10th Aug 2006 07:00
Pfizer's Lipitor Shown to Reduce the Chance of Additional Strokes in Stroke Patients - Stroke Patients With Mildly Elevated Cholesterol Levels Who Took Lipitor Reduced Their Risk of Additional Strokes by 16 Percent - Lipitor Patients Also Had a 35 Percent Reduction in Risk of Major Coronary Events Such as Heart Attack - Investigator: 'This is Important Information for Physicians Because Patients Who Have Had a Stroke Are At Much Greater Risk for Suffering Another One, Yet Treatment Options to Reduce Their Risk Are Limited.' NEW YORK, Aug. 10 -- Patients taking Lipitor(R)(atorvastatin calcium) Tablets (80 mg) who had a prior stroke reduced their chances of having an additional stroke and major coronary event such as heart attack, according to results from the first major study designed to examine the benefits of lipid lowering in stroke patients. The landmark Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial was published today in The New England Journal of Medicine. Up to one in five Americans who survive a first stroke will have another strokewithin five years, according to data from the National Stroke Association.Patients entered the SPARCL trial with a history of stroke or transientischemic attack (TIA or mini-stroke) within the previous six months, onlymildly elevated cholesterol levels and no history of heart disease. In thetrial, Lipitor was shown to reduce the risk of an additional stroke by 16percent and major coronary events such as heart attack, cardiac death orresuscitated cardiac arrest, by 35 percent compared to placebo. "This is important information for physicians because patients who have had astroke are at much greater risk for suffering another one, yet treatmentoptions to reduce their risk are limited," said Dr. Michael Welch, SPARCLinvestigator, neurologist and president of Rosalind Franklin University ofMedicine & Science. "Patients taking Lipitor in this trial showed a significantreduction in stroke and coronary events. This is impressive when you considerthat a majority of patients in the trial were already being treated withmedications such as blood thinning and blood pressure lowering medications thatare often given to reduce stroke risk." Every year, an estimated 15 million people worldwide suffer strokes. In theU.S. alone, there are nearly five million stroke survivors, touching four outof five American families. Stroke survivors often must cope with longrehabilitation to learn to manage paralysis, difficulties understanding orforming speech or problems with awareness and thinking. The lifetime cost oftreating one patient with a stroke can amount to more than $3 million. "Stroke is a fatal or debilitating condition that has significant impact onpatients and their families, and reducing that risk is a key priority incardiovascular medicine," said Dr. John LaRosa, president and professor ofmedicine, SUNY Downstate Medical Center. "These results underscore thepotential benefit of intensive Lipitor therapy for stroke patients who may beat high risk for an additional stroke even in the absence of previous heartdisease." Strokes are generally categorized into two types, ischemic and hemorrhagic.Ischemic stroke (when the blood supply to a part of the brain is suddenlyblocked) is the more common type, accounting for 88 percent of all strokes inthe U.S., according to the American Heart Association. Hemorrhagic strokes(which occur when a blood vessel in the brain leaks or bursts) are less commonand account for approximately 12 percent of all strokes. An analysis of the SPARCL data was designed and conducted after the study endedto explore the types of strokes, ischemic or hemorrhagic, that occurred amongpatients in the study. The vast majority of strokes in this trial were ischemicwhile the number who experienced hemorrhagic was very small. Patients takingLipitor experienced a 22 percent reduction in the risk of ischemic stroke.There were more patients in the Lipitor group who experienced hemorrhagicstroke (2.3 percent) compared to patients taking placebo (1.4 percent). Therewas no difference in the number of deaths from hemorrhagic stroke between thetwo treatment groups. A review of the Lipitor clinical program, involving morethan 10,000 patients with coronary heart disease taking Lipitor 80 mg, showsthe incidence of hemorrhagic stroke was very low (0.3 percent). "Previous clinical trials have demonstrated that Lipitor can reduce the chancesof a first stroke," said Dr. Joseph Feczko, Pfizer's chief medical officer."The new SPARCL data provide physicians and patients with one more reason toconsider the benefits of Lipitor. SPARCL is another example of thegroundbreaking research being supported by Pfizer to identify potentialimprovements in patient care." SPARCL is an investigator-led trial that is being coordinated by an independentsteering committee and funded by Pfizer. In SPARCL, 4,731 patients who had no history of heart disease and hadexperienced a stroke or TIA within six months prior to trial enrollment werefollowed for an average of about five years. Patients had mildly elevatedcholesterol levels, and were treated with either Lipitor (80 mg) or placebo.Before the trial results were known, the investigators leading the trialdecided to analyze the results taking into account baseline characteristics,such as age and gender. Epidemiologic data has shown, for example, that therisk of stroke significantly increases with age. In SPARCL, Lipitor was well-tolerated. The rate of side effects such aselevated liver enzymes, muscle weakness or rhabdomyolysis were low andconsistent with the known safety profile. Important Information Lipitor is the most prescribed cholesterol-lowering therapy in the world, withnearly 121 million patient-years of experience. Lipitor is supported by anextensive clinical trial program involving more than 400 ongoing and completedtrials with more than 80,000 patients. Lipitor is a prescription medication. It is used in patients with multiple riskfactors for heart disease such as family history, high blood pressure, age,elevated LDL ("bad" cholesterol), low HDL ("good" cholesterol) or smoking toreduce the risk of heart attack and stroke. When diet and exercise alone arenot enough, Lipitor is used along with a low-fat diet and exercise to lowercholesterol. Lipitor is also used in patients with type 2 diabetes and at least one otherrisk factor for heart disease such as high blood pressure, smoking orcomplications of diabetes, including eye disease and protein in urine, toreduce the risk of heart attack and stroke. Lipitor is not for everyone. It is not for those with liver problems. And it isnot for women who are nursing, pregnant or may become pregnant. Patients taking Lipitor should tell their doctors if they feel any new musclepain or weakness. This could be a sign of rare but serious muscle side effects.Patients should tell their doctors about all medications they take. This mayhelp avoid serious drug interactions. Doctors should do blood tests to checkliver function before and during treatment and may adjust the dose. The mostcommon side effects are gas, constipation, stomach pain and heartburn. Theytend to be mild and often go away. For additional product information, visit http://www.Lipitor.com. SOURCE Pfizer Inc 08/10/2006 /CONTACT: Shreya Prudlo, +1-212-773-4889, for Pfizer/ /Company News On-Call: Pfizer's press releases are available through PRNewswire's Company News On-Call service on PRN's Web Site. Visit http://www.prnewswire.com/comp/688250.html / /Photo: A free corporate logo to accompany this story is available immediatelyvia Wieck Photo Database to any media with telephoto receiveror electronic darkroom, PC or Macintosh, that can accept overheadtransmissions. To retrieve a logo, please call 972-392-0888/ /Company News On-Call: http://www.prnewswire.com/comp/688250.html / /Web site: http://www.pfizer.com http://www.Lipitor.com / (PFE) ENDPFIZER INCRelated Shares:
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