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Old 08-04-2004, 03:39 PM   #1
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Location: Jersey City, NJ
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zip2play HB User
Vytorin

Talk about SPEED!

I spoke with a friend of mine, an elderly woman who went to the doctor last week and he changed her Lipitor prescription for NO reason at all to VYTORIN. Of course, I scratched my head, never having heard of the pill.

Well it seems it's a mix of ZETIA and ZOCOR for us dimwits who can;t be trusted to take 2 pills.

This drug got FDA approval ON JULY 23, 2004...my friend had it prescribed a WEEK ago.
Doesn't it seem only common sense for a doctor to wait perhaps A MONTH to see if the first few thousand people who take the drug DROP DEAD.
I'll bet the jerk that my friend goes to was prescribing it on July 24! (Now WHAT could POSSIBLY motivate him to act so quickly?)

What SHILLS!

I look forward to the next combo- a single LARGE pill made from Lipitor, Stanols, Niacin, Losartan, HCTZ, Amlopdipine, Atenolol, aspirin and folic acid with a special formulation that includes allopurinol for those with gout: The pills will retail at $22.95 EACH ($22.89 if you have one of George Bush's Prescription Discount Cards for Medicare!)

 
Old 08-04-2004, 06:03 PM   #2
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NineLives HB User
Re: Vytorin

Perhaps perks for the doctor! I think I'll let a few more guinea pigs try first.

 
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Old 08-04-2004, 06:10 PM   #3
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rahod HB User
Re: Vytorin

Quote:
Originally Posted by zip2play
Talk about SPEED!

This drug got FDA approval ON JULY 23, 2004...my friend had it prescribed a WEEK ago.
Doesn't it seem only common sense for a doctor to wait perhaps A MONTH to see if the first few thousand people who take the drug DROP DEAD.
I'll bet the jerk that my friend goes to was prescribing it on July 24! (Now WHAT could POSSIBLY motivate him to act so quickly?)

What SHILLS!

NEW ORLEANS, March 8, 2004 - Results from Phase III clinical trials showed that patients taking ezetimibe with simvastatin experienced significantly greater reductions in LDL (“bad”) cholesterol across the dosing ranges studied compared to reductions seen in patients taking Lipitor (atorvastatin) or ZOCOR® (simvastatin), alone. Results from the studies, conducted in support of VYTORINTM (ezetimibe/simvastatin), an investigational medicine, were presented here today at the 53rd Annual Scientific Meeting of the American College of Cardiology (ACC). Ezetimibe and simvastatin, the active ingredients in VYTORIN, achieve dual inhibition of two sources of cholesterol by inhibiting both cholesterol production in the liver and cholesterol absorption in the intestine.

“Results from these studies showed that ezetimibe with simvastatin provided significantly greater reductions in LDL cholesterol compared to atorvastatin or simvastatin alone. These results suggest that, if approved, this investigational medicine would offer physicians a different treatment option which targets two sources of cholesterol through dual inhibition of both cholesterol production and absorption,” said Christie Ballantyne, M.D., FACC, FACP, director of the Center for Cardiovascular Disease Prevention and professor of medicine at Baylor College of Medicine/The Methodist DeBakey Heart Center in Houston.

Study Results
Ezetimibe with simvastatin provided greater LDL-C reductions
compared to Lipitor
Results from a 24-week, 788-patient study of ezetimibe 10 mg taken with simvastatin (doses ranging from 10 mg to 80 mg) compared to atorvastatin monotherapy (doses ranging from 10 mg to 80 mg) showed significantly greater LDL-C reductions in patients taking ezetimibe with simvastatin compared to patients taking atorvastatin alone across the dosing ranges. The average LDL-C levels at baseline across treatment groups ranged from 179 mg/dL to 181 mg/dL.

The primary endpoint of this study was the efficacy comparison after the first six-week treatment period. After six weeks of therapy, patients taking ezetimibe 10 mg with simvastatin 10 mg and patients taking ezetimibe 10 mg with simvastatin 20 mg experienced greater LDL-C reductions (46 percent and 50 percent, respectively) compared to atorvastatin 10 mg, which produced a 37 percent reduction (p <0.01 for each versus atorvastatin). In addition, as each treatment group was titrated through the dosing ranges (by doubling the respective statin dose up to a maximum of 80 mg), ezetimibe with simvastatin consistently provided greater LDL-C reductions than atorvastatin at all points in the treatment period.

Study patients underwent a four-week diet/placebo run-in period and were then randomized to three treatment groups, each of which underwent four sequential, six-week treatment periods: (1) atorvastatin 10 mg in Period One, titrated to A20 mg, A40 mg, and A80 mg in Periods Two through Four (n=262); (2) ezetimibe with simvastatin 10 mg (10/10) in Period One, titrated to EZE/S20 mg (10/20), EZE/S40 mg (10/40), and EZE/S80 mg (10/80) in Periods Two through Four (n=263); and (3) ezetimibe with simvastatin 20 mg (10/20) in Period One, titrated to EZE/S40 (10/40) mg for Periods Two and Three, then EZE/S80 mg (10/80) in Period Four (n=263).

Results from this study also showed greater mean HDL-C increases across the treatment periods in patients taking ezetimibe with simvastatin (mean of 10 percent, range 8 to 12 percent) compared to patients taking atorvastatin alone (mean of 6 percent, range 5 to 8 percent).

Ezetimibe with simvastatin was well tolerated and had an overall safety profile similar to atorvastatin monotherapy in the study; there were no clinically or statistically significant differences in the incidence of muscle enzyme elevations (5 to 10 times or more than 10 times the upper limit of normal) or consecutive liver enzyme elevations (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] more than 3 times the upper limit of normal).

Ezetimibe with simvastatin provided greater LDL-C reductions
compared to ZOCOR
In another study, patients taking ezetimibe with simvastatin experienced significantly greater LDL-C reductions across the doses tested compared to ZOCOR alone. Ezetimibe 10 mg with simvastatin 20 mg achieved a 51 percent LDL-C reduction compared to reductions of 35 percent and 42 percent, respectively, for simvastatin 20 mg and 40 mg
(typical starting doses for simvastatin) alone. In pooled results across the dosing ranges, patients taking ezetimibe with simvastatin experienced significantly greater LDL cholesterol.

 
Old 08-05-2004, 05:53 AM   #4
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zip2play HB User
Re: Vytorin

I wonder if they studied the incidence of side effects from the two drug combo compared to the single agents.
There was some hooplah a couple months ago about reporting ALL tests...bet they "forgot!"
After all ezetimibe has VERY similar side effects to the statins...i.e., liver strain and skeletal muscle damage (myalgia and rare rhabdo)...these problems just HAVE to be magnified.
I predict that this combo is going to produce BIG problems once it's released widely!

 
Old 08-05-2004, 10:05 AM   #5
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rahod HB User
Re: Vytorin

Quote:
Originally Posted by zip2play
I wonder if they studied the incidence of side effects from the two drug combo compared to the single agents.
There was some hooplah a couple months ago about reporting ALL tests...bet they "forgot!"
After all ezetimibe has VERY similar side effects to the statins...i.e., liver strain and skeletal muscle damage (myalgia and rare rhabdo)...these problems just HAVE to be magnified.
I predict that this combo is going to produce BIG problems once it's released widely!
They did study the combo compared to the agents separately..I didn't post those results, but it was MUCH more effective than the agents alone..dose to dose.

 
Old 08-05-2004, 10:38 AM   #6
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Join Date: May 2004
Posts: 467
rahod HB User
Re: Vytorin

Quote:
Originally Posted by zip2play
I wonder if they studied the incidence of side effects from the two drug combo compared to the single agents.
There was some hooplah a couple months ago about reporting ALL tests...bet they "forgot!"
After all ezetimibe has VERY similar side effects to the statins...i.e., liver strain and skeletal muscle damage (myalgia and rare rhabdo)...these problems just HAVE to be magnified.
I predict that this combo is going to produce BIG problems once it's released widely!
This was comparison to Zocor alone:


Ezetimibe with simvastatin provided greater LDL-C reductions
compared to ZOCOR
In another study, patients taking ezetimibe with simvastatin experienced significantly greater LDL-C reductions across the doses tested compared to ZOCOR alone. Ezetimibe 10 mg with simvastatin 20 mg achieved a 51 percent LDL-C reduction compared to reductions of 35 percent and 42 percent, respectively, for simvastatin 20 mg and 40 mg
(typical starting doses for simvastatin) alone. In pooled results across the dosing ranges, patients taking ezetimibe with simvastatin experienced significantly greater LDL cholesterol reductions ranging from 46 to 61 percent compared to 31 to 46 percent reductions seen with simvastatin alone across the dosing ranges.

This multi-center, double-blind, randomized, placebo-controlled trial was conducted over 12 weeks. After a four-week placebo/diet run-in, 887 patients with LDL-C 145 mg/dL to 250 mg/dL and triglyceride levels at or below 350 mg/dL were randomized to one of 10 daily treatments: placebo (n=93); ezetimibe 10 mg (n=92); simvastatin 10, 20, 40, or 80 mg (n=349); ezetimibe 10 mg with simvastatin 10, 20, 40, or 80 mg (n=353).

Co-administration of ezetimibe with simvastatin was well tolerated and had an overall safety profile similar to that of simvastatin monotherapy in the study. There were more (6 versus 0) cases of asymptomatic, consecutive elevations (more than 3 times the upper limit of normal) of aminotransferases with ezetimibe with simvastatin compared to simvastatin alone. In patients for whom follow-up testing could be obtained (five out of six), transaminase elevations remained asymptomatic and returned to baseline after treatment was discontinued as called for by study design

 
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