Enoch Choi, MD
Enoch Choi, MD
Male, 44
Palo Alto - CA
Specialties: Family Medicine
Interests: sinusitis, Migraine, low back pain, cellulitis, abscess, skin infection, neck pain, Allergies, ear infections
Male, 44
Palo Alto - CA
Specialties: Family Medicine
Interests: sinusitis, Migraine, low back pain, cellulitis, abscess, skin infection, neck pain, Allergies, ear infections
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ENHANCE trial does not prove lipid lowering agents fail the general population
Jan 16, 2008 10:59AM
- 5 comments
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The FDA has not issued an official advisory, but media is hyping and misleading the public regarding results from the ENHANCE trial (Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia). Merck and Schering-Plough submitted this for presentation as an pre-publication abstract at the American College of Cardiology meeting in March 2008.
Can you confirm these that I could dig up:
* No difference between patients treated with ezetimibe/simvastatin 10/80 mg (Vytorin) versus patients treated with simvastatin 80 mg alone, over a two year period, for the primary endpoint of the mean change in intima-media thickness (IMT) measured at three sites in the carotid arteries. Carotid ultrasound studies are seen as reliable surrogate markers and predictive of future cardiac events. There was a NON-statistically significant difference in wall thickness (p=0.29).
* The Heterozygous Familial Hypercholesterolemia (HFH) population studied had baseline LDL measurements > 300 mg/dL. These patients make up 0.2% of the general population and are NOT representative of the typical patient receiving medication for hyperlipidemia.
* Sinc conclusive evidence of ezetimibe's true effect is not available until studies on the general population with more power are published, maximizing statin dosing whenever possible is warranted for many patients with hypercholesterolemia. Niacin or colesevelam (Welchol) are alternatives to consider for statin intolerant patients.
http://www.merck.com/newsroom/press_releases/product/2008_0114.html
Can you confirm these that I could dig up:
* No difference between patients treated with ezetimibe/simvastatin 10/80 mg (Vytorin) versus patients treated with simvastatin 80 mg alone, over a two year period, for the primary endpoint of the mean change in intima-media thickness (IMT) measured at three sites in the carotid arteries. Carotid ultrasound studies are seen as reliable surrogate markers and predictive of future cardiac events. There was a NON-statistically significant difference in wall thickness (p=0.29).
* The Heterozygous Familial Hypercholesterolemia (HFH) population studied had baseline LDL measurements > 300 mg/dL. These patients make up 0.2% of the general population and are NOT representative of the typical patient receiving medication for hyperlipidemia.
* Sinc conclusive evidence of ezetimibe's true effect is not available until studies on the general population with more power are published, maximizing statin dosing whenever possible is warranted for many patients with hypercholesterolemia. Niacin or colesevelam (Welchol) are alternatives to consider for statin intolerant patients.
http://www.merck.com/newsroom/press_releases/product/2008_0114.html
I'm not a doctor, but I will take a stab:
It might have to do with this:
"In the trial, there was a significant difference in low-density lipoprotein (LDL) cholesterol lowering seen between the treatment groups -- 58 percent LDL cholesterol lowering at 24 months on ezetimibe/simvastatin 10/80 mg as compared to 41 percent at 24 months on simvastatin 80mg alone, (p<0.01)."
http://www.merck.com/newsroom/press_releases/product/2008_0114.html
High LDL increases risks to the heart and since it was effective and the small population tested had characteristics of the larger population, then one could assume it would have a similar effect in those without Heterozygous Familial Hypercholesterolemia.
Also,
Since the endpoint of the study (even if it included the general population) was the mean change in wall thickness and there was a Non-statistical difference, then it could also be assumed that it would cause no adverse changes in wall thickness in patients without Heterozygous Familial Hypercholesterolemia.
Safety and efficacy were probably based on the common characteristics that both populations share. The study could have included how the different characteristics could statistically alter the results.
Maybe that is why there is no advisory.
If I am wrong--teach me something--I won't be offended. I just thought I would take a stab at it since I am not doing anything right now.
It might have to do with this:
"In the trial, there was a significant difference in low-density lipoprotein (LDL) cholesterol lowering seen between the treatment groups -- 58 percent LDL cholesterol lowering at 24 months on ezetimibe/simvastatin 10/80 mg as compared to 41 percent at 24 months on simvastatin 80mg alone, (p<0.01)."
http://www.merck.com/newsroom/press_releases/product/2008_0114.html
High LDL increases risks to the heart and since it was effective and the small population tested had characteristics of the larger population, then one could assume it would have a similar effect in those without Heterozygous Familial Hypercholesterolemia.
Also,
Since the endpoint of the study (even if it included the general population) was the mean change in wall thickness and there was a Non-statistical difference, then it could also be assumed that it would cause no adverse changes in wall thickness in patients without Heterozygous Familial Hypercholesterolemia.
Safety and efficacy were probably based on the common characteristics that both populations share. The study could have included how the different characteristics could statistically alter the results.
Maybe that is why there is no advisory.
If I am wrong--teach me something--I won't be offended. I just thought I would take a stab at it since I am not doing anything right now.
Dr. Choi,
Can you ask whomever decides the categories for MedHelp if schizophrenia or a blanket mental illness forum could be added?
I know someone who lived with schizophrenia and died from it. I know that it affects a lot of people and their families. Also, it is hard for these people to talk openly about it because of the stigma surrounding the illness and many other mental illnesses.
Thanks,
Chigirl29
Can you ask whomever decides the categories for MedHelp if schizophrenia or a blanket mental illness forum could be added?
I know someone who lived with schizophrenia and died from it. I know that it affects a lot of people and their families. Also, it is hard for these people to talk openly about it because of the stigma surrounding the illness and many other mental illnesses.
Thanks,
Chigirl29
Oh my goodness, I was surfing around, I went on your profile page--and from there to Flickr. You have an adorable family!!!! I had my baby in the frount pouch too. I have a backpack as well. Your wife and children are adorable. I wish my husband would let me put more personal things online. I thought about making a blog since I write quickly and have lots of interests. However, he doesn't want me to put too many personal things out on the web.
Anyway--I just wanted to say you have an adorable family!
Sorry about taking up so much space on your journal.
Anyway--I just wanted to say you have an adorable family!
Sorry about taking up so much space on your journal.
I've decided to do my own health and medical blog--about studies and their interpretations. You can find more info on the Enhance trial by going to the Wall Street Journal blog. Actually, I was right about the LDL benefits. What people do not realize is that studies have endpoints and you have to evaluate why something is approved based on that data.
You are right, there are statin alternatives for people who cannot tolerate large statin amounts; however, they may not be as effective as the combination--every person is different.
I think advisories should be reserved for drugs that demonstrate adverse changes in the body.
Obviously, I will not target medical professionals--I plan to make my blog more simplistic.
Now--I have found something to do--since I moved and have not been in school--I've been going nuts with sickness (first) and then boredom.
You are right, there are statin alternatives for people who cannot tolerate large statin amounts; however, they may not be as effective as the combination--every person is different.
I think advisories should be reserved for drugs that demonstrate adverse changes in the body.
Obviously, I will not target medical professionals--I plan to make my blog more simplistic.
Now--I have found something to do--since I moved and have not been in school--I've been going nuts with sickness (first) and then boredom.
NNT, NNT, NNT
AKA the Number Needed to Treat
Statins alone,..?
NNT = 27 to 100
Niacin in combo with almost any other Rx,.. NNT = 3 to 12
Read up on this,.. rather shocking.
ALL government funded studies.
CLAS-I, CLAS-II, USAF-SCOR, FATS, FATS 15 year follow-up, HATS, AFREGS.
The LDL Mafia has done a spectacular job brain-washing us for 20 years.
Follow the $$$$$$$$
AKA the Number Needed to Treat
Statins alone,..?
NNT = 27 to 100
Niacin in combo with almost any other Rx,.. NNT = 3 to 12
Read up on this,.. rather shocking.
ALL government funded studies.
CLAS-I, CLAS-II, USAF-SCOR, FATS, FATS 15 year follow-up, HATS, AFREGS.
The LDL Mafia has done a spectacular job brain-washing us for 20 years.
Follow the $$$$$$$$
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