Digital aripiprazole or digital evergreening? A systematic review of the evidence and its dissemination in the scientific literature and in the media.

BACKGROUND

In November 2017, the Food and Drug Administration (FDA) approved a version of a second-generation antipsychotic, aripiprazole, embedded with a sensor (Abilify MyCite).

OBJECTIVE

To systematically review the evidence supporting the FDA's approval of digital aripiprazole and how that evidence was disseminated in the scientific literature and news reports.

STUDY SELECTION

Prospective, double-blind, randomised controlled trials (RCTs), non-randomised and non-comparative studies were included if they focused on the use of digital aripiprazole. All scientific publications citing the trials were included if written in English. For the news reports, all languages were included if an English translation was available, and all records that were published after FDA approval were included.

FINDINGS

In the primary evidence search, no RCT comparing digital aripiprazole with a non-digital formulation, other active comparators or placebo was found. Only three non-comparative uncontrolled cohorts were found. No study provided data on remission, quality of life or any efficacy outcome. Fourteen scientific papers were identified that cited the trials and 70 news stories met the inclusion criteria. Almost 80% (11/14) of the scientific papers and three-fourths (52/70) of the news stories conveyed an unsupported impression of benefit.

CONCLUSIONS

Regulatory approval for this first-ever digital drug was based on weak evidence, and there was no evidence of better adherence with the digital version of aripiprazole compared with the non-digital version. The possibilities afforded by this technology make room for a new type of evergreening (ie, patenting of older drugs with a sensor as a 'new invention'). Both the scientific literature and news reports conveyed an unsupported impression of benefit.

TRIAL REGISTRATION NUMBER

CRD42018089515.