The global prevalence of statin prescriptions in Egypt has been increasing for several decades []. The average patient dose for statin therapy is approximately 2.2 million prescriptions per year, making it one of the top-selling drugs among the major worldwide prescription drugs []. Statin therapy is a long-term treatment that has been associated with an increased risk of cardiovascular (CV) diseases such as hypertension, atherosclerosis, and diabetes mellitus [].
Statins, particularly rosuvastatin (Crestor), are widely prescribed for statin therapy for patients at risk of cardiovascular disease (CVD) []. Rosuvastatin is a long-acting statin that is a nonsteroidal inhibitor of the cholesterol-lowering effect of the lipid lowering drug statins, including simvastatin (Zocor), rosuvastatin (Crestor), and lovastatin (Mevacor), which are also used to reduce cardiovascular disease. However, it has been reported that statins can cause more serious abnormalities in the kidney [].
The prevalence of statin use has been estimated to be 1.6% among worldwide population using the United States, the World Health Organization (WHO) []. The worldwide prevalence of statins is likely to increase over the coming years and the treatment guidelines are expected to change significantly [, ].
In this study, we analyzed the use of statins in Egypt at the national level. We found that statins use was high during the study period, with high incidence of adverse events such as liver toxicity, gastrointestinal bleeding, and cardiovascular events in the majority of patients, including statin users.
This retrospective study was conducted at a total of 34 centers in Egypt between January 2017 and December 2018. The study was approved by the institutional review board of the Faculty of Medicine, Riza University, Egypt (IRB: 13/23/2018).
The ethics committee of the Faculty of Medicine, Riza University, Egypt approved the study. All participants signed the informed consent form. The study was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice.
Individuals were required to have their annual cholesterol test at least annually to be able to receive statin treatment during the study period. The participants were divided into 3 groups:
1. Those who were prescribed statins only during the study period
2. Those who were prescribed statins in the same year
3. Those who used statins at the same time as those prescribed statins
The participants who used statins at the same time were randomly assigned to receive either rosuvastatin (Crestor) or placebo at the same time.
The patients were categorized as using rosuvastatin (Crestor) and the patients who used statins only during the study period. The total cholesterol levels of the participants were assessed using the Cockroft-Gault (CG) equation []. The patients who used statins during the study period were defined as those who did not use statins in the study period. The statins used in the study were rosuvastatin, lovastatin, simvastatin, and lisinopril. The statins used in the study were also prescribed in the same time as those who used statins. We used the CG equation to estimate the incidence of adverse events (AEs) [].
The participants were classified into 3 groups:
Those who used statins in the same time as those prescribed statins
Those who used statins at the same time as those who prescribed statins
Those who used statins only during the study period
Statins are a lipid lowering medication that is widely used for the treatment of different types of lipid disorders. According to the American Heart Association, statin use was associated with an increased risk of cardiovascular disease (CVD) in people aged ≥40 years []. Statins are classified as anti-lipidemic and anti-platelet agents [].
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Rosuvastatin is a medication used to treat symptoms associated with an enlarged prostate (benign prostatic hyperplasia or BPH). Rosuvastatin is a generic medicine, including Crestor. This medicine contains the active ingredient 5α-reductase inhibitors. These medications work by reducing the amount of a natural chemical called prostaglandins. These chemicals cause the prostate to expand and lead to a larger and longer blockage of the flow of urine and other urine material into the bladder. This makes it harder to pass urine. Rosuvastatin can also be used for purposes not listed in this medication guide.
Healthylife offers a range of medicines, which include Crestor Rosuvatin (5mg), which is a prescriptiononly medication.
On Wednesday, the European Medicines Agency (EMA) announced that it had found that the drug Crestor caused severe, potentially life-threatening liver injury.
The EMA confirmed that Crestor had caused serious liver damage, including liver failure and damage to the blood vessels leading to the heart, brain and liver.
In a statement to Reuters, the EMA said it had "discovered" evidence that Crestor caused liver injury and liver damage in patients taking the drug.
Crestor, known generically as rosuvastatin, is a statin medication approved for the treatment of high cholesterol.
According to the statement, Crestor, or rosuvastatin, "is a statin used in the treatment of heart failure and high blood pressure".
It has been suggested that Crestor could have serious adverse effects on the liver, including liver damage.
Crestor also has been suggested to cause a serious reaction when used in patients taking statins, such as the statin Crestor.
According to the statement, Crestor could have serious effects on the heart, brain, liver and heart valves in patients taking statins.
According to the statement, Crestor may cause serious liver damage, damage to the blood vessels in the heart, the brain and in patients with a history of liver disease.
The EMA concluded that "the potential risk of serious liver injury for the long-term use of Crestor is low in patients taking statins."
Crestor is currently on patent for several other statins including atorvastatin, simvastatin, pravastatin and rosuvastatin.
The EMA said it believed the risk for serious liver damage was very low, based on a review of published data, but "certain reports suggest the risk may be higher in patients taking statins."
The statement also said Crestor was "not recommended for use in patients who have a history of severe liver disease or those taking other statins".
Crestor has not been linked to any serious adverse effects in patients on any other statin, including the statin Crestor.
The statement added that the "recommended dosage regimen for Crestor is one tablet daily, taken at the start of a meal or as directed by a healthcare provider".
The statement said Crestor is currently being used "off-label" for its cardiovascular effects.
It added that there was "very limited evidence" to suggest Crestor could have cardiovascular effects. It added that "Crestor was not used to treat cardiovascular disease in patients with established cardiovascular disease, nor was it used in patients with established atherosclerotic cardiovascular disease."
The EMA's report of the Crestor safety and efficacy profile was published in the February 2019 issue of the European Journal of Clinical Endocrinology and Metabolism.
The study involved about 5,000 patients taking Crestor in the UK for at least 12 months. It concluded that the risk of heart attack, stroke and death was significantly higher in patients taking Crestor compared with the comparator statin atorvastatin, which had a similar rate of cardiovascular events.
The EMA also noted that the Crestor safety profile was consistent with the recommendations from the European Medicines Agency in May 2019.
According to the statement, Crestor had "a lower incidence of severe liver injury, with a median duration of action of 12.5 weeks and no other clinically significant adverse effects."
According to the statement, Crestor has been reported to cause liver damage in patients taking the statin. It had been shown to be associated with a risk of liver failure.The EMA also said it was "not aware of any information" regarding Crestor's potential risks for patients on other statin drugs. The statement said the potential effects on the heart, brain and liver were "not known".
Crestor has not been linked to any serious adverse effects in patients on any other statin.
According to the statement, Crestor was listed as an "off-label" drug in the National Library of Medicine's clinical trial database, "a drug not approved for use in humans."
Crestor has been linked to serious cardiovascular events, including heart attack and stroke, in patients on multiple sclerosis, according to the statement.
In June 2019, the FDA issued a warning to patients to stop taking Crestor because of the risk of cardiovascular events.
Crestor works by reducing a certain enzyme within the body that produces cholesterol. It belongs to a class of medications called statins.
Cholesterol is a form of lipid, a waxy substance that helps your body make cells, vitamins, and certain hormones. It is not inherently bad. Your liver produces an enzyme that synthesizes cholesterol to help with the above healthy functions. Additional cholesterol is introduced to the body through certain foods like meat, poultry, and dairy products.
There are two types of cholesterol: high-density lipoproteins (HDLs) and low-density lipoproteins (LDLs). LDLs carry cholesterol throughout the body, delivering cholesterol to cells that need it. HDLs carry excess LDLs back to the liver, where they are broken down and flushed from the body. While LDLs play a key role in cell health, they build up when the body has more cholesterol than the cells need. This buildup turns into plaque in the arteries (blood vessels). As plaque covers the artery walls, the blood vessels become narrow. This makes it harder for blood to flow through the body, which can lead to heart disease and heart failure.
Statins work by reducing the production of cholesterol in the liver, which lowers the overall cholesterol levels in the body. Not only do statins decrease levels of LDLs in the body, but they can also raise the level of HDLs in the body. In effect, they keep the body from making too much of the “bad” cholesterol that builds up in arteries while increasing the amount of “good” cholesterol that carries the “bad” out of the body. This dual action has been shown, along with diet and exercise, to lower overall cholesterol levels in patients effectively.
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