{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,22]],"date-time":"2025-10-22T00:53:51Z","timestamp":1761094431251,"version":"build-2065373602"},"reference-count":35,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2012,1,6]],"date-time":"2012-01-06T00:00:00Z","timestamp":1325808000000},"content-version":"vor","delay-in-days":127,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["accpjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacotherapy"],"published-print":{"date-parts":[[2011,9]]},"abstract":"<jats:p><jats:bold>Study Objective.<\/jats:bold> To assess the drug\u2010related risk of adverse events associated with ziprasidone.<\/jats:p><jats:p><jats:bold>Design.<\/jats:bold> Meta\u2010analysis of 19 randomized, placebo\u2010controlled trials.<\/jats:p><jats:p><jats:bold>Patients.<\/jats:bold> A total of 4132 adults taking oral ziprasidone who had adverse\u2010event data reported in the studies identified.<\/jats:p><jats:p><jats:bold>Measurements and Main Results.<\/jats:bold> A systematic review (January 1996\u2010October 2010) was conducted by using the EMBASE and MEDLINE databases to identify Cochrane reviews, controlled clinical trials, meta\u2010analyses, randomized controlled trials, and systematic reviews; studies were limited to those published in English and those conducted in humans. The <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/www.ClinicalTrials.gov\">www.ClinicalTrials.gov<\/jats:ext-link> Web site was also searched for ziprasidone studies. A total of 887 citations were reviewed; 31 articles met the criteria for inclusion, of which 19 were included in the final analysis. Data were combined for the meta\u2010analysis by using the Mantel\u2010Haenszel method, random\u2010effects model at 95% confidence. The overall rate of treatment\u2010emergent adverse events for ziprasidone was 73% compared with 60% for patients receiving placebo (p&lt;0.0001). Adverse events with the greatest frequency included somnolence (21%), extrapyramidal symptoms (13%), headache (13%), insomnia (11%) and respiratory disorders (10%). Adverse events with highest risk, evaluated by using the risk difference (RD) summary statistic (adverse events due to the drug itself and not the placebo effect), were somnolence (RD 14, 95% confidence interval [CI] 7\u201321), extrapyramidal symptoms (RD 6, 95% CI 1\u201310), asthenia (RD 5, 95% CI 1\u20138), weight gain (RD 4, 95% CI 2\u20137), dizziness (RD 4, 95% CI 2\u20136), and dyspepsia (RD 4, 95% CI 1\u20136). Adverse events reported but likely not caused by ziprasidone included headache (RD 0, 95% CI \u2212\u20133), QTc interval greater than 480 msec (RD 0, 95% CI \u22121\u20131), diarrhea (RD 0, 95% CI \u2212\u20132, and abdominal pain (RD 0, CI \u2212\u20132).<\/jats:p><jats:p><jats:bold>Conclusion.<\/jats:bold> Ziprasidone use increased the risk of 18 specific adverse events when compared with placebo. Small reductions in risk for insomnia, pain, and agitation are likely among patients with schizophrenia but not those with bipolar disorder. The results of the study are limited by the concomitant use of other drugs allowed during the trials, underreporting of adverse events in the clinical trials, and the short length of the trials (most 3\u20136 wks).<\/jats:p>","DOI":"10.1592\/phco.31.9.840","type":"journal-article","created":{"date-parts":[[2011,8,25]],"date-time":"2011-08-25T13:23:42Z","timestamp":1314278622000},"page":"840-849","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Adverse Drug Events Related to Ziprasidone: A Meta\u2010analysis of Randomized, Placebo\u2010Controlled Trials"],"prefix":"10.1002","volume":"31","author":[{"given":"Catherine A.","family":"Harrington","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Clayton","family":"English","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2012,1,6]]},"reference":[{"key":"e_1_2_1_2_2","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.v63n1007"},{"key":"e_1_2_1_3_2","first-page":"105","article-title":"Medication noncompliance in schizophrenia: codification and update","volume":"14","author":"Young JL","year":"1986","journal-title":"Bull Am Acad Psychiatry Law"},{"key":"e_1_2_1_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinthera.2009.07.004"},{"key":"e_1_2_1_5_2","doi-asserted-by":"publisher","DOI":"10.3310\/hta7130"},{"issue":"19","key":"e_1_2_1_6_2","first-page":"4","article-title":"Tolerability of ziprasidone: an expanding perspective","volume":"64","author":"Daniel DG.","year":"2003","journal-title":"J Clin Psychiatry"},{"key":"e_1_2_1_7_2","unstructured":"Forest Laboratories Inc. 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