AstraZeneca and the triglycerides-boosting drugs Takeda Pharmaceuticals LP have been awarded a trial to test the use of a new blood test to monitor the cholesterol levels in patients on a Crestor-approved statin, the company said on Wednesday.
The trial, known as the Lipitor Lipase test, will test whether the statin is working properly.
The trial will use the results of the blood cholesterol testing, and it is being called a “black box” test.
The Crestor-approved drug is already in Phase III trials, and the trial is expected to start early next year.
The trial was the latest in a string of such trials for cholesterol-lowering drugs like Lipitor, Crestor, Bextra and Zocor, which were being tested in conjunction with the FDA’s “black box” test.
The study was conducted on 2,000 patients with LDL-cholesterol levels of 4.7 to 6.5 mg/dL or more, the company said.
The results of the Lipitor test showed that patients on Lipitor had an average of 2.8 less LDL and 5.6 more HDL compared with patients on Zocor.
Patients taking the cholesterol-lowering drug had a 3.2 less LDL and 10.4 fewer HDL.
Takeda said it expects to be able to offer the trial for the first time.
In the trial, which was conducted on 2,200 patients with LDL levels of 4.7 to 6.5 mg/dL or more, patients who were taking statins or had been taking statins for more than a year were given a cholesterol-lowering drug, and those who were taking statins for more than a year were given a placebo.
The researchers noted that the trial was designed to help patients get the benefits of the statin, which was approved in 2010.
Takeda said the trial would allow patients to take the cholesterol-lowering drug statin daily, and that the results would not need to be shared with a clinical trial.
“We expect that in the future, we will be able to provide this trial to physicians and patients. It is important to us that patients with LDL levels below 4.7-6.5 mg/dL will not have to take any drug or take the drug at the same dose,” AstraZeneca said in a statement.
The company also noted that the trial is currently ongoing and that the results of the trial are expected to be available next year.
It also noted that patients will still need to take the drug at the same dose as those who are taking a statin, and that the results of the trial would still need to be shared with a clinical trial.
Takeda said that the results of the trial are being reviewed and that the company intends to release more information about the trial in a future version.
“We will continue to support patients who have been diagnosed with a high-risk or high-risk statin and are taking the drug,” said AstraZeneca vice president and general counsel Dr. Steven Nissen, who is also the chief medical officer at the company.
Takeda said it is not disclosing how much it will pay for the trial, as the company has not disclosed how much it paid for the trial. However, the company is still expected to pay in the next few months.
AstraZeneca also said that it will be conducting clinical trials to see whether the trial is working as intended.
The trial is scheduled to be held in early 2014, and the company is also working on a clinical trial for Crestor.
In the trial, researchers found that patients who were taking the cholesterol-lowering drug Zocor, the best-selling statin, had a 2.3 less LDL compared with patients on a statin.
They also noted that the statin was not used by patients with existing health problems, as they could not be treated.
The Crestor-approved drug is currently approved for use in patients with a family history of certain types of high cholesterol, such as familial hypercholesterolemia, hypercholesterolemia or familial hypercholesterolemia, according to AstraZeneca.
Takeda said it is working with the FDA to have the trial complete and available next month.
Originally Published: March 27, 2013 at 12:00 AM EDT
Copyright 2013 The Associated Press. All rights reserved.AstraZeneca PLC’s Crestor (rosuvastatin) blockbuster is set to lose its patent protection in the United States, after the patent protecting the drug was challenged in Europe. Crestor, also known as rosuvastatin, is a medication used to treat high cholesterol. It is a member of the class of drugs known as “statins” or non-steroidal anti-inflammatory drugs (NSAIDS). The drug’s patent was set to expire in the US in 2013. However, a number of manufacturers have filed for an abbreviated new drug application (ANDA) and the drug is still available under the brand name rosuvastatin. AstraZeneca will continue to manufacture the drug and will continue to market it to physicians and patients. The company will continue to make Crestor.
For information on Crestor, visit.
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References
1.U. S. National Library of Medicine. Statins, non-steroidal anti-inflammatory drugs, and marketing exclusivity for AstraZeneca PLC (Epub ahead of print July 2022). National Center for Biotechnology Information. Published online: July 2022. Accessed July 2, 2023. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4422983/
2.American Heart Association. Statin use, risk of heart attack or stroke: systematic review and meta-analysis. N Engl J Med 2020;346:1472-1480.3.European Heart Journal. Statin: a new drug for the treatment of high cholesterol. J Cardiol 2018;18:569-584.4.N Engl J Med. 2017;360:1-22.5.British Medical Journal. Statin and use of lipid lowering drugs in the management of type 2 diabetes: systematic review and meta-analysis. JAMA 2017;315:2574-2580.
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Crestor 10mg Tablets (Rosuvastatin) are a trusted companion in the management of high cholesterol. They're specifically designed to help you and your healthcare provider assess the potential for adverse effects associated with Crestor use. These tablets are specifically formulated for adult use and have on rarefied by 20 mg/tabs. Every tablet contains 20 mg of Rosuvastatin.
Aim for your dose as directed by your healthcare provider. Depending on your results, you may be prescribed up to 20 mg/m² of tablet.
Take these tablets with water. Swallow the tablet whole with a glass of water. Do not crush or chew the tablet. Keep the tablets out of reach of children. It is recommended to take these tablets at least one hour before a meal to reduce the risk of experiencing nausea and vomiting. If you experience any stomach discomfort, you should discontinue taking the tablets and contact a doctor right away.
Important: Do not exceed the recommended dosage. Consult a healthcare professional if symptoms persist or worsen after one year of use.
Crestor 10mg Tablets (Rosuvastatin) are manufactured by AstraZeneca, a UK-based pharmaceutical company. Rosuvastatin is used to lower the risk of cardiovascular events such as heart attacks and strokes, by blocking the synthesis of cholesterol in the high-density lipoprotein (HDL) Leipophilis.
Crestor 10mg Tablets are used to lower the risk of cardiovascular events (such as heart attacks and strokes) including heart failure, heart failure with edema (swelling), and hypertension (high blood pressure).
Crestor 10mg Tablets are very effective at helping you and your healthcare provider assess your cholesterol levels. They should only be used to lower your risk of cardiovascular events, such as heart attacks or strokes. The benefits of Crestor 10mg Tablets can be seen as early as you and your doctor. The benefits of Crestor 10mg Tablets help ensure that you don't experience adverse effects after starting treatment with Crestor 10mg. You can take Crestor 10mg Tablets with or without food.
Like any medication, Crestor 10mg Tablets can cause side effects, although not everybody gets them.
Common side effects of Crestor 10mg Tablets include headache, muscle pain, feeling sick (nausea), vomiting, feeling sick (vomiting), and feeling hot. These side effects are usually mild and go away on their own without needing to adjust your dosage.
Other side effects of Crestor 10mg Tablets may include muscle pain (myasthenia gravis), bone pain (osteoporosis), dizziness, abnormal vision, and changes in hearing. If you experience any of these side effects while taking Crestor 10mg Tablets, contact your doctor immediately. Contact your healthcare provider right away if you have any further concerns or questions about side effects.
In rare cases, Crestor 10mg Tablets can cause liver problems. Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should not breast-feed while taking Crestor 10mg Tablets. If you become pregnant, talk to your healthcare provider before taking this medication. Crestor 10mg Tablets should not be used during pregnancy, especially if your baby is under 18 years of age. Crestor 10mg Tablets are not recommended for use in women who are or may potentially be pregnant.
Taking Crestor 10mg Tablets may increase your risk of a heart attack or stroke. Discuss any possible side effects with your doctor before starting treatment with Crestor 10mg Tablets. Contact your healthcare provider if you think you may have a side effect that is troublesome or not well-studied. Your healthcare provider will probably tell you not to take Crestor 10mg Tablets.
The dosage of Crestor 10mg Tablets depends on your cholesterol levels and the doctor's advice. The dosage of Crestor 10mg Tablets for adults is determined by your healthcare provider based on your cholesterol goals and your health condition. The recommended starting dose is 20 mg once daily, taken once daily for the maximum recommended dose of 40 mg per day.
Your healthcare provider will determine the appropriate dose for your specific needs. The dosage of Crestor 10mg Tablets will depend on your cholesterol levels, the doctor's recommendations, and your specific needs.
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