Crestor LogoRosuvastatin chemical structure
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Crestor

Rosuvastatin is a member of the drug class of statins, used to treat hypercholesterolemia and related conditions, and to prevent cardiovascular disease. It is currently being marketed by the pharmaceutical company AstraZeneca as Crestor®. more...

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Presentation

Rosuvastatin 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 action

See the article on statins for more details.

Rosuvastatin is a competitive inhibitor of the enzyme HMG-CoA reductase, having a mechanism of action similar to other statins.

Indications and regulation

Rosuvastatin is indicated for the treatment of elevated LDL cholesterol (dyslipidemia), total cholesterol (hypercholesterolemia) and/or triglycerides (hypertriglyceridemia).

As of 2004, rosuvastatin had been approved in 67 countries and launched in 56. Approval in the United States by the FDA came on August 12, 2003.

Marketing and competition

Marketing

The drug was billed as a super-statin during its clinical development, claimed to offer a high potency and improved cholesterol reduction compared to rivals in the class. Currently the main competition for Crestor is Vytorin by Merck & Co. (a combination of simvastatin (Zocor) and ezetimibe (Zetia)); unfortunately, there are no published studies showing which of the two drugs is more effective.

First launched in 2003, sales 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.

Debate & Criticisms

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 and too little on hard clinical endpoints, which are available for other statins. The manufacturer responded by claiming 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."

Read more at Wikipedia.org


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Yet another statin and how it is promoted - Crestor from AstraZeneca
From Healthfacts, 1/1/04

A straZeneca has launched a $1 billion marketing campaign for its new drug, Crestor, the latest statin to enter the U.S. market. As of September 2003, there are now six statins available. Why do we need six versions of the same cholesterol-lowering drug, one might ask. The answer is that they are major moneymakers for the drug companies. Lipitor alone, for example, brought in $6.2 billion in sales for Pfizer in 2002.

There is no way for doctors or consumers to know whether one statin has any advantage over the others. No long-term head to head comparison has ever been done to determine whether one statin is better at reducing the risk of heart attack, or whether one statin is safer than the others. For FDA approval, AstraZeneca simply had to show that Crestor lowered cholesterol more effectively than a placebo. According to The Medical Letter, a physicians' newsletter with no drug industry advertising, Crestor's advantages boil down to decreases in LDL cholesterol (socalled bad cholesterol) and triglycerides that are slightly better than other statins. At its maximum dose of 40 mg, Crestor is cheaper than the other statins of the same dose.

The Medical Letter identified an alarming indication that Asians should avoid Crestor in favor of a statin with a longer safety record. The drug stays in the body longer in Asians--and this could raise the odds of adverse effects. The major concern for Asians, according to the Medical Letter, is severe muscle damage. It has already been determined that rare cases of rhabdomyolysis, a potentially fatal muscle disease, occur almost exclusively at daily statin doses of 80 mg. At this dose level, all statins pose a rare risk of rhabdomyolysis for everyone.

AstraZeneca's Crestor campaign started with the drug industry's favorite marketing strategy: Giving free samples to doctors. According to U.S. News & World Report, the usual giveaway is a seven-day supply, but Astra-Zeneca is giving doctors a one-month supply for their patients. The typical scenario: The doctor says, "Try this free sample to see how you do." And if the person shows no ill effects in that short period of time, he or she remains on the drug. More than half of all drug industry promotional spending goes to free samples--for the simple reason that they work even better than advertising.

COPYRIGHT 2004 Center for Medical Consumers, Inc.
COPYRIGHT 2004 Gale Group

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