Archive for the ‘pfizer’ Category
Sunday, July 13th, 2008
Pfizer has announced that Lipitor 80mg reduced the risk of heart attack and stroke by 32% in patients who have heart disease and chronic kidney disease compared with patients taking the 10mg dose of Lipitor.
The primary endpoint of the Treating to New Targets (TNT) study was the reduction of major cardiovascular events, including death from heart disease, non-fatal heart attacks, resuscitated cardiac arrest, and fatal or non-fatal strokes. This sub-analysis studied 3,107 patients with moderate to severe chronic kidney disease, as defined using a standard measure of kidney function.
The efficacy results in this analysis were primarily driven by reductions in heart attack and stroke. Both doses of Lipitor (80mg and 10mg) were well tolerated. Lipitor 80mg is not a starting dose. The safety of Lipitor 80 mg in patients with chronic kidney disease was similar to that reported for the overall TNT population, with no unexpected safety concerns identified.
Halit Bander, senior director of Pfizer’s global cardiovascular metabolic medical team, said: “The results of this analysis complement the large body of evidence from multiple clinical trials demonstrating the cardiovascular benefits of Lipitor.”
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Sunday, June 29th, 2008
Pfizer Inc announced today that Lipitor® (atorvastatin calcium) 80 mg reduced the risk of heart attack and stroke by 32 percent in patients who have heart disease and chronic kidney disease compared with patients taking the 10 mg dose of Lipitor. This analysis, designed and completed following the closure of the five-year Treating to New Targets (TNT) study, was published in the “Journal of the American College of Cardiology.”
“People with chronic kidney disease are more likely to die from heart disease than to develop kidney failure,” said Dr. James Shepherd, a member of the TNT steering committee and clinical academic consultant, department of pathological biochemistry, University of Glasgow Medical School. “It is critical for us to find new ways to reduce cardiovascular burden in these patients. Intensive statin therapy seems to be at least part of the solution.”
The primary endpoint of the TNT study was the reduction of major cardiovascular events, including death from heart disease, non-fatal heart attacks, resuscitated cardiac arrest, and fatal or non-fatal strokes. This sub-analysis studied 3,107 patients with moderate to severe chronic kidney disease, as defined using a standard measure of kidney function. The efficacy results in this analysis were primarily driven by reductions in heart attack and stroke. Both doses of Lipitor (80 mg and 10 mg) were well tolerated. Lipitor 80 mg is not a starting dose. The safety of Lipitor 80 mg in patients with chronic kidney disease was similar to that reported for the overall TNT population, with no unexpected safety concerns identified.
“The results of this analysis complement the large body of evidence from multiple clinical trials demonstrating the cardiovascular benefits of Lipitor,” said Halit Bander, Ph.D. senior director of Pfizer’s global cardiovascular metabolic medical team.
About Chronic Kidney Disease
An estimated 26 million Americans and 50 million people worldwide have chronic kidney disease, or permanent kidney damage due to injury or disease. Patients with chronic kidney disease do not effectively filter toxins from the blood. When chronic kidney disease progresses to kidney failure, either dialysis or a kidney transplant is needed. Chronic kidney disease recently has been recognized as an important risk factor for cardiovascular disease, the leading cause of death and illness in patients with kidney disease.
About the TNT 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 Lipitor 80 mg. 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. The safety of Lipitor 80 mg in patients with chronic kidney disease was similar to that reported for the overall TNT population, with no unexpected safety concerns identified.
About Lipitor
Lipitor is the only statin proven to provide a combination of impressive average LDL (“bad” cholesterol) lowering of 39 percent to 60 percent, significant and proven cardiovascular event reductions, and a well-established safety profile across a broad range of patients.
It is the most prescribed cholesterol-lowering therapy in the world, with nearly 151 million patient-years of experience. Lipitor is supported by an extensive clinical trial program involving more than 400 ongoing and completed trials with more than 80,000 patients.
Important U.S. Prescribing Information
Lipitor is a prescription medication. It is used in patients with multiple risk factors for heart disease such as family history, high blood pressure, age, low HDL (“good” cholesterol) or smoking to reduce the risk of a heart attack, stroke, certain types of heart surgery and chest pain.
Lipitor is also used in patients with type 2 diabetes and at least one other risk factor for heart disease such as high blood pressure, smoking or complications of diabetes, including eye disease and protein in urine, to reduce the risk of heart attack and stroke.
Lipitor is used in patients with existing coronary heart disease to reduce the risk of heart attack, stroke, certain kinds of heart surgery, hospitalization for heart failure, and chest pain.
When diet and exercise alone are not enough, Lipitor is used along with a low-fat diet and exercise to lower cholesterol.
Lipitor is not for everyone. It is not for those with liver problems. And it is not for women who are nursing, pregnant or may become pregnant.
Patients taking Lipitor should tell their doctors if they feel any new muscle pain 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 may help avoid serious drug interactions. Doctors should do blood tests to check liver function before and during treatment and may adjust the dose. The most common side effects are gas, constipation, stomach pain and heartburn. They tend to be mild and often go away.
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Tuesday, June 10th, 2008
The combination of anti-inflammatory and cholesterol-lowering drugs may be able to stop the progression of prostate cancer, according to new research so far carried out only in mice.
“The two drugs work through different mechanisms of action, but there is a synergistic effect that inhibits the growth of prostate cancer cells,” said Xi Cheng, assistant research professor at Rutgers, the State University of New Jersey, who conducted the study.
His team administered a combination of Celebrex, a non-steroidal anti-inflammatory drug used to treat arthritis and other pain, and Lipitor, a cholesterol lowering statin, to cultured mice tumors in order to measure the transition of early prostate cancer to its more aggressive and potentially fatal stage.
Both drugs are sold by Pfizer Inc, but the company played no role in the National Institutes of Health-funded study, Zheng said.
The researcher said both drugs have been shown in earlier studies to have some impact on cancer growth when used alone.
The Rutgers team found that the combination of low doses of Lipitor and Celebrex had a more potent impact on tumor growth than a higher dose of either agent when used separately.
Prostate cancer is the second-leading cause of cancer death in men in the United States, with more than a quarter-million new cases appearing each year, according to the American Cancer Society.
In the early stage of the disease, prostate cancer cells depend on androgen hormones, such as testosterone, to grow. Treatment involves either decreasing the production of the hormone or blocking its action.
“Anti-androgen therapy slows the prostate cancer but eventually the cancer becomes androgen-independent, the therapy becomes ineffective and the cancer cells become more aggressive,” said Zheng.
“Treatments available for the later stage cancers are not very good,” Allan Conney, director of cancer research at Rutgers, said in a statement. “Oncologists employ classical chemotherapy drugs which are very toxic and don’t work all that well.”
The objective of the Rutgers study was to indefinitely delay the transition to androgen-independence, prolonging the time during which the cancer would be responsive to low-toxicity, anti-hormone therapy.
Zheng said it appears that a cell signaling pathway for tumor cell growth is inhibited by the combination of the two compounds.
He said human clinical trials are being planned.
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Sunday, June 1st, 2008
Patients in the intensive treatment group were given cholesterol-lowering statin drugs such as Lipitor and Merck’s Zocor, sold generically as simvastatin. For those who didn’t reach their goal, Zetia was added.
The group had a decrease in plaque buildup, a finding that clashes with the study, called Enhance, released earlier this month at a medical meeting. That trial showed Zetia, when added to Merck’s Zocor in Vytorin, the combination pill, failed to slow plaque build-up in the carotid arteries.
“It’s a direct conflict to Enhance,” Howard said.
Merck, based in Whitehouse Station, New Jersey, and Kenilworth, New Jersey-based Schering-Plough said the Enhance study was flawed, in part because it looked at patients with an inherited form of high cholesterol who had been aggressively treated for years with powerful drugs like Zetia.
The researchers now are comparing the patients who got Lipitor to those who didn’t, looking for differences in results. The findings will be published later, Howard said.
No Effect on Deaths
Aggressive treatment also led to better heart function, marked by a significantly greater drop in swelling of the left ventricle, the heart’s main pumping chamber, the study found. There were no differences in heart attacks, surgery to clear clogged arteries, chest pain or deaths between the two treatment groups, and the number was lower than anticipated in patients getting less aggressive treatment.
That finding suggests getting more patients to the currently recommended levels for cholesterol and hypertension could dramatically improve their health, Howard said. More than half of diabetic patients don’t get to the recommended targets now, she said.
The study can be used to support both sides of the argument about how low cholesterol and blood pressure levels should go, wrote Eric Peterson and Tracy Wang, from the Duke Clinical Research Institute in Durham, North Carolina, in an editorial that accompanied the study. Some doctors are convinced lower is always better, while “therapeutic nihilists” want clear proof before they accept the theory, Peterson and Wang wrote.
The results show aggressive treatment reduces early signs of disease and should generate better health with time, they said. On the other hand, three years of intense treatment in a high- risk group of patients documented no significant benefit in lowering heart attacks and complications, they said.
Blood Pressure
Until longer studies are completed, it makes sense to use proven drugs such as Pfizer’s Lipitor and AstraZeneca Plc’s Crestor to lower cholesterol as far as possible, Peterson and Wang wrote. More data are needed for blood pressure because those benefits aren’t as clear and the high drug doses led to side effects, such as dangerously low blood pressure, they said.
The larger studies are expensive. The current trial, dubbed Sands, cost about $12 million and followed 500 patients. A 10,000-patient study looking for specific results such as heart attacks, strokes and deaths could cost more than $200 million, they wrote.
Ultimately, there’s no choice except long-term trials, Howard said. When the researchers got high-risk patients to the currently recommended levels, heart attacks and other complications were similar in both groups. Teasing out a benefit from going lower with blood pressure and cholesterol will take time, she said.
“By getting the control group to standard targets and reducing their risks, you don’t have much room to show a difference” between the two treatment approaches, she said. “You have to go longer, with more people.”
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Monday, May 19th, 2008
Pfizer announced that Lipitor® (atorvastatin calcium) 80 mg showed unexpectedly potent reduction in myocardial ischemia (a condition defined by insufficient blood supply and oxygen to the heart) in patients with chronic stable angina (chest pain). These results were presented at the annual meeting of the American College of Cardiology.
Lipitor significantly reduced the average number of ischemic events by nearly 70 percent and total duration of events by more than 60 percent from baseline to week 18 of the study, and sustained these effects until the end of the trial at week 26. In 60 percent of the patients treated with Lipitor, all ischemic events were completely eliminated by the end of the study. This resulted in a substantial decrease in angina attacks and need for nitroglycerin treatment.
“Ischemia is a serious condition in which the collective effect of minor untreated events can lead to a weakening of the heart muscle and the death of heart cells,” said Professor John Deanfield, British Heart Foundation Vandervell Chair of Congenital Heart Disease, professor of cardiology at University College London and lead investigator of the Double-Blind Atorvastatin Amlodipine (DUAAL) study. “These findings were a pleasant surprise because statins are not part of the current standard of care for the treatment of angina.”
About the DUAAL Study
The DUAAL study was a randomized, double-blind, multi-country study comparing Lipitor (n=103), Norvasc® (amlodipine besylate) (n=104) and a combination of the two (n=104) in patients with coronary artery disease and chronic stable angina. Patients received intensive usual care therapy for their coronary artery disease including beta- blockers, long acting nitrates and aspirin.
Lipitor also caused a significant reduction in C-reactive protein, a marker of inflammation that helps in identifying and stratifying individuals at risk for cardiovascular disease. The anti-ischemic results demonstrated by Lipitor alone were remarkably similar to those in patients taking Norvasc alone. Norvasc, a high blood pressure and anti-angina medication in the calcium channel blocker class, is a part of the standard of care for this patient population, so it was expected to have benefit on the patients studied. Norvasc also significantly reduced the average number of ischemic events by approximately 70 percent and total duration of events by more than 60 percent. This was mirrored by a substantial decrease in angina attacks and need for nitroglycerin treatment.
The combination of Lipitor also offered a significant reduction in ischemic events, but there was not an incremental benefit with the combination versus either Lipitor or Norvasc alone. Given the patient characteristics in this study along with the magnitude of ischemic benefits demonstrated by Lipitor individually, no additional benefits were demonstrated in the combination arm. The number of angina attacks and the need for nitroglycerin use was reduced to a similar degree as the ischemic events.
“Previous studies have suggested an anti-ischemic effect with Lipitor, but the magnitude of the benefit seen in this study is notable,” said Dr. Rochelle Chaiken, vice president of Pfizer global medical. “This study complements the cardiovascular benefits of Lipitor in a broad range of patients as demonstrated in more than 10 completed cardiovascular outcomes trials involving Lipitor.”
About Ischemia and Angina
Symptomatic myocardial ischemia is characterized by angina and affects more than 9 million Americans. People with any cardiovascular risk factor are at risk for developing ischemia.
Standard of care for the treatment of symptomatic ischemia typically focuses on reducing the heart’s need for oxygen or improving the supply of oxygen to the heart. This may include taking medications that slow the heart rate, reduce blood pressure and relax the blood vessels. Medication classes for ischemia include beta blockers, calcium channel blockers and nitrates.
About Lipitor
Lipitor is the only statin proven to provide a combination of impressive average LDL (”bad” cholesterol) lowering of 39 percent to 60 percent, significant and proven cardiovascular event reductions, and a well-established safety profile across a broad range of patients.
It is the most prescribed cholesterol-lowering therapy in the world, with nearly 144 million patient-years of experience. Lipitor is supported by an extensive clinical trial program involving more than 400 ongoing and completed trials with more than 80,000 patients.
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Friday, May 16th, 2008
LDL vs. HDL and Everything In Between
Since I am operating a healthy lifestyle blog here, I feel that it is important to address some life or death medical considerations at times. Therefore, today we talk about cholesterol. While circulating blood cholesterol is important to know about, you can also gauge increased cholesterol levels my examining the molecules that transport the cholesterol to the cells. An increase in the number of dense fat-transporting molecules surely means an increase in the risk of cardiovascular disease.
Arterial Cholesterol
Lipoproteins
In order for cholesterol to travel through blood, it must attach itself to small fat-carrying proteins called lipoproteins. A lipoprotein is a biochemical assembly that contains both proteins and lipids. Many molecules in the blood, including enzymes, transporters, and structural proteins, are lipoproteins. The higher the proportion of protein to lipid in the lipoprotein, the greater is its density. The greater the density of the lipoprotein, the more cholesterol it is transporting around to your organs.
The least dense lipoproteins are the chylomicrons, which carry very little cholesterol.
Next, come the very low-density lipoproteins (VLDL), which roughly carry 15% of the circulating cholesterol.
Following the VLDL are the LDL which are the most notorious since they carry roughly 65% of all circulating cholesterol. High LDL levels are almost always a sure sign of atherosclerosis, a life-threatening heart condition. This means an unusually dangerous amount of cholesterol is present in your blood, and therefore arteries, at any given time. Chance are you will end up with major blockages at precarious locations.
Lastly comes the “good” cholesterol, high-density lipoproteins (HDL), which are the smallest and densest of the lipid-carriers. These actually carry cholesterol from the cells to the liver so that they can be processed as bile acids, excreted in the bile as cholesterol, or returned to the plasma as a component of VLDL. In other words, they dispose of the cholesterol.
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Tuesday, May 13th, 2008
High doses of Pfizer Inc’s Lipitor was more effective than low doses of the cholesterol fighter in reducing arterial inflammation in patients with carotid artery disease, according to a small, 12-week study.
Inflammation in arteries has been associated with an increased risk of stroke.
Inflammation and emboli, or small blood clots, were significantly reduced in patients treated with 80 milligrams of Lipitor compared with those who received 10 mg of the drug each day for 12 weeks, said researchers, who presented the data at the American College of Cardiology scientific meeting on Monday.
The study divided 40 patients with diseased carotid arteries into the two groups. The artery was examined for changes in inflammation at six weeks and 12 weeks using a unique contrast agent with high-resolution magnetic resonance imaging (MRI).
While the 80 mg Lipitor, known generically as atorvastatin, reduced inflammation, researchers appeared even more enthusiastic about the technique used to measure the results.
The arteries were viewed using Ultra Small Particles of Iron Oxide, or USPIO-enhanced, high-resolution MRI.
“The real star of this study is this new way of imaging, which allows you to zero in on what is actually going on in these arteries,” said Dr Jonathan Gillard, one of the study’s lead researchers.
The study demonstrates that if you treat patients who have inflammation of the carotid artery with “a high dose of atorvastatin, you substantially reduce the amount of inflammation and risk of stroke, whereas low dose atorvastatin does not reduce risk,” Gillard said.
“Thanks to this imaging technique, we can now figure out which patients need the aggressive treatment before we begin our therapy,” he added.
Lipitor, which lowers levels of LDL, or bad, cholesterol in the blood, is the world’s top-selling prescription medicine with some $12 billion in annual sales.
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Sunday, May 4th, 2008
Take this medication on the dot as it was positive for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor of the Church. Follow the directions on your prescription label.
Take Lipitor with a full glass of water supply.
Lipitor (Atorvastatin) can be taken with or without food.
Lipitor is normally taken erstwhile a day. Try to take your dose at the same time each day. Follow your doctor’s instructions.
To be indisputable this medication is serving your status, your blood will motivation to be tested on a regular basis. Your liver function may besides need to be tested. Do non miss whatever scheduled appointments.
In rare cases, Lipitor can causal agency a condition that results in the breakdown of skeletal musculus tissue. This condition can lead to kidney failure. Call your doctor at once if you possess unexplained muscle pain or tenderness, muscle weakness, pyrexia or influenza symptoms, and dark dyed urine.
Lipitor is only part of a complete program of treatment that also includes diet, example, and weight control. Follow your diet, medication, and exercise routines very closely.
You whitethorn need to take Lipitor on a long-term cornerstone for the treatment of high cholesterin.
Shop Lipitor at room temperature, protected from moisture, heat, and light.What happens if I miss a venereal infection?
Take the missed dosage as shortly as you remember. If it is almost time for the next dot, skip the missed dose and take only the next on a regular basis scheduled dose. Do not take duplicate medicine to make up the lost dose.
What happens if I overdose?
Seek emergency aesculapian attention if you cerebrate you ingest used likewise much of this music.
An overdose of Lipitor is not expected to produce life-threatening symptoms.
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Sunday, April 27th, 2008
A couple of weeks ago Dr. Alicia Fernandez, an associate professor of clinical medicine at UC San Francisco, received a very unusual letter from The International Association of EMTS and Paramedics, an affiliate of The National Association of Government Employees (IAEP/SEIU).
The letter began by noting that Fernandez is part of the union’s approved physician network, and then launched into what can only be described as a shameless sales pitch for Lipitor, Pfizer’s blockbuster cholesterol-lowering drug.
First, the alarming statistics presented in the letter:
* 1 in 3 adults has some form of CVD (cardio-vascular disease)
* About every 26 seconds, an American will suffer a coronary event
* Stroke is a leading cause of serious, long-term disability in the United States
* Every 45 seconds, someone will suffer a stroke.
Then, the endorsement: “Lipitor is available to our members through their prescription plan. IAEP leadership stands behind LIPITOR as the lipid-lowering agent of choice when it is prescribed by a physician. This confidence in LIPITOR is based on its proven efficacy and is supported by its vast clinical experience of more than 15 years…”
The letter went on, at length, to praise Lipitor’s benefits and to downplay the drug’s risks. In clinical trials, the letter states, “the most common adverse events were constipation, flatulence, dyspepsia and abdominal pain.” But while other risks may not be as “common” they are certainly worth mentioning. They include memory loss which can look like Alzheimer’s and severe muscle pain.
A few days ago, Fernandez received a second, identical letter. Never before in her professional experience had she received a drug ad from a union.
“I’ve never seen anything like this. I’ve never seen Labor endorse a drug product,” she told me. “This is incredible.” Unfortunately, Fernandez adds, this is not the first time that she has seen a drug company use a progressive organization to promote its product. …
Why would Pfizer need the union’s help in peddling its drug? Lipitor, after all, is the best-selling drug in the world, with sales of almost $13 billion in 2006.
But recently, Lipitor has been attracting some decidedly negative publicity.
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Wednesday, February 6th, 2008
Although cholesterol drugs are in the news lately, what is getting lost in the discussion is the fact that it’s possible to lower your cholesterol without drugs. It’s just not as easy.
In fact, many doctors think dietary changes are too difficult for most of their patients. While they typically encourage better eating and a diet low in saturated fat, they also prescribe cholesterol-lowering drugs called statins as a faster way to lower bad cholesterol.
But many people can’t tolerate statins and their side effects. Others simply don’t want to take a pill every day or shoulder the cost of a prescription. For those patients, dietary changes may be a better option.
In 2006, The American Journal of Clinical Nutrition reported on a study of 55 patients with high cholesterol who, over the course of a year, started eating a diet rich in soy proteins, fiber and almonds. All those foods may have cholesterol-lowering properties. Twenty-one patients managed to lower their cholesterol by 20 percent or more by the end of the year. The researchers noted that whether the patient was motivated and actually stuck with the diet most of the time was key.
Journalist Tom Burton, a former colleague, wrote about his own efforts to lower cholesterol without drugs for The Wall Street Journal. He found that many doctors don’t really know how to advise patients about dietary changes to lower cholesterol. He found one who did and used him as a nutrition “coach” to help him figure out which changes would be most effective for him.
The problem for Mr. Burton was that he already had a pretty healthful diet. He ran four miles most days and had given up red meat and most cheese. But his bad cholesterol was 169 mg/dL — far above the 100 mg/dL most doctors recommend. Doctors were telling him statin drugs were in his future.
After documenting his eating habits, Mr. Burton was advised by his doctor to cut out a favorite dish — roast chicken with the skin on. He was told that more of his protein should come from fish, beans and nuts. He phased out the chicken as well as shrimp and squid, which are high in dietary cholesterol. He began including steel-cut oatmeal, eggplant, roasted soybeans, whole-wheat pasta and Brussels sprouts in his diet. He also increased his exercise. His cholesterol numbers were slow to move, but eventually they did, dropping 33 percent.
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