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Evidence Synthesis, Practice Guidelines and Real-World Prescriptions of New Generation Antidepressants in the Treatment of Major Depressive Disorder: A Meta-epidemiological Study

Luo, Yan 京都大学 DOI:10.14989/doctor.k23756

2022.03.23

概要

Background: Evidence-based medicine (EBM) is widely considered the guiding principle in today’s clinical practice. However, gaps may exist in evidence synthesis and implementation process. Evidence synthesis may not have been conducted in an unbiased and timely manner; guidelines may not have reflected the most up-to-date evidence; clinicians may not have changed their clinical decision makings in accordance with the relevant evidence.

Objectives: The study aims to present the evolution in three major elements in the process of practicing EBM, namely evidence synthesis, clinical practice guideline (CPG) recommendations and real-world clinical practice, and to describe their concordance or discordance, regarding the prescription of new generation antidepressants for major depressive disorder (MDD) through the past three decades.

Methods: First, cumulative network meta-analyses (NMAs) based on a comprehensive dataset of double-blind randomized controlled trials (RCTs) of the acute phase antidepressant treatment for MDD were conducted to represent ideally synthesized evidence over the years (up to 2016). The primary outcomes of the NMAs were efficacy (treatment response) and acceptability (all-cause discontinuation). The confidence in evidence was assessed using the CINeMA (Confidence in Network Meta-Analysis) framework. A Shiny web application was built to perform and present NMAs interactively. Second, recommendations from several representative practice guidelines published from 1990 until 2018 regarding the antidepressant treatment of MDD were extracted. Next, the real-world prescription patterns of antidepressant monotherapy for MDD were estimated every 5 years from 1990 to 2015, using the Medical Expenditure Panel Survey, a nationally representative database in the US. Finally, the evidence based on cumulative NMAs, the CPG recommendations, and the prescription patterns were compared, in order to find possible discrepancies. Potential reasons and factors that may cause deviations, such as patent expiry, local regulations, and marketing efforts, were also investigated.

Results: Evidence evolution based on cumulative NMAs was shown on the Shiny web, indicating a dramatic change of drugs with relative superiority, and the potentially exaggerated performance of newly approved drugs. CPGs developed by different groups had unique features, and most of them based recommendations primarily on published RCTs and their pairwise meta-analyses. In general, the development of the CPGs followed a rigorously reported methodology which improved over time. The prescription data suggested that sertraline and fluoxetine were among the most frequently prescribed antidepressants throughout the 20 years in the US, while the trend for some new drugs changed dramatically. Comparison between the three elements indicated that most of the drugs recommended by CPGs presented relatively superior performance in efficacy and acceptability with moderate confidence in the evidence. However, the CPG recommendations were often in terms of drug classes rather than particular drugs and the update intervals of all CPGs were longer than 5 years,thus lagging behind the most up-to-date evidence. All the antidepressants prescribed frequently in the US were recommended by CPGs. However, changes in prescriptions did not correspond to alterations in CPGs nor to apparent changes in the effects indicated by cumulative NMAs. For example, escitalopram achieved large prescription volume before formal recommendation, but then gradually lost its market share after being recommended. Many factors including marketing efforts, regulations or patient values may play a role.

Conclusions: The study provides an overview of how accumulating evidence may have influenced CPG recommendations and led to real-world prescriptions regarding antidepressant treatment of MDD in the past three decades. Though CPGs appeared to reflect the evidence, enhancements including accelerating CPG updates, monitoring the impact of marketing on prescriptions, and educating clinicians to actively seek evidence in order to avoid excessive influence from the pharmaceutical companies, should be considered in future EBM implementation.

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