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Drug Safety Evaluations

Olanzapine pamoate for the treatment of schizophrenia – a safety evaluation

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Pages 403-411 | Received 11 Dec 2015, Accepted 11 Jan 2016, Published online: 19 Feb 2016
 

ABSTRACT

Introduction: Non-adherence to long-term treatment is a major issue for patients with schizophrenia and is associated with an increased risk of relapse. Long-acting injectable (LAI) antipsychotics can offer a useful option to improve adherence. Due to the type of sustained-release mechanism, olanzapine pamoate (OLAI) can differ in safety as compared with oral olanzapine. Recent safety data concerning olanzapine pamoate required an update of previous systematic reviews.

Areas covered: Safety data were found in US and EU clinical trial registries, and a literature search was undertaken using the databases PubMed and EMBASE to find all relevant published studies. Where appropriate, the number needed to harm and 95% confidence interval for categorical safety outcomes were calculated.

Expert opinion: The safety profile of OLAI was similar to the well-known safety profile of oral olanzapine, except for the risk of occurrence of post-injection delirium/sedation syndrome (PDSS). Olanzapine pamoate can be a choice for schizophrenic patients with a history of response to and acceptable tolerance of oral olanzapine, who have easy access to mental healthcare settings with emergency services for the treatment of PDSS. Long-term, prospective studies assessing the efficacy and safety of OLAI and head-to-head comparisons with other LAI and oral antipsychotics are needed.

Declaration of Interest

L Samalin has received grants, honoraria, or consulting fees from AstraZeneca, Bristol-Myers Squibb, Janssen-Cilag, Lundbeck, Otsuka, Sanofi-Aventis, and Takeda. PM Llorca has received grants, honoraria, or consulting fees from AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Ferrer, Janssen-Cilag, Lundbeck, Otsuka, Sanofi-Aventis, Servier, and Takeda. RP Garay and A Hameg are members of the non-profit association for therapeutic innovation Craven (Villemoisson-sur-Orge, France). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed

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