One low-dose statin - simvastatin - is available in a low dose to buy from the pharmacist.
The problem is that simvastatin is not as potent a drug as either atorvastatin or Crestor.
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To try to demonstrate this, Merck launched IMPROVE-IT, an 18, 000 patient trial comparing Vytorin to simvastatin.
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Simvastatin is currently marketed in dosage strengths of 5, 10, 20, 40, and 80 mg.
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The patients were given either Vytorin, or a high dose of generic Zocor, known as simvastatin.
Furthermore, one has to wonder if the shifting of patients from atorvastatin to simvastatin proved harmful.
FORBES: Do We Really Need Head-To-Head Comparison Trials With Statins To Improve Cardiac Health?
Therefore, more doctors are opting to move patients from simvastatin to atorvastatin than to switch to Zetia.
FORBES: Merck's Cholesterol Pill Win Is Already Drawing Fire
However, if IMPROVE-IT shows Vytorin to be little different from simvastatin, Merck would essentially lose two products.
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The problem is, simvastatin is known to be a weaker statin than atorvastatin or rosuvastatin (generic Crestor).
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The 80 milligram doses of simvastatin and Vytorin were prescribed 11.3 million and 1 million times, respectively.
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Script data from IMS Health shows that forms of simvastatin were prescribed 100 million times last year.
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No clinically relevant pharmacokinetic interactions were reported between KYNAMRO and warfarin, or between KYNAMRO and simvastatin or ezetimibe.
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The products that will have these label changes include Lipitor (atorvastatin), Mevacor (lovastatin), Crestor (rosuvastatin) and Zocor (simvastatin).
The change also applies to the top dose of The combo pill Vytorin, which contains simvastatin and a second drug.
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Even if IMPROVE-IT shows that Vytorin is vastly superior to simvastatin, Zetia is due to come off patent in 2016.
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For example, atorvastatin and simvastatin are both equally effective, as far as we currently know, and simvastatin came off patent six years ago.
FORBES: Do We Really Need Head-To-Head Comparison Trials With Statins To Improve Cardiac Health?
There is also no plan to develop FDCs with the simvastatin 5 mg dose as use of this dose is quite low as well.
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That means the 80 milligram dose of simvastatin was prescribed more times than all doses of Vytorin, which was prescribed 8.6 million times last year.
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Clinical studies have shown, and it is accepted by CV experts around the world, that atorvastatin lowers LDL to a significantly greater extent than simvastatin.
FORBES: Do We Really Need Head-To-Head Comparison Trials With Statins To Improve Cardiac Health?
Take Simvastatin, one of the highest volume generics, as an example.
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Another statin, atorvastatin (Trade name: Lipitor, Pfizer) became the biggest selling drug of all time and simvastatin also became an all time best seller.
FORBES: Do We Really Need Head-To-Head Comparison Trials With Statins To Improve Cardiac Health?
Cheap generic versions of simvastatin are the second-most popular drug in the U.S., partly because health insurers have pushed them as the most cost-effective cholesterol-lowering approach.
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In 4S, after five years, patients on simvastatin (trade name: Zocor, Merck) had mean decreases of 35% for LDL and 30% fewer deaths than the placebo group.
FORBES: Do We Really Need Head-To-Head Comparison Trials With Statins To Improve Cardiac Health?
As I pointed out in the Times op-ed, the diabetes issue only surfaced in recent trials with higher doses (40 mg of Simvastatin) and atorvastatin (Lipitor) and rosuvastatin (Crestor).
In fact, in 2008 a study using ultrasound images of arteries failed to show that the combination of Zetia and simvastatin prevented artery hardening any better than simvastatin alone.
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Yesterday the Food and Drug Administration told doctors to stop prescribing the top 80-milligram dose of simvastatin, also known by the brand name Zocor, to new patients because of a heightened risk of muscle pain.
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Zetia (generically known as ezetimibe) lowers low-density lipoprotein (LDL), the bad cholesterol involved in causing heart attacks and strokes, but less so than existing drugs like Lipitor (generically known as atorvastatin), Crestor, from AstraZeneca, or simvastatin.
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The types of medications that are particularly concerning include a class of medications called statins that help to lower cholesterol (simvastatin, atorvastatin, lovastatin), as well as some medications to treat heart ailments, cancer, and certain antibiotics.
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The U.S. Food and Drug Administration today approved Juvisync (sitagliptin and simvastatin), a fixed-dose combination (FDC) prescription medication that contains two previously approved medicines in one tablet for use in adults who need both sitagliptin and simvastatin.
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Furthermore, landmark studies such as the Lipid Research Clinics Coronary Primary Prevention Trial (LRC-CPPT) and the Scandanavian Simvastatin Survival Study (4S) showed that lowering LDL cholesterol has the direct result of reducing cardiovascular (CV) deaths.
FORBES: Do We Really Need Head-To-Head Comparison Trials With Statins To Improve Cardiac Health?
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