Crestor liver issues
April 1, 2005 15:48

The Star Online, Wed, 23 Mar 2005 6:59 PM PST. DOCTORS are advising their patients not to stop taking Crestor, after a report on Monday sparked worries about potential side effects of the cholesterol-lowering drug.

The Biloxi Sun Herald, Thu, 24 Mar 2005 1:05 AM PST Q: My doctor wants to prescribe a cholesterol-lowering medication that requires periodic tests of my liver. Can you tell me what tests she's talking about and why they're needed?

The liver's job is to break down drugs for elimination by the body. In some cases, the drug or some of its breakdown products can damage this organ.

The tests your doctor mentioned are likely those that measure the levels of ALT and AST (liver enzymes) and bilirubin in your blood. Normal levels indicate your liver is healthy.

When liver cells are damaged, these enzymes leak into the blood, resulting in higher levels. Bilirubin also can climb higher. The yellow discoloration of jaundice is caused by high bilirubin levels. Minimal elevations of liver enzymes may not be serious. However, significantly higher levels, especially when accompanied by high bilirubin levels, is a red flag.

Statins are a group of drugs, which include Zocor, Pravachol, Lipitor, and others, that lowers LDL "bad" cholesterol levels and can reduce heart attack risk by as much as 50 percent and stroke by 25 percent -- but that's not all.

Recent studies show that statins also fight heart disease by reducing inflammation and may help treat a number of other ailments, including:

* Cancer: Statins may help prevent colon, prostate, and breast cancer;

* Alzheimer's Disease: Studies suggest that people who take statins may reduce their risk of getting Alzheimer's by 30 to 70 percent;

* Diabetes: According to the American Diabetes Association, most diabetes patients should consider taking statins;

* Eye diseases: Long-term statin use can lower the risk of glaucoma and help fight macular degeneration;

* Rheumatoid arthritis: Statins may reduce joint pain by lowering levels of inflammation;

* Multiple Sclerosis (MS): Statins can alter immune responses that may be beneficial for treating MS.

Instead, consumers get billions of dollars of advertising remarkably light on facts. Risk information is typically buried in fine print. And benefit information is even harder to find: The most basic information of how well drugs work is hardly ever provided. Instead, ads use vague promises like ''Zyrtec works" and Crestor for cholesterol lowering ''when diet and exercise aren't enough" -- rather than telling consumers how well Zyrtec works or whether cholesterol lowering with Crestor translates into fewer heart attacks or deaths.

See: http://www.boston.com/news/globe/editorial_opinion/oped/articles/2005/04/20/whats_needed_on_prescription_labels/

Medical News Today, Sat, 23 Apr 2005 4:33 PM PDT

AstraZeneca Fulfills Approval Commitment To Make 5mg Dose Of Crestor Available In EU . AstraZeneca announced today that agreement has been reached under the EU arbitration procedure on label wording for a 5mg dose of CRESTOR, the cholesterol lowering treatment, paving the way for its availability across the European Union The commitment to make the 5mg dose available was made when CRESTOR 10-40mg was first approved in Europe in 2003. Approval of the original dose range of 10-40mg

New Study on Effects of CRESTOR on Carotid Atherosclerosis Presented at European Atherosclerosis Society Congress

PRAGUE, Czech Republic, April 24 /PRNewswire-FirstCall/ -- New data presented today from ORION (Outcome of Rosuvastatin treatment on carotid artery atheroma: a magnetic resonance Imaging ObservatioN) showed that CRESTOR 5 mg and 40 mg reduced the proportion of lipid-rich necrotic core (LRNC) in the most diseased area of atherosclerotic plaques by 17.6% (p=NS) and 35.5% (p=0.006), respectively.

The study compared patient outcomes for atorvastatin (Lipitor), pravastatin (Pravacol), simvastatin (Zocor), lovastatin (Mevacor) and fluvastatin (Lescol). A more recent addition to the statin family, rosuvastatin (Crestor) was not included in the study because of lack of long-term data.

Our results show that there really does not appear to be much difference across statins in terms of their effectiveness," study co-author Dr. Louise Pilote, an internist at the McGill University Health Centre, said from Montreal. "They appear to be similar one to another."

Sales of Crestor came in below forecasts at 273 mln usd, and the company revealed the drug has not managed to improve market share in the key US market beyond 6 pct.

"It doesn't look like the company has reversed the negative publicity (in the US)," Turner said. "It may not generate the revenues they were hoping for."

AstraZeneca announced today that agreement has been reached under the EU arbitration procedure on label wording for a 5mg dose of CRESTOR, the cholesterol lowering treatment, paving the way for its availability across the European Union The commitment to make the 5mg dose available was made when CRESTOR 10-40mg was first approved in Europe in 2003. Approval of the original dose range of 10-40mg was based, in part, on clinical trial data showing that more than 80 per cent of patients reach their LDL-cholesterol target on the 10mg dose.