齐拉西酮的药理机制与临床实践200809-培训课件.pptVIP

* * An important consideration with any medication is the adverse event profile. In schizophrenia studies, the most common adverse events associated with ziprasidone that occurred at an incidence twice that of placebo were somnolence and respiratory tract infection. In the pooled bipolar mania studies, the most common adverse events associated with ziprasidone that occurred at an incidence twice that of placebo were akathisia, somnolence, dizziness, hypertonia, and EPS. In the package insert, EPS is represented as an incidence of 31% in ziprasidone and 12% in?placebo in the bipolar mania trials, and 14% in ziprasidone and 8% in placebo in the schizophrenia trials; this is because it is an aggregate of EPS, hypertonia, dystonia, dyskinesia, hypokinesia, tremor, paralysis, and twitching. None of these adverse events occurred individually at an incidence greater than 10% in bipolar mania trials and greater than?5% in schizophrenia trials.1 Additional Information1: Schizophrenia Approximately 4.1% of ziprasidone-treated patients in short-term, placebo-controlled studies discontinued treatment due to an adverse event, compared with about 2.2% on placebo. The most common event associated with dropout was rash, including 7 dropouts for rash among ziprasidone patients (1%) compared with none for placebo patients Bipolar Mania Approximately 6.5% of ziprasidone-treated patients in short-term, placebo-controlled studies discontinued treatment due to an adverse event, compared with about 3.7% on placebo. The most common events associated with dropout in the ziprasidone-treated patients were akathisia, anxiety, depression, dizziness, dystonia, rash, and vomiting, with 2 dropouts for each of these events among ziprasidone patients (1%), compared with 1 placebo patient each for dystonia and rash (1%) and no placebo patients for the remaining adverse events Data on file. Pfizer Inc, New York, NY. * * As was noted on the previous slide, somnolence was the number 1 reported adv