Evidence map›Paper›PMID 37028980›Full record

ArticleMayo Clinic proceedings2023

Baclofen and the Risk of Encephalopathy: A Real-World, Active-Comparator Cohort Study.

Y Joseph Hwang, Alex R Chang, Daniel J Brotman, Lesley A Inker, Morgan E Grams, Jung-Im Shin

Open access · greenAbstract read
In one paragraph

Article in Mayo Clinic proceedings, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.9field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 9 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Y Joseph HwangDepartment of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD; Center for Drug Safety and Effectiveness, Johns Hopkins University, Baltimore, MD. Electronic address: yhwang19@jhmi.edu.
Alex R ChangDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD; Kidney Health Research Institute, Geisinger Health, Danville, PA.
Daniel J BrotmanDepartment of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD.
Lesley A InkerDivision of Nephrology, Tufts Medical Center, Boston, MA.
Morgan E GramsCenter for Drug Safety and Effectiveness, Johns Hopkins University, Baltimore, MD; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD; Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, MD; Departments of Medicine and Population Health, NYU Grossman School of Medicine, New York City, NY.
Jung-Im ShinCenter for Drug Safety and Effectiveness, Johns Hopkins University, Baltimore, MD; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD; Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, MD.
Johns Hopkins University · USTufts Medical Center · US

Funding

Medication Use and Adverse Events in CKDR01DK115534 · NIDDK · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI Alexander R Chang, Morgan Erika Grams · 2018 to 2026
$5.7M
Prevention and Treatment of Cardiovascular Disease in Patients with Chronic Kidney Disease: Patient-Oriented Research and Mentoring - RenewalK24HL155861 · NHLBI · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI Morgan Erika Grams · 2021 to 2026
$732k
The Comparative Effectiveness and Safety of Second-line Therapy in Patients with Type 2 DiabetesK01DK121825 · NIDDK · JOHNS HOPKINS UNIVERSITY · PI SHIN, JUNG-IM · 2019 to 2022
$615k
NHLBI NIH HHS K24 HL155861NIDDK NIH HHS K01 DK121825NIDDK NIH HHS R01 DK115534
6 · The paper itself

Abstract

objectiveTo quantify the risk of encephalopathy associated with oral baclofen compared with other muscle relaxants-tizanidine or cyclobenzaprine. PATIENTS AND

methodsWe conducted a new-user, active-comparator study of 2 pairwise cohorts using tertiary health system data from Geisinger Health in Pennsylvania (January 1, 2005, through December 31, 2018). Adults (aged ≥18 years) newly treated with baclofen or tizanidine were included in cohort 1. Adults newly treated with baclofen or cyclobenzaprine were included in cohort 2. Propensity score-based inverse probability of treatment weighting (IPTW) was used to balance the respective cohorts on 45 patient characteristics. Fine-Gray competing risk regression was used to estimate the risk of encephalopathy.

resultsCohort 1 included 16,192 new baclofen users and 9782 new tizanidine users. The 30-day risk of encephalopathy was higher in patients treated with baclofen vs tizanidine (IPTW incidence rate, 64.7 vs 28.3 per 1000 person-years) with an IPTW subdistribution hazard ratio (SHR) of 2.29 (95% CI, 1.43 to 3.67). This risk persisted through 1 year (SHR, 1.32 [95% CI, 1.07 to 1.64]). Similarly in cohort 2, baclofen vs cyclobenzaprine was associated with a greater risk of encephalopathy at 30 days (SHR, 2.35 [95% CI, 1.59 to 3.48]) that persisted through the first year of treatment (SHR, 1.94 [95% CI, 1.56 to 2.40]).

conclusionThe risk of encephalopathy was greater with baclofen vs tizanidine or cyclobenzaprine use. The elevated risk was apparent as early as 30 days and persisted through the first year of treatment. Our findings from routine care settings may inform shared treatment decisions between patients and prescribers.

Indexed as

Brain DiseasesMuscle Relaxants, CentralAdolescentAdultAmitriptylineBaclofenCohort StudiesHumansMuscle SpasticityAmitriptylineBaclofencyclobenzaprineMuscle Relaxants, Central

Identifiers

PMID37028980
PMCPMC10159882
OpenAlexW4362607783

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.