Lipitor, Lipitor Plus
[팜뉴스=김민건 기자] In 1985, Dr. Bruce Roth of Warner-Lambert (now Pfizer) succeeded in synthesizing the calcium atorvastatin for the first time. Subsequently, a joint sales agreement with Pfizer was reached in 1996. The brand name of this product became “Lipitor”.
Lipitor was released in Korea in 1999 under the name Zarato. In June 2000, Pfizer and Warner-Lambert decided to merge, building a reputation as a blockbuster drug that led the global dyslipidemia market for 25 years.
In Korea, it is prescribed to 1 million people annually and ranked first in the number of single and combined statin prescriptions for 20 years from 2003 to 2023 (based on IQVIA data). The name Lipitor itself has become a trademark.
Although its patent expired in 2009, it has maintained its number 1 position on the market for over 20 years. How can we get overwhelming prescriptions in the highly competitive dyslipidemia prescription market?
Lipitor’s survival strategy is based on consistent clinical research data. The secret to the growth has been a series of efforts, such as demonstrating the benefits for patients with high blood pressure and diabetes, as well as those who have suffered heart attacks, and improving convenience by expanding the range.
On the 24th, Lipitor plays an important role in the treatment of hyperlipidemia in Korea and around the world and is prescribed to save the lives of patients with dyslipidemia.
The most representative clinical study of Lipitor is the ASCOT-LLA study. This clinical trial is a large-scale study that randomly assigned 10,305 patients aged 40 to 79 years with three or more cardiovascular diseases, including hypertension.
As a result of the follow-up of the Lipitor 10 mg group and the placebo group for 3-5 years, the risk of cardiovascular events in the Lipitor 10 mg group (5,168 people) was reduced by 36% compared to the placebo group (5,137 people). .
The next representative clinical study is the “CARDS” study. This study randomly assigned 2,838 patients with type 2 diabetes between the ages of 40 and 75 years to receive Lipitor 10 mg (1,428 patients) or a placebo group (1,410 patients) and observed them for more than 3 years. had major cardiovascular events. The risk was reduced by 37%. The main reason for this study is that diabetic patients have a very high risk of developing heart disease.
Lipitor didn’t stop there. The effect of secondary prevention of cardiovascular disease in patients at higher risk compared to diabetic patients was also studied. This is the “MIRACL” clinical study. This study looked at the effects of 3,086 patients who suffered a heart attack when they were given a high dose of 80 mg of Lipitor within 24 to 96 hours of hospitalization.
As a result, the Lipitor 80 mg treatment group (1,538 people) was able to reduce the risk of cardiovascular events by 16% compared to the placebo control group (1,548 people).
Sripal Bangalore, Professor, New York University School of Medicine, USA
Sripal Bangalore, a professor at New York University School of Medicine, said at a meeting hosted by Beatrice Korea to celebrate the 25th anniversary of Lipitor’s national launch: “Patients with high blood pressure, diabetes and heart failure have significantly decreased due to the reduction of dyslipidemia”. treatments like Lipitor.” “I’m getting benefits,” she said.
In this regard, Professor Sripal Bangalore introduced another significant clinical fact. This is the “PROVE-IT” study, which compared and analyzed a total of 4,162 patients (2,099 patients) who received Lipitor 80 mg within 10 days after suffering a heart attack and a total of 4,162 patients who used pravastatin 40 mg (2,063 patients) in the control group. Very interesting results were identified in this study.
First, the group treated with Lipitor 80 mg reduced the risk of cardiovascular events by an additional 16% compared to Pravastatin 40 mg. But Professor Sripal Bungalow said: “We discovered something very interesting at the beginning of this study. We saw when the risk curves for cardiovascular events actually separated and when patients could benefit.”
He continued: “The curve started to widen from the first 24 to 48 hours, showing that heart attack patients need to start treatment from the beginning as soon as they arrive at the hospital. Lipitor shows a very noticeable effect within the first 24 hours 48 hours and in the long term “Because it lasts,” she explained.
Professor Sripal Bungalow is a researcher who participated in the drafting of US guidelines for the treatment of dyslipidemia. Based on this research data, it has been stated that national guidelines, including guidelines such as ACC/AHA in 2018 and AHA/ASA in 2021, recommend statin monotherapy as the primary treatment for atherosclerotic cardiovascular disease.
Global guidelines for the treatment of dyslipidemia
Lipitor’s proven effectiveness in treating dyslipidemia, hypertension, diabetes and cardiovascular disease is the secret to maintaining first place in the global market, but it’s not easy.
There are 10 studies that demonstrated actual benefits in terms of cardiovascular disease events, of which 7 studies met the primary endpoint. The ASCOT-LLA (hypertension/cardiovascular system), CARDS (type 2 diabetes), MIRACL and PROVE-IT studies are the only studies among statins that demonstrated primary treatment or secondary prevention in patients who have suffered a heart attack .
Professor Sripal Bungalow explained: “Whether patients receive treatment for primary prevention of cardiovascular disease or for secondary prevention of cardiovascular disease after a heart attack, Lipitor provides benefits across various clinical trials.”
List of Lipitor clinical studies demonstrating prevention of the risk of cardiovascular events
He said: “The reason dyslipidemia guidelines in the United States, Europe and Korea strongly recommend statins as first-line treatment is because through these clinical trials, statins can significantly reduce mortality and prolong the duration of life”.
“Clinical trial data for Lipitor demonstrate significant benefits of statins, including reduced cardiovascular mortality, reduced incidence of stroke, lower risk of readmission for heart attack, and fewer patients requiring repeat procedures,” he said.
In contrast, adverse reactions when using Lipitor are negligible. This is why Professor Sripal Bangalore described Lipitor as “a great treatment”.
▷Specialized clinical research for the Korean market, AMADEUS·AT-GAOL
Not only this. Lipitor also has clinical trials for Korean patients. It is very important that medicines prescribed in the global market are actually effective for domestic patients.
Lipitor was targeted to 440 domestic patients with type 2 diabetes through the “AMADEUS” study. In the study, the administration dose of Lipitor was determined based on the LDL-C level, with 40 mg (74 people) used for high LDL-C levels, 20 mg (181 people) for medium levels, and 10 mg ( 185 people) for low LDL-C levels.
As a result of the study, the rate of achieving LDL-C levels in each drug group was 90%. Overall, LDL-C levels were reduced by more than 40% from baseline, meaning the treatment strategy of providing a dose tailored to the patient’s LDL-C level was beneficial.
Another study conducted at a national level is the “AT-GAOL” study. In this study, 425 people were classified according to cardiovascular risk criteria and LDL-C levels and targets were set for each group.
The low-risk group was set at an LDL-C level of 160 or less, while the high-risk group was set at an LDL-C level of 100 or less. In the study, various doses of statins were prescribed over 8 weeks of follow-up, and more than 80% achieved the goal of reducing LDL-C levels, regardless of risk.
Furthermore, the “TST” study compared patients who had suffered an ischemic stroke with LDL-C levels below 70 and patients with LDL-C levels between 90 and 100. Consequently, it was confirmed that even patients who who suffered an ischemic stroke benefited from reductions in cardiovascular events when they set lower LDL-C reduction goals and used potent statins such as Lipitor.
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