New Analysis Shows Potential For Lipitor To Significantly Reduce The Risk Of Serious Cardiovascular Events Compared To Simvastatin

Main Category: Statins
Also Included In: Cholesterol
Article Date: 09 Mar 2007 - 9:00 PDT

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A retrospective analysis of a U.S. managed care database of 80,909 patients showed that those who took Pfizer's cholesterol-lowering medicine Lipitor® (atorvastatin calcium) had a significant 14 percent reduction in the relative risk of cardiovascular events, including heart attacks and strokes, compared with patients who took simvastatin. The analysis was presented at the American Heart Association's 47th Annual Conference on Cardiovascular Disease Epidemiology and Prevention.1

This study was designed to reflect actual clinical practice with 91% of patients taking Lipitor on 10-20 mg and 84% of patients taking simvastatin on 20-40 mg. To provide a like-for-like comparison the analysis adjusted for expected differences in LDL-C lowering between Lipitor and simvastatin based on the dose used. There was a significant 14 per cent reduction in the relative risk of cardiovascular events in patients taking Lipitor compared with patients taking simvastatin, even after the dose adjustments. 1

Widespread prescribing of generic simvastatin in place of more potent statins has been recommended in the UK to help alleviate some of the financial pressure in the NHS2. The "Better Care, Better Value" initiative sets a benchmark of 69% of patients on generic statins3. The recommendation assumes that this will result in similar cardiovascular benefits. This real world study highlights the potential for poorer cardiovascular outcomes with widespread generic substitution that does not assess patients on a case by case basis.

Dr Jonathan Morrell commented on the analysis: "This analysis reinforces the existing evidence that not all statins are the same and not all patients are suitable to be switched to generics. In the rush to broadly cut costs, the NHS may be ignoring the wider implications of switching patients and putting lives in danger. Each patient should be carefully evaluated before being switched or we may see an increase in CV events among patients who should be on an intensive statin treatment."

In the UK a recent audit on switching from Lipitor to generic simvastatin found that 43% of patients were unsuitable for switch. For the majority, this was due to factors such as inadequate cholesterol control, intolerance to simvastatin or a history of previous simvastatin use that failed to reduce their cholesterol to target.4

The US database analysis is supported by a recent letter to the Lancet describing audit findings from a cardiology unit that treated patients with heart attack or unstable angina with high dose Lipitor in 2005 and moderate dose simvastatin in 2006. Increases in deaths and cardiac readmissions were seen in the cohort of patients taking the less intensive statin regimen and the authors stated that the cost of the additional cardiac readmissions would almost certainly offset the additional costs of high dose statin therapy.5 In addition, a previously published 3,499 patient database study in the Netherlands found that patients taking Lipitor had a significant 30 percent reduction in the relative risk of cardiovascular and cerebrovascular events compared with patients taking other statins combined.6

Key points of the analysis:



-- Patients in the analysis (61,324 taking Lipitor and 19,585 taking simvastatin) had not used statins in the previous six months.



-- The primary endpoint was defined as hospitalisation due to a heart attack, stroke, mini-stroke (transient ischemic attack), chest pain (angina) or coronary artery disease, vascular disease, or certain types of heart surgery.



-- The primary endpoint was assessed after patients had been taking either statin for at least three months.



-- The median observation time was 177 days.



-- To provide a rigorous comparison, the analysis adjusted for differences in expected LDL lowering, prior cardiovascular events and baseline characteristics between the treatment groups.

About Cardiovascular Disease

Cardiovascular disease (CVD) covers any disease of the heart and blood vessels including coronary heart disease and stroke, and is a major cause of death and disability in the UK.7 CVD kills one in three people in the UK8. Important risk factors include obesity, a high blood cholesterol level, high blood pressure and type 2 diabetes.7

About Lipitor ® (atorvastatin)

Lipitor is a prescription only medicine licensed for hypercholesterolaemia and primary prevention of cardiovascular events in patients with type II diabetes with at least one additional risk factor, without clinically evident coronary heart disease, irrespective of whether cholesterol is raised. It has a well-established safety profile. Since the introduction of Lipitor more than nine years ago, its safety and effectiveness have been supported through an extensive clinical trial program, (the Atorvastatin Landmarks Program), with more than 400 ongoing and completed trials involving more than 80,000 patients. Lipitor is the most prescribed cholesterol-lowering therapy in the world, with 115 million patient-years of experience9.

About Pfizer

Pfizer Inc, the world's largest research-based pharmaceutical company, discovers, develops, manufactures and markets prescription medicines in 11 therapeutic areas. Pfizer is also the world's largest animal health company.

Pfizer Inc employs approximately 105,000 colleagues worldwide, all of whom are devoted to working for a healthier world. Pfizer conducts more biomedical research than any other corporation, and has 14,000 professionals working in six major R&D sites worldwide, including Sandwich in Kent. Pfizer's research investment in 2005 was more than $7.4 billion.

In the UK, Pfizer Ltd has its UK business headquarters in Surrey and is the major supplier of medicines to the NHS. pfizer.co.uk

References

1. Willke et al. 47th Annual Conference on Cardiovascular Disease Epidemiology and Prevention in association with the Council on Nutrition, Physical Activity, and Metabolism. Florida, March 2007.

2. NHS could save millions through smarter prescribing of cholesterol-busting drugs. (Department of Health press release online) [28th December 2006]. Available here.

3. Better care, better value. productivity.nhs.uk

4. Usher-Smith, J.A. et al. Evaluation of the cost savings and clinical outcomes of switching patients from atorvastatin to simvastatin and losartan to candesartan in a Primary Care setting. International Journal of Clinical Practice 2007;61:15-23

5. Butler and Wainwright, Lancet 2007; 369:27

6. Dieleman et al, Curr Med Res Opin 2005; 9:1461-8

7. Heart Disease and Stroke (Cardiovascular Disease). (British Nutrition Foundation fact sheet online) Available from nutrition.org.uk/printArticle.asp?dataId=1374, (accessed March 2007)

8. BBC Health - Cardiovascular Disease. Dr Beckie Lang. (BBC fact sheet online) Available from: bbc.co.uk/health/healthy_living/nutrition/dietary_cvd.shtml (accessed March 2007)

9. Lipitor patient years. Data on file: Ato 34