Does anyone know if Cardiac Resynchronisation increases the life span of 93 year olds with end stage HF and EF 10-15%? Or is it more likely to cause problems?
“It’s curious to me that Eli Lily and the academic authors designed such a small underpowered trial.” What if the point of such a small trial was to get a foot in the door for Medicare/Medicaid funding? A small trial might generate a waterfall of funding for heart failure patients. I know that sounds cynical, but medicine in the US is driven by cynicism.
How was the commentary from the attendees/panel after his presentation at the meeting? Was there skepticism at these “practice changing” proclamations? Or were people cheering?
When are trialists going to figure out that counting all endpoints as equally bad is silly? The time-to-first-event endpoint considers all outcomes equally bad. The study is crying out for an ordinal outcome variable constructed from clinical consensus about severities of various outcomes. A treatment should get more credit for reducing mortality and less for other things.
It is beyond the pale that these shameless “experts” declared this trial to be practice changing.
I found it very curious that “hospitalizations” for HF were statistically different, yet intensification of oral diuretics and even need for urgent IV diuretics were not. This drug prevents flash pulmonary edema but does nothing for the insidious progressive fluid retention and volume overload of HFpEF? How does that work?
As for QoL, yes….there was clinically significant additional improvement in KCCQ score (more than 5 pts MORE improvement with active drug than with placebo). However, this was NOT mirrored by additive improvements to 6MWT distance (generally considered to be a threshold of 30-32 meters). So they “felt” better when it was obvious they were on active drug (due to weight loss and GI symptoms)…but that didn’t translate to functional improvement. Well isn’t that curious…..
I completely agree. There is no way such a small, underpowered trial should change anyone’s practice. I think the results are interesting and merit further work. That’s as far as I’m willing go.
My BS meter started flashing red the minute I saw the end points and the numbers confirm the accuracy of my detector. I am somewhat skeptical of diagnoses of heart failure with normal ejection fraction. It almost seems like an oxymoron. The only thing that comes to mind is some type of hypertrophic cardiomyopathy but there is little or nothing to be done for that. I wonder how many non-cardiac disorders with signs or symptoms similar to CHF might be mixed in with the HFpEJ group. The seemingly manic attempts to find new indications for the essentially useless Type 2 Diabetes drugs are getting almost comical.
Screw the heart drug trials. Go a better route and investigate herbs and other supplements. Extremely hot cayenne tincture works better than any drug and there are dozens of other herbs that can do wonders for heart problems. Most are very inexpensive and don't give off any aftereffects.
Im not following the unblinding implications above. Some GLP users have GI side effects, but most don't. Additionally, if a patient presented to their cardiologist with edema and symptoms of failure, it's unlikely they would think the person in front of them has both GI and CHF symptoms and, therefore, should be treated. This as opposed to someone who has CHF symptoms alone and should not.
I notice that 55% of the trial was woman. This is the first study I've seen (as a Sensible Medicine reader) where the majority of participants were woman. Can someone more knowledgeable than me comment on that ?
Excellent critique. The erosion of the quality of endpoints in cardiology trials is concerning. The medical community should reject conclusions based on these outcomes. Need total mortality, total hospitalizations, etc. Amazed that anyone would accept the endpoint “change in medical therapy” as valid. Keep it up!
Really inexcusable for such a common condition, with very easy enrollment criteria. One would hope such an experienced investigator would be holding these companies to a higher standard, in fact, demanding it. This contributes to the slow (drip,drip,drip)inexorable loss of confidence that physicians and the public feel regarding “experts” and the system.
Another example of big pharma lying by using statistics yet hiding the actual real numbers so the truth can be known by all.
Does anyone know if Cardiac Resynchronisation increases the life span of 93 year olds with end stage HF and EF 10-15%? Or is it more likely to cause problems?
“It’s curious to me that Eli Lily and the academic authors designed such a small underpowered trial.” What if the point of such a small trial was to get a foot in the door for Medicare/Medicaid funding? A small trial might generate a waterfall of funding for heart failure patients. I know that sounds cynical, but medicine in the US is driven by cynicism.
we have the largest medical library for medical students.
that can train all of Latin America.
or any Spanish speaking student.
How was the commentary from the attendees/panel after his presentation at the meeting? Was there skepticism at these “practice changing” proclamations? Or were people cheering?
Curious, at the very least. Some will say doubtful.
It is highly shameful that nowadays everything counts as positive trial in the cardiovascular disease world.
When are trialists going to figure out that counting all endpoints as equally bad is silly? The time-to-first-event endpoint considers all outcomes equally bad. The study is crying out for an ordinal outcome variable constructed from clinical consensus about severities of various outcomes. A treatment should get more credit for reducing mortality and less for other things.
It is beyond the pale that these shameless “experts” declared this trial to be practice changing.
I found it very curious that “hospitalizations” for HF were statistically different, yet intensification of oral diuretics and even need for urgent IV diuretics were not. This drug prevents flash pulmonary edema but does nothing for the insidious progressive fluid retention and volume overload of HFpEF? How does that work?
As for QoL, yes….there was clinically significant additional improvement in KCCQ score (more than 5 pts MORE improvement with active drug than with placebo). However, this was NOT mirrored by additive improvements to 6MWT distance (generally considered to be a threshold of 30-32 meters). So they “felt” better when it was obvious they were on active drug (due to weight loss and GI symptoms)…but that didn’t translate to functional improvement. Well isn’t that curious…..
I completely agree. There is no way such a small, underpowered trial should change anyone’s practice. I think the results are interesting and merit further work. That’s as far as I’m willing go.
My BS meter started flashing red the minute I saw the end points and the numbers confirm the accuracy of my detector. I am somewhat skeptical of diagnoses of heart failure with normal ejection fraction. It almost seems like an oxymoron. The only thing that comes to mind is some type of hypertrophic cardiomyopathy but there is little or nothing to be done for that. I wonder how many non-cardiac disorders with signs or symptoms similar to CHF might be mixed in with the HFpEJ group. The seemingly manic attempts to find new indications for the essentially useless Type 2 Diabetes drugs are getting almost comical.
Thank you, very interesting.
8 CV deaths vs 5 does not look that good.
What about all cause mortality ?
Screw the heart drug trials. Go a better route and investigate herbs and other supplements. Extremely hot cayenne tincture works better than any drug and there are dozens of other herbs that can do wonders for heart problems. Most are very inexpensive and don't give off any aftereffects.
Im not following the unblinding implications above. Some GLP users have GI side effects, but most don't. Additionally, if a patient presented to their cardiologist with edema and symptoms of failure, it's unlikely they would think the person in front of them has both GI and CHF symptoms and, therefore, should be treated. This as opposed to someone who has CHF symptoms alone and should not.
I notice that 55% of the trial was woman. This is the first study I've seen (as a Sensible Medicine reader) where the majority of participants were woman. Can someone more knowledgeable than me comment on that ?
Excellent critique. The erosion of the quality of endpoints in cardiology trials is concerning. The medical community should reject conclusions based on these outcomes. Need total mortality, total hospitalizations, etc. Amazed that anyone would accept the endpoint “change in medical therapy” as valid. Keep it up!
Really inexcusable for such a common condition, with very easy enrollment criteria. One would hope such an experienced investigator would be holding these companies to a higher standard, in fact, demanding it. This contributes to the slow (drip,drip,drip)inexorable loss of confidence that physicians and the public feel regarding “experts” and the system.
No mystery, typical gaming the $ystem