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Archive - 12 - 2006

Once-Diabetic Heart/Kidney/Pancreas Transplant Recipient Enjoys Life (And Eating Again)

Posted by dlife on Thu, Dec 28, 06, 02:02 PM 0 Comment

December 28, 2006 (Newswise) At holiday dinners this year, Calabasas, Calif., resident Jim Stavis, 52, was able to eat the same pumpkin pie and special desserts everyone else had, not the sugar-free variety. And when dinner was over, he didnt have to reach for his insulin pump to try to compensate. A pancreas transplant performed at Cedars-Sinai Medical Center in late October cured him of diabetes, which had controlled his life for 35 years.Oh, and a heart and kidney transplant performed at the same place and same time the year before saved his life. Only about eight patients in the United States have received simultaneous transplants of a heart, kidney and pancreas since 1992, according to the Organ Procurement and Transplantation Network (OPTN), and the first European patient to receive this combination of organs simultaneously was reported to be in good health 11 years after the procedure. If a combination like Jims heart and kidney, followed later by a pancreas transplant has been performed, it does not appear to be documented in medical literature. In any case, Jim is among elite company worldwide.Jim was diagnosed with diabetes when he was 17. I was told, back in the early 70s, that having diabetes meant a life of potential amputations, blindness, kidney disease and other problems. He decided to adopt a positive outlook, managing his health as best he could, and accepting life and its challenges as they came. He remained relatively healthy for about 20 years but began to encounter diabetes-related complications such as a blocked coronary artery in the late 1990s. Under the care of cardiologist P.K. Shah, M.D., director of Cedars-Sinais Division of Cardiology and the Atherosclerosis Research Center, Jim was able to manage his heart problems conservatively until more serious problems emerged.In the winter of 2004, we went to visit my daughter at her college in Madison, Wisconsin for Parents Weekend and my kidneys shut down and I went into congestive heart failure, Jim says. That was a big signal that I needed to do something.After more than a week in a hospital in Madison, he came home and saw Shah, who said he would need a heart and kidney transplant, followed by a pancreas transplant.He described the heart and the kidneys as the targets of diabetes, and the pancreas as the trigger. Just addressing the target, without eliminating the trigger, would have created a situation that could jeopardize the new organs, Jim recalls. The first transplants were performed in November 2005. J. Louis Cohen, M.D., surgical director of Kidney Transplantation and medical director of Operating Room Services, headed the kidney transplant team. Alfredo Trento, M.D., chair of the Division of Cardiothoracic Surgery performed the heart transplant, and Lawrence S.C. Czer, medical director of the Heart Transplant Program and director of Transplantation Cardiology, served as Jims primary cardiologist.Two specialists joining Cedars-Sinai, one in 2005 and one in 2006, also became members of Jims medical team: cardiologist Ernst R. Schwarz, M.D., Ph.D., who specializes in several aspects of cardiology, including cardiac transplantation; and Donald C. Dafoe, M.D., director of Pancreas Transplantation. Pancreas transplantation is a relatively new development in the field. It is fairly uncommon and usually performed only in conjunction with a kidney transplant. Dafoe is one of the nations leading pancreas transplant surgeons.Jims operations and recoveries have gone so well that he expects to be golfing and working out by January. Since November, he has returned to work two or three days a week.When Dr. Dafoe came out of surgery to talk to my family and friends in the waiting area, he said, Im happy to report that Jim Stavis is no longer a diabetic, says the owner of a metal fabricating and distributing company in Long Beach. That in itself is quite a statement. When I was a teenager, I hoped there would someday be a cure for diabetes, but I never thought my cure would happen this way. Back then, we never imagined that pancreas transplants were possible.Some aspects of instantly becoming a non-diabetic have taken some adjustment while others have not, Jim says. It seems strange to be permitted to eat normally and enjoy traditional pumpkin pie after 35 years. But it was easy to give up the inconvenience that goes along with managing diabetes.I used to have an insulin pump, so when I would eat I would have to manually put in how much insulin I needed to take after a meal, he says. People have asked me, Isnt it weird to suddenly be able to eat and not reach for the pump? And the reality is that habit was broken in about a minute. I never for a moment looked back.One of seven hospitals in California whose nurses have been honored with the prestigious Magnet designation, Cedars-Sinai Medical Center is one of the largest nonprofit academic medical centers in the Western United States. For 19 consecutive years, it has been named Los Angeles most preferred hospital for all health needs in an independent survey of area residents. Cedars-Sinai is internationally renowned for its diagnostic and treatment capabilities and its broad spectrum of programs and services, as well as breakthroughs in biomedical research and superlative medical education. It ranks among the top 10 non-university hospitals in the nation for its research activities and is fully accredited by the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP). Additional information is available at http://www.cedars-sinai.edu.

FDA Approves BYETTA® (exenatide) Injection for Expanded Combination Use

Posted by dlife on Fri, Dec 22, 06, 01:59 PM 0 Comment

Dec 22, 2006 (>PRNewswire-FirstCall via COMTEX News Network) -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved BYETTA (exenatide) injection as an add-on therapy to improve blood sugar control in people with type 2 diabetes who have not achieved adequate control on a thiazolidinedione (TZD). Healthcare professionals will be educated on this additional use for BYETTA in the coming weeks. In a clinical trial designed to evaluate BYETTA for use in combination with a TZD, 62 percent of patients who added BYETTA to their existing medicines achieved an A1C (a measure of blood glucose levels over time) of 7 percent or less, compared to 16 percent of the patients on placebo. People taking BYETTA also lost an average of 3.3 pounds over 16 weeks, compared to an average weight reduction of 0.4 pounds in the other group. The most common adverse event associated with BYETTA was nausea (40 percent)(1)(2). "Due to the progressive nature of type 2 diabetes, previous approaches to management frequently failed to achieve target levels of A1C, or resulted in subsequent failure over one to three years," said Dr. Robert Ratner, Vice President for Scientific Affairs at the MedStar Research Institute in Washington, DC. "The combination of exenatide with metformin, sulfonylureas, or TZDs not only expands our options to achieve optimal glycemic control, but does so with accompanying weight loss." BYETTA improves blood sugar control by lowering both post-meal and fasting (early morning) glucose levels resulting in better long-term control as measured by A1C. BYETTA controls blood sugar through several physiologic actions, including the stimulation of insulin secretion only when blood sugar is high. BYETTA restores the first-phase insulin response (an activity of the cells in the pancreas that is lost in patients who have type 2 diabetes), decreases glucose output from the liver, regulates gastric emptying, and decreases food intake. The majority of patients in long-term BYETTA clinical studies also experienced weight loss. "Almost half a million people with type 2 diabetes have used BYETTA to help reduce their blood sugar," said Ginger L. Graham, Chief Executive Officer, Amylin Pharmaceuticals. "Now, even more people -- those who use another common category of oral medicines, TZDs -- have a new treatment option and have the opportunity to benefit from the unique clinical benefits of BYETTA." "There are two core defects to type 2 diabetes, beta cell failure and insulin resistance," said Vince Mihalik, Global Brand Development Leader for Diabetes and Endocrine, Lilly. "The ability of BYETTA to improve beta cell responsiveness and lower weight complements the TZD effect on insulin resistance very nicely."

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