EDITOR'S NOTE: This study on the prescription drug terazosin, commercially known as Hytrin, was funded by Abbott Laboratories, the manufacturer of Hytrin. Abbott Laboratories set up the experimental protocol and collected the data. Dr. Robert Guthrie of Ohio State University helped recruit family doctors to participate in the study and wrote the paper, which appeared in The Journal of Family Practice. Dr. Guthrie received a consulting fee for these services.)


COLUMBUS, Ohio -- The prescription drug terazosin is a safe and effective treatment for both high blood pressure and the symptoms of an enlarged prostate -- medically known as benign prostatic hyperplasia (BPH), a recent study shows.

"For men over 45 who have hypertension and BPH, terazosin not only reduced their elevated blood pressure, it also significantly improved their BPH symptoms," said Robert Guthrie, author of the study and associate professor of pharmacology and family medicine at Ohio State University.

"Patients with normal blood pressure also had improved BPH symptoms, but their reductions in blood pressure were clinically irrelevant. This supports the safety of using terazosin in patients with normal blood pressure."

Terazosin, originally a blood pressure medication, was approved as a treatment for BPH by the U.S. Food and Drug

Administration in 1993. However, this study is the first to suggest its effectiveness in treating patients with both high blood pressure and BPH.

The results suggest that all men currently suffering from often-embarrassing BPH symptoms, which can include a frequent urge to urinate and difficulty urinating when the bladder feels full, can get safe, significant relief without surgery, Guthrie said. Whether the drug, which is taken orally, will prevent these men from eventually needing prostate surgery, however, remains to be seen.

"It's not known what percentage of men who take terazosin will eventually require surgery because of disease progression," Guthrie said. "We're probably four or five years away from knowing whether terazosin will make prostate surgery rates fall nationally."

Development of a non-surgical treatment for BPH is a high priority among physicians and researchers, Guthrie said.

"Prostate surgery is not 100 percent successful and it can have side effects," he said. "There's a significant recurrence rate. About 18 to 20 percent of prostate surgery patients have to have a second operation. Also, about 18 percent of patients develop complications after the surgery, such as infections, incontinence, and sexual dysfunction. The side effects of prostate surgery, when they happen, are often significant."

The study, which was recently published in The Journal of Family Practice, included 5,365 men over 45 with high blood pressure. The men were recruited by their family physicians and made at least two office visits with that physician. At the first visit, the physician recorded the patient's blood pressure, determined the severity of the patient's BPH symptoms, if any, and started the patient on terazosin tablets at a dose of 1 mg per day. On the fourth day of the study, the physician increased the dose to 2 mg per day. At the final visit, three months later, the physician again recorded the patient's blood pressure and the severity of his BPH symptoms, if any.

The results:

_ All patients in the study experienced a significant drop in blood pressure after taking terazosin for three months. The average blood pressure for all patients at the beginning of the study was 159/94; the average at the end was about 143/84. Those patients with higher blood pressure experienced proportionally greater reductions than those with normal blood pressure.

_ Of the 5,365 men in the study, about 28 percent had both high blood pressure and symptoms of an enlarged prostate. After taking terazosin for three months, these men reported that, on average, their prostate symptoms were less than half as severe as they were at the start of the study.

_ About 40 percent of men suffering from obstructive BPH symptoms, such as hesitancy in urination and incomplete emptying of the bladder, said these symptoms had disappeared by the end of the study. More than 70 percent of men suffering from irritative BPH symptoms, such as getting up at night to urinate and urinating frequently during the day, said these symptoms had improved by the end of the study.

_ About 11 percent of patients reported side effects from the drug, most of which were minor. Side effects included weakness, headaches, and dizziness.

These results suggest that terazosin will become accepted as a simple, safe and effective way for family doctors to treat high blood pressure and BPH, whether those conditions occur together or separately, Guthrie said.

"It's safe. It's effective. It's well-tolerated by the patients," he said. "For patients, it means they can get significant symptom relief without having to have surgery. It also means they don't have to be uncomfortable for years and years."

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Contact: Robert Guthrie, (614) 298-8052

Written by Kelly Kershner, (614) 292-8308