Pradaxa（达比加群酯）EPAR 评估报告更新至第 47 版，2008 年 3 月 17 日获批状态维持

Pradaxa is taken by mouth and is available as capsules for adults and children above 8 years of age. It is also available as granules for use in children below 12 years of age from the time they are able to swallow soft food. Pradaxa can only be obtained with a prescription.

The dose and duration of treatment depend on the condition Pradaxa is being used to treat, the patients age and kidney function, and other medicines the patient is taking. For children, the dose also depends on their weight.

All patients at increased risk of bleeding should be monitored closely and the doctor may reduce the dose of Pradaxa.

In all patients, kidney function should also be assessed before starting treatment to exclude patients with severely reduced kidney function, and should be re-assessed during treatment if any worsening is suspected. When Pradaxa is used long term in patients with non-valvular atrial fibrillation, or when it is used in patients with DVT or PE, kidney function should be assessed at least once a year if their kidney function is mildly to moderately reduced or if they are over 75 years old.

For more information about using Pradaxa, see the package leaflet or contact your doctor or pharmacist.

Prevention of blood clots after hip or knee replacement

Pradaxa (220 or 150 mg a day) was as effective as enoxaparin (an anticoagulant given by injection) in preventing formation of blood clots or death in patients who had undergone hip or knee replacement in two main studies.

The first study involved a total of 2,101 patients who had had a knee replacement operation. During the treatment period, blood clots were detected in 36% of the patients taking 220 mg Pradaxa (183 out of 503), compared with 38% of the patients receiving enoxaparin (193 out of 512). There was one death in each group (less than 1%).

The second study involved a total of 3,494 patients who had had a hip replacement. During the treatment period, blood clots were detected in 6% of the patients taking 220 mg Pradaxa (53 out of 880), compared with 7% of the patients receiving enoxaparin (60 out of 897). Three patients in the Pradaxa group died (less than 1%), but two of these deaths were unrelated to blood clots.

In both studies, there was some evidence that a 220 mg dose of Pradaxa may be more effective than a 150 mg dose.

Prevention of blood clots or stroke in patients at risk of stroke

Pradaxa (110 mg or 150 mg twice a day) was as effective as warfarin (another anticoagulant given by mouth) in preventing stroke or a blood clot blocking blood vessels in a study involving patients with non-valvular atrial fibrillation who were considered to be at risk of stroke.

In the study around 18,000 adults were treated for one to three years. The proportion of patients who had a stroke or other problems caused by blood clots each year was around 1.5% for patients taking 110 mg Pradaxa (183 patients out of 6,015) and 1.1% for patients taking 150 mg Pradaxa (135 out of 6,076), compared with 1.7% for patients taking warfarin (203 out of 6,022).

Treatment and prevention of DVT and PE

Pradaxa was as effective as warfarin in reducing the formation of blood clots in the veins (DVT) or lungs (PE), or death from a blood clot during treatment.

Two main studies in over 5,100 adults with symptoms of DVT or PE, and who were initially treated with an injectable anticoagulant, compared Pradaxa with warfarin. Blood clots or death from a blood clot occurred in 2.7% (68 out of 2,553) of patients treated with Pradaxa, compared with 2.4% (62 out of 2,554) of patients treated with warfarin.

Another two studies looked at the prevention of DVT or PE in around 4,200 adults with symptoms of recurring blood clots and who were on long-term treatment with anticoagulants. One of these studies

compared Pradaxa with warfarin and the other compared Pradaxa with placebo (a dummy treatment). In the first study, blood clots or death due to a blood clot occurred in 1.8% (26 out of 1,430) of patients treated with Pradaxa, compared with 1.3% (18 out of 1,426) of patients treated with warfarin. In the second study, blood clots or death due to a blood clot occurred in 0.4% (3 out of 681) of patients treated with Pradaxa, compared with 5.6% (37 out of 662) of patients treated with placebo.

In a study in 267 children with confirmed DVT or PE aged from birth to 18 years of age, Pradaxa was compared with standard of care. Treatment with Pradaxa resolved blood clots in 46% of patients compared with 42% of patients treated with standard of care. Blood clots did not reoccur in 96% of patients taking Pradaxa compared with 92% of patients treated with standard of care.