Healthcare Industry News:  rosuvastatin 

Biopharmaceuticals Cardiology

 News Release - September 6, 2006

New EXPLORER Results Show Patients Achieved Dramatic Reductions in C-Reactive Protein And LDL-C Levels With CRESTOR Combination Therapy

LONDON--(HSMN NewsFeed)--Sept. 6, 2006--A combination treatment regimen of CRESTOR(TM) (rosuvastatin) 40 mg and ezetimibe 10 mg demonstrated a 46% reduction in levels of C-reactive protein (CRP), a marker of inflammation and risk factor for cardiovascular disease, in high-risk patients. In just six weeks, the combination regimen also helped more than half (58%) of patients achieve dual CRP/LDL-C goals.(1) These post-hoc analysis findings from the EXPLORER(a) study will be presented for the first time this week at the World Congress of Cardiology in Barcelona. Previous EXPLORER results released at ISA in June showed high-risk patients achieved an unprecedented 70% reduction in LDL-C using CRESTOR combination therapy.(2)

"Physicians have long relied on blood cholesterol as a key indicator of cardiovascular risk, but recent research suggests that adding a CRP goal to existing LDL-C targets could potentially further reduce the risk of cardiovascular outcomes," said lead investigator Professor Christie Ballantyne, director of the Center for Cardiovascular Disease Prevention at the Methodist DeBakey Heart Center and professor at Baylor College of Medicine, Houston, USA. "Although additional studies are still needed, EXPLORER suggests that a treatment regimen using CRESTOR and ezetimibe can help patients not only to achieve optimal cholesterol targets, but also to significantly reduce their levels of CRP."

Previous clinical trials have demonstrated limited success in achieving dual CRP/LDL-C goals(3), particularly for high-risk patients in whom target levels are CRP <2 mg/L combined with LDL-C <100 mg/dL or LDL-C <70 mg/dL (depending on risk category). The significant reductions in both markers seen in the EXPLORER study provide a new opportunity for high-risk patients to potentially reduce their cardiovascular risks with combination therapy.

Inflammation of the blood vessels and arteries can lead to serious complications such as heart attack and stroke(4), and high levels of CRP can predict these risks years before they actually occur. The first outcomes study to examine the effect of statins on cardiovascular morbidity and mortality among individuals with normal to low cholesterol levels and elevated CRP is currently under way. The objective of the study, known as JUPITER (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating rosuvastatin), is to determine whether long-term treatment with CRESTOR will reduce the risk for cardiovascular events in this patient population. CRESTOR already has been shown to be the most effective statin at reducing LDL-C,(5-24) enabling most patients with high cholesterol to successfully achieve their guideline LDL-C goal.

Key findings from EXPLORER:(1,25)
  • Significantly more patients (58% vs. 24%) achieved dual LDL-C/CRP goals of LDL-C <100 mg/dL or <70 mg/dL (depending on risk category) and CRP <2 mg/L at six weeks with CRESTOR 40mg and ezetimibe 10mg compared with CRESTOR monotherapy.
  • CRESTOR and ezetimibe reduced CRP levels by 46% compared with just 29% with CRESTOR monotherapy.
  • CRESTOR and ezetimibe also reduced mean LDL-C by an unprecedented 70%.
  • Significantly (p<0.001) more patients achieved their NCEP ATP III LDL-C goal of <100 mg/dL (94% vs 79%) and their European LDL-C goal (94% vs. 74%) at six weeks with CRESTOR and ezetimibe compared with CRESTOR monotherapy.
  • 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 CRESTOR efficacy data from its extensive GALAXY clinical trials 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.

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

Notes to Editors:

EXPLORER 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.

References:

(a) EXPLORER (Examination of Potential Lipid modifying effects Of rosuvastatin in combination with Ezetimibe versus rosuvastatin alone) 1. Ballantyne C, Sosef F, Duffield E. rosuvastatin Plus Ezetimibe for Achievement of Low-Density Lipoprotein Cholesterol and C-Reactive Protein Goals: Results From the EXPLORER Study. Poster presented at: World Congress of Cardiology; 6 September, 2006; Barcelona, Spain.

2. Ballantyne C, Sosef F, Duffield E. Efficacy and Safety of rosuvastatin Plus Ezetimibe in High-Risk Patients: Results from the EXPLORER Study. Paper presented at: International Symposium on Atherosclerosis; 22 June, 2006; Rome, Italy.

3. Ridker PM et. al. for the Pravastatin or Atorvastatin Evaluation and Infection Therapy - Thrombolysis in Myocardial Infarction 22 (PROVE IT-TIMI 22) Investigators. C-Reactive Protein Levels and Outcomes after Statin Therapy. N Engl J Med 2005;352:20-8.

4. American Heart Association. "Atherosclerosis." 2004. Available: http://www.americanheart.org/presenter.jhtml?identifier=4440

5. Jones PH , Davidson MH, Stein EA et al. Am J Cardiol 2003;92:152-160.

6. Schuster H, Barter P, Stender S et al. Am Heart J 2004;147:705-712.

7. Blasetto JW, Stein EA, Brown WV et al. Am J Cardiol 2003;91(Suppl):3C-10C.

8. Berne C, Siewart-Delle A. Cardiovascular Diabetology 2005; 4:7

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19. Wolffenbuttel B, Franken A, Vincent H et al. J Int Med 2005;257:531-539.

20. Paoletti R, Fahmy M, Mahla G et al. J Cardiovasc Risk 2001;8:383-390.

21. Brown W, Bays HE, Hassman DR et al. Am Heart J 2002;144:1036-1043.

22. Stein E, Strutt KL, Miller E, Southworth H. Am J Cardiol 2003;92:1287-1293.

23. Schneck DW, Knopp RH, Ballantyne CM et al. Am J Cardiol 2003;91:33-41.

24. Leiter LA, Palmer M, Kallend D et al. Atheroscler Suppl 2005;6(1):113 Abs W16-P-051.

25. Ballantyne C, Sosef F, Duffield E. Efficacy and Safety of rosuvastatin Plus Ezetimibe in High-Risk Patients: Results from the EXPLORER Study. Atherosclerosis Supplements 2006;7(3):552 Abs Th-P16:270.


Source: AstraZeneca

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