ENHANCE and JUPITER Studies Revisited
I wanted to once again weigh in on two very important issues discussed at the American College of Cardiology meeting this week in Chicago. The first is about the JUPITER Study and then I will give some further thoughts about the ENHANCE study which I have previously written about in January.
The results of ENHANCE, which was the trial of Vytorin 80/10 vs Zocor 80, was already released in January. Despite the media uproar then, there seems to be more ridiculous hoopla when really nothing is new. The only difference is that the results are now published in the New England Journal of Medicine. As I have said before, this is strictly an imaging study and there is NO OUTCOME DATA!
Despite this, some have made this out to be some groundbreaking study and it is not. The only point new was that Vytorin was superior to Zocor in reducing C-Reactive Protein (48% vs 23%), Apo B, Triglycerides, and most importantly LDL-C. Also there were no adverse outcomes with Vytorin. I am not going to rehash all the facts of the study but there is one important point. Although they looked at patients with Familial Hypercholesterolemia, the baseline Carotid Intimal Thickness (CIMT) was pretty much normal...meaning the arteries were clean in the neck. There was no progression of CIMT meaning both the drugs kept the arteries clean.
How the furor over Zetia and Vytorin has occurred perplexes me but be assured, I will not change my prescribing habits.
Most importantly, the JUPITER trial was stopped using Crestor for ethical reasons because the Crestor arm of the trial had significant improvements in Cardiovascular morbidity and mortality. I have been a fan of Crestor for a long time and once again the superiority of LDL-C lowering was confirmed as was the safety. There is no more effective statin on the market.
I want to also make clear that I have no financial relationship with any pharmaceutical company and my motives for stating this are based on sound evidence-based medicine. Most importantly, I feel it is my obligation as a physician to present the facts and not have my "feelings" based on any financial remuneration. I can tell you that some of the physicians who weigh in on the studies have some kind of financial incentive to do so and I personally believe this clouds their interpretation of the facts.
I will resume Part 2 of O3FA in my next posting.
Related Topics:
Technorati Tags: studies, cholesterol, zetia, vytorin, zocor, crestor
The results of ENHANCE, which was the trial of Vytorin 80/10 vs Zocor 80, was already released in January. Despite the media uproar then, there seems to be more ridiculous hoopla when really nothing is new. The only difference is that the results are now published in the New England Journal of Medicine. As I have said before, this is strictly an imaging study and there is NO OUTCOME DATA!
Despite this, some have made this out to be some groundbreaking study and it is not. The only point new was that Vytorin was superior to Zocor in reducing C-Reactive Protein (48% vs 23%), Apo B, Triglycerides, and most importantly LDL-C. Also there were no adverse outcomes with Vytorin. I am not going to rehash all the facts of the study but there is one important point. Although they looked at patients with Familial Hypercholesterolemia, the baseline Carotid Intimal Thickness (CIMT) was pretty much normal...meaning the arteries were clean in the neck. There was no progression of CIMT meaning both the drugs kept the arteries clean.
How the furor over Zetia and Vytorin has occurred perplexes me but be assured, I will not change my prescribing habits.
Most importantly, the JUPITER trial was stopped using Crestor for ethical reasons because the Crestor arm of the trial had significant improvements in Cardiovascular morbidity and mortality. I have been a fan of Crestor for a long time and once again the superiority of LDL-C lowering was confirmed as was the safety. There is no more effective statin on the market.
I want to also make clear that I have no financial relationship with any pharmaceutical company and my motives for stating this are based on sound evidence-based medicine. Most importantly, I feel it is my obligation as a physician to present the facts and not have my "feelings" based on any financial remuneration. I can tell you that some of the physicians who weigh in on the studies have some kind of financial incentive to do so and I personally believe this clouds their interpretation of the facts.
I will resume Part 2 of O3FA in my next posting.
Related Topics:
Technorati Tags: studies, cholesterol, zetia, vytorin, zocor, crestor
7 Comments:
Awesome post-I wish the mainstream media could ever actually present the true facts about any study and all the "experts" would stop saying so much of their opinions which are clearly based on "consulting fees". It is too bad you can't get on the National Stage and get the facts out to the public the way it needs to be done. I hope the powers that be on WebMD will start using you to write or give your opinion on a relevant topic. I am so tired of hearing from the same boring self-serving physicians.-TT
I am switching to Crestor if you say it's the best! Thanks Dr.Richman
Hello i am 24 years old i have chronic pancreatitis, diabetes, migraines, high cholosterol, and high triglycerides. I was told gallstones are just hardened cholesterol, if this is true than i have A ? Can you still get gallstones if you don't have a gallbladder and if you can could my high cholesterol be producing gallstones, I have been having pains like a gallbladder attack but i have no gallbladder.
do statins inhibit the production of red blood cells? i live in the mountains and i have noticed my hiking ability has not improved in the last six months.i am not sure if it is my age,iam 60 or the medication i take,zocor .i thought your body was supposed to increase the red blood cells to compensate for the altitude.
I appreciate your comments on the ENHANCE trial. As a health care professional, it has been difficult dealing with the panic and confusion caused by this flawed, insignificant study. Your site is a valuable resource for patients. I can also use it to supplement my discussions with patients on this issue.
MS
ok mr. expert:
The crestor trial data (JUPITER) is not published meaning there's been no peer-review and you're ready to buy into a drug without one positive outcomes data??? If you don't know, Crestor did NOT meet the primary endpoint in its first published outcomes trial (CORONA). Evidence-based??? who're you crappin'?
Published on www.brainblogger.com:
A Failed Attempt to Improve Misperceived Greatness: The ENHANCE Trial
While it seems that sponsors of clinical trials usually end up with results that clearly favor their meds studied in their trial, there are rare exceptions, and Merck and Schering proved that with their disappointing ENHANCE Trial, which many have heard about through the media not long ago.
The drugs studied were Vytorin, which was compared with Zocor
Vytorin is a combination med for high cholesterol and contains Merck’s Zocor, which is now generic, and Schering’s Zetia, which works differently than Zocor, which is one of many statin drugs. Both Vytorin and Zetia are co-promoted by Merck and Schering. So, several years ago, an outcomes study was initiated to prove superiority of Vytorin over Zocor as monotherapy. The trial was named the ENHANCE trial, possibly because Zocor is generic now, and not a priority from a profit paradigm of its creator.
After several years passed, a disappointment arrived for the sponsors of this trial, which was first brought to the attention of Schering in March of 2007, yet the results existed since the spring of 2006, I believe upon information and belief.
The disappointment is that Vytorin lacked anticipated benefit or superiority over Zocor. Since about 1 million scripts were written for both Vytorin and Zetia every week in 2007, combined with what I believe was about 5 billion in revenue for these two drugs that year, this was a problem for the drug makers, meaning a fear of shareholder reaction. Perhaps for Schering in particular, it was more of a calamity, since over half of their profits and earnings were from these two drugs with Schering, I understand.
Being the responsible corporations both companies are, of course, alterations occurred after such events were discovered that fractured numerous rules and regulations with clinical trials, possibly in illegal and unethical tactics.
The trial sponsors delayed the release of the trial results for secrecy reasons, it has been speculated. Results from the trial existed, yet were not disclosed at the time of their discovery. After several months of possessing these trial results that were only known to the manufacturers, they created or implemented some atrocious tactics to improve the trial’s unimpressive results following the original results of this ENHANCE study. At the end of 2007, the companies changed the primary endpoint of the trial, which is what the results were measured upon during the entire course of the trial. Sort of like sorting cards to make a good hand not dealt to you. Anyway, since their deliberate concealment of these trial results was clearly wrong, to respond to those who asked where the results were actually as they had been anticipated for quite some time, and while such trial manipulation was occurring and results were being kept secret, Schering stated that continued data analysis from the trial results was the etiology for the delay.
With clinical trials, case report forms are used to record data from the trials, and are created in a manner where further analysis is not normally necessary, as such forms are quite clear and often not subject to interpretation as implied by the trial sponsors, one could conclude. So at the end of 2007, both Merck and Schering got the attention of relevant government officials who contacted both companies regarding this ENHANCE trial due to such suspicions on the facts known and presented, and an investigation began into the activities of both companies regarding this trial at that point.
This became a catalyst for the ENHANCE trial results to be finally released at the beginning of 2008, which caught the attention of major media organizations, as expected. In the spring of 2008, a very large cardiology meeting was held, where the audience was told, I understand, to stick with statins due to this trial’s lack of outcomes for Vytorin, when the ENHANCE trial was discussed at this meeting. Furthermore, it has been said that a cardiologist at this meeting also suggested that a moratorium should occur with the utilization of Vytorin by prescribers, since statins are much less expensive, and are highly regarded, as they have been available for a couple of decades, starting with Mevacor in the 1980s. Of course and as expected, Merck and Schering were not pleased, nor were they surprised at the review of Vytorin at this particular meeting. The following month after this cardiology meeting, Schering’s earnings dropped by 48 percent, as I recall. Also during much of this year, Schering in particular blamed the media for amplifying the situation regarding the ENHANCE trial.
Now, these cholesterol drugs promoted by Merck and Schering, Zetia and Vytorin, were aggressively marketed in a number of ways, including investing I believe about 200million dollars in 2007 for DTC ads for these products. To add to this, and soon after both meds were launched, reps from both companies made inferences to doctors about outcomes regarding plaque accumulation and how Vytorin was superior in that area, which, of course, this ENHANCE trial proved it is in fact not the case whatsoever. It did not matter, apparently, to both Merck and Schering that such claims were is entirely void of proof, which is not unique to any pharma rep, in my opinion. No remorse or regret from the makers of these drug makers, either, which did not shock many. Yet what is known now is that these companies, as stated by other researchers, performed junk science with their deliberate manipulation of this ENHANCE trial using such tactics. Also, last year, Zetia and Vytorin had about 20 percent of the cholesterol lowering market. It does not seem that there will be an increase of this percentage because of this scandal. Possibly if they presented the truth, the future of these meds might be better than what is anticipated presently.
Worst of all regarding this ENHANCE trial scandal is the harm caused to both doctors and patients. The ENHANCE trial concerned and confused both of these participants in the health care system. Furthermore, it’s likely they were devastated by being so clearly misled by the marketing of both Merck and Schering regarding the false benefits of Vytorin they were led to believe by the companies that promoted them- the health care providers in particular.
This whole situation is another example of the progressively frequent discovery of corruption of the scientific method by placing profits over the well-being of patients, which harms the well being of patients. In addition, most were shocked by Merck behaving in such a way in particular because of what use to be their excellent reputation as an ethical pharmaceutical company. And this alone shows the progression and infiltration of such damaging ethical atrophy that desperately needs to be stopped and corrected for the sake of others. For the sake of everyone.
Don’t just say something. Have something to say- to the right people, with conviction and with others who share your views.
“Waste no more time arguing what a good man should be. Be one.” --- Marcus Aurelius
Dan Abshear
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