4th June 2015, 07:56 PM
Epic study re vetmedin and CHF: A Question
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?
Last edited by karen100; 4th June 2015 at 11:12 PM.
5th June 2015, 02:04 PM
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.
Originally Posted by karen100
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.
Post Thanks / Like - 1 Thanks, 0 Likes
5th June 2015, 03:55 PM
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.
Post Thanks / Like - 0 Thanks, 1 Likes
10th June 2015, 09:55 AM
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.
10th June 2015, 03:34 PM
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.
Originally Posted by timclayton
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.