Talk:Anacetrapib
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How do we know that DEFINE was a Phase III trial?
[edit]I am puzzled by the designation of DEFINE as a Phase III trial. Recently an editor changed the title of one of the articles, which in fact does not have 'Phase III' in the full title. The government's trial registry gives the following information for DEFINE, not calling it Phase III: http://clinicaltrials.gov/ct2/show/NCT00685776.
Note the following definition from Clinical trial#Phase_III:
Phase III studies are randomized controlled multicenter trials on large patient groups (300–3,000 or more depending upon the disease/medical condition studied) and are aimed at being the definitive assessment of how effective the drug is, in comparison with current 'gold standard' treatment. Because of their size and comparatively long duration, Phase III trials are the most expensive, time-consuming and difficult trials to design and run, especially in therapies for chronic medical conditions.
A comment from Steve Nissen at theheart.com makes it sound as though a larger trial will necessarily follow, ("whether it reduces morbidity and mortality will have to be determined in a large outcomes trial"), so the drug will not be approved for use solely on the results of DEFINE. (He called DEFINE a 'medium-sized safety trial.') Unless a reference for the fact can be found, I suggest we remove the 'Phase III' from the description of the DEFINE trial. Thanks, EdJohnston (talk) 15:23, 24 November 2010 (UTC)
- Stated in the article under Purpose in the chart Phase III. Lambanog (talk) 13:23, 6 May 2011 (UTC)
What does the "pib" in all these names mean?
[edit]All the CETP inhibitors end in "pib", but why is not obvious. Perhaps add an explanation to:
http://wiki.riteme.site/wiki/CETP_inhibitor
"These drugs' names commonly end in "pib" because ..." — Preceding unsigned comment added by 12.171.88.10 (talk) 19:12, 21 November 2011 (UTC)
Could add REALIZE trial results
[edit]Anacetrapib on Top of Optimal Therapy Provides Large LDL-Lowering Benefit in FH: REALIZE. March 2015 "Among 204 patients who received anacetrapib, LDL-cholesterol levels were reduced from 127 mg/dL at baseline to 81 mg/dL at 1 year. For the 102 patients who received a placebo, LDL-cholesterol levels increased slightly over the 52 weeks. Treatment with anacetrapib also resulted in a significant increase in HDL-cholesterol levels, with baseline levels doubling after 1 year of treatment (up from 54 mg/dL to 108 mg/dL)." - Rod57 (talk) 10:08, 10 March 2016 (UTC)
External links modified
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