Tolazamide

The National Institutes of Health has two words for the 10 million adults in the United States who are currently at high risk for adult onset diabetes--diet and exercise.

Adult onset (type 2) diabetes, the most common form of the disease in the United States, often results from having too much of several good things: cakes, pies and cookies, to name a few. A recent nationwide clinical study of more than 3,200 people enrolled in the NIH study concluded that most people at risk for the disease could sharply lower their chances of getting it with proper diet and exercise. Forty five percent of those enrolled in the study were members of minority groups, which often suffer disproportionately from the disease, including African-Americans, Hispanics, Asians, Pacific Islanders and American Indians.

The study, called the "Diabetes Prevention Program," compared the effectiveness of lifestyle modification with the drug Glucophage (metformin) by Bristol-Myers Squibb in reducing the risk of diabetes. Participants assigned to the "lifestyle intervention" group reduced their risk of getting type 2 diabetes by 58 percent. On average, this group maintained their physical activity at 30 minutes per day, usually with walking or other moderate intensity exercise and lost 5 percent to 7 percent of their body weight. Enrollees taking metformin reduced their risk of getting type 2 diabetes by about 31 percent.

"In view of the rapidly rising rates of obesity and diabetes in America, this good news couldn't come at a better time," Health and Human Services secretary Tommy Thompson said regarding the results. "So many of our health problems can be avoided through diet, exercise and making sure we take care of ourselves."

An article in last month's New England Journal of Medicine reached many of the same conclusions.

Pharmacy products and services

Clearly, this prevalent and treatable disease presents a marketplace full of possibilities for retail pharmacy, while they also can perform a real public health service through their efforts. About 16 million people in the United States have diabetes, 5.4 million of these are unaware they have the condition, and almost 800,000 new cases are diagnosed each year. That's because the vast majority of these cases are type 2, non-insulin dependent diabetics. Unfortunately, this initially silent condition of high levels of glucose in the blood can wreak havoc throughout the body, contributing to heart disease (the leading cause of diabetes-related deaths), strokes, high blood pressure, blindness, kidney disease, nervous system disease, amputations, dental diseases (especially gum problems), pregnancy complications, impotence and frequents bouts of pneumonia and flu.

Pharmacists and pharmacy retailers can play a big part in both diabetes prevention and maintenance, serving as their customers' local point of access for prevention, education and maintenance for and about their disease. Indeed, several of the prevention program's corporate supporters--Bristol-Myers Squibb, Merck and Co., Hoechst Marion Roussell, Lifescan, Slimfast and Health-O-Meter--are some of retail pharmacy's biggest suppliers.

It isn't hard to see why health and medical suppliers have an interest in following the course of this disease in the United States. Ninety-eight billion dollars in medical expenses are related to diabetic care each year. Indirect costs account for about $54 billion. Of the indirect costs, close to $8 billion goes toward controlling diabetes and blood sugar levels, and $11.8 billion goes to treat related chronic conditions such as circulatory, kidney, eye, nerve and skin disorders. Each diabetic spends an average $3,500 for supplies annually, according to one industry professional.

Categories to watch

Here are some product categories to keep an eye on in the penumbra of this prevalent but highly treatable disease. The large majority of diabetic patients want their disease to be as unobtrusive and low-maintenance as possible, and many new products have been driven by this concept.

* Drugs: Sales in the Bristol-Myers Squibb's Glucophage (metformin) suite of oral antidiabetic products remain strong. Second quarter sales for the entire Glucophage "franchise," as BMS calls it, increased 57 percent to a whopping $763 million. Glucophage sales accounted for 7 percent of the increase ($517 million), while sales of Glucovance (glyburide and metoformin HCI tablets) and Glucophage XR (metformin HCl extended-release tablets) were $135 million and $111 million, respectively, after barely one year on the market.

Planning for patent expiration

However, the reign of BMS in this corner of the market is threatened by the imminent release of a generic version of its flagship Glucophage, whose patent protection was due to expire in September but has squeezed out extended life with additional patents. Still, BMS has been preparing for the inevitable loss of the blockbuster drug with a marketing push to switch current Glucophage patients to Glucophage XR, a once daily form of the drug. Another long-acting version of insulin is Lantus (insulin glargine injection), which provides 24-hour glucose control, from Aventis.

A creative marketing maneuver from BMS is its money-back guarantee for combo drug Glucovance. "If at any time during your first three months of therapy your physician and you determine that Glucovance is not helping you reach your blood sugar goal, you are eligible to be reimbursed for up to $300 of your out-of-pocket expenses for Glucovance prescriptions," promises one BMS advertisement.

In addition, IMS Health predicts sales of Glucophage will be boosted by the approval of many of the newer oral antidiabetic drugs to be used in combination with it. Finally, BMS likely will push for an additional indication for its branded metformin in light of the favorable results from the DPP trial, which suggest it may prevent the onset of diabetes.

IMS Health projects sales of insulin sensitizers, which reduce insulin resistance in type 2 diabetes treatments, will continue to grow. Two insulin sensitizers, GlaxoSmithKline's Avandia (rosiglitazone) and Eli Lilly's Actos (pioglitazone), both launched in 1999, can be used alone or in combination with other oral antidiabetic drugs such as metformin and the sulfonylureas, such as Dymelor (acetoheximide), Diabinase (chlorpropamide) Tolinase (tolazamide) and Orniase (tolbutamide). Second generation sulfonylureas include Glucotrol (glipizide), DiaBeta and Micronase (both glyburides) and Amaryl, one of the newest glimeprides along with Glucovance.

Actos and AmaryI scooped up a lot of Rezulin's business after it was yanked off the market a few years ago; however, Avandia ran into problems with the Food and Drug Administration this summer for "downplaying" the possibility of cardiac side effects with the drug.

Drugs treating related conditions may ride on antidiabetics' coattails. Sales of lipid-lowering drugs, antihypertensives and drugs to treat impotence likely will increase in sales hand-in-hand with diabetic drug sales, as diabetes rarely comes alone. Dental, eye, skin and foot care products, both prescription and nonprescription, are likely co-benefactors, too.

* Drug delivery: In spite of some bumps, including reports that study participants began forming insulin antibodies, inhalable insulin has retained its allure as the most comfortable and convenient way to take insulin in the history of the drug. About 5 percent to 10 percent with type 1 diabetes have to contend with daily injections for life.

Recent encouraging news out of the inhalable insulin camp (currently Pfizer and Aventis' Exubera) indicated study patients on the novel therapy achieved HbA1c levels below 7 percent in accordance with American Diabetes Association guidelines.

There are thoughts that inhalable insulin may be appropriate for type 2 patients, as well. The excitement was somewhat dampened with the finding that asthmatics may not absorb as much insulin as non-asthmatic diabetics.

Purdue University scientists also announced this summer what they feel is a way to make insulin for diabetics available in pill by using an acrylic-based, gel-like covering on the pills. The coating allows the drug to survive the acids of the stomach for slow absorption. Unlike the inhalers, which may be on the market next year, the pill version has a way to go.

What all of these new drugs have in common is convenience of dosage. Today's diabetics are and want to remain as active as possible, without having to schedule their lives around insulin shots.

* Maintenance: The bane of many diabetics existence, perhaps more so than insulin shots, is the need for constant blood tests for glucose levels from from blood drawn from the sensitive pads of the fingertips. One glucose monitor, GlucoWatch by Cygnus, promises to cut down on the need to prick the fingers.

After doing an initial finger-stick blood glucose test to calibrate the device, the patient can wear the monitor for 12 hours, while a low-level electric current and gel disks monitor glucose levels through the skin. The prescription-only product received FDA approval last March, but has yet to make its market debut. Anxious U.S. consumers already are asking how they can buy one in international diabetic chat rooms.

California-based Cygnus, which will market the watch with Johnson & Johnson, is aiming to launch GlucoWatch by year's end, but even the company doesn't sound clear on whether it will be sold by mail order or retail pharmacy.

The watch is set to retail anywhere from $225 to up to $450, but the replacement sensor pads, changed daily, will go for $4 to $5.

Another gadget is the AlcNow Monitor by Sunnyvale, Calif.-based Metrika. This device, also scheduled to debut late this year, performs an HbAlc test and presents the patient's average blood glucose levels for the previous three months.

Stephen Freed, R.Ph., a pharmacist turned diabetes educator and publisher of diabetesincontrol.com envisions pharmacists purchasing these disposable units and charging patients to perform the eight minute test in the near future.

Freed said he believes pharmacists are about to enter the diabetes market in a hands-on fashion, to the benefit of their patients' health and their own sales margins. His company recently signed a contract with managed care organization Aetna to provide diabetes education for 50,000 covered lives.

Freed's educational program, recognized by the ADA, soon will seek to enroll pharmacists to be part of the Aetna-covered network. Freed's company will handle the billing side online and will receive a percentage of it as payment. The pharmacist keeps the rest.

Freed also plans to start a 50-hour online continuing education program for pharmacists.

"Diabetes management and education can be huge for pharmacists," Freed predicts. "We will see them a lot more involved with diabetes care this coming year."

Total direct costs for diabetic care were estimated at $44.1 billion, which broke down as follows: $7.7 billion for diabetes and acute glycemic care (control of blood sugar levels). $11.8 billion due to the excess prevalence of related chronic compliations, e.g., circulatory, kidney, eye, nerve and skin disorders. $24.6 billion due to teh excess prevalence of other medical conditions not related to diabetes.

Source: American Diabetes Association, 1998.

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