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.