In the middle of the biggest outbreak of food poisoning caused by the bacterium enterohemorrhagic Escherichia coli (EHEC) that Germany has ever seen, a group of doctors may have found a way to treat the most severe cases. the finding appears today in The New England Journal of Medicine (NEJM).

At least four people have died in the outbreak, thought to have been caused by eating contaminated vegetables. To date, 276 patients have developed hemolytic uremic syndrome (HUS). the potentially fatal syndrome, characterized by a destruction of red blood cells and severe kidney problems caused by the bacteria’s toxin, is the most severe complication of an EHEC infection.

In the article, Franz Schaefer, a nephrologist at the Center for Pediatrics and Adolescent Medicine in Heidelberg, Germany, and other physicians describe how they successfully treated three EHEC-infected children suffering from HUS with a novel approach. They used the monoclonal antibody eculizumab, which has been on the market since 2007, to treat a rare blood disorder. Eculizumab inhibits a part of the human immune system called the complement system that usually destroys invading cells that have been tagged for destruction by other parts of the immune system.

The complement system has been implicated for some time in certain patients who develop HUS without any EHEC infection, known as atypical HUS patients, and eculizumab has been used successfully to treat them. recent research suggests that the complement system might also be involved in the HUS cases caused by EHEC.

Last autumn, Schaefer saw a young girl suffering from HUS due to an EHEC infection. he first tried the most common treatment, replacing the patients’ blood plasma with donor plasma to rid the body of the toxins. (HUS patients are usually not treated with antibiotics because the antibiotics can aggravate the symptoms by releasing the shiga toxin from the bacteria in large amounts.)

When the girl’s health did not improve, Schaefer tried the antibody. “We did not have any other option. She was showing severe neurological symptoms, paralysis of one side of the body, cramps, and then slipped into a coma,” Schaefer remembers. “But when we finally gave her the antibody, she improved immensely within 24 hours,” Schaefer says. “This was not a controlled experiment, of course,” he says. “But the improvements were very suggestive of being due to the treatment.”

Schaefer was apparently not the only one with this idea. When he wrote a case report for NEJM, the editors notified him that two other groups had sent in similar reports around the same time. “So we wrote something all together and it was accepted for publication 14 days ago,“ Schaefer says. a few days later, HUS cases started appearing en masse in northern Germany.

“I could not believe it,” Schaefer says. “HUS cases with severe neurological symptoms are very rare, but now they are everywhere.” he also informed his colleagues elsewhere. “a lot of them have asked about the new treatment, and a few patients are already being treated with it.”

At the university clinic in Essen, Andreas Kribben is treating two HUS patients with the antibody. “We have seven HUS patients altogether, but we are using eculizumab only on the two patients that are not responding to the plasmapheresis,” he says. Kribben wrote the original paper on using eculizumab to treat atypical HUS, so he had experience with the drug. “We actually started treating the first patient on Wednesday, before Schaefer’s paper came out. Sadly, we have not seen the kind of response that Schaefer describes and that we know from the atypical HUS patients,” he says.

Jens Nürnberger, nephrologist at a clinic in Schwerin is somewhat skeptical of the treatment. “There is no real evidence for this treatment,” he says. “it might work or it might not.” the cases described in Schaefer’s paper could also be spontaneous remissions, he cautions. “The other problem is that this drug is hugely expensive, costing at least €15000 per patient, and the health insurance is not going to pay for it.“

However, in cases in which no other option remains, doctors would be right to try the new drug anyway, Nürnberger says. “But we should really be defining groups of patients who will get the drug and groups who do not and make this into a kind of controlled study,” he says. “instead, a lot of people will be treated this way, some will get better, some will not. In the end, we will not have learned anything.“ But he, like everyone else, is still hoping that this will turn out to be the right treatment at the right time.

Addition of boceprevir significantly increased treatment success in more patients and in a significantly shorter time period compared to standard treatment

MONTREAL, March 30 /CNW/ -Two Phase III studies (HCV RESPOND-2 and HCV SPRINT-2) are published in the March 31 edition of the New England Journal of Medicine (NEJM) demonstrating that addition of the investigational oral medication boceprevir to standard treatment significantly improved sustained virologic response (SVR) – the goal of treatment – in a significantly greater number of adult patients who failed previous treatment (treatment-failure) and in those who were new to treatment (treatment-naïve) for chronic hepatitis C virus (HCV) genotype 1, compared to standard therapy alone. Also, both studies investigated a new treatment strategy resulting in many patients being able to shorten the duration of therapy from the standard 48 weeks.1

"these results signal a truly important change in the treatment of hepatitis C genotype 1 infection, one of the most prevalent genotypes in Canada," said Dr. Marc Bilodeau, a Canadian investigator in the SPRINT-2 study and Associate Professor of Medicine at Université de Montréal. "the addition of boceprevir not only substantially increased the success rates, but also by using response-guided therapy – which indicates how individuals are responding to treatment – many patients taking the drugs for the first time saw their treatment times cut almost in half."

"Being able to shorten the length of treatment is extremely important given that one of the most challenging aspects of treating HCV is managing the debilitating side effects. because the side effects are so hard to take, unfortunately some patients stop their course of therapy," said Dr. mark Levstik, an investigator in the SPRINT-2 NEJM-published study and Assistant Professor, Department of Medicine, Division of Gastroenterology, University of Western Ontario.

Boceprevir, an investigational agent not currently available in Canada, belongs to a novel class of direct-acting antiviral agents – called HCV protease inhibitors – that reduce the amount of virus in the blood through inhibition of the function of a viral protein called 'protease' that HCV needs to replicate.2

An estimated 250,000 individuals in Canada are infected with HCV and there are 3,200 to 5,000 newly infected individuals each year.3  HCV damages the liver and may lead to serious complications, including death, when left untreated.4  it is the leading cause of liver transplants in Canada.5

"the use of a protease inhibitor to treat hepatitis C infection is an important advance in the management of the disease," said Dr. Alnoor Ramji, an investigator in both the SPRINT-2 and the RESPOND-2 published studies and a Clinical Assistant Professor at the University of British Columbia. "as a Canadian investigator, I am encouraged that the studies have been published in this prestigious medical journal. it reinforces the importance of our results."

Treatments Improve, Stigma Persists

Karen Stacey lived with the virus for many years before experiencing any symptoms. her diagnosis came slowly, and only after many tests and visits to multiple physicians.

"I remember constantly feeling dizzy and nauseous, and having a hard time with my memory," said Ms. Stacey. "When I was finally diagnosed with hepatitis C, I had this sinking feeling that people felt I deserved to get this disease. In the minds of many people, only drug addicts or alcoholics get this virus."

Past or current drug use accounts for more than 56 per cent of all hepatitis C infection in Canada.6 In addition, the virus may be contracted via use of unscreened blood or blood products in medical procedures, body piercing, mother-child transmission and accidental needle-sticking in medical settings. In Karen's case, she contracted the virus following a blood transfusion, which she required during a failed pregnancy in the 1970s.

"To help eliminate the terrible stigma I suffered following my diagnosis, I'm dedicated to educating Canadians about the disease," said Ms. Stacey. "the most frightening thing about the stigma is that it creates an enormous barrier for people infected with hepatitis C to get diagnosed and receive treatment that could cure their disease."

About HCV: a Silent Disease

Approximately one-in-three of those infected with HCV are not aware of their infection and it often goes undetected for many years until symptoms appear.7 Symptoms can include fever, fatigue, reduced appetite, stomach pain, dark urine, jaundice (yellowing of skin or eyes), nausea and vomiting, aching muscles and joints, and poor concentration.8 If left untreated, HCV may lead, in some patients, to liver fibrosis, cirrhosis, liver cancer and liver failure.9

About the Studies

The two studies (HCV RESPOND-2 and HCV SPRINT-2) each evaluated two new treatment strategies with boceprevir administered in combination with peginterferon alfa-2b and ribavirin (PR) to assess the ability of boceprevir to improve SVR rates – the goal of treatment – and potentially shorten overall treatment duration compared to the use of PR alone for 48 weeks, which is the current standard duration of therapy.

The HCV RESPOND-2 study examined the use of boceprevir in adult patients who previously failed to eradicate the virus with current standard therapy, including patients who had either relapsed after initially clearing the virus or were non-responders to prior treatment with PR. the HCV SPRINT-2 study examined the use of boceprevir in adult patients who were treatment-naïve (no prior treatment).

A total of 1,500 patients participated in the two studies, with nearly 10 per cent of patients (146) recruited at 15 Canadian investigation sites.  In each study, patients were randomized to one of three treatment arms:

• Response-guided therapy (RGT), in which total treatment duration was based on certain early response criteria. Treatment-failure patients with undetectable virus (HCV-RNA) at week eight were eligible to stop all treatment at 36 weeks. Treatment-naïve patients who had undetectable virus (HCV-RNA) during weeks eight through 24 were eligible to stop all treatment at 28 weeks.
• 48 weeks of treatment, in which patients received a four-week lead-in with PR followed by the addition of boceprevir for 44 weeks.
• Control, in which patients received PR for 48 weeks.

In the HCV RESPOND-2 study (treatment-failure patients), the addition of boceprevir in the RGT arm resulted in 59 per cent of patients eliminating the virus and 66 per cent in the 48-week treatment arm, compared to 21 per cent in the control group (p<0.0001).

In the HCV SPRINT-2 study (treatment-naïve patients), the addition of boceprevir in the RGT arm resulted in 63 per cent of patients eliminating the virus and 66 per cent for the 48 week treatment arm, compared to 38 per cent in the control group (p<0.0001).

Study authors reported that nearly half of all patients in the RGT arms of both studies met the early response criteria, meaning that they received a shorter total duration of therapy. In the HCV RESPOND-2 study, 46 per cent of patients met the early response criteria, and were able to stop all treatment at 36 weeks (12 weeks shorter than current standard therapy). In the HCV SPRINT-2 study,  44 per cent of patients met the early response criteria and were able to stop all treatment at 28 weeks (20 weeks shorter than current standard therapy).

In the HCV RESPOND-2 study, the most commonly reported side effects were fatigue, headache, nausea, chills and influenza-like illness. serious adverse events were reported in 10 per cent of patients in the RGT arm of the study, 14 per cent of patients in the 48-week treatment arm and in five per cent of patients in the control group. Discontinuation of treatment due to adverse events over the total course of the study was eight per cent in the RGT arm, 12 per cent for the 48-week treatment arm and three per cent for control.

Tolerability profile in treatment-failure patients

The five most common treatment-related adverse events in the HCV RESPOND-2 study reported for patients receiving boceprevir in RGT, boceprevir in a 48-week treatment regimen and control, respectively, were: fatigue, headache, nausea, anemia and chills.  serious adverse events were reported in 10, 14 and five per cent of patients in the study arms, respectively.  There was one death in the study, a suicide in the group receiving boceprevir in RGT, which occurred 18 weeks after the end of the study treatment and was considered to be unrelated to the study treatment.

Treatment discontinuations due to adverse events over the total course of all treatment were eight per cent and 12 per cent for patients receiving boceprevir in RGT and boceprevir in a 48-week treatment regimen, respectively, compared to two per cent for control. Treatment discontinuations due to anemia were 0 per cent and three per cent for the treatment groups receiving boceprevir, respectively, compared to 0 per cent for control.

Tolerability profile in treatment-naïve patients

The five most common treatment-related adverse events in the HCV SPRINT-2 study reported for patients receiving boceprevir in RGT, boceprevir in a 48-week treatment regimen and control, respectively, were: fatigue, headache, nausea, anemia and dysgeusia (bad taste). serious adverse events were reported in 11, 12 and nine per cent of patients in the study arms, respectively. There were six deaths during the study: four patients in the control group died, as did two patients in the boceprevir groups. two suicides (one patient in the control group and one patient receiving boceprevir in RGT) were judged to have possibly been related to peginterferon.  no other deaths were considered to be drug-related.

Treatment discontinuations due to adverse events over the total course of all treatment were 12 per cent and 16 per cent for patients receiving boceprevir in RGT and boceprevir in a 48-week treatment regimen, respectively, compared to 16 per cent for control.  Treatment discontinuations due to anemia were two per cent for each of the treatment groups receiving boceprevir compared to one per cent for control.

The HCV RESPOND-2 and HCV SPRINT-2 studies each employed futility or "stopping" rules, whereby patients in any treatment arm who had detectable virus at week 12 in the HCV RESPOND-2 study or at week 24 in the HCV SPRINT-2 study were considered treatment failures and discontinued all treatment.   the stopping rules allowed study patients who did not respond to treatment to have therapy stopped early, thereby avoiding unnecessary treatment.

Boceprevir is an investigational medication and not currently available in Canada.

Merck's global commitment to advancing hepatitis therapy

Merck is committed to building on its strong legacy in the field of viral hepatitis by continuing to discover, develop and deliver vaccines and medicines to help prevent and treat viral hepatitis.  Extensive research efforts are underway to develop differentiated oral therapies that bring innovation to viral hepatitis care.

About Merck

Today's Merck is a global healthcare leader working to help the world be well.  Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit merck.ca.

Forward-Looking Statement

This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. such statements may include, but are not limited to, statements about the benefits of the merger between Merck and    Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. such statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.

The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the United States and internationally and the exposure to litigation and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2009 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (sec.gov).

1 Merck news release: In Pivotal Phase III Studies, Merck's Investigational Medicine Boceprevir helped Majority of Patients with Chronic Hepatitis C Genotype 1 Infection Achieve Sustained Virologic Response, the Primary Endpoint of the Studies. Available at:  merck.com/newsroom/news-release-archive/research-and-development/2010_0804.html. March 15, 2011.2  Ibid .3  Canadian Institutes of Health Research. About the Hep C Research Initiative. cihr-irsc.gc.ca/e/38855.html. Accessed March 23, 2011.4  Public Health Agency of Canada. phac-aspc.gc.ca/hepc/pubs/multiling-hepc/index-eng.php. Accessed March 23, 2011.5  Canadian Liver Foundation. liver.ca/Liver_Disease/. Accessed March 23, 2011.6  Sherman M, Shafran S, Burak K, et al. Management of Chronic Hepatitis C: Consensus Guidelines. Can J Gastroenterol (2007).7  Public Health Agency of Canada.phac-aspc.gc.ca/hepc/pubs/ihp-ips/index-eng.php. Accessed March 21, 2011.8  Health Canada. hc-sc.gc.ca/hl-vs/iyh-vsv/diseases-maladies/hepc-eng.php. Accessed March 23, 2011.9  Public Health Agency of Canada. phac-aspc.gc.ca/hepc/pubs/multiling-hepc/index-eng.php. Accessed March 18, 2011.

Public release date: 16-Mar-2011 [ | E-mail | Share ] Contact: NHLBI Communications Office gov301-496-4236NIH/National Heart, Lung and Blood Institute

WHAT: Sirolimus, a drug currently used to help prevent transplant rejection, can improve lung function and quality of life in individuals living with the lung disease lymphangioleiomyomatosis (LAM), according to the results of a new study sponsored and conducted in part by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health.

“Efficacy and Safety of Sirolimus in Lymphangioleiomyomatosis,” will be published online March 16 in the New England Journal of Medicine.

LAM is a rare and progressive lung disease in which cancer-like cells infiltrate the lung, leading to shortness of breath, coughing, chest pain, and in many cases eventual respiratory failure. LAM affects almost exclusively women, primarily of child-bearing age. Though only around 1,000 women in the U.S. have diagnosed LAM, there may be many more as the disease is not well-diagnosed.

This international study, led by the University of Cincinnati, recruited 89 LAM patients to test sirolimus, a drug that can suppress rapid cell growth by blocking an overactive protein called mTOR. Sirolimus is already used as an immune suppressant for organ transplants and is also being tested as a cancer drug. mTOR is also highly active in the invading cells that cause LAM.

The participants took daily oral doses of sirolimus or placebo over 12 months and had their lung function measured at regular intervals. The primary measurement was forced expiratory volume (FEV1), or the volume of air that can be forced out in the first second after taking a deep breath. The sirolimus group displayed stable FEV1 levels over the 12-month treatment period, compared to a roughly 12% decline in the placebo group. The sirolimus group also showed other clinical improvements, and reported a greater ability to carry out day-to-day functions and a better quality of life.

Following the treatment period, the study participants underwent 12-months of observation. After stopping sirolimus, the decline in lung function was similar in both the sirolimus and placebo groups, indicating treatment effectiveness likely requires continued use.

###

Learn more about the Multicenter International LAM Efficacy and Safety of Sirolimus (MILES) Trial at: clinicaltrials.gov/ct2/show/NCT00414648

WHO: Joel Moss, M.D., Ph.D., principal investigator in NHLBI’s Cardiovascular and Pulmonary Branch and a study co-author, is available to comment on the study findings and implications for the future. Dr. Moss’s translational and clinical research program has contributed substantially to the understanding of the natural history and mechanisms of LAM. In addition to evaluating some of the study patients, the NHLBI group also helped with overall study recruitment by referring patients to other study sites.

CONTACT: for more information or to schedule an interview, contact the NHLBI Communications Office at 301-496-4236.

The National Heart, Lung, and Blood Institute (NHLBI) is a component of the National Institutes of Health. NHLBI plans, conducts, and supports research related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders. The Institute also administers national health education campaigns on women and heart disease, healthy weight for children, and other topics. NHLBI press releases and other materials are available online at: nhlbi.nih.gov.

The National Institutes of Health (NIH) ? The Nation’s Medical Research Agency ? includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. it is the primary federal agency for conducting and supporting basic, clinical, and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. for more information about NIH and its programs, visit nih.gov.

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ScienceDaily (Feb. 3, 2011) — Clinical researchers at the National Institutes of Health’s Undiagnosed Diseases Program (UDP) have identified the genetic cause of a rare and debilitating vascular disorder not previously explained in the medical literature. The adult-onset condition is associated with progressive and painful arterial calcification affecting the lower extremities, yet spares patients’ coronary arteries. The new disease finding was published February 2 in the New England Journal of Medicine.

The rare arterial condition caused by calcium buildup in arteries below the waist and in the joints of patient’s hands and feet has been observed in nine individuals from three unrelated families, who are the only people known to have the disorder. The researchers refer to the condition as ACDC, or arterial calcification due to CD73 deficiency. Although symptoms of the disorder include leg and joint discomfort, medical evaluations of the patients ruled out rheumatoid arthritis or other joint-related problems. Genetic analyses performed by the NIH researchers suggested a novel disorder and pinpointed the cause of the condition as mutations, or variants, in the NT5E gene.

The NIH clinical researchers examined members of two families with the arterial calcification disorder as part of the UDP, and identified a third case outside the country. Seven medical cases like those described in this study have been reported in medical journals over the past century, but these previous studies did not include any insights about the molecular basis of the disorder.

The UDP program, entering its third year, receives medical referrals from around the country when cases challenge the diagnostic know-how and resources of the medical community at large. Patients enrolled in the program undergo extensive medical diagnostic testing and evaluation at the NIH Clinical Center in Bethesda, Md.

Members of two of the three families reported in this study were enrolled and examined as part of the UDP. The patients experienced pain and cramping in the calves, thighs, buttocks and feet due to poor circulation. MRIs and x-rays of the patients’ vasculature indicated calcium deposits in artery walls. for one of the patients, advancement of the condition had been treated with surgeries to reroute blood flow through alternate vessels, as well as a joint amputation in the foot. Peripheral blood vessels compensate to some extent for diminished blood flow in affected arteries.

In one of the families with five affected siblings, clinical researchers suspected a recessive inheritance, in which offspring receive two copies of a gene variant — one from each parent — that produces disease symptoms only when combined. The researchers analyzed DNA from all members of the family to compare the parents’ DNA to that of their affected children. This allowed researchers to detect genomic regions where the siblings’ DNA contained two copies of a particular DNA segment compared to their parents’ DNA, which contained just a single copy.

The comparison revealed one such region, which the researchers subsequently analyzed for sequence variants not present in a population of 200 unaffected people. The siblings all had the same variant in a gene called NT5E. This gene normally makes the CD73 protein, which produces a small molecule, adenosine, which protects the arteries from calcifying. The researchers also detected variants in NT5E in all the other affected patients in the study.

The researchers performed laboratory tests to characterize the molecular basis of the arterial calcification disorder and to validate various molecular activities in cells with NT5E variants. "we were able to illustrate that elevated activity of a key enzyme in tissue calcification, called TNAP, was due to the lack of extracellular adenosine," said lead author Cynthia St. Hilaire, Ph.D., a postdoctoral fellow at the National Heart, Lung, and Blood Institute (NHLBI). in turn, TNAP degrades an inhibitor of calcification, called pyrophosphate. The researchers therefore tied the elevation in TNAP activity with increases in arterial calcification. they also suggest that the location of calcification may correspond to the distribution of specific adenosine receptors in the body.

"Vascular calcification often results from poor diet and lack of exercise," said co-author William A. Gahl, M.D., Ph.D., NHGRI clinical director and director of the NIH Undiagnosed Diseases Program. "The calcium buildup in arteries of our patients, however, arises because the systems to inhibit it are not working in their cells. we hope that an understanding of this faulty mechanism will guide us in providing helpful treatments for these patients."

"The diagnosis of this faulty gene is the first molecular description of this disorder," said Manfred Boehm, M.D., lead senior author and NHLBI investigator. "in addition to providing insight for this unique patient group and their physicians, the study has placed this condition among disorders it resembles, adding to our knowledge of vascular biology."

In addition to NHGRI and NHLBI, the study included researchers from the NIH Office of Rare Disease Research; the NIH Clinical Center; St. John the Baptist Hospital, Turin, Italy; University of California, San Francisco; and Great Ormond Street Hospital-University College, London.

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Story Source:

The above story is reprinted (with editorial adaptations by ScienceDaily staff) from materials provided by NIH/National Human Genome Research Institute.

Journal Reference:

1. Cynthia St. Hilaire, Shira G. Ziegler, Thomas C. Markello, Alfredo Brusco, Catherine Groden, Fred Gill, Hannah Carlson-Donohoe, Robert J. Lederman, Marcus Y. Chen, Dan Yang, Michael P. Siegenthaler, Carlo Arduino, Cecilia Mancini, Bernard Freudenthal, Horia C. Stanescu, Anselm A. Zdebik, R. Krishna Chaganti, Robert L. Nussbaum, Robert Kleta, William A. Gahl, Manfred Boehm. NT5EMutations and Arterial Calcifications. New England Journal of Medicine, 2011; 364 (5): 432 DOI: 10.1056/NEJMoa0912923

Note: If no author is given, the source is cited instead.

Disclaimer: This article is not intended to provide medical advice, diagnosis or treatment. Views expressed here do not necessarily reflect those of ScienceDaily or its staff.

The vaccine reduced the risk of contracting an HPV case that persists for at least six months. STORY HIGHLIGHTS

• an estimated 20 million Americans are currently infected with HPV
• HPV can cause certain cancers of the anus and penis in men
• Because symptoms are rare, most people with the virus pass it on without realizing it

(Health.com) — Boys and young men who receive the human papillomavirus vaccine appear to be at reduced risk of contracting the virus and developing the genital warts associated with the common sexually transmitted disease, according to a large international study published this week in the New England Journal of Medicine.

In an effort to prevent cervical cancer, which can be caused by HPV, public health officials have been encouraging young women to get vaccinated since the Food and Drug Administration approved the first HPV vaccine, Gardasil, in 2006. The vaccine has been approved for boys and men since 2009, but health officials and doctors haven’t pushed it with the same urgency.

"Because the story started with cervical cancer, the studies started with females," says the lead author of the study, Anna Giuliano, Ph.D., of the H. Lee Moffitt Cancer Center and Research Institute in Tampa, Florida. "The study of HPV in men is a late bloomer."

Health.com: 12 vaccines your child needs

Gardasil is given in a series of three injections. in the study, which included more than 4,000 sexually active males between the ages of 16 and 26, roughly 0.5 percent of the boys and men who received all three shots developed genital warts during the subsequent 2 to 3 years. by contrast, about 2.8 percent of the study participants who received a placebo vaccine developed warts.

2009: HPV causes oral cancer

The vaccine also reduced the risk of contracting an HPV that persists for at least six months, though not as dramatically.

HPV can cause certain cancers of the anus and penis in men, although those diseases are far less common than cervical cancer in women.

The study was designed and funded by Merck, the maker of Gardasil (also known as Silgard). The National Institutes of Health also provided funding.

Health.com: Top 10 myths about safe sex and sexual health

An estimated 20 million Americans are currently infected with HPV. Symptoms are rare, however, so most people have the virus — and pass it on — without realizing it.

"Men are such a vital component of the whole prevention cycle when looking at HPV or any sexually transmitted infection," says Demetrius Porche, a professor of nursing research and evaluation at the Louisiana State University School of Public Health in New Orleans.

Vaccinating men provides a "double benefit" in that fewer men with HPV will also mean that fewer women are exposed, adds Porche, who was not involved in the current study but has researched HPV in men.

Health.com: What to do if your partner refuses to wear a condom

Earlier this week, for the first time, theAmerican Academy of Pediatrics included the HPV vaccine on its list of recommended vaccines for boys. Porche and Giuliano also urge boys and men to get vaccinated.

Most health insurance plans cover HPV vaccination for both males and females. If a child between the ages of 9 and 18 is underinsured, the federal program Vaccines for Children may be able to provide assistance.

Copyright Health Magazine 2010

RALEIGH, N.C.–(BUSINESS WIRE)–Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the New England Journal of Medicine has published results from TARGET 1 and TARGET 2, the Company’s two pivotal Phase 3 efficacy and safety studies of XIFAXAN® (rifaximin) 550 mg tablets for the treatment of Irritable Bowel Syndrome without constipation, or Non-C IBS. The studies showed XIFAXAN 550 mg tablets demonstrated a statistically significant improvement for the adequate relief of global IBS symptoms, IBS-related bloating, abdominal pain and stool consistency following completion of a 14-day course of therapy. IBS, one of the most common chronic medical conditions, is characterized by altered bowel habits with bloating, abdominal pain and discomfort. The FDA is currently reviewing Salix’s supplemental New Drug Application (sNDA) for XIFAXAN 550 mg tablets for the proposed indication of the treatment of Non-C IBS. The Prescription Drug User Fee Act (PDUFA) goal date for the Agency’s Priority Review of the application is March 7, 2011.

TARGET 1 and TARGET 2 – two identically-designed 600-plus patient, double-blind, placebo-controlled trials – demonstrated that a 14-day course of XIFAXAN 550 mg, taken 3 times daily, achieved adequate relief of global IBS symptoms (primary endpoint) and adequate relief of IBS-related bloating (key secondary endpoint) in a significantly greater proportion of patients, compared with placebo, during the primary evaluation period (first 4 weeks following treatment) as well as during the entire study period (10 weeks following treatment). The statistically significant weekly findings in the primary endpoint and key secondary endpoint noted above were supported by daily findings in the secondary endpoints of global IBS symptoms, bloating, stool consistency and abdominal pain and discomfort. Additionally, the NEJM publication includes results of an analysis of a composite endpoint of abdominal pain or discomfort and loose or watery stools as outlined in the March 2010 draft FDA Guidance for Industry relating to the clinical evaluation of products for treatment of IBS.

“An alteration in gut flora has been proposed as an important contributor to the pathophysiology of IBS that might underlie some of the gastrointestinal symptoms associated with this condition,” said Mark Pimentel, M.D., Gastrointestinal Motility Program Director at Cedars–Sinai Medical Center and Principal Investigator of the clinical trials. “These findings conclusively show that a targeted, gut-selective antibiotic such as rifaximin can provide long-lasting results.”

“These findings show the potential of rifaximin to treat multiple symptoms of IBS and affect gut flora, an underlying cause of IBS, with a side effect profile comparable to placebo,” said Bill Forbes, PharmD., Executive Vice President of Research and Development and Chief Development Officer at Salix Pharmaceuticals. “Rifaximin’s utility to treat the underlying causes of IBS symptoms is a significant scientific development for patients suffering from symptoms associated with IBS without constipation, including bloating, abdominal pain and diarrhea.”

About IBS

IBS affects approximately 15 percent or potentially over 40 million adults in the United States and is among one of the most common, chronic conditions. IBS includes altered bowel habits with bloating, abdominal pain and discomfort. Irritable bowel syndrome without constipation (Non-C IBS) encompasses two of the most common IBS subtypes: patients with diarrhea-predominant symptoms (IBS-D) and patients who suffer from intermittent periods of diarrhea and constipation known as mixed IBS (IBS-M). among other contributors, recent science has shown that alterations in gut flora/bacteria have been identified as a potentially important contributor to the pathophysiology of IBS.

The Company now estimates the U.S. commercial opportunity represented by the non-constipation IBS market to be approximately $7 billion in peak year.

OPTION: to access the full manuscript of “Rifaximin Therapy for Patients with Irritable Bowel Syndrome without Constipation”, please visit: NEJM.org and click on “Current Issue.”

XIFAXAN® (rifaximin) 550 mg tablets

Important Safety Information

XIFAXAN 550 mg is indicated for reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients ? 18 years of age. In the trials of XIFAXAN for HE, 91 percent of the patients were using lactulose concomitantly. XIFAXAN has not been studied in patients with MELD scores > 25, and only 8.6 percent of patients in the controlled trial had MELD scores over 19. There is increased systemic exposure in patients with more severe hepatic dysfunction. therefore, caution should be exercised when administering XIFAXAN to patients with severe hepatic impairment (Child-Pugh C).

XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, any of the rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis.

Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon which may lead to overgrowth of C. difficile. if CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.

The most common adverse reactions occurring in >8 percent of patients in the clinical study were edema peripheral (15 percent), nausea (14 percent), dizziness (13 percent), fatigue (12 percent), ascites (11 percent), muscle spasms (9 percent), pruritus (9 percent), and abdominal pain (9 percent).

About XIFAXAN® (rifaximin)

Rifaximin is a gut-selective antibiotic with negligible systemic absorption and broad-spectrum activity in vitro against both gram-positive and gram-negative pathogens. Rifaximin has a similar tolerability profile to that of placebo.

Rifaximin tablets 200 mg is approved in over 30 countries worldwide. Alfa Wassermann S.p.a. in Bologna, Italy has marketed rifaximin in Italy under the trade name Normix® for over 30 years. Salix acquired rights to market rifaximin in North America from Alfa Wassermann.

About Salix

Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina, develops and markets prescription pharmaceutical products for the prevention and treatment of gastrointestinal diseases. Salix’s strategy is to in-license late-stage or marketed proprietary therapeutic drugs, complete any required development and regulatory submission of these products, and market them through the Company’s gastroenterology specialty sales and marketing team.

Salix markets XIFAXAN® (rifaximin) tablets 200 mg and 550 mg, MOVIPREP® (PEG 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate and Ascorbic Acid for Oral Solution), OSMOPREP® (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) Tablets, VISICOL® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets, APRISO™ (mesalamine) extended-release capsules 0.375 g, METOZOLV® ODT (metoclopramide HCl), PEPCID® (famotidine) for Oral Suspension, Oral Suspension DIURIL® (Chlorothiazide), AZASAN® (Azathioprine) Tablets, USP, 75/100 mg, ANUSOL-HC® 2.5% (Hydrocortisone Cream, USP), ANUSOL-HC® 25 mg Suppository (Hydrocortisone Acetate), PROCTOCORT® Cream (Hydrocortisone Cream, USP) 1% and PROCTOCORT® Suppository (Hydrocortisone Acetate Rectal Suppositories) 30 mg. Crofelemer, budesonide foam and rifaximin for additional indications are under development.

For full prescribing information and important safety information on Salix products, including BOXED WARNINGS for VISICOL, OSMOPREP and METOZOLV, please visit salix.com where the Company promptly posts press releases, SEC filings and other important information or contact the Company at 919 862-1000.

Salix trades on the NASDAQ Global Select Market under the ticker symbol “SLXP”.

For more information, please visit our Website at salix.com or contact the Company at 919-862-1000. Follow us on Twitter (@SalixPharma) and Facebook (facebook.com/SalixPharma). Information on our web site is not incorporated in our SEC filings.

Please Note: The materials provided herein contain projections and other forward-looking statements regarding future events. Such statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: the unpredictability of the duration and results of regulatory review of New Drug Applications and Investigational NDAs; market acceptance for approved products; the cost, timing and results of clinical trials and other development activities involving pharmaceutical products; generic and other competition; litigation and the possible impairment of, or inability to obtain, intellectual property rights and the costs of obtaining such rights from third parties; revenue recognition and other critical accounting policies; and the need to acquire new products. The reader is referred to the documents that the Company files from time to time with the Securities and Exchange Commission.

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