology at the University of North Carolina and author of an accompanying journal editorial.
"We evaluated other medications and predicted that they would have the same side effect on the heart," he said. "Our predictions were verified in these two studies."
Based on the new findings, Roth wants the U.S. Food and Drug Administration to look at all drugs that have this side effect with an eye to banning pergolide (brand named Permax) and cabergoline (Dostinex). "This side effect is very dangerous," he said. "It could result in an individual's death or undergoing valve replacement surgery," he added.
These types of drugs interact with a receptor in the heart valve, causing the valve to overgrow and become floppy and leaky, Roth explained.
In the first report, Dr. Edeltraut Garbe, from the Institute of Clinical Pharmacology, Charité, University Medicine, Berlin, and colleagues collected data on more than 11,000 people 40 to 80 years of age who were taking anti-Parkinson's drugs between 1988 and 2005.
The researchers found that, among 31 patients with newly diagnosed cardiac valve problems, six were taking pergolide, six were taking cabergoline, and 19 had not taken any dopamine agonist in the past year.
Almost 30 percent of the patients taking pergolide or cabergoline were at increased risk for heart valve problems.
"In this study, use of the dopamine agonists pergolide and cabergoline was associated with an increased risk of newly diagnosed cardiac-valve regurgitation," the authors concluded.
In the second study, a team of Italian researchers led by Dr. Renzo Zanettini, from the Istituti Clinici di Perfezionamento, Milan, studied 155 patients taking dopamine agonists for Parkinson's disease. Among these patients, 64 were taking pergolide, 49 were taking cabergoline, and 42 were taking non-ergot-derived dopamine agonists. In addition, there were 90 controls.
Zanettini's group found that about 23 percent of the patients taking pergolide had heart valve problems, as did about 29 percent of the patients taking cabergoline.
In contrast, none of the patients taking non-ergot-derived dopamine agonists had a heart problem, while 5.6 percent of the control patients did.
In addition, patients who took higher doses of pergolide or cabergoline had more advanced heart valve disease, the researchers reported.
"The frequency of clinically important valve regurgitation was significantly increased in patients taking pergolide or cabergoline, but not in patients taking non-ergot-derived dopamine agonists, as compared with control subjects," the researchers wrote. "These findings should be considered in evaluating the risk-benefit ratio of treatment with ergot derivatives," they concluded.
"If you have Parkinson's, you need to find out from your doctor if you're taking a medication that could cause this risk of serious heart damage," Roth said. "I would recommend not prescribing these medications at all. Our hope is that these two studies will encourage the FDA to remove these drugs from use."
Roth also noted that the drug Ecstasy also has the potential to damage the heart in the same way. "People who take Ecstasy on a regular basis may be at risk for this particular side effect," he said.
In a related story, a new drug to treat early Parkinson's, called transdermal rotigotine, has shown in a phase 3 clinical trial that it is safe and effective, according to a report in Neurology.
Rotigotine is a non-ergot-derived dopamine receptor agonist delivered via a patch designed for once-a-day application. The drug is currently being reviewed by the FDA. It is currently marketed in Europe as therapy for early-stage Parkinson's and has received a favorable review for advanced-stage Parkinson's, according to the German drug company Schwarz Pharma, the maker of rotigotine.
the cohort is too little, and itīs not stated that it was a double blind trial, the completely unmotivated "MDA does this too" disqualifies the whole article,
plus the advertisment of a "great" new medicine, thatīs "proven safe" makes it a bunch of poo smelling flowers from..
I wonder whether the heart valve problem is caused by persistent use of these substances over a long term?
Cabergoline reportedly can be used to enhance sex (see the thread in the Sex and Drugs forum titled "Dostinex (cabergoline) as a powerfull afrodisiac").
But the study that found the heart valve problem was for patients taking cabergoline for Parkinson's. I assume they would be taking it on a regular basis. If used to enhance sex, it would only be taken occasionally. I wonder if this would eliminate the problem potential? Anyone have an educated guess?
I'm not really familiar with fen/phen...Did the heart problems with that drug show up right away, or only in people who'd taken it on a long term basis?
I still haven't had a chance to research this thoroughly, but I just found some encouraging news for those of us who are interested in cabergoline as a sex drug:
Originally Posted by http://www.lawyersandsettlements.com/features/dostinex-off-label.html
If you live in the United States and you are taking Dostinex for Parkinson's disease... You shouldn't be.
The drug, approved in 1996 by the U.S. Food and Drug Administration (FDA) for the treatment of the hormone deficiency known as hyperprolactinaemia, is commonly used to treat Parkinson's in other parts of the world, and has been known to creep onto prescription pads for Parkinson's in the United States.
However this is off-label territory - a slippery slope - and the concern over Dostinex in higher dosages more commonly associated with Parkinson's, remains the link to potential heart issues, and specifically valvular heart disease.
While effective, the dosage required for Parkinson's patients is upwards of 40 times higher than levels required for the approved application with hyperprolactinaemia hormone disorder.
It is within the context of these higher dosages that studies have uncovered the link between Dostinex and heart valve problems. In two recent clinical trials conducted outside of the United States, Dostinex was found to contribute a higher risk for heart valve disease, compared to patients taking some other form of medication to control Parkinson's. An Italian study in Milan found that 29 per cent of trial participants taking Dostinex were seen to have heart valve damage in the moderate to severe range. Meanwhile, in Germany, respondents were found to be seven times at risk for leaking heart valves, than those not taking Dostinex.
More worrying for me than the possible heart issues is that it is carcigenic in mice and rats... Google Cabergolinemonograph_1Sept09. since im not allowed to post urls. Swim doesnt remember getting any of nice sideeffects. Stupidly swim was having a bit of a polly-drug day and I remember the rest of the day was intense, but I wouldnt repeat it nowadays,
^ Many things (even some food items) are carcinogenic in mice/rats when injected at very high doses. I don't think the carcinogenicity of cabergoline is really much of an issue. Cardiac issues however are much more likely to occur and could cause permanent damage or death. Here is the exact wording from the monograph. Note that the study used very high amounts of the drug to induce carcinogenicity. (bold is mine).
Carcinogenicity: Cabergoline is carcinogenic in mice and rats at doses equivalent to 4-7 times the maximum recommended human dose; due to species-specific differences in the role of prolactin, the relevance of these findings to humans is not known.