RxFiles Trial Summaries

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We undertake a lot of critical appraisal to create our drug comparison charts. Selected insight from that appraisal is published here. 

Landmark Trial Collections

Hypertension

Lipids

Anemia

Asthma

Diabetes:
CV Outcomes

Menopause

2024

RSV in Older Adults

RSVPreF3 (AREXVY) vaccine for RSV in older adults. 

SELECT

Semaglutide vs placebo in patients with obesity, without diabetes.

    

AOM 

  5 vs 10 days of antibiotic therapy in young children (age 6-23 months) with AOM.

2023

DELIVER

Dapagliflozin (FORXIGA) vs placebo in patients with heart failure and mildly reduced or preserved ejection fraction.

FOURIER

Evolocumab (REPATHA) vs placebo in cardiovascular disease.

REDUCE-IT

Icosapent Ethyl (VASCEPA) vs mineral oil (as placebo) for elevated triglycerides.

2022

PINETREE

Remdesivir (VEKLURY) vs placebo for high-risk COVID-19 outpatients.

TACKLE

Tixagevimab-cilgavimab (EVUSHLED) vs placebo for high-risk COVID-19 outpatients.

COMET-ICE

Sotrovimab (XEVUDY) vs placebo for high-risk COVID-19 outpatients.

UTI in males

7 vs 14 days of antibiotic therapy for UTIs in afebrile men.

SABINA

SABA use and mortality risk in patients with asthma.

MOH

Withdrawal, prophylaxis, or both for the management of medication overuse headache.

EPIC-HR

Nirmatrelvir/ritonavir (PAXLOVID) vs placebo for high-risk COVID-19 outpatients.

PROVENT

Tixagevimab-cilgavimab (EVUSHLED) vs placebo for COVID-19 pre-exposure prophylaxis.

Benzos & Dementia

Benzos / z-drugs and risk of dementia.  

ANTLER

Likelihood of success when stopping an antidepressant. 

STAR*D

Comparison of various strategies for treating depression.

CAPiTA

Pneumococall-13 vaccine (PREVNAR-13) vs placebo in older adults. 

2021

EMPEROR-Preserved

Empagliflozin 10mg vs placebo in heart failure with preserved enjection fraction.

SYGMA 1

Terbutaline prn vs bud-form prn vs budesonide BID + terbutaline prn in asthma. 

SYGMA 2

Bud-form prn vs budesonide BID + terbutaline prn in asthma. 

Novel START

Salbutamol prn vs bud-form prn vs budesonide BID + salbutamol prn in asthma. 

PRACTICAL

Bud-form prn vs budesonide BID + terbutaline prn in asthma. 

Adult Asthma: McKeever et al.

Quadrupling ICS dose in the 'yellow zone' of an asthma action plan vs usual care.

2020

VICTORIA

Vericiguat 10mg vs placebo in heart failure.

Vit D: Burt et al

Vitamin D 400 units vs 4,000 units vs 10,000 units in primary prevention of osteoporosis.

EMPEROR-Reduced

Empagliflozin 10mg vs placebo in heart failure with reduced ejection fraction.

DAPA-CKD

Dapagliflozin 10mg vs placebo in chronic kidney disease.

2019

DECLARE-TIMI 58

Dapagliflozin 10mg vs placebo in type 2 diabetes. 

CREDENCE

Canagliflozin 100mg vs placebo in type 2 diabetes with chronic kidney disease. 

DAPA-HF

Dapagliflozin 10mg vs placebo in heart failure. 

2018

SPACE

Opioids vs non-opioids in chronic pain. 

Opioids: Chang et al

Opioids vs non-opioids in acute pain. 

2017

SPS3 systolic BP

Lower vs higher systolic blood pressure in recent stroke.

PIONEER AF-PCI

Rivaroxaban + P2Y12 inhibitor vs rivaroxaban + DAPT vs warafrin + DAPT in a-fib & PCI. 

MATCH

Clopiodgrel + ASA vs clopidogrel alone in recent stroke or TIA. 

SPS3 antiplatelet

Clopidogrel + ASA vs ASA alone in recent stroke.

CHANCE

Clopiogrel + ASA vs ASA alone in minor stroke or TIA.

SHIFT

Ivabradine vs placebo in heart failure. 

LRTI: Little et al

Amoxicillin vs placebo in acute lower respiratory tract infection.

CAP-START

Beta-lactam vs beta-lactam + macrolide vs fluoroquinolone in community acquired pneumonia.

UTI: Gupta et al

Nitrofurantoin vs TMP/SMX in uncomplicated cystitis. 

SSTI: Talan et al

TMP/SMX vs placebo in uncomplicated skin abscess.

2016

ELIXA

Lixisenatide 20mcg vs placebo in type 2 diabetes.

EMPA-REG

Empagliflozin 10mg vs empagliflozin 25mg vs placebo in type 2 diabetes. 

IRIS

Pioglitazone 45mg vs placebo in recent stroke or TIA.

LEADER

Liraglutide 1.8mg vs placebo in type 2 diabetes. 

TECOS

Sitagliptin 100mg vs placebo in type 2 diabetes. 

DAPT

12 vs 30 months of dual antiplatelet therapy after drug-eluting stents. 

PCI-CLARITY

Clopidogrel vs placebo as pre-treatment before PCI. 

PCI-CURE

Clopidogrel + ASA vs ASA alone as pre-treatment before PCI.

PEGASUS-TIMI 54

Ticagrelor vs placebo in prior MI. 

PLATO

Ticagrelor vs clopidogrel in acute coronary syndrome. 

TRITON-TIMI 38

Prasugrel vs clopiodgrel in acute coronary syndrome. 

FLAME

Indacaterol + glycopyrronium vs salmeterol + fluticasone in COPD. 

SSTI: Cadena et al

Clindamycin vs TMP/SMX in uncomplicated skin infections.

2015

SPRINT

Higher vs lower blood pressure targets. 

IMPROVE-IT

Ezetimibe + simvastatin vs simvastatin alone in cardiovascular disease.

FIELD substudy

Fenofibrate 200mg vs placebo in patients with diabetes, by gender. 

PARADIGM-HF

Valsartan + sacubitril vs enalapril in heart failure.

2014

Smoking: Evins et al

Varenicline vs placebo for smoking cessation in patients with schizophrenia or bipolar disorder.

2013

SAVOR-TIMI 53

Saxagliptin vs placebo in type 2 diabetes. 

ASPIRE

ASA vs placebo to prevent VTE. 

RE-LY

Dabigatran vs warfarin in atrial fibrilation. 

WARFASA

ASA vs placebo following warfarin to prevent VTE. 

SENIOR

Solifenacin vs oxybutynin in overactive bladder in older adults with mild cognitive impairment.

SPREAD-DIMCAD

Metformin vs glipizide in type 2 diabetes. 

2012

RACE-II

Lenient vs strict rate control in atrial fibrillation. 

PALLAS

Dronedarone vs placebo in atrial fibrillation. 

ARISTOTLE

Apixiban vs warfarin in atrial fibrillation. 

ROCKET-AF

Rivaroxaban vs warfarin in atrial fibrillation. 

2011

SHARP

Simvastatin + ezetimibe vs placebo in chronic kidney disease. 

AIM-HIGH

Niacin + simvastatin vs placebo + simvastatin in cardiovascular disease. 

CATIE-AD

Olanzapine vs quetiapine vs risperidone vs placebo in Alzheimer's Disease.

Pain: Solomon et al

NSAIDs vs coxibs vs opioids in arthritis. 

Smoking: Singh et al

Varenicline vs placebo in smoking cessation & CV risk. 

Cough: Paul et al

Vapor rub vs petrolatum vs no treatment in kids with cough.

Hirsutism Landmark Trials

2010

ACCORD LIPID & BP

Aggresive vs standard diabetes targets. 

ARBs: Meta-analysis

Do ARBs increase the risk of cancer?

2009

RECORD

Rosiglitazone vs usual care in type 2 diabetes. 

ACTIVE A

ASA + clopidogrel vs ASA alone in atrial fibrillation. 

ACTIVE W

ASA + clopiodgrel vs warfarin in atrial fibrillation.

2008

ACCORD

Intensive vs standard glycemic control in type 2 diabetes. 

ADVANCE

Intensive vs standard glycemic control in type 2 diabetes. 

ACCOMPLISH

ACEI + amlodipine vs ACEI + hydrochlorothiazide in hypertension. 

ENHANCE

Simvastatin vs simvastatin + ezetimibe in familial hypercholesterolemia. 

JUPITER

Rosuvastatin 20mg vs placebo in cardiovascular disease. 

OAB: Kay et al

Darifenacin vs oxybutynin effects on memory/cognition.

2007

DREAM

Rosiglitazone 8mg vs placebo & ramipril 15mg vs placebo in type 2 diabetes. 

2006

IDEAL

Atorvastatin 80mg vs simvastatin 20-40mg in previous MI. 

SPARCL

Atorvastatin 80mg vs placebo in stroke prevention.

CHARISMA

Clopidogrel + ASA vs ASA alone in cardiovascular disease. 

Asthma Landmark Trials

2005

ASCOT-BPLA

Amlodipine vs atenolol in hypertension. 

2004

CARDS

Atorvastatin 10mg vs placebo in type 2 diabetes. 

PROVE IT-TIMI 22

Atorvastatin 80mg vs pravastatin 40mg in acute coronary sydnrome.

2003

ASCOT-LLA

Atorvastatin vs placebo for cardiovascular disease. 

CHARM

Candesartan vs placebo in heart failure. 

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