Human medicines European public assessment report (EPAR): Emend, aprepitant, Date of authorisation: 11/11/2003, Revision: 31, Status: Authorised
Three main studies have been carried out with Emend capsules involving around 2,000 adults receiving chemotherapy. They compared the effectiveness of Emend, taken in combination with dexamethasone and ondansetron, with that of the standard combination of dexamethasone and ondansetron alone. The main measure of effectiveness was the number of patients who had no nausea and vomiting in the five days after receiving chemotherapy.
The studies showed that adding Emend to the standard combination was more effective than the standard combination alone. In two studies involving patients receiving chemotherapy including cisplatin, 68% of the patients taking Emend had no nausea or vomiting over 5 days (352 out of 520), compared with 48% of the patients who did not take it (250 out of 523). Emend was also found effective during a further five cycles of chemotherapy. In the third study in patients who received chemotherapy with cyclophosphamide, 51% of the patients taking Emend had no nausea or vomiting (220 out of 433), compared with 43% of the patients who did not take it (180 out of 424).
A fourth study was carried out in 307 children from 6 months to 17 years of age, where Emend taken with ondansetron (with or without dexamethasone) was compared with ondansetron alone (with or without dexamethasone). The main measure of effectiveness was ‘complete response’, defined as no vomiting, retching or dry heaves and no need for any other medication to control nausea and vomiting 25 to 120 hours after the start of chemotherapy. The study also looked at how many patients achieved a complete response in the first 24 hours after chemotherapy.
In this study, around 51% (77 out of 152) of children given Emend with ondansetron had a complete response 25 to 120 hours after beginning chemotherapy, compared with 26% (39 out of 150) of children given ondansetron alone. Emend was also effective in the first 24 hours after chemotherapy.
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