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Avandia May Slow Atherosclerosis After Bypass Surgery

Friday, April 4th, 2008

By Steven Reinberg
HealthDay Reporter Wednesday, Apr. 2, 2008; 4:00 AM
Copyright © 2008 ScoutNews, LLC. All rights reserved.

TUESDAY, April 1 (HealthDay News) — The controversial diabetes drug Avandia appears to slow the progression of atherosclerosis in diabetic patients who have undergone cardiac bypass surgery, thus protecting them from new cardiac problems, according to the results of a small study.

Avandia (rosiglitazone) has been associated with increased risk of heart attack and heart failure among patients receiving the drug. In November, the U.S. Food and Drug Administration, while calling the evidence for heart attack inconclusive, agreed to keep the drug on the market, but with a black box warning about the heart attack risk.

In the new study, which included almost 100 patients taking Avandia, the study authors said they found the drug was safe and had no more cardiovascular risks than a placebo.

The VICTORY (Vein Coronary Atherosclerosis and Rosiglitazone After Bypass Surgery) study included 193 patients with type 2 diabetes who had undergone cardiac bypass surgery. They were randomly assigned to receive Avandia or a placebo. The trial was paid for by GlaxoSmithKline, the maker of Avandia.

The researchers found that after one year, patients taking Avandia had better blood sugar control, compared with those on a placebo. In addition, patients taking Avandia showed improved cholesterol levels, fewer signs of inflammation of blood vessels, and lower blood pressure than those patients taking a dummy pill.

Also, there was no significant difference in cardiovascular events between the two groups, the researchers noted.

“The enrollment of high-risk cardiovascular patients with type 2 diabetes in a placebo-controlled trial with rosiglitazone was found to have an acceptable safety profile,” the researchers concluded.

The findings were presented Tuesday at the American College of Cardiology annual meeting, in Chicago. The presenter was Dr. Olivier F. Bertrand, assistant professor at Laval University in Quebec City, Canada.

Despite the study findings, one heart expert said the results were insignificant and didn’t really show that Avandia was safe.

“How exactly can they establish the safety of rosiglitazone in a short-term study with less than 100 patients receiving the drug?” asked Dr. Steven Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic Foundation, who was the first to report the risk of heart attack associated with Avandia. “This was an intravascular ultrasound study, not a morbidity-mortality study.”

Dr. Gregg C. Fonarow, a professor of cardiology at the University of California, Los Angeles, agreed with Nissen that the study was too small to make any valid claims about the safety of Avandia.

“This study with only 193 patients is too small to draw any conclusions regarding the potential benefits and risk of rosiglitazone in this patient population,” he said.

Dr. Paul Aftring, senior director of metabolic research at GlaxoSmithKline, said, “We recognize the limitation of the size of this study, but the safety data were very reassuring. They are consistent with other data in high-risk populations.”

The safety data of any trial is never defined by a population of less than 100 patients, Aftring said. “But the longer-term data in longer-term studies in high-risk populations is actually quite reassuring,” he added.

Aftring noted that the current labeling of Avandia says that the drug should be used with caution in high-risk populations. “Victory adds to the knowledge base that in well-managed populations, careful use of rosiglitazone is appropriate, and there are no safety issues,” he said.

To buy Avandia click here: http://www.myfamilydrugstore.com/item/anti_diabetic/avandia.html

Posted in Avandia, Medications, Type 2 Diabetes | No Comments »

Diabetes Drug Slows Clogging of Arteries

Wednesday, April 2nd, 2008

By Amanda Gardner
HealthDay Reporter Tuesday, Apr. 1, 2008; 4:00 AM
Copyright © 2008 ScoutNews, LLC. All rights reserved.

MONDAY, March 31 (HealthDay News) — The diabetes drug Actos is better than another diabetes drug, Amaryl, at slowing clogging of the arteries in patients with both type 2 diabetes and cardiovascular disease.

The Cleveland Clinic researchers behind the new findings say this is the first time that a diabetes medication has been shown to slow atherosclerosis, giving doctors new insight into which drugs may be most effective and safest for this group of patients.

“As we go forward, the study tells us that we must do comparative effectiveness trials looking at different diabetes strategies,” study author Steve Nissen, chairman of the department of cardiovascular medicine at Cleveland Clinic, said Monday. “We can’t just focus on pricking your finger, getting blood sugar down. The goal in diabetes therapy is to prevent complications, and the most feared complication is heart disease, which will kill 75 percent of all diabetics. I’m thrilled with results.”

Another expert hailed the results.

“The biggest news here is that pioglitazone [Actos] appears safe, does not increase cardiovascular risk, and may even reduce it,” said Dr. Robert Scott III, an assistant professor of internal medicine at the Texas A&M Health Science Center College of Medicine and senior staff cardiologist with Scott&White in Temple, Texas. “It looks safe to use in people with coronary artery disease, and it is well-tolerated. We may need another trial to see how it helps, but at least it doesn’t hurt, and that was our biggest concern.”

The findings are published in the April 2 issue of the Journal of the American Medical Association and were released Monday to coincide with a presentation at the American College of Cardiology annual meeting, in Chicago. The research was funded by Takeda Pharmaceuticals North America Inc., which makes Actos.

Individuals with type 2 diabetes are particularly susceptible to atherosclerosis, as evidenced by the fact that 75 percent of this group eventually die of cardiovascular disease.

Amaryl (glimepiride) belongs to a class of drugs known as sulfulonylureas, which have been prescribed for decades. Actos, along with its cousin Avandia, is a thiazolidinedione, a relatively new class of diabetes drugs.

Both Actos and Avandia appear to increase the risk of heart failure (the entire class now carries a black-box warning to that effect), but Avandia has been associated with an increased risk of heart attack, while Actos has been linked with a reduced risk of negative cardiovascular outcomes.

“Both are associated with heart failure, but there were increased deaths [with Avandia],” said Dr. Stanley Mirsky, an endocrinologist with Lenox Hill Hospital in New York City and co-author of the Diabetes Survival Guide.

For this study, 543 patients with both coronary disease and type 2 diabetes were randomized to receive either Amaryl or Actos for 18 months. Actos works by making the body more sensitive to insulin, while Amaryl works by spurring the body to produce more insulin. All participants were also taking medications for heart disease.

Progression of atherosclerosis was measured by intravascular ultrasonography in the 360 patients who actually completed the study.

One measure found a 0.73 increase in plaque in the Amaryl group versus a 0.16 decrease in the Actos group. A second measure found a 0.64 increase for Amaryl and a 0.06 decrease for Actos.

The study was not designed to measure actual clinical endpoints, meaning cardiovascular events or death.

The authors stated that the exact mechanisms for the decreases associated with Actos were unclear, although several biomarkers linked to atherosclerosis progression were impacted by the drug, including a 16 percent increase in HDL or “good” cholesterol, a 15 percent reduction in triglyceride levels, and a 45 percent drop in C-reactive protein (CRP) levels.

It’s also not clear if the benefits associated with Actos extend to other medications in that class of drugs.

An accompanying editorial found the results “reassuring.”

“You’ve got to take into consideration the benefit of preventing heart attacks may be greater than the few people who get heart failure,” Mirsky said.

If you want to buy Actos click here: http://www.myfamilydrugstore.com/item/anti_diabetic/actos.html

To buy Avandia: http://www.myfamilydrugstore.com/item/anti_diabetic/avandia.html

Amaryl: http://www.myfamilydrugstore.com/item/anti_diabetic/amaryl.html

Posted in Actos, Amaryl, Avandia, Cardiovascular disease, Medications, Type 1 Diabetes, Type 2 Diabetes | No Comments »

Diabetes’ Toll Continues to Grow

Saturday, March 22nd, 2008

By Dennis Thompson
HealthDay Reporter Saturday, Mar. 22, 2008; 4:00 AM
Copyright © 2008 ScoutNews, LLC. All rights reserved.

FRIDAY, March 21 (HealthDay News) — News from the diabetes front seems to grow more discouraging by the day.

Rates of the disease, fueled by obesity and sedentary lifestyles, have risen unchecked in the United States, with diabetes now affecting about 7 percent of the population. That’s an estimated 20.8 million adults and children, according to the American Diabetes Association.

Federal projections estimate that by 2050, some 48 million Americans will have type 2 diabetes. And the disease will bring with it complications such as blindness, hearing loss, kidney disease, nervous system disorders and amputations of extremities.

“Studies have suggested that for the first time in history, the generation of people born in 2000 is probably going to have shorter life expectancy than their parents,” said Dr. Sue Kirkman, vice president of clinical affairs for the American Diabetes Association. “That’s attributable to obesity, diabetes and heart disease. Is that what we want for our children?”

What’s worse, one of the most promising medicines for treating type 2 diabetes — Avandia — now appears to increase a person’s risk of heart attack and heart failure, according to recent studies.

Still, medical experts say the fight against diabetes can be won — if everyone decides to do what’s best for themselves and their families.

That fight will get its yearly boost on Tuesday when the American Diabetes Association will “sound the alert” about diabetes on the 20th annual American Diabetes Alert Day. It’s a one-day “call to action” to encourage those at risk for developing type 2 diabetes or those with loved ones at risk to take the Diabetes Risk Test and, if they score high, to schedule an appointment to see their health-care provider. The Diabetes Risk Test is available in English and Spanish by calling the association at 1-800-DIABETES (1-800-342-2383) or online at www.diabetes.org/alert.

But the finding on Avandia calls into question the safety of the entire class of drugs known as thiazolidinediones. For now, Avandia — and other thiazolidinediones such as Actos — remains on the market. But last year, the U.S. Food and Drug Administration mandated stricter labeling, including “black box” warnings, for the medications.

Medical experts recommend that each person discuss with their physician the risks and rewards of using Avandia.

“Every patient is different,” said Kirkman. “Every patient has different risk factors. Every patient has reasons why one medicine might be better for them than another.”

But medicines are only part of the solution. A better response would be drastic changes to American lifestyles, starting with improved diets and more exercise, to avoid type 2 diabetes in the first place.

“The statistics are pretty gloomy, but we also know people who are at risk for diabetes can do a lot to prevent it from coming on,” Kirkman said. “There’s a lot people can do to try and control their fate.”

Diabetes comes in two types.

The most common form, type 2, or what used to be called adult-onset diabetes, occurs when either the body does not produce enough of the hormone insulin or the cells ignore the insulin. The body needs insulin to transport sugar in the blood to cells for energy. Being overweight, an unhealthy diet, and lack of exercise are common contributors to this form of the disease.

Type 1 diabetes, usually diagnosed in children and young adults, occurs when the body isn’t capable of producing insulin.

Researchers reviewing data from the National Health Interview Survey found that from 1990 to 2005, cases of diabetes increased 4.6 percent each year. They rose from 26.4 cases per 1,000 people to 54.5 per 1,000 people in the most recent year available.

The diabetes epidemic has grave implications for America, said Martha Funnell, a clinical nurse specialist for the University of Michigan and a past president of the American Diabetes Association. Health care costs are expected to soar as more people with diabetes complications fill doctors’ offices and emergency rooms.

Even the U.S. economy will be affected as potentially healthy people find themselves unable to work. “You’re losing folks in the prime of their years, and that has an impact on society and our economy,” Funnell said.

Fortunately, there are steps that can be taken, both large and small, to help fight diabetes.

On the large-scale side, Kirkman said, governments should spend more money on physical education in schools and on public transportation, instead of new road construction.

“We know people who take public transportation are more physically active,” she said. “Do we choose to encourage that?”

On a more personal level, people can make healthy lifestyle choices and help pass those choices along to their children, Funnell said.

But is anyone listening and willing to try?

“The messages are those same old ‘eat healthy and exercise,’ and we hear those to the point where we think, ‘Yeah, yeah, yeah, everybody knows we need to do these things,’ ” Funnell said.

However, even small measures — standing more often during the day or walking during a lunch break or eating an apple instead of ice cream — can help make a difference.

“Maybe it would seem to outsiders as a small step, but it’s just taking that one step and the next step and the next,” Funnell said. “Like global warming, it’s saying, ‘What can I do for myself and my family this week, this month, this year, that will make a difference?’ “

Posted in Avandia, Medications | No Comments »

Fighting Type 2 Diabetes

Sunday, March 16th, 2008

BOSTON (Ivanhoe Broadcast News) — Nearly 21 million people in the United States are living with diabetes, and as many as 95 percent of diabetics have type 2 diabetes. Treating it has been a tough challenge for doctors. There are lots of drugs to help control blood sugar levels but none target the cause.

“None of the currently available medications are perfect, and one of the biggest problems we have with the current medications is they don’t really treat the basic problem,” Steven Shoelson, M.D., Ph.D., a diabetes researcher at Joslin Diabetes Center in Boston, tells Ivanhoe.

Fighting Type 2 Diabetes But Dr. Shoelson says the drug salsalate could change that. It’s an anti-inflammatory drug for arthritis that’s been around since the 1800s. “It’s strange that we are using a drug that has been around for a long time to treat a disease that has been around for a long time,” he says.

New research shows a protein that triggers inflammation is turned on in overweight people. The inflammation leads to insulin resistance and type 2 diabetes. Salsalate shuts off that protein.

“We think getting at the cause may have beneficial effects that we have not even anticipated,” Dr. Shoelson says. An early study shows the drug significantly improves blood sugar levels. “The people who got no drug at all had absolutely no change in their blood sugars.”

The drug also lowers triglyceride levels, and Dr. Shoelson says it may reduce heart disease risk as well.

Fighting Type 2 Diabetes Jerry Silva was in that early study and saw his blood sugars drop. “I tend to be the kind of person who does not like to take medications if I don’t have to,” he says. But since the study ended, he’s lost 20 pounds. Instead of drugs, he now controls his diabetes with diet and exercise. “If I cannot walk around anymore or if my body stops responding positively to natural ways of reducing it; this is something I would definitely consider taking.”

Article by: Ivanhoe Broadcast News, Inc.

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Misreading Avandia

Wednesday, March 12th, 2008

The recent ruckus over the drug rosiglitazone (Avandia ) has been portrayed as another case of Big Pharma foisting a dangerous drug on the public while the overworked FDA can’t keep up.

Search Google for Avandia and Vioxx, and you’ll come up with more than three-quarters of a million hits, including ads from law firms ready to litigate.

There is an enormous difference between the two situations. In the case of Vioxx, it was alleged that otherwise healthy people suffered sudden cardiac disease and death after using the pain reliever. This new study, published in the New England Journal of Medicine on May 21, alleges that Avandia causes an unacceptable rise in risk of heart attack. This—at least from the evidence presented—is hard to believe.

[Image]
From The New England Journal of Medicine , 21 May, 2007

There are several ways to read the statistics that “support” this study.

Those in the Avandia meta-study were not only diabetics, but diabetics whose disease was initially out of control, with average blood sugar levels approaching three times those of non-diabetics and blood sugars at the ends of the studies undisclosed. The complications of diabetes—in this case heart disease—are caused by the prolonged elevation of blood sugars.

With a little math, we can easily conclude, for example, that metformin is about 4.75*-fold more likely to cause more cardiac deaths than insulin. We can also conclude that placebo is about 4.4**-fold more likely to cause more cardiac deaths than insulin. Which should lead us to the conclusion that since insulin is the most effective of these medications at lowering blood sugars, it is likewise more effective at reducing diabetic complications such as the risk of cardiac death.

The other drugs are considerably less effective in doing that job—but the sulfonylureas, while more effective than metformin or rosiglitazone in the short term, are problematic because they can over time, burn out remaining insulin-producing beta cells.

The real story behind these figures is that there are a lot of health care professionals who are not doing their jobs. Anyone with an initial (as in this study) HgbA1c level of 8.2 percent (equating to sustained average blood sugar levels of about 228 milligrams per deciliter) should be treated with insulin (and a low carbohydrate diet) since no combination of the other drugs can get such blood sugars normalized. The other drugs can have marginal effects in reducing blood sugar levels, but are not nearly so effective as insulin.

Blood sugars of diabetics can be normalized. The real ‘scandal’ is that very few health care professionals think that diabetics have the right to the same blood sugars as non-diabetics. They therefore leave their patients wide open to an unnecessary “potential for serious adverse cardiovascular effects.

Product Description

Most important information about Avandia

Pharmacokinetics

Possible Side Effects

More information about AVANDIA (Rosiglitazone):

AVANDIA (Rosiglitazone): What You Should Know

Can Avandia or other drugs prevent diabetes?

Actos beats Avandia in sugar, fat control: study

Avandia approved for combination with insulin in type 2 diabetes treatment

Avandia Reduces Risk of Progresson from Pre-Diabetes to Type 2 Diabetes by 62 percent

EMEA Statement on Recent Publication on Cardiac Safety of Rosiglitazone (Avandia, Avandamet, Avaglim)

GSK Revises US Labeling for Avandia