Gila Monster drug for those with Type 2 Diabetes

There's quite a stir in the medical community about Byetta, a drug that lowers blood sugar and can potentially help extend the lives of those with Type 2 diabetes. Byetta, also called exenatide, is an injectable drug that comes in a pre-filled pen with easy instructions and can be used with metformin, a sulfonylurea, or a thiazolidinedione, though the FDA may approve it for monotherapy. It is a synthetic version of a Gil monster (lizard) venom protein that supports the production and digestion of insulin. The drug is being joint marketed by the companies Amylin and Eli Lilly and was introduced in 2005.

Exciting the medical community is a new major clinical study called 'Accord', which found that those who took Byetta had a 75 percent lower chance of dying than those taking other drugs. The trial had 10,000 patients and although only 825 of the patients took Byetta, those who did showed a much healthier outcome. Even the company's marketing the drug were surprised by the findings.

Sales of the drug are thought to reach nearly $700 million this year alone, though so far prescriptions are not as abundant as they had expected. At present the drug is taken by twice a day injections, though Amylin and Eli Lilly are working on a new formulation which would only require an injection once a week. It has not been approved by the Food and Drug Administration as of yet. Many doctors and patients do not like prescribing and taking the drug because it is an injectable.

Byetta is the first of its kind; a new class of medicines called incretin mimetics. This means it mimics the natural hormones in the body that lower blood sugar. Byetta does come with side effects. The most common is nausea, which can be moderate to severe, but typically subsides over time. There is also a chance of hypoglycemia (low blood sugar), though the chances are much less than other diabetes medicines. It can also cause dizziness, diarrhea, nervousness, vomiting, headache and acid stomach. Many people also lose weight on the drug, typically a few pounds per year.

Although the 'Accord' study is very promising to the medical community, there will still need to be larger trials that would take the cardiac health and the death rates of the patients into question. The larger study will need to be with Byetta and placebos, instead of Byetta and other medicines. There is no current plan for this trial of as yet.

Many suspect that Byetta helps mortality rates due to weight loss and less chances of hypoglycemia.



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