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Additional information about the drug Rosuvastatin


Rosuvastatin (marketed by AstraZeneca as Crestor) 10 mg tablets
Rosuvastatin ( INN ), marketed under the tradename Crestor, is a member of the drug class of statins, used in combination with exercise, diet, and weight-loss to treat high cholesterol and related conditions, and to prevent cardiovascular disease.
It was developed by Shionogi. In 2013 Crestor was the fourth-highest selling drug in the United States, accounting for approx. $5.2 billion in sales.
Contents
1 Medical uses
1.1 Effects on cholesterol levels
2 Side effects and contraindications
3 Drug interactions
4 Structure
5 Mechanism of action
6 Pharmacodynamics
7 Pharmacokinetics
8 Society and culture
8.1 Indications and regulation
8.2 FDA advisory for East Asian patients
8.3 Patent protection and generic versions
8.4 Marketing
8.5 Debate and criticisms
8.6 Myopathy
8.7 Diabetes mellitus
9 References
10 References
11 External links
Medical uses
The primary use of rosuvastatin is for the treatment of dyslipidemia.
Effects on cholesterol levels
The effects of rosuvastatin on LDL cholesterol are dose-related. Higher doses were more efficacious in improving the lipid profile of patients with hypercholesterolemia than milligram-equivalent doses of atorvastatin and milligram-equivalent or higher doses of simvastatin and pravastatin.
Meta-analysis showed that rosuvastatin is able to modestly increase levels of HDL cholesterol as well, as with other statins. HDL increases by 7% with no dose effect noted.
Side effects and contraindications
Side effects are uncommon. The following side effects should be reported to the prescribing doctor if they persist or get worse:
constipation
heartburn
dizziness
sleeplessness
depression
joint pain
cough
memory loss or forgetfulness
confusion
The following rare side effects are more serious. Like all statins, rosuvastatin can possibly cause myopathy, rhabdomyolysis. Stop taking rosuvastatin and contact the prescribing doctor if any of these occur:
muscle pain, tenderness, or weakness
lack of energy
fever
chest pain
jaundice : yellowing of the skin or eyes
dark colored, or foamy urine
pain in the upper right part of the abdomen
nausea
extreme tiredness
weakness
unusual bleeding or bruising
loss of appetite
flu -like symptoms
sore throat, chills, or other signs of infection
If any signs of an allergic reaction develop, contact an emergency medical service immediately:
rash
hives
itching
difficulty breathing or swallowing
swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
hoarseness
numbness or tingling in fingers or toes
Rosuvastatin has multiple contraindications, conditions that warrant withholding treatment with rosuvastatin, including hypersensitivity to rosuvastatin or any component of the formulation, active liver disease, elevation of serum transaminases, pregnancy, or breastfeeding.
Drug interactions
The following drugs can have negative interactions with rosuvastatin and should be discussed with the prescribing doctor:
Coumarin anticoagulants (‘blood thinners’, e.g. warfarin ) can affect the removal of rosuvastatin
Ciclosporin, colchicine
Drugs that may decrease the levels or activity of endogenous steroid hormones, e.g. cimetidine, ketoconazole, and spironolactone
Additional medications for high cholesterol such as clofibrate, fenofibrate, gemfibrozil, and niacin (when taken in lipid-modifying doses of 1 g/day and above)
Specific protease inhibitors including atazanavir (when taken with ritonavir ), lopinavir/ritonavir and simeprevir
Alcohol intake should be reduced while on rosuvastatin in order to decrease risk of developing liver damage
Aluminum and magnesium hydroxide antacids should not be taken within two hours of taking rosuvastatin
Coadministration of rosuvastatin with eluxadoline may increase the risk of rhabdomyolysis and myopathy : 8
Structure
Rosuvastatin has structural similarities with most other synthetic statins, e.g., atorvastatin, cerivastatin and pitavastatin, but unlike other statins, rosuvastatin contains sulfur (in sulfonyl functional group).
Crestor is actually a calcium salt of rosuvastatin, i.e. rosuvastatin calcium, in which calcium replaces the hydrogen in the carboxylic acid group on the right of the skeletal formula at the top right of this page.
Mechanism of action
Further information: Statin
Rosuvastatin is a competitive inhibitor of the enzyme HMG-CoA reductase, having a mechanism of action similar to that of other statins.
Putative beneficial effects of rosuvastatin therapy on chronic heart failure may be negated by increases in collagen turnover markers as well as a reduction in plasma coenzyme Q 10 levels in patients with chronic heart failure.
Pharmacodynamics
In a Cochrane systematic review the dose-related magnitude of rosuvastatin on blood lipids was determined. Over the dose range of 1 to 80 mg/day strong linear dose‐related effects were found; total cholesterol was reduced by 22.1% to 44.8%, LDL cholesterol by 31.2% to 61.2%, non-HDL cholesterol by 28.9% to 56.7% and triglycerides by 14.4% to 26.6%.
Pharmacokinetics
Absolute bioavailability of rosuvastatin is about 20% and C max is reached in 3 to 5 hours; administration with food did not affect the AUC according to the original sponsor submitted clinical study and as per product label. It is likely that closer to 0.25 (25%) of the administered dose is absorbed.
Rosuvastatin is metabolized mainly by CYP2C9 and not extensively metabolized; approximately 10% is recovered as metabolite N -desmethyl rosuvastatin. It is excreted in feces (90%) primarily and the elimination half-life is approximately 19 hours.
Society and culture
Indications and regulation
Rosuvastatin is approved in the United States 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.
The results of the JUPITER trial (2008) suggested rosuvastatin may decrease the relative risk of heart attack and stroke in patients without hyperlipidemia, but with elevated levels of highly sensitive C-reactive protein. This could strongly impact medical practice by placing many patients on statin prophylaxis who otherwise would have been untreated.
The AURORA trial randomized 2776 patients undergoing hemodialysis due to kidney damage to receive either rosuvastatin or placebo. The randomized, double-blind study (2005 to 2009) found no difference in the two groups in the primary end-point, a combination of cardiovascular mortality, nonfatal myocardial infarction, or nonfatal stroke. The study found no difference in all-cause mortality among this population at a mean follow-up of 3.8 years.
FDA advisory for East Asian patients
According to the FDA, the risk of myopathy during rosuvastatin therapy may be increased in Asian Americans:
Because Asians appear to process the drug differently, half the standard dose can have the same cholesterol-lowering benefit in those patients, though a full dose could increase the risk of side-effects, a study by the drug’s manufacturer, AstraZeneca, indicated.
Therefore, physicians should start Asian-American or East Asian patients at the lowest dose level.
Patent protection and generic versions
The main patent protecting rosuvastatin (RE37,314 — due to expire in 2016) was challenged as being an improper reissue of an earlier patent. This challenge was rejected in 2010, confirming protection until 2016.
In April 2016 the FDA approved the first generic version of rosuvastatin (from Watson Pharmaceuticals Inc).
In July 2016 Mylan gained approval for its generic rosuvastatin calcium.
Marketing
The drug was billed as a “super-statin” during its clinical development; the claim was that it offers high potency and improved cholesterol reduction compared to rivals in the class. The main competitors to rosuvastatin are atorvastatin (Lipitor) and simvastatin (Zocor). However, people can also combine ezetimibe with either simvastatin or atorvastatin and other agents on their own, for somewhat similar augmented response rates. As of 2006
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 over 4 million by the end of 2004.
Annual cost to the UK National Health Service (NHS) in 2018 for 5-40mg rosuvastain daily was £24-40, compared to £10-20 for 20-80mg simvastatin.
Debate and criticisms
In October 2003, several months after its introduction in Europe, Richard Horton, the editor of the medical journal The Lancet, criticized 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 rely too much on extrapolation from the lipid profile data (surrogate end-points) and too little on hard clinical end-points, which are available for other statins that 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 organization 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 that demonstrated no basis for concerns about rosuvastatin compared with the other statins approved for marketing in the United States.
Myopathy
As 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
Diabetes mellitus
Statins increase the risk of diabetes,
References
^ a b c d e Aggarwal, RK; Showkathali, R (June 2013). “Rosuvastatin calcium in acute coronary syndromes”. Expert Opinion on Pharmacotherapy. 14 (9): 1215–1227. doi : 10.1517/14656566.2013.789860. PMID   23574635.
^ a b c d e “Crestor (rosuvastatin calcium) Tablets. Full Prescribing Information” (PDF). AstraZeneca Pharmaceuticals LP. Retrieved 29 November 2016.
^ “International Nonproprietary Names for Pharmaceutical Substances (INN). Recommended International Nonproprietary Names (Rec. INN): List 45” (PDF). World Health Organization. 2001. p. 50. Retrieved 29 November 2016.
^ “Top 100 Drugs for Q2 2013 by Sales”. Retrieved 24 August 2013.
^ “FDA approves first generic Crestor”. FDA. April 29, 2016. Retrieved 3 May 2016.
^ “Crestor”. The American Society of Health-System Pharmacists. Retrieved 3 April 2011.
^ 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.
^ McTaggart F (Aug 2008). “Effects of statins on high-density lipoproteins: a potential contribution to cardiovascular benefit”. Cardiovasc Drugs Ther. 22 (4): 321–38. doi : 10.1007/s10557-008-6113-z. PMC   2493531. PMID   18553127.
^ “Lipid-lowering efficacy of rosuvastatin”. Cochrane Database Syst Rev. 11 : CD010254. Nov 2014. doi : 10.1002/14651858.CD010254.pub2. PMID   25415541.
^ a b c “Rosuvastatin”. MedlinePlus. U.S. National Library of Medicine. 15 June 2012. Retrieved 1 December 2012.
^ a b c d e f “Crestor”. RxList. 14 November 2012. Retrieved 1 December 2012.
^ “Rosuvastatin”. LactMed. U.S. National Library of Medicine. Retrieved 1 December 2012.
^ “Viberzi (eluxadoline) Tablets, for Oral Use, CIV. Full Prescribing Information”. Actavis Pharma, Inc. Retrieved 29 November 2016.
^ a b “FDA Alert (03/2005) – Rosuvastatin Calcium (marketed as Crestor) Information”. The Food and Drug Administration. March 14, 2005. Archived from the original on 2005-03-05. Retrieved 2005-03-20. – This page is subject to change; the date reflects the last revision date.
^ 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. Archived from the original (PDF) on 2007-09-29.
^ Ashton E, Windebank E, Skiba M, et al. (January 2010). “Why did high-dose rosuvastatin not improve cardiac remodeling in chronic heart failure? Mechanistic insights from the UNIVERSE study”. Int J Cardiol. 146 (3): 404–7. doi : 10.1016/j.ijcard.2009.12.028. PMID   20085851.
^ Adams, Stephen P.; Sekhon, Sarpreet S.; Wright, James M. (2014-11-21). Rosuvastatin for lowering lipids. Cochrane Database of Systematic Reviews. John Wiley & Sons, Ltd. doi : 10.1002/14651858.cd010254.pub2.
^ Li, Yunxia; Jiang, Xuehua; Lan, Ke; Zhang, Ruoqi; Li, Xue; Jiang, Qian (2007-10-01). “Pharmacokinetic Properties of Rosuvastatin After Single-Dose, Oral Administration in Chinese Volunteers: A Randomized, Open-Label, Three-Way Crossover Study”. Clinical Therapeutics. 29 (10): 2194–2203. doi : 10.1016/j.clinthera.2007.10.005. ISSN   0149-2918.
^ a b “Rosuvastatin Calcium”. pp. Professional. Retrieved 21 September 2015.
^ Bergman, Ebba; Lundahl, Anna; Fridblom, Patrik; Hedeland, Mikael; Bondesson, Ulf; Knutson, Lars; Lennernäs, Hans (2009-12-01). “Enterohepatic Disposition of Rosuvastatin in Pigs and the Impact of Concomitant Dosing with Cyclosporine and Gemfibrozil”. Drug Metabolism and Disposition. 37 (12): 2349–2358. doi : 10.1124/dmd.109.029363. ISSN   1521-009X. PMID   19773540.
^ “Page 45 of FDA Drug Approval Package, Clinical Pharmacology Biopharmaceutics Review(s) (PDF)”. U.S. Food and Drug Administration. U.S. Food and Drug Administration. 29 January 2004. Retrieved 22 June 2016.
^ “Core Data Sheet, Crestor Tablets” (PDF). AstraZeneca PLC. June 17, 2003. Archived from the original (PDF) on May 8, 2005. Retrieved March 20, 2005. – NOTE: this is provider-oriented information and should not be used without the supervision of a physician.
^ a b http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021366s016ltr.pdf
^ “FDA Approves New Drug for Lowering Cholesterol”. The Food and Drug Administration. August 12, 2003. Archived from the original on 2005-02-07. Retrieved 2005-03-20.
^ Everett, BM; Glynn, RJ; MacFadyen, JG; Ridker, PM (21 December 2009). “Rosuvastatin in the Prevention of Stroke Among Men and Women with Elevated Levels of C-Reactive Protein: Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER)” (PDF). Circulation. 121 (1): 143–50. doi : 10.1161/circulationaha.109.874834. PMID   20026779.
^ Ridker, PM; Danielson, E; Fonseca, FAH; Genest, J; Gotto, AM; Kastelein, JJP; Koenig, W; Libby, P; Lorenzatti, AJ; MacFadyen, JG; Nordestgaard, BG; Shepherd, J; Willerson, JT; Glynn, RJ (20 November 2008). “Rosuvastatin to Prevent Vascular Events in Men and Women with Elevated C-Reactive Protein”. New England Journal of Medicine. 359 (21): 2195–207. doi : 10.1056/nejmoa0807646. PMID   18997196.
^ Fellstrom BC, Jardine AG, et al. (April 2009). “Rosuvastatin and Cardiovascular Events in Patients Undergoing Hemodialysis”. N. Engl. J. Med. 360 (14): 1395–1407. doi : 10.1056/NEJMoa0810177. PMID   19332456.
^ FDA Advisory Targets Asian Patients (Los Angeles Times).
^ Asian-Americans Among Groups More at Risk of Serious Muscle Damage (WebMD).
^ “AstraZeneca’s Crestor patent upheld;No generic competition until 2016”.
^
AstraZeneca (June 29, 2010). “CRESTOR Patent Upheld By US Court”. PR Newswire. United Business Media. Retrieved 2012-04-25.
^
Berkrot, Bill; Tom Hals (June 29, 2010). “UPDATE 2-U.S. judge rules AstraZeneca Crestor patent valid”. Reuters. Retrieved 2012-04-25.
^
Starkey, Jonathan (July 1, 2010). “AstraZeneca patent upheld”. The News Journal. Wilmington, Delaware. Retrieved 2012-04-25. (subscription required)
^ FDA approves first generic Crestor. April 2016
^ Mylan Launches Generic Crestor® Tablets. July 2016
^ “COST COMPARISON CHARTS” (PDF). REGIONAL DRUG AND THERAPEUTICS CENTRE (NEWCASTLE). August 2018.
^ 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).
^ Sattar, N; Preiss, D; Murray, HM; Welsh, P; Buckley, BM; de Craen, AJ; Seshasai, SR; McMurray, JJ; Freeman, DJ; Jukema, JW; Macfarlane, PW; Packard, CJ; Stott, DJ; Westendorp, RG; Shepherd, J; Davis, BR; Pressel, SL; Marchioli, R; Marfisi, RM; Maggioni, AP; Tavazzi, L; Tognoni, G; Kjekshus, J; Pedersen, TR; Cook, TJ; Gotto, AM; Clearfield, MB; Downs, JR; Nakamura, H; Ohashi, Y; Mizuno, K; Ray, KK; Ford, I (February 27, 2010). “Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials”. Lancet. 375 (9716): 735–42. doi : 10.1016/S0140-6736(09)61965-6. PMID   20167359.
^ “FDA Drug Safety Communication: Important safety label changes to cholesterol-lowering statin drugs”.

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