EHRA Issues Guide for New Afib Drugs

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38762

By Chris Kaiser, Cardiology Editor, MedPage Today

Published: April 30, 2013

Reviewed by F. Perry Wilson, MD, MSCE; Instructor of Medicine, Perelman School of Medicine at the University of Pennsylvania

Action Points

  • Note that this guidance document from the European Heart Rhythm Association provides clinical support for the management of nonwarfarin anticoagulants in atrial fibrillation.
  • Be aware that the quality of evidence for most of the recommendations is quite low (primarily expert opinion).

A practical guide that summarizes the similarities and differences of the new oral anticoagulants and describes their use in specific clinical situations has been published by the European Heart Rhythm Association (EHRA).

The three drugs, which are discussed in terms of stroke prevention in nonvalvular atrial fibrillation and are approved in the European Union and the U.S. for this indication, are:

  • Dabigatran (Pradaxa) — direct thrombin inhibitor, doses 150 and 110 mg bid, pivotal trial: RE-LY
  • Rivaroxaban (Xarelto) — factor Xa inhibitor, doses 20 and 15 mg qd, pivotal trial: ROCKET-AF
  • Apixaban (Eliquis) — factor Xa inhibitor, doses 5 and 2.5 mg bid, pivotal trials: ARISTOTLE and AVERROES

Hein Heidbuchel, MD, from the University of Leuven in Leuven, Belgium, led the writing committee. The document was published online in Europace.

The guide presents 15 clinical scenarios regarding oral anticoagulants, from starting the drugs to treating patients with atrial fibrillation (Afib) and cancer.

Regarding the latter clinical scenario, the writing committee noted that Afib patients with cancer are at increased risks for thromboembolic events and interaction between cancer and antithrombotic therapy, as well as the potential for an increased risk of bleeding associated with the cancer therapy.

For these reasons, the document suggests warfarin as the initial choice of anticoagulation therapy because it is more familiar to clinicians, can be closely monitored, and is easily reversed.

The updated European Society of Cardiology (ESC) guidelines on Afib treatment recommend using the new oral anticoagulants over warfarin.

The American Heart Association updated its guidelines in 2012 and laid out the evidence for each drug:

Warfarin: Class I, Level of Evidence A

Dabigatran: Class I, Level of Evidence B

Apixaban: Class I, Level of Evidence B

Rivaroxaban: Class IIa, Level of Evidence B

Heidbuchel and colleagues included a comprehensive table in the guidance document that details certain potential drug-drug interactions and how the dosage of the oral anticoagulants could be adjusted.

One of the more challenging clinical aspects associated with anticoagulants is switching between them. When warfarin is replacing a new oral anticoagulant, for example, clinicians should be aware of large fluctuations in the international normalized ratio (INR).

Warfarin’s slow onset of action (5 to 10 days) requires the administration of both drugs concomitantly until the INR is in the appropriate range. Because the new oral anticoagulants can influence the INR, the guide suggests checking the INR before the next oral anticoagulant is administered and re-test the patient 24 hours after the last dose.

Regarding compliance, Heidbuchel and colleagues stressed the importance of patient education, offered advice to schedule follow-up visits, and noted that technological aids might help.

The authors included another comprehensive table on measures to enact in case of bleeding. The table is divided into non-life-threatening and life-threatening bleeds.

The investigators admit the evidence for a specific antidote for the new oral anticoagulants is scarce, and the available evidence “reflects experts’ opinions or laboratory endpoints.”

However, they present a thorough list of options should the need arise to reverse one of these drugs.

Other scenarios in the guidance document include:

  • Patients in need of urgent surgical intervention
  • Patients who require anticoagulation and antiplatelet therapy
  • Patients who need to undergo cardioversion
  • Patients with intracranial bleeding or ischemic stroke

In response to the rapidity with which new medical data become available, the EHRA has dedicated a portion of its ESC website to house the latest information on this topic.

This article and its related educational material (slide set, website, booklet, etc.) were produced by and under the sole responsibility of the European Heart Rhythm Association, and funded by unrestricted and unconditional educational grants from Boehringer-Ingelheim, Bayer, Daiichi Sankyo, and the Pfizer/BMS Alliance. The writing committee collaborated with medical experts from the different companies to assure data accuracy and completeness.

Heidbuchel reported relationships with Biosense Webster, St Jude Medical, Siemens Medical Solutions, Boehringer-Ingelheim, Bayer HealthCare, sanofi-aventis, AstraZeneca, Medtronic, Biotronik, and Boston Scientific. His co-authors reported relationships with Bristol-Myers Squibb, Daiichi Sankyo, sanofi-aventis, Servier, Boehringer Ingelheim, Bayer HealthCare, ThromboGenics, Boston Scientific, Pfizer, Merck Sharp and Dohme, AstraZeneca, Pioneer Medical Devices, Actelion Pharmaceuticals, ARYx Therapeutics,Cardiome Pharma, CV Therapeutics, Menarini Group, Novartis Pharmaceuticals, Xention, Johnson & Johnson, Micrus Endovascular, PhotoThera, 3M Medica, MEDA Pharma, Otsuka Pharma, Takeda, Omron, GSK, and Abbott. P.V.

From the American Heart Association:

  • AHA Emerging Science Series 2012: Outcomes of Discontinuing Rivaroxaban Compared with Warfarin in Patients with Nonvalvular Atrial Fibrillation: Analysis from the ROCKET AF Trial
  • ACC/AHA/ESC 2006 Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death – Full Text

Primary source: Europace
Source reference:
Heidbuchel H, et al “European heart rhythm association practical guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation” Europace 2013; 15l:625–651.

Related Article(s):

  • AHA: Pradaxa Safety Appears Durable
  • Apixaban Shines in ARISTOTLE Canadian Cohort
  • ESC: Novel Drug Beats Aspirin in Afib Patients

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Skin Cancer Tx No Help for Sick Older Patients?

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38749

By Cole Petrochko, Staff Writer, MedPage Today

Published: April 29, 2013

Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco

Action Points

  • Surgical treatment of nonmelanoma skin cancer in elderly patients with other underlying health conditions may do more harm than good.
  • Note that 43% of patients with limited life expectancy and nonmelanoma skin cancer died within 5 years of the study baseline from complications unrelated to their skin cancer.

Surgical treatment of nonmelanoma skin cancer in elderly patients with other underlying health conditions may do more harm than good, researchers found.

In a cohort of nonmelanoma skin cancer patients, those with limited life expectancy experienced more complications with therapy (20%) than those who did not have limited life expectancy (15%), according to Eleni Linos, MD, DrPH, of the University of California San Francisco, and colleagues.

In addition, 43% of patients with limited life expectancy and nonmelanoma skin cancer died within 5 years of the study baseline from complications unrelated to their skin cancer, such as heart disease, prostate cancer, and Alzheimer’s disease, they wrote online in JAMA Internal Medicine.

Patients were considered of limited life expectancy if they were 85-years-old or older or if they had a Charlson Comorbidity Index score of 3 or greater, the authors explained.

Nonmelanoma skin cancers “grow slowly, rarely metastasize or affect survival, and typically do not result in significant morbidity or diminished quality of life.” These tumors are often asymptomatic “and patients are often unaware of them,” the authors said, adding that treatment for nonmelanoma skin cancer is meant to prevent expansion and local recurrence of the tumor.

They also noted that nonmelanoma skin cancer is the fifth most costly cancer for Medicare.

The researchers compared treatment patterns and clinical outcomes in patients with nonmelanoma skin cancer who were of limited life expectancy with patients who were not of limited life expectancy at two California dermatology clinics (one private and one university-affiliated Veterans Administration program).

Treatment options included elliptical excision, chemosurgery (Mohs surgery), tumor destruction, and no treatment. Overall, 68.7% of tumors underwent surgery.

Data were collected through clinician notes and pathology records.

The patient population included 1,360 patients with 1,739 tumors, including 332 patients with 428 tumors who were of limited life expectancy. Median patient age was 69 years. Most participants were male (72.7%) and had a comorbidity index score of 1. Roughly one quarter of patients were bothered by their tumor frequently (22%).

Tumor recurrence was uncommon both in the overall study population and among patients with limited life expectancy at 5 years (3.7% for both). Among limited life expectancy patients with tumor recurrence, 9 of 14 died within a median time of 21 months after recurrence of non-nonmelanoma skin cancer causes.

Patients who were not of limited life expectancy had better 5-year mortality than those of limited life expectancy (11% versus 43.3%, P<0.001). Overall 10-year mortality was 49.9%, but was significantly higher among those with limited life expectancy (76.8% versus 32.7%, P<0.001).

No patients in the study died of nonmelanoma skin cancer-related causes. Leading causes of death in the study population included ischemic heart disease and myocardial infarction, cerebrovascular disease, lung cancer, pneumonia and chronic respiratory diseases, prostate cancer, and Alzheimer’s disease.

Most patients’ tumors were treated surgically, either with excision (34.5%) or chemosurgery (34.2%). Roughly a quarter (26.7%) of patients’ tumors were destroyed through cryotherapy, electrodessication and curettage, laser, or irradiation. Only 3.1% of patients received no treatment. Rates of treatment did not differ significantly between limited life expectancy and nonlimited life expectancy groups.

In a subsample of patients who responded to a questionnaire about treatment-related complications (671 patients, including 212 with limited life expectancy), 30% reported a complication after treatment. Of those reporting complications, 32% were of limited life expectancy.

Common complications included poor wound healing, numbness, itching, and pain.

Finally, treatment patterns did differ between the two study sites, with more surgery (chemosurgery plus excision) performed at the VA center compared with the private clinic (multivariable adjusted relative risk 0.87, 95% CI 0.77 to 1.00, P=0.04).

The authors noted that although symptomatic or medically nonmelanoma skin cancer tumors should be treated regardless of a patient’s life expectancy, asymptomatic tumors “may not be indicated,” and treatment should be considered for benefits, risks, and patient preference.

In an accompanying editorial, Neil Wenger, MD, MPH, of the University of California Los Angeles, seconded the emphasis for shared decision making, particularly in limited life expectancy patients who may not be at increased risk of mortality from disease and who may have quality of life affected by invasive treatment.

“The findings suggest that we are training a new generation of physicians who will inadequately regard the importance of open, honest, patient-oriented communication that strives to facilitate optimal clinical decisions,” he wrote.

The authors noted that the major study limitation was an observational design. The study was also limited by potential lack of generalizability because half of the cohort were veterans.

The study was supported by the National Center for Research Resources, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the NIH, and the American Skin Association and Dermatology Foundation.

One co-author received support from Genentech.

Wenger declared no conflicts of interest.

Primary source: JAMA Internal Medicine
Source reference:
Linos E, et al “Treatment of nonfatal conditions at the end of life” JAMA Intern Med 2013; DOI:10.1001/jamainternmed.2013.639.

Additional source: JAMA Internal Medicine
Source reference:
Wenger NS “Skin cancer and shared decision making” JAMA Intern Med 2013; DOI: 10.1001/jamainternmed.2013.6685.

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U.S.-born kids have more allergies, asthma

By Genevra Pittman

NEW YORK | Mon Apr 29, 2013 4:04pm EDT

NEW YORK (Reuters Health) – Kids and teens who are born abroad and immigrate to the United States are about half as likely to have asthma and allergies as those who are born in the U.S., according to a new study.

Researchers surveyed the parents of 80,000 children in one of six languages and found that association held even after they took into account where families lived and how often they moved, as well as their race and income.

“This is definitely something we see clinically and we’re trying to better understand, what is it in our environment that’s increasing the risk of allergic disease?” said Dr. Ruchi Gupta, who studies allergies at the Northwestern University Feinberg School of Medicine in Chicago but wasn’t involved in the new research.

“Food allergies have increased tremendously,” she told Reuters Health. “We do see people who come from other countries don’t tend to have it, but immigrants who are maybe second generation, they’re identical (to U.S.-born people).”

It’s not obvious what explains that pattern, researchers said.

According to Gupta, two possible culprits are the so-called hygiene hypothesis – which suggests kids in the U.S. are too clean, and their immune systems never get exposed to common allergens – or the poor quality of American diets.

Lead researcher Dr. Jonathan Silverberg from Beth Israel Medical Center and St. Luke’s-Roosevelt Hospital Center in New York said climate, obesity and various infections might also be playing a role.

“The results of the study suggest that there are environmental factors in the U.S. that trigger allergic disease,” he told Reuters Health in an email.

“Children born outside the U.S. are likely not exposed to these factors early in life and are therefore less likely to develop allergic diseases.”

Surveys were completed by parents of kids and teens in 2007 and 2008. Just over 20 percent of children born outside the U.S. had any type of allergic disease – including asthma, eczema, hay fever or food allergies – compared to between 34 and 35 percent of those born in the U.S.

What’s more, the risk of allergies increased with the more time foreign-born children spent in the U.S., Silverberg and his colleagues wrote in JAMA Pediatrics.

For example, 27 percent of foreign-born kids who had immigrated more than a decade earlier had any type of allergy, according to their parents’ reports, versus 17 to 18 percent of those who had moved to the U.S. within the past two years.

“You acclimate to wherever you are and you pick up whatever is going on there,” Gupta explained. “The findings here are very interesting – and not surprising.”

Silverberg said he hoped the results would lead to further discoveries of what puts U.S. kids at risk for allergies and how to prevent them.

For now, Gupta recommended parents make sure their children eat a diet with plenty of fruits and vegetables. And allowing them to play in the mud a little bit probably wouldn’t hurt, she said – with proper hand-washing afterward, of course.

SOURCE: bit.ly/KEGTVv JAMA Pediatrics, online April 29, 2013.

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Should old, sick patients get skin cancer surgery?

By Genevra Pittman

NEW YORK | Mon Apr 29, 2013 4:02pm EDT

NEW YORK (Reuters Health) – More than two-thirds of people with non-melanoma skin cancer underwent surgery to treat the condition, according to a new study – including patients who were at least 85 years old or had multiple other chronic diseases.

Researchers found 43 percent of those patients with limited life expectancies died within five years of their diagnosis – but none from skin cancer. Many of them reported poor wound healing after skin surgery or other treatment-related complications including pain, numbness and itching.

The study team said its findings suggest many older patients may not live long enough to benefit from treatment for non-melanoma skin cancers, but can still be harmed by it.

“For so many conditions we just use a standard treatment without thinking about the long-term (clinical) cost,” said Dr. Ashish Jha, a health policy researcher from the Harvard School of Public Health in Boston.

“What I think doctors often underestimate is how often patients don’t want aggressive care.”

Skin cancer is the most common type of cancer. About 2.2 million Americans are diagnosed with non-melanoma skin cancers – which include basal and squamous cell cancers – each year. But according to the American Cancer Society, only 2,000 people die annually from those cancers – less than 0.1 percent of the number diagnosed.

“Non-melanoma skin cancer in some ways is a classic example of a cancer that rarely kills people and it is something that can be treated in a variety of ways and (treatment) really should be customized,” Jha, who wasn’t involved in the new research, told Reuters Health.

Researchers led by Dr. Eleni Linos from the University of California, San Francisco, followed 1,360 people who were diagnosed with non-melanoma skin cancer at one of two dermatology clinics in 1999 and 2000.

Those patients were 69 years old, on average. About one-quarter of them had a limited life expectancy because they were at least 85 or had more than one chronic health condition, including heart, lung or kidney disease, diabetes and dementia.

Most of those older, sicker patients said they weren’t frequently bothered by their skin cancers. Some may not have even noticed them, Linos said.

Age and underlying health did not influence what type of treatment patients received, she and her colleagues reported Monday in JAMA Internal Medicine. About 69 percent of all skin cancers were treated surgically – half with simple excisions and half with lengthier, more intensive procedures.

That was the case even for people who died within two years of getting skin cancer – from a heart attack or stroke, for example.

“We found that regardless of how old people were, how sick or frail they were, what their life expectancy was, they were getting similar treatment,” Linos told Reuters Health. “We saw that as evidence that at the moment, we’re not tailoring our treatment to specific patients.”

She and her colleagues said that for some old and sick patients, just getting to the doctor and sitting in the waiting room may be trying – not to mention undergoing a three-hour surgery.

AGE DETERMINES TREATMENT?

Jha said he doesn’t think age should be the determining factor behind who does or doesn’t undergo surgery for non-melanoma skin cancer. Rather, patients should be given the relevant information about their diagnosis and underlying health and decide for themselves how aggressively their illness is treated.

“There are 80-, 85-year-olds who are extremely healthy (and) vigorous and my take is we should treat them as aggressively as they would like to be treated,” he said, “whereas there are people in their 50s or 60s with advanced diseases who may have a much shorter lifespan.”

Linos agreed.

“We would never want to restrict access to care based on age,” she said.

“Our goal really is to involve patients in this decision and to be able to say, ‘Here are the risks, here are the benefits, what do you want?'”

SOURCE: bit.ly/MbBLbb JAMA Internal Medicine, online April 29, 2013.

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Parasite 'resistant to malaria drug'

28 April 2013 Last updated at 20:03 ET

By Rebecca Morelle Science reporter, BBC World Service

Plasmodium falciparumThe malaria-causing parasites in Cambodia were genetically different from other strains

New drug-resistant strains of the parasite that causes malaria have been identified by scientists.

Researchers found parasites in western Cambodia that are genetically different from other strains around the world.

These organisms are able to withstand treatment by artemisinin – a frontline drug in the fight against malaria.

Reports of drug resistance in the area first emerged in 2008. The problem has since spread to other parts of South East Asia.

The study is published in the journal Nature Genetics.

The lead author, Dr Olivo Miotto, of the University of Oxford and Mahidol University in Thailand, said: “All the most effective drugs that we have had in the last few decades have been one by one rendered useless by the remarkable ability of this parasite to mutate and develop resistance.

“Artemisinin right now works very well. It is the best weapon we have against the disease, and we need to keep it.”

Genetic fingerprint

Western Cambodia has been described by scientists as a hotspot for malaria resistance.

They do not understand why, but since the 1950s parasites there have developed a resistance to a succession of malaria drugs. The problem has spread to other parts of Asia and Africa.

Now scientists are worried the same thing will happen with artemisinin. This drug is used widely around the world against the mosquito-borne disease and can treat an infection in a few days when it is used in combination with other drugs.

To investigate, scientists sequenced the genomes of 800 malaria-causing parasites (Plasmodium falciparum) collected from around the world.

“When we compared the DNA of the parasites in Cambodia, they seem to have formed some new populations that we have not really seen elsewhere,” Dr Miotto said.

The international team found three distinct groups of drug-resistant parasites present in the area.

The researchers said they did not yet understand what genetic mutations had occurred that enabled the parasites to withstand artemisinin treatment.

But they said that understanding their genetic fingerprint would help them to quickly spot and track these strains if they spread further.

Dr Miotto said: “It could be a tool for detecting in real time the emergence of drug resistance.”

The World Health Organisation has stated that a major objective is to stop the spread of malaria parasites resistant to drugs.

According to its latest estimates, there were about 219 million cases of malaria in 2010 and 660,000 deaths.

Africa is the most affected continent: about 90% of all malaria deaths occur there.

Visit the Source Site

Parasite ‘resistant to malaria drug’

28 April 2013 Last updated at 20:03 ET

By Rebecca Morelle Science reporter, BBC World Service

Plasmodium falciparumThe malaria-causing parasites in Cambodia were genetically different from other strains

New drug-resistant strains of the parasite that causes malaria have been identified by scientists.

Researchers found parasites in western Cambodia that are genetically different from other strains around the world.

These organisms are able to withstand treatment by artemisinin – a frontline drug in the fight against malaria.

Reports of drug resistance in the area first emerged in 2008. The problem has since spread to other parts of South East Asia.

The study is published in the journal Nature Genetics.

The lead author, Dr Olivo Miotto, of the University of Oxford and Mahidol University in Thailand, said: “All the most effective drugs that we have had in the last few decades have been one by one rendered useless by the remarkable ability of this parasite to mutate and develop resistance.

“Artemisinin right now works very well. It is the best weapon we have against the disease, and we need to keep it.”

Genetic fingerprint

Western Cambodia has been described by scientists as a hotspot for malaria resistance.

They do not understand why, but since the 1950s parasites there have developed a resistance to a succession of malaria drugs. The problem has spread to other parts of Asia and Africa.

Now scientists are worried the same thing will happen with artemisinin. This drug is used widely around the world against the mosquito-borne disease and can treat an infection in a few days when it is used in combination with other drugs.

To investigate, scientists sequenced the genomes of 800 malaria-causing parasites (Plasmodium falciparum) collected from around the world.

“When we compared the DNA of the parasites in Cambodia, they seem to have formed some new populations that we have not really seen elsewhere,” Dr Miotto said.

The international team found three distinct groups of drug-resistant parasites present in the area.

The researchers said they did not yet understand what genetic mutations had occurred that enabled the parasites to withstand artemisinin treatment.

But they said that understanding their genetic fingerprint would help them to quickly spot and track these strains if they spread further.

Dr Miotto said: “It could be a tool for detecting in real time the emergence of drug resistance.”

The World Health Organisation has stated that a major objective is to stop the spread of malaria parasites resistant to drugs.

According to its latest estimates, there were about 219 million cases of malaria in 2010 and 660,000 deaths.

Africa is the most affected continent: about 90% of all malaria deaths occur there.


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MS patients missing out on drugs

28 April 2013 Last updated at 21:42 ET

A woman taking a drug treatment for multiple sclerosis

Only 40% of people eligible for drugs to combat multiple sclerosis in the UK are actually taking them, says a report from the MS Society.

A survey of more than 10,000 adults with MS showed that many were missing out on the seven licensed medicines approved for use.

The charity said a lack of information and access to specialists was to blame.

It is calling for the government to provide a personalised care plan to every person with MS.

The MS Society’s survey and accompanying report showed that there were differences in access to disease-modifying treatments (DMTs) across the four nations of the UK.

These are medicines that can reduce the frequency and severity of MS attacks, and in some cases can slow the progression of the disabling condition.

Someone living in Northern Ireland with MS was twice as likely to be taking a DMT (68%) than someone with the condition in Wales (30%), for example.

Access to treatment in Scotland and England was only a little higher at 36% and 40%.

Continue reading the main story

What is multiple sclerosis?

Multiple sclerosis (MS) is a neurological condition that affects around 100,000 people in the UK.

Most patients have it diagnosed between the ages of 20 and 40, but it can affect younger and older people too.

Almost three times as many women as men have MS.

In Europe, additional research shows that only Poland and Romania have a smaller proportion of people with MS taking licensed medicines.

Routine assessment

The charity’s report said that being well informed about the medicines available was crucial.

Those who felt they had enough information about medicines were 32% more likely to be taking a DMT, the survey found, and those with access to a specialist MS nurse or neurologist were more than twice as likely to be taking the appropriate drugs.

Northern Ireland is the only place in the UK where most people with MS are routinely invited every six months to see a neurologist or MS nurse for a review.

This means that people with MS are constantly having their treatment options assessed, the report says.

As a result, they are more likely to get the information they need and discuss issues such as side-effects.

Continue reading the main story

UK licensed medicines for MS

  • Avonex, Betaferon, Rebif and Copaxone were all made available on the NHS in 2002 throughout the UK.
  • Extavia was licensed in 2009 and reduces relapses by a third.
  • Tysabri is a monthly infusion administered by a healthcare professional. It can reduce the number of relapses by an estimated 67% and slow disability. It was approved for use on the NHS across the UK in 2007.
  • Gilenya, the first pill for MS, is said to reduce relapse rates by 54-60% and slows disability progression by around 30%. It was approved in 2012.

Yet this may not be the only solution. Forty-one per cent of those who said they did have enough information about drug treatments still did not take a disease-modifying treatment.

The report concluded: “This could be due to barriers to accessing medicines; because individuals make an informed decision not to take them; or because they don’t know what information is out there that they could have access to, such as around new treatments or new evidence of efficacy.”

New policy

Nick Rijke, director for policy and research at the MS Society, said people with multiple sclerosis were facing a lottery.

“These findings worryingly suggest that the likelihood of someone receiving a life-changing treatment is often based on luck – like where they live or how helpful their healthcare professional is – rather than their genuine clinical need.

“When it comes to prescription rates, the UK ranks 25th out of 27 European countries. Given the relative wealth of the UK this is simply unacceptable.”

The MS Society is now calling on all four governments in the UK to ensure every person with MS has a personalised treatment, care and support plan, with two comprehensive reviews each year.

Ed Holloway, head of care and services research at the MS Society, said that because some MS drugs were costly, they were often not offered when they should be because of restricted NHS budgets.

‘Speak to doctor’

A spokesman for NHS England, which has recently taken on the commissioning of treatment for MS from primary care trusts, said a new policy from 1 April would mean that people across England would have the same access to treatment.

“By making decisions nationally about specialist treatments, we are confident that patients will now be able to receive the treatment they need, irrespective of where they live.

“As with all policies, we will continue to collect and review the outcome of treatments for patients and consider them when our policy is reviewed.

“If a patient has concerns about the treatment they are receiving we would urge them to speak to their GP or consultant.”


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Merck, Pfizer to jointly develop diabetes drug

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A view of the Merck & Co. campus in Linden, New Jersey March 9, 2009. REUTERS/Jeff Zelevansky

1 of 2. A view of the Merck & Co. campus in Linden, New Jersey March 9, 2009.

Credit: Reuters/Jeff Zelevansky

Mon Apr 29, 2013 8:10am EDT

(Reuters) – Drugmakers Pfizer Inc and Merck & Co Inc said they would jointly develop Pfizer’s experimental type 2 diabetes drug, ertugliflozin, and expect late-stage trials to start later in 2013.

Pfizer has so far received $60 million in upfront and milestone payments and will be eligible for additional payments associated with clinical, regulatory and commercial milestones.

Merck and Pfizer will share potential revenue and certain costs on a 60/40 percent basis, the companies said.

Merck and Pfizer will collaborate on the development and marketing of ertugliflozin and ertugliflozin-containing fixed-dose combinations with metformin, a common diabetes treatment, and Merck’s Januvia tablets.

Merck will continue to retain the rights to its existing portfolio of Januvia-containing products.

(Reporting by Esha Dey in Bangalore; Editing by Saumyadeb Chakrabarty)

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Auxilium cuts sales view on drugs, expands urology business

Mon Apr 29, 2013 12:22pm EDT

(Reuters) – Auxilium Pharmaceuticals Inc reported a big fall in quarterly sales in the United States for both its drugs, and said it acquired Actient Holdings LLC to bolster its urology business.

Shares of Auxilium fell as much as 13.5 percent to $13.87 — their lowest in a year-and-a-half — on the Nasdaq on Monday.

Revenue fell 10 percent in the first quarter to $66.2 million, below analysts’ average estimate of $81.23 million, according to Thomson Reuters I/B/E/S.

Testosterone gel Testim’s sales, almost all of which come from the United States, fell 23 percent to $45.5 million.

Chief Executive Adrian Adams blames the slide on slowing growth of the testosterone replacement therapy market, competition and reduced managed care cover.

Testim covered 71 percent of patients under managed care plans, down from 83 percent in the fourth quarter.

Endo Pharmaceuticals Inc’s Fortesta, which bagged some big managed care contracts, could have affected Testim sales by competitive pricing, Stifel Nicolaus analyst Annabel Samimy said.

“It seems like the competitive environment is overwhelming them. They were going to depend on market growth to maintain their sales level.”

U.S. sales of Xiaflex, a drug that treats a thickening of the fibrous tissue layer underneath the skin of the palm and fingers, fell 5 percent to $12 million in the quarter ended March 31. The drug’s total sales, however, grew 39 percent.

Auxilium cut its forecast range for 2013 global Testim sales to $210 million to $240 million from $250 million to $265 million.

The company also reduced its U.S. sales forecast for Xiaflex — also being developed as a treatment for Peyronie’s disease, a curvature of the penis caused by scar tissue — by $10 million to between $65 million and $80 million.

Auxilium also announced the acquisition of Actient from private equity firm GTCR for $585 million plus contingent payments.

“You’ve got a deal that was done on the same day as they reported unfortunate performance for their base products, so it calls into question the urgency of the deal,” Samimy said.

“It feels a bit like a defensive move for Auxilium.”

Actient’s testosterone replacement therapies Testopel and Striant and erectile dysfunction products such as Edex complement Auxilium’s drugs.

The combined company will sell 11 products for urology, orthopedic and respiratory ailments.

“With a broader portfolio we will have a more diverse revenue stream, reducing our reliance on any single product,” CEO Adams said.

Auxilium expects the deal to contribute $85 million to $95 million to 2013 revenue and immediately add to adjusted net income. It now expects 2013 revenue of $360 million to $415 million, up from $325 million to $355 million forecast earlier.

The company said it would fund the deal by cash on hand and a $225 million loan from Morgan Stanley Senior Funding Inc.

Auxilium recorded a net loss of $8.2 million, or 17 cents per share, in the quarter ended March 31, compared with a loss of $1.7 million, or 4 cents per share, a year earlier.

Shares of the company, one of the biggest losers on the Nasdaq on Monday, were trading down 11.6 percent at $14.16 a little after noon.

(Reporting By Vrinda Manocha in Bangalore)

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