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Dear healthcare professional,
PO Box 1000
North Wales, PA 19454-1099
Dear Health Care Professional:
Merck/Schering-Plough Pharmaceuticals recently announced the primary end point and
other results of the ENHANCE trial. You have no doubt seen some of the extensive news
coverage generated by our announcement. This has created lots of confusion and questions
from health care professionals and patients about VYTORIN® (ezetimibe/simvastatin) and
The purpose of this communication is to provide you with information about the ENHANCE
trial that may help answer some of your questions or those of your patients. Rest assured
that Schering-Plough, Merck, and Merck/Schering-Plough Pharmaceuticals stand behind the
low-density lipoprotein cholesterol (LDL-C) efficacy and safety profiles of both VYTORIN and
ENHANCE was an imaging study conducted in 720 patients with Heterozygous Familial
Hypercholesterolemia (HeFH), a rare condition that affects approximately 0.2% of the
population. The primary end point was the mean change in the intima-media thickness (IMT)
measured at 3 sites in the carotid arteries. ENHANCE did not meet its primary end point. It
did not show a significant difference between VYTORIN and simvastatin in mean change in
the IMT measured at 3 sites in the carotid arteries. ENHANCE was not designed to examine
differences in clinical outcomes, such as reductions in heart attacks or strokes. We suggest
that clinical decisions should not be made based on the ENHANCE study alone.
Please see the news release at www.msppharma.com for additional information. Several key points to consider:
Lowering LDL-C remains the primary target of lipid-modifying therapy.
National guidelines, based on more than 20 years of scientific evidence, recommend LDL-C
lowering as the primary target of lipid therapy. These important findings are reflected in the
National Cholesterol Education Panel (NCEP) guidelines. The NCEP ATP III 2004 Update
recommended an LDL-C target of less than 100 mg/dL in high-risk patients and an optional
LDL-C goal of less than 70 mg/dL in very high-risk patients. Many patients with high LDL-C
are not at recommended treatment goals.1 ENHANCE was an imaging study; it was not designed to examine differences in
clinical outcomes, such as reductions in heart attacks or strokes.
Merck, Schering-Plough, and Merck/Schering-Plough suggest that clinical decisions should
not be made based on the ENHANCE study alone. We would refer you to the position
statements issued by the American College of Cardiology (www.acc.org) and the American
Heart Association (www.americanheart.org). A Clinical Outcomes Study Comparing VYTORIN and Simvastatin Is Under Way.
ENHANCE was an imaging study and not a clinical outcomes study. No incremental benefit
of VYTORIN on cardiovascular morbidity and mortality over and above that demonstrated for
simvastatin has been established. The IMPROVE-IT trial, a large clinical outcomes trial
comparing VYTORIN and simvastatin and including more than 10,000 patients, is under way.
What should you tell your patients who are taking VYTORIN
When counseling your patients on VYTORIN or ZETIA, we would encourage you to respond
based on your independent clinical judgment about the importance of lowering LDL-C by
eating right, staying active, and following recommended prescribed medications. Merck/Schering-Plough hopes to present additional results of the ENHANCE trial at
the American College of Cardiology meeting in March.
The study analysis required meticulous examination of over 30,000 images of IMT of the
carotid and femoral arteries. This process was time consuming and took longer than
anticipated. The decision was made to release the results of the primary end point because
of the growing level of scientific interest with the results. Important Information About ZETIA:
ZETIA, administered alone or in combination with an HMG-CoA reductase inhibitor
(statin), is indicated as adjunctive therapy to diet
for the reduction of elevated TOTAL-C,
LDL-C, and Apo B in patients with primary (heterozygous familial and nonfamilial)
hypercholesterolemia when diet alone is not enough.
ZETIA is not indicated to slow the progression of atherosclerosis.
The effects of ZETIA, either alone or in addition to a statin, on the risk of cardiovascular
morbidity and mortality have not been established.
There are no specific studies of ZETIA in statin-intolerant patients or those who can only
tolerate a low-dose statin. Contraindications for ZETIA:
hypersensitivity to any component of this medication. Contraindications when used with a statin:
active liver disease; unexplained persistent
elevations of serum transaminases. Statins are contraindicated in pregnant and nursing
women; refer to the statin label for details.
When ZETIA was coadministered with a statin, consecutive elevations in serum transaminases
(≥3 × ULN) were slightly higher (1.3%) than those of statins alone (0.4%). Liver function tests
should be performed when ZETIA is added to statin therapy and according to statin
Patients should be advised to promptly report muscle pain, tenderness, or weakness.
Discontinue drug if myopathy is diagnosed or suspected.
ZETIA is not recommended in patients with moderate or severe hepatic insufficiency.
Exercise caution when using ZETIA and cyclosporine concomitantly because exposure to
both drugs is increased. Cyclosporine concentrations should be monitored in these patients.
In clinical trials, the most frequent side effects for ZETIA alone vs placebo included back
pain (4.1% vs 3.9%), arthralgia (3.8% vs 3.4%), and fatigue (2.2% vs 1.8%); for ZETIA +
statin vs statin or placebo alone: back pain (4.3% vs 3.7% vs 3.5%), abdominal pain (3.5%
vs 3.1% vs 2.3%), and fatigue (2.8% vs 1.4% vs 1.9%).
Before prescribing ZETIA, please read the accompanying Prescribing Information.
Important Information About VYTORIN® (ezetimibe/simvastatin): VYTORIN is indicated as adjunctive therapy to diet
for the reduction of elevated
TOTAL-C, LDL-C, Apo B, TG, and non–HDL-C, and to increase HDL-C in patients with
primary (heterozygous familial and nonfamilial) hypercholesterolemia or mixed
hyperlipidemia when diet alone is not enough.
VYTORIN is not indicated to slow the progression of atherosclerosis.
No incremental benefit of VYTORIN on cardiovascular morbidity and mortality over and
above that demonstrated for simvastatin has been established. Contraindications for VYTORIN:
hypersensitivity to any component of this medication;
active liver disease; unexplained persistent elevations of serum transaminases; and women
who are pregnant, nursing, or may become pregnant. SELECTED CAUTIONARY INFORMATION
Myopathy sometimes takes the form of rhabdomyolysis with or without
acute renal failure secondary to myoglobinuria, and rare fatalities have occurred. The risk of
myopathy/rhabdomyolysis is dose related. Tell patients to promptly report muscle pain,
tenderness, or weakness. Discontinue drug if myopathy is suspected or CPK levels rise
Myopathy Caused by Drug Interactions: Use of VYTORIN with itraconazole,
ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors,
nefazodone, or large quantities of grapefruit juice (>1 quart daily) should be avoided
because of the increased risk of myopathy, particularly at higher doses.
The concomitant use of VYTORIN and fibrates (especially gemfibrozil) should be
avoided. Although not recommended, the dose of VYTORIN should not exceed
10/10 mg if used with gemfibrozil.
The benefit of further alterations in lipid levels by the combined use of VYTORIN with
niacin should be carefully weighed against the potential risks of myopathy. The dose
of VYTORIN should not exceed 10/10 mg daily in patients receiving cyclosporine or
danazol, and 10/20 mg daily in patients receiving amiodarone or verapamil, due to the
increased risk of myopathy. The combined use of VYTORIN at doses higher than
10/20 mg daily with amiodarone or verapamil should be avoided unless the clinical
benefit is likely to outweigh the increased risk of myopathy.
It is recommended that liver function tests be performed before the initiation of
treatment and thereafter when clinically indicated. Additional tests are recommended prior to
and 3 months after titration to the 10/80-mg dose, and semiannually for the first year
The incidence of consecutive elevations (≥3 × ULN) in serum transaminases was 1.7%
overall and appeared to be dose related, with an incidence of 2.6% for 10/80 mg. In long-
term (48-week) extensions, which included both newly treated and previously treated
patients, the incidence was 1.8% overall and 3.6% for 10/80 mg. These elevations were
generally asymptomatic, not associated with cholestasis, and reversible whether treatment
was maintained or discontinued.
VYTORIN is not recommended in patients with moderate or severe hepatic insufficiency.
In clinical trials, the most commonly reported side effects, regardless of cause, included
headache (6.8%), upper respiratory tract infection (3.9%), myalgia (3.5%), influenza
(2.6%), and extremity pain (2.3%).
VYTORIN tablets contain ezetimibe and simvastatin: 10 mg of ezetimibe and 10, 20, 40,
or 80 mg of simvastatin (VYTORIN 10/10, 10/20, 10/40, or 10/80 mg, respectively).
Before prescribing VYTORIN, please read the accompanying Prescribing Information.
Enclosures: Prescribing Information for VYTORIN® (ezetimibe/simvastatin)
Prescribing Information for ZETIA® (ezetimibe)
Keevil JG, Cullen MW, Gangnon R, McBride PE, Stein JH. Implications of cardiac risk and low-density
lipoprotein cholesterol distributions in the United States for the diagnosis and treatment of dyslipidemia: data from the
National Health and Nutrition Examination Survey 1999 to 2002. Circulation
VYTORIN and ZETIA are registered trademarks of MSP Singapore Company, LLC.
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