(Press-News.org) Since 2014 dulaglutide has been approved alone or in combination with other drugs for the treatment of adults with type 2 diabetes. The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in a dossier assessment whether this new drug offers an added benefit over the appropriate comparator therapies.
IQWiG found a hint of minor added benefit for the combination with short-acting insulin with or without metformin. In contrast, an added benefit of dulaglutide versus the respective appropriate comparator therapy is not proven for the combination with long-acting insulin, for monotherapy, and for combinations with one or two oral antidiabetics.
Combination with metformin: positive and negative effects are balanced
Metformin plus sulfonylurea is the appropriate comparator therapy for the combination of dulaglutide with an oral antidiabetic. The drug manufacturer combined dulaglutide with metformin; it presented no data for combinations with other oral antidiabetics. It conducted an indirect comparison of two studies. For some of the outcomes investigated, there were no relevant data or there were no statistically significant differences between the treatment arms.
In the outcome category of non-serious and non-severe side effects, there were both positive and negative effects, which outweighed each other: A hint of considerably lesser harm of the dulaglutide-metformin combination in confirmed symptomatic hypoglycaemia was offset by hints of considerably greater harm in nausea, vomiting and diarrhoea.
Dulaglutide in combination with short-acting insulin: advantages predominate
For the comparison between dulaglutide plus insulin (with or without an oral antidiabetic) and metformin plus human insulin, the manufacturer presented data from the AWARD-4 study, in which short-acting insulin was combined with dulaglutide. There were also both positive and negative effects. However, the negative effects - such as nausea or vomiting - all belonged to the outcome category of non-serious and non-severe events. Hence they do not completely raise doubts about the positive effect in serious adverse events, but weaken it. No sufficient data were available on micro- and macrovascular late complications. Due to a lack of data, also no conclusion can be drawn on the combination with a long-acting insulin.
No conclusion on added benefit can be drawn for two further research questions
Dulaglutide was to be compared with a sulfonylurea for monotherapy of patients in whom diet and exercise alone do not provide adequate glycaemic control. In its dossier, the manufacturer presented no data that were relevant for this research question so that the advantages and disadvantages of the treatments could not be compared.
For the combination of dulaglutide with two oral antidiabetics, the manufacturer conducted an indirect comparison between dulaglutide, metformin and glimepiride on one side, and a combination of metformin and human insulin on the other side. However, the two studies it used for this comparison differed so greatly regarding the common comparator and the study populations that no conclusion on an added benefit of the dulaglutide combination could be derived from it.
Hence a hint of a minor added benefit of the new drug in combination with short-acting insulin remains.
G-BA decides on the extent of added benefit
This dossier assessment is part of the early benefit assessment according to the Act on the Reform of the Market for Medicinal Products (AMNOG) supervised by the Federal Joint Committee (G-BA). After publication of the dossier assessment, the G-BA conducts a commenting procedure and makes a final decision on the extent of the added benefit.
INFORMATION:
An overview of the results of IQWiG's benefit assessment is given by a German-language executive summary. In addition, the Website gesundheitsinformation.de, published by IQWiG, provides easily understandable German-language Information.
More English-language information will be available soon (Sections 2.1 to 2.6 of the dossier assessment as well as subsequently published health information on informedhealthonline.org). If you would like to be informed when these documents are available, please send an e-mail to » info@iqwig.de.
The G-BA website contains both general English-language information on benefit assessment pursuant to §35a Social Code Book (SGB) V and specific German-language information on the assessment of dulaglutide.
Studies have long associated low-income areas with poor oral health. But dental researchers at Case Western Reserve University and University of Washington sensed that other factors related to income may be at work -- in particular, education level.
So they recently investigated how a parent or other caregiver's education level and dental habits affect children's dental health.
With data from 423 low-income African-American kindergarteners and their caregivers from a CWRU dental school study in 2007, researchers tested the hypothesis that a caregiver's education ...
MAYWOOD, IL - Patients infected with human immunodeficiency virus (HIV) can, in rare cases, experience bleeding on the brain that causes a type of stroke called intracerebral hemorrhage.
A Loyola University Medical Center case study demonstrates that a virus called varicella-zoster can cause inflammation of blood vessels in the brain. This inflammation, known as cerebral vasculitis, can cause both hemorrhagic and non-hemorrhagic strokes.
The study by Daniel Vela Duarte MD, David Pasquale, MD, and senior author Murray Flaster, MD, PhD, was presented during a meeting of ...
Madrid, Spain - 3 May 2015: A new test has been developed to predict sudden cardiac death in hemodialysis patients in whom such forecasts were previously impossible. The novel method was presented at ICNC 12 by Dr Akiyoshi Hashimoto, a cardiologist at Sapporo Medical University in Japan. The test uses a combination of nuclear medicine, C-reactive protein and electrocardiogram (ECG).
ICNC is organised by the Nuclear Cardiology and Cardiac CT section of the European Association of Cardiovascular Imaging (EACVI), a registered branch of the European Society of Cardiology ...
HIV-1 replication requires the coordinated movement of the virus's components toward the plasma membrane of an immune cell, where the virions are assembled and ultimately released. A study in The Journal of Cell Biology reveals how a Rab protein that controls intracellular trafficking supports HIV-1 assembly by promoting high levels of an important membrane lipid.
New HIV-1 particles assemble at specialized sites in the plasma membrane that are enriched in PIP2, a phospholipid component of the membrane that recruits a viral protein called Pr55Gag (Gag) that directs HIV-1 ...
What do you think is the biggest cause of death for firefighters on duty? Well if your first thought was burns or smoke inhalation you'd be wrong! According to research published in the June edition of Vascular Medicine "since 1977, sudden cardiac death has accounted for the largest share of on-duty deaths among firefighters - surpassing burns, trauma, asphyxiation and smoke inhalation."
Although the number of deaths amongst firefighters is declining, cardiac death still counts for 42% of deaths in on-duty firefighters over the past 5 years. This is an astonishingly ...
Even non-professionals may someday be able to create high-quality video panoramas using multiple cameras with the help of an algorithm developed by a team of Disney researchers.
Their method smooths out the blurring, ghosting and other distortions that routinely occur when video feeds from unstructured camera arrays are combined to create a single panoramic video. The algorithm corrects for the apparent difference in position of an object caused by different camera angles - known as parallax - and image warping that occurs because of slight timing differences between ...
Madrid, Spain - 4 May 2015: Patients with rheumatoid arthritis are at increased risk of a surprise heart attack, according to new research presented today at ICNC 12 by Dr Adriana Puente, a cardiologist in the National Medical Centre "20 de Noviembre" ISSSTE in Mexico City, Mexico. Risk was increased even when patients had no symptoms and was independent of traditional cardiovascular risk factors such as smoking and diabetes.
Dr Puente said: "Our study suggests that one quarter of patients with rheumatoid arthritis and no symptoms of heart disease could have a heart attack ...
New research from the Canadian Healthy Infant Longitudinal Development (CHILD) study shows that exposure to outdoor air pollution during the first year of life increases the risk of developing allergies to food, mould, pets and pests.
The study, published in the journal Environmental Health Perspectives, showed that the sensitivity to allergens was associated with exposure to traffic-related air pollution during infancy.
"With the increasing rates of allergies amongst children in Canada and elsewhere, we were interested in determining if air pollution from traffic might ...
Two ocean hot spots have been found to be the potential drivers of the hottest summers on record for the Central US in 1934 and 1936. The research may also help modern forecasters predict particularly hot summers over the central United States many months out.
The unusually hot summers of 1934/36 broke heat records that still stand today. They were part of the devastating dust bowl decade in the US when massive dust storms travelled as far as New York, Boston and Atlanta and silt covered the decks of ships 450km off the east coast.
Research by Dr Markus Donat from the ...
Doping is damaging the image of sport without benefitting athletes' results, according to University of Adelaide research.
Researchers from the University's School of Medical Sciences collated sporting records (including Olympic and world records) of male and female athletes across 26 sports, between 1886 and 2012. Comparisons were made between pre-1932 records (when steroids became available) and post, and it was found that the times, distances and other results did not improve as expected in the doping era.
The findings were published in the Journal of Human Sport ...
