Overactive Bladder Treatment Enablex(r) Does Not Impair Cognition in Older Individuals

Main Category: Urology / Nephrology
Article Date: 28 Feb 2005 - 13:00 PDT

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A new study published in this month's Journal of Urology reports that Enablex® (darifenacin), a once-daily treatment for overactive bladder (OAB), does not impair cognition in elderly patients. Older individuals - in this study people over age 65 - make up the majority of OAB sufferers, as the prevalence of the condition increases significantly with age. Older people are also more susceptible to cognitive disorders as well as drug-induced cognitive impairment.

"Despite the fact that cognitive function is critical to maintaining independence, little has been done to study the cognitive effects - or lack thereof - of chronic medications commonly used by the elderly," said Richard B. Lipton, MD, vice chair and professor of neurology, epidemiology and population health at the Albert Einstein College of Medicine, and attending physician at Montefiore Medical Center in New York City. "This study is important for older people who seek to manage their OAB symptoms, but are concerned about possible detrimental effects of medication."

The study, a randomized, double-blind, placebo controlled, three-period crossover study, evaluated the effects of Enablex (3.75 mg, 7.5 mg or 15 mg tablets once daily; or 5 mg immediate release tablets three times daily) on cognitive function in 129 volunteers aged 65 years or older without clinical dementia. While the study was powered to detect an improvement in cognitive function, the authors noted that Enablex had no effect on the three primary cognitive endpoints (memory scanning sensitivity, speed of choice reaction time, and word recognition sensitivity) at any dose. There were no statistically significant differences in secondary variables (simple reaction time, digit vigilance speed or accuracy, or word recognition speed) compared with placebo, except for memory scanning speed, which increased in all groups relative to baseline, but was greater with placebo than with 3.75mg of Enablex. In this study the most common treatment-related adverse events were dry mouth and constipation, which were typically of mild or moderate intensity.

Enablex has a unique M3 profile and is a potent muscarinic receptor antagonist that works by blocking the M3 receptor, which is primarily responsible for bladder muscle contraction. Enablex was approved by the Food and Drug Administration (FDA) in December 2004 for the treatment of OAB with symptoms of urge urinary incontinence, urgency and frequency.

OAB affects an estimated 33 million Americans. In fact, sixteen percent of the population over the age of 40 suffers from the chronic and troublesome symptoms of OAB, which is caused by the untimely contraction of the bladder muscle. People with OAB often limit travel, social and even work activities to avoid potentially embarrassing episodes that can occur with this condition.

In total, Enablex has been studied in 98 clinical trials involving more than 10,000 people. In clinical trials, the most frequently reported adverse events with Enablex were dry mouth, constipation, dyspepsia and abdominal pain, however patient discontinuation rates due to these events were low. The majority of adverse events in Enablex treated subjects were mild or moderate and mostly occurred during the first two weeks of treatment. As with other OAB medications, Enablex is contraindicated in patients with urinary retention, gastric retention or uncontrolled narrow-angle glaucoma and in patients who are at risk for these conditions. Enablex is also contraindicated in patients with known hypersensitivity to the drug or its ingredients.

This release contains certain forward-looking statements relating to Novartis Pharmaceuticals Corporation's business, which can be identified by the use of forward-looking terminology, or by express or implied discussions regarding potential future sales of Enablex. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results with Enablex to be materially different from any future results, performance, or achievements expressed or implied by such statements. There can be no guarantee that Enablex will reach any particular level of sales. Any such results can be affected by, among other things, competition in general; government, industry, and general public pricing pressures; unexpected clinical trial results; the company's ability to maintain patent or other proprietary intellectual property protection; as well as factors discussed in the Company's Form 20-F filed with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis

Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including central nervous system disorders, organ transplantation, cardiovascular diseases, dermatological diseases, respiratory disorders, cancer and arthritis. The company's mission is to improve people's lives by pioneering novel healthcare solutions.

Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG. Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2004, the Novartis Group's businesses achieved sales of USD 28.2 billion and a net income of USD 5.8 billion. The Group invested approximately USD 4.2 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 81,400 people and operate in over 140 countries around the world. For further information, please consult http://www.novartis.com.

Editor's Note: Full prescribing information available at http://www.enablex.com or by contacting Kate O'Connor of Novartis Pharmaceuticals Corporation at (862) 778-5588 or via e-mail at kate.oconnor@pharma.novartis.com.

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