Magazin

2007-10-23

Two New Studies Provide Real World Data on Cardiovascular Events in CRESTOR Users


London (ots/PRNewswire) - Data from two observational studies ofover 470,000 patients taking statins in routine clinical practiceinvestigating the incidence of cardiovascular events in patientstaking CRESTOR(TM) (rosuvastatin) and other statins were presentedtoday at the International Society for Pharmacoeconomics and OutcomesResearch (ISPOR) 10th Annual European Congress in Dublin.

The results from one study with a median duration of therapy ofeleven months suggest that patients taking CRESTOR (mean dose 11mg)had significantly fewer cardiovascular events compared to patientstaking simvastatin (mean dose 22mg) and pravastatin (mean dose 34mg)and a favourable trend towards fewer cardiovascular events comparedto patients taking atorvastatin (mean dose 17mg). The results fromthe other study showed that CRESTOR users had a similar incidence ofcardiovascular events to users of other statins at a median durationof therapy of 100 days, however amongst patients who were on statintherapy for nine months or longer the incidence of events wassignificantly lower in CRESTOR users. These studies have limitationstypical of observational research.

"These pharmacoepidemiological studies add to the extensiveknowledge we have gathered through the CRESTOR clinical trialsprogram, which continues to show that CRESTOR offers outstandingeffects on lowering LDL-C with the additional benefit of raisingHDL-C" said Elisabeth Björk, CRESTOR Medical Science Director atAstraZeneca.

The first study conducted in the Netherlands, compared thedifferences in incidences of hospitalisations for cardiovascularevents - including fatal and non-fatal ischaemic heart disease andstroke- between users of selected statins (rosuvastatin, simvastatin,atorvastatin, pravastatin). 76,147 statin-naïve patients from thePHARMO Institute database, who had not experienced cardiovascularevents in the preceding year were followed for up to two years, witha median duration of therapy of eleven months.

In this study, the incidence of hospitalisation for cardiovascularevents was significantly lower (28%, RR 0.72 (95 percent CI0.56-0.94)) in patients taking CRESTOR compared with those takingother statins (simvastatin, atorvastatin, or pravastatin). Meanstatin doses were CRESTOR 11mg, atorvastatin 17mg, simvastatin 22mg,and pravastatin 34mg. When individually compared to other statingroups, the incidence of cardiovascular events in CRESTOR users was:

- 40% lower than pravastatin users (0.60 (95%CI 0.45-0.80))significant

- 29% lower than simvastatin users (0.71 (95%CI 0.54-0.94))significant

- 17% lower than atorvastatin users (0.83 (95%CI 0.63-1.10)) notsignificant

The second study conducted in the US, assessed real worldeffectiveness of statins by comparing the incidence of fatal andnon-fatal cardiovascular events (hospital cardiovascular death, heartattack, unstable angina, coronary revascularization, stroke, andcarotid revascularization) in users of CRESTOR versus users of otherstatins. 395,039 statin-naïve patients from the Thomson Healthcare'sMarketScan research database were followed for up to two years andfour months, with a median duration of therapy of 100 days. Mean doseof CRESTOR was 11 mg and was lower than the other statins.

In this study, CRESTOR patients had a similar incidence ofcardiovascular events to patients taking other statins for 90 days ormore, or for 180 days or more (greater than or equal to 90 daysexposure, HR=0.97, (95 percent CI=0.86-1.09); greater than or equalto 180 days, HR=0.91, (95 percent CI=0.78-1.06)). However, whenpatients remained on therapy for at least nine months, patientstaking CRESTOR had a significantly lower incidence of cardiovascularevents (20% lower, HR 0.80 (95 percent CI 0.64-1.00)) than patientstaking other statins.

CRESTOR is indicated for the treatment of lipid disorders. CRESTORhas now received regulatory approvals in more than 90 countries. Morethan 11 million patients have been prescribed CRESTOR worldwide. Datafrom clinical trials(1) and marketed use(2),(3) show that the safetyprofile for CRESTOR is in line with other marketed statins.

CRESTOR should be used according to the prescribing information,which contains recommendations for initiating and titrating therapyaccording to individual patient profiles. In most countries, theusual recommended starting dose of CRESTOR is 10mg

About AstraZeneca

AstraZeneca is a major international healthcare business engagedin the research, development, manufacture and marketing ofprescription pharmaceuticals and the supply of healthcare services.It is one of the world's leading pharmaceutical companies withhealthcare sales of USD26.47 billion and leading positions in salesof gastrointestinal, cardiovascular, neuroscience, respiratory,oncology and infection products. AstraZeneca is listed in the DowJones Sustainability Index (Global) as well as the FTSE4 Good Index.For more information about AstraZeneca, please visit:http://www.astrazeneca.com

This press release has been made available on worldwide presscommunication media for the benefit of correspondents writing for themedical professional press. Differing national legislation, codes ofpractice, medical practice etc mean that you should contact yourlocal AZ press office to obtain information designed for use in yourcountry. In particular this press release has not been prepared foruse in the USA.

For further information please visit:http://www.AstraZenecaPressOffice.com

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(1) Shepherd J, Vidt DG et al. Safety of rosuvastatin: update on16,876 rosuvastatin-treated patients in a multinational clinicaltrial program. Cardiology 2007 107:433-43

(2) McAfee AT, Ming EE, Seeger JD et al. The comparative safety ofrosuvastatin: a retrospective matched cohort study in over 48,000initiators of statin therapy. Pharmacoepidemiol Drug Saf. 200615:444-53

(3) Goettsch WG, Heintjes EM, Kastelein JJ et al. Results from arosuvastatin historical cohort study in more than 45,000 Dutch statinusers, a PHARMO study. Pharmacoepidemiol Drug Saf. 2006 15:435-43.

ots Originaltext: AstraZenecaIm Internet recherchierbar: http://www.presseportal.de

Contact:For further information please contact: Ben Strutt, Global PR Manager, Cardiovascular Therapy Area, AstraZeneca, Tel: +44(0)1625-230076, Mob: +44(0)7919-565990, Email: ben.strutt@astrazeneca.com.

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