Dostinex aka cabergoline linked to heart valve problems
01-04-2007 10:08 PM
Dostinex aka cabergoline linked to heart valve problems
Parkinson’s drugs may be riskier than thought
Heart valve problems linked to two medications, studies find
Parkinson's drugs riskier than thought - More Health News - MSNBC.com
Jan 3, 2007
The risk of heart valve damage with two drugs for Parkinson’s disease may be far greater than was known, new research suggests.
The drugs are not the main treatment for Parkinson’s, but one is also sometimes used to treat restless legs syndrome.
A study by Italian researchers found that roughly one-fourth of Parkinson’s patients taking pergolide or cabergoline, sold as Permax, Dostinex and other brands, had moderate to severe heart valve problems. Another study, by German doctors, found that users of either drug were five to seven times more likely to have leaky heart valves than those on other types of Parkinson’s medications. Both studies were reported in Thursday’s New England Journal of Medicine.
“This is an extraordinarily high risk,” said Dr. Bryan Roth, a pharmacology professor at the University of North Carolina at Chapel Hill.
“It’s a bad side effect. As far as I know, there are no medications that can reverse it,” and valve replacement surgery is the only solution, he said.
Roth had no role in the studies but directs a drug screening program for the National Institute of Mental Health. He also published a paper several years ago warning that these drugs appeared to trigger the same heart-related mechanism that the fen-phen diet combination did. The diet pills, sold as Pondimin and Redux, were pulled from the market in 1997 after they were linked to valve problems.
One of the Parkinson’s drugs — pergolide, sold as Permax and other brands — also is used to treat restless legs syndrome. Cabergoline, sold as Dostinex, Cabaser and other names, is mostly used in Europe.
About half a million people had taken Permax during its first 14 years on the market when its developer, Eli Lilly and Co., added valve damage to the potential side effects listed on the package insert in 2003. But the company said the risk was extremely low — five in 100,000 users.
Roth believed there were more cases, a theory he said the new studies confirmed.
“This is an example of, if you don’t look for it, you don’t see it,” said Dr. C. Warren Olanow, chairman of neurology at Mount Sinai School of Medicine in New York, who had no role in the work. The findings will lead more doctors to prescribe other Parkinson’s treatments, he said.
About 1.5 million Americans and 6 million people worldwide have Parkinson’s disease, which results in tremors, loss of muscle control and sometimes death.
It’s caused by a lack of the brain chemical, dopamine. The main treatment is levodopa, which spurs the body to make more dopamine. Pergolide and cabergoline often are given in addition to that drug or in place of it, especially if symptoms worsen over time.
In one study, Dr. Renzo Zanettini and others at the Instituti Clinici di Perfezionamento in Milan obtained echocardiogram images of the hearts of 155 patients taking various Parkinson’s medications and a comparison group of 90 healthy people.
Moderate to severe valve problems were seen in 23 percent of those on pergolide and nearly 29 percent of those on cabergoline but none of those on other Parkinson’s drugs and less than 6 percent of the comparison group. The study was paid for by the Milan clinic and two Parkinson’s foundations.
In the other study, Dr. Rene Schade and colleagues in Berlin and in Montreal used records from more than 11,400 Parkinson’s patients in the United Kingdom. The rate of newly diagnosed leaky valves was increased among pergolide and cabergoline users but not the others, they found. The Canadian government and a drug company provided partial support for the study. Many researchers in both studies have consulted for Parkinson drug makers.
Pergolide sales have dropped in recent years but still amounted to more than $10 million last year in the United States, according to IMS Health, a health care information firm.
The rights to Permax in the U.S. now belong to Valeant Pharmaceuticals of Aliso Viejo, Calif. A company statement said Permax is safe and effective, but Valeant is no longer promoting the product. All such drugs should be used “with caution,” the statement says.
Cabergoline is approved in the U.S. for treating a hormone problem, excessive prolactin in the blood, but not Parkinson’s.
Roth has been urging companies developing new drugs to test for the mechanism involved in the Parkinson and fen-phen pills, saying those that that have it shouldn’t be sold.
Other articles on same topic:
Heart-Valve Disease Linked to Two Parkinson's Drugs - CME Teaching Brief® - MedPage Today
01-04-2007 11:11 PM
01-04-2007 11:12 PM
01-05-2007 07:05 PM
Good old-fashioned bromocryptine and just plain old mucuna extract(L-Dopa)then I guess.
Goes to show sometimes that new is not always better.
01-05-2007 07:08 PM
Wow that's pretty scary news. I wonder if they further broke down what kind of dosages of these drugs people were taking, in order to correlate dosing levels with heart valve problems? And further to that, were the heart problems more likely in those using these drugs for Parkinsons symptoms as opposed to other uses? The 1 in 4 number is certainly frightening, but I can't help but wonder whether there are more factors involved than the numbers would indicate.
01-06-2007 10:10 AM
WOW thats some pretty upsetting news!! I also would love to see more about dose and lenght of use in the results. There are a LOT of us who have used this at least short term.
01-10-2007 12:04 AM
here is another one
Parkinson's Drugs Can Damage Heart Valves
01.03.07, 12:00 AM ET
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, Charite, 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."
01-10-2007 12:14 AM
What's key here is that they didn't just find a correlation between use and health problems (which could be a coincidence) but they identified the mechanism of harm (activation of a receptor in the heart valve leading to unwanted growth). This seems pretty definative in my opinion.
01-10-2007 06:08 AM
Curiously the dose used in those studies is missing.
Parkinson's treatment dose:
High prolactin treatment dose:
* Initiation of cabergoline requires slow initial dose titration, starting from 1mg once daily and increasing the dose by 0.5-1mg at weekly or bi-weekly intervals. The dosage should be increased until maximum therapeutic response or intolerable side effects occur. The recommended therapeutic dosage is 2-6mg/day.
There is a huge difference between taking 14-42mg/w and 1-2mg/w.
The dose of cabergoline will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of cabergoline. If your dose is different, do not change it unless your doctor tells you to do so.
* For oral dosage form (tablets):
o For disorders of high prolactin levels or pituitary tumors:
+ Adults—0.25 mg two times a week.
Dose may be increased every four weeks as needed, according to body prolactin levels, up to 1 mg two times a week.
+ Children—Use and dose must be determined by the doctor.
01-10-2007 12:12 PM
Regardless of dose, do you really want to take that risk? The problem with the theory of saying, well that was a high dose and I just take a low dose, so i'm safe is wrong. The dosage is just what they happened to study in regards to what parkisins patients are using. The same effects can happen i'm sure at lower doses, but why make a study for the recreational abuser?
Originally Posted by B5150
01-10-2007 03:09 PM
Much of the value of the dosage info that B5150 provided is regarding whether or not those who have already used Cab in low dose/multiple week regimines, should be worried, and continue to worry.
Originally Posted by joebo
Personally, after consuming ~14mg over the past several months, I feel better after seeing the disparity in dosage between Parkinsons and prolactin petients. Would I use Cab again? Almost certainly not...an entire post cycle therapy worrying about whether or not I'm damaging my heart is not good.
Also, you mentioned in your last sentence something about a study for an abuser. Of course such a study is unlikely, but if you take another look at B5150's post, you'll see that these dosages are not just being taken by steroid users, but that these ergot derivatives have siginificant use in treatment of pituitary tumors and high prolactin levels in general. I don't know if a heart valve study exists for these latter users. If no study exists, perhaps no leaky valves in excess of the rate of the general population have been seen with these patients.
01-10-2007 04:25 PM
that is an excellent point not to mention most BBers do not use it long term like the people with Parkinson’s do but there is also another complication, there is no info that I know of that takes in consideration that most BBers using this are also taking large doses of powerful steroids. Who knows what the effect is? As they are interacting with a receptor it may not take a large dose or the steroids may affect the way it acts.
Originally Posted by B5150
01-10-2007 04:35 PM
I think B5150 makes a very valid point, but there are alot of things that should go into consideration when choosing to use a drug. So if one is self medicating with anabolic steroids then the addition of one of these drugs would not be a wise choice even if the dosages are not equivalent. Reasoning being that there could be additional issues or complications that could arise due to the mixing of drugs.
01-10-2007 05:40 PM
My point was not the merit or the risk to reward factor. My point is to consider being a bit more critical of the data that is being presented and not jumping on the alarmist bandwagon that many do when the media gets a hold of something and sensationalizes it.
Originally Posted by joebo
FYI: You also risk developing pathological gambling.
Pathological gambling with cabergoline
In the past 2 years ADRAC has received 4 reports describing the development of pathological gambling in association with cabergoline (Cabaser). These are the only 4 reports of this problem in the ADRAC database. All 4 patients were taking long-term levodopa and the excessive gambling commenced a number of months after cabergoline was added. In 3 of the 4 Australian cases, the patient also developed obsessive, inappropriate or abnormal behaviour. In all cases the gambling and other behavioural problems resolved when cabergoline was stopped.
Pathological gambling has been reported before in association with dopaminergic therapy for Parkinson's disease.1 Almost all of these patients were taking long-term levodopa and some were also taking dopamine receptor agonists such as pergolide and pramipexole. In a number of cases, the appearance of pathological gambling occurred after an increase in dosage of levodopa and/or a dopamine receptor agonist.
It has been proposed that an increase in stimulation of dopaminergic rewards systems is important in the development of pathological gambling and other addictive and compulsive behaviours. This is probably a very rare adverse effect but prescribers should be alert for its occurrence in patients who are taking combinations of levodopa and dopamine receptor agonists.
1. Driver-Dunckley E, Samanta J, Stacy M. Pathological gambling associated with dopamine agonist therapy in Parkinson's disease. Neurology 2003; 61: 422-23 Australian Adverse Drug Reactions Bulletin, Volume 24, Number 4, August 2005
01-10-2007 06:50 PM
That is interesting to say the least. For myself I have never used it nor considered it as I have been adverse to using things the directly **** with my brain chemistry (don't think I can afford to lose anything in that department) But with out a real pressing clinical need for the stuff I would not go near now.
You do bring up a good point in that over reacting is not productive. And I do have a somewhat of a prejudice against these type of drugs when used for BBers as I feel that using them crosses a line of risk vs. rewards, if your have to use something of this nature to continue to use steroids or to use certain steroids then I think you have crossed the line of use vs. abuse but that is just a personal opinion and everyone had one.
01-11-2007 07:57 AM
Running with the Big Boys
So, bodybuilding and drug taking involves some sort of risks???
These same risks are relative to dose and duration of exposure???
...and there are unqualified exponetial risks from exotic drug combinations???
I should consider these risks before taking cabergoline or any other drug?
Wow, there is a lot to think about.
Are there any drugs that can safely help me think?
(just havin' fun)...be careful out there!...its a dangerous world!!!
Ps. Arnold was never afrad of no stinkin heart valve, and he's president of the United States!!!!..right?
01-11-2007 08:48 AM
I must have taken your statement the wrong way. I'm just so used to ignorant people who can reason their way to use harmful chemicals. The people who still think superdrol is safe, people who continue to use m1t, etc.. You could show them numberous reasons the chemicals are harmful, but they will somehow in a round-a-bout way make it safe for them. I personally think bodybuilding is an odd thing for some. For me, its being natural and healthy while for others its eating well and poisoning their body and killing their organs only for appearance. Anyways, sorry for misinterpreting your reasoning.
Originally Posted by B5150
01-20-2007 06:49 PM
Hot Italian Goldmember
02-22-2007 11:14 AM
However, the risk was not increased among patients treated with other ergot-derived dopamine agonists, bromocriptine or Dopergine (lisuride) or with dopamine agonists that are not derived from ergot, Requip (ropinirole) or Mirapex (pramipexole), the researchers found.
So its not too bad. Simply stick to Bromo and you should be free of the valve problems.
Using conditional logistic-regression analysis, the researchers found that the potent 5-hydroxy-tryptamine 2B (5-HT2B) agonists, Permax and Dostinex, were significantly associated with cardiac valve disease affecting the mitral, aortic, and tricuspid valves.
06-03-2007 10:32 AM
Looks like i'll be throwing out my bottle of cabergoline... I was hoping to use it to reduce prolactin, what else could I take in place of it?
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