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 control is recommended.
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 is also increasing.
In fact, according to the ‘2022 Dyslipidemia Fact Sheet’ recently announced by the Korean Society for Lipid and Atherosclerosis, 87% of diabetic patients as of 2020 were found to be accompanied by dyslipidemia. In addition to diabetes, 72% of the patients were diagnosed with dyslipidemia. According to the ‘Diabetes Fact Sheet 2022’ of the Korean Diabetes Association, 76.1% of diabetic patients suffer from accompanying symptoms of hypercholesterolemia (blood LDL cholesterol of 100 mg/dL or more).
Pitavastatin proves safe once morest new diabetes mellitus
These chronic diseases require not only steady 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 diseases.
However, as research results came out in 2008 that statins might cause new diabetes, the U.S. Food and Drug Administration (FDA) mandated that all statins contain a warning that “can increase HbA1c levels” from 2012. did. Despite the risk of new diabetes mellitus (NODM) of statins, most medical staff are prescribing statins to patients with dyslipidemia because they have excellent cardiovascular disease prevention effects.
When high-strength statin drugs are administered to increase the preventive effect of cardiovascular disease, the risk of liver and muscle toxicity and NODM increases.
Recently, a research team led by Professor Seo Won-woo of the Department of Cardiovascular Medicine at Gangdong Sacred Heart Hospital conducted a study using clinical data from 14,605,368 patients in 10 large hospitals in Korea using the ‘International Standard Common Data Model (CDM)’. was published on Although the NODM safety of 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 pitavastatin-administered group was significantly lower by 28% than the other statin drug-administered groups. 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. As pitavastatin’s NODM safety was proven through domestic and international studies, it was the only statin class to include 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, a combination therapy of medium-intensity statin and ezetimibe is recommended to reduce the possibility of NODM due to high-intensity statin use. This is because, when administering a combination of medium-intensity statin and ezetimibe, it can achieve the same LDL cholesterol level reduction effect as high-intensity statin and secure NODM safety.
Accordingly, the ‘Dyslipidemia Treatment Guidelines’, revised four years following 2018, recommends lowering LDL cholesterol to 55 mg/dL in patients with coronary artery disease. Combination drugs may be a treatment alternative.
With the recent release of a number of statin and ezetimibe combinations, the related market is also growing. The combination drug market, which recorded regarding 609.9 billion won in 2021, is expected to expand to 720 billion won this year.
In October of 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 regarding 54% compared to the existing statin single drug, so it is attracting attention from the market and showing growth. According to UBIST, a pharmaceutical market research institute, sales of pitavastatin + ezetimibe complex, which was 1.7 billion won in the fourth quarter of last year, recorded 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 pays attention to pitavastatin’s NODM safety, predicting that sales of single and combination drugs will exceed 100 billion won this year.
Reporter Ahn So-hee ash0303@donga.com
