Limits...
Efficacy and tolerability of aripiprazole once monthly for schizophrenia: a systematic review and meta-analysis of randomized controlled trials.

Oya K, Kishi T, Iwata N - Neuropsychiatr Dis Treat (2015)

Bottom Line: The pooled AOM group showed significantly lower incidence of all-cause discontinuation (RR =0.54, 95% CI =0.41-0.71, n=1,139, NNH =4) and inefficacy (RR =0.28, 95% CI =0.21-0.38, n=1,139, NNH =5) than placebo, but was not superior to placebo regarding discontinuation due to adverse events (AEs) or death.There were no significant differences in extrapyramidal symptoms scale scores between AOM and placebo or between AOM and OA.AOM resulted in higher weight gain than placebo (SMD =0.41, 95% CI =0.18-0.64, n=734) but lower than OA (SMD =-0.16, 95% CI =-0.29 to -0.02, n=847).

View Article: PubMed Central - PubMed

Affiliation: Department of Psychiatry, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.

ABSTRACT

Objective: We conducted a systematic review and meta-analysis of the efficacy of aripiprazole once monthly (AOM) for schizophrenia.

Methods: Randomized controlled trials (RCTs) on AOM, published until June 25, 2015, were retrieved from PubMed, Cochrane, and PsycINFO databases. Relative risk (RR), standardized mean difference (SMD), 95% confidence intervals (95% CIs), and numbers needed to treat/harm (NNT/NNH) were calculated.

Results: We identified four relevant RCTs (total n=1,860), two placebo-controlled trials, one noninferiority trial comparing AOM to oral aripiprazole (OA), and one including therapeutic doses of AOM and OA, as well as an AOM dose below therapeutic threshold (control arm). AOM was superior to placebo for decreasing Positive and Negative Syndrome Scale (PANSS) total scores (SMD =-0.65, 95% CI =-0.90 to -0.41, n=1,126). However, PANSS total scores did not differ significantly between pooled AOM and OA groups. The pooled AOM group showed significantly lower incidence of all-cause discontinuation (RR =0.54, 95% CI =0.41-0.71, n=1,139, NNH =4) and inefficacy (RR =0.28, 95% CI =0.21-0.38, n=1,139, NNH =5) than placebo, but was not superior to placebo regarding discontinuation due to adverse events (AEs) or death. The AOM group exhibited a lower incidence of all-cause discontinuation than OA (RR =0.78, 95% CI =0.64-0.95, n=986, NNH =14), but there were no intergroup differences in discontinuation due to inefficacy, AEs, or death. There were no significant differences in extrapyramidal symptoms scale scores between AOM and placebo or between AOM and OA. AOM resulted in higher weight gain than placebo (SMD =0.41, 95% CI =0.18-0.64, n=734) but lower than OA (SMD =-0.16, 95% CI =-0.29 to -0.02, n=847).

Conclusion: AOM has antipsychotic efficacy and low risk of discontinuation due to AEs.

No MeSH data available.


Related in: MedlinePlus

Preferred reporting items for systematic reviews and meta-analyses (PRISMA) flow diagram.
© Copyright Policy
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC4562720&req=5

f1-ndt-11-2299: Preferred reporting items for systematic reviews and meta-analyses (PRISMA) flow diagram.

Mentions: Searches of PubMed, Cochrane Library, and PsycINFO databases yielded 129 hits. We excluded 59 duplicate studies; 36 studies based on title or abstract review; and 30 studies after full text reading, including two RCTs, because of study design. Therefore, four eligible studies were included (Figure 1). Across the four RCTs (mean duration: 38.5 [range, 12–52] weeks), 1,860 adult patients with schizophrenia were randomized to either AOM (n=930), OA (n=493), or control (placebo, n=306 or AOM-50 mg, n=131) groups. The study of Fleischhacker et al15 consisted of three arms comparing AOM, OA, and AOM-50 mg. Sample sizes ranged from 340 to 662 participants. All studies were published in English, and all were sponsored by Otsuka Pharmaceutical Co., Ltd. All four were of high methodological quality based on Cochrane Risk of Bias Criteria (they were double-blind RCTs and contained the required study design detail). Two were placebo-controlled studies,13,14 one OA controlled,16 and the other compared AOM, OA, and AOM-50 mg (defined as placebo as this dose is subthreshold).15 The characteristics of the studies are summarized in Table 1.


Efficacy and tolerability of aripiprazole once monthly for schizophrenia: a systematic review and meta-analysis of randomized controlled trials.

Oya K, Kishi T, Iwata N - Neuropsychiatr Dis Treat (2015)

Preferred reporting items for systematic reviews and meta-analyses (PRISMA) flow diagram.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4562720&req=5

f1-ndt-11-2299: Preferred reporting items for systematic reviews and meta-analyses (PRISMA) flow diagram.
Mentions: Searches of PubMed, Cochrane Library, and PsycINFO databases yielded 129 hits. We excluded 59 duplicate studies; 36 studies based on title or abstract review; and 30 studies after full text reading, including two RCTs, because of study design. Therefore, four eligible studies were included (Figure 1). Across the four RCTs (mean duration: 38.5 [range, 12–52] weeks), 1,860 adult patients with schizophrenia were randomized to either AOM (n=930), OA (n=493), or control (placebo, n=306 or AOM-50 mg, n=131) groups. The study of Fleischhacker et al15 consisted of three arms comparing AOM, OA, and AOM-50 mg. Sample sizes ranged from 340 to 662 participants. All studies were published in English, and all were sponsored by Otsuka Pharmaceutical Co., Ltd. All four were of high methodological quality based on Cochrane Risk of Bias Criteria (they were double-blind RCTs and contained the required study design detail). Two were placebo-controlled studies,13,14 one OA controlled,16 and the other compared AOM, OA, and AOM-50 mg (defined as placebo as this dose is subthreshold).15 The characteristics of the studies are summarized in Table 1.

Bottom Line: The pooled AOM group showed significantly lower incidence of all-cause discontinuation (RR =0.54, 95% CI =0.41-0.71, n=1,139, NNH =4) and inefficacy (RR =0.28, 95% CI =0.21-0.38, n=1,139, NNH =5) than placebo, but was not superior to placebo regarding discontinuation due to adverse events (AEs) or death.There were no significant differences in extrapyramidal symptoms scale scores between AOM and placebo or between AOM and OA.AOM resulted in higher weight gain than placebo (SMD =0.41, 95% CI =0.18-0.64, n=734) but lower than OA (SMD =-0.16, 95% CI =-0.29 to -0.02, n=847).

View Article: PubMed Central - PubMed

Affiliation: Department of Psychiatry, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.

ABSTRACT

Objective: We conducted a systematic review and meta-analysis of the efficacy of aripiprazole once monthly (AOM) for schizophrenia.

Methods: Randomized controlled trials (RCTs) on AOM, published until June 25, 2015, were retrieved from PubMed, Cochrane, and PsycINFO databases. Relative risk (RR), standardized mean difference (SMD), 95% confidence intervals (95% CIs), and numbers needed to treat/harm (NNT/NNH) were calculated.

Results: We identified four relevant RCTs (total n=1,860), two placebo-controlled trials, one noninferiority trial comparing AOM to oral aripiprazole (OA), and one including therapeutic doses of AOM and OA, as well as an AOM dose below therapeutic threshold (control arm). AOM was superior to placebo for decreasing Positive and Negative Syndrome Scale (PANSS) total scores (SMD =-0.65, 95% CI =-0.90 to -0.41, n=1,126). However, PANSS total scores did not differ significantly between pooled AOM and OA groups. The pooled AOM group showed significantly lower incidence of all-cause discontinuation (RR =0.54, 95% CI =0.41-0.71, n=1,139, NNH =4) and inefficacy (RR =0.28, 95% CI =0.21-0.38, n=1,139, NNH =5) than placebo, but was not superior to placebo regarding discontinuation due to adverse events (AEs) or death. The AOM group exhibited a lower incidence of all-cause discontinuation than OA (RR =0.78, 95% CI =0.64-0.95, n=986, NNH =14), but there were no intergroup differences in discontinuation due to inefficacy, AEs, or death. There were no significant differences in extrapyramidal symptoms scale scores between AOM and placebo or between AOM and OA. AOM resulted in higher weight gain than placebo (SMD =0.41, 95% CI =0.18-0.64, n=734) but lower than OA (SMD =-0.16, 95% CI =-0.29 to -0.02, n=847).

Conclusion: AOM has antipsychotic efficacy and low risk of discontinuation due to AEs.

No MeSH data available.


Related in: MedlinePlus