Detrol

Center for Medical Consumers, New York, NY

"Designed specifically for overactive bladder" is the message of the Detrol ads which usually feature a middle-aged woman or man. The Food and Drug Administration (FDA) approved Detrol in 1998, and by the next year, this drug became one of the 200 most commonly prescribed drugs in the U.S. But the prescribing enthusiasm appears to be a manifestation of the multi-million dollars its manufacturer, Pharmacia & Upjohn, spends promoting Detrol to physicians and the general public. It certainly can't be that Detrol is superior to the older drugs used for bladder problems. Any assumption along those lines will be refuted by reading the FDA's pre-market review of Detrol's study results now available on the agency's web site.

The FDA approved Detrol, whose generic name is tolterodine, for the treatment of people "who have bladder conditions that cause the feeling of having to urinate immediately, urinate too often, or have an inability to control urine." In some--but not all--of the studies reviewed by the FDA, Detrol was shown to be better than a placebo (an inactive lookalike pill). But the drug was less effective than its strongest competitor Ditropan in one clinical trial. It is unusual for pre-approval test results submitted by a drug manufacturer, in this case Pharmacia & Upjohn, to include those of a study pitting its drug against another. (An FDA spokesman explained that drug companies cannot withhold research that shows unfavorable results for their products.)

Modest Benefit

It is also unusual for a pharmaceutical company to state in its print ads--aimed at physicians and the general public--exactly what has been proven in terms of effectiveness. And the efficacy here is very modest. Some of the ads say, "reduced urge incontinence by 50%" and then go on to explain that after 12 weeks on the drug, people taking Detrol had 1.2 episodes of incontinence daily as compared with 2.4 episodes daily for the people taking a placebo.

Perhaps Pharmacia & Upjohn took this seemingly courageous step of forthright advertising because it knows full well that hardly anyone--doctors or consumers--reads beyond the drug ad headlines. Detrol's efficacy results came from a "pooled analysis" of studies that did and did not show the drug was better than a placebo. (In two of three studies, Detrol proved to be better than a placebo.)

The large multi-center clinical trial that compared Detrol with its competitor Ditropan (generic name: oxybutynin) was conducted in Europe. After assessing its results, the FDA reviewers found that the older drug "tended to demonstrate increased efficacy compared to tolterodine [Detrol]."

You might ask why the FDA approved this drug which costs about $74 a month (Ditropan is about $58). The answer appears to be that Detrol has one advantage over Ditropan--a lower rate of adverse reactions. Here is what Worst Pills Best Pills says about the older drug: "Potential adverse effects include severe memory impairment, difficulty swallowing, retention of urine, blurred vision, and constipation. People over the age of 60 who are taking the usual doses of oxybutynin [Ditropan] may experience excitement, restlessness, drowsiness, or confusion."

Dry mouth, the most common side effect of both drugs, occurs at a far lower rate in people taking Detrol (40% vs 61%) and with less severity (4% vs 29%). FDA reviewers had been concerned about cognitive impairment and cardiac abnormalities because Detrol is what is called an antimuscarinic drug and these adverse reactions are associated with older drugs of this type. No cardiovascular problems were found to be associated with Detrol, though the full picture of any new drug is not known until years after approval.

What You Can Do

-Review the drugs you are currently taking. Urinary incontinence can be a side effect of several drug classes, including diuretics (e.g., Lasix), hypertension drugs, such as reserpine (e.g., Serpasil), and angiotensin-converting enzyme (ACE) inhibitors (e.g., Vaseretic).

-Limit caffeine intake. One study showed that women whose daily caffeine intake averaged 484 mg were more likely to suffer urinary incontinence than those whose intake was 193 mg, the equivalent of one or two cups of brewed coffee.

-Consider behavioral treatment. In one study of 197 incontinent women, behavioral treatment was significantly more effective than Ditropan in reducing frequency of incontinent episodes (JAMA , 12/16/98). Behavioral therapy includes the teaching of pelvic muscle exercises, muscle control, and relaxation methods.

-Contact the not-for-profit National Association for Continence to learn about prevention, diagnostic tests and treatment options. Call 1(800) BLADDER or visit the Web site (www.nafc.org).

COPYRIGHT 2001 Center for Medical Consumers, Inc.
COPYRIGHT 2001 Gale Group