Lipitor Image via WikipediaThree Vytotin/Zetia reps just came to me and said, "When do you feel comfortable using Zetia? After all, Lipitor titration is a failed step. It only reduces LDL by 6%."
I gently referred them to the PROVE IT trial, asked them to come back when they had positive mortality data, and walked away.
Has anyone else encountered this strategy by the Zetia reps?
In my country, they called this "rule of 6." It mean that you can decrease LDL by only 6% each time you double the dosage of any statin drug. But PROVEIT trial also show that lower LDL is better, right? And vytorin can help the patient reach the goal. I think to give the best thing to the patients. We should give patient both zetia and lipitor, instead of vytorin . What do you think about this idea?
I feel pretty strongly about this. Treatment with a statin, independent of degree of LDL reduction saves lives (HPS), in patients with a prior ACS, LDL reduction to a level below 70 mg/dl saves lives. Niacin therapy to lower cholesterol saves lives. There is even event reduction data with resins. Ezetimibe does not have any data showing that using it to block cholesterol absorption confers a mortality benefit.
We have to be careful when worshiping at the alter of a surrogate marker (cholesterol this time). If you cannot prove that your class of agent does not reduce events, reducing a 2ndary marker is worthless.
Treating hypertension, for example, is good. There is good evidence that using alpha blockers to do it, doesn't help and may harm (ALLHAT). Atenolol may harm (Lancet article, 2006 I believe).
The classic example is the CAST trial (Cardiac Arrhythmia Suppression Trial). The hypothesis was PVCs post MI predict mortality. Flecanide/Encanide suppress PVCs. Flecanide/Encanide must therefore be good. There was a raging fight over the use of a placebo arm. Flecanide and Encanide were shown to kill people post MI!
Huck, thanks. You identified what annoyed me -- there's no positive mortality data with Zetia, and lowering LDL isn't a good surrogate for improved mortality. Had they said "Doubling the statin dose only lowers LDL by 6% more," that would be have been okay. But to call it a *failed* strategy -- when they have no positive mortality data -- turned me off immediately.
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