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Olanzapine long-acting injection: a review of first experiences of post-injection delirium/sedation syndrome in routine clinical practice.

Bushe CJ, Falk D, Anand E, Casillas M, Perrin E, Chhabra-Khanna R, Detke HC - BMC Psychiatry (2015)

Bottom Line: Data sources included two ongoing post-marketing safety studies as well as spontaneously reported adverse events from routine clinical practice over a 5-year period (1 March 2009 to 1 March 2014).The most common symptoms (occurring in >30% of cases) were sedation (61%), confusion (56%), dysarthria (54%), somnolence (46%), dizziness (45%) and disorientation (35%).Overall, PDSS occurred with approximately 0.07% of injections and in 0.46-1.03% of patients (reporting and incidence rates from spontaneous reports and post-marketing safety studies, respectively).

View Article: PubMed Central - PubMed

Affiliation: Eli Lilly, Lilly House, Priestly Road, Basingstoke, Hampshire, RG24 9NL, UK. bushe_chris@lilly.com.

ABSTRACT

Background: Olanzapine long-acting injection (LAI) for the treatment of schizophrenia was associated with a cluster of symptoms termed post-injection delirium/sedation syndrome (PDSS) in a small percentage (~2%) of patients during clinical trials. The objective of this analysis was to evaluate the rate and clinical characteristics of PDSS since olanzapine LAI entered commercial use.

Methods: Cases of PDSS were identified from all reported adverse events during worldwide commercial use of olanzapine LAI through to 1 March 2014. Data sources included two ongoing post-marketing safety studies as well as spontaneously reported adverse events from routine clinical practice over a 5-year period (1 March 2009 to 1 March 2014).

Results: A total of 338 PDSS events were identified. Of these, 91% occurred within 1 hour of injection, and 52% of these occurred within 15 minutes. None of the PDSS events in this analysis were fatal, and most resolved within 72 hours. The most common symptoms (occurring in >30% of cases) were sedation (61%), confusion (56%), dysarthria (54%), somnolence (46%), dizziness (45%) and disorientation (35%). Overall, PDSS occurred with approximately 0.07% of injections and in 0.46-1.03% of patients (reporting and incidence rates from spontaneous reports and post-marketing safety studies, respectively).

Conclusions: The PDSS events reported during routine clinical use of olanzapine LAI are generally similar in incidence and presentation to those reported in clinical trials. Caution should be applied when interpreting spontaneously reported rates of adverse events, however, due to potential under-reporting. Implemented risk-minimisation activities may contribute substantially to the identification and appropriate management of patients with PDSS in clinical practice.

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Related in: MedlinePlus

Time to onset of PDSS among cases presenting in the first 60 minutes after injection. The figure illustrates the percentage of cases of PDSS in routine clinical practice according to time to onset among 294 cases presenting in the first 60 minutes after injection. PDSS = post-injection delirium/sedation syndrome.
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Fig1: Time to onset of PDSS among cases presenting in the first 60 minutes after injection. The figure illustrates the percentage of cases of PDSS in routine clinical practice according to time to onset among 294 cases presenting in the first 60 minutes after injection. PDSS = post-injection delirium/sedation syndrome.

Mentions: For both the post-marketing safety studies and spontaneous data, the longest reported time to onset of PDSS was 173 minutes. Since the launch of olanzapine LAI, no cases of PDSS have been reported beyond 180 minutes after injection. Approximately 91% of cases of PDSS presented within the first 60 minutes (Table 2). Of the 294 cases identified in the first 60 minutes, 52% (154/294) presented within the first 15 minutes (Figure 1). Time to onset of PDSS was unknown in 15 cases.Figure 1


Olanzapine long-acting injection: a review of first experiences of post-injection delirium/sedation syndrome in routine clinical practice.

Bushe CJ, Falk D, Anand E, Casillas M, Perrin E, Chhabra-Khanna R, Detke HC - BMC Psychiatry (2015)

Time to onset of PDSS among cases presenting in the first 60 minutes after injection. The figure illustrates the percentage of cases of PDSS in routine clinical practice according to time to onset among 294 cases presenting in the first 60 minutes after injection. PDSS = post-injection delirium/sedation syndrome.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4389990&req=5

Fig1: Time to onset of PDSS among cases presenting in the first 60 minutes after injection. The figure illustrates the percentage of cases of PDSS in routine clinical practice according to time to onset among 294 cases presenting in the first 60 minutes after injection. PDSS = post-injection delirium/sedation syndrome.
Mentions: For both the post-marketing safety studies and spontaneous data, the longest reported time to onset of PDSS was 173 minutes. Since the launch of olanzapine LAI, no cases of PDSS have been reported beyond 180 minutes after injection. Approximately 91% of cases of PDSS presented within the first 60 minutes (Table 2). Of the 294 cases identified in the first 60 minutes, 52% (154/294) presented within the first 15 minutes (Figure 1). Time to onset of PDSS was unknown in 15 cases.Figure 1

Bottom Line: Data sources included two ongoing post-marketing safety studies as well as spontaneously reported adverse events from routine clinical practice over a 5-year period (1 March 2009 to 1 March 2014).The most common symptoms (occurring in >30% of cases) were sedation (61%), confusion (56%), dysarthria (54%), somnolence (46%), dizziness (45%) and disorientation (35%).Overall, PDSS occurred with approximately 0.07% of injections and in 0.46-1.03% of patients (reporting and incidence rates from spontaneous reports and post-marketing safety studies, respectively).

View Article: PubMed Central - PubMed

Affiliation: Eli Lilly, Lilly House, Priestly Road, Basingstoke, Hampshire, RG24 9NL, UK. bushe_chris@lilly.com.

ABSTRACT

Background: Olanzapine long-acting injection (LAI) for the treatment of schizophrenia was associated with a cluster of symptoms termed post-injection delirium/sedation syndrome (PDSS) in a small percentage (~2%) of patients during clinical trials. The objective of this analysis was to evaluate the rate and clinical characteristics of PDSS since olanzapine LAI entered commercial use.

Methods: Cases of PDSS were identified from all reported adverse events during worldwide commercial use of olanzapine LAI through to 1 March 2014. Data sources included two ongoing post-marketing safety studies as well as spontaneously reported adverse events from routine clinical practice over a 5-year period (1 March 2009 to 1 March 2014).

Results: A total of 338 PDSS events were identified. Of these, 91% occurred within 1 hour of injection, and 52% of these occurred within 15 minutes. None of the PDSS events in this analysis were fatal, and most resolved within 72 hours. The most common symptoms (occurring in >30% of cases) were sedation (61%), confusion (56%), dysarthria (54%), somnolence (46%), dizziness (45%) and disorientation (35%). Overall, PDSS occurred with approximately 0.07% of injections and in 0.46-1.03% of patients (reporting and incidence rates from spontaneous reports and post-marketing safety studies, respectively).

Conclusions: The PDSS events reported during routine clinical use of olanzapine LAI are generally similar in incidence and presentation to those reported in clinical trials. Caution should be applied when interpreting spontaneously reported rates of adverse events, however, due to potential under-reporting. Implemented risk-minimisation activities may contribute substantially to the identification and appropriate management of patients with PDSS in clinical practice.

Show MeSH
Related in: MedlinePlus