Potential Adverse Events Research Articles

Mineralocorticoid Receptor Antagonists in Diabetic Kidney Disease: Clinical Evidence and Potential Adverse Events

Diabetic kidney disease (DKD) is the leading cause of chronic kidney disease (CKD) globally and is associated with an increased risk of developing cardiovascular disease (CVD). DKD management requires a multipronged approach to decrease the progression of CKD and CVD. Mineralocorticoid receptor antagonists (MRAs) added to renin-angiotensin-aldosterone system blockade and sodium–glucose cotransporter 2 inhibitor therapy reduce the incidence of cardiovascular outcomes and progression of CKD. This review examines the cardiorenal benefits of MRAs and summarizes evidence on potential risks for acute kidney injury, hyperkalemia, and sexual dysfunction for steroidal and nonsteroidal MRAs.

Short-term safety and tolerability profile of 5-methoxy-N,N-dimethyltryptamine in human subjects: a systematic review of clinical trials.

Psychedelic agents have regained the attention of pharmaceutical companies as promising treatments for depressive episodes. 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT), an atypical psychedelic, is emerging as a potentially effective, novel rapid-acting antidepressant. In this systematic review, we analyze the safety and tolerability evidence from clinical trials. Following the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines, electronic databases (PubMed, SCOPUS, Web of Science, EMBASE, and EBSCO) were searched from inception until 15 May 2024 to identify clinical trials (regardless of phase) reporting on short-term safety and tolerability profile of 5-MeO-DMT using the following keywords in various combinations: 5-methoxy-N, N-dimethyltryptamine, 5-MeO-DMT, safety, adverse, adverse reaction, side effects, tolerability, dropout, healthy volunteer, healthy participant, depression, major depressive disorder. Only studies written in English were considered. Initial search yielded 100 records, out of which 3 met the inclusion criteria. These studies reported on the results from clinical trial phases I and I/II, with a total of 78 participants included; two studies involved healthy volunteers, and one included patients with treatment-resistant depression. Although the data is limited, it confirms a good short-term safety and tolerability profile for 5-MeO-DMT, with no serious adverse events (SAEs) reported. Furthermore, no drop-outs were reported. 5-MeO-DMT administration in human subjects presents favorable short-term safety and tolerability profile. Importantly, no SAEs have been documented, and no adverse events led to participant withdrawal from the studies There is a need for future randomized, double-blind, placebo-controlled trials with larger samples and follow-up to assess potential chronic adverse events.

Knowledge, attitudes and practices towards toxoplasmosis among pregnant women receiving antenatal care in Sana'a city, Yemen

Background and Aims: There is a lack of studies on pregnant women’s knowledge, attitudes, and practices (KAPs) towards toxoplasmosis in Yemen. Therefore, this study assessed these KAPs among pregnant women receiving antenatal care in Sana’a city, Yemen. Subjects and Methods: A KAP survey was conducted among 410 pregnant women in Sana’a using a structured questionnaire. The association between women’s characteristics and their KAPs was then studied. Results: Of 410 women, 58.5% had heard of toxoplasmosis. Of these, 53.3% had good knowledge and 73.3% had positive attitudes towards it. Women with no previous miscarriage or premature birth had significantly higher levels of poor knowledge (OR = 4.1, 95% CI: 2.39–7.10; p <0.001 and OR = 2.9, 95% CI: 1.61–5.05; p <0.001, respectively) and negative attitudes (OR = 5.6, 95% CI: 23.00–10.57; p <0.001 and OR = 2.7, 95% CI: 1.36–5.48; p = 0.004, respectively) than their counterparts. Negative attitudes were significantly higher in primigravida than multigravida women (OR = 2.1, 95% CI: 1.17–3.79; p = 0.012), but significantly lower among women in the first (OR = 0.3, 95% CI: 0.20–0.56; p <0.001) or second trimester (OR = 0.2, 95% CI: 0.10–0.48; p <0.001) than their counterparts. Acceptable practices were reported by 95.4% of women, with no association with demographic or obstetric characteristics. Conclusion: There is a need for educational interventions for pregnant women in Sana’a about toxoplasmosis to prevent its potential adverse events in their fetuses.

Stratified analysis of the association between anti-obesity medications and digestive adverse events: a real-world study based on the FDA adverse event reporting system database

BackgroundNumerous digestive system adverse events (dsAEs) have been observed during the use of anti-obesity medications (AOMs), leading to concerns about the safety of these medications. However, most current studies are limited to the association of one class of drugs with specific digestive disorders, and there is no cascading analysis of AOMs in the digestive system. This study aims to use data from the United States Food and Drug Administration Adverse Event Reporting System (FAERS) for a stratified analysis of the reported associations between AOMs and dsAEs.MethodsWe analyzed adverse event reports submitted to FAERS between January 2015 and December 2023 related to obesity treatment. It is important to note that FAERS data cannot establish causality or incidence rates. Pharmacovigilance (PV) signals were detected by disproportionate analyses through proportionate reporting ratio (PRR), reporting odds ratios (ROR), and information components (IC) to detect dsAEs associated with AOMs. Reporting rates, severity, and response outcomes of digestive adverse events were compared across AOMs by multivariate logistic regression analysis.ResultsAmong 34,396 adverse events (AEs) related to obesity treatment, 8844 dsAEs were analyzed. Comparing with semaglutide and liraglutide, tirzepatide exhibited fewer reported dsAEs while semaglutide and liraglutide showed a high correlation with non-lethal pancreatitis reports. Bupropion-naltrexone (31.65%) reported the highest number of dsAEs, and a PV signal was detected in mouth and lips AEs (ROR = 2.97, 95% CI: 2.42–3.6). Orlistat (ROR = 3.30, 95% CI: 3.08–3.55) exhibited the highest association with gastrointestinal AEs compared to other AOMs. PV signal for hepatobiliary AEs (ROR = 6.13, 95% CI: 3.45–10.88) with phentermine-topiramate still needs further clarification.ConclusionsTirzepatide may be considered for patients with a history of digestive system disease or an elevated risk of pancreatitis based on the pattern of reported dsAEs. Caution is needed for the orofacial AEs when using bupropion-naltrexone. Orlistat has a higher reporting rate of gastrointestinal AEs, but these events are typically less severe. Phentermine-topiramate’s association with liver impairment requires further clinical investigation. This article provides insights into the reported associations between AOMs and dsAEs, which may aid clinicians in making more informed decisions about individualizing medication and managing potential adverse events.

Clinical guidance for cannabidiol-associated hepatotoxicity: A narrative review.

There is increasing evidence that cannabidiol (CBD) use is associated with clinically significant liver enzyme (LE) elevations and drug-induced liver injury (DILI). The proportion of LE elevations and DILI events reported in the literature meet the Council for International Organizations of Medical Sciences' (CIOMS) classification of a common adverse drug reaction. However, these potential adverse events are unknown to many clinicians and may be overlooked. The increasing use of CBD for both medical and non-medical use necessitates clear direction in the diagnosis and management of CBD-associated hepatotoxicity. To our knowledge, no such clinical guidance currently exists. For people presenting with elevated LEs, CBD use should be screened for and be considered in the differential diagnosis. This narrative review will provide clinicians with guidance in the prevention, detection, and management of CBD-related hepatotoxicity.

Subgroup disproportionality analysis of dementia-related adverse events with sacubitril/valsartan across geographical regions

This study aimed to evaluate the association between sacubitril/valsartan and dementia-related adverse events (AEs) in geographical subpopulations using subgroup disproportionality analysis. Cases from the FDA adverse event reporting system involving patients aged 60 or older with sacubitril/valsartan or angiotensin receptor blockers (ARBs) were analyzed. The adjusted reporting odds ratios (RORs) for dementia-related AEs were calculated for each continent. A total of 61,518 AEs associated with sacubitril/valsartan or ARBs were identified. Among these, 1441 were dementia-related AEs. In Asia, Europe, and Africa, the reporting risk of dementia-related AEs associated with sacubitril/valsartan was lower compared to ARBs (adjusted ROR, 0.57 [95% CI 0.31–1.01]; adjusted ROR, 0.89 [95% CI 0.69–1.14]; adjusted ROR, 0.40 [95% CI 0.27–0.61], respectively). In Latin America and Oceania, the reporting risk of dementia-related AEs associated with sacubitril/valsartan was similar to that associated with ARBs (adjusted ROR, 1.04 [95% CI 0.75–1.44]; adjusted ROR, 1.02 [95% CI 0.31–3.37], respectively). On the contrary, in North America, the reporting risk associated with sacubitril/valsartan was higher compared to ARBs (adjusted ROR, 1.29 [95% CI 1.10–1.53]). Although the ROR value did not meet the criteria for signal detection, the significantly greater than 1 ROR observed in North America suggests that caution may be warranted regarding potential dementia-related adverse events associated with sacubitril/valsartan.

A disproportionality analysis of sunitinib in the FDA adverse event reporting system (FAERS)

ObjectiveThis study aimed to analyze the FAERS database to identify adverse event associated with sunitinib to offer valuable insights for the judicious utilization of medication in clinical settings. MethodsVarious disproportionality analysis techniques, such as the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPN), and multi-gamma Poisson shrinkage (MGPS), were employed to analyze adverse drug reaction (ADR) reports pertaining to sunitinib in the FAERS database from its market introduction up to the first quarter of 2023. Subsequently, a secondary screening process was conducted to identify reliable positive signals. ResultsThe analysis of sunitinib adverse event signals at the system-organ classification level encompassed 27 organ systems, with gastrointestinal and endocrine disorders emerging as the predominant SOCs. A total of 237 significant adverse events meeting all four algorithms were detected. Notably, this study revealed previously unreported adverse events, including pleural effusion and ascites, while potential adrenal toxicity-related adverse events, highlighted in the drug's specification, were not identified in this analysis. The study examined the relationship between the duration of sunitinib dosing and the onset of adverse events, revealing a median onset of 48 days (IQR, 15–160 days). The findings indicated that a majority of adverse events manifested early in the dosing period, with tumor progression, disease progression, and mortality becoming more prevalent after one year of treatment. ConclusionIn the clinical utilization of sunitinib, vigilant monitoring of potential adverse reactions is imperative during the initial phase of drug administration. In addition to the documented adverse reactions outlined in the drug specification, healthcare providers should remain attentive to potential adverse reactions such as pleural effusion, ascites, and tumor development.

109 Endotracheal tube cuff detachment secondary to patient bite during extubation as a potential life-threatening adverse airway event complicating emergence from general anesthesia

109 Endotracheal tube cuff detachment secondary to patient bite during extubation as a potential life-threatening adverse airway event complicating emergence from general anesthesia

Efficacy and safety evaluation of Monoblue Dual View and Monoblue ILM View vital stains during vitrectomy surgery.

To compare the staining properties of Monoblue inner limiting membrane (ILM) View and Monoblue DUAL View (study products) vital stains during vitrectomy surgery to those of ILM Blue or Membrane Blue Dual (control products). In this study, 105 patients were included in the Ophthalmic Clinic of the University Hospitals Leuven from September 2021 to April 2022. For prospective data collection in this study, patients were randomized between a control group (ILM Blue or Membrane Blue Dual, manufactured and commercialized by DORC®) and a study group (Monoblue ILM View or Monoblue DUAL View, manufactured and commercialized by Arcadophta®-BVI®). For retrospective data collection, patients were divided into similar surgery groups. Efficacy was analyzed using a binary subjective evaluation of the visualization of stained membranes during vitrectomy. The rate and severity of potential adverse events related to the study products were tracked, allowing both treatment groups to be compared with the corresponding control groups (ILM Blue and Membrane Blue Dual). Based on the results and findings, none of the comparisons (primary outcomes) were statistically significant, showing similar efficacy of the dyes used. The study products were found to be safe in this study since no serious adverse events were reported. The present findings indicate that the Monoblue ILM View and Monoblue DUAL View dyes can safely be used during vitrectomy to stain the ILM and/or epiretinal membrane (ERM) when removal is needed.

Pregnancy related adverse events and congenital disorders associated with fluoroquinolones: A real-world pharmacovigilance study of the FDA adverse event reporting system (FAERS)

BackgroundFluoroquinolones, including ciprofloxacin, levofloxacin, and moxifloxacin, are extensively employed as broad-spectrum antibacterial agents. However, their use is discouraged during pregnancy due to potential adverse events (AEs). The aim of this study is to systematically investigate the association between fluoroquinolones (specifically ciprofloxacin, levofloxacin, and moxifloxacin) and AEs related to pregnancy, as well as their potential impact on congenital disorders. MethodsA disproportionality analysis was conducted utilizing FDA Adverse Event Reporting System (FAERS) data spanning from the first quarter of 2004 to September 2023. The objective was to identify potential AEs signatures associated with fluoroquinolones through conducting reporting odds ratios (RORs) and Bayesian confidence propagation neural networks (BCPNN). Assessing the potential risk of pregnancy-associated AEs involved comparing each fluoroquinolone with all other medications. Additionally, in-depth comparative analyses were carried out between various fluoroquinolones and a reference drug (azithromycin). ResultsA total of 1159 cases were identified, involving AEs related to pregnancy and congenital disorders. Obvious disproportionate association of abortion spontaneous and other nine AEs was identified for fluoroquinolone during gestation. Upon comparison with all the other drugs, ciprofloxacin exhibited an elevated risk of spontaneous abortion, non-site specific bone disorders congenital and 10 other significant signals. Levofloxacin demonstrated an increased risk of congenital tongue disorders and three other significant signals. Moxifloxacin displayed a noteworthy signal indicating multiple congenital cardiac abnormalities. ConclusionsWe present compelling evidence regarding pregnancy-related AEs and congenital disorders linked to fluoroquinolones. Considering perinatal and genotoxicity aspects, we explore whether levofloxacin or moxifloxacin might be preferable when fluoroquinolones are deemed necessary to balance the benefits of pregnant women and fetuses.

A real-world pharmacovigilance study of cardiac adverse events induced by sugammadex in the FDA adverse event reporting system

ABSTRACT Background Sugammadex is a novel agent that reverses neuromuscular blockade during general anesthesia. Recent case reports have raised concerns regarding potential cardiac adverse events (CAEs). However, no large-scale real-world studies have yet evaluated the potential link between sugammadex and CAEs. Research design and methods Data from the FDA Adverse Event Reporting System were obtained. The association between sugammadex and CAE was evaluated using reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker methods. Serious outcomes resulting from sugammadex-related CAEs were assessed, and complications associated with CAEs were evaluated. Results Nineteen CAEs were identified and classified into two categories: cardiac arrhythmias and coronary artery disorders. The most frequent CAEs were bradycardia (n = 202), cardiac arrest (n = 119), tachycardia (n = 30), and Kounis syndrome (n = 22). Subgroup analysis based on age, sex, and weight revealed parallel findings. The CAEs most likely to result in serious consequences were pulseless electrical activity and cardiac arrest. The most common concurrent adverse effects with CAEs were hypotension (n = 51), anaphylactic reactions (n = 46), and anaphylactic shock (n = 23). Conclusion This study suggests a potential link between sugammadex and CAEs, highlighting the need for careful monitoring and personalized risk assessment, especially in patients with cardiovascular risk factors.

A survey-based, quasi-experimental study assessing a high-cannabidiol suppository for menstrual-related pain and discomfort

The endocannabinoid system is involved in gynecological functions, with cannabidiol (CBD) demonstrating promise for alleviating menstrual-related symptoms. This survey-based, quasi-experimental study assessed pro re nata (PRN) use of a commercially-available, hemp-derived, broad-spectrum, high-CBD (100 mg) vaginal suppository (Foria®) for menstrual-related pain and discomfort compared to a treatment-as-usual (TAU) group (CBD n = 77, TAU n = 230), with survey assessments collected at baseline and two monthly follow-ups (~2 menstrual cycles). The CBD group demonstrated significantly reduced frequency and severity of menstrual-related symptoms, impact of symptoms on daily functioning, need for analgesics, and number of analgesics used relative to the TAU group (ps ≤ 0.032). Correlation analyses indicated a potential dose-dependent response, with increased suppository use associated with greater reduction of symptoms (ps ≤ 0.025). Most CBD participants reported at least moderate improvement of symptoms (follow-up 1 = 72.9%, follow-up 2 = 81.1%). Future studies (including replication in randomized clinical trials) assessing pharmacokinetics/pharmacodynamics, mechanism(s) of action, efficacy for other gynecological indications, and potential adverse events (e.g., drug-drug interactions) are indicated.

Delayed Hypersensitivity Reaction to Dermal Fillers Following mRNA COVID-19 Vaccination

Dear Editor, I wish to bring attention to a potential delayed immune reaction associated with dermal fillers in the context of mRNA COVID-19 vaccines. While severe vaccine reactions remain uncommon, the widespread administration of mRNA vaccines and the prevalent use of dermal fillers necessitate a closer examination of their possible interactions. We recently encountered a 59-year-old female patient who developed persistent facial swelling months after receiving the Pfizer-BioNTech SARS-CoV-2 mRNA vaccine. Notably, the patient had a history of dermal filler injections, predominantly hyaluronic acid, administered three to four years prior. Despite various therapeutic interventions, including antihistamines, corticosteroids, and ACE inhibitors, she experienced recurrent episodes of swelling. Ultrasound assessment revealed the absence of residual filler material, leading us to consider an immune-mediated response potentially triggered by the mRNA vaccine. This case highlights the importance of further research into the interaction between mRNA COVID-19 vaccines and dermal fillers. It suggests that individuals with a history of dermal fillers may be susceptible to delayed inflammatory reactions post-vaccination. Clinicians should be aware of this potential adverse event, particularly when evaluating patients with unexplained facial swelling following vaccination.

Analysis of lumateperone data for patients with schizophrenia using related adverse events from the FDA adverse reporting system

ABSTRACT Background Our study utilized the U.S. Food and Drug Administration’s Adverse Event Reporting System (FAERS) to analyze and study the adverse event (AEs) signals of second-generation antipsychotic drug lumateperone, providing a reference for clinical safety monitoring in the treatment of schizophrenia. Methods The International Dictionary of Medical Terminology (version 26.0) was used to standardize the preferred system organ category (SOC) and preferred terminology (PT) for adverse drug events (ADE) data related to lumateperone. ADE signals were classified and described using four algorithms: reporting odds ratios (ROR), proportional reporting ratios (PRR), Bayesian confidence-propagation neural network (BCPNN) and Multinomial gamma-poisson shrinkage (MGPS). Result Among the 2542 case reports collected from the FAERS database, 1762 reports with lumateperone as a ‘principal suspect(PS)’ AEs were identified. Lumateperone-induced AEs occurred in 26 system organ categories (SOC). A total of 118 significant disproportionate preferred terms (PTs) meeting the requirements of 4 algorithms were retained, and unexpected major events, such as burning sensation, tremor, migraine etc. may also occur. The median time to onset of lumateperone-related adverse events was 9 days (interquartile range [IQR] 2–31.25 days), and most AEs occurred within the first 10 days and 1 month after initiation of lumateperone therapy. Conclusion Our research may provide a better understanding of the potential adverse events that may be caused by lumateperone and those not recorded in the drug instructions, providing valuable signals for clinical use.

Endoscopic ultrasound-guided rendezvous techniques for difficult biliary cannulation: Technical review.

Endoscopic retrograde cholangiopancreatography (ERCP) is the standard procedure for the diagnosis and treatment of biliary diseases. However, selective biliary cannulation, the essential first step in ERCP, can sometimes fail due to anatomical variations or technical limitations. In these cases, the endoscopic ultrasound-guided rendezvous technique (EUS-RV) offers a valuable salvage option. Nevertheless, it is crucial to be aware of potential adverse events associated with bile duct puncture. To optimize the success rate and safety of EUS-RV, understanding the basic techniques, technical tips for each procedural step, and troubleshooting strategies for potential difficulties is essential. This review article summarizes the clinical outcomes and technical considerations of EUS-RV, including a comprehensive analysis of the current evidence.

A Framework for Best Practices and Readiness in the Advent of Anti-Amyloid Therapy for Early Alzheimer's Disease in Asia.

Advances in biomarker-based diagnostic modalities, recent approval of anti-amyloid monoclonal antibodies for early Alzheimer's disease (AD; mild cognitive impairment or mild dementia due to AD) and late-stage clinical development of other disease-modifying therapies for AD necessitate a significant paradigm shift in the early detection, diagnosis and management of AD. Anti-amyloid monoclonal antibodies target the underlying pathophysiological mechanisms of AD and have demonstrated a significant reduction in the rate of clinical decline in cognitive and functional outcome measures in patients with early AD. With growing recognition of the benefit of early interventions in AD, an increasing number of people may seek diagnosis for their subjective cognitive problems in an already busy medical system. Various factors such as limited examination time, lack of expertise for cognitive assessment and limited access to specialized tests can impact diagnostic accuracy and timely detection of AD. To overcome these challenges, a new model of care will be required. In this paper, we provide practical guidance for institutional readiness for anti-amyloid therapies for early AD in Asia, in terms of best practices for identifying eligible patients and diagnosing them appropriately, safe administration of anti-amyloid monoclonal antibodies and monitoring of treatment, managing potential adverse events such as infusion reactions and amyloid-related imaging abnormalities, and cross-disciplinary collaboration. Education and training will be the cornerstone for the establishment of new pathways of care for the identification of patients with early AD and delivery of anti-amyloid therapies in a safe and efficient manner to eligible patients.

First-trimester medication abortion via telemedicine: A retrospective cohort study

BackgroundFollowing the decriminalization of abortion in Colombia and amidst a global health crisis due to COVID-19, Profamilia implemented a telemedicine-assisted first-trimester Medication Abortion (MAB) program. This is an opportunity to reduce inequalities in access and to promote empowerment and sexual and reproductive rights. This study aims to describe socio-demographic and clinical characteristics of users and to assess its effectiveness and safety. Study designA retrospective cohort study. MethodsThe study analyzed data from users who received Profamilia's telemedicine abortion services between August 2021 and August 2022 (n = 3073). A descriptive analysis of their sociodemographic and clinical characteristics was performed, grouping, and comparing them according to follow-up status and abortion outcome. Effectiveness was assessed by the percentage of complete abortions without surgical intervention, and safety by the incidence of complications, potential adverse events, and potentially dangerous signs. ResultsMost of the users were less than 8 weeks gestation at the start of treatment (88.3 %), from low socioeconomic strata (84.8 %), affiliated to the subsidized healthcare system (87.6 %), with educational levels up to secondary school (81.6 %), between 18 and 35 years (87.4 %), from urban areas (97.8 %) and singles (90,8 %). 94.9 % of users had a complete abortion using medication, and 0.3 % of cases reported complications. ConclusionsFirst-trimester MAB through telemedicine in the Latin American context is an effective and safe choice. Telehealth is an important strategy to expand access to safe abortion care, especially for those with limited financial means or educational backgrounds. Rural and marginalized populations need more attention to improve access.

Intraoperative Complications in Medial Opening Wedge High Tibial Osteotomy.

Medial opening wedge high tibial osteotomy has been established for treatment of medial symptomatic knee arthrosis with varus malalignment in young and elderly but active patients. To obtain satisfactory results, it is essential for surgeons performing osteotomy to identify, prevent, and treat potential intraoperative adverse events. Lateral hinge fracture (LHF) is the most common intraoperative complication while popliteus artery injury is rare but limb-threatening. Computed tomography is the benchmark to detect LHF, the risk of which increased markedly with the opening gap larger than 11 mm. Setting the lateral hinge in a safe zone is the most important preventive measure. Medial long locking plate fixation may allow patients even with unstable hinge fractures to start early full weight bearing. Additional fixation of LHF is optional, and bone void filling is not routinely used. For protection of popliteus artery injury, flexing the knee joint is unreliable. It is paramount to place a protective retractor just behind the posterior tibial cortex toward the proximal tibiofibular joint before osteotomy, particularly in case of aberrant artery. A repertoire of surgical pearls is described in detail in this review to identify, prevent, and manage those intraoperative complications.

Botulinum toxin treatment for hemifacial spasm: harmonising neurological and aesthetic outcomes.

Hemifacial spasm (HFS) represents a challenging cranial movement disorder primarily affecting the facial nerve innervated muscles, with significant prevalence among Asians. Botulinum toxin type A (BoNT/A) injections, established as a primary therapeutic intervention since FDA approval, offer considerable effectiveness in alleviating spasms, albeit accompanied by challenges such as temporary effects and potential adverse events including facial asymmetry. This comprehensive review underscores the crucial need for harmonising neurological benefits and aesthetic outcomes in HFS management. The discussion delves into the interplay between facial aesthetics and neurological objectives in BoNT/A injections, emphasising precise techniques, dosages, and site considerations. Distinct aspects in neurological and aesthetic domains are also examined, including detailing the targeted muscles and injection methodologies for optimal therapeutic and aesthetic results. Importantly, evidence regarding various BoNT/A formulations, recommendations, and reconstitution guidelines in both neurology and aesthetics contexts are provided, along with a schematic approach outlining the stepwise process for BoNT/A injection in HFS treatment, addressing critical areas such as orbicularis oculi muscle sites, eyebrow correction strategies, mid- and lower-face considerations, contralateral injection sites, and post-injection follow-up and complication management. By highlighting the culmination of neurological efficacy and facial esthetics in BoNT/A treatment for HFS patients, this review proposes a holistic paradigm to achieve balanced symptomatic relief and natural aesthetic expression, ultimately enhancing quality of life for individuals grappling with HFS.

Effectiveness and Safety of the Allurion Swallowable Intragastric Balloon for Short-term Weight Loss: A Systematic Review and Meta-analysis.

Obesity poses a severe health problem worldwide, with an estimated impact on 17.5% of the adult population by 2035. Among the endoscopic applications for treating this comorbidity, intragastric balloons are the most widely used. The new liquid-filled swallowable balloon meets the requirements of major guidelines and allows significant weight loss with few adverse events. This systematic review and meta-analysis aims to demonstrate the efficacy and safety profile of this new device for weight loss. We conducted a search from 2016 to 2024 to assess the efficacy of the swallowable intragastric balloon for weight loss, including improvements in metabolic profiles and anthropometric measurements. Additionally, we evaluated potential adverse events related to the device to demonstrate its safety. Eleven observational studies totalling 2107 patients were included, showing a reduction of 4.75 in BMI (95% CI: -5.02; -4.47), a mean total weight loss of 12.47% (95% CI: -13.77; -11.17), a mean excess weight loss of 48.04% (95% CI: -50.61; -45.48), and a rate of serious adverse events of 0.90%. An improvement in the metabolic profile was observed for three parameters: HDL, triglycerides, and glycaemia. The swallowable liquid-filled intragastric balloon is safe and effective for managing weight loss within a four-month follow-up period.