The primary endpoint of the TNT study was the time to first major cardiovascular event, including death from heart disease, non-fatal heart attack, resuscitated cardiac arrest, and fatal or non-fatal stroke. The new analysis studied 2,656 patients with moderate to severe chronic kidney disease, as defined using a standard measure of kidney function. Both doses were well tolerated.(1)
"These findings show that more aggressive treatment with atorvastatin in patients with kidney disease can help reduce the risk of heart attack and stroke" said Professor James Shepherd, a member of the TNT steering committee and clinical academic consultant, department of pathological biochemistry, University of Glasgow Medical School.
An estimated six million people in the UK (2) and 50 million people worldwide(3) have chronic kidney disease. Chronic kidney disease recently has been recognized as an important risk factor for cardiovascular disease,(4) the leading cause of death and illness in patients with kidney disease.(5) People with chronic kidney disease are more likely to die from heart disease than to develop kidney failure.(5)
Cardiovascular disease, (CVD) which includes heart attacks and strokes, is the number one killer(6) and leading cause of disabilities in the UK.(7) More than one in three people in the UK die from CVD.(6) Every year, 268,000 people in the UK have a heart attack (8) leading to about one in five deaths among men and one in six among women. (6)
This analysis demonstrates the significant benefits in terms of CV event risk reduction resulting from intensive lipid lowering treatment with atorvastatin in this high risk patient population.
###
Notes:
It is estimated that around one in ten people in the UK have chronic kidney disease (CKD). People with CKD are more likely to die from heart disease than develop kidney failure
Patients with heart disease and CKD treated intensively with Lipitor (atorvastatin) 80 mg reduced their relative risk of heart attacks and stroke by 40% compared with patients taking low-dose atorvastatin (10mg)
The absolute risk reduction was substantial at 5.6%, yielding a number needed to treat of 18 to prevent one major cardiovascular event over 4.9 years
About the TNT Renal Study
The TNT study was a landmark investigator-led trial coordinated by an independent steering committee and funded by Pfizer. It was the largest study to date evaluating the efficacy and safety of atorvastatin 80 mg. A total of 10,001 patients with coronary disease and LDL-C levels of < 3.4mmol/L were randomised to double-blind therapy with either atorvastatin 10 mg or 80 mg following 8 weeks open-label therapy with atorvastatin 10 mg. They were followed up for an average of 4.9 years.
Two serum creatinine based estimates of glomerular filtration rate (eGFR) were used to determine the renal function of the trial participants: the Modification of Diet in Renal Disease (MDRD) and the Cockroft-Gault (CG) equation. Baseline renal data were available for 8233 patients (4114 on atorvastatin 10 mg and 4119 on atorvastatin 80 mg). Patients with CKD were defined as having a baseline eGFR < 60 mL/min/1.73 m2.
There were 2,656 patients with CKD defined using the MDRD estimate of renal function. A major cardiovascular event occurred in 14.8% of patients on atorvastatin 10mg compared with 9.2% on atorvastatin 80mg. This represented a relative risk reduction of 40% (HR 0.60, 95% CI 0.48-0.76).
The absolute risk reduction in patients with CKD was substantial at 5.6%, yielding a number needed to treat of 18 to prevent one major cardiovascular event over 4.9 years.
Similar event reductions were obtained using the Cockroft-Gault estimate of renal function.
About Chronic Kidney Disease (CKD)
Patients with CKD do not effectively filter toxins from the blood. When CKD progresses to kidney failure, either dialysis or a kidney transplant is needed. The two main causes of CKD are diabetes and high blood pressure which are responsible for up to two thirds of diagnosed cases. Other conditions that commonly affect the kidneys are genetic diseases, autoimmune diseases and repeated urinary infections. CKD has been recognised as an important risk factor for heart disease - the leading cause of death and illness in kidney disease patients.
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 and one of the world's largest marketers of consumer healthcare products.
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.
About Lipitor ® (atorvastatin)
Atorvastatin is a prescription only medicine licensed for hypercholesterolemia 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, Atorvastatin Landmarks, 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 121 million patient-years of experience.
References
1. Shepherd, J et al. Intensive Lipid Lowering With Atorvastatin is Associated With Significant Cardiovascular Benefits in Patients With and Without Chronic Kidney Disease: The Treating to New Targets (TNT) Study presentation at the Annual Scientific Sessions of the American Heart Association in Chicago on November 15, 2006 (Abstract 3731)
2. Kidney Research UK. Stages of Kidney Disease. Available online at URL: http://www.kidneyresearchuk.org/content/view/255/320/. Last accessed November 17, 2006
3. Dirks, J.H et al. International Society of Nephrology Commission for the Global Advancement of Nephrology Study Group. 2005. Prevention of chronic kidney and vascular disease: toward global health equity--the Bellagio 2004 Declaration.Kidney International Supplement. (98) S1-6.
4. Tonelli M, Pfeffer MA. Kidney Disease and Cardiovascular Risk. Annu Rev Med. 2006 Nov 2. [Epub ahead of print]
5.
6. British Heart Foundation Statistics Database. Available online at URL: http://www.heartstats.org Last accessed November 17, 2006
7. The Stroke Association. What is a stroke? Available online at URL:
8. Healthcare Commission. Getting to the heart of it. Coronary heart disease in England: A review of progress towards national standards.
For further information please go to:
Pfizer And Lipitor