Proof of added benefit of apixaban in hip replacement
September 17, 2012 in Medications
The clot-inhibiting drug apixaban (trade name: Eliquis) was approved in May 2011 for the prevention of thrombosis (blood clots) after operations to replace a hip or knee joint. In an early benefit assessment pursuant to the "Act on the Reform of the Market for Medicinal Products" (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined the added benefit of apixaban.
IQWiG found proof of minor added benefit for adult patients who had undergone hip replacement: symptomatic clots in the deep veins of the leg occurred less frequently with apixaban treatment than with the comparator therapy.
Symptomatic clots in the deep leg veins also occurred less frequently with apixaban treatment in adults after knee replacement. However participants in the studies suffered clots in the lungs (pulmonary embolisms) more often under treatment with apixaban than the comparator group. From weighing up the benefits and harms (risk of side effects) on the basis of the data presented in the manufacturer's dossier, IQWiG identified no proof of added benefit of apixaban over the appropriate comparator therapy in knee replacement operations.
Enoxaparin as comparator therapy
After the insertion of an artificial hip or knee, there is an increased risk of blood clots (thrombi) that are swept away in the bloodstream and can block a blood vessel in another part of the body. Clots that cause symptoms (symptomatic thromboembolism) may, for instance, occur in the lungs and deep veins of the legs.
Apixaban is approved for the prevention of venous thromboembolism (VTE) in adults following hip or knee replacement surgery. The Federal Joint Committee (G-BA) specified low molecular weight heparins (clot inhibitors), which are approved for the prevention of deep vein thrombosis, as the appropriate comparator therapy. The comparison between apixaban and the drug enoxaparin chosen by the manufacturer in its dossier corresponds to this definition.
Added benefit offset by lesser benefit in knee replacement surgery
Deaths were generally rare in both the relevant studies and mortality with apixaban treatment in hip or knee replacement operations did not differ from that with enoxaparin. With both types of surgery, the incidence of bleeding or other side effects and study withdrawals was also no greater under apixaban than under the comparator therapy. Neither of the relevant studies examined the quality of life.
Both studies showed that apixaban was more effective in preventing symptomatic deep vein thrombosis than the comparator therapy: about one in 1000 patients who took apixaban developed a symptomatic deep vein thrombosis; the figure for patients who injected enoxaparin was about 4 in 1000. A minor added benefit of apixaban is proven in this case.
In hip replacement surgery, there was no difference between the treatment groups in respect of pulmonary embolisms. However after knee replacement, these occurred more frequently under apixaban than under enoxaparin: About 5 in 1000 patients who took apixaban had a pulmonary embolism, compared to about one in 1000 under enoxaparin. This leads to an indication of a lesser benefit of apixaban compared to the comparator therapy. The extent of this lesser benefit was classified as "considerable". From weighing up the benefits and harms on the basis of the data presented in the manufacturer's dossier, IQWiG found no proof of added benefit of apixaban over the appropriate comparator therapy in knee replacement surgery.
G-BA decides on the extent of added benefit
The dossier assessment is part of the overall procedure for early benefit assessment conducted by the G-BA. After publication of the manufacturer's dossier and its assessment by IQWiG, the G-BA initiates a formal commenting procedure which provides further information and can 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.
Provided by
Institute for Quality and Efficiency in Health Care
-
Added benefit of linagliptin is not proven
Jan 06, 2012 |
not rated yet |
0
-
Belimumab for lupus erythematosus: Added benefit not proven
Aug 29, 2012 |
not rated yet |
0
-
Added benefit of fampridine is not proven
Aug 29, 2012 |
not rated yet |
0
-
Added benefit of Cannabis sativa for spasticity due to multiple sclerosis is not proven
Sep 17, 2012 |
not rated yet |
0
-
Abiraterone: Indication of considerable added benefit in certain patients
Jan 06, 2012 |
not rated yet |
0
-
Motion perception revisited: High Phi effect challenges established motion perception assumptions
Apr 23, 2013 |
3 / 5 (2) |
2
-
Anything you can do I can do better: Neuromolecular foundations of the superiority illusion (Update)
Apr 02, 2013 |
4.5 / 5 (11) |
5
-
The visual system as economist: Neural resource allocation in visual adaptation
Mar 30, 2013 |
5 / 5 (2) |
9
-
Separate lives: Neuronal and organismal lifespans decoupled
Mar 27, 2013 |
4.9 / 5 (8) |
0
-
Sizing things up: The evolutionary neurobiology of scale invariance
Feb 28, 2013 |
4.8 / 5 (10) |
14
-
Why is zone 1 in liver more prone to ischemic injury?
17 hours ago
-
How can there be villous adenoma in colon, if there are no villi there
May 22, 2013
-
How can there be a term called "intestinal metaplasia" of stomach
May 21, 2013
-
Pressure-volume curve: Elastic Recoil Pressure don't make sense
May 18, 2013
-
If you became brain-dead, would you want them to pull the plug?
May 17, 2013
-
MRI bill question
May 15, 2013
- More from Physics Forums - Medical Sciences
More news stories
Merck ends development of Parkinson's disease drug
(AP)—Merck & Co. says it is ending development of an experimental Parkinson's disease drug because the drug wasn't working.
Medications
3 hours ago |
1 / 5 (1) |
0
J&J expects 10-plus new drug applications by 2017
(AP)—Johnson & Johnson is developing what could eventually be game-changing treatments for depression and pain, and it's aiming to apply for approval of more than 10 new medicines by 2017, executives said Thursday during ...
Medications
4 hours ago |
5 / 5 (1) |
0
Experts favor US approval of Merck sleeping pill (Update)
An independent panel of experts on Wednesday recommended US approval of a new Merck sleeping pill called suvorexant, but expressed concerns over the highest dosage and risks of drowsy daytime driving.
Medications
May 22, 2013 |
not rated yet |
0
Glaxo, US partnering to develop new antibiotics
GlaxoSmithKline PLC says it's starting an unusual collaboration with the U.S. government to develop several antibiotics for both bioterrorism threats and bacterial infections resistant to current medicines.
Medications
May 22, 2013 |
not rated yet |
0
Study finds new pneumococcal vaccine appears to be as safe as previously used vaccine
The new 13-valent pneumococcal conjugate vaccine (PCV13) appears to be as safe as the previous version used prior to 2010, the 7-valent pneumococcal conjugate vaccine (PCV7), according to a Kaiser Permanente study published ...
Medications
May 22, 2013 |
not rated yet |
0
Type 2 diabetes progresses faster in kids, study finds
(HealthDay)—Type 2 diabetes is more aggressive in children than adults, with signs of serious complications seen just a few years after diagnosis, new research finds.
Controlling mood through the motions of mitochondria
(Medical Xpress)—Regulating the distribution of power in neurons is done by a system that makes the national electric grid look simple by comparison. Each neuron has several thousand mitochondria confined ...
Scientists discover molecule triggers sensation of itch
Scientists at the National Institutes of Health report they have discovered in mouse studies that a small molecule released in the spinal cord triggers a process that is later experienced in the brain as ...
Multiple research teams unable to confirm high-profile Alzheimer's study
Teams of highly respected Alzheimer's researchers failed to replicate what appeared to be breakthrough results for the treatment of this brain disease when they were published last year in the journal Science.
Researchers find common childhood asthma unconnected to allergens or inflammation
Little is known about why asthma develops, how it constricts the airway or why response to treatments varies between patients. Now, a team of researchers at Weill Cornell Medical College, Columbia University Medical Center ...
Motion quotient: IQ predicted by ability to filter motion (w/ video)
A brief visual task can predict IQ, according to a new study. This surprisingly simple exercise measures the brain's unconscious ability to filter out visual movement. The study shows that individuals whose ...