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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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Štítky
Interné lekárstvo

Článok vyšiel v časopise

PLOS Medicine


2011 Číslo 5
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Autori: MUDr. Tomáš Ürge, PhD.

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