Aripiprazole in the Maintenance Treatment of Bipolar Disorder: A Critical Review of the Evidence and Its Dissemination into the Scientific Literature
Background:
Aripiprazole, a second-generation antipsychotic medication, has been
increasingly used in the maintenance treatment of bipolar disorder and
received approval from the U.S. Food and Drug Administration for this
indication in 2005. Given its widespread use, we sought to critically review
the evidence supporting the use of aripiprazole in the maintenance treatment
of bipolar disorder and examine how that evidence has been disseminated in
the scientific literature.
Methods and Findings:
We systematically searched multiple databases to identify double-blind,
randomized controlled trials of aripiprazole for the maintenance treatment
of bipolar disorder while excluding other types of studies, such as
open-label, acute, and adjunctive studies. We then used a citation search to
identify articles that cited these trials and rated the quality of their
citations. Our evidence search protocol identified only two publications,
both describing the results of a single trial conducted by Keck et al.,
which met criteria for inclusion in this review. We describe four issues
that limit the interpretation of that trial as supporting the use of
aripiprazole for bipolar maintenance:
(1) insufficient duration to
demonstrate maintenance efficacy; (2) limited generalizability due to its
enriched sample; (3) possible conflation of iatrogenic adverse effects of
abrupt medication discontinuation with beneficial effects of treatment; and
(4) a low overall completion rate. Our citation search protocol yielded 80
publications that cited the Keck et al. trial in discussing the use of
aripiprazole for bipolar maintenance. Of these, only 24 (30%)
mentioned adverse events reported and four (5%) mentioned study
limitations.
Conclusions:
A single trial by Keck et al. represents the entirety of the literature on
the use of aripiprazole for the maintenance treatment of bipolar disorder.
Although careful review identifies four critical limitations to the
trial's interpretation and overall utility, the trial has been
uncritically cited in the subsequent scientific literature.
:
Please see later in the article for the Editors' Summary
Vyšlo v časopise:
Aripiprazole in the Maintenance Treatment of Bipolar Disorder: A Critical Review of the Evidence and Its Dissemination into the Scientific Literature. PLoS Med 8(5): e32767. doi:10.1371/journal.pmed.1000434
Kategorie:
Research Article
prolekare.web.journal.doi_sk:
https://doi.org/10.1371/journal.pmed.1000434
Souhrn
Background:
Aripiprazole, a second-generation antipsychotic medication, has been
increasingly used in the maintenance treatment of bipolar disorder and
received approval from the U.S. Food and Drug Administration for this
indication in 2005. Given its widespread use, we sought to critically review
the evidence supporting the use of aripiprazole in the maintenance treatment
of bipolar disorder and examine how that evidence has been disseminated in
the scientific literature.
Methods and Findings:
We systematically searched multiple databases to identify double-blind,
randomized controlled trials of aripiprazole for the maintenance treatment
of bipolar disorder while excluding other types of studies, such as
open-label, acute, and adjunctive studies. We then used a citation search to
identify articles that cited these trials and rated the quality of their
citations. Our evidence search protocol identified only two publications,
both describing the results of a single trial conducted by Keck et al.,
which met criteria for inclusion in this review. We describe four issues
that limit the interpretation of that trial as supporting the use of
aripiprazole for bipolar maintenance:
(1) insufficient duration to
demonstrate maintenance efficacy; (2) limited generalizability due to its
enriched sample; (3) possible conflation of iatrogenic adverse effects of
abrupt medication discontinuation with beneficial effects of treatment; and
(4) a low overall completion rate. Our citation search protocol yielded 80
publications that cited the Keck et al. trial in discussing the use of
aripiprazole for bipolar maintenance. Of these, only 24 (30%)
mentioned adverse events reported and four (5%) mentioned study
limitations.
Conclusions:
A single trial by Keck et al. represents the entirety of the literature on
the use of aripiprazole for the maintenance treatment of bipolar disorder.
Although careful review identifies four critical limitations to the
trial's interpretation and overall utility, the trial has been
uncritically cited in the subsequent scientific literature.
:
Please see later in the article for the Editors' Summary
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