Media Release - from Merck Sharp & Dohme NZ - 12 May 2004
The 150,000 New Zealanders taking the cholesterol-lowering (‘statin’) medicine LIPEX(® (simvastatin, MSD) should be confident in the effectiveness and safety of the medicine, the medicine's developer Merck Sharp & Dohme New Zealand (MSD NZ) said today (12 May 2004).
Recent press releases which described LIPEX as a generic were incorrect and gave the false impression that New Zealand patients taking LIPEX were receiving less than world class treatment, MSD NZ managing director Alister Brown said.
LIPEX (previously marketed in NZ as ZOCOR® and still marketed internationally as ZOCOR) has been available in New Zealand since 1989 and has been the world’s most prescribed statin medicine over the past decade1 .
The landmark scientific studies which have contributed to the increased prescribing of statins worldwide (such as the 1994 Scandinavian Simvastatin Survival Study2, and the 2002 Oxford University Heart Protection Study3) exclusively used LIPEX, Mr Brown said.
“LIPEX has more evidence than any other statin medicine that it reduces deaths and cardiovascular events, and patients should be reassured about its effectiveness and safety,” Mr Brown said.
He said MSD NZ had signed a provisional agreement with PHARMAC which would make a major contribution to improved cardiac health of New Zealanders in two major ways.
“Firstly, the agreement provides uninterrupted access to LIPEX until the end of the decade, at a price which will allow PHARMAC to fund access to many more New Zealanders.
"Secondly, the agreement provides access to two new world class cardiac medicines, EZETROL® and VYTORIN®4, which is a welcome development in a market where timely access to new medicines has been a problem for a number of years."
EZETROL will enable GPs and specialists to reduce cholesterol levels in patients unable to tolerate a statin drug5.
EZETROL in combination with a statin will allow GPs and specialists to more effectively treat "high risk" patients who require a substantial reduction in their cholesterol levels. This combination allows a more effective reduction in cholesterol levels than any other statin when used alone (in monotherapy)6.
"In our view, the agreement we have entered into allows PHARMAC to work within its budget but most importantly provide for the needs of patients by ensuring continued access to LIPEX and funding two new innovative cardiac medicines."
For further information, contact:
Phil Johnstone
09 523 6116
021 281 76584
® LIPEX is a Registered Trademark of Merck & Co., Inc. Whitehouse Station, NJ, USA.
® EZETROL is a Registered Trademark of MSP Singapore Company, LLC.
12 May 2004
THINGS TO KNOW BEFORE USING LIPEX (simvastatin) 10, 20 & 40 mg tablets:
LIPEX is indicated for patients at high risk of coronary heart disease (CHD) or with existing CHD and as an adjunct (addition) to diet for patients with high cholesterol (hyperlipidemia). LIPEX should not be taken by patients who have a hypersensitivity reaction, active liver disease, who are pregnant or nursing. Precaution should be taken when administering LIPEX to patients with muscle pain, increased creatine kinase, history of liver disease, raised liver function tests and children. Common side effects are: abdominal pain, constipation, flatulence. Rarely: muscle pain (myopathy), rhabdomyolysis and hepatitis. LIPEX is a fully subsidised, prescription only medicine, a prescription charge will apply. Consult your doctor to see if LIPEX is right for you, a normal doctors visit fee will usually apply. Use only as directed and if symptoms continue or you have side effects, see your doctor, pharmacist or health professional. Marketed by: Merck Sharp & Dohme (NZ) Limited, Newmarket, Auckland. For detailed prescribing information, consult the data sheet or consumer medicine information phone 0800 500 673 or refer to the Medsafe website www.medsafe.govt.nz . [MPI-ZCR-2]
THINGS TO KNOW BEFORE USING EZETROL (ezetimibe) 10mg tablet:
EZETROL, administered with an HMG-CoA reductase inhibitor (statin) or alone, is indicated as adjunctive (added) therapy to diet for the reduction of elevated total cholesterol. EZETROL should not be taken by patients who have a hypersensitivity reaction. Precaution should be taken when administering EZETROL to patients with raised liver enzymes, liver dysfunction, pregnant women and nursing mothers. Common side effects are: headache, abdominal pain, diarrhoea, constipation, flatulence, nausea, increased ALT,AST (liver enzymes), muscle pain (myalgia), hypersensitivity, rash and angioedema. When EZETROL is to be administered with a statin, please refer to the data sheet or consumer medicine information for that particular statin. EZETROL is a prescription only medicine, fully subsidised under special authority for those who meet specified criteria. Consult your doctor to see if EZETROL is right for you, a normal doctors visit fee will usually apply. Use only as directed and if symptoms continue or you have side effects, see your doctor, pharmacist or health professional. Marketed by: Merck Sharp & Dohme (NZ) Limited, Newmarket, Auckland. For detailed prescribing information, consult the data sheet or consumer medicine information phone 0800 500 673 or refer to the Medsafe website www.medsafe.govt.nz . [MPI-EZE-2]
EZETROL is available by prescription only and a charge may apply for this medicine, please consult with your doctor or pharmacist. Tablets: 10mg.
® EZETROL and VYTORIN are registered trademarks of a joint venture between Merck & Co, Inc. and Schering-Plough Corporation, USA. PRESCRIPTION MEDICINE.
References
1. Data on file
2. The Scandinavian Simvastatin Survival Study Group. Randomised trial of cholesterol lowering in 444 patients with coronary heart disease. The Scandinavian Simvastatin Survival Study (4S). Lancet. 344 (8934) 1383-1389, Nov 19, 1994.
3. Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of Cholesterol Lowering with Simvastatin in 5963 people with diabetes; A Randomised placebo-controlled trial. Lancet 2003; 36: 2005-2016.
4. Not yet registered in New Zealand, VYTORIN is a pill that combines EZETROl and LIPEX
5. EZETROL Clinical Prescribing Information.
6. Gagne, C, Bays HE, Weiss SRT et al, for the Ezetimibe Study Group. Efficacy and safety of ezetimibe added to ongoing statin therapy for treatment of patients with primary hypercholesterolemia. Am. J Cardiol. 2002; 90: 1084-1091.
About EZETROL
EZETROL (ezetimibe), a cholesterol absorption inhibitor, has been developed and is being marketed by Merck & Co., Inc. (NYSE:MRK) and Schering-Plough Corporation (NYSE:SGP) in connection with a partnership formed by both companies to develop and market worldwide (excluding Japan) new prescription medicines in cholesterol management. EZETROL is marketed in New Zealand by Merck Sharp & Dohme NZ Ltd, and has been available since June 2003.
About LIPEX
The clinical benefits of LIPEX have been documented in numerous large scale clinical trials including the landmark Heart Protection Study (HPS) and the Scandinavian Simvastatin Survival Study (4S). The HPS was the largest clinical study with a statin ever conducted that conclusively demonstrated that long-term therapy (5 years) with LIPEX 40mg saved lives and significantly reduced the risk of heart attack and stroke in a broad range of high risk patients, especially those with CHD and diabetes, and with average or below-average cholesterol levels. The landmark Scandinavian Simvastatin Survival Study 4S was the first to show that LIPEX reduced the risk of all-cause mortality by 30 percent, and the risk of coronary mortality by 42 percent, in patients with CHD and total cholesterol in the range 5.5 – 8.0 mmol/L (212-309 mg/dL) and triglycerides ≤ 2.5 mmol/L (221 mg/dL) at baseline.
What you should know about LIPEX®
LIPEX® (simvastatin, MSD) belongs to a group of medicines known as HMG-CoA reductase inhibitors and is used to lower high cholesterol and triglyceride levels and reduce the health risks associated with coronary heart disease. If you have coronary heart disease, diabetes, history of stroke, or other vessel disease (regardless of the amount of cholesterol in your blood), LIPEX can prolong your life by reducing the risk of heart attack or stroke; reduce the need for surgery to increase blood flow to the legs and major organs such as the heart; and reduce the need for hospitalisation for chest pain (angina). Before you take LIPEX discuss with your doctor the risks and benefits associated with taking LIPEX, also tell your doctor about any other medication you may be on or if you are allergic to anything. You should not take LIPEX if you are allergic to any component of the medicine or if you are pregnant or breast feeding. Be sure to tell your doctor if you have any liver disease or muscle pain. Most commonly reported adverse reactions include: constipation, diarrhoea, wind, stomach upset, feeling sick, headache, dizziness and muscle pain. Do not be alarmed by this possible list of adverse effects, you may not experience any of them, tell your doctor if you experience any adverse effect. LIPEX® is the Merck registered trademark for simvastatin.
Check with your doctor that EZETROL® and LIPEX® are right for you. Normal doctor’s fees will apply.
Click here for full Prescribing Information.
Click here for full Consumer Medicine Information.
About Merck & Co., Inc.
Merck & Co., Inc., which operates in many countries as Merck Sharp & Dohme, is a global research-driven pharmaceutical products and services company. Merck discovers, develops, manufactures and markets a broad range of innovative products to improve human and animal health, directly or through join ventures.
About Schering-Plough
Schering-Plough Corporation is a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical products worldwide.
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