A post-hoc analysis of two Phase III trials for Emend (aprepitant) presented last Saturday at the 26th Annual San Antonio Breast Cancer Symposium showed that treatment with Emend in combination with a 5-HT3 receptor antagonist and a corticosteroid ("regimen with Emend") significantly improved emetic control in both genders and was generally well tolerated compared to a 5-HT3 receptor antagonist and a corticosteroid alone ("control regimen"). Although women generally experience more nausea and vomiting after undergoing chemotherapy, women have not responded as well as men have to antiemetic therapies in large, randomized studies using highly emetogenic chemotherapy (chemotherapy that causes most patients to vomit if they do not receive anti-vomiting medicines prior to treatment).
In addition, the analysis showed that Emend in combination with standard antiemetics provided similar efficacy for both women and men, in both the acute (day one) and delayed (days two through five) phases of nausea and vomiting.
"In this analysis, with the addition of Emend, we saw equal protection from nausea and vomiting in both women and men," said Richard J. Gralla, M.D., President, Multinational Association of Supportive Care in Cancer (MASCC). "This is the first study to demonstrate equal protection from nausea and vomiting in both genders."
The multi-center, randomized, double-blind, placebo-controlled clinical trials evaluated 1,043 patients (435 female; 608 male) who were randomly assigned to one of two treatment groups: a control regimen or a regimen with Emend. Patients were asked to record episodes of nausea and vomiting in a diary, and the primary endpoint was complete response (no emesis and no rescue therapy for nausea or vomiting). In an analysis of the combined study data for each gender, the percentage of patients with overall complete response (days 1-5) was significantly higher in the group receiving the regimen including Emend than in the control regimen group (66 per cent versus 41 per cent for women and 69 per cent versus 53 per cent for men). The rates of control in this analysis of complete response were nearly identical for men and women receiving the regimen with Emend.
In separate comparisons for complete response on day 1 (acute emesis) and during days 2-5 (delayed emesis), similar superiority was observed with the regimen including Emend in both genders (acute phase: 86 per cent versus 66 per cent for women and 87 per cent versus 80 per cent for men; delayed phase: 76 per cent versus 47 per cent for women and 77 per cent versus 58 per cent for men). In an analysis of each study separately, the trend of the treatment effect is the same in both Phase III studies.
The regimen with Emend was generally well tolerated, with a side effect profile similar to the control group.
Emend is approved in the United States for use in combination with other anti-vomiting medicines for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy, including high-dose cisplatin. Emend is an oral capsule that is taken once daily for three days. The recommended dosing regimen is Emend 125mg orally one hour prior to chemotherapy treatment (Day 1) and 80mg once daily in the morning on Days 2 and 3. Emend may be taken with or without food. Chronic continuous use of Emend for prevention of nausea and vomiting is not recommended because it has not been studied and because the drug interaction profile may change during chronic continuous use.
Emend is an antiemetic medicine for use in adult patients. An antiemetic is a medicine used to prevent and control nausea and vomiting. Emend is always used With Other Medicines to prevent and control nausea and vomiting caused by chemotherapy treatment. Emend is not used to treat nausea and vomiting that patients already have.
Patients should tell their doctor about all their medical problems, and about all the medicines they are taking or plan to take, prescription and nonprescription medicines, vitamins, and herbal supplements. Emend may cause serious life-threatening reactions if used with certain medicines. Some medicines can affect Emend. Emend may also affect some medicines, including chemotherapy, causing them to work differently in your body. Women who use birth control pills while taking Emend should also use a backup method of contraception to avoid pregnancy.
Patients should tell their doctor if they are pregnant or plan to become pregnant, if they are breast-feeding, or if they have liver problems. It is not known if Emend passes into breast milk and if it can harm the baby.
Patients should not take Emend if they are taking any of the following medicines: Orap (pimozide), Seldane (terfenadine), Hismanal (astemizole) or Propulsid (cisapride). Taking Emend with these medicines could cause serious or life-threatening problems.
Patients should not take Emend if they are allergic to any of the ingredients in Emend. The active ingredient is aprepitant.
A patient's doctor may check to make sure their other medicines are working while they are taking Emend. Patients who take Coumadin (warfarin) may need to have blood tests after each 3-day treatment with Emend to check their blood clotting.
The overall safety of Emend was evaluated in approximately 3,300 individuals. In two well-controlled clinical studies in patients receiving highly emetogenic chemotherapy, 544 patients were treated with Emend during the first cycle of chemotherapy and 413 of those patients continued into the multiple cycle extension for up to six cycles of chemotherapy. The most common side effects with Emend are tiredness, nausea, hiccups, constipation, diarrhea, and loss of appetite. These are not all of the possible side effects of Emend.