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Jinichi Hirano,1,2 Koichiro Watanabe,3 Takefumi Suzuki,1,4 Hiroyuki Uchida,1 Ryosuke Den,5 Taishiro Kishimoto,1 Takashi Nagasawa,5 Yusuke Tomita,4 Koichiro Hara,6 Hiromi Ochi,7 Yoshimi Kobayashi,1 Mutsuko Ishii,1 Akane Fujita,1 Yoshihiko Kanai,1 Megumi Goto,1 Hiromi Hayashi,1 Kanako Inamura,1 Fumiko Ooshima,1 Mariko Sumida,1 Tomoko Ozawa,1 Kayoko Sekigawa,1 Maki Nagaoka,1 Kae Yoshimura,1 Mika Konishi,1 Ataru Inagaki,1 Takuya Saito,8 Nobutaka Motohashi,9 Masaru Mimura,1 Yoshiro Okubo,8 Motoichiro Kato,11Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan; 2Ohizumi Hospital, Tokyo, Japan; 3Department of Psychiatry School of Medicine, Kyorin University, Tokyo, Japan; 4Inokashira Hospital, Tokyo, Japan; 5Komagino Hospital, Tokyo, Japan; 6Asai Hospital, Chiba, Japan; 7Kurumegaoka Hospital, Tokyo, Japan; 8Department of Psychiatry School of Medicine, Nippon Medical School, Tokyo, Japan; 9Department of Psychiatry, School of Medicine, University of Yamanashi, Yamanashi, JapanObjective: The use of an algorithm may facilitate measurement-based treatment and result in more rational therapy. We conducted a 1-year, open-label study to compare various outcomes of algorithm-based treatment (ALGO) for schizophrenia versus treatment-as-usual (TAU), for which evidence has been very scarce.Methods: In ALGO, patients with schizophrenia (Diagnostic and Statistical Manual of Mental Disorders, fourth edition) were treated with an algorithm consisting of a series of antipsychotic monotherapies that was guided by the total scores in the positive and negative syndrome scale (PANSS). When posttreatment PANSS total scores were above 70% of those at baseline in the first and second stages, or above 80% in the 3rd stage, patients proceeded to the next treatment stage with different antipsychotics. In contrast, TAU represented the best clinical judgment by treating psychiatrists.Results: Forty-two patients (21 females, 39.0 ± 10.9 years-old) participated in this study. The baseline PANSS total score indicated the presence of severe psychopathology and was significantly higher in the ALGO group (n = 25; 106.9 ± 20.0) than in the TAU group (n = 17; 92.2 ± 18.3) (P = 0.021). As a result of treatment, there were no significant differences in the PANSS reduction rates, premature attrition rates, as well as in a variety of other clinical measures between the groups. Despite an effort to make each group unique in pharmacologic treatment, it was found that pharmacotherapy in the TAU group eventually became similar in quality to that of the ALGO group.Conclusion: While the results need to be carefully interpreted in light of a hard-to-distinguish treatment manner between the two groups and more studies are necessary, algorithm-based antipsychotic treatments for schizophrenia compared well to treatment-as-usual in this study.Keywords: algorithm, open-label clinical trial, measurement-based treatment, schizophrenia, treatment-as-usual

Hiroyuki Kawaji,1 Masaji Ishii,1 Yasunobu Tamaki,1 Kan Sasaki,2 Michiaki Takagi,21Department of Orthopaedic Surgery, Saiseikai Yamagata Saisei Hospital, 2Department of Orthopaedic Surgery, Yamagata University Faculty of Medicine, Yamagata, JapanAbstract: Fatal pulmonary thromboembolism is the most serious complication following surgery. Patients undergoing major orthopedic surgeries, including total hip replacement, total knee replacement, and hip fracture surgery, represent a group at particularly high risk of venous thromboembolism. Therefore, prophylaxis for thromboembolic events has been of great concern to surgeons. Edoxaban is a novel, orally available, and highly specific and direct factor Xa inhibitor. This new agent was approved for the prevention of venous thromboembolism in patients undergoing major orthopedic surgery, including total hip replacement, total knee replacement, and hip fracture surgery, by the Japanese Ministry of Health, Labor, and Welfare in 2011. Preclinical and Phase I clinical trials demonstrated several promising properties. Its rapid absorption and short life-time in blood are known. Edoxaban inhibits factor Xa activity directly and selectively. It also has a strong antithrombotic effect without any influence of food intake. Coagulation monitoring is not required. Edoxaban has predictable linear pharmacokinetic and pharmacodynamic profiles. Phase II and III clinical trials have been completed to examine its efficacy and safety in patients undergoing major orthopedic surgery. In these clinical trials, oral administration of edoxaban showed efficacy superior to that of oral placebo or subcutaneously administered dalteparin or enoxaparin. Edoxaban can be regarded as a first choice to prevent venous thromboembolism after major orthopedic surgery.Keywords: edoxaban, thromboprophylaxis, venous thromboembolism, total hip replacement, total knee replacement, hip fracture surgery