Attention to hyperlipidemia drugs that reduce the risk of developing diabetes … Expand related markets

Statin treatment of dyslipidemia
Lowers cholesterol levels, but increases diabetes levels with continued administration
As a result of a study using large-scale clinical data, ‘Pitavastatin’ is safe from diabetes
In recent dyslipidemia treatment guidelines, active cholesterol management is recommended.

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Diabetes, dyslipidemia, and hypertension are representative chronic diseases of modern people that require special attention even before diagnosis because they can lead to metabolic syndrome. In particular, the possibility of other symptoms accompanying these diseases is very high, so the need for continuous management also increases.

In fact, according to the ‘Dyslipidemia Fact Sheet 2022’ recently published by the Korean Society for Lipid and Atherosclerosis, 87% of diabetic patients have been found to have dyslipidemia as of 2020. In addition to diabetes, 72% of patients were diagnosed with dyslipidaemia. According to the ‘Diabetes Fact Sheet 2022’ of the Korean Diabetes Association, 76.1% of diabetic patients suffer from associated symptoms of hypercholesterolemia (blood LDL cholesterol of 100 mg/dL or more).

Pitavastatin is safe against new diabetes mellitus

These chronic diseases require not only constant daily management but also drug treatment, and statin drugs are prescribed for patients with dyslipidemia. Statins are effective in lowering LDL cholesterol levels and preventing cardiovascular disease.

However, as research results came out in 2008 that statins could cause new diabetes, the US Food and Drug Administration (FDA) ordered that all statins carry a warning that “may increase HbA1c levels” from 2012. Despite the risk of diabetes mellitus new (NODM) of statins, most medical staff prescribe statins to patients with dyslipidemia because they have excellent cardiovascular disease prevention effects.

When high-potency statin drugs are administered to increase the preventive effect of cardiovascular disease, the risk of liver and muscle toxicity and NODM increases.

A research team led by Professor Seo Won-woo from the Department of Cardiovascular Medicine at Gangdong Sacred Heart Hospital recently conducted a study using clinical data from 14,605,368 patients in 10 major hospitals in Korea using the ‘Common Data Model’ International Standard (CDM)’ Published on Although the safety of NODM pitavastatin has been proven through numerous domestic and foreign studies, the results of a large-scale study using CDM are the first in Korea. As a result of the study, it was found that the NODM of the group administered by pitavastatin was significantly lower by 28% than the other groups administered by statin drugs. NODM for each comparison group was found to be 31% and 26% lower for pitavastatin than for atorvastatin and rosuvastatin, respectively. There was no difference in the risk of NODM between atorvastatin and rosuvastatin. Since the safety of NODM pitavastatin has been proven through domestic and international studies, it is the only statin group to insert the phrase “no signs of diabetes risk” in the drug product description (SmPC) of 32 foreign countries.

Pay attention to the combination of ‘Pitavastatin + Ezetimibe’

Recently, combination therapy of a medium-intensity statin and ezetimibe has been recommended to reduce the possibility of NODM due to high-intensity statin use. This is because when a combination of a medium-intensity statin and ezetimibe is administered, it can achieve the same LDL-cholesterol-lowering effect as a high-intensity statin and ensure the safety of NODM.

Accordingly, the ‘Dyslipidemia Treatment Guidelines’, revised four years after 2018, recommend lowering LDL cholesterol to 55 mg/dL in patients with coronary artery disease. Combination drugs can be an alternative treatment.

With the recent release of several statin and ezetimibe combinations, the associated market is also growing. The combination drug market, which recorded about 609.9 billion won in 2021, is expected to expand to 720 billion won this year.

In October last year, the combination of pitavastatin and ezetimibe (product name ‘Rivarojet’) was released for the first time in Korea. The combination of pitavastatin and ezetimibe can reduce LDL cholesterol levels by about 54% compared to the current single statin drug, so it is attracting attention from the market and showing growth. According to UBIST, a pharmaceutical market research institute, sales of complex pitavastatin + ezetimibe were recorded, which was 1.7 billion won in the fourth quarter of last year, 8.3 billion won in the third quarter, following 3.5 billion won in the first quarter and 5.6 billion won in the second quarter of this year. In particular, the market is paying attention to the safety of NODM pitavastatin, predicting that sales of single and combined drugs will exceed 100 billion won this year.

Reporter Ahn So-hee [email protected]

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