Introduction

Apixaban (trade name: Eliquis) has been approved in Germany for the treatment of deep vein thrombosis or lung embolism in adults since July 2014. The drug can also be used in a low dose to prevent further thromboses or lung embolisms.

Deep vein thrombosis or lung embolism develops when a vital blood vessel is clogged by a blood clot (thrombus) for a long period of time. One reason these blood clots develop is that people do not move their legs enough over a long period of time – perhaps because they have had major surgery, or have a serious illness or injury.

Most blood clots are broken down by the body fast enough to not cause any symptoms. However, a blood clot can also be carried away in the blood and clog a blood vessel somewhere else in the body. If a blood clot forms in a vein it is called venous thrombosis. Venous thrombosis usually affects the veins in the legs. If a blood clot reaches the lungs, it can cause a life threatening lung embolism.

Apixaban reduces blood clotting in order to prevent vein thromboses or lung embolisms.

Application

When treating acute vein thrombosis or pulmonary embolism, a dose of 10 mg of apixaban is taken twice a day. The dose is then decreased to 5 mg twice a day after seven days. Treatment can be continued for up to six months. If treatment is continued for long-term prevention, a dose of 2.5 mg of apixaban is taken twice a day.

Other treatments

Vitamin K antagonists (such as phenprocoumon or warfarin) are the standard therapy options. Because it takes a number of days for these drugs to have an effect, heparin (such as enoxaparin) is also used when starting treatment.

Assessment

In late 2014, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of apixaban for people with acute vein thrombosis or pulmonary embolism compared to other standard therapies.

The manufacturer did not provide any suitable data regarding long-term prevention.

The following results therefore only apply to patients with acute vein thrombosis or pulmonary embolism whose treatment lasted no longer than six months. Half of the participants were given apixaban, the other half warfarin (combined with enoxaparin at the beginning of treatment). The data suggest that the various advantages and disadvantages of apixaban depend on the patient's body mass index (BMI).

What are the advantages of apixaban? 

  • Serious bleeding: Apixaban proved to have an advantage here. About 18 out of 1,000 people who were treated with enoxaparin / warfarin had serious bleeding. Bleeding is considered to be serious if it requires special treatment such as a blood transfusion. 6 out of 1,000 people treated with apixaban had serious bleeding as a side effect.
  • Minor bleeding: Apixaban proved to have an advantage here too. Overall, about 80 out of 1,000 people treated with enoxaparin / warfarin had less serious bleeding which usually did not require any special treatment. 38 out of 1,000 people who were treated with apixaban had minor bleeding as a side effect.
  • Deep vein thrombosis: Results indicated an advantage of treatment with apixaban for people with a BMI of over 28. Deep vein thromboses were less common in this group during treatment with apixaban than in people taking enoxaparin / warfarin. Out of 1,000 people with a BMI of over 28 who took apixaban, about 7 had a deep vein thrombosis. Around 17 out of 1,000 people who were treated with enoxaparin / warfarin were affected. There was no difference between treatments for patients with a BMI of under 28

What are the disadvantages of apixaban?

  • Pulmonary embolism: BMI seems to have an impact here as well. No difference was found between treatments in patients with a BMI of over 28. However, there was an indication that people with a BMI of under 28 had a disadvantage. In this group, pulmonary embolisms developed more frequently during treatment with apixaban than in people who took enoxaparin / warfarin. Out of 1,000 people with a BMI of under 28 who took apixaban, about 14 had a pulmonary embolism. Around 4 out of 1,000 people treated with enoxaparin / warfarin were affected.

Where was there no difference?

  • Life expectancy: In both groups, around 20 out of 1,000 people died. There was no discernible difference.
  • Severe side effects: In both groups, around 120 to 130 out of 1,000 patients developed serious side effects such as a respiratory or vascular disease, or an infection.
  • Termination of treatment due to side effects: There was no discernible difference here either. In both groups, around 40 out of 1,000 people terminated their treatment because of side effects such as gastrointestinal disorders, infections or headaches.

What remains unanswered?

  • Quality of life: The manufacturer did not provide any data regarding quality of life.
  • Long-term prevention: It is unclear what advantages and disadvantages apixaban has if treatment lasts longer than 6 months.

More information

This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the "early benefit assessment of medications." On the basis of this review and the hearings received, G-BA passed a resolution on the added benefit of apixaban (Eliquis).

The next time we check whether this information is still up-to-date will be during the update of our "In Brief" What is anti-clotting medication and how is it used safely?

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