Avandia And Actos: Unclear Link To Heart Failure
 People with Type 2 diabetes who are unable to control their disease through lifestyle changes such as diet and exercise are often prescribed oral medications called glitazones. One of these, Rezulin, was taken off the market two years ago because of links to liver damage. Recently, a study was conducted to see if there is a connection between the other glitazones and heart failure.
The study was conducted by researchers from Policy Analysis Inc. in Brookline, Massachusetts, and was presented at the American College of Cardiology meeting in Atlanta, Georgia (March 19, 2002). The results of the study were based on the analysis of the records from an insurance claims database. The records were from 8,288 people with diabetes who were taking glitazones and 41,440 who were not taking the drugs.
The researchers found that those taking glitazones such as Avandia and Actos had a 4.5% risk of developing heart failure, while those who were not taking the drugs had a 2.6% increase. The researchers took into account other risk factors like obesity, high blood pressure, and smoking, and found glitazones to be an independent predictor for heart failure.
Study authors note that these results were based on observational data. This type of study can introduce skewing of data, such as that people with more severe insulin resistance, a known risk factor for heart failure, might be more likely to be placed on these drugs. A well-designed clinical trial would need to be be conducted for a more accurate assessment of possible risk.
  
Liver Damage: One Case From Actos
After the Type 2 diabetes drug Rezulin was taken off the market in the year 2000 because of its link to severe liver damage and death in many people, doctors became concerned that similar drugs would have the same side effects. One recent case shows that it can happen.
In a recent issue of the Annals of Internal Medicine (volume 136; pages 449-452, 480-483; March 19, 2002), researchers from the Gastrointestinal Associates of Rockland in New City, New York describe a case of a 49-year-old man who developed liver disease after taking pioglitazone (Actos) for six months to treat type 2 diabetes.
The man took 15 mg of pioglitazone per day for four months, but his prescription was increased to 30 mg for two months when his blood sugar levels rose. After the increase, he had abdominal pain, nausea, loss of appetite and weight loss. Tests revealed liver damage caused by medication, as the man did not have any other risk factors for liver damage. When the man was taken off the drug, his liver returned to normal within six weeks.
Pioglitazone is made by Takeda Pharmaceuticals North America in Lincolnshire, Illinois, and is co-marketed by Lilly. The companies note that the drug label recommends that people should have their liver enzymes monitored when they begin taking the drug and then every two months during their first year being on the drug. In addition, the drug should not be given to people who have active liver disease. With tens of thousands of people taking Actos and Avandia, liver damage appears to occur in only very isolated cases with these medications.
Blood Pressure Pill Prevents Stroke And Diabetes
When people develop blood pressure that is high enough to warrant concern for heart attack or stroke, doctors are quick to prescribe medication to reduce blood pressure. A new study compares two medications that are often prescribed with an unusual result.
The study was conducted by researchers at Goteburg University in Sweden, and was funded by the pharmaceutical company Merck. This company produces the angiotensin II antagonist blood pressure medicine called Cozaar. In the study, Cozaar was compared to atenolol, which is a beta blocker blood pressure medicine. About 9,200 men and women with hypertension from Scandinavia and the US participated in the study.
The study lasted for approximately five years, during which time some of the participants were prescribed Cozaar, and some of whom where prescribed atenolol. During the study, there were 232 strokes among the participants on Cozaar, and 309 among those on atenolol. Also, 241 people taking Cozaar developed diabetes, while 319 on atenolol developed the disease. Among those participants who already had diabetes, the risk of dying from cardiovascular disease was 37% lower for those taking Cozaar.
While both medications appeared to have identical benefits in terms of lowering people's blood pressure, people on Cozaar appeared to be 25% less likely to have strokes and 25% less likely to develop diabetes. More research is needed to determine why Cozaar appears to have these other benefits.
Other Benefits Of Hypertension Drugs
High blood pressure is a dangerous condition because it can lead to a thickening of the wall of the heart's largest blood-pumping chamber and stop it from contracting effectively. This can ultimately lead to heart failure if left untreated. Two presentations at the meeting of the American College of Cardiology in Atlanta (March 20, 2002) offer hope for a drug therapy that can not only reduce blood pressure, but also reduce kidney damage.
In the first presentation, researchers from the University of Michigan Health System described a study of 153 people with mild to moderate hypertension and left-ventricular hypertrophy (LVH). The participants were divided into three groups: one was given eplerenone, a once-daily pill that works by blocking the hormone aldosterone, which is involved in the development and progression of hypertension and heart failure; the second was given enalapril, an ACE inhibitor; and the third was given a combination of the two.
After nine months, the researchers found that eplerenone reduced LVH by 14.5 grams, enalapril by 19.7 grams, and the combination therapy by 27.2 grams. In addition, the researchers measured the participants levels of potassium in the blood, as high levels can lead to heart arrhythmia. High levels were found in 10.9% of the people taking eplerenone, 2.8% of the people taking enalapril, and 4.5% of people taking a combination of the two.
In another study, which was conducted by researchers at the University of Miami School of Medicine, people with diabetes and high blood pressure were given a similar drug treatment. After 24 weeks, the levels of protein in the participants' urine were measured. High levels indicate impaired kidney function, which is a common complication of diabetes. Those who had been treated with eplerenone had a reduction in proteinuria of 62%, as compared to 45% with enalapril and 74% with a combinaton of the two.
The researchers believe that the results indicate that eplerenone's effect on protein levels in urine is caused by its blocking of aldosterone, as blood pressure levels were similar in all three groups.
Survival After Angioplasty Increases With Statins
When cholesterol levels in the blood vessels become so high that a heart attack appears eminent, a procedure called angioplasty may be necessary. This involves inserting a balloon-tipped catheter into the blocked artery in order to flatten fatty plaque against the artery wall. A new study shows that the survival rate after this procedure may be improved with cholesterol-lowering drugs called statins.
This study was conducted by researchers at the Cleveland Clinic in Ohio, who presented their findings at the American College of Cardiology's annual meeting in Atlanta (March 18, 2002). They had included 6,647 people in their study, all of whom had undergone an angioplasty between the years of 1993 and 1999. Of these, 23.5% were given a follow-up treatment of statins.
The researchers found that statin therapy was linked toa 60% lower mortality at 30 days and a 37% reduction in 6 months. Of those who received statins, 3.1% died, whereas 4.9% of those in the non-statin group died. These results were true regardless of gender, high cholesterol, diabetes, or unstable angina, which is a heart-related chest pain that happens when a person is resting.
The researchers postulate that the positive results of statin therapy are due to statins' anti-inflammatory action, as well as their ability to reduce platelet stickiness. In addtion, statins may be able to improve the function of blood vessel linings and stabilize plaque build-up.
Adverse Reactions And Death From Obesity Drug?
Recently, the anti-obesity drug Reductil has gotten some bad press, as reports surface linking the drug with adverse reactions and death. However, the pharmaceutical company Abbott Laboratories Inc., which markets the drug, states that these problems might not be caused by the drug at all.
Reductil was first marketed in 1997, although testing on humans began several years before that. Nearly nine million people have taken the drug, and the reported death rate is only two per 100,000 treated per year, compared with study findings showing a death rate of 400 per 100,000 per year in obese people. The company claims awareness of 34 deaths of people taking the drug since it was first tested in humans, but that there is not evidence that the deaths were caused by the drug.
Britain's Department of Health has reported that two patients died, and over 200 others had suspected adverse reactions in the UK. Last week, Italy suspended sales of the drug after receiving 50 reports of adverse reactions, including two deaths. Earlier this week, French drug regulators said that they had received 99 reports of side effects, 10 of which were serious, but no deaths in patients taking Reductil. Other national agencies have been examining the number of adverse drug reaction reports, as a Europe-wide review by the European Medicines Evaluation Agency will soon begin.
Enzyme May Lead To Insulin Resistance
One of the precursors to Type 2 diabetes is insulin resistance, although it is not clear why this develops. In a new study, researchers focused on blood levels of a particular enzyme and its connection to insulin resistance.
The enzyme is called ADMA, and is involved in stopping a compound that causes blood vessel dilation. ADMA has already been shown to reduce the ability of blood vessels to widen when it is present in elevated amounts, increasing the risk of heart and blood vessel disease. In a study conducted at Stanford University, researchers attempted to discover the link between ADMA and insulin resistance.
Sixty-four people participated in the study, sixteen of whom had high blood pressure, seven of whom had insulin resistance, and none of whom had diabetes. Over nine months, the researchers measured the participants' cholesterol, insulin level, ADMA, and other factors. Those people who had insulin resistance were also given the diabetes drug rosiglitazone for 12 weeks.
The researchers found that the participants' blood levels of ADMA were directly related to their degree of insulin resistance, regardless of blood pressure. However, the rosiglitazone significantly improved the participants' sensitivity to insulin and reduced ADMA levels in the blood. The researchers have published their findings in The Journal of the American Medical Association (volume 287; page 1420; March 20, 2002), and believe more research is needed to better understand the way ADMA can influence cardiovascular disease risk and treatment.
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