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JAMA Network Open Apr 2023Thyroid storm is the most severe form of thyrotoxicosis, with high mortality, and is treated with propylthiouracil and methimazole. Some guidelines recommend...
IMPORTANCE
Thyroid storm is the most severe form of thyrotoxicosis, with high mortality, and is treated with propylthiouracil and methimazole. Some guidelines recommend propylthiouracil over methimazole, although the difference in outcomes associated with each treatment is unclear.
OBJECTIVE
To compare outcomes associated with use of propylthiouracil vs methimazole for the treatment of thyroid storm.
DESIGN, SETTING, AND PARTICIPANTS
This comparative effectiveness study comprised a large, multicenter, US-based cohort from the Premier Healthcare Database between January 1, 2016, and December 31, 2020. It included 1383 adult patients admitted to intensive or intermediate care units with a diagnosis of thyroid storm per International Statistical Classification of Diseases and Related Health Problems, Tenth Revision codes and treated with either propylthiouracil or methimazole. Analyses were conducted from July 2022 to February 2023.
EXPOSURE
Patients received either propylthiouracil or methimazole for treatment of thyroid storm. Exposure was assigned based on the initial thionamide administered.
MAIN OUTCOMES AND MEASURES
The primary outcome was the adjusted risk difference of in-hospital death or discharge to hospice between patients treated with propylthiouracil and those treated with methimazole, assessed by targeted maximum likelihood estimation.
RESULTS
A total of 1383 patients (656 [47.4%] treated with propylthiouracil; mean [SD] age, 45 [16] years; 473 women [72.1%]; and 727 [52.6%] treated with methimazole; mean [SD] age, 45 [16] years; 520 women [71.5%]) were included in the study. The standardized mean difference for age was 0.056, and the standardized mean difference for sex was 0.013. The primary composite outcome occurred in 7.4% of of patients (102 of 1383; 95% CI, 6.0%-8.8%). A total of 8.5% (56 of 656; 95% CI, 6.4%-10.7%) of patients who initiated propylthiouracil and 6.3% (46 of 727; 95% CI, 4.6%-8.1%) who initiated methimazole died in the hospital (adjusted risk difference, 0.6% [95% CI, -1.8% to 3.0%]; Pā=ā.64). There were no significant differences in duration of organ support, total hospitalization costs, or rates of adverse events between the 2 treatment groups.
CONCLUSION AND RELEVANCE
In this comparative effectiveness study of a multicenter cohort of adult patients with thyroid storm, no significant differences were found in mortality or adverse events in patients who were treated with propylthiouracil or methimazole. Thus, current guidelines recommending propylthiouracil over methimazole for treatment of thyroid storm may merit reevaluation.
Topics: Adult; Humans; Female; Middle Aged; Methimazole; Propylthiouracil; Thyroid Crisis; Antithyroid Agents; Critical Illness; Hospital Mortality
PubMed: 37067797
DOI: 10.1001/jamanetworkopen.2023.8655 -
Journal Der Deutschen Dermatologischen... Feb 2022
Topics: Antibodies, Antineutrophil Cytoplasmic; Humans; Propylthiouracil; Vasculitis
PubMed: 34951512
DOI: 10.1111/ddg.14654 -
Report on Carcinogens : Carcinogen... 2011
Topics: Animals; Antimetabolites; Antithyroid Agents; Carcinogens; Humans; Neoplasms; Propylthiouracil
PubMed: 21863091
DOI: No ID Found -
The Cochrane Database of Systematic... Oct 2005Randomised clinical trials have addressed the question whether propylthiouracil has any beneficial effects in patients with alcoholic liver disease. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Randomised clinical trials have addressed the question whether propylthiouracil has any beneficial effects in patients with alcoholic liver disease.
OBJECTIVES
To assess the beneficial and harmful of propylthiouracil for patients with alcoholic liver disease.
SEARCH STRATEGY
The Cochrane Hepato-Biliary Group Controlled Trials Register (May 2005), The Cochrane Central Register of Controlled Trials in The Cochrane Library (Issue 2, 2005), MEDLINE (1950 to May 2005), EMBASE (1980 to May 2005), and The Web of Science (May 2005) were searched. These electronic searches were combined with full text searches. Manufacturers and researchers in the field were also contacted.
SELECTION CRITERIA
Randomised clinical trials studying patients with alcoholic steatosis, alcoholic fibrosis, alcoholic hepatitis, and/or alcoholic cirrhosis were included irrespective of blinding, publication status, or language. Interventions encompassed propylthiouracil at any dose versus placebo or no intervention.
DATA COLLECTION AND ANALYSIS
All analyses were performed according to the intention-to-treat method in RevMan Analyses. The methodological quality of the randomised clinical trials was evaluated by components (generation of the allocation sequence; allocation concealment; double blinding; follow-up).
MAIN RESULTS
Combining the results of six randomised clinical trials including 710 patients demonstrated no significant effects of propylthiouracil versus placebo on all-cause mortality (relative risks (RR) 0.93, 95% confidence interval (CI) 0.66 to 1.30), liver-related mortality (RR 0.80, 95% CI 0.50 to 1.29), complications of the liver disease, or liver histology. Propylthiouracil was associated with a non-significant increased risk of non-serious adverse events and with the seldom occurrence of serious adverse events (leukopenia).
AUTHORS' CONCLUSIONS
We could not demonstrate any significant beneficial effect of propylthiouracil on all-cause mortality, liver-related mortality, liver complications, and liver histology of patients with alcoholic liver disease. Propylthiouracil was associated with adverse events. Confidence intervals were wide. Accordingly, there is no evidence for using propylthiouracil for alcoholic liver disease outside randomised clinical trials.
Topics: Antimetabolites; Humans; Liver Diseases, Alcoholic; Propylthiouracil; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 16235302
DOI: 10.1002/14651858.CD002800.pub2 -
The Cochrane Database of Systematic... 2002Alcohol is the most common cause of liver disease in the Western world today. Randomised clinical trials have addressed the question whether propylthiouracil has any... (Review)
Review
BACKGROUND
Alcohol is the most common cause of liver disease in the Western world today. Randomised clinical trials have addressed the question whether propylthiouracil has any efficacy in patients with alcoholic liver disease.
OBJECTIVES
The objectives were to assess the efficacy of propylthiouracil on mortality, clinical symptoms and complications, liver biochemistry, and liver histology in patients with alcoholic liver disease. Adverse events were also analysed.
SEARCH STRATEGY
The Cochrane Hepato-Biliary Group Controlled Trials Register (searched July 2001), The Cochrane Controlled Trials Register (Cochrane Library Issue 3, 2001), MEDLINE (January 1966 to July 2001), EMBASE (January 1985 to July 2001) were searched. These electronic searches were combined with full text searches. Manufacturers and researchers in the field were also contacted.
SELECTION CRITERIA
Randomised clinical trials studying patients with alcoholic steatosis, alcoholic fibrosis, alcoholic hepatitis, and/or alcoholic cirrhosis were included. Interventions encompassed propylthiouracil at any dose versus placebo or no intervention. The trials could be double-blind, single-blind, or unblinded. The trials could be unpublished or published as an article, an abstract, or a letter and no language limitations were applied.
DATA COLLECTION AND ANALYSIS
All analyses were performed according to the intention-to-treat method. The statistical package (RevMan and MetaView) provided by the Cochrane Collaboration was used. The methodological quality of the randomised clinical trials was evaluated by components of quality and the Jadad-scale.
MAIN RESULTS
Combining the results of six randomised clinical trials including 710 patients demonstrated no significant effects of propylthiouracil versus placebo on mortality (Peto odds ratio (OR) 0.91, 95% confidence interval (CI) 0.59 to 1.40), liver related mortality (OR 0.78, 95% CI 0.45 to 1.33), complications of the liver disease (OR 1.14, 95% CI 0.58 to 2.24), or liver histology. Propylthiouracil was associated with a non significant trend towards an increased risk of non-serious adverse events (OR 1.49, 95% CI 0.74 to 2.99) and with the seldom occurrence of serious adverse events (leukopenia).
REVIEWER'S CONCLUSIONS
This systematic review could not demonstrate any significant efficacy of propylthiouracil on any clinically important outcomes (mortality, liver related mortality, liver complications, and liver histology) of patients with alcoholic liver disease and propylthiouracil was associated with adverse events. Accordingly, there is no evidence for using propylthiouracil for alcoholic liver disease outside randomised clinical trials.
Topics: Antimetabolites; Humans; Liver Diseases, Alcoholic; Propylthiouracil; Randomized Controlled Trials as Topic
PubMed: 12076451
DOI: 10.1002/14651858.CD002800 -
Journal of the National Medical... Jan 1991The case of a 43-year-old female with propylthiouracil-induced hepatitis is reported. The case is unique because the patient's liver function deteriorated 2 weeks after...
The case of a 43-year-old female with propylthiouracil-induced hepatitis is reported. The case is unique because the patient's liver function deteriorated 2 weeks after medication was discontinued.
Topics: Adult; Chemical and Drug Induced Liver Injury; Female; Graves Disease; Humans; Liver Function Tests; Propylthiouracil
PubMed: 1994070
DOI: No ID Found -
Allergy Aug 2004
Topics: Adult; Asthma; Drug Hypersensitivity; Female; Humans; Hyperthyroidism; Propylthiouracil
PubMed: 15230825
DOI: 10.1111/j.1398-9995.2004.00427.x -
Archives of Internal Medicine Nov 1985
Topics: Adult; Chemical and Drug Induced Liver Injury; Child; Female; Humans; Male; Propylthiouracil
PubMed: 4062471
DOI: No ID Found -
The Medical Journal of Australia Jun 2019
Topics: Carbimazole; Female; Graves Disease; Humans; Middle Aged; Propylthiouracil; Thyroidectomy; Vasculitis, Leukocytoclastic, Cutaneous
PubMed: 31124148
DOI: 10.5694/mja2.50198 -
CMAJ : Canadian Medical Association... Oct 1987
Topics: Breast Feeding; Female; Humans; Milk, Human; Propylthiouracil
PubMed: 3651938
DOI: No ID Found