Comparative effectiveness of valproic acid in different serum concentrations for maintenance treatment of bipolar disorder: A retrospective cohort study using target trial emulation framework

Chen, Yang-Chieh Brian; Liang, Chih‐Sung; Wang, Liang‐Jen; Hung, King-Chü; Carvalho, André F.; Solmi, Marco; Vieta, Eduard; Tseng, Ping‐Tao; Lin, Pao‐Yen; Tu, Yu‐Kang; Hsu, Chih‐Wei; Lai, Edward Chia‐Cheng

doi:10.1016/j.eclinm.2022.101678

Cited by 8 publications

(20 citation statements)

References 27 publications

(51 reference statements)

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…We retrieved 3133 unique records, of which 200 were included in the review (Figure 1). All reasons for excluding records after full-text review are given in eAppendix 6 in Supplement 1.…”

Section: Resultsmentioning

confidence: 99%

“… The included studies spanned 26 fields of medicine, predominately infectious disease (43 [22%]; 27 [14%] on COVID-19), cardiology (30 [15%]), and oncology (30 [15%]) . One hundred and thirty-one studies (66%)…”

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

“…One-hundred and fifteen studies (58%) completely reported how the target trial protocol was emulated. Eighty-seven studies (44%) provided both the protocol of the target trial and described how it was emulated (Table 2). The following items of the emulation were frequently reported: eligibility criteria (193 [97%]), treatment strategies (191 [96%]), assignment procedures (173 [87%]), primary outcome (196 [98%]), the follow-up period (186 [93%]), a causal contrast (146 [73%], and an analysis plan (194 [97%]) (Table 2).…”

Section: Resultsmentioning

confidence: 99%

See 3 more Smart Citations

Reporting of Observational Studies Explicitly Aiming to Emulate Randomized Trials

Hansford,

Cashin,

Jones

et al. 2023

JAMA Netw Open

View full text Add to dashboard Cite

ImportanceObservational (nonexperimental) studies that aim to emulate a randomized trial (ie, the target trial) are increasingly informing medical and policy decision-making, but it is unclear how these studies are reported in the literature. Consistent reporting is essential for quality appraisal, evidence synthesis, and translation of evidence to policy and practice.ObjectiveTo assess the reporting of observational studies that explicitly aimed to emulate a target trial.Evidence ReviewWe searched Medline, Embase, PsycINFO, and Web of Science for observational studies published between March 2012 and October 2022 that explicitly aimed to emulate a target trial of a health or medical intervention. Two reviewers double-screened and -extracted data on study characteristics, key predefined components of the target trial protocol and its emulation (eligibility criteria, treatment strategies, treatment assignment, outcome[s], follow-up, causal contrast[s], and analysis plan), and other items related to the target trial emulation.FindingsA total of 200 studies that explicitly aimed to emulate a target trial were included. These studies included 26 subfields of medicine, and 168 (84%) were published from January 2020 to October 2022. The aim to emulate a target trial was explicit in 70 study titles (35%). Forty-three studies (22%) reported use of a published reporting guideline (eg, Strengthening the Reporting of Observational Studies in Epidemiology). Eighty-five studies (43%) did not describe all key items of how the target trial was emulated and 113 (57%) did not describe the protocol of the target trial and its emulation.Conclusion and RelevanceIn this systematic review of 200 studies that explicitly aimed to emulate a target trial, reporting of how the target trial was emulated was inconsistent. A reporting guideline for studies explicitly aiming to emulate a target trial may improve the reporting of the target trial protocols and other aspects of these emulation attempts.

show abstract

“…We retrieved 3133 unique records, of which 200 were included in the review (Figure 1). All reasons for excluding records after full-text review are given in eAppendix 6 in Supplement 1.…”

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 2 more Smart Citations

Reporting of Observational Studies Explicitly Aiming to Emulate Randomized Trials

Hansford,

Cashin,

Jones

et al. 2023

JAMA Netw Open

View full text Add to dashboard Cite

show abstract

“…Patients, heterozygous and homozygous carriers of the CYP2C9*3 (rs1057910; 1075A>C) and CYP2C9*2 (rs1799853; 430C>T) alleles, had an increased concentration of toxic VPA metabolites in plasma compared to homozygous carriers of the CYP2C9*1 allele [ 66 ]. It has been shown that elderly female patients require a 30–50% lower dose of VPA to achieve therapeutic concentrations of the drug compared to young men [ 67 ]. Studying the CYP2C9 profile in pediatric patients before starting treatment allowed us to optimize the dose of VPA and minimize exposure to suboptimal or toxic concentrations, thereby reducing the incidence of ADRs such as hyperammonemia.…”

Section: Pharmacometabolomics and Pharmacogenomics Of Valproic Acidmentioning

confidence: 99%

Therapeutic and Toxic Effects of Valproic Acid Metabolites

et al. 2023

View full text Add to dashboard Cite

Valproic acid (VPA) and its salts are psychotropic drugs that are widely used in neurological diseases (epilepsy, neuropathic pain, migraine, etc.) and psychiatric disorders (schizophrenia, bipolar affective disorder, addiction diseases, etc.). In addition, the indications for the appointment of valproate have been expanding in recent years in connection with the study of new mechanisms of action of therapeutic and toxic metabolites of VPA in the human body. Thus, VPA is considered a component of disease-modifying therapy for multiple tumors, neurodegenerative diseases (Huntington’s disease, Parkinson’s disease, Duchenne progressive dystrophy, etc.), and human immunodeficiency syndrome. The metabolism of VPA is complex and continues to be studied. Known pathways of VPA metabolism include: β-oxidation in the tricarboxylic acid cycle (acetylation); oxidation with the participation of cytochrome P-450 isoenzymes (P-oxidation); and glucuronidation. The complex metabolism of VPA explains the diversity of its active and inactive metabolites, which have therapeutic, neutral, or toxic effects. It is known that some active metabolites of VPA may have a stronger clinical effect than VPA itself. These reasons explain the relevance of this narrative review, which summarizes the results of studies of blood (serum, plasma) and urinary metabolites of VPA from the standpoint of the pharmacogenomics and pharmacometabolomics. In addition, a new personalized approach to assessing the cumulative risk of developing VPA-induced adverse reactions is presented and ways for their correction are proposed depending on the patient’s pharmacogenetic profile and the level of therapeutic and toxic VPA metabolites in the human body fluids (blood, urine).

show abstract

Alterations in salivary biochemical composition and redox state disruption induced by the anticonvulsant valproic acid in male rat salivary glands

de Freitas,

da Silva,

Fiais

et al. 2023

Archives of Oral Biology

View full text Add to dashboard Cite

Comparative effectiveness of valproic acid in different serum concentrations for maintenance treatment of bipolar disorder: A retrospective cohort study using target trial emulation framework

Cited by 8 publications

References 27 publications

Reporting of Observational Studies Explicitly Aiming to Emulate Randomized Trials

Reporting of Observational Studies Explicitly Aiming to Emulate Randomized Trials

Therapeutic and Toxic Effects of Valproic Acid Metabolites

Alterations in salivary biochemical composition and redox state disruption induced by the anticonvulsant valproic acid in male rat salivary glands

Contact Info

Product

Resources

About