Common Side Effects Research Articles

Knowledge, Awareness, And Practice Of Multidisciplinary Team (MDT) Involved In The Rehabilitation Of Head And Neck Cancer Patients Regarding Post-Radiotherapy Prosthetic Options.

BACKGROUND: Head and neck cancer (HNC) patients require specialized multidisciplinary team care throughout the diagnosis, treatment, and survival. To achieve rehabilitation goals, a multidisciplinary team (MDT) should have adequate information regarding post-radiotherapy prosthetic options. This enables optimal rehabilitation and improves their quality of life. AIM: To assess the Knowledge, awareness, and practice of a multidisciplinary team involved in the rehabilitation of Head and Neck cancer patients regarding post-radiotherapy prosthetic options. SETTINGS AND DESIGN: Descriptive survey. MATERIALS AND METHODS: The URLs of the questionnaire consisting of fifteen closed-ended questions were shared via the web to the MDT team practicing in Tamilnadu and Pondicherry, to obtain a response of 119 which was the predetermined sample size. STATISTICAL ANALYSIS: Frequency and percentages and the results were further analysed statistically by the Chi square test. RESULT: Majority of the members in the multidisciplinary team were aware of few information on the impact of common treatment side effects on prosthetic rehabilitation and prosthetic options available, but were not practicing. CONCLUSION: Prosthetic options in postradiotherapy patients provides better results in terms of retention, stability, masticatory efficiency, comfort, and psychological well-being of the patient. Hence, the awareness of MDT should be increased regarding various available options of the prosthetic rehabilitation, advantages and disadvantages of prosthesis, and possibilities for retreatment in the case of failure for a successful treatment outcome.

The Effect of Complementary Acupressure Therapy on the Incidence of Nausea and Vomiting After Regional Block Anesthesia (Spinal Anesthesia) in the Recovery Room of the Imelda Buruh Indonesia General Hospital, Medan

Postoperative nausea and vomiting is one of the common side effects of spinal anesthesia. Nausea and vomiting affect patient morbidity such as stress, discomfort, dehydration, prolonging treatment time and increasing treatment costs. This study aims to determine the effect of acupressure therapy on the incidence of nausea and vomiting after spinal anesthesia in the recovery room of the Imelda Labor Indonesia General Hospital, Medan. This type of research is a quantitative study with a quasi-experimental research method. Data reports in the province of North Sumatra, there are 25,602 patients undergoing surgery. While at the Umim Labor Indonesia Hospital, Medan, the data on surgical patients as of January-March 2024 amounted to 666 patients, 250 patients were found to have spinal anesthesia. This study was conducted in February - June 2024 at the Imelda Labor Indonesia General Hospital, Medan. A sample of 20 respondents was taken.: The results of the statistical test obtained an α value of 0.000 (α <0.05), thus it was concluded that there was an effect of acupressure therapy on the incidence of nausea and vomiting after spinal anesthesia at the Imelda Labor Indonesia General Hospital, Medan. Based on the characteristics of respondents based on age, they were in the age range of 36-40 years, which was 55%, based on gender, the majority of respondents were women, which was 60%, respondents based on a history of smoking were 65%, the distribution of respondents with a history of nausea and vomiting was 55% and the majority of respondents with an incidence of nausea and vomiting was 60%. The recommendation for this study is that acupressure therapy can be applied in nursing practice so that patients are able to do it independently. For the Imelda Labor Indonesia General Hospital, Medan, it is necessary to carry out a risk scoring of nausea and vomiting in patients before surgery to minimize the incidence of nausea and vomiting after surgery.

Intravenous paracetamol-related loss of consciousness at induction of anesthesia: A case report

Paracetamol (Acetaminophen) is an analgesics, antipyretic, and non-steroidal anti-inflammatory drugs. It is known to be one of the commonly used analgesics globally. Intravenous paracetamol has been frequently used in patients as analgesics and antipyretics. In therapeutic doses, paracetamol is well-tolerated and devoid of severe adverse reactions. However, significant adverse reactions associated with intravenous paracetamol may occur rarely. Nausea, vomiting, and constipation are known to be the common side effects of paracetamol. Other side effects include pain and reaction at the site of injection. The adverse reactions of paracetamol are as follows; hypotension, malaise, hypersensitivity reaction, elevation of liver enzymes, and thrombocytopenia. In our center, we found a case of intravenous paracetamol-related loss of consciousness at induction of anesthesia in a patient booked for myomectomy.

The Ambivalence of Post COVID-19 Vaccination Responses in Humans.

The Coronavirus disease 2019 (COVID-19) pandemic, caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), has prompted a massive global vaccination campaign, leading to the rapid development and deployment of several vaccines. Various COVID-19 vaccines are under different phases of clinical trials and include the whole virus or its parts like DNA, mRNA, or protein subunits administered directly or through vectors. Beginning in 2020, a few mRNA (Pfizer-BioNTech BNT162b2 and Moderna mRNA-1273) and adenovirus-based (AstraZeneca ChAdOx1-S and the Janssen Ad26.COV2.S) vaccines were recommended by WHO for emergency use before the completion of the phase 3 and 4 trials. These vaccines were mostly administered in two or three doses at a defined frequency between the two doses. While these vaccines, mainly based on viral nucleic acids or protein conferred protection against the progression of SARS-CoV-2 infection into severe COVID-19, and prevented death due to the disease, their use has also been accompanied by a plethora of side effects. Common side effects include localized reactions such as pain at the injection site, as well as systemic reactions like fever, fatigue, and headache. These symptoms are generally mild to moderate and resolve within a few days. However, rare but more serious side effects have been reported, including allergic reactions such as anaphylaxis and, in some cases, myocarditis or pericarditis, particularly in younger males. Ongoing surveillance and research efforts continue to refine the understanding of these adverse effects, providing critical insights into the risk-benefit profile of COVID-19 vaccines. Nonetheless, the overall safety profile supports the continued use of these vaccines in combating the pandemic, with regulatory agencies and health organizations emphasizing the importance of vaccination in preventing COVID-19's severe outcomes. In this review, we describe different types of COVID-19 vaccines and summarize various adverse effects due to autoimmune and inflammatory response(s) manifesting predominantly as cardiac, hematological, neurological, and psychological dysfunctions. The incidence, clinical presentation, risk factors, diagnosis, and management of different adverse effects and possible mechanisms contributing to these effects are discussed. The review highlights the potential ambivalence of human response post-COVID-19 vaccination and necessitates the need to mitigate the adverse side effects.

COVID-19 Vaccine Preferences in General Populations in Canada, Germany, the United Kingdom, and the United States: Discrete Choice Experiment.

Despite strong evidence supporting COVID-19 vaccine efficacy and safety, a proportion of the population remains hesitant to receive immunization. Discrete choice experiments (DCEs) can help assess preferences and decision-making drivers. We aim to (1) elicit preferences for COVID-19 vaccines in Canada, Germany, the United Kingdom, and the United States; (2) understand which vaccine attributes people there value; and (3) gain insight into the choices that different population subgroups make regarding COVID-19 vaccines. Participants in the 2019nCoV-408 study were aged ≥18 years; self-reported antivaccinationists were excluded. A DCE with a series of 2 hypothetical vaccine options was embedded into a survey to determine participant treatment preferences (primary objective). Survey questions covered vaccine preference, previous COVID-19 experiences, and demographics, which were summarized using descriptive statistics to understand the study participants' backgrounds. In the DCE, participants were provided choice pairs: 1 set with and 1 without an "opt-out" option. Each participant viewed 11 unique vaccine profiles. Vaccine attributes consisted of type (messenger RNA or protein), level of protection against any or severe COVID-19, risk of side effects (common and serious), and potential coadministration of COVID-19 and influenza vaccines. Attribute level selections were included for protection and safety (degree of effectiveness and side effect risk, respectively). Participants were stratified by vaccination status (unvaccinated, or partially or fully vaccinated) and disease risk group (high-risk or non-high-risk). A conditional logit model was used to analyze DCE data to estimate preferences of vaccine attributes, with the percentage relative importance calculated to allow for its ranking. Each model was run twice to account for sets with and without the opt-out options. The mean age of participants (N=2000) was 48 (SD 18.8) years, and 51.25% (1025/2000) were male. The DCE revealed that the most important COVID-19 vaccine attributes were protection against severe COVID-19 or any severity of COVID-19 and common side effects. Protection against severe COVID-19 was the most important attribute for fully vaccinated participants, which significantly differed from the unvaccinated or partially vaccinated subgroup (relative importance 34.8% vs 30.6%; P=.049). Avoiding serious vaccine side effects was a significantly higher priority for the unvaccinated or partially versus fully vaccinated subgroup (relative importance 10.7% vs 8.2%; P=.044). Attributes with significant differences in the relative importance between the high-risk versus non-high-risk subgroups were protection against severe COVID-19 (38.2% vs 31.5%; P<.000), avoiding common vaccine side effects (12% vs 20.5%; P<.000), and avoiding serious vaccine side effects (9.7% vs 7.5%; P=.002). This DCE identified COVID-19 vaccine attributes, such as protection against severe COVID-19, that may influence preference and drive choice and can inform vaccine strategies. The high ranking of common and serious vaccine side effects suggests that, when the efficacy of 2 vaccines is comparable, safety is a key decision-making factor.

Comparison of immune response parameters between homologous and heterologous COVID-19 vaccines: A scoping review

It has been over 4 years since the emergence of the coronavirus disease 2019 (COVID-19) pandemic. This highly contagious respiratory infection has endangered the health of millions and significantly impacted healthcare systems and economies. Vaccines are believed to confer immunity against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the causative agent of COVID-19, reducing both the severity of infection and the spread of the virus. Within a short period, various COVID-19 vaccines were developed and extensively tested before being approved by the WHO for distribution and administration. Now, due to concerns about emerging new strains of the virus and limited vaccine availability, a heterologous vaccine strategy is being deployed. Therefore, this paper aims to conduct a scoping review of existing evidence to compare the immunogenicity of heterologous vaccines with homologous vaccines and determine which confers better immunity against COVID-19. A literature search was conducted across three electronic databases (Ovid MEDLINE, PubMed, and Scopus). The retrieved studies were screened for relevance and eligibility using the online platform Covidence. A total of 31 articles were shortlisted for data extraction and analysis. Among these, 21 were observational studies, and 10 were clinical trials. The analysis demonstrated that participants who received heterologous vaccination regimens generated higher levels of IgG antibodies against the spike protein of SARS-CoV-2, antibodies targeting the receptor-binding domain, and T-cell responses compared to those who received homologous vaccination regimens. Furthermore, heterologous vaccination produced higher titers of neutralizing antibodies against several variants of concern (VOC), including Alpha, Beta, Gamma, Delta, and Omicron. No severe vaccine-related adverse events were reported in these studies, and common local and systemic side effects were manageable. Overall, heterologous vaccination regimes induced strong humoral and cellular immunity, comparable to homologous vaccination regimes, with stronger neutralizing antibody activity against VOCs.

A phase I trial of accelerated intermittent theta burst rTMS for amnestic MCI

BackgroundEmerging evidence suggests that repetitive transcranial magnetic stimulation (rTMS) enhances cognition in mild cognitive impairment (MCI). Accelerated intermittent theta burst stimulation (iTBS) rTMS protocols are promising as they substantially reduce...

Real-World Clinical Effectiveness of Liraglutide for Weight Management in Türkiye: Insights from the LIRA-TR Study

Introduction: Obesity is a complicated chronic disease associated with a series of other conditions. A weight loss of 5–10% has been shown to reduce obesity-related complications and improve quality of life. The efficacy and safety of liraglutide for reducing body weight have been demonstrated in clinical trials. This study evaluated the weight loss efficacy and adverse effects of liraglutide in those with obesity in the Turkish population. Methods: This is a retrospective cohort study; the patients that were included had a body mass index (BMI) of 27 or greater with additional comorbidities or a BMI of 30 or greater, and the patients were prescribed liraglutide for obesity treatment from the tertiary private clinic between January 2022 and January 2024. Their metabolic and anthropometric parameters were recorded at the initial appointment, and their body weight and adverse effects were followed up on during therapy. Results: For the 568 patients, of whom 487 (85.6%) were female, the mean values for age, weight, and BMI were 42.37 ± 10.50, 98.09 ± 17.48 kg, and 35.77 ± 5.45 kg/m2, respectively. Reductions in body weight at the 4th, 8th, 12th, and 24th weeks were 6.45 ± 2.32 kg, 10.66 ± 3.41 kg, 15.38 ± 8.30 kg, and 19 ± 9.06 kg, respectively; reductions in BMI at the 4th, 8th, 12th, and 24th weeks were 2.36 ± 1.00, 3.88 ± 1.25, 5.36 ± 1.76, and 7.09 ± 2.93, respectively; and the percentages of overall body weight loss at the 4th, 8th, 12th, and 24th weeks were 6.62 ± 2.1%, 10.75 ± 2.71%, 14.97 ± 6.8%, and 18.55 ± 4.63%, respectively (all p values &lt; 0.0001). The percentage of patients who lost more than 5% and more than 10% of their initial weight was 100% at the 24th week. The most common side effect was nausea; no pancreatitis was observed. Conclusions: The results of our study indicate that liraglutide is an efficacious and safe treatment option for obesity in the Turkish population, in accordance with the findings from previous research.

Predicting chemotherapy-induced thrombotoxicity by NARX neural networks and transfer learning

BackgroundThrombocytopenia is a common side effect of cytotoxic chemotherapies, which is often dose-limiting. Predicting an individual’s risk is of high clinical importance, as otherwise, a small subgroup of patients limits dosages for the overall population for safety reasons.MethodsWe aim to predict individual platelet dynamics using non-linear auto-regressive networks with exogenous inputs (NARX). We consider different architectures of the NARX networks, namely feed-forward networks (FNN) and gated recurrent units (GRU). To cope with the relative sparsity of individual patient data, we employ transfer learning (TL) approaches based on a semi-mechanistic model of hematotoxicity. We use a large data set of patients with high-grade non-Hodgkin’s lymphoma to learn the respective models on an individual scale and to compare prediction performances with that of the semi-mechanistic model.ResultsOf the examined network models, the NARX with GRU architecture performs best. In comparison to the semi-mechanistic model, the network model can result in a substantial improvement of prediction accuracy for patients with irregular dynamics, given well-spaced measurements. TL improves individual prediction performances.ConclusionNARX networks can be utilized to predict an individual’s thrombotoxic response to cytotoxic chemotherapy treatment. For reasonable model learning, we recommend at least three well-spaced measurements per cycle: at baseline, during the nadir phase and during the recovery phase. We aim at generalizing our approach to other treatment scenarios and blood lineages in the future.

The Most Common Side Effects, Concerns and Discontinuation Patterns of Oral Contraceptive Pills Among Polish Women: A Cross-Sectional Study.

Over the decade, variety and effectiveness of contraception methods have greatly improved, resulting in increased popularity of oral contraceptive pills (OCPs). However, hormonal contraception carries the risk of multiple side effects. The lack of sufficient knowledge often leads to the development of health concerns, which can affect patient's adherence. The aim of our research was to describe a side effect profile of OCPs and assess the most frequent concerns and discontinuation reasons in Polish women. The survey included questions regarding OCPs utilization patterns, side effects, health concerns and attitudes of the responders. This cross-sectional study was based on a survey, which was distributed online and open from 29 April to 15 May 2022. The survey included questions regarding OCPs utilization patterns, side effects, health concerns and attitudes of the responders. Out of 1699 respondents, the current OCPs intake was reported by two thirds of women and 22% had a history of using them in the past. Seventy-nine percent of all OCPs users experienced adverse effects while 9% reported having concerns about safety and potential adverse effects. Decreased libido and weight gain were the most significant reasons for ceasing hormonal contraception. Moreover, the most common concerns and the most unfavorable side effects varied in different age groups. The occurrence of anxiety depended on age and education. Healthcare professionals prescribing OCPs should provide their patients with comprehensive counseling. Understanding and addressing concerns of young women can improve their compliance and reduce the number of unintended pregnancies.

Incidence of Benzodiazepine Use and Misuse Among Adults in Selected Areas of Bangladesh

Background: Benzodiazepines (BDZ) are widely prescribed for anxiety and insomnia in Bangladesh, but their misuse has become a major public health concern. Objective: The aim of this study was to identify the incidence and patterns of use and misuse of BDZ in Bangladesh, and to explore the factors contributing to their misuse. Methodology: A cross-sectional study, including 368 current BDZ users, was conducted in the department of Pharmacology, Monno Medical College, Manikganj, during January, 2021 to December, 2022. The participants were selected randomly. Structured questionnaires were used to include participants’ personal information, drug use characteristics, physiological and psychological effects of drugs usage. Verbal consent was taken from each of the respondents. Results: In this study, 268(72.83%) of the participants were male, where 157(42.66%) were from the age group 31-40 years and 139(37.77%) were single. Among the study population, 51(13.86%) were students, 79(21.47%) had monthly family income above 50,000 Bangladeshi taka. Many of the participants reported that they used BDZs to relieve stress/pressure (108, 29.35%), followed by 95(25.82%) to manage insomnia, 79(21.47%) for relieving anxiety, depression and to get pleasure and others The mostly used drug was clonazepam (112, 30.43%), followed by diazepam (108, 29.35%) and others. Most of the users were influenced by friends (115, 31.25%). The common side effects of using BDZs were confusion (47, 12.77%), fatigue (45, 12.22%), drowsiness (37, 10.05%), and others. The mostly experienced withdrawal effect was headache (86, 23.28%), followed by insomnia (59, 16.25%), confusion (50, 13.48%) and others. Conclusion: BZDs were widely used in selected areas of Bangladesh with high incidence of misuse. The most common reason of misuse was self-medication. Increasing awareness program should be taken for safe and effective use of the drug. Journal of Monno Medical College December, 2023; 9 (2):68-72

Investigating the capabilities of advanced large language models in generating patient instructions and patient educational material

ObjectivesLarge language models (LLMs) with advanced language generation capabilities have the potential to enhance patient interactions. This study evaluates the effectiveness of ChatGPT 4.0 and Gemini 1.0 Pro in providing...

Could macrocytosis predict survival In advanced breast cancer patients that were treated with CDK 4–6 inhibitors?

IntroductionCyclin Dependent Kinase (CDK) 4–6 inhibitors are the recommended first-line treatment option for hormone-positive metastatic breast cancer (MBC). They show their effects by causing cell cycle arrest in G1-S phase. Neutropenia is the most common haematological side effect. In the literature, data on the association between CDK 4–6 inhibitors and macrocytosis are limited. We aimed to investigate the effect of macrocytosis on survival. MethodsWe retrospectively analysed 133 patients with de novo hormone positive MBC using CDK 4–6 inhibitors in first line treatment. Mean Corpuscular Volume (MCV) > 100 was considered macrocytosis and patients were divided into two groups; MCV<100 and MCV >100. The association of macrocytosis with clinicopathological features, Progression Free Survival (PFS) and Overall Survival (OS) were evaluated. Results42 patients were receiving palbociclib and 81 patients were receiving ribociclib. Median OS was determined as 33 months and median PFS was determined as 22 months. Macrocytosis ever rate was 45.8 % during follow-up. Macrocytosis was observed in 4.2 % of the patients in the first month, 16.7 % in the third month, 41.6 % in the sixth month and 42.2 % in the twelfth month. ER receptor level, ki-67, macrocytosis at 6–12 months and macrocytosis-ever which were found to affect OS as a result of univariate Cox regression analysis, were evaluated with multivariate Cox regression models and it was observed that they had significant effect on PFS and OS. ConclusionMacrocytosis may be a useful biomarker for the prediction of PFS and OS in MBC patients receiving CDK 4–6 inhibitors.

Predictors of moderate-to-severe side-effects following COVID-19 mRNA booster vaccination: a prospective cohort study among primary health care providers in Belgium

BackgroundCOVID-19 vaccine effectiveness declines months after vaccination. Therefore, it is likely that during the next few years, people may be repeatedly offered a booster vaccine to enhance humoral immunity levels. A growing number of people are questioning whether the benefits of a booster vaccine outweigh the side-effects.ObjectiveThis study aims (1) to identify the most frequently reported side-effects after different doses of COVID-19 mRNA vaccines, (2) and the longest lasting symptoms; and (3) to predict the likelihood of having moderate-to-severe side-effects after a booster COVID-19 mRNA vaccine given individual- and vaccine-specific characteristics.Design, setting, and participantsSecondary analysis of a prospective cohort study in primary health care providers (PHCPs) in Belgium conducted between December 2020 and December 2021, and in February-March 2023.MethodsIn nine subsequent surveys over a period of 2 years vaccine dose-number and side-effects after COVID-19 vaccines were collected. A Generalized Estimation Equations approach on the data of the first and second booster dose was used to investigate the probability of having moderate-to-severe side-effects after mRNA booster vaccination. Predictive performance of a binary classifier was assessed by looking at discrimination (i.e., quantified in terms of the area under the receiver operating characteristic curve). The final prediction model was validated using data with regard to the third booster by assessing misclassification rate, sensitivity and specificity.ResultsIn total, 11% of the PHCPs had moderate-to-severe side-effects after their booster COVID-19 mRNA vaccine. The most common side-effects of COVID-19 mRNA doses included fatigue, local pain at the injection site, general pains, and headache. These side-effects typically lasted for a median of 1 to 2 days. The final model included five predictors: sex, alcohol consumption, history of moderate-to-severe side-effects after any previous dose, recent COVID-19 infection, and the booster dose-number (first, second). Having experienced moderate-to-severe side-effects after any previous dose was the strongest predictor of moderate-to-severe side-effects following an mRNA vaccine booster, with an odds ratio (OR) of 3.64 (95% CI: 2.80–4.75). The OR for female sex was 1.49 (95% CI: 1.21–1.84) implying that females have a higher odds of moderate-to-severe side-effects following booster vaccination. The differences in effect for booster dose-number, alcohol consumption and recent COVID-19 infection was not significant.Conclusion and relevanceCOVID-19 mRNA booster vaccination implies a low prevalence of moderate-to-severe side-effects among PHCPs, with a short median duration of symptoms if any. The strongest predictors are a history of moderate-to-severe side-effects after any previous dose and being female. These reassuring findings can help addressing concerns about booster vaccination and encourage their uptake.Trial RegistrationNCT04779424 (registration date: 2021-02-22).

Drug-Induced Acne in Inflammatory Bowel Disease: A Practical Guide for the Gastroenterologist.

Drug-induced acne is a common side effect to a wide array of pharmacological therapies and is characterized by a monomorphic, papulopustular eruption typically affecting the face, scalp, and the upper thorax. Corticosteroids and Janus kinase inhibitors (JAKi) are commonly used for the treatment of inflammatory bowel disease (IBD) and are known to aggravate a prior tendency to acne or trigger the development of new acneiform eruptions. Recent attention on managing drug-induced acne has been driven by the increasing use of JAKi, an expanding therapeutic class in IBD and several other immune-mediated inflammatory diseases. Both randomized controlled trials and real-world studies have identified acne as one of the most common treatment-emergent adverse events in JAKi. Left untreated, this common skin reaction can significantly impact patient self-esteem and quality of life leading to poor treatment adherence and suboptimal IBD control. This review examines the characteristics of drug-induced acne in IBD treatments, provides a practical guide for gastroenterologists to manage mild to moderate occurrences, and highlights when to seek specialist dermatology advice. Such approaches enable early treatment of a common and often distressing adverse event and optimizes the management of IBD by preventing the premature discontinuation or dose reduction of efficacious IBD drugs.

Safety and efficacy of COVID-19 vaccines in children and adolescents with cancer.

Children with cancer have a higher morbidity and mortality due to COVID-19. Vaccination of children with cancer is important. In this study, we aimed to investigate the effectiveness and side effects of the COVID-19 vaccines in children and adolescents with cancer. Fifty-eight patients from four centers were included in the study. Antibodies to the SARS-CoV-2 spike protein levels were measured. Vaccine-related complaints were recorded. There were 33 male and 25 female patients. The mean age was 16.9±2.3 years. In 58.6% of cases, the diagnosis was hematological malignancies. Twenty patients were currently under treatment, while 38 had completed the treatment. Forty-eight patients received chemotherapy ± radiotherapy, 13 received immunotherapy, and 3 underwent stem cell transplantation. CoronoVac© and BNT162b2© vaccines were administered in 24% and 76%, respectively. The mean antibody level was lower in patients who received CoronaVac© than that of BNT162b2©, although the difference was not significant. The levels were within the protective limits in both groups. No significant difference was found in antibody levels according to diagnostic subgroups, treatment status, type of treatment, line of treatment, disease status and time between vaccines and measurement of antibody level. The most common side effects were pain at the injection site (37.9%) and malaise/weakness (17.2%), which were similar for both vaccines. Our study showed that both mRNA and inactivated vaccines elicit an immune response in children with cancer. However, the seroconversion rate is significantly higher in mRNA vaccines. Side effects were similar to those seen in healthy children.

12330 Progestogen Experience And Perception Among Transfeminine Adults - A National Survey

Abstract Disclosure: J.J. Chang: None. N. Khai Tran: None. A. Flentje: None. M.E. Lubensky: None. J. Obedin-Maliver: Consulting Fee; Self; Ibis Reproductive Health, Hims, Incorporated, Folx, Incorporated, Upstream, Incorporated. M.R. Lunn: Consulting Fee; Self; Hims, Incorporated, Otsuka Pharmaceutical Development and Commercialization, Inc., American Dental Association. D. Ariel: None. Background: Current guidelines recommend estradiol with consideration of anti-androgens for gender-affirming hormone therapy (GAHT) in transfeminine adults. Many individuals also seek progestogens as part of feminizing GAHT, particularly to enhance breast development. Though progestogen use seems common, few studies describe its use, reported benefits, and side effects. SpecificAims: 1) To describe progestogen use in feminizing GAHT among transfeminine individuals in the U.S. 2) To evaluate reasons for progestogen initiation and perceived physical and emotional impact; 3) To investigate side effects and adverse events. Materials and Methods: In this cross-sectional study, participants were recruited from The PRIDE Study, a U.S.-based longitudinal cohort study of LGBTQIA+-identifying adults. Included participants were assigned male sex at birth and had a feminine/transfeminine or non-binary gender identity. Those assigned female sex at birth (AFAB) or born with 1 or more ovaries were excluded. Descriptive statistics were used to describe socio-demographic characteristics, progestogen use patterns, initiation reasons, perceived physical and mental impacts, side effects, adverse events, and care satisfaction. Results: 543 participants were eligible and completed the study. Mean age was 43.2 years (standard deviation: 14.9). Of 310 progestogen users, the most common progestogen forms were micronized progesterone (58.4% oral; 10.6% rectal) and medroxyprogesterone acetate (7.7% oral). Median progestogen use duration was 2 years (interquartile range: 1-4). Breast development (85.2%) and mimicking the hormone pattern of those AFAB (58.1%) were the two most reported reasons for progestogen initiation. Most progestogen users reported improved breast development (79.7%); none reported worsening. Sex drive, sleep, and concentration did not change with progestogen use in 46.5%, 51.3%, and 73.9% of participants, respectively. Adverse events included lower extremity deep vein thrombosis (n = 6) and pulmonary embolism (n = 4). The most common side effects were breast pain (28.7%), mood fluctuation (21.9%), fatigue (19.7%), and weight gain (19.0%). Most users expressed satisfaction with progestogens (71.9%) and would recommend to others (73.5%). Among 68 former progestogen users, 20.6% reported stopping progestogens due to negative side effects, and 32.4% stopped due to lack of perceived efficacy. Conclusions: In the largest study describing progestogens in GAHT to date, over half of transfeminine adults used progestogens, particularly for breast development. Most reported improvement with breast development and overall satisfaction. However, perceived impacts on other effects were variable. Future prospective studies are needed to investigate the effects of progestogens versus other components of feminizing GAHT. Presentation: 6/1/2024

12330 Progestogen Experience And Perception Among Transfeminine Adults - A National Survey

Abstract Disclosure: J.J. Chang: None. N. Khai Tran: None. A. Flentje: None. M.E. Lubensky: None. J. Obedin-Maliver: Consulting Fee; Self; Ibis Reproductive Health, Hims, Incorporated, Folx, Incorporated, Upstream, Incorporated. M.R. Lunn: Consulting Fee; Self; Hims, Incorporated, Otsuka Pharmaceutical Development and Commercialization, Inc., American Dental Association. D. Ariel: None. Background: Current guidelines recommend estradiol with consideration of anti-androgens for gender-affirming hormone therapy (GAHT) in transfeminine adults. Many individuals also seek progestogens as part of feminizing GAHT, particularly to enhance breast development. Though progestogen use seems common, few studies describe its use, reported benefits, and side effects. SpecificAims: 1) To describe progestogen use in feminizing GAHT among transfeminine individuals in the U.S. 2) To evaluate reasons for progestogen initiation and perceived physical and emotional impact; 3) To investigate side effects and adverse events. Materials and Methods: In this cross-sectional study, participants were recruited from The PRIDE Study, a U.S.-based longitudinal cohort study of LGBTQIA+-identifying adults. Included participants were assigned male sex at birth and had a feminine/transfeminine or non-binary gender identity. Those assigned female sex at birth (AFAB) or born with 1 or more ovaries were excluded. Descriptive statistics were used to describe socio-demographic characteristics, progestogen use patterns, initiation reasons, perceived physical and mental impacts, side effects, adverse events, and care satisfaction. Results: 543 participants were eligible and completed the study. Mean age was 43.2 years (standard deviation: 14.9). Of 310 progestogen users, the most common progestogen forms were micronized progesterone (58.4% oral; 10.6% rectal) and medroxyprogesterone acetate (7.7% oral). Median progestogen use duration was 2 years (interquartile range: 1-4). Breast development (85.2%) and mimicking the hormone pattern of those AFAB (58.1%) were the two most reported reasons for progestogen initiation. Most progestogen users reported improved breast development (79.7%); none reported worsening. Sex drive, sleep, and concentration did not change with progestogen use in 46.5%, 51.3%, and 73.9% of participants, respectively. Adverse events included lower extremity deep vein thrombosis (n = 6) and pulmonary embolism (n = 4). The most common side effects were breast pain (28.7%), mood fluctuation (21.9%), fatigue (19.7%), and weight gain (19.0%). Most users expressed satisfaction with progestogens (71.9%) and would recommend to others (73.5%). Among 68 former progestogen users, 20.6% reported stopping progestogens due to negative side effects, and 32.4% stopped due to lack of perceived efficacy. Conclusions: In the largest study describing progestogens in GAHT to date, over half of transfeminine adults used progestogens, particularly for breast development. Most reported improvement with breast development and overall satisfaction. However, perceived impacts on other effects were variable. Future prospective studies are needed to investigate the effects of progestogens versus other components of feminizing GAHT. Presentation: 6/1/2024

8088 Connecting the Dots: Semaglutide, Constipation, and Diverticulitis - A case report

Abstract Disclosure: K. Tiwari: None. F. Sajid: None. J.G. Karam: None. Introduction: Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist used for the treatment of type 2 diabetes mellitus and weight management. Common side effects, primarily gastrointestinal (&amp;gt;10%), include nausea, vomiting, diarrhea, and constipation. Here, we present a case of acute sigmoid diverticulitis with an adjacent abscess in a patient who was recently initiated on GLP-1 receptor agonist therapy. Case presentation: A 76-year-old female with a medical history of type 2 diabetes mellitus on metformin and empagliflozin, hypertension, chronic kidney disease stage 3A, obesity (BMI: 43), and no known history of diverticulosis was started on semaglutide for additional glycemic, renal, and weight loss benefits, given suboptimal control of her obstructive sleep apnea, blood pressure, and knee arthritis. She received semaglutide subcutaneously at a dose of 0.25 mg weekly for 4 weeks, followed by an increased dosage of 0.5 mg for one week. However, she experienced a slight worsening of underlying constipation as a side effect. On the sixth week of therapy, she started having progressive lower abdominal pain with nausea, chills, and diarrhea, for which she presented to the Emergency Department. She was found to have leukocytosis, and a Computed Tomography (CT) of the abdomen/pelvis revealed peri-colonic fat stranding in the mid-ascending colon, wall thickening in the distal sigmoid colon, and a low-density fluid collection abutting the sigmoid/descending colonic wall, indicative of diverticulitis with a small abscess. She was admitted to the hospital for six days and was treated conservatively with Intravenous (IV) antibiotics, and her diet was slowly advanced as tolerated. Semaglutide was discontinued, and the patient was discharged home with outpatient endocrinology and gastrointestinal follow-up. A post-discharge colonoscopy showed diffuse diverticulosis. Conclusion: Constipation and old age are common risk factors for diverticulitis. While GLP1-1 receptor analogs have proven significant and multiple benefits, more knowledge about associated gastrointestinal complications resulting from slower food transit in the gastrointestinal tract is emerging. Older patients with underlying constipation and/or diverticulosis should particularly be monitored and treated for worsening constipation to avoid complications such as acute diverticulitis. Vigilance and awareness in recognizing and managing this potential complication are crucial with the wider indications and use of GLP-1 receptor analogs. Presentation: 6/3/2024

8208 Unexpected And Significant Rise In TSH In The Setting Of Relugolix Use

Abstract Disclosure: A.Y. Groysman: None. A. Poloju: None. P. Majety: None. T. Abraham: None. Background: Relugolix is a gonadotropin-releasing hormone antagonist used as androgen deprivation therapy for metastatic and nonmetastatic castration-resistant prostate cancer that was FDA-approved in December 2020. Common side effects include hot flashes, increased glucose and triglycerides, and decreased hemoglobin. We report a case of Relugolix interference with the absorption of levothyroxine, which has not been reported in the literature. Case: A 79-year-old white man with high-risk, Gleason 9 prostate cancer and Hashimoto’s hypothyroidism presented for evaluation of elevated thyroid stimulating hormone (TSH) level- 52.87 mIU/L (0.28-4.10 mIU/L). He did not have cold intolerance, constipation, fatigue, or weight gain. He was diagnosed with hypothyroidism in 1998 and was on a stable dose of levothyroxine 88mcg daily from 2016 until the time of this presentation. He is adherent and reports following a routine of having breakfast with coffee soon after taking levothyroxine for many years. In June 2022, his TSH was 4.48 mIU/L. In July 2022, he started taking Relugolix along with levothyroxine. Following this, his TSH levels increased to 30.08 mIU/L (FT4: 0.67 ng/dL), 35.43 mIU/L (FT4: 0.57 ng/dL), 52.87 mIU/L (FT4: 0.48 ng/dL) on 2/24/23, 3/3/23, and 3/14/23, respectively. No new medications were reported. His other medications were atorvastatin, tamsulosin, and vitamin D, which he took at night. He did not take calcium or biotin supplements. He had gradual weight gain (8 lbs) over the last 9 months. Levothyroxine dose was increased from 88 to 125 mcg daily and he was instructed to separate Relugolix from levothyroxine so he started taking Relugolix at bedtime. Repeat TSH was low at 0.12 mIU/L. The levothyroxine dose was eventually titrated back to 88 mcg daily and TSH was 5.2 (appropriate for age). Conclusion: Several medications are known to interfere with the absorption of levothyroxine. Our case suggests that Relugolix may be one of them. The significant rise in TSH and levothyroxine requirements months after starting Relugolix and the ability to return to the previous dose of levothyroxine only by separating Relugolix from levothyroxine strongly suggests that there is an interference between these medications that has not been reported. Presentation: 6/2/2024