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Issue 108 Item 5 Crestor New and Improved Statin Gets FDA Approval

ESC: Crestor (Rosuvastatin) Superior Impact On Lipid Levels Confirmed. 98 percent of Crestor patients achieved their goals. AstraZeneca confirmed that it received an approvable letter from the Food and Drug Administration for its next potential blockbuster, Crestor (rosuvastatin), a cholesterol drug. Crestor is considered to be a potential competitor to statins such as Pfizer’s Lipitor (atorvastatin calcium) and Merck’s Zocor (simvastatin).

The first long-term Phase III Crestor (rosuvastatin) data presented at the 23rd annual congress of the European Society of Cardiology today reinforced its record of superior impact on lipid levels and greater ability to achieve patients’ cholesterol targets than other currently available and widely prescribed statins (atorvastatin, pravastatin and simvastatin).1,2

The data presented come from two comparator ‘titration to guideline’ 52 week studies which involved over 800 hypercholesterolemic patients. After 12 weeks initial treatment, the dosages of Crestor (5mg and 10mg) and the comparator statins (atorvastatin 10mg, pravastatin 20mg and simvastatin 20mg) were titrated up as necessary to reach LDL-C goal.

In these 52 week studies, Crestor produced significantly superior reductions in LDL-C (a major marker for the development of cardiovascular disease) compared with either atorvastatin, simvastatin or pravastatin.1,2 For those patients who started on a 10mg dose, the average reduction in LDL-C demonstrated by Crestor was 53 percent, whereas atorvastatin yielded a 44 percent reduction1. In comparison with simvastatin and pravastatin, again taking those Crestor patients who started on 10mg, the LDL-C reductions were 48 percent on Crestor, and 32 percent and 38 percent on pravastatin and simvastatin respectively.2 These data support the findings seen in similar studies with Crestor conducted over 12 weeks. 6,7

The NCEP (National Cholesterol Education Program) ATPII guidelines provide guidance to prescribers in their treatment of people with cholesterol disorders and cardiovascular disease.3 In the 52 week ‘titration to guidelines’ studies presented today, the data demonstrated that Crestor brought LDL-C levels in all categories of patients included in these studies (including high-risk patients with clinically evident coronary heart disease, peripheral vascular disease or diabetes), down to the LDL-C goals recommended by NCEP.1,2 Using doses from 10mg going up to 80mg if needed to achieve NCEP ATPII LDL-C goals, 98 percent of Crestor patients achieved this goal, compared to 87 percent of patients receiving atorvastatin; furthermore 82 percent of the Crestor patients achieved goal on 10mg without the need for titration, compared with 59 percent of patients on atorvastatin. 1,9

Crestor also showed a superior impact on LDL-C and ability to get patients to goal than either pravastatin or simvastatin 2. Using doses from 10mg up to 80mg if needed, 88 percent of Crestor patients achieved NCEP ATP-II LDL-C goal, whereas 60 percent of pravastatin patients and 73 percent of simvastatin patients achieved their NCEP goal. In addition, 79 percent of the Crestor patients achieved goal on 10mg without the need for titration, compared with 31 percent and 50 percent of patients on pravastatin and simvastatin respectively.2,9

In conclusion, more patients on Crestor remained on their first dose for the duration of the studies, without the need for dose titration to achieve LDL-C goal, compared with those patients on atorvastatin, pravastatin and simvastatin.1,2,9

"Research shows that most patients on currently available lipid-lowering therapies and life-style modifications do not reach internationally recognized targets and therefore are at risk of cardiovascular disease.4 These studies, which clearly show that rosuvastatin has the ability to improve LDL-C and therefore get more patients to their LDL-C goal, are of great importance to the prescribing and patient community. Clinical trials to date, show that rosuvastatin has the potential to be a reliable choice in the treatment of hypercholesterolemia" said Professor Anders Olsson, Professor of Internal Medicine, Linköping University Hospital, Sweden and Principal Investigator for the atorvastatin comparative study.

During these studies, all treatments were well tolerated and there were no obvious differences or trends noted in the side-effect profiles of Crestor, atorvastatin, pravastatin and simvastatin.1,2 The most commonly reported side-effects were gastrointestinal and upper respiratory symptoms and headache, which are all typical of adverse events which are seen occasionally with statin therapy.1,2 These newly announced Phase III 52 week studies confirm the excellent efficacy and tolerability seen in the Phase III 12 week studies. 6,7

References:

1. Olsson AG et al: Long-term efficacy and safety of rosuvastatin: results of a 52 week comparator-controlled trial versus atorvastatin. 23rd Annual Session of the European Society of Cardiology (ESC), September 2001.

2. Brown WV et al: Long-term efficacy and safety of rosuvastatin: results of a 52 week comparator-controlled trial versus pravastatin and simvastatin. 23rd Annual Session of the European Society of Cardiology (ESC), September 2001

3. Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. The Expert Panel. Arch Intern Med 1988;148:36-69

4. Pearson TA et al (2000). The Lipid Treatment Assessment Project (L-TAP). Archives of Internal Medicine 2000; 160: 459-467.

5. Hunninghake DB et al: Rosuvastatin markedly improved the atherogenic lipid profile in hypertriglyceridemic patient., 23rd Annual Session of the European Society of Cardiology (ESC), September 2001

6. Davidson M et al. ZD4522 is superior to atorvastatin in decreasing low density lipoprotein cholesterol and increasing high density lipoprotein cholesterol in patients with type IIa or IIb hypercholesterolemia. 50th Annual Scientific Session of the American College of Cardiology (ACC), March 2001.

7. Paoletti R et al. ZD4522 is superior to pravastatin and simvastatin in reducing low-density lipoprotein cholesterol, enabling more hypercholesterolemic patients to achieve target low-density lipoprotein cholesterol guidelines. 50th Annual Scientific Session of the American College of Cardiology (ACC), March 2001.

8. IMS WinEl, AZ World, Qtly MATS, Actual Rox

9. Data on file, AstraZeneca