Analysis Suggests That Improvements In Kidney Function In Patients Treated With Lipitor Strongly Correlate With A Reduced Risk Of Cardiovascular Event

Main Category: Statins
Also Included In: Urology / Nephrology;  Cardiovascular / Cardiology
Article Date: 19 Nov 2008 - 2:00 PST

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Improvements in kidney function in patients treated with LIPITOR*® (atorvastatin calcium) were shown to strongly correlate with a reduced risk of major cardiovascular events in patients with pre-existing cardiovascular disease, according to a post hoc sub-analysis of the five-year Treating to New Targets (TNT) study presented on 12 November, 2008 at the Annual Scientific Sessions of the American Heart Association.

"This is important for patients, since studies have shown that people with high cholesterol have a more rapid decrease in kidney function over time and that chronic kidney disease is more frequent in patients with cardiovascular disease" said Dr James Shepherd, clinical academic consultant, department of pathological biochemistry, University of Glasgow Medical School, and lead investigator of the analysis.

In this new post hoc analysis, kidney function was assessed using estimated glomerular filtration rate (eGFR), as recommended by the American National Kidney Foundation. Increases in eGFR indicate improved kidney function.

LIPITOR*® has previously been shown to provide dose-dependent increases in eGFR in heart disease patients. Findings from this new analysis showed that in patients with heart disease treated with LIPITOR*®, for each 1 mL/min/1.73 m2 increase in eGFR there was a 2.7 percent relative reduction in risk of major cardiovascular events. Similar risk reductions per 1 mL/min/1.73 m2 increase in eGFR were observed for secondary endpoints such as major coronary events, nonfatal heart attack and fatal or nonfatal stroke.

Throughout the TNT study, both doses of Lipitor (10 and 80 mg) were generally well-tolerated.

About the TNT Study

The TNT study was an investigator-led trial coordinated by an independent steering committee and funded by Pfizer. The study enrolled 10,001 men and women with clinically evident coronary heart disease aged 35 years to 75 years in 14 countries and followed them for an average of five years. Patients were randomly assigned to double-blind therapy with 10 or 80 mg/day LIPITOR*® (atorvastatin). Primary study results were published in The New England Journal of Medicine in 2005.

The primary endpoint of the original TNT study was the occurrence of a first major cardiovascular event, defined as death from heart disease, non-fatal heart attacks, resuscitated cardiac arrest, or fatal or non-fatal strokes.

Important Information for Australian Doctors

LIPITOR*® (atorvastatin) is indicated as an adjunct to diet for the treatment of patients with hypercholesterolaemia. Also indicated in hypertensive patients with multiple risk factors for CHD to reduce the risk of non-fatal myocardial infarction and non-fatal stroke.

Before prescribing please review full Product Information available from Pfizer Australia Pty Ltd (ABN 50 008 422 348) 38-42 Wharf Road, WEST RYDE NSW 2114.

Minimum Product Information: LIPITOR*® (atorvastatin) 10mg, 20mg, 40mg and 80mg Tablets.

Contraindications: Hypersensitivity to the active substance or to any of the excipients, active liver disease or unexplained persistent elevations of serum transaminases; pregnancy and lactation. Women of child-bearing potential.

Precautions: Liver Dysfunction: liver tests should be performed before initiation of treatment and periodically thereafter; patients who consume substantial quantities of alcohol and/or have a history of liver disease; myopathy (monitor cpk); risk factors predisposing to development of renal failure secondary to rhabdomyolysis; †history of haemorrhagic stroke or lacunar infarct; use of concomitant medications that may reduce activity/levels of steroid hormones (ketoconazole, spironolactone and cimetidine); interactions with other medicines: inhibitors of cytochrome P450 3A4, other HMG-CoA reductase inhibitors, antacid, colestipol, †OATP1B1 transporter inhibitors, e.g. cyclosporin, erythromycin/ clarithromycin, protease inhibitors, †diltiazem hydrochloride, †itraconazole, †grapefruit juice, digoxin, oral contraceptives.

Adverse Reactions: For complete list see full Product Information. Headache, asthenia, abdominal pain, dyspepsia, nausea, flatulence, constipation, diarrhoea, insomnia, myalgia.

Dosage: 10-80mg/day as a single daily dose.

Presentation: 10mg, 20mg, 40mg and 80mg Tablets in foil blister packs of 30. Based on full Product Information approved on 11 July 2008.

†Please note changes to Product Information.

LIPITOR*® Reg Trademark Pfizer Inc. Pfizer Medical Affairs: 1800 675 229. H&T PZR0012.

For additional product information, visit http://www.Pfizer.com.au

About Pfizer Australia

Pfizer Australia is the nation's leading research-based health care company, investing over $A50m in local research and development annually. It develops, manufactures and markets innovative medicines for both humans and animals. For more information visit http://www.pfizeraustralia.com.au

Source
Amy O'Hara
Media Communications Assistant
Public Affairs & Policy
Pfizer Australia
http://www.pfizeraustralia.com.au