Singapore’s HSA approves combination therapy drug ATOZET® for high-risk patients to lower LDL cholesterol

0
1526

MSD Atozet 3 strengths

MSD (known as Merck in the US and Canada) has announced the approval of ATOZET® in Singapore by the Singapore Health Sciences Authority to treat patients who are unable to control their cholesterol levels with a single statin alone. ATOZET® which is a combination of two statins – ezetimibe and atorvastatin – has been clinically proven to lower cholesterol levels significantly than doubling the dose of atorvastatin.

The once-daily combination tablet effectively lowers cholesterol through its dual mechanism of action: it treats the two main sources of cholesterol in the blood by inhibiting the absorption of cholesterol in the digestive tract – through ezetimibe – and the production of cholesterol in the liver – through atorvastatin

The approval helps to address an urgent medical need as a recent Dyslipidemia International Study (DYSIS) revealed more than 70 percent of patients from thirty countries worldwide (across Europe, the Middle East, Canada, Africa and Asia) with post acute coronary syndrome (ACS) and stable coronary heart disease (CHD) were unable to achieve low-density lipoprotein (LDL) cholesterol targets despite diet, exercise, and statin therapy.

ATOZET is indicated as an adjunctive therapy to diet for use in adults with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia in patients not appropriately controlled with a statin alone or already treated with a statin and ezetimibe. ATOZET is also indicated as adjunctive therapy to diet for use in adults with homozygous familial hypercholesterolaemia (HoFH).

Associate Professor Poh Kian Keong, one of the investigators of DYSIS (as the national coordinator for Singapore) and Senior Consultant, Department of Cardiology at the National University Heart Centre, Singapore said: “With cardiovascular disease accounting for nearly 30% of all deaths in Singapore, there is an urgent need for more effective therapies for high risk patients to lower their uncontrolled LDL cholesterol levels. Furthermore, recent results from DYSIS showed that 70 per cent of ACS and CHD patients in Singapore did not achieve the European Society of Cardiology guideline of recommended LDL cholesterol target while taking moderate-intensity statin mono therapy”.

“For high-risk patients who may need further LDL cholesterol reduction beyond statin monotherapy, the ezetimibe and atorvastatin combination tablet, along with a healthy diet, can be an effective lipid-lowering treatment option.  Adding ezetimibe to atorvastatin has been shown in clinical trials to provide significantly greater mean additional LDL cholesterol reduction than doubling the dose of atorvastatin,” said Dr Peter Yan Chee Hong, Consultant Cardiologist and Physician at Gleneagles and Mount Elizabeth Hospitals, specializing in interventional cardiology and implantation of stents.

ATOZET (or coadministration of ezetimibe and atorvastatin equivalent to ATOZET) has been evaluated for safety in more than 2400 patients in 7 clinical trials. ATOZET was generally well tolerated. Common side effects (≥1/100, <1/10) include: diarrhea and myalgia. In controlled clinical trials, the incidence of clinically important elevations in serum transaminases (ALT and/or AST ≥3 X ULN, consecutive) was 0.6% for patients treated with ATOZET. These elevations in transaminases were generally asymptomatic, not associated with cholestasis, and returned to baseline spontaneously or after discontinuation of therapy.