Abnormal Blood Vessels (Arteriovenous Malformations)

March 14, 2016

University of Bern and Roche issued positive results of a phase II study of tocilizumab for induction and maintenance of remission in giant cell arteritis. The single center, randomized, double-blind, placebo-controlled trial enrolled patients aged 50 years and older. Patients with new-onset or relapsing disease were randomly assigned (2:1) to receive either tocilizumab (8mg/kg) or placebo intravenously. Thirteen infusions were given in four-week intervals until week 52. Both groups received oral prednisolone, starting at 1mg/kg per day and tapered down to 0mg according to a standard reduction scheme defined in the study protocol. Between March 3, 2012, and Sept. 9, 2014, 20 patients were randomly assigned to receive tocilizumab and prednisolone, and 10 patients to receive placebo and glucocorticoid; 16 (80%) and seven (70%) patients, respectively, had new-onset giant cell arteritis. 17 (85%) of 20 patients given tocilizumab and four (40%) of 10 patients given placebo reached complete remission by week 12 (risk difference 45%, 95% CI 11–79; p=0.0301). Relapse-free survival was achieved in 17 (85%) patients in the tocilizumab group and two (20%) in the placebo group by week 52 (risk difference 65%, 95% CI 36–94; p=0.0010). The mean survival-time difference to stop glucocorticoids was 12 weeks in favour of tocilizumab (95% CI 7–17; p<0.0001), leading to a cumulative prednisolone dose of 43mg/kg in the tocilizumab group versus 110mg/kg in the placebo group (p=0.0005) after 52 weeks. Seven (35%) patients in the tocilizumab group and five (50%) in the placebo group had serious adverse events.

March 4, 2013

Boehringer Ingelheim published results from a phase II trial of dabigatran compared to warfarin for the treatment of venous thromboembolism (VTE) in the New England Journal of Medicine. This randomized study, RE-MEDY, enrolled 2,856 patients with recurrent VTE. Subjects received dabigatran 150mg twice daily or warfarin for six to 36 months. Data demonstrated that dabigatran 150mg was non-inferior to warfarin in preventing recurrent VTE, including VTE-related death (26 patients,1.8% versus 18 patients, 1.3%, respectively; p=0.01). In addition, there were fewer major bleeding events in patients with a prior history of VTE receiving dabigatran compared with those receiving warfarin. There also was a significantly lower risk (46%; p<0.001) of major or clinically relevant bleeding events in this same set of patients. The drug was well tolerated. Boehringer Ingelheim did not note its plans for dabigatran.

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