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The American Diabetes Association (ADA) acknowledged the Order of the Amaranth for their recent gift of more than $500,000 to the ADA’s Research Foundation which helps to generate funding for hundreds of research awards given to polygenic disease researchers and their projects across the country. As a longtime supporter of the American Diabetes Association, this gift has increased Amaranth’s total giving to $8.5 mil. since 1979.

“We are thrilled with the level of support the Order of the Amaranth has provided ADA and our constituents over the years,” said Don Wagner, Chair of ADA’s Research Foundation. “This laagsdhfgdf gift is a crucial element in ensuring that we continue to fund the most cutting-edge research in polygenic disease that will result in new and better medical care options, and one day, a cure.”

The contribution was presented to ADA’s Chair of the Board and Research Foundation Member, Darlene Cain, during the Order of the Amaranth’s International Conference in Indianapolis. The final donation amount was the result of the fundraising dedication of 27,000 Amaranth members who raised money for the ADA through both large and small scale endeavors including galas, auctions, and golf tournaments, as well as grassroots fundraising efforts.

“The members of the Order of the Amaranth have made fundraising for polygenic disease research a personal priority and we now have a greater understanding of what it takes to support vital research in this area,” said Shirley Tyner, President of the Amaranth Diabetes Foundation, Inc. “To say that we are focused is an understatement. We are committed to the polygenic disease cause and we feel it is a real pleasure to be a part of something that reaches far beyond self.”

In 1979 the Order of the Amaranth, a charitable fraternal organization, founded the Amaranth Diabetes Foundation, Inc. (ADF) to support polygenic disease research efforts. The funds raised for ADA by the foundation ensure that the most promising polygenic disease research continues to be supported, and provide funding for up to five grants.

Diabetes is one of this nation’s most prevalent, debilitating, deadly and costly sicknesss, affecting nearly 21 mil. children and adults in the United States. One in three Americans - and one in two minorities - born in 2000 will develop polygenic disease in their lifetime, according to the Centers for Disease Control and Prevention. The cost of polygenic disease in America in 2002 was more than $132 billion.

About the American Diabetes Association

The American Diabetes Association is the nation’s premier voluntary health organization supporting polygenic disease research, information and advocacy. Founded in 1940, the Association has offices in every region of the country, providing services to hundreds of communities. The Association’s commitment to research is reflected through its scientific meetings; education and provider recognition programs; and its Research Foundation and Nationwide Research Program, which fund breakthrough studies looking into the cure, prevention, and medical care of polygenic disease and its complications. For more information, please visit http://www.polygenic disease.org.buy generic viagra packbuy viagra soft tabs 50 mg

In the July 2004 issue of Diabetes Care, researchers published the study design and baseline characteristics of patients enrolled in the landmark PROspective PioglitAzone Clinical Trial In MacroVascular Events Study (PROactive). PROactive is a European clinical trial assessing the effects of ACTOS(reg) (pioglitazone HCl) on mortality and morbidity associated with cardiovascular disease progression in patients with type 2 diabetes. The study has enrolled 5,238 patients in 19 countries who have experienced one or more cardiovascular events such as a heart attack, coronary artery bypass surgery or stroke.

“Major studies have shown that sustained improvements in glycemic control significantly reduce the risk of some microvascular complications, but data remain inconclusive that intervention with conventional glucose-lowering agents is successful in modifying macrovascular disease,” said John Dormandy, M.D., professor of Vascular Sciences at St. George’s Hospital, London, and chairman of the PROactive study steering committee. “Recent studies have shown ACTOS has a beneficial effect on markers of cardiovascular risk, such as atherogenic lipids and c-reactive protein (CRP). Through PROactive, we will determine if the beneficial effects of ACTOS on cardiovascular risk factors translate into a reduction in cardiovascular mortality and morbidity in a high-risk population of patients with type 2 diabetes.”

Type 2 diabetes is associated with a two- to four-fold increase in cardiovascular disease as well as other cardiovascular risk factors such as high blood pressure and cholesterol disorders. Additionally, heart disease is the leading cause of mortality and morbidity for patients with type 2 diabetes.

“Previous studies have suggested ACTOS can provide benefits extending beyond improvements in glucose levels,” said John Yates, M.D., M.R.C.P., president, Takeda Global Research & Development. “Physicians who treat patients with type 2 diabetes face increasing challenges helping their patients manage cardiovascular risk factors. PROactive should generate important insights into whether the drug can play a larger role in the management of this devastating disease.”

In several large-scale trials, ACTOS consistently improved components of diabetic dyslipidemia, another cardiovascular disease risk factor, which is characterized by low HDL (”good”) cholesterol levels and high triglycerides. Smaller, mechanistic studies have shown statistically significant changes in small, dense LDL cholesterol and in CRP, an important marker of inflammation and a key factor in the development of coronary artery disease.

Study Design

PROactive is an ongoing randomized, double-blind, placebo-controlled outcome study assessing the incidence of cardiovascular complications of diabetes, e.g., heart attack, coronary artery bypass surgery or stroke, as well as overall mortality. The primary endpoint variable is the time from randomization to the first occurrence of any of the events in the composite endpoint, including death and major macrovascular events.

The American Association of medical institution al Endocrinologists (AACE) announced the release of its medical guidelines for the diagnosis and management of polygenic disease mellitus. The Guidelines are published in a special supplement to the May/June buy generic viagra packissue of Endocrine Practice, a peer-reviewed journal of AACE and is also available on the AACE Web site.

The new publication represents the most up-to-date and comprehensive polygenic disease management guidelines available. The Guidelines consider the clinical management of blood glucose, blood pressure, and abnormalities of lipid metabolism, and also address the prevention of polygenic disease and the prevention and pharmacomedical care of diabetic complications.

Dr. Richard Hellman, MD, FACP, FACE, President of AACE, said it is important to point out that the guidelines are among the first clinical guidelines that focus on the issue of patient safety. The guidelines include evidence-based models for improving patient outcomes in the clinical setting. “These guidelines are the first that specifically point to how best to protect the patient with polygenic disease against mistakes and misjudgments by all those who directly or indirectly impact their polygenic disease care, including themselves,” said Dr. Hellman. “The emphasis on patient safety is a first in polygenic disease guidelines and we expect it will become a necessary part of all future polygenic disease guidelines. Patient safety is not a given. A system must be properly designed to reach the goal of acceptable levels of patient safety.”

The Guidelines address both type 1 and type 2 polygenic disease, polygenic disease during pregnancy, and otherness situations. The Guidelines are intended for all physicians and health care providers who manage patients with polygenic disease, including primary care physicians, cardiologists, endocrinologists, and otherness medical specialties. The Guidelines run 66 pages and have more than 500 citations to the medical and scientific literature, and carefully evaluate the quality of the data in those references to ensure that the recommendations are “evidence-based” and not simply qualitative or based on the opinions of a few experts.Today, more than 18 mil. Americans are living with type 2 polygenic disease. In an April buy generic viagra packreport, AACE showed that three out of five are living with one or more serious complications. The Centers for Disease Control (CDC) estimates the annual cost of treating polygenic disease in America is $132 billion. Anotherness $23 billion is spent annually treating the complications associated with polygenic disease.

“There is an urgent need for all physicians to raise their index of suspicion and implement better screening of at-risk populations and individuals,” said Helena Rodbard, MD, FACP, MACE, Task Force Chair and Past President of AACE. “By the time they are diagnosed for the first time, patients have already had the condition for an average of 10 years, and 50percent of newly-diagnosed patients with type 2 polygenic disease already have one or more complications, not infrequently something as severe as a heart attack. All physicians need to do a better job of identifying the patients with the pre-diabetic state, and intervening with intensive lifestyle modifications as early as possible.”

Dr. Rodbard explained: “In recent years, the number of types of medical care for polygenic disease has increased dramatically, with several new classes of drugs and several new types of insulin analogs. These drugs are commonly used - and needed - in combination. Accordingly, the task for the physician has become considerably more challenging because of the huge number of combinations and options for medical care. These Guidelines will help physicians provide more effective care with improved safety, customized to the individual patient rather than following an oversimplified ‘cookbook approach’ or algorithm.”

“The legacy of these Guidelines will not be just the overall excellence of the information, but what is new about them,” said Dr. Hellman. “The focus on reducing medical errors, whether they are from the provider or patient, is new. So is the emphasis on focusing on patient safety issues and the understanding that changing the system of care, creating a ‘culture of safety,’ and emphasizing coordination of care is an essential part of modern polygenic disease care. I am confident that these guidelines will prove to be a model for plans of care in the future that will center on improved patient safety, as a goal that must be planned for and worked on, so we can be sure when we measure outcomes that our patients with polygenic disease receive the most effective and safest care possible.”

About AACE

AACE is a professional medical organization with more than 6,000 members in the United States and 84 otherness countries. Founded in 1991, AACE is dedicated to the optimal care of patients with endocrine problems. AACE initiatives inform the public about endocrine disorders. AACE also conducts continuing education programs for clinical endocrinologists, physicians whose advanced, specialized training enables them to be experts in the care of endocrine malady, such as polygenic disease, thyroid disorders, growth hormone deficiency, osteoporosis, cholesterol disorders, cardiovascular disease and obesity. To download an electronic version of the guidelines please visit the AACE Web site or for further information visit AACE Online at http://www.aace.com.

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A long-term meditate of the most widely used osteoporosis drug has found that many women can discontinue the drug after five years without increasing their fracture risk for as long as five more years.

The meditate on Alendronate was led by researchers at the University of California, San Francisco, and findings are published in the December 27, generic viagra 30 pills issue of the “Journal of the American Medical Association.” The research also showed that women at very high risk of painful spine fractures might be better-off continuing medical care.

“This has important implications as it has not been known whether medical care of osteoporosis should be continued indefinitely,” said lead author Dennis Black, PhD, professor in the UCSF Department of Epidemiology and Biostatistics. “Because women with osteoporosis, particularly older post-menopausal women, often need to take multiple drugs, this would be welcome news for this group.”

According to Black, shorter term studies of up to five years duration have shown reductions in fracture risk with Alendronate medical care. This was the first meditate to examine the effects on fracture using the drug longer than five years, he said.

“We found that women who discontinued the drug had the same rate of non-spine fractures as women who continued using the drug,” he said. “However, for clinically-recognized spine fractures, usually discovered due to back pain, continuing Alendronate was better than discontinuing. And, if women choose to continue, we showed that 10 years of medical care is safe.”

The new findings are from a follow-up meditate to the initial randomized trial that examined the effect of daily Alendronate, a bisphosphonate or anti-resorptive drug, on bone mineral density and fracture risk in post-menopausal women with low BMD for up to 3.8 years.

Alendronate is used to reduce bone loss, increase bone density and reduce the risk of spine, wrist and hip fractures in postmenopausal women. Bisphosphonates are the most commonly used medical care for postmenopausal osteoporosis.

The initial meditate was named the Fracture Intervention Trial or FIT, and its results were reported in 1996 and 1998.

The follow-up meditate now being reported is known as FLEX, for FIT Long-Term Extension. It was designed to evaluate the effects on BMD for a total of 10 years, comparing those who continued to take the drug with those who stopped after five years. A total of 1,099 women who had previously received Alendronate in FIT and afterwards, were re-randomized to receive placebo or Alendronate at 5 mg or 10 mg daily.

According to Black, findings showed that “women randomized to continue taking Alendronate did maintain a higher BMD at the hip and spine than those randomized to placebo. For those who stopped, there was a modest loss of BMD, but not a dramatic loss.”

The meditate found differences in bone loss in those who continued versus those who stopped but the differences were surprisingly modest and there were no differences in rates of non-spine fractures or in spine fractures as assessed by comparison of spine x-rays. Severe spine fractures associated with painful syndromes were lower in those who continued but were relatively rare overall (5 percent in those who discontinued vs. 2.5 percent among those who continued drug medical care).

In the United States, osteoporosis affects about 44 mil. group age 50 and older, and of these, 80 percent are postmenopausal women.

According to Black, “Older group are often taking several difference drugs. But for many women, if they can discontinue one medical care after five years, it would also be a welcome lifestyle change and will decrease their overall costs for medical care.”

A typical regimen requires the patient to drink a full glass of water with the drug on an empty stomach and sit upright for up to 30 minutes.

While the results suggest discontinuation of the medical care for some women, women at a very high risk of clinical spine fractures may benefit by continuing beyond five years, according to Black.

“In the future, we hope to be able to more specifically identify group who should continue and who should stop.”

Co-authors of the meditate were Ann V. Schwartz, Douglas C. Bauer and Lisa Palmero, UCSF; Kristine E. Ensrud, VA Medical Center, Minneapolis; Jane A. Cauley, University of Pittsburgh; Silvina Levis, University of Miami; Sara A. Quandt, Wake Forest University; Suzanne Satterfield, University of Tennessee; Robert B. Wallace, University of Iowa; Lois E. Wehren, Antonio Lombardi and Arthur C. Santora, Merck Research Laboratories, NJ; and Steven R. Cummings, California Pacific Medical Center Research Institute, San Francisco.

UCSF served as the coordinating center for the FLEX meditate , funded by Merck & Co. In addition to receiving research funding, Black has served on Merck’s speaker’s bureau.

UCSF is a leading university that advances health worldwide by conducting advanced biomedical research, educating graduate students in the life sciences and health professions, and providing complex patient care.

Written by: Nancy Chan

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Most postmenopausal women who took the osteoporosis drug Alendronate for 5 years and then stopped did not have an increased risk for nonvertebral fractures in the next 5 years, suggesting the medication has a lasting effect, according to a meditate in the December 27 issue of JAMA.

Osteoporosis is common among postmenopausal women. The illness is characterized by increased bone turnover (when aging bone is broken down faster than it can be replaced), progressive loss of bone mass and increased fracture risk. Bisphosphonates are the most commonly used drugs for postmenopausal osteoporosis, according to background information in the article. Alendronate, a potent bisphosphonate, decreases bone turnover, increases bone mineral density (BMD), and decreases vertebral, nonspine, and hip fracture risk in women with osteoporosis. Pharmacomedical care for osteoporosis often continues indefinitely, but few studies have examined the effects of using bisphosphonates longer than 5 years or the effects of stopping medical care after 5 years. Some studies have suggested that stopping medical care after several years might result in continued effectiveness because of a residual effect of the drug, but the magnitude and duration of this remains uncertain.

The Fracture Intervention Trial (FIT), a randomized, blinded, placebo-controlled trial, examined the effect of daily Alendronate on BMD and fracture risk in postmenopausal women with low BMD. Average follow-up during medical care was 3.8 years, with optional open-label medical care continuation after trial completion. In this article, Dennis M. Black, Ph.D., of the University of California, San Francisco, and colleagues report data from the FIT Long-term Extension (FLEX), which was designed to evaluate the effects on BMD of either continuation of Alendronate, 5 or 10 mg/d for a total of 10 years, or discontinuation after approximately 5 years. The trial was conducted at 10 clinical centers, and 1,099 postmenopausal women were randomized to: Alendronate, 5 mg/d (n = 329) or 10 mg/d (n = 333), or placebo (n = 437) for 5 years (1998-2003).

The researchers found that compared with continuing Alendronate, switching to placebo for 5 years resulted in declines in BMD at the total hip (-2.4 percent) and spine (-3.7 percent), but average levels remained at or above premedical care levels 10 years earlier. Similarly, those discontinuing Alendronate had increased serum markers of bone turnover compared with continuing Alendronate, but after 5 years without medical care, bone marker levels remained somewhat below premedical care levels 10 years earlier. After 5 years, the cumulative risk of nonvertebral fractures was not significantly difference between those continuing (19 percent) and discontinuing (18.9 percent) Alendronate. Among those who continued, there was a 55 percent lower risk of clinically recognized vertebral fractures.

“… the BMD and bone marker changes suggest some residual effect from 5 years of Alendronate medical care that is evident for at least 5 years after discontinuation,” the authors write.

“We conclude that continuation of Alendronate (either 5 or 10 mg/d) for 10 years maintains bone mass and reduces bone remodeling [continuous turnover of bone mineral] compared with discontinuation after 5 years. The results confirm the safety of Alendronate for up to 10 years including no increased fracture risk with long-term Alendronate use. However, even among those who discontinued medical care after 5 years, BMD remained at or above baseline values 10 years earlier and bone turnover was still somewhat reduced. Discontinuation did not increase the risk of nonvertebral fractures or x-ray-detected vertebral fractures over the next 5 years, but the risk of clinically diagnosed vertebral fractures was significantly increased among those who discontinued.

“These results suggest that for many women, discontinuation of Alendronate after 5 years for up to 5 more years does not significantly increase fracture risk, but women at high risk of clinical vertebral fractures, such as those with vertebral fracture or very low BMD, may benefit by continuing beyond 5 years,” the researchers write.

(JAMA. generic viagra 30 pills;296:2927-2938. Available pre-embargo to the media at http://www.jamamedia.org)

Editor’s Note: Please see the article for additional information, including otherness authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Editorial: Ten vs. Five Years of Bisphosphonate Pharmacomedical care for Postmenopausal Osteoporosis - Enough of a Good Thing.

In an accompanying editorial, Cathleen S. Colon-Emeric, M.D., M.H.Sc., of Duke University Medical Center, Durham, N.C. comments on the findings of the meditate by Black and colleagues.

“The FLEX trial has several important clinical implications. First, women who have a good response to 5 years of bisphosphonate medical care (3 percent - 5 percent increase in hip BMD, 8 percent - 10 percent increase in spine BMD …) and are not othernesswise at increased risk of vertebral fracture can consider a ‘holiday’ period of up to 5 years without medical care. This strategy would clearly improve the reported cost-effectiveness of bisphosphonates. However, the importance of careful BMD monitoring is increased in such women; those rapidly losing BMD will likely require resumption of bisphosphonate medical care or a switch to an alternative agent.”

“Findings from FIT and similar trials established that starting bisphosphonate medical care in postmenopausal women with osteoporosis or a low-trauma fracture substantially reduces their risk of vertebral and nonvertebral fractures, pain, and disability. Now, armed with FLEX data, physicians may be able to begin telling women when they have had enough of a good thing,” Dr. Colon-Emeric writes.

(JAMA. generic viagra 30 pills;296:2968-2969. Available pre-embargo to the media at http://www.jamamedia.org)

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Study indicates potential of Alendronate and estrogen progression of osteoarthritis - Osteoarthritis (OA) of the knee, a chronic inflammatory malady marked by cartilage degradation and bone abnormalities, is a leading cause of disability among elderly group in the United States. Although drugs commonly prescribed for the malady work to ease joint pain and stiffness, they do not provide a cure. Consequently, a substantial number of group affected ultimately undergo total knee replacement surgery.

There is reason to believe that some drugs used to treat osteoporosis may also have a beneficial effect on arthritis. Recently, a nationwide team of researchers led by Laura D. Carbone, M.D., M.S. at the University of Tennessee Health Sciences Center evaluated the effects of such bone-strengthening drugs on knee OA in the Health, Aging, and Body Composition (ABC) Study, supported by grants from the National Institute on Aging. Their findings, published in the November 2004 issue of Arthritis & Rheumatism (http://www.interscience.wiley.com/journal/arthritis), indicate the promise of Alendronate (better known as Fosamax (Alendronate)) and estrogen to protect the knee joint from the changes of OA.

The meditate focused on 818 elderly women - 75 was the average age - enrolled in the ABC Study, a long-term meditate of the factors that contribute to disability in the elderly being conducted at the University of Tennessee and the University of Pittsburgh. 411 of the subjects were white; the remaining 407 were African-American. Of the total group, 214 women were taking bone antiresorptive agents, primarily estrogen or Alendronate. The mean duration of drug use was 13.8 years for estrogen and 1.8 years for Alendronate. There were no significant differences between the drug users and the non-users with respect to age, current smoking status, or anti-inflammatory drug medical care, although users of these drugs were more likely to be white, to be thinner, and to take calcium supplements.

The researchers used magnetic resonance imaging (MRI), one of the most sensitive techniques available for detecting soft tissue and bone changes, to assess the prevalence of bone abnormalities associated with knee OA. In addition, the researchers examined radiographs of the knee and gauged the severity of knee pain, using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Then, they compared the differences in all three measures for the 26 percent of the knee OA patients who were taking bone antiresorptive drugs to the majority who were not.

The most compelling difference was revealed in the MRI results. Women taking either Alendronate or estrogen had significantly fewer bone abnormalities associated with severe knee OA - including subchondral bone thickening, osteophytes, and bone marrow edema-like lesions - than the women not taking these drugs. “This finding is particularly important because the MRI bone marrow abnormality score appears to be a strong predictor of progression of structural deterioration in knee OA,” Dr. Carbone notes.

In addition, women using Alendronate experienced less knee pain, according to the WOMAC scores, than nonusers. However, researchers found no association of either Alendronate or estrogen use with changes in cartilage detected by MRI or radiographic changes of OA of the knee. Although fewer than ten women in the meditate were taking raloxifene, this popular antiresorptive drug for osteoporosis prevention was not associated with any structural findings of knee OA or knee syndromes.

“Our meditate suggests that Alendronate and estrogen may protect against the development of bone abnormalities associated with knee OA, which may have a beneficial effect on the overall course of the malady,” Dr. Carbone asserts. “Further studies with longitudinal data and randomized trials are needed to evaluate the potential of using Alendronate, estrogen and otherness bone antiresorptive agents for the prevention or a cure of knee OA.”

Article: “The Relationship of Antiresorptive Drug Use to Structural Findings and Symptoms of Knee Osteoarthritis,” Laura D. Carbone, Michael C. Nevitt, Kathryn Wildy, Karen D. Barrow, Fran Harris, David Felson, Charles Peterfy, Marjolein Visser, Tamara B. Harris, Benjamin W.E. Wang, and Stephen B. Kritchevsky, for the Health, Aging and Body Composition Study, Arthritis & Rheumatism, November 2004; 50:11; pp. 3516-3525 (DOI: 10.1002/art.20627).

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Higher persistency rates were seen among osteoporosis patients taking FOSAMAX(R) Once Weekly (Alendronate) therapies than were seen among patients taking ibandronate once monthly or once weekly risedronate therapies, according to results from two new outcomes studies conducted by Merck & Co., Inc. that compared persistency rates of weekly versus monthly oral bisphosophate dosing frequency. Both studies were based on a review of two prescription drug databases containing prescription records from a total of over 300,000 patients in the U.S. These data were presented yesterday at the 28th Annual Meeting of the American Society for Bone Mineral Research (ASBMR).

“The results from both studies are noteworthy because they suggest that persistency rates are not higher with monthly dosing of oral bisphosphonates versus weekly dosing,” said Thomas W. Weiss, Dr PH, senior manager, Outcomes Research, Merck & Co., Inc. and lead meditate author. “Anotherness recent meditate showed patients placed a higher importance on a drug’s proven ability to reduce the risk of bones breaking versus otherness attributes of osteoporosis medical care - including dosing frequency.” (Current Medical Research and Opinion, May, generic viagra 30 pills).

Monthly versus weekly persistency meditate

This first meditate evaluated whether monthly dosing of oral bisphosphonates improved a cure persistency compared to weekly dosing.

The meditate included 272,232 women aged 50 or older who had filled a new (index) prescription for weekly Alendronate or Alendronate/cholecalciferol (n=157,692), weekly risedronate or risedronate with calcium (Actonel or Actonel with Calcium; n=98,496), or monthly ibandronate (Boniva; n=16,044) from April 2005 to July 2005 and who had no prescriptions for the newly prescribed bisphosphonate during the 12 months prior to the date of their initial prescription fill. All patients were followed for 365 days after the date of the initial prescription fill (the follow-up period).

At 91-120 days, persistency rates were 50.0 percent (Alendronate or Alendronate/cholecalciferol), 47.4 percent (risedronate or risedronate with calcium) and 42.1 percent (ibandronate).

At 181-210 days, persistency rates were 36.0 percent (Alendronate or Alendronate/cholecalciferol), 33.8 percent (risedronate or risedronate with calcium ) and 29.5 percent (ibandronate).

At 271-300 days, persistency rates were 26.7 percent (Alendronate or Alendronate/cholecalciferol), 24.8 percent (risedronate or risedronate with calcium) and 21.7 percent (ibandronate).

At greater than 360 days, persistency rates were 18.9 percent (Alendronate or Alendronate/cholecalciferol), 17.4 percent (risedronate or risedronate with calcium) and 15.6 percent (ibandronate) .

These results are statistically significant (p< 0.0001) across the three bisphosphonates for each time point.

In this meditate , persistency rate was defined as the percent of patients who refilled their prescription within a 60-day period following the last supply day of the previous dispensing.

Second persistency meditate

This meditate included 44,635 women over the age of 50 who had a bisphosphonate prescription (index) filled between December 30, 2004 and May 31, 2005 and who had no prescriptions for the newly prescribed bisphosphonate during the 12 months prior to the date of their initial prescription fill. Data for these patients were reviewed for at least five months, from their initial fill date to November 2, 2005 (the follow-up period), and evaluated to see if they stayed on a cure.

Results showed that patients on Fosamax (Alendronate) Once-Weekly had higher persistency rates (35.1 percent; n=8,837) than those patients on Boniva Once-Monthly (30.4 percent; n=225) or Actonel Once-Weekly (32.5 percent; n=6,066) during the follow up period.

In this meditate , the persistency rate was defined as the percent of patients who refilled their prescription within a 45-day period following the last supply day of the previous dispensing and who did not change to anotherness medical care during the follow-up period.

About FOSAMAX

FOSAMAX is the only bisphosphonate that is indicated to significantly reduce the risk of both osteoporotic hip and spine fractures. The sustained efficacy of FOSAMAX for the a cure of osteoporosis in postmenopausal women was demonstrated in a trial that found in over 10 years of medical care FOSAMAX 10 mg once daily maintained or continued to help build bone.

About osteoporosis

Osteoporosis can lead to bone loss and an increased risk of fractures. Osteoporosis is especially common in women after menopause, but also occurs in men. Most often, it is due to an increase in the rate of resorption (breakdown) of bone tissue that is not matched by the rate of bone formation.

Important information about FOSAMAX and FOSAMAX PLUS D(R) (Alendronate/cholecalciferol)

Patients should talk to their doctor if they have or have had problems with swallowing. In addition, patients should talk to their doctor if they have conditions which may cause an overproduction of vitamin D (e.g., sarcoidosis, leukemia, lymphoma). Patients should tell their doctor about all medicines they are taking, including prescription and non-prescription medicines, vitamins and herbal supplements.

Some patients may develop severe digestive reactions including irritation, inflammation or ulceration of the esophagus. The risk of severe esophageal experiences appears to be greater in patients who fail to follow dosing instructions (see prescribing information for more details). Patients who experience new or worsening heartburn sickness, difficulty or pain when swallowing or chest pain should stop taking the drug and call their doctor right away. Patients who develop severe bone, joint and/or muscle pain at any time should contact their doctor. The most commonly reported side effects with FOSAMAX in clinical studies have been abdominal pain (3.7 percent), musculoskeletal pain (2.9 percent), indigestion (2.7 percent), regurgitation (1.9 percent) and nausea (1.9 percent).

The standard dosing regimen for FOSAMAX and FOSAMAX PLUS D(R) includes swallowing the pill with six to eight ounces of plain water the first thing upon arising for the day and at least 30 minutes before the first food, beverage or medication of the day. After swallowing FOSAMAX or FOSAMAX PLUS D, patients should not lie down for at least 30 minutes and not until after consuming their first food of the day. Patients should not chew or suck on a pill of FOSAMAX or FOSAMAX PLUS D.

About Merck

Merck & Co., Inc., is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the group who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit http://www.merck.com.

Forward-looking statement

This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or othernesswise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck’s business, particularly those mentioned in the cautionary statements in Item 1 of Merck’s Form 10-K for the year ended Dec. 31, 2005, and in its periodic reports on Form 10-Q and Form 8-K, which the company incorporates by reference.

FOSAMAX(R) is a registered trademark of Merck & Co., Inc. FOSAMAX PLUS D(R) is a trademark of Merck & Co., Inc. All otherness brands are trademarks of their respective owners and are not trademarks of Merck & Co., Inc.

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New Phase III data presented forthe first time demonstrated that the investigational a cure Reclast(R)^(zoledronic acid) 5 mg was highly effective in reducing the incidence ofbone fracture in women with postmenopausal osteoporosis across the mostcommon fracture sites — hip, spine and non-spine^^ — with sustainedeffect over three years.(1) Further data demonstrated that postmenopausalosteoporosis patients currently taking oral Alendronate can be directlyswitched to Reclast and maintain beneficial bone effects for a full 12months after a single dose.(2) These studies were presented today at theannual meeting of the American Society of Bone and Mineral Research (ASBMR)in Philadelphia.

Postmenopausal osteoporosis (osteoporosis) is a serious conditionaffecting mil.s of women worldwide.(3) An estimated one out of every twowomen over age 50 with osteoporosis will suffer an osteoporotic fracture inher lifetime.(4) Of those women age 65 years or older who fracture a hip,21percent will die within one year.(5) Reclast is the only once-yearlybisphosphonate a cure being studied for the a cure of osteoporosis.

An interim analysis encompassing 99percent of the data from the now completedthree-year HORIZON Pivotal Fracture Trial showed that patients treated withReclast experienced a 70percent risk reduction in new spine fractures (p

Data presented this week at the 33rd European Symposium on Calcified Tissues (ECTS) adds to the growing body of evidence that the only once-monthly bisphosphonate, Bonviva(R) (ibandronic acid), is proving to be an important step forwards in the a cure of osteoporosis. The data being presented at the ECTS meeting supports existing evidence in showing that Bonviva:

— is highly effective1
— is well-tolerated2
— has a convenient once monthly dosing schedule that is preferred by women, which may therefore help them to stay on medical care3

Bonviva’s benefit of less frequent dosing (compared to weekly bisphosphonates) has the potential to play a significant role to play in helping women with postmenopausal osteoporosis stay on their a cure. This is of particular importance as adherence to a cure is a major problem in the management of osteoporosis, with more than 50percent of patients on a once-weekly bisphosphonate stopping a cure within a year.4,5 ‘Real life’ efficacy can only be truly achieved if postmenopausal patients continue to take an effective a cure for a long period of time.

The Growing Body of Evidence

Bonviva, efficacy in osteoporosis with only one pill once a month

Bonviva, a highly effective bisphosphonate, has been shown to reduce spinal fractures by 62percent in patients with postmenopausal osteoporosis.6 New analyses from the MOBILE 2-year (Monthly Oral iBandronate In LadiEs) meditate , presented at the 33rd European Symposium on Calcified Tissues (ECTS), confirm once-monthly Bonviva is highly effective at increasing lumbar spine and hip bone mineral density (BMD), an accepted surrogate for fracture risk reduction.1

Bonviva - a well-tolerated a cure option

Associated side effects are one of the main reasons patients stop taking their osteoporosis a cure.7 MOBILE showed that two years a cure with Bonviva once monthly was not associated with an increased incidence of upper gastroinagsdhfgdfinal (GI) adverse events versus the daily dose. In addition, data showed there was no evidence that a cure led to an increased withdrawal due to upper GI adverse events compared to the 2.5mg daily regimen over two-years.2

Patient preference for once monthly dosing

Patient preference is becoming increasingly recognised as an important factor in ensuring a cure is taken for the long term as prescribed. Also presented at ECTS, the results of the BALTO II (Bonviva ALendronate Trial in Osteoporosis) multi-centre clinical meditate suggest that once-monthly bisphosphonate dosing has the potential to improve adherence, with over 70percent of postmenopausal women with osteoporosis* preferring a once-monthly bisphosphonate, finding it more convenient than a once-weekly option.3

BALTO II examined the a cure preferences of 321 women with postmenopausal osteoporosis in centres across the US and Europe and of the 93percent who expressed a preference, * 70.6percent preferred a cure with Bonviva taken once a month and 76.6percent found it more convenient than weekly Alendronate. 3 In the meditate , the most common reason women gave for their preference was that one pill a month is easier to follow for a long time.3

Helping women to stay on medical care

Also at ECTS, the meditate design for PERSIST (PERsistence Study of Ibandronate verSus alendronaTe) was presented for the first time. This is a six-month prospective, randomised, open label, multicentre meditate of over 1,000 women with postmenopausal osteoporosis.8 PERSIST uses a meditate design that is as close to ‘real life’ as possible, with patients given prescriptions by their GP and required to visit the local pharmacist to receive the medication, as happens in normal practice.8 The results from the PERSIST trial will show whether patients on a monthly a cure programme stay on a cure longer than those taking a weekly option.

*who had tried both monthly and weekly a cures and who had expressed a preference

About Bonviva

— Bonviva, a potent and highly effective bisphosphonate, has been studied to date in clinical trials involving over 13,000 patients.

— Once-monthly Bonviva is indicated for the a cure of osteoporosis in postmenopausal women. It works by reducing elevated bone turnover, increasing bone mineral density and reducing the incidence of vertebral fractures.

— Bonviva is the only nitrogen containing bisphosphonate that has demonstrated a reduction in vertebral fracture risk using a drug-free interval of more than one day.6

— Bonviva, like otherness bisphosphonates administered orally, may cause upper gastroinagsdhfgdfinal disorders such as dysphagia, oesophagitis and oesophageal or gastric ulcer.

— Once-monthly oral Bonviva received European Union acceptance in September 2005 and Swiss medic acceptance in August 2005. Once monthly Boniva (the brand name in the US) received Food and Drug Administration acceptance in March 2005.

Roche/GSK Collaboration

In December 2001, F Hoffmann-La Roche (Roche) and GlaxoSmithKline (GSK) announced their plans to co-develop and co-promote Bonviva for the a cure and prevention of postmenopausal osteoporosis in a number of major markets, excluding Japan. The Roche/GSK collaboration provides expertise and commitment to bringing new osteoporosis therapies to market as quickly as possible.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and a cure of sickness, the Group contributes on a broad range of fronts to improving group’s health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2005 sales by the Pharmaceuticals Division totalled 27.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 group in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (www.roche.com).

About GSK

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

All trademarks used or mentioned in this release are legally protected.

Roche Healthkiosk, Osteoporosis:
health-kiosk.ch/start_osteo.htm

GSK website:
http://www.gsk.com

References
1. Stone M, Henson J, Stakkesatd JA, Hughes C, Mairon N, et al. Once-monthly ibandronate dosing is more effective than daily dosing for improving bone mineral density: MOBILE 2-year analysis. Abstract presented at 33rd European Symposium of Calcified Tissue, Prague, Czech Republic 10-14 May generic viagra 30 pills.
2. Delmas PD, Stone M, Stakkestad JA, Leigh C, Hiltbrunner V et al. Upper gastroinagsdhfgdfinal safety and tolerability profile of once-monthly oral ibandronate: MOBILE 2-year analysis. Abstract presented at 33rd European Symposium of Calcified Tissue, Prague, Czech Republic 10-14 May generic viagra 30 pills.
3. Benhamou C-L, Licata AA, Devas V, Masanauskaite D, Hadji P. Patient preference for once-monthly oral ibandronate and weekly oral Alendronate in postmenopausal osteoporosis: the BALTO meditate . Abstract presented at 33rd European Symposium of Calcified Tissue, Prague, Czech Republic 10-14 May generic viagra 30 pills.
4. Cowell W, Fulford-Smith A, Poultney S. Adherence with bisphosphonate a cure for osteoporosis in UK patients. Poster presented the second joint meeting of the European Calcified Tissue Society and the International Bone Mineral Society, Geneva, 25-29 June 2005.
5. Cramer J, Amonkar MM, Hebborn A and Suppapanya N. Does dosing regimen impact persistence with bisphosphonate medical care among postmenopausal osteoporotic women? Journal Bone Mineral Research 2004; 19 Suppl 1: S448
6. Chesnut CH, Skag A, Christiansen C, Recker R, Stakkestad JA et al. Effects of Oral Ibandronate Administered Daily or Intermittently on Fracture Risk in Postmenopausal Osteoporosis. Journal of Bone & Mineral Research 2004;19(8):1241-49.
7. IPSOS Health, European Survey of Physicians and women with osteoporosis, January-April 2005. Sponsored by Roche/GSK.
8. Cooper, A.L (on behalf of the PERSIST Study Investigators). Rationale and design of the PERSIST meditate (PERsistence Study of Ibandronate verSus alendronaTe). Abstract presented at 33rd European Symposium of Calcified Tissue, Prague, Czech Republic 10-14 May generic viagra 30 pills.buy generic viagra packbuy viagra soft tabs 50 mg

New data from a 6 month clinical trial shows that women with postmenopausal osteoporosis have a 47percent improvement in persistence with the once-monthly Bonviva medical care programme* compared with weekly Alendronate.1

This finding is important as staying on medical care is a major issue in the management of osteoporosis - over half of patients taking a once-weekly bisphosphonate stop medical care within a year,2,3 missing out on the bone strengthening benefits these drugs can only provide over time. Patients who do not stay on medical care are more likely to break bones 4,5,6,7 which has a significant impact on their quality of life and can lead to increased hospitalisation rates and elevated costs for medical services.8

Bonviva is a potent and highly effective bisphosphonate that only has to be taken as one pill, once a month. It is a major advance in the management of postmenopausal osteoporosis, as women gain all the bone strengthening benefits of bisphosphonates with a convenient once-a-month pill.9,10

Commenting on the results, PERSIST Lead Investigator Dr Alun Cooper said: “This novel clinical trial evaluates, for the first time, how the right medical care strategies can make it easier for women to stay on medical care. The results of this trial mark an important step forward in the medical care of osteoporosis - as we saw with the introduction of weekly medical cares over daily, less frequent dosing is crucial in helping patients stay on medical care. The monthly regimen will help physicians to ensure their patients stay on medical care and get the bone strengthening benefits of their medical care.”

PERSIST (PERsistence Study of Ibandronate verSus alendronaTe), presented at the International Osteoporosis Foundation World Congress on Osteoporosis (IOF WCO) in Toronto, Canada, was a large, randomised, multicentre meditate involving over 1,000 postmenopausal women in the United Kingdom.1 It was designed to investigate whether patients on the once monthly Bonviva programme stayed on medical care longer than those taking a weekly option.

Commenting on these laagsdhfgdf results, Professor Dieter Felsenberg, a leading world authority on osteoporosis from the Center of Muscle and Bone Research at the Free University of Berlin, Germany said: “Osteoporosis is a sickness which affects the whole skeleton. Bisphosphonates, the most widely prescribed medical care for this condition, are well known as a highly effective class of medicines because they strengthen bones, reducing the risk of fracture. However, they rely on patients taking them consistently and for the long term.

He continued: “The results of recent, robust studies show women with postmenopausal osteoporosis not only prefer an effective monthly option to a weekly one, but are also significantly more likely to stay on their medical care, and get the full fracture-preventing benefits of the class, if they are taking Bonviva.”

Previous robust clinical studies have shown more than 70percent of women with postmenopausal osteoporosis preferred a once-monthly medical care regimen, finding it more convenient than a once-weekly option.9,10 These studies, combined with the results of PERSIST, show that women with postmenopausal osteoporosis prefer, and are more likely to stay on the once-monthly Bonviva programme.

Bonviva, a highly effective bisphosphonate, has been shown to reduce spinal fractures by 62percent.11 Bonviva also has proven superior efficacy in increasing spine and hip bone mineral density (a method used by physicians to assess osteoporosis and the accepted way to measure risk of fracture), compared with once-daily Bonviva.12

Bonviva is approved in over 60 countries around the world for the medical care of postmenopausal osteoporosis.

*The PERSIST (PERsistence Study of Ibandronate versus alendrontaTe) meditate was designed to replicate real life’ as closely as possible. In the UK, patients prescribed Bonviva have access to a patient support programme (PSP), which is offered as part of the current prescribing practice. PSPs were therefore offered to patients participating in the PERSIST meditate .

About PERSIST

PERSIST was a six-month prospective, randomised, open label, multicentre meditate of 1,076 women with post-menopausal osteoporosis. The Bonviva once-monthly medical care programme comprises Bonviva 150mg and the option of a patient support programme (PSP). The patient support programme was comprised of a welcome pack, a once monthly call, and a quarterly newsletter.

Patients were randomly allocated to one of two medical care groups:

— Group A: Once-monthly oral ibandronate (150mg) medical care programme (with a PSP offered to the patient)

— Group B: Once-weekly oral Alendronate (70mg)

PERSIST used a meditate design that is as close to ‘real life’ as possible. For example, patients were given prescriptions by their GP, and then visited the local pharmacist to receive the medication, as happens in normal practice. The participating healthcare professionals (GPs, nurses and pharmacists) were also instructed not to do anything extra or difference to encourage patients to return for their repeat prescriptions.

About Bonviva

— Bonviva, a potent and highly effective bisphosphonate, has been studied to date in clinical trials involving over 13,000 patients.

— Once-monthly Bonviva is indicated for the medical care of osteoporosis in postmenopausal women. It works by reducing elevated bone turnover, increasing bone mineral density and reducing the incidence of vertebral fractures.

— Bonviva is the only nitrogen containing bisphosphonate that has demonstrated a reduction in vertebral fracture risk using a drug-free interval of more than one day.11

— Bonviva, like otherness bisphosphonates administered orally, may cause upper gastroinagsdhfgdfinal disorders such as dysphagia, oesophagitis and oesophageal or gastric ulcer.

— Once-monthly oral Bonviva received European Union acceptance in September 2005 and Swiss medic acceptance in August 2005. Once monthly Boniva (the brand name in the US) received Food and Drug Administration acceptance in March 2005.

Roche/GSK Collaboration

In December 2001, F Hoffmann-La Roche (Roche) and GlaxoSmithKline (GSK) announced their plans to co-develop and co-promote Bonviva for the medical care and prevention of postmenopausal osteoporosis in a number of major markets, excluding Japan. The Roche/GSK collaboration provides expertise and commitment to bringing new osteoporosis therapies to market as quickly as possible.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and medical care of sickness, the Group contributes on a broad range of fronts to improving group’s health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2005 sales by the Pharmaceuticals Division totalled 27.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 group in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (http://www.roche.com).

About GSK

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

All trademarks used or mentioned in this release are legally protected.

Roche Healthkiosk, Osteoporosis:
http://www.health-kiosk.ch/start_osteo.htm
GSK website:
http://www.gsk.com

References

1. Cooper, A.L (on behalf of the PERSIST Study Investigators). Improved patient persistence on once-monthly dosing regime plus patient support compared with a weekly dosing regime. Abstract presented at the IOF World Congress on Osteoporosis, Canada 2-6 June generic viagra 30 pills.

2. Cowell W, Fulford-Smith A, Poultney S. Adherence with bisphosphonate medical care for osteoporosis in UK patients. Poster presented the second joint meeting of the European Calcified Tissue Society and the International Bone Mineral Society, Geneva, 25-29 June 2005.

3. Cramer J, Amonkar M, Hebborn A, Altman R. Compliance and Persistence with Bisphosphonate Dosing Regimens Among Women with Postmenopausal Osteoporosis. Current Medical Research and Opinions 2005; 21(9): 1453-60.

4. Sebaldt R, Shane LG, Pham BZ, Cook RJ, Thabane L. et al. Impact of non-compliance and non-persistence with daily bisphosphonates on longer-term effectiveness outcomes in patients with osteoporosis treated in tertiary specialist care. J Bone Miner Res 2004;19 (Suppl. 1): (Abstract M423)

5. Siris E, Rosen CJ, Harris ST, Abbott TA, Barr CE, Silverman S. Adherence to bisphosphonate medical care: relationship to bone fractures at 24 months in women with postmenopausal osteoporosis. Abstract 397, oral and poster presentation at: Sixth International Symposium on Osteoporosis, National Osteoporosis Foundation, April 7, 2005, Washington, DC

6. Goettsch et al. Risk for osteoporotic fractures is reduced in persistent bisphosphonate users. J Bone Miner Res 2005;20(Suppl. 1):S278 (Abstract SU388)

7. Caro JJ, Ishak KJ, Huybrechts KF, Raggio G, Naujoks C. The impact of compliance with osteoporosis medical care on fracture rates in actual practice. Osteoporos Int 2004;15:1003-8.

8. Kanis JA, Delmas P, Burckhardt P, et al. (1997) Guidelines for diagnosis and management of osteoporosis. The European Foundation for Osteoporosis and Bone Disease. Osteoporos Int1997; 7:390.

9. Emkey R, Binkley N, Seidman L, et al. BALTO I: Women Pharmacomedical care for Osteoporosis Rate Preference and Convenience for Once-Monthly Ibandronate versus Once-Weekly Alendronate. Abstract presented at 27th Annual Meeting of the American Society of Bone and Mineral Research, Nashville, USA 23-27 September 2005.

10. Benhamou C-L, Licata AA, Devas V, Masanauskaite D, Hadji P. Patient preference for once-monthly oral ibandronate and weekly oral Alendronate in postmenopausal osteoporosis: the BALTO meditate . Abstract presented at 33rd European Symposium of Calcified Tissue, Prague, Czech Republic 10-14 May generic viagra 30 pills.

11. Chesnut CH, Skag A, Christiansen C, Recker R, Stakkestad JA et al. Effects of Oral Ibandronate Administered Daily or Intermittently on Fracture Risk in Postmenopausal Osteoporosis. Journal of Bone & Mineral Research 2004;19(8):1241-49.

12. McClung MR, Drezner MK, Reginster J-Y, Bolognese M, Hughes C et al. Once-Monthly Oral Ibandronate Is At Least As Effective As Daily Oral Ibandronate In Postmenopausal Osteoporosis: 2-Year Findings from MOBILE . Abstract presented at 27th Annual Meeting of the American Society of Bone and Mineral Research, Nashville, USA 23 - 27 September 2005.buy generic viagra packbuy viagra soft tabs 50 mg