![]() ![]() The drugs of interest in the current review were the second-generation AHs that were available or expected to be available in Japan. ![]() Relevant studies were selected from the existing database collated in the previous literature reviews, , as well as newly identified studies. ![]() The data used for the PIR calculation were extracted from the studies previously reviewed by Shamsi & Hindmarch (2000) and McDonald et al (2008), together with those published after their reviews, if any. The aim of the current review was to assess the cognitive and psychomotor function potential of second-generation AHs marketed in Japan using the PIRs and their 95% CIs. The larger the sample size of the test results, the narrower the CI around the PIR, i.e., the more reliable or precise the estimation. Interval estimates, such as 95% CIs, expand on point estimates by incorporating the uncertainty of the point estimates. In order to reduce the uncertainty inherent in comparing PIRs derived from databases of different sizes and especially when only a small number of test results are available, a 95% confidence interval (CI) was used. This point estimate does not differentiate between a more reliable PIR derived from 100 test results or that calculated from a database of only 10 test results. In all previous reviews using the PIR, , the calculated value of PIR was a point estimate - a single number, without any indication of the reliability of the estimate. However, not all second-generation drugs were found to be totally free from cognitive and psychomotor effects and there are inter-drug differences in the extent to which essential intellectual and behavioural activities are disturbed. In the previous reviews, the calculated PIRs demonstrated much greater psychometric impairment with first-generation than with second-generation AHs. The greater the PIR, the greater are the impairments associated with the use of that AH. The PIR is a calculation technique adapted from that used in pharmacovigilance and shows whether the use of an AH is associated with psychomotor impairment and, if so, the extent of that impairment when compared to the effects of other AHs. In reviews of the literature, , the untoward effects of AHs were ranked using a proportional impairment ratio (PIR). Second-generation AHs are generally considered to have a lower potential for H 1 receptor occupancy in the brain compared to the older, first-generation medications however, there are differences among the second-generation drugs in the degree to which an administered drug passes through the blood-brain barrier and causes cognitive and psychomotor impairment. AHs that cross the blood-brain barrier and bind to H 1 receptors in the brain suppress central nervous system (CNS) arousal and disrupt circadian sleep-wake rhythmicity, thus impairing both cognitive function and psychomotor performance, including attention, memory, sensorimotor coordination, information processing, and psychomotor performance. The treatment effects of AHs are primarily due to antagonism of histamine-1 receptors (H 1 receptors) in targeted tissues. Although most of these medications still require a prescription, some of them have recently been made available over the counter. In Japan, a number of the newer, so-called second-generation, AHs have been launched on the market, as in other countries. This does not alter the authors' adherence to all the PLOS ONE policies on sharing data and materials.Īntihistamines (AHs), especially newer oral AHs, are the most widely used therapeutic option to manage allergic diseases such as allergic rhinitis, urticaria, and other allergic skin disorders. AM and KI are employees of CLINICAL STUDY SUPPORT, Inc. The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.Ĭompeting interests: TI and NK are founders of CLINICAL STUDY SUPPORT, Inc. for data collection and analysis as well as reporting. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.įunding: CLINICAL STUDY SUPPORT, Inc., which some authors belong to, was funded by Sanofi.K.K. Received: JAccepted: NovemPublished: December 12, 2014Ĭopyright: © 2014 Isomura et al. PLoS ONE 9(12):Įditor: Roland Seifert, Medical School of Hannover, Germany (2014) Central Nervous System Effects of the Second-Generation Antihistamines Marketed in Japan -Review of Inter-Drug Differences Using the Proportional Impairment Ratio (PIR). Citation: Isomura T, Kono T, Hindmarch I, Kikuchi N, Murakami A, Inuzuka K, et al. ![]()
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