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crestor
RosuvastatinSystematic (IUPAC) name(3R,5S,6E)-7--3,5-dihydroxyhept-6-enoic acidIdentifiersCAS number287714-41-4ATC codeC10AA07PubChem6439133DrugBankAPRD00546ChemSpider393589Chemical dataFormulaC22H28FN3O6S Mol. mass481.539SMILESeMolecules & PubChemPharmacokinetic dataBioavailability20%MetabolismLiverHalf life19 hoursExcretionUrine / FaecesTherapeutic considerationsPregnancy cat.D(AU) X(US)Legal statusPrescription Only (S4)(AU) POM(UK) ℞-only(US)RoutesoralRosuvastatin is a member of the drug class of statins, used to treat high cholesterol and related conditions, and to prevent cardiovascular disease. Shionogi developed the product and the pharmaceutical company AstraZeneca markets it as Crestor.// PresentationRosuvastatin is available as Crestor in tablet form (5, 10, 20, or 40 mg) for oral administration. Tablets are pink, round or oval (40 mg), biconvex, film-coated, and imprinted with "ZD4522" and tablet strength. Japanese approval is in the dose range of 2.5 mg to 20 mg; therefore, smaller dose tablet forms might also be available outside the United States. Note that 97% of worldwide sales have been at or below the 20 mg dose. Mechanism of actionFurther information: StatinRosuvastatin is a competitive inhibitor of the enzyme HMG-CoA reductase, having a mechanism of action similar to other statins. Its approximate elimination half life is 19 hours and its time to peak plasma concentration are reached in 3-5 hours following oral administration. Indications and regulationRosuvastatin is approved for the treatment of high LDL cholesterol (dyslipidemia), total cholesterol (hypercholesterolemia) and/or triglycerides (hypertriglyceridemia).As of 2004, rosuvastatin had been approved in 154 countries and launched in 56. Approval in the United States by the FDA came on August 12, 2003.In 2008, research emerged that rosuvastatin could reduce the risk of heart attack, stroke, and other vascular complications in patients with elevated C-reactive protein but no other risk factors. This could strongly impact medical practice by placing many patients on statin prophylaxis that otherwise would have been untreated.The results of the JUPITER trial suggested that rosuvastatin may decrease the relative risk of heart attack and stroke in patients without hyperlipidemia. Effects on cholesterol levelsThe effects of rosuvastatin on LDL cholesterol are dose-related. At the 10mg dose, the average LDL cholesterol reduction was found to be 46% in one trial. Increasing the dose from 10 mg to 40 mg gave a modest increase of an additional 9% absolute reduction in LDL levels (55% below baseline levels). Marketing and competition MarketingThe drug was billed as a super-statin during its clinical development; the claim was that it offered high potency and improved cholesterol reduction compared to rivals in the class. The main competitors to rosuvastatin are atorvastatin (Lipitor), and the combination product ezetimibe/simvastatin (Zetia+Zocor, together marketed as Vytorin by Merck & Co.). However, people can also combine ezetimibe with either rosuvastatin or atorvastatin and other agents on their own, for somewhat similar augmented response rates. So far, some published information for comparing rosuvastatin, atorvastatin and ezetimibe/simvastatin results is available, but many of the relevant studies are still in progress.First launched in 2003, sales of rosuvastatin were $129 million and $908 million in 2003 and 2004, respectively, with a total patient treatment population of >4 million by the end of 2004.Typical per patient costs to the UK NHS are £26/month (compared to £1.50/month for simvastatin). Debate & criticismsIn October 2003, several months after its introduction in Europe, Richard Horton, the editor of the medical journal The Lancet, criticised the way Crestor had been introduced. "AstraZeneca's tactics in marketing its cholesterol-lowering drug, rosuvastatin, raise disturbing questions about how drugs enter clinical practice and what measures exist to protect patients from inadequately investigated medicines," according to his editorial. The Lancet's editorial position is that the data for Crestor’s superiority relies too much on extrapolation from the lipid profile data (surrogate endpoints) and too little on hard clinical endpoints which are available for other statins which had been on the market longer. The manufacturer responded by stating that few drugs had been tested so successfully on so many patients. In correspondence published in The Lancet, AstraZeneca's CEO Sir Tom McKillop called the editorial "flawed and incorrect" and slammed the journal for making "such an outrageous critique of a serious, well-studied medicine."In 2004, the consumer interest organisation Public Citizen filed a Citizen's Petition with the FDA asking that Crestor be withdrawn from the US market. On March 11, 2005, the FDA issued a letter to Sidney M. Wolfe, M.D. of Public Citizen both denying the petition and providing an extensive detailed analysis of findings which demonstrated no basis for concerns about rosuvastatin compared with the other statins approved for marketing in the United States.. MyopathyAs with all statins, there is a concern of rhabdomyolysis, a severe undesired side effect. The FDA has indicated that "it does not appear that the risk is greater with Crestor than with other marketed statins", but has mandated that a warning about this side effect, as well as a kidney toxicity warning, be added to the product label. Notes^ a b "Core Data Sheet, Crestor Tablets" (PDF). AstraZeneca PLC. June 17 2003. http://www.crestor.info/gUserFiles/CRESTOR_CDS_10_40_mg_FINAL_170603.pdf. Retrieved on 2005-03-20. - NOTE: this is provider-oriented information and should not be used without the supervision of a physician.^ a b Nissen SE, Nicholls SJ, Sipahi I, et al (2006). "Effect of very high-intensity statin therapy on regression of coronary atherosclerosis: the ASTEROID trial" (PDF). JAMA 295 (13): 1556–65. doi:10.1001/jama.295.13.jpc60002. PMID 16533939. http://jama.ama-assn.org/cgi/reprint/jama;295/13/1556.pdf?ijkey=Md42dlk7z9TzyL8&keytype=finite. ^ Retrieved from package insert on 2009-03-11^ "FDA Approves New Drug for Lowering Cholesterol". The Food and Drug Administration. August 12, 2003. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01247.html. Retrieved on 2005-03-20. ^ Stein, Rob. Study: Blood Test Can Spot Risks for Heart Attack, Stroke The Washington Post 9 November 2008^ Ridker PM, Danielson E, et al (November 2008). "Rosuvastatin to Prevent Vascular Events in Men and Women with Elevated C-Reactive Protein". N. Engl. J. Med. 359 (21): 2195–207. doi:10.1056/NEJMoa0807646. PMID 18997196. ^ Jones PH, Davidson MH, Stein EA, Bays HE, McKenney JM, Miller E, Cain VA, Blasetto JW. (2003). "Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR Trial)". Am J Cardiol 92 (2): 152–60. doi:10.1016/S0002-9149(03)00530-7. PMID 12860216. ^ Horton, Richard (October 25 2003). "The statin wars: why AstraZeneca must retreat". Lancet 362 (9393): 1341. doi:10.1016/S0140-6736(03)14669-7. PMID 14585629. McKillop T (November 1 2003). "The statin wars". Lancet 362 (9394): 1498. doi:10.1016/S0140-6736(03)14698-3. PMID 14602449. ^ Food and Drug Administration. "Docket No. 2004P-0113/CP1" (PDF). http://www.fda.gov/cder/drug/infopage/rosuvastatin/crestor_CP.pdf. ^ "FDA Alert (03/2005) - Rosuvastatin Calcium (marketed as Crestor) Information". The Food and Drug Administration. March 14, 2005. http://www.fda.gov/cder/drug/infopage/rosuvastatin/default.htm. Retrieved on 2005-03-20. - This page is subject to change; the date reflects the last revision date.
In fact, the medications (technically a class of drugs called HMG-CoA reductase inhibitors) have been so hyped as a pill-popping easy way to quickly lower soaring . AstraZeneca just spent handsomely to get its product Crestor into the headlines and onto front pages..Using Crestor to prevent heart attacks and save lives in apparently healthy people would add nearly $10 billion a year to the nation's medical bill, according to calculations released Monday. Today you'll see how Crestor can actually harm your health.People with low cholesterol and no big risk for heart disease had dramatically lower rates of heart attacks, death & stroke if they took the cholesterol pill Crestor, a large study found.Daily papers seem to feel the crunch and publish adverts now as front page news. The hype is undeserved, the data less than compelling, and when it came to whether the statin drug used in the study (Crestor) actually saved lives, the headlines should have said the (Adds study details, further comment) By Bill Berkrot and Ransdell Pierson NEW ORLEANS, Nov 9 (Reuters) - A study that showed AstraZeneca's cholesterol fighter Crestor slashed deaths, heart attacks, strokes and artery-clearing procedures in apparently
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crestor
Learn about CRESTOR, a statin that helps lower LDL cholesterol, raise HDL cholesterol, and slow atherosclerosis progression.
What CRESTOR Does
Crestor lawyer representing victims of Crestor side effects including those who have suffered from rhabdomyolysis and kidney disease. Free Crestor lawsuit case evaluation offered ...
Crestor Side Effects Lawsuit Rhadomyolysis Lawyer
Learn about the prescription medication Crestor (Rosuvastatin Calcium), drug uses, dosage, side effects, drug interactions, warnings, and patient labeling.
Crestor (Rosuvastatin Calcium) Drug Information: Uses, Side Effects ...
Learn about CRESTOR, a prescription cholesterol medication that lowers LDL cholesterol, raises HDL cholesterol and slows atherosclerosis progression.
About CRESTOR
CRESTOR® bevat het geneesmiddel rosuvastatine, dat behoort tot de groep geneesmiddelen bekend als 'statines'. Deze medicijnen verlagen een te hoog cholesterol.
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