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

PloS One
Arif KhanWalter A Brown

Abstract

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...Continue Reading

References

Dec 19, 1981·Lancet·B A GouldE B Raftery
Mar 7, 2001·The British Journal of Psychiatry : the Journal of Mental Science·G Andrews
Apr 10, 2002·JAMA : the Journal of the American Medical Association·B Timothy WalshMadelyn Gould
Apr 16, 2003·The Journal of Nervous and Mental Disease·Arif KhanCraig Mallinckrodt
Jan 18, 2008·The New England Journal of Medicine·Erick H TurnerRobert Rosenthal
Oct 1, 2008·European Neuropsychopharmacology : the Journal of the European College of Neuropsychopharmacology·George I Papakostas, Maurizio Fava
Jan 16, 2013·The American Journal of Psychiatry·Bret R Rutherford, Steven P Roose
Jun 4, 2016·Current Opinion in Nephrology and Hypertension·Liliya M YamaleyevaJasmina Varagic
Nov 21, 2016·Journal of the American Society of Hypertension : JASH·Marcel WilhelmBettina K Doering
May 13, 2017·World Psychiatry : Official Journal of the World Psychiatric Association (WPA)·Arif KhanWalter A Brown
Dec 22, 2017·Diabetes Care

❮ Previous
Next ❯

Citations

Jun 26, 2018·International Clinical Psychopharmacology·Arif KhanWalter A Brown
May 3, 2019·The Journal of Rheumatology·Katie BechmanJames B Galloway
Jul 1, 2020·Clinical Pharmacology and Therapeutics·Kathryn T HallNancy R Cook
Oct 28, 2017·Expert Opinion on Drug Safety·Igho J OnakpoyaJeffrey K Aronson
Jul 17, 2019·Arthritis Research & Therapy·ZeYu HuangVirginia Byers Kraus

❮ Previous
Next ❯

Software Mentioned

Statistical Package for the Social Sciences ( SPSS

Related Concepts

Related Feeds

Antihypertensive Agents: Mechanisms of Action

Antihypertensive drugs are used to treat hypertension (high blood pressure) which aims to prevent the complications of high blood pressure, such as stroke and myocardial infarction. Discover the latest research on antihypertensive drugs and their mechanism of action here.

Attention Disorders

Attention is involved in all cognitive activities, and attention disorders are reported in patients with various neurological diseases. Here are the latest discoveries pertaining to attention disorders.