FDA approves Pfizer’s leukemia drug

(Reuters) – The U.S. Food and Drug Administration (FDA) on Friday approved Pfizer Inc’s drug, Mylotarg, for certain patients with acute myeloid leukemia (AML), re-clearing a drug that had been pulled off the market in 2010.

The drug was cleared to treat adults with newly diagnosed AML and tumors expressing the CD33 antigen, as well as patients aged 2 years and older with CD33-positive AML who have relapsed, or did not respond to initial treatment.

The FDA said the drug has a boxed warning as it may cause severe or fatal liver damage, including blockage of veins in the liver. (reut.rs/2gv6KYu)

Mylotarg got accelerated approval in 2000 as a standalone treatment for adult patients with CD33-positive AML who had experienced a relapse, but was voluntarily withdrawn as subsequent confirmatory studies failed to show clinical benefit and had safety concerns, including a high number of deaths.

Friday’s approval includes a lower recommended dose, a different dosing schedule and a new patient population, the FDA said.

A cycle of Mylotarg is expected to cost $24,600, Pfizer said. Mylotarg is thought to work by taking the anti-tumor agent to the AML cells that express the CD33 antigen, blocking the growth of cancerous cells and causing cell death.

AML is a cancer that originates in the bone marrow and progresses rapidly, resulting in an abnormal increase in white blood cells.

About 21,380 people will be diagnosed with AML this year and of those, 10,590 patients will succumb to the disease, according to estimates from the National Cancer Institute.

Reporting by Akankshita Mukhopadhyay in Bengaluru and Michael Erman in New York; Editing by Martina D’Couto and Sandra Maler

Our Standards:The Thomson Reuters Trust Principles.

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ESC: Triple Vascular Screening Reduces Deaths

BARCELONA – Non-invasive population-wide screening for high blood pressure, abdominal aortic aneurysm and peripheral artery disease appears to be life-saving, feasible and cost-effective, according to researchers who performed the Danish Viborg Vascular (VIVA) study that included 50,000 men.

When compared with the men who were not screened, there was a 7% reduction in mortality – or it required 169 screenings to save one life (P=0.01), said Jes Lindholt, MD, professor of vascular surgery,at Odense University Hospital, Denmark.

“Screening for cardiovascular disease hasn’t caught much attention,” Lindholt said at a press conference at the annual congress of the European Society of Cardiology. “We sought to test whether triple vascular screening for abdominal aortic aneurysm, peripheral artery disease and hypertension could reduce overall mortality in 64-75 year old men.”

He said that only men were considered for the trial because the diseases were predominantly found in the male population.

The screening and usual care groups were followed using national registries for hospital admissions, surgeries, and overall and cause-specific death. After 5 years, 149 more lives were saved in the screening group. There were 2,566 deaths in the screening group versus 2,715 in the control group.

“A result of this magnitude has never been seen before in general population screening programs,” said Lindholt. “We believe that it is primarily explained by the 2.5 times higher incidence of elective aneurysm repairs and the doubled initiation rates of anti-thrombotic and lipid-lowering therapy in the group invited to screening.”

He noted, “These diseases are often asymptomatic and can be life threatening. Of course, elective repair of an aneurysm can prevent dying of rupture. However, pharmacological therapy for peripheral artery disease, aneurysms or hypertension holds a much larger potential to reduce the risk of dying from coronary heart disease, stroke, and heart attack.”

The study was published online in The Lancet at the same time it was presented at the conference.

The prospective study randomized 50,156 men ages 65 to 74 years, all of whom lived in the central region of Denmark. Half were invited to screening and the other half to usual care where disease is typically detected only if a man reacts to symptoms or is in contact with healthcare for other reasons. The primary outcome was all-cause mortality.

Men in the screening group underwent a 10-minute procedure in which their aorta was scanned using ultrasonography and their blood pressure was measured and compared for the ankle and the arm. Two specially trained nurses undertook the procedure.

More than 20% of those attending screening had positive test results: 3% had an abdominal aortic aneurysm (AAA or triple A), 11% had peripheral artery disease, and 11% had suspected hypertension that was untreated. “We were quite surprised that despite modern healthcare with diagnostic technology being available essentially everywhere, one out of five men had undiagnosed vascular disease,” said Lindholt.

Men who tested positive for abdominal aortic aneurysm and/or peripheral artery disease had a confirmatory test and consultation where individualized prophylactic activities, including smoking cessation and pharmacological therapy, were recommended. If not already prescribed, low dose aspirin (75 mg/day) and simvastatin (40 mg/day) were prescribed. Those with an aneurysm larger than 50 mm in diameter were referred to a vascular surgeon to assess the need for elective repair. Men with suspected hypertension were referred to their general practitioner.

The cost of screening (using 2014 prices) was estimated at an additional $175 per citizen in comparison with usual care from a healthcare sector perspective.

In commenting on the study, George Vetrovec, MD, professor emeritus of cardiology at Virginia Commonwealth University, Richmond, told MedPage Today, “The VIVA trial really shows what you can do with a rather simple, large data study. They screened 50,000 patients in central Denmark. Of the invited patients to be screened, only 75% showed up. This starts to talk about perhaps some of the difficulties in clinical medicine.

“If a triple A was found, then they were referred for follow-up – to medical treatment if the aneurysm was less than 5 centimeters and to surgical treatment if it was greater in size. When peripheral artery disease was found, the patients were started on statins or aspirin or both. And the hypertension patients were referred a specialist physician,” Vetrovec explained.

“It turns out that they were very successful and over 5 years they were able to reduce mortality over the screened group by 7% which was statistically significant. They had excellent follow-up,” he said.

‘What was disappointing, was that the number of patients started with statins or aspirin was about a third of the patients who had the disease and the percentage of hypertension patients treated was small,” Vetrovec said. “So the potential could have been greater.

“They did look at quality of life and there was a little anxiety for people who occasionally got a false diagnosis for peripheral artery disease but overall, the quality of life was positive, and the cost savings by doing this screening was well within the $50,000 per quality year life saved. You only had to screen 169 people to save a life. So overall a very positive study,” he said.

Lindholt and Vetrovec disclosed no relevant relationships with industry.

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ESC: Frequent Smartphone Afib Monitoring Catches Arrhythmia

BARCELONA — Twice-weekly use of a smartphone device for single-lead electrocardiogram detection of atrial fibrillation caught more cases than usual care, although with a fairly low yield in seniors with afib risk factors.

Screening picked up 3.9-fold more atrial fibrillation than found in routine care — 19 versus five cases out of the evenly divided 1,001 participants (P=0.007), Julian Halcox, MD, of Swansea University in Wales, reported here at the European Society of Cardiology meeting and simultaneously online in Circulation.

“The data from this study confirm results from studies with implanted pacemakers, cardioverter-defibrillators, and loop recorders and other AF screening studies that … the more we look for AF, the more we will find it,” wrote Albert Waldo, MD, PhD, of UH Case Medical Center in Cleveland, and John Camm, MD, of St. George’s University of London, in an accompanying Circulation editorial.

Intermittent monitoring with a smartphone device “will tend to reveal infrequent arrhythmia, but the short recording period gives little idea of the duration of the arrhythmia, and mere identification is not enough,” they cautioned, concluding: “Clearly, we have more work to do.”

While the trial was underpowered for hard clinical outcomes, the number of strokes and transient ischemic attacks or systemic embolic events was nominally lower with the intervention (six versus 10, HR 0.61, 95% CI 0.22–1.69). All detected paroxysmal atrial fibrillation was treated with anticoagulation.

That “quite low” 0.02% adverse event rate in the 1,001 participants mirrored what has been seen in virtually all the previous studies looking for asymptomatic episodes of so-called subclinical atrial fibrillation, the editorialists noted. And, they pointed out, “of the 16 total strokes, 14 were either causally unrelated to AF or of undetermined origin.”

In fact, there’s no evidence from implantable cardiac monitors, patch monitors, or other such devices to prove that the extra detection of brief or silent afib actually translates into clinical benefit, Alfred Bove, MD, PhD, of Temple University, commented to MedPage Today in an interview. But from his early background as an engineer, “I think technology is going to solve a lot of problems,” he said. “The question is what are you going to do with the data.”

“These results support consideration of evaluation in an appropriately powered, event-driven randomized trial to confirm clinical and cost-effectiveness of such an approach to stroke prevention in AF,” the researchers concluded.

The cost per diagnosis came in at $10,780, driven by the personnel time needed for overreads of ECGs uploaded by the device, Halcox noted at a press conference for the Hot Line session.

The projected cost per quality-adjusted life-year of $26,118 was calculated from a “hub-and-spoke” model in which ECGs are fed to commercial entities that determine which should be read by humans in a U.K. National Health Service setting. That figure was in line with other studies of systematic opportunistic screening and systematic population screening for atrial fibrillation (followed by non-vitamin K antagonist oral anticoagulation as indicated) and would likely be cost-effective compared with the current practice of no screening, the researchers noted.

Their REHEARSE-AF study (Assessment of Remote Heart Rhythm Sampling Using the AliveCor Heart Monitor to Screen for Atrial Fibrillation) included patients 65 and older with a CHA2DS2-VASc score of at least 2 and without a history of atrial fibrillation. Patients also had to have wireless internet access.

While the device does do automated overread of ECGs, the study included human overread of any abnormal or indeterminate results, as were 10% of normals for quality control.

Adherence with the requested Monday and Wednesday ECGs was fairly good, with about 80% of participants doing it at least once a week and more than two-thirds doing it twice a week at least 75% of weeks. Notably, the seniors reported general confidence in the device and satisfaction with it. Fewer than one in 10 using the device noted even moderate anxiety about their heart rhythm.

“These findings provide reassurance that if such a program is considered clinically and economically viable in the future, it will also be highly acceptable to the target population,” the researchers wrote.

The trial was funded by the Welsh Government and by a project grant from AliveCor (25% of study funding).

Camm has received research grants from Boehringer Ingelheim and Daiichi Sankyo, served as a speaker for Bayer, and received honoraria from all three.

Waldo has served as a speaker for Pfizer and Bristol-Meyers Squib and he has received honoraria from Biosense Webster, AtriCure, Milestone Pharmaceuticals, and Daiichi Sankyo.

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Gout patient hospitalizations: what’s causing the increase?

August 31, 2017

An interview with Dr. Gurkirpal Singh, Stanford University, conducted by April Cashin-Garbutt, MA (Cantab)

Can you please outline the gout patient hospitalization data presented at the Annual European Congress of Rheumatology (EULAR) 2017?

We looked at all hospitalizations in patients with gout. The concern is that gout is often considered as a disease of just the joints, specifically of the big toe. Yet, there have been quite a lot of studies that have talked about the many other comorbidities that occur because of hyperuricemia and gout. The idea is that it’s not just the crystal deposits in the joint, but other consequences that are happening because of this disease in the rest of the body.

Credit: PopTika/Shutterstock.com

We have access to a large database that is representative of all hospitalizations in the US. Previous work has been done in a particular hospital, data set, insurance company, or country for example. However, we wanted to look at the entire country of the United States, and look over 20 years, to see what is happening to these patients with gout. One of the most serious things that can happen to you is a hospitalization.

We wanted to look at all hospitalizations (which we refer to as all-cause hospitalizations) and look at every hospitalization in patients with gout and see what has been happening to those hospitalizations over the last 20 years.

How do these figures compare to the number of hospitalizations for the overall US population?

We were quite surprised with what we found, which was that from 1993 to 2014, the hospitalizations in gout increased by about 400%.

We were surprised at the magnitude of the findings. We were thinking that we might find a small increase because we are recognizing gout hospitalizations more.

Also the population is aging in the US, as in most developed countries. You would therefore expect that as the population is aging, the number of hospitalizations would go up too. That was what was happening from about 1993 to about 2005, for the first 10 years or so.

However, the US is also getting healthier: the incidence of cardiovascular disease is coming down, diabetes is better managed, and so we, as a population, are getting healthier.

Overall, all hospitalizations have remained stable, they haven’t increased a lot, but they’ve gone up by about 4% or 5%, whereas the gout hospitalizations have gone up ~400%.

What do you think are the reasons behind the increase in gout patient hospitalizations?

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It is most likely a result of two things. One, we are getting better at documenting this, better at recognizing that gout is a serious disease, and we are better at looking for other things that happen in patients with gout and recording them.

Two, our medical records are improving, because now most of the country have switched to electronic medical records, where everything is electronically recorded, and perhaps that is also contributing to the results we are measuring now.

We’re beginning to recognize the true comorbidities in patients with gout. Conversely, what it also means is that the data we’ve been working on so far from the past decade or so, grossly underestimates this problem. The extent of the problem is much bigger than what anybody’s ever thought or published before.

The next thing we’re going to do is to look in more detail at these patients and figure out what is putting them in the hospital. Is it cardiovascular disease, is it kidney failure, what is happening? That is something that we’re going to be working on now.

What needs to be done to improve disease management in gout patients?

We need to recognize that gout is a systemic disease. When you are treating the joint, you’re not just treating the joint, but you’re treating the patient.

When you’re treating the patient, you need to recognize other things, too. You need to look at hypertension, cardiovascular risk, and kidney function etc. The entire patient must be considered, rather than just treating the joint, and thinking that if the joint gets better everything is going to be fixed.

We saw the same issue in rheumatoid arthritis a few years ago, we presented data there too, and now there is better recognition of the comorbidities. They were presented at EULAR and showed that the cardiovascular comorbidities in rheumatoid arthritis are now declining.

Recognition plays an important role, you don’t treat what you don’t know, what you don’t see. We hope to see a similar trend in gout as well. Now that we’ve shown what is happening, we should be treating it more aggressively and recognize the comorbidities in these patients, bringing things under control, thinking not only are we controlling the joint, but we’re going to be controlling the whole disease process in the entire patient.

What are the main challenges and how can they be overcome?

The biggest challenge is one of knowledge and recognition. Once it is recognized, these things are not difficult to treat, it is a matter of recognition.

We already know how to manage cardiovascular risk for example, and we already know that hyperuricemia can produce cardiovascular risk, therefore we need to control hyperuricemia.

Of course, we also need to treat the gout aggressively thinking that it is not just the joint, it is more than the joint, but at the same time recognizing how we treat the comorbidities, that also is something we should be doing.

What do you think the future holds for gout patients?

The future looks good for gout patients because we have now treatment from mild to severe gout that can control the disease considerably well. There are also new drugs being developed, and so there are more things that are coming down the pipeline. Once we recognize that we need to treat the disease aggressively, I think the medications are now there.

Where can readers find more information?

About Dr. Gurkirpal Singh

Adjunct Clinical Professor of Medicine
Division of Gastroenterology and Hepatology
Stanford University School of Medicine
Chief Science Officer
Institute of Clinical Outcomes Research and Education
Palo Alto, California

Prof. Gurkirpal Singh received his MD degree and completed a residency in pediatrics from All-India Institute of Medical Sciences in New Delhi, India. He has completed fellowships in Allergy-Immunology and Nutrition at the Memorial University of Newfoundland in St. John’s, Canada; Immunology and Rheumatology at Stanford University School of Medicine in Stanford, California; and Pediatric Rheumatology at the Children’s Hospital of Philadelphia in Philadelphia, Pennsylvania.

Prof. Singh is internationally renowned for his work on clinical epidemiology, health economics and outcomes in several disease areas including inflammation, rheumatology, pain management, cardiology and gastroenterology. Prof. Singh has conducted numerous large randomized clinical trials as well as prospective and retrospective observational studies involving several thousand patients.

Prof. Singh has worked closely with the US Federal Government for the past several years. He was invited for expert testimonies on drug safety issues by both the US Senate and the US House of Representatives, and continues to work on these issues regularly. Prof. Singh has served as a Consultant to the Arthritis Advisory Committee of the US Food and Drug Administration in Rockville, Maryland, and continues to work in these areas in his research.

Prof. Singh was a member of the US Medicare Coverage Advisory Committee, and worked with Department of Human and Health Services Centers for Medicare and Medicaid Services in evaluating coverage decisions for new medicines, procedures and diagnostics. He also serves as a scientific grant reviewer for the National Institutes of Health and other US Federal Government organizations.

Prof. Singh is well-published in the international peer-reviewed literature with over 200 peer-reviewed articles, abstracts, book chapters and reviews.

Prof. Singh is an avid golfer, with more enthusiasm than skill, unfortunately.

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