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Biggest LDL-C Reduction Ever Shown in Patients Is Achieved With Rosuvastatin/Ezetimibe Combination

New study results offer hope as an important treatment option for difficult-to-treat patients

LONDON, UK -- July 20, 2006 -- A combination treatment regimen of Crestor(TM) (rosuvastatin) 40 mg and ezetimibe 10 mg achieved an unprecedented 70% reduction in LDL-C which is the largest reduction in LDL-C ever seen in a statin clinical trial.

In just six weeks, this combination treatment also helped more high-risk patients (94%) -- whose LDL-C needs to be reduced to less than 100mg/dL-- achieve their guideline LDL-C goals than those treated with Crestor alone (79% ) (P <.001).

These results from the EXPLORER study will be presented for the first time this week at the International Symposium on Atherosclerosis.

"Cardiologists have long recognised the challenge in helping patients with dangerously high cholesterol levels – and especially the high risk patient with high cholesterol – reach their target lipid levels," said the lead investigator, Professor Christie Ballantyne, Baylor College of Medicine, Houston, USA. "Several studies have already demonstrated that rosuvastatin, as a statin monotherapy, is highly effective at lowering elevated cholesterol levels. EXPLORER now shows that a treatment regimen using rosuvastatin as a base and adding-on ezetimibe can help even the difficult-to-treat patient population achieve optimal cholesterol targets."

Crestor has consistently been shown to be the most effective statin at reducing LDL-C, enabling most patients with high cholesterol to successfully achieve their guideline LDL-C goal. However, combination therapy provides a treatment option for a small group of patients, particularly high-risk patients, with very high LDL-C who are unable to achieve their guideline LDL C goals on the maximum statin dose and therefore remain at a high-risk of a heart attack.

Providing a further treatment option is particularly important given the more recent lower guideline LDL-C goals that have been set for these patients. In EXPLORER, patients' LDL-C was between 160 and 250 mg/dL (average baseline LDL-C was approximately 190mg/dL) and they had not reached their cholesterol goals with statin monotherapy.

Key findings from EXPLORER:
· At six weeks, Crestor and ezetimibe reduced mean LDL-C from 4.9 mmo/L (190 mg/dL) to 1.5 mmol/L (57 mg/dL), representing an unprecedented 70% reduction, compared to Crestor monotherapy, which reduced mean LDL-C from 4.9 mmol/L (190 mg/dL) to 2.1 mmol/L (82 mg/dL), representing a 57% reduction.
· This impressive reduction in LDL-C enabled significantly (P <.001) more patients to achieve their US guidelines' LDL-C goal of <100 mg/dL (94% vs 79%) and also their European LDL-C goal (94% vs 74 percent) at six weeks with Crestor and ezetimibe compared with Crestor monotherapy.
· In addition, both Crestor monotherapy and Crestor combined with ezetimibe produced similar increases in HDL-C ("good" cholesterol) (8.5% vs 10.8%).
· Crestor and ezetimibe were both well tolerated.

The results from EXPLORER add to the outstanding efficacy data for Crestor from its extensive clinical trials programme which together with the findings from a comprehensive pharmacoepidemiology programme, comprising nine studies that investigated the real-life use of statins in more than 100,000 patients in four countries -- Canada, The Netherlands, United Kingdom and United States -- support the favourable benefit:risk profile of Crestor and confirm that its safety profile is similar to other currently available statins.

Crestor is also the only statin to demonstrate the regression of atherosclerosis in a major clinical trial across all endpoints. Results from the ASTEROID study showed for the first time regression of plaque across all endpoints with Crestor, using the cutting edge technology of intravascular ultrasound (IVUS), and is thus a major milestone in statin research. In ASTEROID, Crestor demonstrated plaque regression in the arteries of four out of five patients with an average overall reduction in plaque build-up between seven and nine%.

Several other clinical trials demonstrating the LDL-C lowering benefits of Crestor in various patient populations are all part of AstraZeneca's GALAXY Programme, designed to address important unanswered questions in statin research and to investigate the impact of Crestor on cardiovascular risk reduction and patient outcomes. Currently, more than 51,000 patients have been recruited from 55 countries worldwide to participate in the GALAXY Programme.

Crestor has now received regulatory approvals in more than 75 countries across five continents. Over seven million patients have been prescribed Crestor worldwide and from clinical trials, marketed use, the recently published National Lipid Association safety evaluation and early pharmacoepidemiology data the safety profile is in line with other marketed statins.

The 40 mg dose is the highest registered dose of Crestor. Crestor should be used according to the prescribing information, which contains recommendations for initiating and titrating therapy according to the individual patient profile. In most countries the usual recommended starting dose of Crestor is 5 or 10mg.

EXPLORER
Examination of Potential Lipid modifying effects Of Rosuvastatin in combination with Ezetimibe versus Rosuvastatin alone was a 12-week, randomised trial of 469 patients with LDL-C 160-<250 mg/dL (4.1-<6.5 mmol/L) designed to evaluate whether adding ezetimibe to Crestor would enable more patients with severely high cholesterol to achieve guideline lipid goals compared with Crestor monotherapy. Patients participated in a six-week dietary lead-in followed by six weeks of randomised treatment with rosuvastatin 40 mg alone or in combination with ezetimibe 10 mg.

The LDL-C goals are as defined by the National Cholesterol Education Program Audit Treatment Panel III (NCEP ATP III).


SOURCE: AstraZeneca

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