Comments on: Does A Lipitor Study Give Vytorin A Boost? http://www.pharmalot.com/2008/07/does-a-lipitor-study-give-vytorin-a-boost/ News, Comment and Conversation Fri, 10 Feb 2012 21:15:01 +0000 http://wordpress.org/?v=2.6.2 By: dr stat http://www.pharmalot.com/2008/07/does-a-lipitor-study-give-vytorin-a-boost/#comment-369316 dr stat Thu, 14 Aug 2008 15:39:42 +0000 http://www.pharmalot.com/?p=14497#comment-369316 Generally, the blog does better. It fails to present the obvious. This is an additional piece of evidence, an apparently suppressed by PFE, that statins in women are not cardioprotective. This is not an obscure view, but shared by the many in the unconflicted health services research community. Generally, the blog does better. It fails to present the obvious. This is an additional piece of evidence, an apparently suppressed by PFE, that statins in women are not cardioprotective. This is not an obscure view, but shared by the many in the unconflicted health services research community.

]]> By: Curious http://www.pharmalot.com/2008/07/does-a-lipitor-study-give-vytorin-a-boost/#comment-366215 Curious Thu, 10 Jul 2008 12:23:52 +0000 http://www.pharmalot.com/?p=14497#comment-366215 I'm curious as to why Merck & Shering Plough have been beaten up by EVERYONE in the media and even had congressional investigation because results of Enhance were not available for approx. 2 yrs. I understand CASHMERE (Pfizer) was completed 2 yrs ago - where's the upset? Where's the congressional investigation? Is Nissen going to demand everyone stop their Lipitor now too? Pfft! I’m curious as to why Merck & Shering Plough have been beaten up by EVERYONE in the media and even had congressional investigation because results of Enhance were not available for approx. 2 yrs. I understand CASHMERE (Pfizer) was completed 2 yrs ago - where’s the upset? Where’s the congressional investigation? Is Nissen going to demand everyone stop their Lipitor now too? Pfft!

]]> By: Doc http://www.pharmalot.com/2008/07/does-a-lipitor-study-give-vytorin-a-boost/#comment-366079 Doc Wed, 09 Jul 2008 00:14:37 +0000 http://www.pharmalot.com/?p=14497#comment-366079 PR Hack, TIMI-22 was not a placebo controlled study as we know. It was vs pravastatin, however there was an absolute reduction in actual CV events using Lipitor vs using pravastatin. The Kaplan Mier curves do represent a relative risk reduction, but there was an absolute reduction in CV events also. I do not know any practitioner who prescribes statins in patients that are not indicated for them. Your 'certainty' of organ damage is not proven. The use of statins has prevented many more CV events and death than any organ damage. Of course when drugs are used in combination, physicians must watch for side effects. But to say there is 'certainty' of organ damage is irresponsible, at best. PR Hack,
TIMI-22 was not a placebo controlled study as we know. It was vs pravastatin, however there was an absolute reduction in actual CV events using Lipitor vs using pravastatin. The Kaplan Mier curves do represent a relative risk reduction, but there was an absolute reduction in CV events also.

I do not know any practitioner who prescribes statins in patients that are not indicated for them. Your ‘certainty’ of organ damage is not proven. The use of statins has prevented many more CV events and death than any organ damage. Of course when drugs are used in combination, physicians must watch for side effects. But to say there is ‘certainty’ of organ damage is irresponsible, at best.

]]> By: pharma PR hack http://www.pharmalot.com/2008/07/does-a-lipitor-study-give-vytorin-a-boost/#comment-366035 pharma PR hack Tue, 08 Jul 2008 15:06:38 +0000 http://www.pharmalot.com/?p=14497#comment-366035 Doc, First paragraph of the TIMI-22 study pasted below- you'll note two things: 1) it reduces risk - not actual events. I can reduce the risk of auto accidents by taking the bus; It doesn't mean I am a better driver or I won't wreck - just lowers the probability. 2) These "reduced risk benefits" are truly limited to high risk populations for exisiting disease --- not every joe smoe out there currently taking a statin. 3) the organ damage done by long term use of statin along with other drugs isn't just a probability but a certainty. Maybe a closer looks should be taken at targeting medications for those currently in need versus preventing possible effects at the cost/certainty of creating damage. http://www.timi.org/files/shows/prove%20it%20article%20cpc.pdf Lowering cholesterol levels can reduce the risk of coronary events in highrisk patients and in those with chronic CHD. Current ACC/AHA guidelines recommend that lipid levels are managed through diet, or by treatment with lipid-lowering drugs such as statins, if LDL-C levels are 130 mg/dL. Although previous studies suggest that the percentage decrease in cholesterol levels is important in reducing risk at high baseline LDL-C levels, there is currently no evidence to demonstrate thatreducing cholesterol levels below 100 mg/dL in the majority of patients has additional benefit. Doc, First paragraph of the TIMI-22 study pasted below- you’ll note two things:
1) it reduces risk - not actual events.

I can reduce the risk of auto accidents by taking the bus; It doesn’t mean I am a better driver or I won’t wreck - just lowers the probability.

2) These “reduced risk benefits” are truly limited to high risk populations for exisiting disease — not every joe smoe out there currently taking a statin.

3) the organ damage done by long term use of statin along with other drugs isn’t just a probability but a certainty. Maybe a closer looks should be taken at targeting medications for those currently in need versus preventing possible effects at the cost/certainty of creating damage.

http://www.timi.org/files/shows/prove%20it%20article%20cpc.pdf

Lowering cholesterol levels can reduce
the risk of coronary events in highrisk
patients and in those with chronic
CHD. Current ACC/AHA guidelines recommend
that lipid levels are managed through
diet, or by treatment with lipid-lowering
drugs such as statins, if LDL-C levels are
130 mg/dL. Although previous studies
suggest that the percentage decrease in
cholesterol levels is important in reducing
risk at high baseline LDL-C levels, there is
currently no evidence to demonstrate thatreducing cholesterol levels below 100
mg/dL in the majority of patients has additional
benefit.

]]> By: Dingle http://www.pharmalot.com/2008/07/does-a-lipitor-study-give-vytorin-a-boost/#comment-366023 Dingle Tue, 08 Jul 2008 13:54:31 +0000 http://www.pharmalot.com/?p=14497#comment-366023 Ed, In your post above you write "there are still no data proving that Vytorin reduces the risk of heart attacks more than Zocor, but that previous studies did reach that conclusion about Lipitor." I don't recall Lipitor having shown an outcomes benefit vs. Zocor. They just added outcomes to their label last year, and I believe that was a study vs. placebo. What study are you referring to? Thanks. Ed,
In your post above you write “there are still no data proving that Vytorin reduces the risk of heart attacks more than Zocor, but that previous studies did reach that conclusion about Lipitor.” I don’t recall Lipitor having shown an outcomes benefit vs. Zocor. They just added outcomes to their label last year, and I believe that was a study vs. placebo. What study are you referring to?

Thanks.

]]> By: Doc http://www.pharmalot.com/2008/07/does-a-lipitor-study-give-vytorin-a-boost/#comment-366012 Doc Tue, 08 Jul 2008 09:42:15 +0000 http://www.pharmalot.com/?p=14497#comment-366012 Pharma pr hack, Read the TIMI-22 study. Lipitor reduces CV events and death. CV event reduction is also in the FDA approved label for Lipitor. Or read the 4S study with simvastatin, it is indicated to reduce total mortality. Vytorin needs an outcome study that shows sig CV event reduction, then they can market it appropriately. Pharma pr hack,

Read the TIMI-22 study. Lipitor reduces CV events and death. CV event reduction is also in the FDA approved label for Lipitor.

Or read the 4S study with simvastatin, it is indicated to reduce total mortality.

Vytorin needs an outcome study that shows sig CV event reduction, then they can market it appropriately.

]]> By: Bruce http://www.pharmalot.com/2008/07/does-a-lipitor-study-give-vytorin-a-boost/#comment-365999 Bruce Tue, 08 Jul 2008 04:01:55 +0000 http://www.pharmalot.com/?p=14497#comment-365999 The whole concept of cholesterol is way too simplistic. Its not all about a number. Lower may not mean anything. There are many elderly with no events living late into life with high LDL and their HDL is out of "norm". They conveniently ignore this when they talk about their theories. I am not saying don't use statins, but I am saying I would not rush to put children on them. Lifestyle management is still the best approach. The whole concept of cholesterol is way too simplistic. Its not all about a number. Lower may not mean anything. There are many elderly with no events living late into life with high LDL and their HDL is out of “norm”. They conveniently ignore this when they talk about their theories.

I am not saying don’t use statins, but I am saying I would not rush to put children on them. Lifestyle management is still the best approach.

]]> By: pharma pr hack http://www.pharmalot.com/2008/07/does-a-lipitor-study-give-vytorin-a-boost/#comment-365997 pharma pr hack Tue, 08 Jul 2008 02:41:58 +0000 http://www.pharmalot.com/?p=14497#comment-365997 I'm sorry Doc but are there studies out there which aren't cherry picked meta-analysis from managed care files that show Lipitor reduces CV events? Marilyn, thank you very much for the insight. You noted the high discontinuation rate- all these trials are small periods of time but we are talking about individuals taking these medications preventatively for years. When does the cost of outweighing an event that may or may not ever happen to you get figured in the equation? Specifically the side-effects and quality of life issues. I’m sorry Doc but are there studies out there which aren’t cherry picked meta-analysis from managed care files that show Lipitor reduces CV events?

Marilyn, thank you very much for the insight. You noted the high discontinuation rate- all these trials are small periods of time but we are talking about individuals taking these medications preventatively for years.

When does the cost of outweighing an event that may or may not ever happen to you get figured in the equation? Specifically the side-effects and quality of life issues.

]]> By: anonymous http://www.pharmalot.com/2008/07/does-a-lipitor-study-give-vytorin-a-boost/#comment-365993 anonymous Tue, 08 Jul 2008 02:12:18 +0000 http://www.pharmalot.com/?p=14497#comment-365993 LOWER IS BETTER!!! KEEP IT SIMPLE. PERIOD. LOWER IS BETTER!!! KEEP IT SIMPLE. PERIOD.

]]> By: Marilyn Mann http://www.pharmalot.com/2008/07/does-a-lipitor-study-give-vytorin-a-boost/#comment-365992 Marilyn Mann Tue, 08 Jul 2008 02:07:42 +0000 http://www.pharmalot.com/?p=14497#comment-365992 Sorry, did not intend to be anonymous, that last comment was from me. Sorry, did not intend to be anonymous, that last comment was from me.

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