Diabetes This Week
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New Insulin-Like Compound Found In Fugus
In an article in Science magazine, researchers say they tested more than 50,000 natural and synthetic substances before finding a compound, derived from the fungus, Pseudomassaria, that acts like insulin. Like many similar "breakthroughs" of the past, this again raises the possibility that those who use insulin might in the future take pills instead of shots. Merck Research Laboratory Scientists isolated the insulin-like compound from a fungus found in the jungles of Congo in West Africa. When tested on mice with diabetes, they found that it significantly lowered the sugar in the animals' blood.
The researchers said the compound, called L-783,281, is a mimic of insulin, the natural hormone that allows the body to metabolize sugar. It was found to be promising in test tube studies, so the researchers carried it to the next step testing it on animals. Like insulin, L-783,281 links up with a specific molecule on the surface of each cell which activates an enzyme that sets off a series of biological steps, enabling the cells to absorb and use sugar. But unlike insulin, can be taken as pills. The compound can be absorbed by the digestive system and still act on the cells of the body.
The new compound has the benefit of acting on the insulin receptor, which may make it a "cleaner" drug, other than the possibility of hypoglycemia. However, researchers do not yet know if it may also work on other types of receptors where activation may be unwanted. L-783,281 might also suffer if it is unable to perform all of insulin's actions, such as being able to suppress lipogenesis or fat formation. 800,000 people are newly diagnosed with diabetes each year in the U.S. and this number is rising. Once diabetes is diagnosed, insulin production continues to fall gradually, and no therapy stops this progressive loss. In everyone with diabetes, insulin therapy becomes necessary for keeping blood sugars controlled and avoiding diabetes complications after a certain number of years. L-783,281 or some derivative of it may aid in this effort.
New Glitazones Create Competition
The world of Warner-Lambert Co.'s Rezulin, an oral diabetes treatment currently used by 1.6 million people with diabetes, is about to be shaken. Two similar medicines, Takeda Chemical Industries' Actos and SmithKline Beecham's Avandia are likely to be released this summer as second generation glitazones. An additional two to three glitazones are expected to be released over the next 18 months.
Which of these drugs will emerge as the leader is unclear. Although Rezulin was released first, its problem with severe liver damage, even though rare, has caused concern in many users and physicians. But whether the new glitazone drugs are any less likely to create liver damage is not known yet. No liver damage was seen with either of the new drugs in clinical studies done for the FDA. But Warner-Lambert contends that those drugs' safety profiles will remain unknown until thousands of patients have taken the newer drugs for several months. "You don't know what the drugs are going to do until they're in 100,000 people," Warner-Lambert Chief Executive Melvin R. Goodes said at the company's annual meeting. Once Actos and Avandia reach the market, "We will then do head-to-head studies," he said.
Glucophage (metformin), which is not a glitazone, showed very good outcomes in the UKPDS Study in England and Europe. Significant reductions were seen in diabetes complications as well as in heart attack rates (when all metformin users were included in the comparison), as well as a decrease in death rates for overweight patients. Part of these benefits in believed to be due to metformin's favorable effects on cholesterol levels. The glitazones do not have the same effects as metformin on cholesterol and lipids, and this may limit their health benefit. Only a head to head comparison of metformin to some of the glitazone drugs will let users and physicians know which drugs may be best.
Rezulin is a glitazone that has been linked to Vitamin E to create a long-acting antioxidant. This might also have some overall benefits compared to some of the other glitazones, but again this has not been tested. Rezulin generated sales of $748 million, or 7 percent of the company's total, in 1998. Indianapolis-based Eli Lilly & Co., which markets Actos for Takeda America in Princeton, expects sales of $500 million to $600 million in the U.S. next year, and Avandia sales are expected to be similar.
High Blood Pressure Dashed By Diet
High blood pressure drops on the DASH diet, also known as the "Dietary Approaches to Stop Hypertension" clinical study. The study, paid for by the National Institutes of Health, involved more than 400 people with mild high blood pressure who ate a diet rich in grains, fruits, vegetables and low-fat dairy for eight weeks. Participants did not lower their salt intake, alcohol intake, nor modify exercise. These variables were kept constant so only the diet would effect blood pressure in the study. Calorie intake was also adjusted to keep participant's weight stable so that weight loss could not affect their blood pressure.Many people actually complained of being too full from eating all of the grains, fruits and vegetables.
Results? Well, fantastic! In just two weeks, blood pressures had already dropped significantly with an average drop of 11.4 points systolic (the high number) and 5.5 points diastolic (the low number). Furthermore, the drop was maintained throughout the study and the drop is the same if one were to start on blood-pressure medications. The DASH diet appears to be an excellent combination to existing blood pressure treatment. Some 50 million Americans have hypertension or high blood pressure, which remains a leading cause of strokes and heart attacks.
Unlike the average American diet, the DASH diet is rich in fruits, vegetables and low-fat dairy foods, but low in saturated and total fat. The overall fat level contributes less than 30 percent of the total calories. The diet is also low in cholesterol, but high in dietary fiber, potassium, calcium and magnesium.Participants in the study consumed a total of 2,000 calories a day, ate 7 to 8 servings of grain foods; 4 to 5 servings of vegetables; 4 to 5 servings of fruits; 2 to 3 servings of low-fat or non-fat dairy foods; 6 ounces or less of animal protein, 1 serving of nuts, seeds and legumes, and 2.5 servings of fat. For more information, a 16 page document in Adobe format may be obtained at the National Institutes of Health Web site.
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For information on how many calories or fat grams a particular food has, visit the U.S. Department of Agriculture . More information on research on fruits and vegetables is available from the The Better Health Foundation. |
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BP Cuffs Available
For the visually impaired, A&D Medical has just introduced the Talking Blood Pressure Monitor, the first blood pressure monitor with voice readout. Steve Hibbard, business unit director, medical division, A&D Medical cites diabetes as the leading cause of blindness among Americans aged 10-to-74. The number of people over the age of 65 is projected to rise from 390 million today to 800 million by the year 2025, and over 80 percent of circulatory disease deaths will occur in people over 65. Hypertension ranks as the second most frequently occurring condition among the elderly.
Less TV Equals Less Weight In Kids
A Stanford University study, presented at the Pediatric Academic Societies annual meeting in San Francisco, suggests that, for grade-school children, watching less television may be a key to limiting weight gain. Children involved in a one-year curriculum to reduce their TV viewing gained significantly less body fat compared to a control group of peers. The study of 192 third and fourth graders from two San Jose elementary schools is showed not only a connection between watching TV and weight gain, but it also showed some of the first evidence that a behavioral program delivered in schools can motivate children to reduce their television viewing, according to study author, Thomas N. Robinson, MD, assistant professor of pediatrics and medicine at Stanford University.
American children spend, on average, more than four hours a day watching TV and videos or playing video games, adding up to 60 full days each year spent in front of the tube. Meanwhile childhood obesity has sky-rocketed, doubling in the last 20 years. Type 2 or obesity-related diabetes now makes up 25% of cases of new diabetes in children in many locations. Local education officials in San Jose picked two schools with similar ethnic composition, socioeconomic standing and scholastic achievement for the study.
At one school, children received an 18 lesson program, presented by classroom teachers as part of the normal school curriculum, that was designed to reduce TV and videotape watching and video game playing. TV reduction lessons began by encouraging children to keep track of how much time they spent watching TV. Next, the children were encouraged to go 10 days without TV and two-thirds accomplished this. Then the lessons turned to setting TV watching limits of 7 hours per week and becoming more selective viewers.
Children attending this school reduced their television watching by about one-third compared with their peers. More importantly, they also showed a significantly smaller increase in waist size, waist-to-hip ratio and body mass index, a measure of weight adjusted for height. On average, pupils at the TV-reduction school gained nearly 2 pounds less than the average student at the control school. Dr. Robinson believes that, freed from the TV, children may simply have been moving around more, though this kind of activity is extremely difficult to measure. Another possibility is that the difference in weight stemmed from how many meals the kids ate in front of the TV. Robinson has subsequently received a grant from the National Heart, Lung and Blood Institute to replicate his study with 900 students in 12 elementary schools. Might also be a great group to check to see if reduced TV/video watching leads to less violence.
Statins Shown To Reduce Cardiac Risk Factors In Women
Heart disease kills more than 500,000 American women a year, more deaths than the next 16 causes combined. Its incidence increases sharply in postmenopausal women, probably triggered by the decline in estrogen levels as menopause is reached which results in higher LDL-C ("bad" cholesterol) levels and lower HDL- C ("good" cholesterol) levels. A new Canadian study called the Women's Atorvastatin (LIPITOR) Trial on Cholesterol or WATCH study supports the use of statins as first line drug therapy for lowering high blood cholesterol levels in post menopausal women. The American Heart Association and American College of Cardiology together recommend statin use for postmenopausal women in the scientific statement, "Guide to Preventive Cardiology for Women," published in the Journal of the American College of Cardiology.
The WATCH study was funded by Parke-Davis Canada and Pfizer Canada Inc. "The WATCH results provide physicians with the valuable information needed to adequately treat women with coronary and other atherosclerotic diseases, or heart disease risk factors to appropriate LDL-C target levels," said Dr. Jacques Genest Jr., principal co-investigator of the study. "Not only did the majority of women reach established U.S. LDL-C target levels, but they also met the more aggressive new recommended Canadian cholesterol treatment guidelines recently developed," added Dr. Genest Jr., also co-author of the Canadian Working Group recommendations. The 16-week study, conducted at 43 centers in Canada with 318 women aged 18 to 75 years, determined that when patients were put on Lipitor (an HMG-CoA reductase inhibitor, or "statin.") at doses between 10 mg and 80 mg once a day, 87 per cent of women with two or more risk factors for coronary heart disease (CHD) reached target LDL-C levels, while 81 per cent of women with established CHD reached target LDL-C levels.
"There is a significant difference in women and men when it comes to assessing heart disease, identifying risk factors and determining treatment," said Dr. Ruth McPherson, WATCH principal co-investigator from the Lipoprotein & Atherosclerosis Group, at the University of Ottawa Heart Institute. "The WATCH results show us that women with either established CHD or CHD risk factors, and treated with Lipitor, can reach or surpass treatment targets as both study groups achieved dramatic and comparable results," added Dr. McPherson. Lipitor was well tolerated with a rate of discontinuation similar to that seen in the placebo group, with fewer than 2 percent of patients being discontinued from clinical trials due to side effects. Side effects included constipation, flatulence, dyspepsia and abdominal pain. Liver function tests are recommended prior to and at 12 weeks following both the start of therapy and with any elevation of dose, and periodically thereafter. Myopathy should be considered in any patient with diffuse myalgias, muscle tenderness or weakness and/or marked elevation of creatine phosphokinase (CPK).
Two Davids Make A Goliath?
Although, Integ Incorporated does not yet have revenues, Susan L. Critzer, president and chief executive officer, commented, "In the first quarter of 1999, we achieved a major goal for the company by finalizing a strategic alliance with Amira Medical that will accelerate development of Integ's LifeGuide(TM) System. "Our alliance, with Amira Medical of Scotts Valley, Calif., will allow us to move forward quickly with the LifeGuide System by combining Integ's ISF collection technology with Amira's proven measurement micro-technology," said Critzer. "The design of the first prototype system integrating these two technologies is nearly complete and we will begin testing using this system in the second quarter. We are in the process of finalizing our joint product development plans and will announce timing for clinical trials as soon as we have completed this planning process."
Amira is currently introducing it's AtLast(TM) system, the first all-in-one blood glucose system to eliminate fingersticks, using their proprietary micro-technology. Integ is developing the LifeGuide(TM) System, a hand-held glucose monitoring product that uses interstitial fluid (ISF), the clear fluid found between cells throughout the body. Because the quantities of ISF are small, Amira's micro-technology may aid their quest.
Shorts
Meanwhile, SpectRx is developing bloodless personal diabetic glucose monitoring products with Abbott Laboratories, and a non-invasive diabetes detection product with Roche Diagnostics.
New guidelines have been released for contraceptive use in women with diabetes by the World Health Organization. All modern contraceptive methods are good choices for women with diabetes who do not have vascular disease. For women with vascular disease or who have had diabetes for more than 20 years, the intrauterine device (IUD) is a good method, as well as some hormonal contraceptives (Norplant and oral contraceptives that use only progestin) are second choices.However, oral contraceptives that use both estrogen and progestin, and injectable contraception are usually unacceptable or undesirable. While male or female sterilization is a good option for those with diabetes, extra precautions are needed during the surgical procedures.