Monday, pharmaceutical giant Pfizer Inc. (PFE), said that Lipitor or atorvastatin calcium 80 mg significantly reduced the relative risk of a first cardiovascular event by 23% among patients aged 65 and older with established coronary heart disease. Lipitor 80 mg was also indicated to provide significant reductions in the risk of subsequent second, third and fourth cardiovascular events over a period of five years compared to Lipitor 10 mg. The data was presented at the 58th Annual Scientific Sessions of the American College of Cardiology in Orlando, Florida.
Lipitor is a prescription medication that blocks the production of cholesterol or a type of fat in the body. Lipitor reduces low-density lipoprotein or LDL cholesterol and total cholesterol in the blood. The drug is prescribed to patients with multiple risk factors for heart disease such as family history, high blood pressure, age, low HDL or good cholesterol or smoking to reduce the risk of heart attack and stroke, certain kinds of heart surgery and chest pain.
The New York-based company stated that post hoc sub-analysis was designed and completed following the Treating to New Targets or 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 coronary heart disease aged 35 years to 75 years in 14 countries and followed them for an average of five years. 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 attack, resuscitated cardiac arrest, or fatal or non-fatal stroke. The endpoint for this sub-analysis of older patients was any cardiovascular event, defined as death from heart disease, non-fatal heart attack, resuscitated cardiac arrest, revascularization procedure, procedure-related heart attack, chest pain, fatal or non-fatal stroke, peripheral arterial disease or hospitalization due to chronic heart failure. Lipitor 80 mg, however, is not a starting dose.
Most cardiovascular outcomes trials, including the overall TNT trial, evaluate only the time to a patient's first cardiovascular event and thus may underestimate potential longer-term effects of treatment. This sub-analysis evaluated any cardiovascular event during the full duration of the five-year TNT study in 3,809 patients aged 65 and older with stable coronary heart disease.
In this study, Lipitor 80 mg demonstrated several risk reductions compared to Lipitor 10 mg which include a significant 23% relative risk reduction in a first cardiovascular event and a significant 25% relative risk reduction in a subsequent second cardiovascular event. The study also indicated a significant 30% relative risk reduction in a subsequent third cardiovascular event, a significant 33% relative risk reduction in a subsequent fourth cardiovascular event and a 22% relative risk reduction in a subsequent fifth cardiovascular or CV event, which did not reach statistical significance.
Although the original TNT study was not formulated to look at subsequent cardiovascular events beyond the first CV event, these results suggest sustained risk reductions with Lipitor 80 mg compared with Lipitor 10 mg in this patient population. The company noted that throughout the overall TNT study, both doses of Lipitor were generally well tolerated.
Sales of Lipitor, the best selling drug in history, fell 13% to $1.6 billion in the third-quarter of fiscal 2008. Simvastatin, a cholesterol drug, the generic version of Merck's Zocor, is a major competitor to Lipitor.
Pfizer's fourth-quarter net income was $266 million or $0.04 per share, down from $2.72 billion or $0.40 per share in the year-ago quarter. On an adjusted basis, earnings climbed 29% to $4.39 billion or $0.65 per share, up from $3.40 billion or $0.50 per share in the prior year quarter. Quarterly revenue decreased 4% to $12.35 billion from $12.87 billion in the same quarter a year ago. Adjusted revenue was $12.31 billion, down 4% from $12.80 billion last year.
Looking ahead to fiscal 2009, Pfizer had projected earnings in the range of $1.34 - $1.49 per share, higher than last year's earnings of $1.20 per share. Adjusted earnings are expected between $1.85 and $1.95 per share, significantly below last year's $2.42 per share. Annual revenues are estimated between $44 billion and $46 billion, lower than previous year's $48.3 billion. Wall Street analysts currently estimate earnings of $2.49 per share on revenue of $48.81 billion for the year.
Earlier this month, Pfizer completed an offering of $13.5 billion of senior unsecured notes. The offering consisted of $1.25 billion of floating rate notes due 2011, $3.5 billion of 4.45% notes due 2012, $3 billion of 5.35% notes due 2015, $3.25 billion of 6.2% notes due 2019, and $2.5 billion of 7.2% notes due 2039. The company said that it will be using the net offering proceeds for general corporate purposes, including funding a portion to the proposed Wyeth acquisition and the refinancing of existing debt.
Pfizer closed Monday's regular trading at $13.70, down $0.34 or 2.42%, on a volume of 59.49 million shares on the NYSE. In after-hours, the stock gained 2 cents, trading at $13.72.
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