In a large and comprehensive cohort of persons in placebo-controlled trials of rFVIIa, treatment with high doses of rFVIIa on an off-label basis significantly increased the risk of arterial but not venous thromboembolic events, especially among the elderly. (Funded by Novo Nordisk.).

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Patients with MDD responded well to long-term treatment with either escitalopram or citalopram. This study demonstrated the importance of extending treatment of depression beyond 8 weeks.

Background: Alzheimer’s disease (AD) is a progressive neurodegenerative disorder and delaying disease worsening is a relevant treatment outcome. Methods: Data from 6 randomized, double-blind, placebo-controlled, 6-month studies were pooled and a subgroup of patients (867 on placebo, 959 on memantine) with moderate to severe AD (Mini- Mental State Examination <20) was analyzed. ‘Any clinical worsening’ was defined as a decline on the Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-cog) or the Severe Impairment Battery (SIB) and on the Clinician’s Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) and the Alzheimer’s Disease Cooperative Study – Activities of Daily Living Inventory (ADCS-ADL), and ‘marked clinical worsening’ as ≧4 points decline on the ADAS-cog or ≧5 points on the SIB and decline on the CIBIC-plus and the ADCS-ADL. Results: More placebo-treated than memantine-treated patients showed any clinical worsening (28 vs. 18%; p < 0.001), and 21% placebo-treated patients compared to 11% memantine-treated patients had marked clinical worsening (p < 0.001). Conclusion: In this population of moderate and severe AD patients, treatment with memantine was associated with reducing worsening of clinical symptoms in AD during the 6-month study period.

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Escitalopram is the S-enantiomer of citalopram. In this study, we compared the efficacy of equivalent dosages of escitalopram and citalopram in the treatment of moderate to severe major depressive disorder (MDD), based on data from two, pooled, randomized, double-blind, placebo-controlled studies of escitalopram in which citalopram was the active reference. The primary efficacy parameter was the mean change from baseline in the Montgomery Asberg Depression Rating Scale (MADRS) total score. Significant differences in favour of escitalopram were observed for the MADRS [P<0.05, observed cases (OC)/last observation carried forward (LOCF)] and Clinical Global Improvement-Severity of Illness scores (CGI-S; P<0.05, OC/LOCF). Escitalopram separated from placebo at week 1 on the primary efficacy parameter, whereas citalopram first separated from placebo at week 6. An analysis of time to response showed that escitalopram-treated patients responded significantly faster to treatment than citalopram-treated patients (P<0.01). More patients responded to and achieved remission with escitalopram than to citalopram (P<0.05, OC). The HAMD scale was only used in the fixed-dose study, where escitalopram-treated patients had a significant reduction in HAMD-17 total score at week 8 compared to citalopram-treated patients (P<0.05, OC/LOCF). In the pooled subpopulation of severely ill patients (MADRS> or = 30), escitalopram-treated patients showed greater improvement than citalopram-treated patients (P<0.05, LOCF/OC). Escitalopram showed consistently superior efficacy compared to citalopram in the treatment of moderate to severe MDD on all efficacy parameters, and was similarly well tolerated.