MiniMed Says Its Insulin Pump Has Software Error

MiniMed Inc., the manufacturer of insulin pumps as well as other diabetes devices, is notifying customers who have purchased the Model 508 insulin pump on sale since October 4 this year that a software error could occur in some of these pumps. Pumps affected include those containing "02A" near the end of their serial number. 

The problem appears to be created when the user changes two or more basal rates after the initial basal rates have been set. MiniMed says that this can cause unwanted changes in the timing of the new basal rates. The notification sent to users contains specific programming instructions for "zeroing out" the current basal rates and times before programming in the new rates to eliminate this "rare and minor" error. 

All pumps shipped since November 18 when the notification went out contain upgraded software. MiniMed says it plans to recall and reprogram the pumps already sent out which contain the software problem.  

MiniMed plans to begin upgrading the software in the affected pumps early next year. Initial estimates for the cost for this notification and "software upgrade" was projected to be between $1 million and $1.5 million.

Treat Hypertension In The Elderly 

A first in a series of landmark studies from the Swedish Hypertension Society published in The Lancet shows that treating high blood pressure in the elderly using any of the standard hypertension drugs saves lives. The significant finding in this study is that newer therapies with fewer side effects are as effective as older drugs which may have side effects the elderly can not tolerate. These side effects often means that hypertension goes untreated. Since the study provides physicians with a wider range of effective treatments to match to individual patients, it encourages aggressive treatment which will save lives. 

This study, called the Swedish Trial in Old Patients with Hypertension-2 (STOP-2), had 6,614 participants between 70 and 84 years old randomized to once-daily treatment with ACE inhibitors (lisinopril 10-20mg, enalapril 10-20 mg), beta blockers (atenolol 50 mg, metoprolol 100 mg, pindolol 5 mg), calcium antagonists (felodipine 2.5-5 mg, isradipine 2.5-5 mg) or a diuretic (hydrochlorothiazide 25 mg, amiloride 2.5 mg). It pitted newer treatments for hypertension like ACE inhibitors and calcium antagonists in a head-to-head comparison to older treatments like beta-blockers and diuretics. The study found that the newer treatments were just as effective at lowering high blood pressure.

The study was designed to research the effect of these treatments primarily on a combination of fatal stroke, fatal heart attack, and other fatal cardiovascular disease. Secondary goals of the study included incidence of fatal and non-fatal cardiovascular disease, mortality from all causes, development of Type 2 diabetes, heart failure or atrial fibrillation, need for institutional care, drug side effects and healthcare economics. Additional data from this large study is expected to be published in upcoming research publications. 

STOP-2 reinforces the findings of other studies including the Hypertension Optimal Treatment (HOT) Study and the United Kingdom Prospective Diabetes Study (UKPDS) and supports the 1999 guidelines for the aggressive management of hypertension by six major drug classes. These guidelines were issued by the World Health Organization (WHO) and the International Society of Hypertension (ISH). STOP-2 is the first major trial to compare the different classes of blood pressure drugs. 

The study also shows that the ACE inhibitors used in the study are as effective as diuretics and beta-blockers in reducing fatal and non-fatal stroke. Calcium antagonists were shown to prevent cardiovascular episodes as well as ACE inhibitors and older therapies. The STOP-2 study was sponsored by drug manufacturers AstraZeneca, Merck Sharpe & Dohme and Novartis.

New Fat Fighting Drugs On The Horizon

A recent issue of the Journal of the American Medical Association (JAMA) reviewed current obesity research, including details of the problem and some upcoming solutions. Responding to one article in the journal regarding research using the hormone leptin, Hoffmann-La Roche Inc. representatives cautioned that promising weight loss results from leptin should not lead people to believe that a prescription drug will be available anytime soon. 

The research cited required daily injections of high levels of leptin for several months before obese patients lost significant amounts of weight. Although these results show that leptin, a hormone produced by fat cells that works in the brain to suppress appetite, can effectively reduce weight, the ideal drug would be one taken orally. 

Roche is also studying melanocortin 4 (MC4), a brain receptor that regulates appetite. Recent research shows that a selective MC4 agonist or mimic causes weight loss in animals. In addition to the MC4 receptor, other potential areas for obesity research include CRH, corticosterone releasing hormone; NPY, neuropeptide Y; AgRP, agouti-related protein; MCH, melonin-concentrating hormone and orexins.

Fat Fighter Xenical's Effectiveness Confirmed

Two new studies confirm the results of one and two year clinical trials that showed Xenical is an effective weight reduction drug because of its action on fat in the gastrointestinal tract. Data from these studies was announced at the Annual Congress of the North American Association for the Study of Obesity (NAASO) in Charleston. 

One study conducted in high-risk obese patients showed Xenical is effective when added to a reduced calorie diet in long-term obesity treatment. The weight loss which occurs improves some of the risk factors associated with obesity. In another short term study, Xenical blocked as much as 40% of fat in the diet in healthy adults. 

In the results of the first 24-month, randomized, placebo-controlled study, Jon Hauptman, MD, presented data that evaluated long-term obesity management with diet and Xenical. Results showed 66.7% and 37.9% of subjects treated with a reduced-calorie diet and Xenical sustained 5% and 10% loss of their initial weight, compared to 54.8% and 26.7% of diet and placebo patients. A 5-10% drop in weight is sufficient to improve weight-related risk factors for coronary heart disease and diabetes. Patients who lost weight with Xenical also showed a decrease in cholesterol, fasting blood glucose and diastolic blood pressure compared to the placebo group.

In a second, smaller short-term study, Xenical's fat absorption action was compared to Chitosan, an over-the-counter homeopathic supplement not regulated or approved by FDA. Principal investigator, Hans Lengsfeld, MD, presented data suggesting that Xenical inhibits fat absorption from a standard meal by approximately 40%, while Chitosan, a dietary fiber extracted from crustacean shells, has minimal effect. The study measured the amount of dietary fat in the fecal excretions of 23 healthy volunteers who received 120mg of Xenical or 750mg of Chitosan during a standardized test meal containing 30-35g of fat.

Xenical, the only prescription lipase inhibitor approved by the FDA, blocks the absorption of dietary fat by approximately 1/3. Other anti-obesity agents work in the brain to suppress appetite, but this drug works in the gastrointestinal tract and does not enter into the bloodstream or brain. It is recommended for use three times daily with meals that contain up to 30% of calories from fat, consistent with current U.S. dietary guidelines. 

Gastrointestinal symptoms are the most common side effects associated with the its use. Because the drug blocks some fat absorption, it can also reduce absorption of some fat-soluble vitamins. Therefore patients are advised to take a daily multi-vitamin supplement containing vitamins D, E, K and beta-carotene.

Topical Impotence Drug Undergoing Tests

Topiglan, a topical drug for impotence, has passed a test showing that it has no negative effects on female partners during or after vaginal intercourse, reports MacroChem Corporation, its developer. In the September Journal of Urology, the drug had already demonstrated that it enables erections in 75% of men who had previously been able to achieve erection using alprostadil injections.

Topiglan works by temporarily reducing the skin's resistance to absorbing alprostadil, the drug usually injected into the penis or inserted into the urethra to encourage an erection. Alprostadil, also known as prostaglandin E1, is a natural ingredient in semen. Of major concern was whether some of the alprostadil in Topiglan transfers to a female partner during intercourse, and if so, what systemic or local effects does it cause. But the topical drug passed the test in a double-blind, placebo-controlled, randomized study. It caused no systemic effects in female partners during or after vaginal intercourse with males who had applied the drug to their penises 15 minutes earlier. Vital signs were monitored up to 8 hours after coitus. 

Impotence often occurs because of atherosclerosis or diabetes, conditions which constrict blood vessels, restricting blood flow into the penis. Most of the oral drugs used in treating impotence are vasodilators, drugs that dilate blood vessels. However, individuals with a history of vascular disease may be at some risk if vasodilators, intended for local use in the penis, also dilate arteries and veins of the heart or brain, or intensify the effects of nitrate-containing drugs used to treat symptoms of heart disease. Alprostadil in Topiglan is also a vasodilator, but because it's applied topically to the penis, effects only penile blood vessels and doesn't interact with systemwide nitrate drugs. 

In this Phase II trial reported at Boston University, a 1% alprostadil formulation of Topiglan induced intercourse-capable erections, displayed no evidence of systemic vasodilation, and began inducing erections in as little as 15 minutes after application six times more often than a placebo. In the study, 37 couples were divided into two groups. Of the 36 couples completing the study, one group was randomly given a half-strength Topiglan dose or placebo; the second group received a full 1% Topiglan dose or placebo. Twice as many couples received Topiglan as placebo. Some local effects were noted in both Topiglan and placebo groups, in both men and women though mostly in the males. The effects were thought to be caused by the cream used to apply the alprostadil. 

New Insulin Skin Patch

A patch administering human insulin has effectively reduced blood sugar levels for more than two days in animal studies. Results of this animal study was presented in New Orleans at the Annual Meeting of the Association of American Pharmaceutical Scientists by Dr. Martin King. Reduced and stabilized blood sugar levels were observed in the diabetic rats for 50 hours following the application of a single patch, designed by Helix BioPharma Corp. Scheduling for the long-term goal of this research, development of an insulin patch for use in humans, has yet to be annuounced.

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