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Another Pill to Help Diabetes

March 31, 2009 By AnaLise Leave a Comment

We continue to find the results of research that help individuals with diabetes have more medication and other tools to control diabetes and the symptoms that go with it. One new discovery is a new diabetes pill from Bristol-Myers Squibb Co. and AstraZeneca PLC did not increase the risk of heart attack or stroke in a US review, boosting shares in New York and London as investors bet the drug will be approved.

The medicine, saxagliptin, meets new guidelines for cardiovascular safety, according to a staff report posted on the Food and Drug Administration’s website. Outside advisers to the FDA will consider the findings when they meet tomorrow to discuss whether the companies should be allowed to sell the drug in the United States under the name Onglyza.

The FDA review of saxagliptin focused primarily on six core studies submitted by Bristol-Myers and AstraZeneca that followed patients for at least one year after the initial three-to-six month study period. It found an overall low rate of major cardiovascular events, according to Monday’s documents. In higher-risk patients, the rates appeared to be similar between patients taking saxagliptin and those getting a placebo or, in one study, the popular diabetes drug metformin, at about 2%.

Drug makers are striving to introduce new treatments for the 24 million Americans with diabetes, as some older therapies pose heart risks and fail to control blood sugar. Bristol-Myers and AstraZeneca need new products to revive sales and replace drugs facing generic competition, and analysts have been worried that safety concerns at the FDA may preclude saxagliptin’s approval.

AstraZeneca agreed in January 2007 to pay Bristol-Myers as much as $1.35 billion for rights to develop and market saxagliptin and another diabetes drug called dapagliflozin. AstraZeneca’s share of annual sales may reach $578 million in 2015 and $893 million by 2018, according to Deutsche Bank AG analyst Brian Bourdot.

An FDA panel will also consider liraglutide, an experimental shot for diabetes made by Novo Nordisk A/S. The agency usually follows the recommendations of its advisers.

Filed Under: Diabetes News Tagged With: diabetes, diabetes control, diabetes medication, diabetes treatment, heart disease

Good News about Diabetes Control

March 31, 2009 By AnaLise Leave a Comment

The search for medications and treatments for individuals with diabetes continues aggressively and is making strides. There is some good news that just came out regarding the medication Byetta that many individuals with diabetes are using to help control their diabetes, is doing even better than thought.

The experimental long-acting version of Byetta, being developed by Amylin Pharmaceuticals Inc (AMLN.O) and Eli Lilly and Co (LLY.N), demonstrated superior blood sugar control and weight loss when compared to two other widely used diabetes medicines in a head-to-head study.

The drug only needs to be taken once a week and in this time when the economy is so difficult, the results of the research about Byetta sent Amylin shares up as much as 19 percent on Tuesday, while shares of Lilly, the much larger drugmaker, were 2 percent higher.

Amylin expects to file for regulatory approval of once weekly Byetta by the end of June. The version of Byetta currently on the market is typically injected twice a day. This would eliminate a lot of injections and control diabetes in most individuals much better than the options they have now.

The 26-week study compared Byetta LAR, also known as exenatide once weekly, with maximum doses of Merck & Co Inc’s (MRK.N) Januvia, known chemically as sitagliptin, and pioglitazone, sold under the brand name Actos by Japan’s Takeda Pharmaceutical Co Ltd (4502.T).

Type 2 diabetes patients taking Byetta LAR experienced a reduction in A1C — a measure of average blood sugar over three months — which wa more than the other medications and these results are significant because they can change the way diabtes is treated and controlled in the near future. In addition, there has been excellent weight loss during the study and researchers feel that the weight loss wil increase over the next trial.

Some quotes and statistics from Reuters.

Filed Under: Diabetes News Tagged With: diabetes, diabetes control, diabetes medication, Diabetes Research, diabetes treatment

Diabetes Medication Can Create Heart Problems

January 22, 2009 By AnaLise Leave a Comment

One high risk for individuals with diabetes is heart disease. Many individuals that have diabetes, high blood pressure or other vascular complications, could have serious complications including heart disease. In addition, one problem is that many medications are believed to increase the risk of heart disease leading to heart attack. Most of these medications are not being tested for their effects on the heart

Pharmaceutical companies have not been doing much testing for heart problems because it takes longer to get the medications approved if these tests are performed and it costs the pharmaceutical companies more money. As a result, tests and clinical trials are not usually unless problems are reported by users after the fact.

Things have recently changed. A Food and Drug Administration (FDA) advisory panel made up of outside medical experts voted this summer to have the FDA require drug makers to perform long term testing which is critical because heart disease and heart related and other cardiovascular issues are primary causes of death in many people with diabetes. If diabetes medication is causing or contributing to those causes it is critical to find out which medicines – if any – are causing the problems.

Because this is an FDA Advisory Panel and not the Congress recommending long-term studies of medication for diabetes, it is not mandatory at this point. However, the FDA usually follows what the advisory boards suggest to them. In addition, there are steps that the FDA can take to create recommendations that are stronger and guidelines that push medication manufacturers to perform these long-term tests.

Until then is important to be informed about as much as possible – especially the side effects – of your diabetes medication. If you have any doubts or concerns, do your homework. Check the web, ask your doctor. Take care of your diabetes and the rest of your health.

Filed Under: Diabetes News Tagged With: diabetes, diabetes medication, FDA, heart problem