Comments on: Will The Crestor Study Sell More Cholesterol Pills? http://www.pharmalot.com/2008/11/will-the-crestor-study-sell-more-cholesterol-pills/ News, Comment and Conversation Fri, 10 Feb 2012 21:43:11 +0000 http://wordpress.org/?v=2.6.2 By: James http://www.pharmalot.com/2008/11/will-the-crestor-study-sell-more-cholesterol-pills/#comment-580832 James Tue, 16 Nov 2010 12:06:01 +0000 http://www.pharmalot.com/?p=17418#comment-580832 My doctor switched me from Lipitor to Crestor because I was getting incredible leg pain and joint swelling. The Crestor has performed equally as well without any of the uncomfortable side effects. My doctor switched me from Lipitor to Crestor because I was getting incredible leg pain and joint swelling. The Crestor has performed equally as well without any of the uncomfortable side effects.

]]> By: Jack Friday http://www.pharmalot.com/2008/11/will-the-crestor-study-sell-more-cholesterol-pills/#comment-381047 Jack Friday Tue, 11 Nov 2008 09:37:00 +0000 http://www.pharmalot.com/?p=17418#comment-381047 My bottom line: Good result for a "not needed" statin. James Stein and Jon Keevil of the University of Wisconsin-Madison calculated it would cost about $408,000 to save a life using Crestor, compared with $24,000 using a generic. My bottom line:

Good result for a “not needed” statin. James Stein and Jon Keevil of the University of Wisconsin-Madison calculated it would cost about $408,000 to save a life using Crestor, compared with $24,000 using a generic.

]]> By: Jim http://www.pharmalot.com/2008/11/will-the-crestor-study-sell-more-cholesterol-pills/#comment-381007 Jim Mon, 10 Nov 2008 21:02:01 +0000 http://www.pharmalot.com/?p=17418#comment-381007 I read the post on Gooz and it answered some of my questions and made some valid points. I also went to the NEJM site and looked over the various reports. The reports show that among other things, individuals were identified as smokers; having metabolic disorder, or having a family history of CVE. I must admit I am a statistical illiterate and am curious as to how many of the individuals who suffered a CVE during the span of the study came from the above groups? I read the post on Gooz and it answered some of my questions and made some valid points.
I also went to the NEJM site and looked over the various reports.
The reports show that among other things, individuals were identified as smokers; having metabolic disorder, or having a family history of CVE.
I must admit I am a statistical illiterate and am curious as to how many of the individuals who suffered a CVE during the span of the study came from the above groups?

]]> By: Justice in MI http://www.pharmalot.com/2008/11/will-the-crestor-study-sell-more-cholesterol-pills/#comment-380993 Justice in MI Mon, 10 Nov 2008 18:15:06 +0000 http://www.pharmalot.com/?p=17418#comment-380993 I'd second Insider's suggestion to read Gooz on this. It is the kind of analysis that led to my questions about NNT in the first place, not only about CV risk reduction but about diabetes risk increase. In terms of relative risk, they are fairly close. I’d second Insider’s suggestion to read Gooz on this. It is the kind of analysis that led to my questions about NNT in the first place, not only about CV risk reduction but about diabetes risk increase. In terms of relative risk, they are fairly close.

]]> By: Justice in MI http://www.pharmalot.com/2008/11/will-the-crestor-study-sell-more-cholesterol-pills/#comment-380992 Justice in MI Mon, 10 Nov 2008 18:09:55 +0000 http://www.pharmalot.com/?p=17418#comment-380992 Nathan - on McNeil/Lehrer, Nissen even called the results a 'blockbuster.' Perhaps he is, indeed, running for Commish. Nathan - on McNeil/Lehrer, Nissen even called the results a ‘blockbuster.’

Perhaps he is, indeed, running for Commish.

]]> By: Outside the Box http://www.pharmalot.com/2008/11/will-the-crestor-study-sell-more-cholesterol-pills/#comment-380985 Outside the Box Mon, 10 Nov 2008 16:51:57 +0000 http://www.pharmalot.com/?p=17418#comment-380985 These data seem to be very positive for statin use - especially in providing physicians with a strong argument to get patients to continue on therapy once their cholesterol is down to normal. As for approval for use of statins in the normal cholesterol / high CRP group, I wonder if anyone has actually explained the mode of action here? Is it possible that statins are actually vascular anti-inflammatory agents and that their effect on cholesterol is actually a side-effect? I may be wrong here, but doesn't the body produce cholesterol as part of its anti-inflammatory process? Whatever the MOA is, isn't it going to be necessary to demonstrate it before the FDA will approve the CRP indication? Are there other diagnostic methods of identifying the presence of vascular inflammation that would support or replace CRP as the marker? Either way, it is hard to see these data being anything other than beneficial for the entire class of statins. These data seem to be very positive for statin use - especially in providing physicians with a strong argument to get patients to continue on therapy once their cholesterol is down to normal. As for approval for use of statins in the normal cholesterol / high CRP group, I wonder if anyone has actually explained the mode of action here? Is it possible that statins are actually vascular anti-inflammatory agents and that their effect on cholesterol is actually a side-effect? I may be wrong here, but doesn’t the body produce cholesterol as part of its anti-inflammatory process? Whatever the MOA is, isn’t it going to be necessary to demonstrate it before the FDA will approve the CRP indication? Are there other diagnostic methods of identifying the presence of vascular inflammation that would support or replace CRP as the marker?

Either way, it is hard to see these data being anything other than beneficial for the entire class of statins.

]]> By: Insider http://www.pharmalot.com/2008/11/will-the-crestor-study-sell-more-cholesterol-pills/#comment-380978 Insider Mon, 10 Nov 2008 14:49:36 +0000 http://www.pharmalot.com/?p=17418#comment-380978 NNT = the reciprocal of the absolute risk reduction. Gooze has a nice piece: http://www.gooznews.com/archives/001243.html Lets cut thru the CRP! NNT = the reciprocal of the absolute risk reduction.

Gooze has a nice piece:

http://www.gooznews.com/archives/001243.html

Lets cut thru the CRP!

]]> By: Nathan http://www.pharmalot.com/2008/11/will-the-crestor-study-sell-more-cholesterol-pills/#comment-380976 Nathan Mon, 10 Nov 2008 13:54:59 +0000 http://www.pharmalot.com/?p=17418#comment-380976 Interesting that even Steve Nissen, ever the pharma critic, seems to view this trial favorably. Here's a quote from the NPR article: "That is a larger reduction in the things that we care the most about — morbidity and mortality — than we've ever seen in a statin trial," says Steven Nissen, who chairs the department of cardiovascular medicine at the Cleveland Clinic. "And it occurred very quickly, in only 1.9 years of average duration of treatment." Interesting that even Steve Nissen, ever the pharma critic, seems to view this trial favorably. Here’s a quote from the NPR article:

“That is a larger reduction in the things that we care the most about — morbidity and mortality — than we’ve ever seen in a statin trial,” says Steven Nissen, who chairs the department of cardiovascular medicine at the Cleveland Clinic. “And it occurred very quickly, in only 1.9 years of average duration of treatment.”

]]> By: Condor http://www.pharmalot.com/2008/11/will-the-crestor-study-sell-more-cholesterol-pills/#comment-380975 Condor Mon, 10 Nov 2008 13:44:44 +0000 http://www.pharmalot.com/?p=17418#comment-380975 Hey PaulGGG -- this has been discussed to death here and elsewhere -- but the official jury (the FDA) is still out on the elevated risks of cancer (found in SEAS) from Vytorin/Zetia. Cheers! Hey PaulGGG — this has been discussed to death here and elsewhere — but the official jury (the FDA) is still out on the elevated risks of cancer (found in SEAS) from Vytorin/Zetia.

Cheers!

]]> By: Dan A. http://www.pharmalot.com/2008/11/will-the-crestor-study-sell-more-cholesterol-pills/#comment-380974 Dan A. Mon, 10 Nov 2008 13:31:26 +0000 http://www.pharmalot.com/?p=17418#comment-380974 CRP is primarily elevated upon an inflammatory reaction that may be caused by many medical conditions. So CRP being a CV risk factor is understandable, yet could be indicative of another disease state, such as a microbe invasion. Makeres of HTN meds have and are doing studies to prove a correlation between elevated CRP and the development of ... Read Morehypertension as well. Yet CRP overall is a non-specific prognostic indicator due to the numerous etiologies that could be attributed to the CRP elevation, and as such, many etiologies should be ruled out before it is presumed to be solely attributed to CV dysfunction. CRP is primarily elevated upon an inflammatory reaction that may be caused by many medical conditions. So CRP being a CV risk factor is understandable, yet could be indicative of another disease state, such as a microbe invasion. Makeres of HTN meds have and are doing studies to prove a correlation between elevated CRP and the development of … Read Morehypertension as well. Yet CRP overall is a non-specific prognostic indicator due to the numerous etiologies that could be attributed to the CRP elevation, and as such, many etiologies should be ruled out before it is presumed to be solely attributed to CV dysfunction.

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