No Increased Heart Risk with New Diabetes Pill Saxagliptin
A staff report posted on the U.S. Food and Drug Administration website revealed that new drug saxagliptin from Bristol-Myers Squibb Co. and AstraZeneca PLC did not cause an increase in risk for cardiovascular conditions such as heart attack and stroke, a side effect which has been observed in other diabetes drugs.
The review was released in advance of a scheduled Endocrinologic and Metabolic Drugs Advisory Committee meeting on April 1.
Since 2008, the FDA adopted more stringent standards for reviewing anti-diabetic medication, asking companies to prove that their drug will not trigger an increase in risk for heart attack or stroke. In June, the agency increased their safety requirements even further after the controversy that surrounded the drug Avandia (rosiglitazone), which was said to trigger an increase in the risk for cardiovascular conditions.
The new pill was able to meet the cardiovascular safety guidelines set by the FDA. The Advisory Committee meeting will consider these findings and will provide their opinions on the data, which were taken from trials that were not designed to evaluate such risks. They will not be asked to take a vote on an overall approval recommendation for the drug.
Drug manufacturers are actively developing new diabetes treatments for the estimated 24 million Americans suffering from the disease, especially since older therapies have been seen to cause heart risks.
Saxagliptin is similar to the Merck drug Januvia, a DPP-4 inhibitor. Januvia is a treatment for Type 2 diabetes by stimulating the pancreas to produce more insulin and the liver to produce less glucose.
There were eight studies conducted. In four studies, patients were given either saxagliptin or placebo; in three, saxagliptin was added to an existing anti-diabetic treatment; and the last study consisted of patients receiving a combination of saxagliptin and metformin.
Afinitor is classified as a kinase inhibitor, and works by blocking the mTOR protein. mTOR assists in the division of cancer cells and the growth of blood vessels, and by blocking the protein, Afinitor is able to delay the growth and spread of cancer cells. Although Afinitor lagged behind Torisel from Wyeth, a drug with the same properties which was released earlier, it may possess an added marketing advantage since it is a daily pill to be taken orally. The pioneering Torisel is administered through weekly injections.
Darwin Labarthe, MD, PhD, the director of the Division for Heart Disease and Stroke Prevention of the CDC, has expressed that this may be hurting a significant majority of the population. Excessive consumption of sodium is a known risk factor for developing heart disease and stroke. Salt intake triggers an increase in blood pressure, and high blood pressure consequently increases risk for these diseases. An act as simple as lowering salt intake can significantly help remove this risk.
Another temptation to resist is turning to alcohol. I have a rather personal experience regarding this, as my grandfather dealt with post-war depression by turning to the bottle and tobacco. What followed was a series of heart, lung and gastro-intestinal issues that eventually claimed his life.
Recession can trigger stress, anxiety and depression – factors that can affect the heart. Stress may lead to accelerated artherosclerosis or hardening of the arteries, elevated blood pressure and increased heart rate.
The bill, which was unanimously approved by the House of Representatives (116-0), allows the Illinois High School Association (IHSA) to conduct random steroid testing at any point during the sports season from a test pool composed of all participating athletes; currently, testing is only being done among teams who advance to the postseason. The IHSA, which is the governing body for high school athletics in Illinois, can also disqualify a player who tests positive. The player’s school can determine the accompanying penalty on a case to case basis.
This news is rather chilling, and leads us to question whether this same scenario is happening anywhere else. It gives an entirely new meaning to drinking and driving. If taking the wheel after a few drinks is deemed irresponsible, there is no way to describe drinking and flying, when the lives of almost a hundred people depend on your ability to think clearly.
The esophagus is the muscular tube that carries anything that is taken in through the mouth – such as food and beverages – into the stomach. Cancers of the esophagus claims the lives of more than half a million people annually. The most common type of throat cancer is esophageal squamous cell carcinoma (OSCC). The main cause of throat cancer in Europe and America is the use of tobacco and alcohol, but consuming hot beverages has also been thought to be a risk factor. Throat cancer is more common in men than in women.
An increase in cholesterol levels is generally brought about by a person’s lifestyle and eating habits. Unfortunately, as most people deal with the challenges and pressures of urban living and career building, what commonly follows is the development of an unhealthy lifestyle. Fortunately, though, it is exactly this very same urban lifestyle and consequent fascination for gadgets that may well pave the way towards a healthier life for the young urban professional.
The results of the study, which was conducted in collaboration with the Living Heart Foundation, is scheduled to be presented on Tuesday, March 31, at the American College of Cardiology Annual Scientific Session in Orlando.

