Does the rising placebo response impact antihypertensive clinical trial outcomes? An analysis of data from the Food and Drug Administration 1990-2016

Recent studies show that placebo response has grown significantly over time in clinical trials for antidepressants, ADHD medications, antiepileptics, and antidiabetics. Contrary to expectations, trial outcome measures and success rates have not been impacted. This study aimed to see if this trend of...

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Bibliographic Details
Published in:PloS one 2018-02, Vol.13 (2), p.e0193043-e0193043
Main Authors: Khan, Arif, Fahl Mar, Kaysee, Schilling, Joshua, Brown, Walter A
Format: Article
Language:English
Subjects:
Antidepressants
Antidiabetics
Antihypertensive agents
Antihypertensives
Attention deficit hyperactivity disorder
Blood
Blood pressure
Clinical trials
Data processing
Effectiveness
FDA approval
Hypertension
Medical research
Medicine and Health Sciences
Pharmacological research
Physical Sciences
Physiology
Placebo effect
Psychiatry
Regression analysis
Research and Analysis Methods
Statistical analysis
Success
Supervision
Systematic review
Testing
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Summary:Recent studies show that placebo response has grown significantly over time in clinical trials for antidepressants, ADHD medications, antiepileptics, and antidiabetics. Contrary to expectations, trial outcome measures and success rates have not been impacted. This study aimed to see if this trend of increasing placebo response and stable efficacy outcome measures is unique to the conditions previously studied or if it occurs in trials for conditions with physiologically-measured symptoms, such as hypertension. For this reason, we evaluated the efficacy data reported in the US Food and Drug Administration Medical and Statistical reviews for 23 antihypertensive programs (32,022 patients, 63 trials, 142 treatment arms). Placebo and medication response, effect sizes, and drug-placebo differences were calculated for each treatment arm and examined over time using meta-regression. We also explored the relationship of sample size, trial duration, baseline blood pressure, and number of treatment arms to placebo/drug response and efficacy outcome measures. Like trials of other conditions, placebo response has risen significantly over time (R2 = 0.093, p = 0.018) and effect size (R2 = 0.013, p = 0.187) drug-placebo difference (R2 = 0.013, p = 0.182) and success rate (134/142, 94.4%) have remained unaffected, likely due to a significant compensatory increase in antihypertensive response (R2 = 0.086, p
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0193043