title: Risk of cardiovascular morbidity with risperidone or paliperidone treatment: analysis of 64 randomized, double-blind trials.
abstract: A post hoc analysis of the risperidone (RIS)/paliperidone (Pali) clinical trials database comprising 64 studies was conducted. Risk of sudden death, cardiovascular (CV), and cerebrovascular events during RIS or Pali treatment was estimated. Treatment emergent CV adverse events were identified using 7 prespecified Standardised MedDRA Queries as follows: embolic/thrombotic events, cerebrovascular disorders, ischemic heart disease, cardiac arrhythmias, cardiac failure, torsades/QT prolongation, and convulsions. Risk in the RIS/Pali pooled group was significantly increased compared to placebo for the following adverse events: syncope, tachycardia, palpitations, edema peripheral, dysarthria, and transient ischemic attack. Incidence of death related to CV events was low and similar across groups. Consistent with the known pharmacologic profile and product information, this analysis of treatment emergent adverse event data from a large, randomized, controlled clinical trials database described increased risk versus placebo for several specific CV events. Apart from events described in existing product labeling, no new safety findings emerged.
authors: Johnson & Johnson Pharmaceutical Research & Development, LLC, Raritan, NJ, USA. sgopal2@its.jnj.com
authors: Srihari
authors: S
authors: Gopal
authors: David
authors: D
authors: Hough
authors: Keith
authors: K
authors: Karcher
authors: Isaac
authors: I
authors: Nuamah
authors: Joseph
authors: J
authors: Palumbo
authors: Jesse A
authors: JA
authors: Berlin
authors: Alan
authors: A
authors: Baseman
authors: Yimei
authors: Y
authors: Xu
authors: Justine
authors: J
authors: Kent
mesh_terms: D014150:Antipsychotic Agents / Q000009:adverse effects*; D002318:Cardiovascular Diseases / Q000139:chemically induced* / Q000453:epidemiology / Q000503:physiopathology; D016208:Databases, Factual; D004348:Drug Labeling; D006801:Humans; D015994:Incidence; D007555:Isoxazoles / Q000009:adverse effects*; D000068882:Paliperidone Palmitate; D011743:Pyrimidines / Q000009:adverse effects*; D016032:Randomized Controlled Trials as Topic; D012306:Risk; D018967:Risperidone / Q000009:adverse effects*
chemical_list: D014150:Antipsychotic Agents; D007555:Isoxazoles; D011743:Pyrimidines; D018967:Risperidone; D000068882:Paliperidone Palmitate