Hormone Replacement Therapy In Patients Research Articles

Analysis of the Effects and Incidence of Adverse Reactions of Hormone Replacement Therapy for Perimenopausal Syndrome

Objective: To introduce hormone replacement therapy for patients with perimenopausal syndrome and observe its clinical application effect. Methods: Patients with perimenopausal syndrome were the subjects of this study, with a total of 110 participants clinically admitted from January 2022 to December 2023. Upon enrollment, patients were divided into groups based on differences in treatment modes. The observation group (n = 55) received routine health care combined with hormone replacement therapy, while the control group (n = 55) received only routine health care treatment. Evaluation criteria included psychological state, symptom scores, improvement in hormone levels, and the incidence of adverse reactions. The clinical effects of different treatment options were compared. Results: Post-treatment, scores of the Self-Rating Anxiety Scale (SAS) and the Self-Rating Depression Scale (SDS) in the observation group were significantly lower than those in the control group (P < 0.05). Additionally, the female menopausal syndrome self-diagnosis assessment scale (Kupperman) score was 12.31 ± 1.25 points in the observation group compared to 15.22 ± 1.84 points in the control group (t = 9.7018, P < 0.05). Furthermore, levels of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) were lower in the observation group than in the control group, while estradiol (E2) and progesterone levels were higher in the observation group than in the control group (P < 0.05). There was no statistically significant difference in the total incidence of adverse reactions between the observation and control groups (P > 0.05). Conclusion: The application of hormone replacement therapy in Chinese medicine can improve patients’ mental state, alleviate clinical symptoms, and restore hormone levels. This treatment modality is deemed safe with minimal adverse reactions, thus offering positive value.

Study of patient satisfaction with thyroid hormone replacement therapy in patients with hypothyroidism

Study of patient satisfaction with thyroid hormone replacement therapy in patients with hypothyroidism

Postoperative hypothalamic-pituitary dysfunction and long-term hormone replacement in patients with childhood-onset craniopharyngioma.

Hypothalamic-pituitary axis dysfunction is a common complication in post-operative craniopharyngioma(CP) patients, and it greatly impacts the long-term quality of life of such patients. To better understand the effects of postoperative hypothalamic-pituitary dysfunction and long-term hormone replacement therapy in patients with childhood CP, we assessed approximately 200 patients with childhood-onset CP postoperatively. Clinical details of patients with childhood-onset CP who underwent sellar tumor resection in Beijing Children's Hospital and Beijing Tiantan Hospital from 2018 to 2019 were retrieved retrospectively. The participants were followed up to assess the effects of post-operative long-term hormone replacement therapy and assess the tumor recurrence rate. The median age of admission was 8.1 (1.8, 14.3) years. Headache (45.5%), visual impairment (39.5%), and nausea (33.0%) were the most common clinical manifestations. ACP accounted for 95% of all CP cases. The incidence of central adrenal insufficiency and central hypothyroidism within the first week after surgery was 56.2% and 70.3%, respectively. At the same time 85.5% of the patients required at least one dose of desmopressin to control urine output. Total survival and tumor recurrence rates were 98.6% and 26.1%, respectively, with a median follow-up time of 29.7 (19.0, 40.3) months. During the follow-up period, 28.1% patients met the diagnostic criteria for short stature, while 54.4% fit the criteria for obesity. In addition, 94.4% of the patients were taking at least one kind of hormone substitution, and 74.7% were taking three or more. The prevalence of levothyroxine, glucocorticoid, desmopressin, and growth hormone replacement therapy was 87.3%, 77.5%, 78.9% and 31.0%, respectively. The proportion of patients treated with the substitutive combination of levothyroxine, hydrocortisone, and desmopressin was 54.9%. This study is a large-sample systematic postoperative endocrine function evaluation of patients with childhood-onset CP. Due to the high prevalence of post-operative hypothalamic-pituitary dysfunction, patients with CP usually require long-term multiple hormone substitution therapy. Individualized management and accurate hormone replacement dosage for postoperative childhood-onset CP patients are of great importance.

FEATURES OF MENOPAUSE MANAGEMENT AS AN AGING PREVENTION (review article)

Menopause is a physiological transition period in a woman’s life from the reproductive phase with regular ovulatory cycles and corresponding cyclic changes in the reproductive system to the postmenopausal state. The modern concept of female reproductive aging is to recognize the leading role of depletion of the ovarian follicular apparatus. Climacteric syndrome (CS) is the earliest and most common complication of the menopausal period. Most of the pathological manifestations that occur during peri- and postmenopausal periods are associated with an estrogen deficiency state and are subject to correction by hormone replacement therapy (HRT). In addition, in postmenopause the frequency of many diseases that reflect the biological aging of the body increases. Therefore, in order to develop optimal HRT regimens and understand the role of a rational lifestyle in the correction of these manifestations, it is necessary to consider the evolution of views on the menopause in general and HRT in particular. Until now, there has been no consensus regarding the tactics of a differentiated approach when prescribing HRT, taking into account existing systemic disorders in women with a history of “diseases of civilization.” Individualization of HRT in patients with a history of impaired reproductive function should be determined not only by the clinical variability of the manifestations of CS, but also taking into account the presence of extragenital pathology, which requires the implementation of our proposed diagnostic algorithm and the basis for the development of such a HRT strategy.

Short-term Impact of Hormone Replacement Therapy on Risk of Breast Cancer in BRCA Mutation Carriers: A Nationwide Study in South Korea.

BRCA1/2 mutations are well-known risk factors for breast and ovarian cancers in women. Risk-reducing salpingo-oophorectomy (RRSO) is the standard treatment for preventing ovarian cancer with BRCA mutations. Postmenopausal syndrome (symptoms after RRSO can be alleviated by hormone replacement therapy (HRT); however, the use of HRT in carriers of BRCA mutations has been controversial because of the concern that HRT increases the risk of breast cancer. This study aimed to evaluate the effects of HRT in BRCA mutation carriers who underwent RRSO. A total of 151 carriers, who underwent RRSO between 2013 and 2020 after the diagnosis of BRCA1 or BRCA2 mutations were selected and followed up for a median of 3.03 years. Patients were divided into two groups: those who received HRT after RRSO (n=33) and those who did not (n=118). We compared the incidence of breast cancer over time between these two groups. There was no significant difference in the incidence of breast cancer between women who received HRT and those who did not (p=0.229). Multivariate logistic regression analysis, adjusted for age and parity revealed no significant difference in the risk of breast cancer between these two groups (hazard ratio, 0.312; 95% confidence interval, 0.039 to 2.480; p=0.278). In this study, we found no relationship between post-RRSO HRT and breast cancer in the population with BRCA mutations. Therefore, healthcare providers may consider the alleviation of symptoms of postmenopausal syndrome through HRT in patients who underwent RRSO.

P-612 Comparison the effectiveness and safety of letrozole-stimulated and hormone replacement treatment in endometrial preparation for frozen embryo transfer in patients with polycystic ovary syndrome

Abstract Study question Whether letrozole-stimulated protocol has advantages over hormone replacement therapy (HRT) in frozen embryo transfer in patients with polycystic ovary syndrome (PCOS)? Summary answer Letrozole-stimulated protocol is more suitable for endometrial preparation than HRT in patients with PCOS, which can increase the live birth rate and reduce pregnancy complications. What is known already The current routine endometrial preparation protocol for women with PCOS is HRT. However, HRT is expensive, and recent studies have found HRT may increase the risk of adverse maternal and neonatal complications such as hypertensive disorders of pregnancy. Letrozole induces mono-ovulatory and has no antiestrogenic effect, and has been found to increase live birth rate compared with clomiphene in fresh embryo cycles. However, Letrozole is rarely used in frozen embryo cycles. Whether letrozole-stimulated protocol is suitable for frozen embryo transfer in patients with PCOS and for whom is suitable is still lack of evidence. Study design, size, duration This is a retrospective cohort study involving all frozen embryo transfer cycles with letrozole-stimulated and HRT for PCOS during the period from August 2018 to December 2020 at a tertiary care center. Participants/materials, setting, methods A total of 2011 letrozole-stimulated cycles and 2211 HRT cycles were included in the analysis. Multivariate Logistic regression was used to analyze the differences in clinical pregnancy rate, live birth rate, miscarriage rate, the incidence of other pregnancy and obstetric outcomes between letrozole-stimulated protocol and HRT after adjusting for possible confounding factors. Subgroup analysis was used to explore the population for which letrozole-stimulated protocol was suitable. Main results and the role of chance After adjusting for confounding, letrozole-stimulated protocol increased the clinical pregnancy rate (OR,1.44; 95%CI,1.21-1.70), live birth rate (OR,1.49; 95%CI,1.27-1.74) and reduced the incidence of miscarriage (OR, 0.71; 95%CI,0.55-0.92), hypertensive disorders of pregnancy (OR, 0.66; 95%CI,0.45,0.98), gestational diabetes mellitus (OR,0.75; 95%CI,0.57,0.98) and cesarean section (OR,0.78; 95%CI,0.61,0.99) than HRT. There were no significant differences in other outcomes such as preterm birth, small for gestational age, and large for gestational age between the two endometrial preparation protocols. Subgroup analysis according to maternal age, BMI, insulin resistance and PCOS classification showed that the live birth rate of letrozole-stimulated protocol was significantly higher than that of HRT in all subgroups. Limitations, reasons for caution This study is a retrospective study, the population characteristics of the two endometrial preparation protocols existed differences. Although multivariate logistic regression was used to adjust some factors, the interference of known and unknown factors on the outcomes cannot be completely avoided. Wider implications of the findings This retrospective study found letrozole-stimulated protocol has more advantages than HRT, which can improve the live birth rate and reduce the incidence of hypertensive disorders of pregnancy, gestational diabetes mellitus in patients with PCOS. High-quality well-powered randomised clinical trials and possible mechanistic studies are needed to further validate this conclusion. Trial registration number NA

Cognitive impairment in patients with hypothyroidism and possibilities of its correction

Aim. To identify and correct cognitive impairment in patients with hypothyroidism.Materials and methods. The study included 76 patients with primary hypothyroidism. All patients were divided into 2 groups: compensated and decompensated hypothyroidism. In addition to general clinical, and hormonal blood tests all participants in the study underwent ultrasound of the thyroid gland and ECG, the neurophysiological study of cognitive evoked potentials, and testing according to the Montreal cognitive function assessment scale.Results. In the majority of patients with a lack of thyroid hormones, cognitive impairments were detected, which increase with worsening compensation for hypothyroidism according to the results of Montreal Cognitive Assessment Scale testing. The study of evoked potentials in patients with hypothyroidism revealed an increase in latency and a decrease in the amplitude of the P300 indicator, indicating the presence of cognitive deficit. The addition of ethylmethylhydroxypyridine succinate to hormone replacement therapy in patients with hypothyroidism significantly improves cognitive performance more than hormone monotherapy.Conclusions. This study showed the need to identify cognitive impairments in patients with primary hypothyroidism, and their correction with the help of complex therapy increases the cognitive potential and the effectiveness of their treatment.

Multicenter retro-prospective observational study on chronic hypoparathyroidism and rhPTH (1–84) treatment

PurposeThe main purpose of this study was to investigate the effects of 12 months of rhPTH (1–84) (Natpar®) treatment in a cohort of patients selected according to the indications of hypoparathyroidism guidelines. The use of recombinant human PTH (1–84) [rhPTH (1–84)] is approved as hormonal replacement therapy in patients with hypoparathyroidism not adequately controlled with conventional therapy.MethodsIt is a multicenter, observational, retro-prospective, open label study. Eleven Italian Endocrinological centers, members of Hypoparathyroidism Working Group of the Italian Society of Endocrinology (HypoparaNET) were involved. Main outcome measures were serum and urinary calcium and phosphate concentration, calcium-phosphate product, renal function, oral calcium and vitamin D doses, and clinical manifestations.ResultsFourteen adult subjects, affected by chronic hypoparathyroidism, were treated with rhPTH (1–84) for 12 months. At 12 months of rhPTH (1–84) treatment, 61.5% of patients discontinued calcium supplement and 69.2% calcitriol. Mean albumin-adjusted total serum calcium levels quickly normalized after initiation of rhPTH (1–84) treatment compared to baseline (p = 0.009), remaining in the normal range until 12 months. Rare hypo-hypercalcemia episodes were reported. Renal function was maintained normal and no renal complications were reported. Serum and urinary phosphate and urinary calcium were maintained in the normal range. Mean phosphatemia levels linearly decreased from 3 months up to 12 months compared to baseline (p = 0.014). No severe adverse events were described.ConclusionsBiochemical and clinical results confirm the efficacy and safety of rhPTH (1–84) therapy, which represents an important option for hypoparathyroid patients unresponsive to conventional therapy.

Prevalence of hypothyroidism and effect of thyroid hormone replacement therapy in patients with non-alcoholic fatty liver disease: A population-based study.

BACKGROUNDNon-alcoholic fatty liver disease (NAFLD) is currently considered as the most common cause of chronic liver disease worldwide. Risk factors for NAFLD have been well-described, including obesity, type 2 diabetes mellites (T2DM), dyslipidemia (DLP) and metabolic syndrome. Hypothyroidism has been identified as an independent risk factor for the development of NAFLD, although the literature is inconsistentAIMTo evaluate the prevalence of hypothyroidism in patients with NAFLD, assess if it is an independent risk factor and explore the effect of thyroxine replacement therapy.METHODSOur cohort’s data was obtained using a validated, large, multicenter database (Explorys Inc, Cleveland, OH, United States) aggregated from pooled outpatient and inpatient records of 26 different healthcare systems, consisting of a total of 360 hospitals in the United States, and utilizing Systematized Nomenclature of Medicine-Clinical Terms for coding. We evaluated a cohort of patients with hypothyroidism and NAFLD. Multivariate analysis was performed to adjust for confounding risk factors including hypertension (HTN), T2DM, DLP, obesity and metabolic syndrome. SPSS version 25, IBM Corp was used for statistical analysis, and for all analyses, a 2-sided P value of < 0.05 was considered statistically significant. Exclusion criteria were limited to age < 18 years.RESULTSAmong the 37648180 included individuals in this database who are above the age of 18 years, there were a total of 2320 patients with NAFLD (6.16 per 100000) in the last five years (2015-2020), amongst which 520 patients (22.4%) had hypothyroidism. Baseline characteristics of patients in this database are described in Table 1. Patients with NAFLD were also more likely to have obesity, T2DM, DLP, HTN, and metabolic syndrome (Table 2). While males and females were equally affected, patients in the age group 18-65 years as well as Caucasians seem to be at a higher risk. There was an increased risk of NAFLD among patients with hypothyroidism (OR = 1.587). Furthermore, thyroid hormone replacement was not associated with a decreased risk for developing NAFLD (OR = 1.106, C = 0.952-1.285, P = 0.303).CONCLUSIONHypothyroidism seems to be an independent risk factor for the development of NAFLD. Thyroid hormone replacement did not provide a statistically significant risk reduction. Further studies are needed to evaluate the effect of thyroid hormone replacement and assess if being euthyroid while on thyroid replacement therapy affects development and/or progression of NAFLD.

Impact of endometrial preparation on early pregnancy loss and live birth rate after frozen embryo transfer: a large multicenter cohort study (14 421 frozen cycles).

STUDY QUESTIONDoes the endometrial preparation protocol (artificial cycle (AC) vs natural cycle (NC) vs stimulated cycle (SC)) impact the risk of early pregnancy loss and live birth rate after frozen/thawed embryo transfer (FET)?SUMMARY ANSWERIn FET, ACs were significantly associated with a higher pregnancy loss rate and a lower live birth rate compared with SC or NC.WHAT IS KNOWN ALREADYTo date, there is no consensus on the optimal endometrial preparation in terms of outcomes. Although some studies have reported a higher pregnancy loss rate using AC compared with NC or SC, no significant difference was found concerning the pregnancy rate or live birth rate. Furthermore, no study has compared the three protocols in a large population.STUDY DESIGN, SIZE, DURATIONA multicenter retrospective cohort study was conducted in nine reproductive health units in France using the same software to record medical files between 1 January 2012 and 31 December 2016. FET using endometrial preparation by AC, modified NC or SC were included. The primary outcome was the pregnancy loss rate at 10 weeks of gestation. The sample size required was calculated to detect an increase of 5% in the pregnancy loss rate (21–26%), with an alpha risk of 0.5 and a power of 0.8. We calculated that 1126 pregnancies were needed in each group, i.e. 3378 in total.PARTICIPANTS/MATERIALS, SETTING, METHODSData were collected by automatic extraction using the same protocol. All consecutive autologous FET cycles were included: 14 421 cycles (AC: n = 8139; NC: n = 3126; SC: n = 3156) corresponding to 3844 pregnancies (hCG > 100 IU/l) (AC: n = 2214; NC: n = 812; SC: n = 818). Each center completed an online questionnaire describing its routine practice for FET, particularly the reason for choosing one protocol over another.MAIN RESULTS AND THE ROLE OF CHANCEAC represented 56.5% of FET cycles. Mean age of women was 33.5 (SD ± 4.3) years. The mean number of embryos transferred was 1.5 (±0.5). Groups were comparable, except for history of ovulation disorders (P = 0.01) and prior delivery (P = 0.03), which were significantly higher with AC. Overall, the early pregnancy loss rate was 31.5% (AC: 36.5%; NC: 25.6%; SC: 23.6%). Univariable analysis showed a significant association between early pregnancy loss rate and age >38 years, history of early pregnancy loss, ovulation disorders and duration of cryopreservation >6 months. After adjustment (multivariable regression), the early pregnancy loss rate remained significantly higher in AC vs NC (odds ratio (OR) 1.63 (95% CI) [1.35–1.97]; P < 0.0001) and in AC vs SC (OR 1.87 [1.55–2.26]; P < 0.0001). The biochemical pregnancy rate (hCG > 10 and lower than 100 IU/l) was comparable between the three protocols: 10.7% per transfer.LIMITATIONS, REASONS FOR CAUTIONThis study is limited by its retrospective design that generates missing data. Routine practice within centers was heterogeneous. However, luteal phase support and timing of embryo transfer were similar in AC. Univariable analysis showed no difference between centers. Moreover, a large number of parameters were included in the analysis.WIDER IMPLICATIONS OF THE FINDINGSOur study shows a significant increase in early pregnancy loss when using AC for endometrial preparation before FET. These results suggest either a larger use of NC or SC, or an improvement of AC by individualizing hormone replacement therapy for patients in order to avoid an excess of pregnancy losses.STUDY FUNDING/COMPETING INTEREST(S)The authors declare no conflicts of interest in relation to this work. G.P.-B. declares consulting fees from Ferring, Gedeon-Richter, Merck KGaA, Theramex, Teva; Speaker’s fees or equivalent from Merck KGaA, Ferring, Gedeon-Richter, Theramex, Teva. N.C. declares consulting fees from Ferring, Merck KGaA, Theramex, Teva; Speaker’s fees or equivalent from Merck KGaA, Ferring. C.R. declares a research grant from Ferring, Gedeon-Richter; consulting fees from Gedeon-Richter, Merck KGaA; Speaker’s fees or equivalent from Merck KGaA, Ferring, Gedeon-Richter; E.M.d’A. declares Speaker’s fees or equivalent from Merck KGaA, MSD, Ferring, Gedeon-Richter, Theramex, Teva. I.C-D. declares Speaker’s fees or equivalent from Merck KGaA, MSD, Ferring, Gedeon-Richter, IBSA. N.M. declares a research grant from Merck KGaA, MSD, IBSA; consulting fees from MSD, Ferring, Gedeon-Richter, Merck KGaA; Speaker’s fees or equivalent from Merck KGaA, MSD, Ferring, Gedeon-Richter, Teva, Goodlife, General Electrics.TRIAL REGISTRATION NUMBERN/A.

Associations among FT4 level, FT3/FT4 ratio, and non-alcoholic fatty liver disease in Chinese patients with hypopituitarism.

Non-alcoholic fatty liver disease (NAFLD) is the most common hepatic metabolic disorder. Thyroid function is associated with NAFLD in different populations; however, little attention has been paid in patients with hypopituitarism. To analyze the association between thyroid function and NAFLD, we included 134 patients with hypopituitarism admitted to the Tianjin Medical University General Hospital between June 2013 and May 2019. Participants were divided into the NAFLD(-) and NAFLD(+) groups based on abdominal ultrasonography findings. We evaluated 68 male and 66 female patients with hypopituitarism. The prevalence of NAFLD was 52.24%. The NAFLD(+) group had a significantly higher free triiodothyronine/free thyroxine (FT3/FT4) ratio than the NAFLD(-) group (p = 0.003). The NAFLD(+) group showed significantly lower levels of FT4 and the growth hormone (GH) than the NAFLD(-) group (p = 0.003 and 0.016, respectively). We observed an association of the FT4 level and FT3/FT4 ratio with NAFLD in the univariate model, which was non-significant after adjustment for metabolic parameters (BMI, HDL-C, triglycerides, serum uric acid, blood pressure, fasting glucose). To better understand the role of each metabolic parameters, we performed additional models for each of those predictors individually after adjustment for age and gender, the association between FT4 level and FT3/FT4 ratio lost significance after adjustment for HDL-C and TG, but not for other predictors. Our findings suggest that thyroid dysfunction may be crucially involved in NAFLD by regulating whole-body metabolism, especially lipid utilization. Therefore, sufficient thyroid hormone replacement therapy for patients with hypopituitarism is recommended from the early stage.

Estrogen and Progesterone Therapy and Meningiomas

Meningiomas are common intracranial tumors with a female predominance. Their etiology is still poorly documented. The role of sexual hormones has long been evoked, and data have been conflicting across studies. However, a dose-dependent relationship between the incidence and growth of meningiomas and hormonal treatment with the progestin cyproterone acetate (CPA) has recently been established. CPA-associated meningiomas seem to be mainly located in the anterior and middle skull base, are more likely to be multiple, may harbor P1K3CA mutations in up to one-third of cases, and are more common with a longer duration of treatment. A similar but lower risk of meningiomas has been recently reported with the use of chlormadinone acetate and nomegestrol acetate as progestin treatments. Concerning hormonal replacement therapy (HRT) in menopausal patients, evidence from epidemiological studies seem to favor an increased risk of meningiomas in treated patients although a recent study failed to show an increased growth of meningiomas in HRT treated vs nontreated patients. Until larger studies are available, it seems wise to recommend avoiding HRT in patients with meningiomas. Evidence from published data does not seem to support an increased risk of meningiomas with oral contraceptive oral contraceptive (OR) use. Data are too scarce to conclude on fertility treatments. Based on studies demonstrating the expression of hormonal receptors in meningiomas, therapies targeting these receptors have been tried but have failed to show an overall favorable clinical outcome in meningioma treatment.

Malignancies Associated with Extraovarian Endometriosis: A Literature Review

Endometriosis-associated ovarian malignancies have been well documented. Although these malignancies also occur as extraovarian lesions, little is known about them. Thus, this literature review aimed to further explore these rarely experienced tumors. A total of 257 published cases between April 1990 and April 2020 were found using PubMed, and 212 cases were included in the analysis considering Sampson’s criteria and the history of endometriosis. We classified these cases as follows: intestine, abdominal scar, vagina and vulva, peritoneum and deep endometriosis, urinary tract, uterine cervix, and others. Age of patients, history of endometriosis, types of past hormonal therapy, symptoms, histological types, and treatment were identified. The most common tumor site was the intestine. Endometrioid carcinoma was the dominant histological type. Contrary to the ovary, clear cell carcinoma was rare in extraovarian sites. On the other hand, clear cell carcinoma represented the largest number of abdominal scars. This difference may help us to understand the development of endometriosis-related malignancies. Hormonal treatment was mentioned in 67 cases and estrogen replacement therapy in 33 cases. Although risks of estrogen therapy are still controversial, the highly differentiated histological types and hormone-dependent characteristics of endometriosis-associated malignancy should be considered. Physicians should be careful about estrogen monotherapy after hysterectomy and long-term hormone replacement therapy in patients with a history of endometriosis.

The effects of amiodarone on thyroid function in pediatric and adolescent patients.

Amiodarone-induced thyroid dysfunction is well established. The present review discusses recent literature related to the effects of amiodarone on the thyroid gland and thyroid function in pediatrics. Current guidelines in adults treated with amiodarone recommend baseline thyroid function testing followed by initiation of thyroid hormone monitoring after 3 months on therapy. Two retrospective studies to evaluate amiodarone-induced thyroid dysfunction in children and young adults reveal thyroid dysfunction as soon as 2 weeks after amiodarone initiation with a greater percentage of pediatric patients developing amiodarone-induced hypothyroidism rather than thyrotoxicosis. Although additional studies are needed to determine if AIH is associated with negative impact on growth and neurocognitive development, what is clear is that in both adults and pediatrics, there is low compliance with recommended side effect-monitoring guidelines. Pediatric patients are at similarly high risk to develop amiodarone-induced thyroid dysfunction as are adults. It is hoped that through improved education of providers and patients further research into the incidence, the potential risks of amiodarone therapy and the potential benefits of thyroid hormone replacement therapy in patients with AIH will be investigated and reported.

Association of Thyroid Hypofunction with Clinical Outcomes after Microvascular Decompression for Hemifacial Spasm

Introduction: Data regarding the association between thyroid dysfunction and hemifacial spasm (HFS) are limited. We conducted a single-center, retrospective study to investigate the predictive value of thyroid dysfunction in patients with HFS after microvascular decompression (MVD). Methods: Between July 2004 and January 2015, 156 patients who were tested for thyroid hormones after MVD for HFS were enrolled in the present study. We assessed their detailed history, clinical manifestations, serum thyroid hormone levels, and surgical outcomes. The patients were classified into low and high groups based on thyroid hormone concentrations, and clinical outcomes were evaluated in each group. Results: In a total of 156 patients with a median follow-up period of 40.9 months, the improvement rate was 87.8%. The patients were classified into low (76, 48.7%) or high (80, 51.3%) groups based on serum thyroxine (T4) levels. There was a difference between the 2 groups in terms of postoperative outcomes following MVD (p = 0.020). There were no differences in the outcomes according to serum tri-iodothyronine (T3) levels as well as other factors associated with the outcomes. Conclusions: We found that decreased serum T4 levels are associated with poor postoperative outcomes among patients with HFS. Further studies are needed to examine the clinical benefit of thyroid hormone replacement therapy for patients with suboptimal T4 concentrations as well as active thyroid hormone screening for patients with HFS.

TransCon PTH as a potential hormone replacement therapy for patients with hypoparathyroidism: PaTH forward open-label extension trial week 26 results

Searchable abstracts of presentations at key conferences in endocrinology ISSN 1470-3947 (print) | ISSN 1479-6848 (online)

TransCon PTH as a Hormone Replacement Therapy for Patients with Hypoparathyroidism: 6-Month Update from the PaTH Forward Open-Label Extension

Background: Hypoparathyroidism (HP) is characterized by insufficient levels of parathyroid hormone (PTH), resulting in hypocalcemia, hyperphosphatemia, hypercalciuria, and a reduced quality of life (QoL). PTH replacement therapy should restore physiologic levels of PTH and restore downstream physiologic levels of calcitriol, promoting independence from Ca and active vitamin D supplements and normalization of QoL.TransCon PTH is an investigational long-acting prodrug of PTH(1–34) for the treatment of HP. During the initial 4-week fixed-dose period of the PaTH Forward Trial, TransCon PTH enabled 82% of subjects to achieve independence from standard of care (SoC; no active vitamin D and Ca ≤ 500 mg/day) compared to 15% with placebo. Here, we report 6-month (Week 26) results from the open-label extension (OLE). Methods: PaTH Forward is a phase 2, double-blind, placebo-controlled trial evaluating TransCon PTH in adult HP patients treated with SoC. Subjects received fixed doses of TransCon PTH 15, 18, or 21 µg PTH(1–34)/day or placebo for 4 weeks, followed by an OLE period during which TransCon PTH dose was titrated (6–30 µg PTH[1–34]/day) per individual dosing requirement. Safety and efficacy endpoints were evaluated at predefined timepoints over the OLE. Endpoints were evaluated at Week 26 including 1) sCa, 2) 24-hour uCa, 3) independence from active vitamin D, and 4) independence from therapeutics doses of oral calcium. QoL was assessed by the SF-36 and the Hypoparathyroidism Patient Experience Scales (HPES). Results: All 59 subjects completed the initial 4-week period and continued in the OLE; 58 subjects continue in the OLE beyond 6 months (1 withdrew unrelated to safety or efficacy). TransCon PTH enabled independence from SoC (no active vitamin D and Ca ≤ 500 mg/day) in 91% of subjects and independence from all supplements (no active vitamin D and no Ca) in 76% of subjects by Week 26. Mean 24-hour uCa decreased from a baseline mean of 415 mg/24h to 178 mg/24h by Week 26 (n = 44) while maintaining sCa, and reducing sP and CaxP to fall within the normal range. The mean scores for all SF-36 summary and domains increased from below normal at baseline to within the normal range by Week 26. The HPES Symptom and Impact scores continuously improved through 26 weeks for TransCon PTH and placebo subjects switching to TransCon PTH. TransCon PTH continued to be well-tolerated with no treatment-related serious or severe adverse events. Conclusions: Results from the OLE of the PaTH Forward Trial demonstrated that TransCon PTH continued to enable independence from active vitamin D and Ca supplements for most subjects while maintaining normal sCa, sP, uCa, and demonstrating enhanced quality of life, supporting its potential as a hormone replacement therapy for patients with HP. TransCon PTH will be further evaluated in the phase 3 PaTHway Trial.

Week 26 results from the PaTH Forward Open-Label Extension Trial Support TransCon PTH as a potential hormone replacement therapy for patients with hypoparathyroidism

Week 26 results from the PaTH Forward Open-Label Extension Trial Support TransCon PTH as a potential hormone replacement therapy for patients with hypoparathyroidism

Follicular development during hormone replacement therapy in patients with premature ovarian insufficiency.

PurposeTo provide information about the relationship between follow‐up period and follicular development in patients with infertility due to premature ovarian insufficiency (POI) who are undergoing hormone replacement therapy (HRT). It is necessary to detect follicle development for artificial insemination or in vitro fertilization.MethodsThis retrospective cohort study was conducted at a university hospital in Tokyo, Japan, from April 2014 to February 2019 in 20 patients [follicular development group, 11 women (55%); non‐follicular development group, 9 women (45%)] with POI; their follicular development was followed up weekly. Background characteristics, including age, follicle‐stimulating hormone (FSH) and anti‐Mullerian hormone levels (AMH), the period from the last spontaneous menstruation to hormone replacement therapy initiation, and follow‐up period during HRT were investigated. The period without follicular development was tabulated, and the subsequent cumulative follicular development detection rate was calculated.ResultsAt least 1‐year follow‐up, the cumulative follicular development rate was 70%; follicular development was observed with a probability of 49.1% at 3 months, 33.4% at 6 months, and 8.3% at 12 months in the follow‐up period.ConclusionsThe results show that the longer the non‐follicle development period, the lower the probability of subsequent follicular development in patients with POI during HRT.

Bidirectional Interaction of Thyroid-Kidney Organs in Disease States.

Purpose Thyroid hormones play an important role in growth, development, and physiology of the kidney. The kidney plays a key role in the metabolism, degradation, and excretion of thyroid hormones and its metabolites. The aim of this study is to investigate the prevalence of disease states of thyroid-kidney organs and detecting the correlation between thyroid and kidney function abnormalities. Materials and Methods In this retrospective study, a total of forty-five patients with thyroid and kidney dysfunction were investigated. Clinical features, laboratory data at initial presentation, management, and outcomes were collected. The paper has been written based on searching PubMed and Google Scholar to identify potentially relevant articles or abstracts. Median, percentage, mean ± standard deviation (SD), and the two-tailed t-test were used for statistical analyses. The correlation between variables was assessed by Pearson's, Spearman's correlation tests and regression analyses. Results The mean ± SD of age of study patients was 48.2 ± 22.93 years (ranging from 1 to 90 years). There was no correlation between serum thyroid-stimulating hormone, free thyroxine levels with estimated glomerular filtration rate, and proteinuria. No association between antimicrosomal antibodies with estimated glomerular filtration rate was seen. Cardiovascular disease was the most common complication of overt hypothyroidism in kidney dysfunction patients. Conclusion The present study showed more prevalence of primary hypothyroidism in comparison with other thyroid dysfunctions in patients with kidney dysfunction. Reduced mean values of thyroid function profiles after treatment suggest that this thyroid disease should be considered and ameliorated with thyroid hormone replacement therapy in patients with kidney disease.