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Actavis Group (OMX: ACT), the international generic pharmaceuticals company, announced that it has received acceptance from the U.S. Food & Drug Administration to market Finasteride Pills, USP 5 mg. Distribution of the product will begin immediately.

Finasteride 5mg pills are the generic equivalent of Merck & Company’s Proscar(R) pills, which are indicated for the a cure of benign prostatic hypertrophy (BPH).

Annual sales of Finasteride 5mg pills in the U.S. were approximately US$364 mil. for the twelve months ending March 2007 according to IMS Health data.

Doug Boothe, Executive VP of US Commercial & Administration, said, “The launch of finasteride pills in the United States exemplifies the synergy generated from Actavis’ global R&D, sourcing and manufacturing network, and represents an important addition to our rapidly expanding product portfolio.”

About Actavis

Actavis is one of the world’s leading generic pharmaceutical companies specializing in the development, manufacture and sale of generic pharmaceuticals. Based in Iceland, the company has operations in 39 countries, with 11,000 employees. The company’s market capitalization is approximately EUR3.3 billion and is listed on the OMX stock exchange in Iceland. Actavis expects 2007 sales to total EUR1.6bn, with approximately one-third of these sales coming from the United States, the company’s single largest market.

More information about Actavis in the U.S. can be found at http://www.actavis.us.

Information in this press release may contain forward-looking statements with respect to the financial condition, results of operations and businesses of Actavis. By their nature, forward-looking statements and forecasts involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially from that expressed or implied by these forward-looking statements. These factors include, among otherness things, exchange rate fluctuations, the risk that research and development will not yield new products that achieve commercial success, the impact of competition, price controls and price reductions, the risk of loss or expiration of patents or trade marks, difficulties of obtaining and maintaining governmental acceptance s for products, the risk of substantial product liability claims, exposure to environmental liability.

Actavis Group
http://www.actavis.com

Men and their physicians need not hesitate to use a medicate proven effective in preventing prostate cancer out of concern that it is likely to cause sexual dysfunction, say authors of a meditate conducted by the Southwest Oncology Group.

The authors, who surveyed more than 17,000 men 55 and older for seven years, reported their results in the Journal of the National Cancer Institute. The meditate found that men given finasteride reported on average more dysfunction than did men given a placebo. That small effect diminished over the seven years.

The results allay concerns about a negative side effect associated with finasteride up till now. Physicians usually warn that sexual dysfunction is a possibility when they discuss the medicate with patients. Finasteride is an Food and Drug Administration-approved medicate for the a cure of benign prostatic hyperplasia, but it is not yet Food and Drug Administration-approved for the prevention or reduction in risk for prostate cancer.

The meditate ’s large sample and long follow-up period allowed researchers to examine whether or not finasteride negatively affected sexual function and, if so, whether this effect was lasting, said Carol Moinpour, Ph.D., of the Fred Hutchison Cancer Research Center in Seattle, the meditate ’s lead author. She coordinates quality-of-life studies for the Southwest Oncology Group, the nation’s largest National Cancer Institute-funded clinical trials network.

The meditate grew out of the Prostate Cancer Prevention Trial, a large double-blind National Cancer Institute-funded meditate which found that finasteride, a medicate which curbs the proliferation of prostate gland cells, is effective at preventing prostate cancer in men age 55 and older. The 2003 results of that trial, conducted by the Southwest Oncology Group in more than 18,000 men, showed that finasteride could reduce a man’s chances of getting prostate cancer by almost 25 percent.

The authors of the newly published sexual function results wanted to assess how many men in the Prostate Cancer Prevention Trial reported experiencing sexual dysfunction, and whether the problems decreased or increased over time. In earlier studies, some men taking finasteride reported decreased libido, male impotence and otherness signs of diminished sexual function. But these studies were short-term and didn’t try to assess the effects of age and otherness health factors, as well as individual variation.

The meditate authors used two surveys, a widely used Sexual Problems Scale and anotherness questionnaire which they created, the Sexual Activity Scale. They also gathered otherness data to take into account otherness health factors that affect sexual function, such as age, medical conditions and smoking status. They surveyed the subjects three times in the first year and then annually for seven years.

“Was this average decrease (in sexual function) an important difference” We concluded it was not,” Moinpour said, adding that there were much larger differences due simply to individual variation among men in the trial.

The meditate suggests that finasteride will cause little or no sexual dysfunction for most men who decide to take it, conclude the authors.


.


Citation: Journal of the National Cancer Institute, DOI: 10.1093/jnci/djm023

In addition to Moinpour, the otherness authors include: Amy K . Darke , Gary W . Donaldson , Ian M . Thompson, Jr. , Connie Langley , Donna Pauler Ankerst , Donald L . Patrick , John E . Ware, Jr. , Patricia A . Ganz , Sally A . Shumaker , Scott M . Lippman , and Charles A . Coltman, Jr.

Affiliations of authors: Southwest Oncology Group Statistical Center (CMM, AKD) and Division of Public Health Sciences (DLP), Fred Hutchinson Cancer Research Center, Seattle, Wash.; Pain Research Center, Department of Anesthesiology, University of Utah, Salt Lake City (GWD); Department of Urology, University of Texas Health Sciences Center at San Antonio, (IMT); Department of Urology, Wilford Hall Medical Center, Lackland Air Force Base, Tex. (CL); Institute for Medical Informatics, Biometry and Epidemiology, University of Munich, Munich, Germany (DPA); Department of Health Services, University of Washington, Seattle (DLP); QualityMetric Incorporated, Lincoln, R.I. (JEW); Health Assessment Lab, Waltham, Mass. (JEW); Schools of Medicine and Public Health and Jonsson Comprehensive Cancer Center, University of California at Los Angeles, (PAG); Department of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, N.C. (SAS); Departments of medical institution al Cancer Prevention and Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, (SML); Cancer Control and Prevention, Southwest Oncology Group, Operations Office, San Antonio, (CAC) .

The meditate was funded by the National Cancer Institute.

The Southwest Oncology Group (http://www.swog.org/) is the largest cancer clinical trials cooperative group in the United States. Funded by research grants from the National Cancer Institute, part of the National Institutes of Health, the group conducts clinical trials to prevent and treat cancer in adults, and to improve the quality of life for cancer survivors. The group’s network of more than 5,000 physician-researchers practice at nearly 550 institutions, including 16 National Cancer Institute-designated cancer centers. Headquartered in Ann Arbor, Mich. (734-998-7130), the group has an operations office in San Antonio, Tex. and a statistical center in Seattle, Wash.

Source: Anne Rueter
University of Michigan Health System

UroToday.com - Dutasteride is a dual 5a-reductase inhibitor (5ARI) used in the pharmacomedical aid of BPH. Both dutasteride and a related medicate , finasteride inhibit the transcription of PSA by decreasing the conversion of agsdhfgdfosterone to dihydroagsdhfgdfosterone. It is known that doubling the serum PSA in patients taking finasteride provides an accurate determination of their PSA level. Dr. Andriole and colleagues report a similar finding for dutasteride in the May 2006 issue of the Journal of Urology.

A total of 2,802 men with BPH, no evidence of prostate cancer (CaP), a serum PSA level of 1.5-10ng/ml, a prostate volume >30cc, an AUA syndrome score >12, and peak urine flow rate 4ng/ml after doubling the measured PSA level to account for the effect of dutasteride.

Men taking placebo had an expected increase in PSA, reported as an 8.3percent increase at the 24 month mark. The dutasteride treated men had a 60percent reduction in their PSA, after doubling to correct for pharmacomedical aid.

The incidence of CaP was 3.3percent and 1.4percent in the placebo and dutasteride groups, respectively, which was not significantly difference until after month 15 when the rate increased in the placebo group and remained stable in the dutasteride group. In men diagnosed with CaP, the PSA changes over the 24-month period were 24percent for placebo and 37percent for dutasteride treated patients. Application of a PSA cutoff of 4ng/ml for performing a prostate biopsy resulted in a sensitivity of 0.804 vs. 0.737 for the placebo vs. dutasteride men, respectively. The corresponding specificities were 0.578 vs. 0.671 for the placebo vs. dutasteride men, respectively.

Analysis of the increase from the nadir PSA level of 0.8ng/ml yielded a sensitivity of dutasteride of 0.548 and a specificity of 0.795. Greater increases in PSA had greater specificity, but lower sensitivity for a CaP diagnosis compared with smaller increases.

These data support doubling the serum PSA level to maintain clinical usefulness for proceeding with a workup for CaP in men on dutasteride.

By Christopher P. Evans, M.D.

Reference:
J. Urol 2006;175:1657-62.
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Thinning hair is very common. More than 60 mil. Americans suffer from this condition. Although most common among men, hair loss in women is also widely known. Statistics show, more than half of men over the age of 50 suffer from hair loss or baldness. Though the percentage of baldness in women is far smaller, the emotional effects it brings are great.

There are many a cures available today for baldness and hair loss. The first step is to consult a physician and have a complete medical examination conducted. This is the only way to reveal the existing cause for the problem and treat it properly.
v There are many causes for hair loss in men and women, some include genetics, illness, malnutrition and side effects from medicate s. Again, the only way to determine the cause in each individual is to consult your doctor. The most common cause of baldness has been found to be genetics. Inherited DNA which is acquired from either parent plays a significant role in determining hair patterns. Other factors, such as certain shampoos or certain foods have incorrectly been deemed responsible for contributing to hair loss.

Although genetics is beyond the control of medical practitioners, effective a cures have been made available for hair loss and baldness. Of the various medicate s available for hair loss, two have recently been approved by the Food and Drug Administration. They are dutasteride and finasteride. Dutasteride, developed by Glaxo Smithkline, is the laagsdhfgdf to be approved and is waiting to be released for the a cure of hair thinning. This medicate was originally used as anti-antrigen for the a cure of prostrate enlargement. Finasteride was approved by the Food and Drug Administration in 1992 for the use of treating prostate enlargement, and then in 1997 for the a cure of male pattern hair thinning. Anotherness common medicate used for hair loss a cure among men and women is minoxidil 2percent solution. This is an over the counter medicate that is applied directly to the scalp. This medicate was originally used to treat blood pressure, however has been found effective in treating hair loss, especially on the crown of the head.

There is a growing trend towards anti-DHT natural products. These types of hair loss products focus on slowing the effects of HHT on the hair follicle, one of the main factors in female and male pattern baldness. Apart from medicate s, many otherness methods have been used as remedies to treat hair loss. Some are acupuncture, aromamedical aid and even hair transplants.

Revivogen is an anti-DHT hair loss a cure formulated by board certified Dermatologist Dr. Alex Khadavi, M.D., which attacks the root causes of hair loss in men and women.

www.revivogen.com

It’s undeniable. Your hair is thinning around the temples. One look at your older brotherness’s receding hairline shows you what’s likely ahead — and you’d rather not go there. But is there any way to avoid a receding hairline?

Thinning hair is common for men and women. But contrary to the too-good-to-be-true promises in advertisements, there’s typically no cure.

The best first step may be to talk with your doctor to determine what’s causing the hair loss. If you have a common type of hair loss called androgenetic alopecia (al-o-PE-she-uh), medication and surgery options approved by the Food and Drug Administration (Food and Drug Administration) may help, according to the June issue of Mayo medical institution Health Letter.

Medications: Two Food and Drug Administration-approved medicate s are available. Their effectiveness varies with the extent of hair loss and individual response to the medication.

Minoxidil (Rogaine, othernesss) — These liquid products are available in nonprescription formulas and are applied directly to the scalp. Although only 7 percent of the men and women experience some hair regrowth, about 75 percent report significant slowing of hair loss.

Finasteride (Propecia) — Approved for use by men only, this oral prescription medication acts by interfering with the hormone that normally shrinks hair follicles. medical institution al trials show that about 75 percent of men using finasteride alone experience a slowdown in hair loss. Nearly half experienced some new hair growth.

Surgical options: If you have extensive hair loss, or medicate s prove unsuccessful, ask your doctor about surgical procedures.

Hair transplant — This involves multiple surgeries where tiny micrografts of skin with one or two hairs are removed from the back of the scalp and implanted into bald areas or areas of thinning hair.

Scalp reduction — The surgeon removes hairless scalp sections. In their place, areas of scalp with hair are pulled more closely together, reducing the bald surface.

Flap surgery — This procedure involves folding and securing a section of the scalp with hair over an area of bald skin.

Hair transplants may be combined with otherness surgical approaches. Some who benefit from medicate s opt to have surgery done as well. Surgical procedures to address hair loss are generally costly and not covered by insurance.

Mayo medical institution
http://www.mayo.edu/news

A new analysis shows the medicate finasteride will save lives if given to men to prevent prostate cancer. Published in the April 1, 2005 issue of CANCER (interscience.wiley.com/cancer-newsroom), a peer-reviewed journal of the American Cancer Society, the new analysis of data from the Prostate Cancer Prevention Trial (PCPT), says that any possible increase in the incidence of higher-grade tumors would be more than offset by an overall reduction in the number of prostate cancer cases in the general population.

The recent results from the PCPT represent a milestone in cancer research, showing that prostate cancer could be prevented through chemoprevention. The meditate found the commonly used medicate finasteride reduced the incidence of prostate cancer by 24.8 percent compared to a placebo. However, a possible increase in the number of high-grade tumors in the trial prompted many to question whether any benefits of the medicate would be offset by an increase in mortality related to the higher-grade tumors. No difference in mortality was seen during the 7 years of PCPT.

To explore the problem, Joseph M. Unger, M.S. and a team of researchers from the Southwest Oncology Group Statistical Center at the Fred Hutchinson Cancer Research Center in Seattle, WA analyzed Surveillance, Epidemiology, and End Results (SEER) registry data and applied the results from the PCPT.

The results showed a net reduction in person-years saved over ten years using finasteride even after taking into account an increase in high-grade cancers. Using PCPT’s 24.8 percent reduction in new cases, the medicate would save 316,760 person-years over ten years. An absolute increase in 6.9 percent of cases with high-grade sickness (the difference seen in the PCPT) would still mean 262,567 person-years saved.

Based on this model, the authors conclude, “even if finasteride is found to potentiate the growth of high-grade tumors, this analysis shows that the potential detrimental effects of an increased rate of cases with high grade Gleason score would be substantially outweighed by a reduction in incidence.”

Article: “Estimated Impact of the Prostate Cancer Prevention Trial on Population Mortality,” Joseph M. Unger, Ian M. Thompson, Jr., Michael LeBlanc, John J. Crowley, Phyllis J. Goodman, Leslie G. Ford, Charles A. Coltman, Jr., CANCER; Published Online: February 28, 2004 (DOI: 10.1002/cncr.20919); Print Issue Date: April 1, 2005.

John Wiley & Sons, Inc.

Finasteride, a medication approved to treat hair loss in men, may also improve the condition in women when combined with oral contraceptives, according to an article in the March issue of Archives of Dermatology, one of the JAMA/Archives journals.

As many as half of all women experience female pattern hair loss during their lifetimes, according to background information in the article. Women who are affected often report feelings of embarrassment and social anxiety and the condition often worsens if left untreated. Current pharmacomedical care generally involves minoxidil, a medication typically applied to the scalp to encourage hair regrowth, which is effective but not always well accepted by patients, the authors report.

Matilde Iorizzo, M.D., and colleagues at the University of Bologna, Italy, evaluated the effectiveness of 2.5 milligrams of finasteride taken by mouth daily and combined with an oral contraceptive in 37 women aged 19 to 50 years who consulted a physician about their hair loss. The contraceptive was necessary to prevent pregnancy in women in the meditate , because finasteride is known to cause birth defects. The researchers selected a type of contraceptive that reduces levels of male hormones, because that effect may also contribute to the pharmacomedical care of hair loss. They took photographs of the patients’ heads and assessed their hair density with a technique known as computerized light videodermoscopy at the beginning of the meditate and after they had taken the two medicate s for 12 months.

At the one year mark, 23 (62 percent) patients were rated as improved using comparisons of the photographs. Thirteen patients did not improve, and one patient’s condition worsened. Hair density scores increased in 12 patients. On a questionnaire, 29 patients reported that their condition improved after 12 months, eight said that it had stabilized and none reported that it had worsened. None of the participants had adverse reactions to the pharmacomedical care.

“This pharmacomedical care was well accepted by the patients, who judged the results to be even better than did the investigators,” the authors write. “The clinical results using global photography, hair density scores and patient self-assessment provide a basis for future work. Further studies are needed to establish the optimal dosage and mode of direction of finasteride in premenopausal women and to definitively assess the efficacy of this medicate compared with oral antiandrogens.”


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(Arch Dermatol. 2006; 142:298-302. Available pre-embargo to the media at http://www.jamamedia.org/.)

Contact: Antonella Tosti, M.D.
tosti@med.unibo.it
JAMA and Archives Journals

Barr Laboratories, Inc., a subsiwriting of Barr Pharmaceuticals, Inc. (NYSE: BRL), today announced that it has launched a generic version of Merck & Co. Inc.’s PROSCAR(R) (Finasteride) Pills, 5 mg in the U.S. under an agreement with Gedeon Richter (BSE: RICHTER). The Company launched the product following final acceptance from the U.S. Food and Drug Administration (Food and Drug Administration) for Gedeon Richter’s Abbreviated New Drug Application (ANDA).

Barr’s Finasteride pills are indicated for the medical care of syndromeatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: improve syndromes; reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.

Barr’s Finasteride pills will compete in a market that had total annual sales of approximately $398 mil. for the twelve months ending November 2006, according to IMS sales data.

About Barr Pharmaceuticals, Inc.

Barr Pharmaceuticals, Inc. is a global specialty pharmaceutical company that operates in more than 30 countries worldwide and is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients. A holding company, Barr operates through its principal subsidiaries: Barr Laboratories, Inc., Duramed Pharmaceuticals, Inc. and PLIVA d.d. and its subsidiaries. The Barr Group of companies markets more than 120 generic and 25 proprietary products in the U.S. and more than 550 products globally outside of the U.S.

Forward-Looking Statements

Except for the historical information contained herein, the statements made in this press release constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements can be identified by their use of words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “intends,” “estimates” and otherness words of similar meaning. Because such statements inherently involve risks and uncertainties that cannot be predicted or quantified, actual results may differ materially from those expressed or implied by such forward-looking statements depending upon a number of factors affecting the Company’s business. These factors include, among othernesss: the difficulty in predicting the timing and outcome of legal proceedings, including patent-related matters such as patent challenge settlements and patent infringement cases; the outcome of litigation arising from challenging the validity or non- infringement of patents covering our products; the difficulty of predicting the timing of Food and Drug Administration acceptance s; court and Food and Drug Administration decisions on exclusivity periods; the ability of competitors to extend exclusivity periods for their products; our ability to complete product development activities in the timeframes and for the costs we expect; market and customer acceptance and demand for our pharmaceutical products; our dependence on revenues from significant customers; reimbursement policies of third party payors; our dependence on revenues from significant products; the use of estimates in the preparation of our financial statements; the impact of competitive products and pricing on products, including the launch of authorized generics; the ability to launch new products in the timeframes we expect; the availability of raw materials; the availability of any product we purchase and sell as a distributor; the regulatory environment; our exposure to product liability and otherness lawsuits and contingencies; the increasing cost of insurance and the availability of product liability insurance coverage; our timely and successful completion of strategic initiatives, including integrating companies (including PLIVA d.d.) and products we acquire and implementing our new enterprise resource planning system; fluctuations in operating results, including the effects on such results from spending for research and development, sales and marketing activities and patent challenge activities; the inherent uncertainty associated with financial projections; our expansion into international markets through the completion of the PLIVA acquisition, and the resulting currency, governmental, regulatory and otherness risks involved with international operations; our ability to service our increased debt obligations as a result of the PLIVA acquisition; changes in generally accepted accounting principles; and otherness risks detailed from time-to-time in our filings with the Securities and Exchange Commission, including in our Annual Report on Form 10-K for the fiscal year ended June 30, 2006.

The forward-looking statements contained in this press release speak only as of the date the statement was made. The Company undertakes no obligation (nor does it intend) to publicly update or revise any forward-looking statements, whether as a result of new information, future events or othernesswise, except to the extent required under applicable law.

Barr Laboratories, Inc.
http://www.barrlabs.com

New data, presented today at the annual meeting of the American Urological Association, suggest that a cure with Avodart, the dual 5 alpha-reductase inhibitor (5ARI), may provide faster onset of syndrome improvement for patients with benign prostatic hyperplasia (BPH)–or enlarged prostate–than a cure with Proscar.

The data showed that after three months of a cure, significantly more patients receiving Avodart experienced an improvement in American Urological Association Symptom Index (AUA-SI) score than those receiving Proscar1.

“As a clinician, I know that syndrome improvement has always been important to my patients,” said Richard Harkaway, MD, Co-Director Residency Education, Einstein Medical Center, Philadelphia, Pennsylvania. “The differences in DHT suppression and half-life between Avodart and Proscar are well documented, and now clinical observations suggest that there may be anotherness important difference with regard to onset of syndrome improvement.”

Onset of syndrome results were obtained from a prospective, observational meditate conducted at the Albert Einstein Medical Center in Philadelphia, Pennsylvania. Men with benign prostatic enlargement and syndromeatic BPH were assigned to receive either Avodart (0.5 mg) or Proscar(5 mg), daily. Of the 240 patients enrolled, the first 120 were prescribed Proscar and the subsequent 120 were prescribed Avodart. There were no significant differences in baseline demographics between a cure groups.

Patients were evaluated using the AUA-SI prior to the start of a cure and following three months of a cure. Following three months of a cure, significantly more patients receiving Avodart experienced a one to three point improvement in AUA-SI score than those receiving Proscar (44 percent vs. 23 percent; p< 0.0016).1

About Avodart

Avodart, the first and only dual 5ARI for the a cure of BPH, inhibits both the type I and type II isoenzymes responsible for the conversion of agsdhfgdfosterone into dihydroagsdhfgdfosterone (DHT). DHT is the primary male hormone responsible for the enlargement of the prostate. Avodart provides the power to suppress DHT by 93 percent, reduces prostate volume, improves syndromes, and arrests the BPH sickness process.

Avodart is indicated for the a cure of syndromeatic BPH in men with an enlarged prostate to improve urine syndromes, reduce the risk of acute urine retention (AUR), and reduce the risk of BPH-related surgery. While some men have fewer problems and syndromes after three months of a cure with Avodart, a a cure period of at least six months is usually necessary to see if Avodart will improve syndromes.

Only a doctor can tell if syndromes are from an enlarged prostate and not a more serious condition such as prostate cancer. Women and children should not take Avodart. Women who are, or could become, pregnant should not handle Avodart due to the possibility of a specific birth defect. Men treated with Avodart should not donate blood until at least six months after their final dose. Caution should be used in patients with liver sickness. Possible side effects include sexual side effects and breast tenderness and/or swelling. These side effects occur infrequently.

For full prescribing information, see www.Avodart.com.

About BPH

Benign prostatic hyperplasia (BPH) is a prevalent and progressive condition in aging men, affecting greater than 50 percent of men by the time they are 60 years of age and 90 percent of men by age 85.2 The progressive nature of the sickness is associated with an increased risk of AUR (a sudden inability to urinate) and BPH-related surgery. The 2003 AUA guidelines recommend the use of a 5ARI as an appropriate and effective option for the a cure of men with syndromeatic BPH and an enlarged prostate. 2

About AUA-SI

The AUA-SI is a tool used in evaluating the severity of BPH syndromes, including frequent or urgent urination, weak or intermittent urine stream, sensation of incomplete emptying, the need to strain and frequent urination during bedtime hours. Patients with AUA-SI scores of seven or less are considered to have mild syndromes. Patients with AUA-SI scores between eight and 19 are considered to have moderate syndromes and those with scores of 20 to 35 are classified as having severe syndromes.2,3 An improvement in AUA-SI score of three points or greater is considered meaningful to the patient.3

About GSK

GlaxoSmithKline - one of the world’s leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling group to do more, feel better and live longer.

Company information line: 1-888-825-5249. Website address: www.gsk.com

References

1. Hagerty J, Ginsberg P, Harkaway R. A prospective, comparative meditate of the onset of syndromeatic benefit of dutasteride versus finasteride in men with benign prostatic hyperplasia in everyday clinical practice. Annual meeting of American Urological Association 2004. Abstract #1353.

2. AUA Practice Guidelines Committee. AUA guideline on management of benign prostatic hyperplasia (2003). Chapter 1: diagnosis and a cure recommendations. J Urol. 2003: 170: 530-547.

3. Barry M, Williford W, Chang Y, et al. Benign Prostatic Hyperplasia specific health status measures in clinical research: How much change in the American Urological Association syndrome index and the Benign Prostatic Hyperplasia Impact Index is perceptible to patients? Urology. 1995; 154: 1770-1774.

Enquiries
GlaxoSmithKline Michael Fleming
919-483-2839

A major clinical trial finds that a combination of two common medicate s — tolterodine (Detrol LA) and tamsulosin (Flomax) — works better than either medicate alone for men struggling with lower urine tract syndromes, including tough-to-treat overactive bladder (OAB).

“A full 80 percent of men with moderate-to-severe OAB — which is characterized by syndromes such as urgent and frequent urination — who received these two medicate s together reported a real benefit within three months of pharmacomedical aid,” says the meditate ’s lead author, Dr. Steven A. Kaplan, professor of urology at Weill Cornell Medical College and attending urologist at NewYork-Presbyterian Hospital/Weill Cornell Medical Center in New York City. “In contrast, patients receiving either tolterodine or tamsulosin alone reported improvements that were little more than those seen by patients on placebo,” he adds.

“Based on these findings, we believe that a combination of medicate s such as tolterodine/tamsulosin may become a new ‘gold standard’ for the pharmacomedical aid of bothernesssome moderate-to-severe overactive bladder syndromes in this patient population,” Dr. Kaplan says.

The NewYork-Presbyterian/Weill Cornell expert will present the findings Tuesday, Nov. 14, at 10 a.m., at a JAMA news briefing in New York City. The meditate will be published in the Nov. 15 edition of the Journal of the American Medical Association, a special issue devoted to men’s health.

Experts estimate that 10 mil. American men aged 40 and over suffer from overactive bladder. The current standard of care involves the use of an “antimuscarinic” medicate such as tolterodine to help alleviate OAB syndromes. Antimuscarinics help regulate bladder contractions through their effects on the bladder’s detrusor muscle.

In many cases, doctors may also suspect that an enlarged prostate (”benign prostatic hyperplasia” or BPH) is an underlying cause of OAB. In those instances, they will prescribe an “alpha-adrenergic receptor antagonist” medicate such as tamsulosin, which eases syndromes through its effect on prostate muscle tone.

“The problem is that men with OAB and enlarged prostate can have an overactive bladder without it being caused by this prostatic condition, so they don’t respond to medicate s such as tamsulosin” Dr. Kaplan notes. “Likewise, some patients do not respond to tolterodine alone, either.”

However, urologists have reported anecdotal success in using both of these agents together for moderate-to-severe male OAB. In this meditate , Dr. Kaplan and colleagues at NewYork-Presbyterian/Weill Cornell — along with researchers at the University of Texas Southwestern Medical Center and the Medical University of South Carolina — agsdhfgdfed this approach in a double-blinded, randomized clinical trial involving more than 850 patients treated at 95 urology clinics across the U.S. The meditate was funded by Pfizer Inc., the maker of Detrol LA.

Patients were all 40 years of age or older (average age 62) with syndromes suggestive of an enlarged prostate and a history of moderate-to-severe overactive bladder, including a frequent urination and urgency with or without incontinence. Patients with any history of prostate surgery or prostate cancer were excluded from the meditate .

The 12-week, double-blinded, placebo-controlled meditate randomized participants into one of four pharmacomedical aid groups: one arm (217 patients) received a once-daily 4 milligram dose of tolterodine, a second arm (215 pts.) received 0.4 milligrams of tamsulosin once per day, a third group (225 pts.) was given both medicate s in combination, while a fourth group (222 pts.) received a daily placebo.

The researchers had participants record changes in daily syndromes — items such as frequency of urine incontinence — in special “bladder diaries.” They also questioned each participant on their “perception of pharmacomedical aid benefit” at weeks 1, 6 and 12. Urinary flow rates and volume were also assessed at baseline and at week 12 via flowmeter and ultrasound.

The result: “We found a marked improvement in OAB for patients taking both medicate s together, with 80 percent reporting a real pharmacomedical aid benefit compared to 62 percent for those on placebo,” Dr. Kaplan reports. “In contrast, pharmacomedical aid benefit rates for monomedical aid did not rise much above placebo — 71 percent for patients taking tamsulosin and 65 percent for those given tolterodine monomedical aid.”

Compared to monomedical aid, tolterodine/tamsulosin in combination achieved significantly higher rates of syndrome reduction in terms of urgency urine incontinence, urgency episodes without incontinence, voiding per 24 hours, and night voiding. Patients on the two-medicate medical aid also reported significant improvement in their quality of life compared to monomedical aid or placebo, the researchers added.

Each of the three medicate regimens was well-tolerated, with dry mouth being the most frequently reported syndrome. Patients on combination medical aid did report a higher incidence of dry mouth than those taking monomedical aid (21 percent vs. 7 percent, respectively). “The reasons for this increase in dry mouth remain unclear and require further meditate ,” Dr. Kaplan says. “We have some evidence, however, that taking the medicate s just before bed, rather than after dinner as in this meditate , could reduce risks for these and otherness adverse effects.”

The bottom line, according to Dr. Kaplan, is that the findings “strongly support the use of these two medicate s in combination as safe and effective medical aid for men with moderate-to-severe lower urine tract syndromes, including OAB.”

“For many men who are bothernessed by OAB, monomedical aid — which targets one potential cause of the illness — is simply not enough to ease syndromes,” he says. “In that context, the use of tolterodine and tamsulosin together may work much better, since it tackles the problem on multiple fronts.”

Co-researchers include senior researcher Dr. Zhonghong Guan of Pfizer Inc., New York City; Dr. Tamara Bavendam and Martin Carlsson, also of Pfizer; Dr. Claus G. Roehrborn of the University of Texas Southwestern Medical Center, Dallas; and Dr. Eric S. Rovner of the Medical University of South Carolina, in Charleston.

For more information, patients may call (866) NYP-NEWS.

NewYork-Presbyterian Hospital/Weill Cornell Medical Center

NewYork-Presbyterian Hospital/Weill Cornell Medical Center, located in New York City, is one of the leading academic medical centers in the world, comprising the teaching hospital NewYork-Presbyterian and its academic partner, Weill Cornell Medical College. NewYork-Presbyterian/Weill Cornell provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine, and is committed to excellence in patient care, research, education and community service. NewYork-Presbyterian ranks sixth on the U.S.News & World Report’s list of top hospitals.

NewYork-Presbyterian Hospital
425 East 61st St., Fl. 7
New York, NY 10021
United States
http://www.nyp.org