title: [Comparative study of the time period between the initiation of various interferon therapies and the onset of suicide- or diabetes-related side effect].
abstract: To compare the safety profiles of the various interferon (IFN) therapies, the time period between the initiation of IFN therapy and the onset of suicide- or diabetes-related side effects and clinical outcomes was extracted from open-source data obtained from spontaneous reports published on the homepage of the Pharmaceutical and Medical Devices Agency on October 18, 2012. The analysis of the time period between the initiation of therapy and the onset of diabetes-related side effects in 114 cases showed that the period of the group treated with IFN-alpha (median 0.78 years, interquartile range 0.44-1.19) was significantly longer than those of the IFN-beta group (0.12, 0.04-0.48) and the pegylated IFN group (0.48, 0.27-0.76) (P < 0.05). In the case of suicide-related side effects, the analysis of 68 cases showed that the time period did not differ significantly between the IFN-alpha group (0.09 years, 0.05-0.49) and the IFN-beta group (0.31, 0.11-0.65) , but was significantly shorter than that of the pegylated IFN group (0.32, 0.18-0.58) (P < 0.05). In clinical outcomes, the percentage of deaths was 56% (10/18) in the IFN-alpha group, 7% (1/14) in the INF-beta group, and 29% (9/31) in the pegylated IFN group. These results suggested that the side-effect profiles differed among the various IFNs.
authors: Division of Biological Chemistry and Biologicals, National Institute of Health Sciences, 1-18-1 Kamiyoga, Setagaya-ku, Tokyo 158-8501. kobayash@nihs.go.jp
authors: Tetsu
authors: T
authors: Kobayashi
mesh_terms: D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D062313:Databases, Pharmaceutical; D003920:Diabetes Mellitus / Q000139:chemically induced* / Q000453:epidemiology; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects*; D016899:Interferon-beta / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000009:adverse effects; D011994:Recombinant Proteins / Q000009:adverse effects; D012254:Ribavirin / Q000009:adverse effects; D013405:Suicide / Q000706:statistics & numerical data*; D013997:Time Factors; D055815:Young Adult
chemical_list: D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; D016899:Interferon-beta; C417083:peginterferon alfa-2b