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Epic study re vetmedin and CHF: A Question

karen100

Active member
Can anyone shed some light on this:


"A mid-study analysis in mid-February 2015 indicated that pimobendan is clearly beneficial and did not raise any concern over the administration of pimobendan. Based on these results, the interim analysis committee recommended that the study be stopped, and the study was ended earlier this month."

From what I understand, the EPIC study looked to study the effects of vetmedin on dogs not yet in CHF. Am I to understand that they just decided everything was okey dokey and summarily terminated the study?

Edited to add: my vet spoke to a cardiologist, who felt Buddy wasn’t in CHF, but nonetheless wasn’t concerned about Buddy taking vetmedin. He said it was the least concerning of the meds he was on (referring to benzapril). Say what?
 
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Can anyone shed some light on this:


"A mid-study analysis in mid-February 2015 indicated that pimobendan is clearly beneficial and did not raise any concern over the administration of pimobendan. Based on these results, the interim analysis committee recommended that the study be stopped, and the study was ended earlier this month."

From what I understand, the EPIC study looked to study the effects of vetmedin on dogs not yet in CHF. Am I to understand that they just decided everything was okey dokey and summarily terminated the study?

Edited to add: my vet spoke to a cardiologist, who felt Buddy wasn’t in CHF, but nonetheless wasn’t concerned about Buddy taking vetmedin. He said it was the least concerning of the meds he was on (referring to benzapril). Say what?

Karen: The EPIC Trial, which is to determine the value and safety of giving pimobendan to dogs with MVD before they reach congestive heart failure (CHF), ALWAYS was scheduled to end in early 2015. It started in 2010 and was planned from its beginning to be a 5-year study. So for that press release's reference to a "mid-study analysis" in February, is completely fictitious. It appears to be an effort by the manufacturer of pimobendan (Vetmedin) to raise expectations.

Currently, the manufacturer's label and the US government's Food & Drug Administration warn against giving pimobendan to MVD-dogs prior to CHF and/or not in need of "augmentation of cardiac output", because studies showed that the drug could accelerate the deterioration of the mitral valves and the heart walls in dogs not in CHF. Also, the earlier studies showed that even dogs in CHF but with hearts which were adequately compensating for the MVD, should not be prescribed pimobendan because the pimo could force the heart muscle to over-extend itself.

The EPIC Trial involves 36 cardiologists from all over the world, and now that the study has ended, the drafting of the report begins. That is followed by a distribution of the draft to "peers" for a "peer review" of the article. None of that has happened yet. Therefore, the press release statement that pimobendan is beneficial to MVD-dogs prior to CHF is in breach of the peer-review process and technically is unethical, based upon the ethical standards of the scientific community.

I know of cavaliers which died because pimobendan ripped their hearts apart. So, I never would take lightly the premature administration of pimobendan to any cavalier.
 
Thanks Rod. I was wondering about that “ending the study early because the results are so outstanding” malarky. I’ve never heard of such a thing occuring in the scientific community--studies usually end early because of damage/injury to the participants.

I was shocked when my vet told me that the cardiologist with whom she was consulting fluffed off concerns about pimo, especially since he also speculated that Buddy was not in heart failure. That’s one of the many drawbacks of veterinary consultation: the owner isn’t there to ask the questions.
 
My little Chesney was offered vetmedin 1.5 yrs ago after I detected a 1/6 murmur. I was strongly advised on this forum to avoid vetmedin alone. The study has been published now and shows a clear protective effect from starting vetmedin at first detection of a murmur. Appreciate atrial rupture is a side effect of severe MR/TR. I have now started him on vetmedin, recent echo was stage 1/2 failure, moderate enlarged atrium, good systolic function, murmur now 3/6. I was also recommended Cardalis, I think I will go ahead and use both. As a rule trials are stopped early when it is clear a drug is better than a placebo and therefore should be given as in this trial.
 
... The study has been published now and shows a clear protective effect from starting vetmedin at first detection of a murmur. ...

timclayton, as far as I know, no such study (EPIC Trial) has been published. I don't believe the final draft of it has even been prepared and agreed upon among the 36 cardiologists involved in the research, much less distributed to other cardiologists for peer reviewing.

Also, as far as I know, the EPIC Trial did not start dogs on Vetmedin (pimobendan) "at the first detection of a murmur". The EPIC Trial website states the purpose of the trial as follows: "Does chronic oral administration of pimobendan in dogs with evidence of increased heart size secondary to preclinical MMVD delay the onset of signs of congestive heart failure?"

To the contrary, there ARE published studies which show that premature administration of pimobendan can cause the MVD to progress more rapidly, can cause the chords to shred, and there are numerous anecdotal reports of sudden death within days of starting pimobendan not already in heart failure.
 
I have just returned from France where the vet there gave me a completely opposite advice to what I had been given in the UK. I am really confused now. Chesney seems well, has a morning cough ( that I have been advised is due to his slight aortic enlargement) I was advised to use spironolactone. I think I will make an appointment to see the UK vet again and as planned have the repeat echo. I am not sure any medication can prevent or slow the condition and maybe should have done what my wife said all along and stop listening to his heart and treat him only if he becomes symptomatic. Just want him to stay healthy. He really enjoyed France!
 
I will be interested when there is some clarity on the issue of pimobendan -- most of the specialists I have spoken to seem to feel 50/50 about its use before CHF. I have one dog on it now for going on two years -- when I got her as a 9 year old rescue she had a couple of sessions where we had to raise all her meds and I'd assumed she might have 6-9 months or so to live; instead she has completely stabilised and can do a mile or two walk now etc.

Cardalis actually has spironolactone in it.

I've never treated any of my cavaliers for MVD until they are symptomatic.

I think the best preventatives are to keep them fit and slim. Every ounce of extra fat adds weight that has to be carried, and requires an extensive network of extra blood vessels --- both equalling more effort for the heart to pump blood and earlier chance of it wearing out.

It really depresses me sometimes to see so many overweight cavaliers -- belonging to owners who really love them and don't consider that those extra treats and food are almost definitely shortening their dog's life.
 
I will be interested when there is some clarity on the issue of pimobendan -- most of the specialists I have spoken to seem top feel 50/50 about its use before CHF. I have one dog on it now for going on two years -- when I got her as a 9 year old rescue she had a couple of sessions where we had to raise all her meds and I'd assumed she might have 6-9 months or so to live; instead she has completely stabilised and can do a mile or two walk now etc.

I agree Karlin. Leo has been on Vetmedin and Cardalis for nearly 2 years and its been marvellous for him. its really improved him. We've had to increase his Cardalis last week and already there's an improvement. His Vetmedin is still the original dose but Im thankful these meds were available for him.
 
My vet always says cavaliers seem to be able to go amazingly long with MVD. Not that they should all be predisposed to it in the first place -- I hate that it is almost inevitable for every cavalier :( -- but at least there are meds and a constitution that can sometimes adapt for a good while. My vet says cavaliers seem to go far longer than other breeds with MVD -- if diagnosed in others the timeline tends to be much shorter, he says.
 
One of the pluses in research into MVD is that it has improved the drugs available - when my Meg went into heart failure in the early 1990s, there was just 'the red pill', which was quite effective - she lived another 9 months. The downside of this is that most vets don't seem to be horrified that Cavaliers still have this scourge - it's just something they have and isn't it great that we can keep them alive longer with all these better drugs. But after 30 years of MVD research shouldn't we have got further than just improving ways of keeping dogs in heart failure alive for longer? What about a DNA test?? I am tired of watching my Cavaliers die.

Kate and Ruby (who at 6 still has a clear heart (y) )
 
Excellent point Kate……cl*pcl*p
wouldn't it be lovely if MVD becomes the exception as a pos to the norm with Cavaliers.
 
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