to Pharmacology Articles
Wednesday, 28th July 2004
Studies show that Vytorin can lower LDL or "bad" cholesterol more effectively than a statin alone.
The Food and Drug Administration
has approved a new cholesterol-lowering drug called Vytorin,
offering millions of patients and their doctors a potentially new way to
reduce the risk of heart disease. Vytorin was approved on July
Vytorin, combines a popular drug,
Zocor (simvastatin), from a class
known as statins, with a non-statin medication, Zetia (ezetimibe), in a single pill.
Studies show that it can lower LDL or "bad" cholesterol more effectively
than a statin alone.
The starting dose of Vytorin contains 10
mg of Zetia and 10 mg of Zocor. Zocor is from the
class of drugs known as
statins, and lowers cholesterol by cutting its
production in the liver. Zetia, meanwhile, limits the absorption of
cholesterol in the intestines.
The drug is being marketed by a joint venture between
Zocor maker Merck & Co. and Schering-Plough, which manufactures
Zetia in a bid to compete against market leader
which holds a 55 percent share of prescriptions and 49 percent of sales.
The potential market for the new drug is huge. According
to the CDC, approximately a fifth of U.S. adults over 20 years of age
have elevated cholesterol, and 23 million suffer from heart disease.
Heart disease and strokes are two of the three leading causes of death.
New guidelines for lowering cholesterol
The main goal of cholesterol-lowering treatment is to
lower 'the bad cholesterol", LDL level enough to reduce the risk of
developing heart disease or having a heart attack.
Guidelines for cholesterol lowering include
- Therapeutic Lifestyle Changes (TLC): includes a
cholesterol-lowering diet (called the TLC diet), physical activity,
and weight management. TLC is for anyone whose LDL is above goal.
- Drug Treatment: if cholesterol-lowering drugs are needed, they are
used together with TLC treatment to help lower your LDL.
Vytorin's approval coincides with
the release last week of new guidelines issued by The National
Cholesterol Education Program that call for
high-risk heart patients to lower their so-called bad cholesterol, or
LDL, to 70 instead of 100 as previously recommended. The
guidelines also greatly expanded the number of Americans who may be
candidates for cholesterol-lowering medications.
A trial published in The New England Journal of
Medicine in April suggested that lowering cholesterol as far as
possible with statins helps prevent repeat heart attacks and death in
heart disease patients. Patients who had their LDL lowered by 50%
reduced their risk of a heart attack by 18% and their chances of dying
by 30% two years later. That could spur a lot of doctors and patients to
use Vytorin since it appears to cut cholesterol more effectively than
Further, a consumer group is asking the FDA to remove
the cholesterol-lowering drug Crestor (AstraZeneca) from the market,
claiming that it has killed one person and injured close to two dozen
others since its approval late last summer The 39 year old woman taking
the drug died from kidney damage caused by a muscle-destroying disease
that is a rare, but recognized, side effect seen with all
cholesterol-lowering medications. AstraZeneca spokesman commented that
the drug's safety profile continues to mirror the other approved
and the drug has been effective in lowering cholesterol for patients who
are unable to get to goal on other
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In a multi-center, double-blind,
placebo-controlled clinical study of 1,528 patients with LDL cholesterol
levels of 145 mg/dL to 250 mg/dL, Vytorin provided LDL cholesterol
reductions of 52 percent at the recommended starting dose (10/20 mg), 55
percent at the 10/40 mg dose and 60 percent at the maximum dose (10/80
Vytorin has been shown in studies
to lower cholesterol better than market leader
and simvastatin (Zocor). In a multi-center, randomized, double-blind
study of 788 patients, Vytorin (doses ranging from 10/10 mg to 10/80 mg)
was compared to atorvastatin monotherapy (doses ranging from 10 mg to 80
mg). At the recommended usual starting doses, Vytorin 10/20 mg lowered
LDL cholesterol by 50 percent vs. 37 percent for atorvastatin 10 mg and
44 percent for atorvastatin 20 mg. The impact on clinical outcomes of
these differences in lipid altering effects is unknown.
In another study of 1,528
patients with LDL cholesterol levels of 145 mg/dL to 250 mg/dL, those
taking Vytorin experienced significantly greater LDL cholesterol
reductions compared to simvastatin. Vytorin 10/20 mg achieved a 52
percent LDL cholesterol reduction compared to reductions of 34 percent
and 41 percent, respectively, for simvastatin 20 mg and 40 mg (typical
starting doses for simvastatin). No incremental benefit of Vytorin on
cardiovascular morbidity and mortality over and above that demonstrated
for simvastatin has been established.
Results from a phase III,
multi-center, randomized, double-blind controlled study of 710 patients
showed that, Vytorin 10/20 mg lowered LDL cholesterol by 53 percent
compared to a 38 percent reduction with simvastatin 20 mg. This greater
LDL cholesterol reduction resulted in 83 percent of patients treated
with Vytorin 10/20 mg achieving the study LDL cholesterol goal of less
than 100 mg/dL as compared to 46 percent of patients taking simvastatin
Vytorin was well tolerated with a low incidence of
adverse events. In clinical trials, the most commonly reported side
effects, regardless of cause, included headache (6.8 percent), upper
respiratory tract infection (3.9 percent), myalgia (3.5 percent),
influenza (2.6 percent), and extremity pain (2.3 percent).
Words of caution
Some caution that manufacturers have not proven that the
drug actually prevents more cardiovascular events or deaths than
currently available drugs just that it lowers LDL more effectively. A
Merck/Schering-Plough joint venture representative says they are working
to conduct a study to find out whether Vytorin actually prevents more
heart attacks or saves more lives than a statin alone.
Another point is that the two-drug combination contains
half the regular starting dose of the normal 20 mg of Zocor.
also raise HDL, the so-called "good" cholesterol, and have been
shown to reduce the markers of inflammation associated with heart
disease. At 10 mg, the benefits of
statins, which go beyond the drugs' LDL lowering effects, could be lost. However, it can be argued that
though the starting dose of Vytorin contains 10 mg of Zetia and 10 mg of
Zocor, Vytorin also comes in other combinations with higher dose of
Zocor. The amount of Zetia remains the same, but the dose can be
increased as needed, based on desired cholesterol, up to include 20 mg,
40 mg, or 80 mg of Zocor.
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