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Longest BPH Trial Verifies Flomax (Tamsulosin HCL) Significantly Improves Patient 'Quality of Life' Scores And New Head-to-Head Data Shows More Rapid Symptom Relief and Fewer Adverse Events with Flomax than Hytrin (terazosin HCI): Presented at AUA

ORLANDO, FL -- May 29, 2002 -- New studies presented at the American Urological Association (AUA) annual meeting show that Flomax® (tamsulosin HCL), the first selective alpha1A blocker treatment for benign prostate hyperplasia (BPH), is the leading treatment choice for significantly improving and maintaining BPH patients' quality of life for up to six years, and provides faster BPH symptom relief and is less likely to cause adverse cardiovascular events than Hytrin® (terazosin HCI). BPH, commonly referred to as enlarged prostate, is a non-cancerous urological disease that affects millions of men as they age and may cause symptoms such as urinary frequency.

"Quality of life is at the forefront for men with BPH," said lead investigator Michael P. O'Leary, MD, MPH, Associate Professor of Surgery, Harvard Medical School. "Most patients report that the nuisance and embarrassment of their BPH symptoms cause a host of problems ranging from losing sleep to curtailing social activities. Now physicians can be confident prescribing Flomax for long-term relief in these patients."

The signs of BPH range from the urgent and frequent need to urinate --especially at night (nocturnia) -- or the feeling of not completely emptying the bladder to an intermittent urinary stream or the inability to urinate at all. These symptoms -- which can disrupt a man's daily activities and have negative consequences -- are prevalent and pervasive. It is estimated that 20 to 30 percent of men will need medical treatment for BPH before age 80.(1)

In the longest trial of its kind, Dr. O'Leary and his fellow investigators found that Flomax reduced BPH symptoms and significantly improved a patient's quality of life, reinforcing earlier clinical findings.(2) Six hundred and nine patients were enrolled in the study for up to six years (109/159 patients with at least two years Flomax exposure completed six years of treatment and 419/609 patients, completed five years). Following a one-year open-label study and a 57-week double-blind, placebo-controlled study, all patients continued their existing Flomax regimen (0.4 or 2 x 0.4 mg/d) for four more years. Baseline values for each patient had been established prior to their first dose of Flomax. Results for efficacy parameters were based on multiple standardized scoring systems.

All categories showed statistically significant improvement from baseline for each year of exposure. Categories included AUA symptom scores (total [T], irritative [I], obstructive [O], bother [B], nocturia [N]); Boyarsky scores (T, I, O, N); and peak and average urine flow rates. Statistically significant improvement in Quality of Life scores -- evaluated with the BPH Impact Index - was sustained throughout all years of the study.

"We confirmed the results of previous studies demonstrating the sustained effectiveness of Flomax in treating signs and symptoms of BPH," said Dr. O'Leary. "Given the high percentage of men who are affected, Flomax does make a significant difference in quality of life -- individually and collectively." Importantly, Flomax also has been shown to have no effect on men's sexual function, such as abnormal ejaculation.(3)

"Many patients have active lifestyles, but their BPH symptoms may limit their daily activities, sometimes to the point where they have to plan their day around proximity to a men's room," said Dr. O'Leary. "Patients on Flomax and are able to quickly get back to their daily routines."

Investigator Perinchery Narayan, MD, Director of the North Florida Research Institute, North Florida Urology Associates P.A., and Worldwide Medicine Group LLC, compared the early onset of BPH relief in 1,993 patients with BPH. After a three-week placebo lead-in period, patients took either Flomax (0.4 mg qd) or Hytrin (5 mg qd with standard titration schedule) for eight weeks in an open-label, randomized, multicenter, parallel-design study. Of the enrolled patients, 1,789 comprised the efficacy evaluable population. These patients completed the first post-baseline assessment after four days of study drug administration.

The investigators concluded that patients on Flomax had a significantly more rapid onset of clinical action than patients on Hytrin, after only four days of treatment.(4) "We found Flomax not only provides physicians and patients with a fast measure of effectiveness, but also a convenient alternative since it does not require titration," said Dr. Narayan. Randomized Trial to Evaluate the Side Effect Profile of Tamsulosin vs. Terazosin in 1,983 Men With Benign Prostatic Hyperplasia

The safety and tolerability of Flomax (0.4 mg qd) were compared with Hytrin (5 mg qd, dose-titrated) in 1,983 men with moderate to severe BPH. Franklin Lowe, MD, Associate Director, Department of Urology, St Luke's/Roosevelt Hospital, New York and Dr. Bob Djavan led the 11-week(eight-week active, three-week placebo lead-in), open-label, randomized, multicenter, parallel-design study. They analyzed changes in physical findings, including digital rectal examination of the prostate, electrocardiogram findings, vital sign measurements (sitting systolic and diastolic blood pressure and heart rate), clinical laboratory test results from pre-treatment to post-treatment, and on summaries of treatment emergent adverse events that were reported throughout the study.

"The Hytrin group experienced a greater lowering of blood pressure than those on Flomax," said Dr. Lowe. "Additionally, Hytrin-treated patients had more adverse events associated with this hemodynamic effect.(3) This is significant because we are dealing with an older population whose cardiovascular safety is of particular concern." Specifically, at day 19, the Hytrin group experienced a greater lowering of blood pressure than the Flomax group, irrespective of patients' baseline hypertension status. And, no Flomax patients experienced a serious adverse reaction related to an electrocardiogram (ECG) abnormality.

"We hear from doctors all the time that they want head-to-head data and we're thrilled we can provide them with this information," said Dr. Kirk Shepard, Vice President of Clinical and Scientific Affairs, of Boehringer Ingelheim Pharmaceuticals. Inc., distributors of Flomax. "Most importantly, patients on Flomax can tell within just a few days that their treatment is working and see long-lasting improvement in their BPH symptoms with fewer side effects."

About Flomax

Co-promoted by Boehringer Ingelheim Pharmaceuticals, Inc. and Abbott Laboratories, Flomax is the most widely prescribed alpha-blocker in the United States, indicated for the treatment of the signs and symptoms of BPH. Flomax is generally well tolerated, has minimal effect on blood pressure and can be started at a therapeutically effective dose, which does not require titration.

The most common side effects in men with BPH, taking Flomax, were stuffy nose, a decrease in semen and dizziness. As with other drugs of this type, there is a risk of fainting. Therefore, men beginning Flomax treatment should avoid situations where injury could result should this occur.

About Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group of companies, with headquarters in Ingelheim (Germany) is one of the 20 leading pharmaceutical firms in the world and reported revenues of almost US $5.8 billion in 2000.

Boehringer Ingelheim, which has some 140 affiliated companies worldwide, focuses on human pharmaceuticals and animal health. The human pharmaceuticals business, which accounts for 95% of sales, comprises prescription medicines, consumer health care products and chemicals and biopharmaceuticals for industrial customers. Research and development, production, and distribution facilities are located around the globe. In 2000, Boehringer Ingelheim spent almost US $914 million on R&D, equivalent to 15.6% of net sales.

For more information on Boehringer Ingelheim Corporation, please see the Internet website http://www.us.boehringer-ingelheim.com or http://www.flomax-bph.com

References
1. Agency for Health Care Policy and Research (AHCPR) BPH Treatment Guidelines, 1989
2. O'Leary M., Tamsulosin Demonstrates Long-term Efficacy on Multiple Clinical and Quality-of-life Scoring Systems (2002)
3. Lowe F., Djavan B. Prospective, Randomized Trial to Evaluate the Side Effect Profile of Tamsulosin vs. Terazosin in 1983 Men With Benign Prostatic Hyperplasia (2002)
4. Perinchery N., Djavan B. Prospective, Randomized Multicenter Trial of Tamsulosin vs. Terazosin to Evaluate the Velocity of the Onset of Action (2002)

SOURCE: Boehringer Ingelheim Pharmaceuticals, Inc.

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