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Biotech / Medical : PFE (Pfizer) How high will it go? -- Ignore unavailable to you. Want to Upgrade?

To: Anthony Wong who wrote (6274)	11/11/1998 6:30:00 PM
From: Anthony Wong	Read Replies (1) \| Respond to of 9523

AHA SCIENTIFIC SESSIONS: Aggressive Cholesterol Lowering With Lipitor Results In Significant Cardiovascular Benefit DALLAS, TX -- Nov. 11, 1998 -- The results of a landmark trial presented here today revealed that patients with stable coronary artery disease (CAD) achieved significant cardiovascular benefit by aggressively reducing low density lipoprotein cholesterol (LDL-C) to levels below 100 mg/dL (2.6 mmol/L). Results from the AVERT (Atorvastatin Versus Revascularization Treatments) trial demonstrated that 87 percent of patients randomised to Parke-Davis' and Pfizer's Lipitor (atorvastatin calcium), who were originally candidates for angioplasty, were able to remain instead on this medical therapy for the duration of the 18-month trial period, without experiencing any cardiovascular events. In addition, patients in the trial who were treated with Lipitor had a 36 percent reduction in the combined incidence of cardiovascular events, such as nonfatal heart attack, bypass surgery, revascularisation and worsening angina, as compared with patients receiving angioplasty followed by usual care. In the trial, 13 percent of patients treated with Lipitor suffered a cardiovascular event compared with 21 percent of patients receiving angioplasty and usual care. These results were clinically important and trended toward statistical significance. The trial also demonstrated that patients treated with Lipitor had a significant delay in the time to their first ischemic event, compared with patients who received angioplasty followed by usual medical care. In the angioplasty group, usual care resulted in one-third of patients receiving stents and 71 percent of patients receiving statin therapy. These data were announced for the first time today at the 71st American Heart Association scientific sessions. "These data showed that we should be far more aggressive in our lipid-lowering goals and we should be doing a better job of getting our patients to or below current U.S. guidelines. We really want to get people with stable coronary artery disease and elevated LDLs to below 100 mg/dL [2.6 mmol/L]," said Bertram Pitt, M.D., professor of internal medicine at the University of Michigan School of Medicine, Ann Arbor and chairman of the advisory and safety committee overseeing the AVERT trial. "Here we got patients to below 80. While further research is needed in this area, certainly aggressive lipid lowering and getting patients to below 100 mg/dL [2.6 mmol/L] is something that we haven't done as well as we should be doing." The cardiovascular benefits demonstrated by AVERT were achieved by aggressively lowering LDL-C with Lipitor 80 mg. For patients with CAD, the U.S. National Cholesterol Education Program recommends that LDL-C levels should be lowered to 100 mg/dL (2.6 mmol/L) or below. Guidelines recently issued jointly by the European Society of Cardiology, the European Atherosclerosis Society and the European Society of Hypertension, recommend a LDL-C level of 115 mg/dL (3.0 mmol/L) or below for CAD patients. Patients treated with Lipitor achieved a mean LDL-C value of 77 mg/dL (2.0 mmol/L), compared with a mean value of 119 mg/dL (3.1 mmol/L) for patients in the angioplasty and usual care group. There was a significant correlation between LDL-C reductions and cardiovascular event rates in favour of Lipitor therapy. Patients treated with Lipitor who achieved reductions in LDL-C values of less than 40 percent experienced significantly fewer ischemic events than those whose LDL-C values decreased by greater than/less than 40 percent. In addition, in the study Lipitor was well tolerated. "This is a big step forward for patients with stable cardiovascular artery disease. I don't think that we doubted the ability of atorvastatin to lower LDL-C dramatically or to achieve the kind of results that we saw here," said David Waters, M.D., chief of the division of cardiology, Hartford Hospital and professor of medicine at the University of Connecticut, a member of the advisory and safety committee. "But we wondered how patients would fare over the 18-month period. AVERT showed us that patients fared quite well." "In general, effective management of patients with stable coronary artery disease should include aggressive lipid lowering, either alone or in combination with angioplasty and usual care," Dr. Pitt said. The 18-month trial included 341 patients from 37 centres in the United States, Canada and Europe, randomised either to 80 mg/day of Lipitor or to angioplasty followed by usual care. At the time of enrolment, patients in the AVERT trial had at least one coronary artery with at least 50 percent narrowing, had no symptoms or mild to moderate chest pain, relatively normal left ventricular function and were candidates for angioplasty. AVERT is the first study ever initiated to determine the role of aggressive lipid-lowering therapy in patients with stable CAD versus revascularisation. Lipitor is indicated as an adjunct to diet to reduce elevated total-C, LDL-C, apo B, and TG levels in patients with primary hypercholesterolemia and mixed dyslipidemia. The recommended starting dose of Lipitor is 10 mg once daily. The dosage range is 10 mg to 80 mg once daily. Lipitor is generally well-tolerated. Adverse reactions usually have been mild and transient, with fewer than two percent of patients being discontinued from clinical trials due to side effects related to Lipitor. This rate of discontinuation was comparable to that of placebo. The most frequent adverse effects of atorvastatin are constipation, flatulence, dyspepsia and abdominal pain. It is recommended that liver function tests be performed prior to and at 12 weeks following both the initiation of therapy and any elevation of dose, and periodically thereafter. Myopathy should be considered in any patient with diffuse myalgias, muscle tenderness or weakness and/or marked elevation of creatine phosphokinase (CPK).

To: Anthony Wong who wrote (6274)	11/11/1998 6:32:00 PM
From: Anthony Wong	Respond to of 9523

AHA SCIENTIFIC SESSIONS: Norvasc Slows Hardening Of Arteries In Some Key Arteries, But Not Others WINSTON-SALEM, NC -- Nov. 11, 1998 -- A large clinical trial on whether a major calcium channel blocker could slow hardening of the arteries and thus reduce heart disease and stroke produced mixed results, a research team reported today at the American Heart Association meeting. The research team -- headed by Curt Furberg, M.D., Ph.D. of Wake Forest and Bertram Pitt, M.D. of the University of Michigan -- reported that Norvasc (amlodipine) had no significant effect in preventing new coronary artery atherosclerosis -- hardening of the arteries -- or on the progression of pre-existing coronary artery atherosclerosis. However, it appeared to slow progression of atherosclerosis in the carotid arteries in the neck. The coronary arteries supply blood to the heart, and a blocked coronary artery can lead to a heart attack. The carotid arteries provide blood to the brain and a blocked carotid can lead to stroke. There was no difference in the overall mortality, in rate of heart attack or stroke, or in major vascular events between patients on amlodipine and those on an inert placebo -- which was consistent with a lack of effect on the coronary arteries, said Robert Byington, Ph.D., associate professor of public health sciences and head of the section on epidemiology at Wake Forest, who headed the study's national data co-ordinating centre. However, Pitt added that Norvasc significantly reduced the incidence of angina pectoris, severe chest pain that results from lack of oxygen to heart muscles. "This reduction in angina is a known symptomatic effect of amlodipine," Furberg said. This reduction in symptoms led to fewer procedures to relieve angina, such as coronary artery bypass surgery. Because of that finding, amlodipine may have an important role in the management of symptoms of patients with coronary artery lesions by deferring the need for bypass surgery or angioplasty, he said. The study, which was called PREVENT (prospective randomised evaluation of the vascular effects of Norvasc trial) involved 825 patients at 16 clinical centres in the United States and Canada who had coronary artery disease documented through heart catheterisation. To be part of the trial, at least one coronary artery had to have less than 30 percent blockage. The patients were randomised to amlodipine or placebo and followed for three years. At the end of the three years, the patients had a second heart catheterisation. The investigators had hoped to show that regular administration of amlodipine over three years would reduce the progress of atherosclerosis in segments of the coronary arteries with less than 30 percent blockage, as measured by heart catheterisation (also known as angiography). However, amlodipine appeared to slow the progression of carotid artery atherosclerosis, as measured by ultrasound. That study involved 376 of the 825 patients. These participants had an ultrasound exam at baseline and then every six months. The differences between those who got amlodipine and those who got placebo, as measured by ultrasound, were highly significant in the common carotid artery, the major carotid artery. Byington noted that the heart catheterisation and the ultrasonography were really measuring different things. The heart catheterisation measures the size of the inside of the artery, which doctors call the lumen, whereas the ultrasound measures thickening of the arterial wall, which may or may not be accompanied by compensating enlargement (dilation) of the artery. "There was no difference, angiographically, between placebo and amlodipine, but there was a difference in ultrasound," Byington said. The investigators found the results somewhat surprising, since two other studies of calcium channel blockers -- involving nifedipine and nicardipine, had suggested an effect. Nifedipine was reported to reduce the formation of new atherosclerosis lesions, while nicardipine reduced the progression of atherosclerosis in lesions that already had begun. There were no major safety concerns linked to use of amlodipine.

To: Anthony Wong who wrote (6274)	11/11/1998 6:41:00 PM
From: Anthony Wong	Respond to of 9523

Pfizer says Norvasc cuts cardiovascular events Wednesday November 11, 12:09 pm Eastern Time By Ransdell Pierson DALLAS, Nov 11 (Reuters) - Pfizer Inc. (NYSE:PFE - news) said Wednesday that patients taking its flagship hypertension and angina drug Norvasc had 31 percent fewer cardiovascular events than patients taking a placebo. Pfizer was to formerly present data from its 825-patient trial of coronary artery disease patients later Wednesday at the annual American Heart Association scientific sessions being held here. Dr. Rob Scott, Pfizer's cardiovascular medical director, said the events that were apparently reduced by Norvasc, a calcium channel blocker, included heart attack, stroke, death, angioplasty, bypass surgery, hospitalizations for severe angina and heart failure. He said patients taking Norvasc (amlodipine) required 46 percent fewer angioplasty and bypass procedures, and had 35 percent fewer hospitalizations for severe chest pain. In angioplasties, surgeons open up clogged arteries by threading through them a catheter tipped with an inflated balloon. Bypass surgery involves the grafting of an artery from elsewhere in the body into the heart to restore blocked blood flow to the pumping organ. Scott told Reuters the study was the first to show such impressive preventive benefits for any calcium channel blocker. Previous trials of other channel blockers by other companies showed dismal results that had blackened the reputation of the class of drugs, he said. Scott and other researchers, however, said that both placebo patients and patients taking Norvasc in the Pfizer trial showed no real difference in the progression of their atherosclerosis, or clogging of the arteries. But the amount of plaque buildup in the carotid artery, which supplies blood from the neck to the brain, was significantly lower in the Norvasc group, he said. ''That is important because as you get increased plaque in the carotid artery, you have an increased danger of stroke,'' he said. The lesser clogging of the carotid artery in the Norvasc group was among the most important findings in the three-year study. Norvasc is currently approved for hypertension and angina but not for prevention of stroke, Scott said. About 14 million Americans have coronary artery disease, which Pfizer said causes 500,000 deaths a year and is the leading cause of death in the United States. Sales of Norvasc in 1997 totaled $2.2 billion, about triple the expected 1998 sales of Pfizer's blockbuster impotence drug Viagra. Pfizer said the Norvasc study, which began in 1992, took two years to recruit patients, who were then tracked for three years. ''Of all the calcium channel blockers, Norvasc has the longest duration of action,'' Scott said, an aspect that he said might help account for its better performance in preventing incidents than previously-tested channel blockers. Older drugs in the class include Procardia-XL, another Pfizer drug, and generic drugs such as Nicardipine, Scott said. biz.yahoo.com

To: Anthony Wong who wrote (6274)	11/11/1998 6:44:00 PM
From: Anthony Wong	Read Replies (1) \| Respond to of 9523

(Dow Jones) Study Finds Cholesterol Drugs May Help Some More Than Angioplasty November 11, 1998 3:49 PM By Raymond Hennessey, Staff Reporter DALLAS -(Dow Jones)- Some patients who are currently being treated with balloon angioplasty for their stable coronary artery disease may benefit more from aggressive drug treatment to reduce cholesterol, according to a study released Wednesday. The trial showed that, 18 months after the patients first reported symptoms, 87% of people given a high dosage of the drug Lipitor didn't need angioplasty or a bypass, or have a heart attack or die, said Dr. Bertram Pitt, professor of medicine at the University of Michigan. Lipitor is marketed jointly by Warner-Lambert Co. (WLA) and Pfizer Inc. (PFE). It belongs to a heavily competitive class of drugs known as "statins" which have been shown to dramatically reduce cholesterol. There was also a "borderline significant" reduction in the amount of time that the patients who later received surgical treatment needed it. Of the 350 people studied, all had been referred to surgeons for angioplasty. But Pitt instead treated some with 80 milligrams of Lipitor. Pitt said the study indicates that it may be more cost effective to give patients with only one or two instances of blood vessel disease an aggressive dose of Lipitor or another of the statin family of cholesterol-lowering drugs, instead of an angioplasty. But, that will take a philosophical shift on the part of interventional cardiologists who perform the angioplasties, Pitt said. For one thing, doctors tend to see these patients "and think they're going to fall over tomorrow" with their artery disease, Pitt said. But, in some cases, it will be cheaper and possbily more effective to use a drug therapy, he said. And interventional cardiologists will also have to make the lowering of cholesterol higher on their list of priorities. But drug treatment isn't right for all patients, with Pitt estimating that it would be effective in only about 20% to 25% of heart patients. "If you need an angioplasty, you should get one," he said. Drug therapy to raise the levels of HDL, or the so-called good cholesterol, may also help a subset of patients who have unusually low levels of both HDL and the LDL, or "bad" cholesterol, said Dr. Hanna Rubins, chief of general internal medicine at the V.A. Medical Center in Minneapolis. Using the generic gemfibrozil, which is sold by Parke Davis under the brand Lopid, on 2,500 men with heart disease, Rubins found there were 22% fewer heart attacks and 26% fewer strokes compared with men who didn't take the drug. The research shows that gemfibrozil is as effective for patients with low levels of good cholesterol as statins are for patients with high levels of the bad form, Rubins said. Like Pitt, Rubins said her data shows that some doctors may be inappropriately treating their patients and not paying enough attention to lowering cholesterol. -Raymond Hennessey; 201-938-5240; raymond.hennessey@cor.dowjones.com Copyright (c) 1998 Dow Jones & Company, Inc. All Rights Reserved. smartmoney.com