Sex and Gender Differences in Clinical Pharmacology: Implications for Transgender Medicine

Cirrincione, Lauren R.; Huang, Kai J.

doi:10.1002/cpt.2234

Cited by 33 publications

(34 citation statements)

References 94 publications

(194 reference statements)

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“…In a timely and landmark state‐of‐the‐art review, Cirrincione and Huang 2 provide an in‐depth assessment of sex‐ and gender‐related differences in clinical pharmacology and their implications for transgender medicine. Despite the fact that 25 million people aged 15 years and older worldwide are transgender and that this population is growing, transgender medicine is still an evolving and relatively young discipline and there is a lack of clinical pharmacology data in transgender individuals.…”

Section: Figurementioning

confidence: 99%

Diversity in Clinical Pharmacology and Therapeutics

Graaf

2021

Clin Pharma and Therapeutics

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Section: Figurementioning

confidence: 99%

Diversity in Clinical Pharmacology and Therapeutics

Graaf

2021

Clin Pharma and Therapeutics

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“…Transgender people (TG) represent a sub-group of population with a gender identity that differs from the assigned sex at birth [1]. They may show binary gender identities (i.e., TG men or TG women) or nonbinary; this last is an umbrella term entailing gender identities falling outside the binary gender frame.…”

Section: Introductionmentioning

confidence: 99%

Risk Assessment of Transgender People: Development of Rodent Models Mimicking Gender-Affirming Hormone Therapies and Identification of Sex-Dimorphic Liver Genes as Novel Biomarkers of Sex Transition

Tassinari¹,

Tammaro²,

Lori³

et al. 2022

Preprint

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Transgender (TG) describes individuals whose gender identity differs from the social norms. Some TG people undergo gender-affirming hormone therapy (HT) and may be considered as a sub-group of population susceptible to environmental contaminants for their targets and modes of action. Aim of the work is to set appropriate HT doses and identify specific biomarkers to implement TG animal models. Four adult rats/group/sex are subcutaneously exposed to 3 doses of HT (plus control) selected starting from available data. Demasculinizing-feminizing model (dMF): β-estradiol plus cyproterone acetate: 0.09+0.33, 0.09+0.93 and 0.18+0.33 mg, 5 times/week. Defeminizing-masculinizing model (dFM): testosterone 0.45, 0.95 and 2.05 mg, 2 times/week. Clitoral gain and sperm count, histophatological analysis of reproductive organs and liver, hormone serum levels and gene expression of sex-dimorphic CYP450 are evaluated. In dMF model, the selected doses, leading to T serum levels at the range of the corresponding cisgender, induced strong general toxicity and cannot be used in long-term studies. In dFM model, 0.45 mg of testosterone represents the correct dose. In addition, the endpoints selected are considered suitable and reliable to implement the animal model. The sex-specific CYP expression is a suita-ble biomarker to set proper (de)masculinizing/(de)feminizing HT and to implement TG animal models.

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“…6 Although it is unclear whether hormone therapy influences kidney function directly, it typically causes marked physiologic and body composition changes within months after initiation among transgender adults. 7 Increased or decreased percent lean muscle mass, and corresponding increases or decreases in serum creatinine concentrations, may alter creatinine-based kidney function estimating equations. [8][9][10][11][12] Because estimating equations include a sex-based modifier to account for average body composition differences between sexes, [13][14][15] clinicians have recommended using equations based on gender identity, rather than one's sex assigned at birth, among transgender adults undergoing hormone therapy.…”

Section: Introductionmentioning

confidence: 99%

A Retrospective Analysis of Creatinine-Based Kidney Function With and Without Sex Assigned at Birth Among Transgender Adults

et al. 2021

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Background Clinicians use sex-based kidney function estimating equations, but the appropriate sex modifier for transgender adults undergoing hormone therapy (HT) is undetermined. Objectives Compare median estimated creatinine clearance (eCrCL; Cockcroft-Gault) and estimated glomerular filtration rates (eGFRs; Modification of Diet in Renal Disease [MDRD] and Chronic Kidney Disease Epidemiology Study [CKD-EPI]) before and during HT when estimated with and without sex assigned at birth. Methods Single-system retrospective cohort study of transgender adults (2007-2017) prescribed ≥90 days HT (index date = first order) and measured serum creatinine ≤6 months pre-index date (baseline) and ≤12 months post-index date. We grouped patients based on testosterone or estrogen treatment and compared eCrCL and eGFRs at baseline up to 6-12 months post-index date using equations based on sex assigned at birth (female or male modifier in testosterone or estrogen groups, respectively) or gender identity (male or female modifier in testosterone or estrogen groups, respectively). We used Wilcoxon signed-rank tests (Bonferroni correction) for all comparisons. Results In total, 29 (median age 26 years, follow-up 259 days) and 41 patients (29 years, 250 days) were prescribed testosterone or estrogen, respectively. In the testosterone group, the maximum eCrCL and eGFR changes based on sex assigned at birth were −14%, P = 0.0181; −18%; P = 0.0009, respectively, and based on gender identity were +5%, P > 0.025 and +11%, P = 0.0094, respectively. In the estrogen group, eCrCL or eGFRs based on sex assigned at birth did not change from baseline but based on gender identity were −17%, P < 0.0001 and −26%, P < 0.0001, respectively. Conclusion and Relevance Female-based equations may underestimate kidney function in transgender adults undergoing testosterone or estrogen treatment. Prospective cohort studies are needed to confirm the clinical significance of these findings.

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Sex and Gender Differences in Clinical Pharmacology: Implications for Transgender Medicine

Cited by 33 publications

References 94 publications

Diversity in Clinical Pharmacology and Therapeutics

Diversity in Clinical Pharmacology and Therapeutics

Risk Assessment of Transgender People: Development of Rodent Models Mimicking Gender-Affirming Hormone Therapies and Identification of Sex-Dimorphic Liver Genes as Novel Biomarkers of Sex Transition

A Retrospective Analysis of Creatinine-Based Kidney Function With and Without Sex Assigned at Birth Among Transgender Adults

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