A Phase 3, randomized, double-blind study of single-dose fosaprepitant for prevention of cisplatin-induced nausea and vomiting: Results of an Indian population subanalysis.

Context: Currently, there is limited data on the prevention of chemotherapy-induced nausea and vomiting (CINV) in Indian patients. Aims: This post hoc study assessed the efficacy and safety of fosaprepitant compared with aprepitant for prevention of CINV in the Indian population. A subgroup analysis was performed from data collected in a phase 3 study of intravenous (IV) fosaprepitant or oral aprepitant, plus the 5-HT 3 antagonist ondansetron and the corticosteroid dexamethasone, in cisplatin-naοve patients with solid malignancies. Materials and Methods: Patients scheduled to receive cisplatin (≥70 mg/m 2 ) were administered a single IV dose of fosaprepitant dimeglumine (150 mg) on day 1 or a 3-day dosing regimen of oral aprepitant (day 1:125 mg, days 2 and 3:80 mg) with standard doses of ondansetron and dexamethasone. Patients recorded nausea and/or vomiting episodes and their use of rescue medication and were monitored for adverse events (AEs) and tolerability. Statistical Analysis Used: Differences in response rates between fosaprepitant and aprepitant were calculated using the Miettinen and Nurminen method. Results: In the Indian subpopulation (n = 372), efficacy was similar for patients in both the fosaprepitant or aprepitant groups; complete response in the overall, acute, and delayed phases and no vomiting in all phases were approximately 4 percentage points higher in the fosaprepitant group compared with the aprepitant group. Fosaprepitant was generally well-tolerated; common AEs were similar to oral aprepitant. Conclusions: IV fosaprepitant is as safe and effective as oral aprepitant in the Indian subpopulation and offers an alternative to the oral formulation.

Cerebral venous thrombosis in pregnancy and puerperium--a prospective study.

During a prospective study of cerebrovascular accidents we evaluated 64 cases of cerebral venous thrombosis (CVT) in pregnancy and puerperium. CVT made up approximately half of the young strokes and 40% of strokes occurring in females. Majority of them were below 25 years of age, multipara women from rural areas who were delivered at home by untrained dais. While 79.6% cases occurred during first two weeks after delivery, the incidence of antepartum CVT was also higher at 7.8%. Majority of the patients had meningoencephalitic (70.32%) presentation. Others in the spectrum had either acute fulminant type (18.7%), neuropsychiatric (6.25%) or pseudotumour cerebri like presentation (4.68%). Patients with neuropsychiatric and pseudotumour cerebri like presentation had a better prognosis while those with acute fulminant type had a poorer outcome. The patients with bilateral hemorrhagic infarcts and diffuse cerebral edema on CT scan had a poorer prognosis. A lower mortality rate (18.75%) could be achieved with early diagnosis and quick institution of planned therapy.