PRESS-NEWS.org - Press Release Distribution
PRESS RELEASES DISTRIBUTION

Aflibercept in diabetic macular oedema: Added benefit not proven

Neither positive nor negative effects for some patients, data lacking for other patients

2014-12-15
(Press-News.org) Since August 2014, aflibercept (trade name Eylea) has been available also for patients with visual impairment due to diabetic macular oedema (DMO). The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in a dossier assessment whether this drug offers an added benefit over the appropriate comparator therapy.

According to the findings, an added benefit in this therapeutic indication is not proven: The data showed no relevant differences between the treatment groups for patients in whom the fovea centralis is also affected. The drug manufacturer did not submit any data for other patients.

IQWiG already assessed aflibercept twice, in 2013 and in 2014, for therapeutic indications of the eye. In both cases, it concluded that an added benefit is not proven.

G-BA specifies appropriate comparator therapy

High blood glucose levels over a long period of time can lead to oedema in the retina of the eye. The fovea centralis, a small pit in the back of the eye, is the part of most acute vision. The area around the fovea is known as the macula or "yellow spot". An oedema in the macula can impair visual acuity and even result in blindness.

The Federal Joint Committee (G-BA) differentiated between two groups of patients for the assessment, and specified an appropriate comparator therapy for each of them: If the fovea is affected, aflibercept was to be compared with the drug ranibizumab. If the fovea is not affected, aflibercept was to be compared with focal/grid laser photocoagulation.

Studies suitable for indirect comparison

The manufacturer did not submit any direct comparative study for the first patient group, but results from an adjusted indirect comparison. These were four randomized controlled trials (RCTs) in total in which either aflibercept or ranibizumab were tested against laser photocoagulation.

The design of the studies and the patients investigated were sufficiently similar for the results to be used for an indirect comparison. However, these data showed no statistically significant differences between the aflibercept and the ranibizumab group in any of the patient-relevant outcomes, i.e. neither for visual acuity, nor for side effects or quality of life. Hence an added benefit of aflibercept is not proven for patients in whom the oedema affects the fovea.

Since the manufacturer presented no data for the second patient group (fovea not affected), there is also no proof of added benefit for this Group.

INFORMATION:

G-BA decides on the extent of added benefit

The dossier assessment is part of the overall procedure for early benefit assessments according to the Act on the Reform of the Market for Medicinal Products (AMNOG) supervised by the G-BA. After publication of the manufacturer's dossier and IQWiG's assessment, the G-BA conducts a commenting procedure, which may provide further information and result in a change to the benefit assessment. The G-BA then decides on the extent of the added benefit, thus completing the early benefit assessment.

An overview of the results of IQWiG's benefit assessment is given by a German-language executive summary. In addition, the website » http://www.gesundheitsinformation.de, published by IQWiG, provides easily understandable and brief German-language information on aflibercept.

The G-BA website contains both general English-language information on benefit assessments pursuant to §35a Social Code Book (SGB) V and specific German-language information on the assessment of aflibercept.

More English-language information will be available soon (Sections 2.1 to 2.5 of the dossier assessment as well as subsequently published health information on » http://www.informedhealthonline.org). If you would like to be informed when these documents are available, please send an e-mail to » info@iqwig.de.



ELSE PRESS RELEASES FROM THIS DATE:

Squid supplies blueprint for printable thermoplastics

Squid supplies blueprint for printable thermoplastics
2014-12-15
Squid, what is it good for? You can eat it and you can make ink or dye from it, and now a Penn State team of researchers is using it to make a thermoplastic that can be used in 3-D printing. "Most of the companies looking into this type of material have focused on synthetic plastics," said Melik C. Demirel, professor of engineering science and mechanics. "Synthetic plastics are not rapidly deployable for field applications, and more importantly, they are not eco-friendly." Demirel and his team looked at the protein complex that exists in the squid ring teeth (SRT). ...

Do you speak cow? Researchers listen in on 'conversations' between cattle

Do you speak cow? Researchers listen in on conversations between cattle
2014-12-15
The team from The University of Nottingham and Queen Mary University of London, spent ten months studying to the ways cows communicate with their young, carefully examining acoustic indicators of identity and age. They identified two distinct maternal 'calls'. When cows were close to their calves, they communicated with them using low frequency calls. When they were separated - out of visual contact - their calls were louder and at a much higher frequency. Calves called out to their mothers when they wanted to start suckling. And all three types of calls were individualised ...

War metaphors for cancer hurt certain prevention behaviors

2014-12-15
ANN ARBOR--It's not unusual for people to use war metaphors such as "fight" and "battle" when trying to motivate patients with cancer. But a new University of Michigan study indicates that using those words can have an unintended negative effect. David Hauser, a U-M doctoral student in psychology, and colleague Norbert Schwarz of the University of Southern California, found in three studies that exposure to metaphoric language relating cancer to an enemy significantly lessens the extent to which people consider cancer-prevention behaviors. "Hearing metaphoric utterances ...

Potential new tool for cervical cancer detection and diagnosis

Potential new tool for cervical cancer detection and diagnosis
2014-12-15
WASHINGTON D.C., Dec. 15, 2014--Cervical cancer is, in many ways, a shining example of how successful the war on cancer can be. Thanks largely to the advent of Pap smear screening, U.S. cervical cancer deaths decreased dramatically, by more than 60 percent, between 1955 and 1992. In the last two decades, better treatment outcomes and more powerful imaging techniques have steadily pushed 5-year survival rates ever higher. The latest weapons in modern medicine's arsenal are two new vaccines that were recently approved by the U.S. Food and Drug Administration for preventing ...

Mobile radio passive radar makes harbors safer

Mobile radio passive radar makes harbors safer
2014-12-15
Airports are now subject to careful security surveillance, but many coastal towns and ports are not; they often lack radar installations to keep track of small boats, meaning terrorists could easily use speedboats to approach the coastline and bring explosives on land. Now, researchers at the Fraunhofer Institute for Communication, Information Processing and Ergonomics FKIE in Bonn developed a passive surveillance system for littoral regions based on mobile radio illumination called Passive Coherent Location (PCL). It passively employs the continuous radio signals emitted ...

New floor covering can lead to breathing problems in babies

2014-12-15
Leipzig. New flooring in the living environment of pregnant women significantly increases the risk of infants to suffer from respiratory diseases in their first year of life. This is the result of a study carried out by the Helmholtz Centre for Environmental Research (UFZ) and the "St Georg" Municipal Hospital, which demonstrates that exposure to volatile organic compounds in the months before and after birth induces breathing problems in early childhood . The scientists therefore recommend that redecoration should be avoided during pregnancy or in the first year of children's ...

Skipping meals increases children's obesity and cardiometabolic risk

2014-12-15
Children who skip main meals are more likely to have excess body fat and an increased cardiometabolic risk already at the age of 6 to 8 years, according to a Finnish study. A higher consumption of sugary drinks, red meat and low-fat margarine and a lower consumption of vegetable oil are also related to a higher cardiometabolic risk. "The more of these factors are present, the higher the risk," says Ms Aino-Maija Eloranta, MHSc, who presented the results in her doctoral thesis at the University of Eastern Finland. The dietary habits, eating behaviour and dietary determinants ...

Less than half of parents think their 18-year-olds can make a doctors appointment

2014-12-15
ANN ARBOR, Mich. - Most parents agree their children should be ready to move out of the pediatrician's office into adult-focused care by age 18 - but just 30 percent actually make that transition by that age, according to the University of Michigan C.S. Mott Children's Hospital National Poll on Children's Health. As health care becomes more complex, it's difficult for teens to shift from relying on their parents to taking on their own health care needs. The C.S. Mott National Poll on Children's Health asked a national sample of parents of adolescents and young adults ...

Climate change could leave cities more in the dark

Climate change could leave cities more in the dark
2014-12-15
Cities like Miami are all too familiar with hurricane-related power outages. But a Johns Hopkins University analysis finds climate change will give other major metro areas a lot to worry about in future storms. Johns Hopkins engineers created a computer model to predict the increasing vulnerability to hurricanes of power grids in major cities on or relatively near the Atlantic and Gulf coasts. They factored historic hurricane information in with plausible scenarios for future storm behavior, given a global rise in average temperatures. With that data, the team could pinpoint ...

Mathematicians prove the Umbral Moonshine Conjecture

2014-12-15
Monstrous moonshine, a quirky pattern of the monster group in theoretical math, has a shadow - umbral moonshine. Mathematicians have now proved this insight, known as the Umbral Moonshine Conjecture, offering a formula with potential applications for everything from number theory to geometry to quantum physics. "We've transformed the statement of the conjecture into something you could test, a finite calculation, and the conjecture proved to be true," says Ken Ono, a mathematician at Emory University. "Umbral moonshine has created a lot of excitement in the world of math ...

LAST 30 PRESS RELEASES:

Sensitive ceramics for soft robotics

Trends in hospitalizations and liver transplants associated with alcohol-induced liver disease

Spinal cord stimulation vs medical management for chronic back and leg pain

Engineered receptors help the immune system home in on cancer

How conflicting memories of sex and starvation compete to drive behavior

Scientists discover ‘entirely unanticipated’ role of protein netrin1 in spinal cord development

Novel SOURCE study examining development of early COPD in ages 30 to 55

NRL completes development of robotics capable of servicing satellites, enabling resilience for the U.S. space infrastructure

Clinical trial shows positive results for potential treatment to combat a challenging rare disease

New research shows relationship between heart shape and risk of cardiovascular disease

Increase in crisis coverage, but not the number of crisis news events

New study provides first evidence of African children with severe malaria experiencing partial resistance to world’s most powerful malaria drug

Texting abbreviations makes senders seem insincere, study finds

Living microbes discovered in Earth’s driest desert

Artemisinin partial resistance in Ugandan children with complicated malaria

When is a hole not a hole? Researchers investigate the mystery of 'latent pores'

ETRI, demonstration of 8-photon qubit chip for quantum computation

Remote telemedicine tool found highly accurate in diagnosing melanoma

New roles in infectious process for molecule that inhibits flu

Transforming anion exchange membranes in water electrolysis for green hydrogen production

AI method can spot potential disease faster, better than humans

A development by Graz University of Technology makes concreting more reliable, safer and more economical

Pinpointing hydrogen isotopes in titanium hydride nanofilms

Political abuse on X is a global, widespread, and cross-partisan phenomenon, suggests new study

Reintroduction of resistant frogs facilitates landscape-scale recovery in the presence of a lethal fungal disease

Scientists compile library for evaluating exoplanet water

Updated first aid guidelines enhance care for opioid overdose, bleeding, other emergencies

Revolutionizing biology education: Scientists film ‘giant’ mimivirus in action

Genetic variation enhances cancer drug sensitivity

Protective genetic mutation offers new hope for understanding autism and brain development

[Press-News.org] Aflibercept in diabetic macular oedema: Added benefit not proven
Neither positive nor negative effects for some patients, data lacking for other patients