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Medical Forum / General / Cardiology / January 2008Vytorin, Zetia and surrogate endpoints
The FDA allowed Zetia on the market using results that measured a surrogate endpoint. They measured LDL-C reduction instead of heart- attack or death. This isn't a bad thing in itself. The problem is that the FDA allowed them to use an inferior surrogate endpoint. Why are cardiologists still treating to LDL-C outcomes when more specific outcomes are available? You're going to the effort and expense of running a randomized clinical trial. You've got the patient in the lab and are already drawing blood. Why not run a VAP or a Berkeley cholesterol test and look at the LDL and HDL subtypes? Why didn't the FDA make them look at (and report) LDL particle counts, hs- CRP and Lp(a)? While you're at it, howabout checking urine albumin, fasting blood glucose, fasting insulin and A1c? A much smaller, shorter trial with a more comprehensive set of tests would have told us a lot more about Zetia a lot earlier -- $3+ billion worth of prescriptions ago. Adam Becker Sr ps. What (relatively cheap) test would *you* have wanted the FDA to have demanded from the original Zetia studies? In article <e8edf20e-6b93-4cf5-bca5-401c541f3551@u10g2000prn.googlegroups.com>, > The FDA allowed Zetia on the market using results that measured a > surrogate endpoint. They measured LDL-C reduction instead of heart- [quoted text clipped - 18 lines] > ps. What (relatively cheap) test would *you* have wanted the FDA to > have demanded from the original Zetia studies? This would be something to consider. Bill .............................. : Drug Saf. 2007;30(3):195-201. Psychiatric adverse reactions with statins, fibrates and ezetimibe: implications for the use of lipid-lowering agents. Tatley M, Savage R. New Zealand Pharmacovigilance Centre, Department of Preventative and Social Medicine, University of Otago, Dunedin, New Zealand. michael.tatley@stonebow.otago.ac.nz The HMG-CoA reductase inhibitors ('statins') have come into widespread use internationally. There has been a long history of their use in New Zealand and this use has increased in recent years. There has also been an increase in the number of reports to the New Zealand Centre for Adverse Reactions Monitoring (CARM) of suspected psychiatric adverse reactions associated with statins. The reactions mentioned in these reports include depression, memory loss, confusion and aggressive reactions. Convincing reports to CARM of recurrence of these reactions upon rechallenge add weight to recent studies reporting serious psychiatric disturbances in association with statin treatment. Aggressive reactions associated with statins are poorly documented in the literature. These observations emphasise the need to be vigilant in looking for these reactions as they can have a significant personal impact on a patient. The observation that other lipid-lowering agents have similar adverse effects supports the hypothesis that decreased brain cell membrane cholesterol may be important in the aetiology of these psychiatric reactions. PMID: 17343428 [PubMed - indexed for MEDLINE]  SignatureGarden in shade zone 5 S Jersey USA ICAO = KMIV Millvile Weather > : Drug Saf. 2007;30(3):195-201. > > Psychiatric adverse reactions with statins, fibrates and ezetimibe: > implications for the use of lipid-lowering agents. Interesting. I was aware of some bizarre psychiatric effects with statins (e.g. see http://www.spacedoc.net/) but I didn't realize that there were reports of comparable effects with other cholesterol- lowering approaches. On Jan 28, 10:53 am, sphynx....@gmail.com wrote: > The FDA allowed Zetia on the market using results that measured a > surrogate endpoint. They measured LDL-C reduction instead of heart- [quoted text clipped - 18 lines] > ps. What (relatively cheap) test would *you* have wanted the FDA to > have demanded from the original Zetia studies? You mean that from the drug makers view the 3 billion plus was not the really important number. I expect they milked this drug for all it was worth > You mean that from the drug makers view the 3 billion plus was not the > really important number. I expect they milked this drug for all it was > worth. Well, yes, obviously. But what I'm asking is, "Should the FDA allow drugs on the market based on surrogate endpoints?" After Zetia/Vytorin, one is tempted to say "Heck NO!" But remember that the current practice (of allowing drugs to market based on surrogate endpoints) was forced on the FDA. They were refusing to let AIDS drugs onto the market quickly -- because there weren't RCTs with hard endpoints. I think the FDA should continue to (sometimes) allow drugs on the market quickly, even without hard endpoint studies. But there's a proviso. If manufacturers are forgoing hard endpoints, they should have to use the best possible surrogates. |
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