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

2007-10-23 00:38 541

LONDON, Oct. 23 /Xinhua-PRNewswire/ -- Data from two observational studies of over 470,000 patients taking statins in routine clinical practice investigating the incidence of cardiovascular events in patients taking CRESTOR(TM) (rosuvastatin) and other statins were presented today at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 10th Annual European Congress in Dublin.

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

"These pharmacoepidemiological studies add to the extensive knowledge we have gathered through the CRESTOR clinical trials program, which continues to show that CRESTOR offers outstanding effects on lowering LDL-C with the additional benefit of raising HDL-C," said Elisabeth Bjork, CRESTOR Medical Science Director at AstraZeneca.

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

In this study, the incidence of hospitalisation for cardiovascular events was significantly lower (28%, RR 0.72 (95 percent CI 0.56-0.94)) in patients taking CRESTOR compared with those taking other statins (simvastatin, atorvastatin, or pravastatin). Mean statin doses were CRESTOR 11mg, atorvastatin 17mg, simvastatin 22mg, and pravastatin 34mg. When individually compared to other statin groups, 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)) not


The second study conducted in the US, assessed real world effectiveness of statins by comparing the incidence of fatal and non-fatal cardiovascular events (hospital cardiovascular death, heart attack, unstable angina, coronary revascularization, stroke, and carotid revascularization) in users of CRESTOR versus users of other statins. 395,039 statin-naive patients from the Thomson Healthcare's MarketScan research database were followed for up to two years and four months, with a median duration of therapy of 100 days. Mean dose of CRESTOR was 11 mg and was lower than the other statins.

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

CRESTOR is indicated for the treatment of lipid disorders. CRESTOR has now received regulatory approvals in more than 90 countries. More than 11 million patients have been prescribed CRESTOR worldwide. Data from clinical trials(1) and marketed use(2),(3) show that the safety profile 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 therapy according to individual patient profiles. In most countries, the usual recommended starting dose of CRESTOR is 10mg.

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of USD26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4 Good Index. For more information about AstraZeneca, please visit:

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(1) Shepherd J, Vidt DG et al. Safety of rosuvastatin: update on 16,876 rosuvastatin-treated patients in a multinational clinical trial program. Cardiology 2007 107:433-43

(2) McAfee AT, Ming EE, Seeger JD et al. The comparative safety of rosuvastatin: a retrospective matched cohort study in over 48,000 initiators of statin therapy. Pharmacoepidemiol Drug Saf. 2006 15:444-53

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

Source: AstraZeneca