Pharmaceuticals (Basel). 2023 Oct 21;16(10):1500. doi: 10.3390/ph16101500.

ABSTRACT

Drug-induced pruritus triggers a desire to scratch, thereby diminishing one's quality of life. Certain instances of this phenomenon follow complex mechanisms of action that diverge from histamine-mediated pathways, known contributors to pruritus. However, investigations into the relationship between drugs and pruritus are limited. In this study, data mining techniques were employed to comprehensively analyze the characteristics of drugs linked to pruritus, using the FDA's Adverse Event Reporting System (FAERS) data. Reports linked to pruritus demonstrated noteworthy differences in gender, age, and weight when compared with non-pruritus cases. Among the leading candidates for drugs prompting pruritus were ophthalmic drugs, systemic antibacterials, contrast media, dermatological antifungals, and dermatological preparations. A principal component analysis showed that the second principal component served as an indicator for distinguishing between onsets at mucous membranes or the skin's surface. Additionally, the third principal component functioned as an indicator for categorizing administration methods as either invasive or noninvasive. Furthermore, a hierarchical cluster analysis conducted on these obtained principal components revealed the potential for classifying drugs based on the site of pruritus onset and the method of drug administration. These findings contribute to the development of targeted prevention and treatment strategies for avoiding pruritus in clinical practice.

PMID:37895971 | DOI:10.3390/ph16101500

BMC Med Ethics. 2023 Oct 27;24(1):91. doi: 10.1186/s12910-023-00969-y.

ABSTRACT

BACKGROUND: Since the beginning of the COVID-19 pandemic, different countries sought to manufacture and supply effective vaccines to control the disease and prevent and protect public health in society. The implementation of vaccination has created many ethical dilemmas for humans, which must be recognized and resolved. Therefore, the present study was conducted to analyze the ethical considerations in vaccination against COVID-19 from the perspective of service providers.

METHODS: The present qualitative research was conducted in 2022 in the north of Iran. The participants included 23 health workers with at least five years of work experience and members of the COVID-19 vaccination team. The data were initially collected through systematic semi-structured interviews, then snowball sampling and finally continued until data saturation. The next steps were transcription of interviews, identification of meaning units, coding, categorization based on similarity and symmetry, extraction of themes and the analysis of themes through content analysis.

RESULTS: The analysis of participants' experiences led to the extraction of five main categories of themes and fifteen sub-categories of the ethical considerations of COVID-19 vaccination. Safe and standard vaccine production, vaccine supply, fairness, respect for autonomy, and accountability were the main categories. The subcategories included compliance with scientific and ethical procedures, effectiveness and profitability of vaccine, absence of severe adverse effects, allocation of resources for vaccine supply, vaccine availability, diversity and comprehensiveness of alternative vaccines, vaccination prioritization, prioritization of the vulnerable populations of society, autonomy of patient (equal rights), autonomy of community, autonomy of service providers, reporting correct information, reporting vaccine side effects, public trust and acceptance.

CONCLUSION: The health system managers should be adequately prepared to solve the ethical problems posed by COVID-19 vaccination. Therefore, it is recommended to avoid haste in vaccination and pay more attention to vaccination safety standards, provide sufficient resources for a comprehensive vaccine supply, pay close attention to collective interests versus individual interests, and meet community needs.

PMID:37891543 | PMC:PMC10612281 | DOI:10.1186/s12910-023-00969-y

Sci Rep. 2023 Oct 27;13(1):18459. doi: 10.1038/s41598-023-45783-z.

ABSTRACT

Neuroleptic malignant syndrome (NMS) is a rare but serious and sometimes fatal complication in patients taking antipsychotic drugs, and its underlying mechanism still remains unclear. The pharmacotherapy for psychotic disorders is complicated and often involves a combination of two or more drugs, including drugs other than antipsychotics. In the present study, we used the Japanese Adverse Drug Event Report (JADER) database to broadly investigate the drugs associated with NMS, following their related pathways, as well as the drug-drug interactions (DDIs) in NMS. All analyses were performed using data from the JADER database from April 2004 to May 2022. Single-drug signals were evaluated using the reporting odds ratio (ROR) and proportional reporting ratio (PRR), and drug pathways were investigated using the Kyoto Encyclopedia of Genes and Genomes (KEGG). DDIs were evaluated using the Ω shrinkage measure and Chi-square statistics models. All drugs associated with 20 or more NMS cases in the JADER database exhibited signals for NMS, including non-antipsychotics. Pathways associated with the drugs included the dopaminergic or serotonergic synapses related to antipsychotics. DDIs leading to NMS were confirmed for several drug combinations exhibiting single-drug signals. This study confirmed the significant association of various drugs, including non-psychotics, with NMS and suggested that various pathways related to these drugs may be involved in the progression of NMS. In addition, several combinations of these drugs were found to interact (DDI), increasing the risk of NMS, which suggests that appropriate caution should be taken when administering these drugs.

PMID:37891209 | PMC:PMC10611799 | DOI:10.1038/s41598-023-45783-z

Sci Rep. 2023 Oct 27;13(1):18475. doi: 10.1038/s41598-023-45403-w.

ABSTRACT

Agriculture plays a pivotal role in the economies of developing countries by providing livelihoods, sustenance, and employment opportunities in rural areas. However, crop diseases pose a significant threat to both farmers' incomes and food security. Furthermore, these diseases also show adverse effects on human health by causing various illnesses. Till date, only a limited number of studies have been conducted to identify and classify diseased cauliflower plants but they also face certain challenges such as insufficient disease surveillance mechanisms, the lack of comprehensive datasets that are properly labelled as well as are of high quality, and the considerable computational resources that are necessary for conducting thorough analysis. In view of the aforementioned challenges, the primary objective of this manuscript is to tackle these significant concerns and enhance understanding regarding the significance of cauliflower disease identification and detection in rural agriculture through the use of advanced deep transfer learning techniques. The work is conducted on the four classes of cauliflower diseases i.e. Bacterial spot rot, Black rot, Downy Mildew, and No disease which are taken from VegNet dataset. Ten deep transfer learning models such as EfficientNetB0, Xception, EfficientNetB1, MobileNetV2, EfficientNetB2, DenseNet201, EfficientNetB3, InceptionResNetV2, EfficientNetB4, and ResNet152V2, are trained and examined on the basis of root mean square error, recall, precision, F1-score, accuracy, and loss. Remarkably, EfficientNetB1 achieved the highest validation accuracy (99.90%), lowest loss (0.16), and root mean square error (0.40) during experimentation. It has been observed that our research highlights the critical role of advanced CNN models in automating cauliflower disease detection and classification and such models can lead to robust applications for cauliflower disease management in agriculture, ultimately benefiting both farmers and consumers.

PMID:37891188 | PMC:PMC10611743 | DOI:10.1038/s41598-023-45403-w

Int J Environ Res Public Health. 2023 Oct 19;20(20):6943. doi: 10.3390/ijerph20206943.

ABSTRACT

Numerous UK surveys conducted during COVID-19 examined the pandemic's detrimental effects on health, and the consequences of lockdown and other public health restrictions on mental health. Some surveys considered specific populations and social inequities exacerbated during COVID-19. Fewer surveys examined the ways in which the adverse effects of public health restrictions, such as lockdown, shielding and social distancing, might be alleviated. Drawing upon self-determination theory, the purpose of the current study was to assess whether culture-, health- and nature-based engagement would mitigate the effects of these restrictions on psychological wellbeing, social connectedness and loneliness. Quantitative data from a smaller-scale survey (n = 312) and a subset of questions embedded in a larger-scale survey (n = 3647) were analyzed using univariate and multivariate methods. Frequency of engagement, whether participation was online or offline and with or without other people, and the extent to which type of participation was associated with psychological wellbeing, social connectedness and loneliness were examined. Sports and fitness, gardening and reading occurred frequently in both surveys. For the smaller-scale survey, increases in connectedness and frequency of participation and decreases in loneliness were significantly associated with improved wellbeing, whereas the type of participation and age range were not significant predictors. Outcomes from the smaller-scale survey approximated the larger-scale survey for measures of loneliness, type and frequency of participation and proportion of respondents in each age range. As the frequency of participation was a significant predictor of wellbeing, but the type of participation was not significant, the findings implied that any type of participation in a sufficient quantity would be likely to boost wellbeing.

PMID:37887681 | PMC:PMC10606618 | DOI:10.3390/ijerph20206943

Cells. 2023 Oct 11;12(20):2440. doi: 10.3390/cells12202440.

ABSTRACT

Calcineurin inhibitors (CNI) can suppress allo- and autoimmunity by suppressing T cell function but also have anti-proteinuric effects by stabilizing the cellular components of the kidney's filtration barrier. Therefore, CNI are used in autoimmune kidney diseases with proteinuria. However, the traditional CNI, cyclosporine A and tacrolimus, have a narrow therapeutic range, need monitoring of drug levels, and their use is associated with nephrotoxicity and metabolic alterations. Voclosporin (VOC), a novel CNI, no longer requires drug level monitoring and seems to lack these adverse effects, although hypertension and drug-drug interactions still occur. VOC demonstrated efficacy superior to standard-of-care in controlling active lupus nephritis in the phase 2 AURA-LV and the phase 3 AURORA-1 trials and was approved for the treatment of active lupus nephritis. However, how to implement VOC into the current and changing treatment landscape of lupus nephritis is still debated. Here, we review the unique chemistry, pharmacology, and toxicity profile of VOC, summarize the efficacy and safety data from the AURA-LV and AURORA-1 trials, and discuss the following four possible options to implement VOC into the management of lupus nephritis, namely regarding B cell-targeting therapy with belimumab (BEL). These include: 1. patient stratification to either VOC or BEL, 2. VOC/BEL combination therapy, 3. VOC-BEL sequential therapy, or 4. alternative options for the rapid antiproteinuric effect of VOC.

PMID:37887284 | PMC:PMC10605893 | DOI:10.3390/cells12202440

Hepatol Commun. 2023 Oct 27;7(11):e0276. doi: 10.1097/HC9.0000000000000276. eCollection 2023 Nov 1.

ABSTRACT

BACKGROUND: Portal hypertension is a severe complication of cirrhosis. This Phase Ib study (NCT03842761) assessed the safety, tolerability, and pharmacokinetics of soluble guanylyl cyclase activator BI 685509 in patients with mild or moderate hepatic impairment (Child-Pugh [CP] A or B cirrhosis) and healthy volunteers (HVs).

METHODS: In this single-center, randomized, placebo-controlled study, patients received BI 685509 (maximum doses: 1, 2, or 3 mg, twice daily [BID]) or placebo for 28 days. HVs received one 0.5 mg dose of BI 685509 or placebo.

RESULTS: In total, 64 participants (CP-A, n=24; CP-B, n=25; HVs, n=15) were included; most commonly with NAFLD (36.7%), alcohol-associated (30.6%), or chronic viral hepatitis-related cirrhosis (28.6%). In patients with CP-A cirrhosis, drug-related adverse events (AEs) occurred in 5.6% of BI 685509-treated patients and 16.7% of placebo recipients. In patients with CP-B cirrhosis, drug-related AEs occurred in 26.3% of BI 685509-treated patients only. No serious AEs occurred in patients with CP-A cirrhosis; in patients with CP-B cirrhosis, serious AEs (not drug-related) occurred in 10.5% of BI 685509-treated patients and 16.7% of patients receiving placebo. BI 685509 was rapidly absorbed; exposure increased with dosage and was similar between etiologies and between patients with CP-A cirrhosis and patients with CP-A cirrhosis but lower in HVs. The mean percentage portal-systemic shunt fraction was measured in patients with CP-A cirrhosis and decreased at the end of treatment in the 2 mg BID (-11.2 ± 11.9%) and 3 mg BID (-14.0 ± 8.4%) BI 685509 dose groups, but not in the placebo group (+1.0 ± 27.3%).

CONCLUSION: BI 685509 was generally well tolerated, with 3 serious, not drug-related AEs reported in patients with CP-B cirrhosis. In patients with CP-A cirrhosis, portal-systemic shunt fraction in the exploratory efficacy analysis was reduced by 2 mg BID and 3 mg BID BI 685509.

PMID:37889522 | DOI:10.1097/HC9.0000000000000276

Toxics. 2023 Oct 18;11(10):867. doi: 10.3390/toxics11100867.

ABSTRACT

Hepatotoxicity is one of the significant side effects of chronic diabetes mellitus (DM) besides nephrotoxicity and pancreatitis. The management of this disease is much dependent on the restoration of the liver to its maximum functionality, as it is the central metabolic organ that gets severely affected during chronic diabetes. The present study investigates if the silver nanoparticles decorated with curcumin (AgNP-Cur) can enhance the efficacy of metformin (a conventional antidiabetic drug) by countering the drug-induced hepatoxicity. Swiss albino rats were categorized into six treatment groups (n = 6): control (group I without any treatment), the remaining five groups (group II, IV, V, VI) were DM-induced by streptozocin. Group II was untreated diabetic positive control, whereas groups III was administered with AgNP-cur (5 mg/kg). Diabetic group IV treated with metformin while V and VI were treated with metformin in a combination of the two doses of NPs (5 and 10 mg/kg) according to the treatment schedule. Biochemical and histological analysis of blood and liver samples were conducted after the treatment. The groups V and VI treated with the combination exhibited remarkable improvement in fasting glucose, lipid profile (HDL and cholesterol), liver function tests (AST, ALT), toxicity markers (GGT, GST and LDH), and redox markers (GSH, MDA and CAT) in comparison to group II in most of the parameters. Histological evaluation and comet assay further consolidate these biochemical results, pleading the restoration of the cellular structure of the target tissues and their nuclear DNA. Therefore, the present study shows that the NPs can enhance the anti-diabetic action by suppression of the drug-mediated hepatoxicity via relieving from oxidative stress, toxic burden and inflammation.

PMID:37888717 | DOI:10.3390/toxics11100867

Pharmacy (Basel). 2023 Oct 7;11(5):160. doi: 10.3390/pharmacy11050160.

ABSTRACT

Pharmacotherapy plays a crucial role in symptom management in palliative care and is associated with risks potentially leading to drug-related problems (DRP). Pharmacists can identify DRPs and advise prescribers on optimizing drug therapy. The aim of this study was to identify DRP in a palliative care unit (PCU) and evaluate corresponding pharmaceutical interventions. A non-randomized before-and-after study in a PCU starts with a control phase, an interphase, and an intervention phase. Primary endpoint: DRP, including pharmaceutical interventions and their acceptance. The medication of all inpatients was recorded at set time points, assessed for potential and manifest DRP, and categorized. In the control phase, the ward pharmacist did not interfere with the clinical team. In the intervention phase, the pharmacist could intervene when a DRP was identified and give recommendations. During the 12-month period, 284 patients were included (control phase n = 138; intervention phase n = 146) and 1079 DRPs were identified (control phase n = 634; intervention phase n = 445). The number of DRPs/patient was significantly reduced by the pharmacist's interventions between the control and intervention phases (4 vs. 3 DRPs, p = 0.001). Overall acceptance of pharmaceutical interventions by prescribers was very high (227/256; 88%). DRPs are hardly preventable. With a clinical pharmacist as a member of the palliative care team, it is possible to reduce the number of DRPs and identify potential problems earlier.

PMID:37888505 | DOI:10.3390/pharmacy11050160

Case Rep Infect Dis. 2023 Oct 18;2023:8865265. doi: 10.1155/2023/8865265. eCollection 2023.

ABSTRACT

We report a hemodialysis MDR HIV-infected patient switched to fostemsavir with lenacapavir plus lamivudine for more than a year. She maintained a suppressed viral replication and did not present any clinical or biological drug-related side effects. The combination of lenacapavir plus fostemsavir looks promising in terms of safety and efficacy even in patients with end-stage renal disease awaiting renal transplant. Both drugs are first in class ARVs so that there is no cross resistance with previous drugs, maintaining their efficacy against MDR HIV.

PMID:37886135 | PMC:PMC10599868 | DOI:10.1155/2023/8865265

Endocr Metab Immune Disord Drug Targets. 2023 Oct 25. doi: 10.2174/0118715303180615231011053011. Online ahead of print.

ABSTRACT

BACKGROUND: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist used for the treatment of type 2 diabetes mellitus (T2DM). So far, few severe side effects have been reported for it.

CASE PRESENTATION: A 41-year-old woman was admitted to the Emergency Room with diffuse abdominal pain. The patient had a known case of T2DM, fatty liver disease, and hypertension and was treated with Metformin, Liraglutide, and Losartan. Her liver functional test (LFT) was consistent with hepatocellular injury; however, laboratory tests and abdominal ultrasound were used to rule out autoimmune hepatitis. Due to concerns for drug-induced liver injury (DILL), liraglutide was discontinued and N-acetyl cysteine was prescribed. On the fifth day of hospitalization, the patient's symptoms resolved and his LFT started to decrease on the sixth day after 2 months, the patient's liver enzyme levels returned to normal.

CONCLUSION: Liraglutide is one of the most important drugs in the treatment of T2DM.The most common side effects of this drug are constipation, nausea, vomiting, diarrhea, indigestion, and loss of appetite. In rare cases, symptoms of thyroid cancer, pancreatitis, and hypoglycemia have been reported, however, DILL is one of the extremely rare side effect of Liraglutide. It is important to increase the awareness of physicians about the liver injury of Liraglutide.

PMID:37885115 | DOI:10.2174/0118715303180615231011053011

BMC Pediatr. 2023 Oct 26;23(1):531. doi: 10.1186/s12887-023-04336-z.

ABSTRACT

BACKGROUND: A error in intravenous injection in pediatric wards can cause irreparable injuries. This study aimed to determine the level of knowledge and performance of nurses in terms of preparation and injection of intravenous drugs in pediatric wards of hospitals affiliated to Isfahan University of Medical Sciences.

METHODS: This cross-sectional study was conducted in 2022 on 156 nurses working in pediatric wards. The data was collected with demographic information questionnaire and the knowledge and performance of the participants were determined using a researcher-made questionnaire, including the five rights of medication administration (preparation and injection, medication error, drug side effects, family empowerment, and documentation) using self-reporting and observation methods. Formal and content validity was calculated using the opinions of 10 experts and Cronbach's alpha with 40 samples.

RESULTS: The mean and standard deviation of total nurses' knowledge and performance scores were 58.31 + 10.1 and 66.1 + 14.4, respectively. Moreover, the mean and standard deviation of nurses' knowledge scores were 63.55 + 14.3 for documentation, 46.1 + 7.9 for preparation and injection, 73.9 + 12.3 for drug side effects, 58.4 + 10.2 for medication error, and 69.4 + 9.4 for family empowerment. Besides, the mean performance was 69.1 + 17.6 for documentation, 61.3 ± 9.9 for preparation and injection, 78.21 + 12 for drug side effects, 58.6 + 15 for medication error, and 65.4 + 17.7 for family empowerment.

CONCLUSION: The results showed that the mean knowledge and pharmacological performance of nurses working in pediatric wards in different areas of the principles of medicine were not at the desired level, and this can affect children adversely.

PMID:37884932 | PMC:PMC10601159 | DOI:10.1186/s12887-023-04336-z

S Afr Med J. 2023 Aug 3;113(8):63-68. doi: 10.7196/SAMJ.2023.v113i8.428.

ABSTRACT

BACKGROUND: Phentermine is an internationally recognised amphetamine derivative with significant appetite-suppressing properties. The drug is indicated for the short-term management of obesity, as the long-term (LT) use of phentermine may potentially be associated with severe cardiovascular side-effects, abuse and dependence. The LT use hereinafter describes periods exceeding 12 consecutive weeks. This use may also be associated with potential drug-drug interactions (PDDIs), which may result in adverse drug reactions (ADRs). The literature reports that phentermine is often prescribed LT and for several other off-label indications, increasing the risk for individuals to experience adverse drug events (ADEs) and drug-drug interactions (DDIs). There are, to our knowledge, no South African (SA) studies investigating the prevalence of co-prescribing LT phentermine with drugs that may potentially cause DDIs.

OBJECTIVE: To determine the prevalence of mild, moderate and severe DDIs with phentermine use when the duration of therapy in private healthcare exceeded 12 consecutive weeks.

METHODS: A cross-sectional drug utilisation review (DUR) was done by using data obtained from a SA pharmacy benefit management (PBM) company's database. Retrospective data of medicine claims for phentermine, from 1 January 2015 to 31 December 2019, were extracted for analysis. The number of days phentermine was supplied was used to identify the study population, in other words, those patients who received the drug LT. A drug interaction checker (Drugs.com) was used to identify potential mild, moderate and severe DDIs when using phentermine and co-prescribed drugs concurrently.

RESULTS: A total of 889 patients received phentermine LT. The top 20 drugs identified as being frequently co-prescribed in this study population demonstrated no mild PDDI, 15 (75%) moderate PDDIs and 5 (25%) severe PDDIs. The most common co-prescribed drug in the moderate group was dextromethorphan (n=282, 31.72%) and the least co-prescribed was formoterol (n=52, 5.85%). Among the drug group 'severe PDDIs', tramadol (n=416, 46.79%) was most frequently prescribed, whereas phenylpropanolamine (n=69, 7.76%) was the least prescribed to patients in this group.

CONCLUSION: There are patients who receive LT phentermine therapy despite the potential severe consequences that may result. These patients may receive concomitant therapy with phentermine and other pharmaceutical constituents, which may potentially cause DDIs, more specifically, moderate and severe DDIs. As such, these patients are not only confronted with the consequences of DDIs but are also at risk to experience ADRs as the residual effect of PDDIs.

PMID:37882119 | DOI:10.7196/SAMJ.2023.v113i8.428

Rev Med Suisse. 2023 Oct 25;19(847):2002-2006. doi: 10.53738/REVMED.2023.19.847.2002.

ABSTRACT

Acute heart failure is a leading cause of hospitalisations with an increasing economic and public health burden. Management of acute heart failure involves the use of diuretics to treat congestion and improve morbimortality. Despite current guidelines, numerous patients maintain congestion and often leave the hospital setting with incomplete volume depletion, leading to an increased risk of rehospitalisation. A recent multicentric randomised controlled trial studied the administration of acetazolamide in addition to standard care with loop diuretics in the acute setting. There was a significantly faster decongestion, based on a pragmatic clinical score, with very few side effects.

PMID:37878100 | DOI:10.53738/REVMED.2023.19.847.2002

Support Care Cancer. 2023 Oct 25;31(12):652. doi: 10.1007/s00520-023-08128-0.

ABSTRACT

PURPOSE: Oral anti-cancer agents (OAAs) represent a new frontier in cancer treatment, but we do not know how well patients incorporate the strategies that they are taught for managing the side effects of OAAs into their daily lives. The purpose of this study was to understand how OAA side effects influenced patients' lives and what strategies patients used to manage them.

METHODS: The study used an interpretive descriptive design utilizing photo elicitation interviews (PEI). Two pharmacists employed at the study ambulatory oncology clinic assisted with recruitment. Participants took photos and subsequent interviews focused on talking to participants about each photo, eliciting participant perspectives describing side effects of OAAs and management strategies. A directed content analysis approach was used to analyze the transcribed interviews.

RESULTS: A total of nine participants were included in the study. Three themes and associated sub-themes emerged: making changes to nutritional habits due to OAA side effects (hydration and food), strategies to alleviate OAA side effects (medication and non-medication related), and methods of coping with OAA effects (intra- and interpersonal). Changing nutritional habits was an important strategy to manage OAA side effects. Medication-related strategies to alleviate OAA side effects could be nuanced and, additionally, there was wide variability in coping methods used.

CONCLUSION: Patient education on OAAs and side effects is not always tailored to each unique patient and their circumstances. This study uncovered how participants devised their own distinct strategies to prevent or manage OAA side effects in an effort to help improve patients' experiences when taking OAAs.

PMID:37878093 | DOI:10.1007/s00520-023-08128-0

Drug Ther Bull. 2023 Oct 25:dtb-2023-000057. doi: 10.1136/dtb.2023.000057. Online ahead of print.

NO ABSTRACT

PMID:37879879 | DOI:10.1136/dtb.2023.000057

Drug Ther Bull. 2023 Oct 25:dtb-2023-000007. doi: 10.1136/dtb.2023.000007. Online ahead of print.

ABSTRACT

Semaglutide (▼Ozempic solution for injection, ▼Rybelsus tablets-Novo Nordisk) was initially granted market authorisation for the treatment of type 2 diabetes as an adjunct to diet and exercise. In 2021 and 2022, regulatory agencies in the USA and Europe licensed semaglutide (▼Wegovy solution for injection-Novo Nordisk) for the treatment of individuals who are obese, or overweight and who have at least one weight-related comorbidity. Manufacturer-sponsored randomised controlled trials have shown a loss of almost 12% of body weight over a 68-week period, however, once the medication is stopped people regain most of their pretreatment weight. Gastrointestinal adverse events occur commonly with semaglutide, and pancreatitis, diabetic retinopathy and severe allergic reactions have also been reported. Extensive hype in social and general media has resulted in increased demand for semaglutide leading to supply problems across the various licensed products including those used for treatment of diabetes. In the UK, the National Institute for Health and Care Excellence has recommended semaglutide as an option for weight management for a maximum treatment duration of 2 years. Further studies are underway to assess the effect of semaglutide on longer-term health benefits.

PMID:37879878 | DOI:10.1136/dtb.2023.000007

Drug Ther Bull. 2023 Nov;61(11):162. doi: 10.1136/dtb.2023.000055.

NO ABSTRACT

PMID:37875311 | DOI:10.1136/dtb.2023.000055

Zhonghua Zhong Liu Za Zhi. 2023 Oct 23;45(10):898-903. doi: 10.3760/cma.j.cn112152-20220530-00373.

ABSTRACT

Objective: To evaluate the safety and antitumor activity of envafolimab monotherapy in Chinese patients with advanced solid tumors. Methods: This open-label, multicenter phase I trial included dose escalation and dose expansion phases. In the dose escalation phase, patients received subcutaneous 0.1, 0.3, 1.0, 2.5, 5.0 or 10.0 mg/kg envafolimab once weekly (QW) following a modified "3+ 3" design. The dose expansion phase was performed in the 2.5 mg/kg and 5.0 mg/kg (QW) dose cohorts. Results: At November 25, 2019, a total of 287 patients received envafolimab treatment. During the dose escalation phase, no dose-limiting toxicities (DLT) was observed. In all dose cohorts, drug-related treatment-emergent adverse events (TEAEs) for all grades occurred in 75.3% of patients, and grade 3 or 4 occurred in 20.6% of patients. The incidence of immune-related adverse reactions (irAE) was 24.0% for all grades, the most common irAEs (≥2%) included hypothyroidism, hyperthyroidism, immune-associated hepatitis and rash. The incidence of injection site reactions was low (3.8%), all of which were grades 1-2. Among the 216 efficacy evaluable patients, the objective response rate (ORR) and disease control rate (DCR) were 11.6% and 43.1%, respectively. Median duration of response was 49.1 weeks (95% CI: 24.0, 49.3). Pharmacokinetic (PK) exposure to envafolimab is proportional to dose and median time to maximum plasma concentration is 72-120 hours based on the PK results from the dose escalation phase of the study. Conclusion: Subcutaneous envafolimab has a favorable safety and promising preliminary anti-tumor activity in Chinese patients with advanced solid tumors.

PMID:37875426 | DOI:10.3760/cma.j.cn112152-20220530-00373

Expert Opin Drug Saf. 2023 Oct 24. doi: 10.1080/14740338.2023.2274946. Online ahead of print.

ABSTRACT

BACKGROUND: The triglyceride-lowering drug, icosapent ethyl (IPE), was granted a new indication for the reduction of atherosclerotic cardiovascular disease risk in 2019.This study aimed to investigate the safety profile of IPE by mining the FDA Adverse Event Reporting System (FAERS) database.

METHODS: The reporting odds ratio was used to analyze IPE's adverse events (AEs) based on the FAERS data from July 2012 to December 2022. We described the characteristics of AE reports and evaluated the clinical prioritization of AEs. Then we defined and analyzed nine interested adverse drug reactions (ADRs) in both overall and subgroups, and investigated the times to onset.

RESULTS: The findings of our study strengthen the evidence for an increased risk of atrial fibrillation using IPE. IPE alone may not increase the risk of bleeding unless combined with antithrombotic drugs. Similar to statins, IPE alone can increase the risk of musculoskeletal pain, drug-related hepatic disorders, and hyperglycemia, but the risk could not double when IPE was combined with statins. Most ADRs occur in the early stage of treatment.

CONCLUSIONS: This study provides a comprehensive real-world safety profile of IPE, which indicates that IPE is well-tolerated.

PMID:37873598 | DOI:10.1080/14740338.2023.2274946