Drug-induced Adverse Events

A NEW HYPOTHESIS IN THE TREATMENT OF RECURRENT GLIOBLASTOMA MULTIFORME (GBM). PART 1: INTRODUCTION
Pol Merkur Lekarski. 2023;51(4):430-432. doi: 10.36740/Merkur202304119.
ABSTRACT
Modern treatment of glioblastoma multiforme (GBM) is based on neurosurgical methods combined with radiotherapy and chemotherapy. The prognosis for patients with GBM is extremely poor. Often, complete removal of the tumor is impossible and it often recurs. Therefore, in addition to standard regimens, modern methods such as modulated electrohyperthermia, monoclonal antibodies and individualised multimodal immunotherapy (IMI) based on vaccines and oncolytic viruses are also used in the treatment of GBM. Radioiodine therapy (RIT) also holds out hope for an effective treatment of this extremely aggressive brain tumor. The expression of the sodium iodide symporter (NIS) gene has been proven to have a positive effect on the treatment of selected cancers. Research confirm the presence of expression of this gene in GBM cells, although only in animal studies. Is it possible and therapeutically effective to treat GBM with RIT without the use of an exogenous NIS gene? The safety of therapy is relevant, as the only more serious adverse effect may be hypothyroidism. The use of RIT requires further clinical studies in patients. Perhaps it is worth revolutionizing GBM therapy to give sufferers a "new life".
PMID:37756465 | DOI:10.36740/Merkur202304119
Sickening: who is protecting pharma consumers?
Perspect Biol Med. 2023;66(2):327-343. doi: 10.1353/pbm.2023.0018.
ABSTRACT
In 2022, John Abramson published Sickening: How Big Pharma Broke American Healthcare and How We Can Repair It. The book illustrates how large pharmaceutical companies have become misinformation machines that have corrupted peer-reviewed journals, systematic review authors, and guideline committees. Industry influence includes selective reporting of clinical trial results and selection of control groups likely to enhance benefits and disguise side effects. Other documented forms of influence include clear conflicts of interest for members of guideline committees and even direct intimidation. The book concludes with a series of implementable reforms, such as ensuring the accuracy and completeness of evidence, developing an independent National Health Board, designing clinical research to optimize health outcomes, requiring the posting of research data so that independent scholars can replicate analyses, and ensuring the accuracy of direct consumer advertising. Abramson's book is a must read for students of medicine, public health, and public policy.
PMID:37755720 | DOI:10.1353/pbm.2023.0018
Older people, medication usage and long-term care pharmacists: a retrospective cohort study
Eur J Hosp Pharm. 2023 Sep 27:ejhpharm-2023-003908. doi: 10.1136/ejhpharm-2023-003908. Online ahead of print.
ABSTRACT
OBJECTIVE: To investigate the impact of the presence of a pharmacist on medication usage in long-term care facilities.
METHODS: The study followed a retrospective cohort design, with a sample of patients aged ≥65 years admitted to three long-term care facilities over 30 months. Data on age, gender, type of stay, the presence or absence of a pharmacist and pharmacotherapeutic profile at admission and discharge were obtained for study patients. Variations in the number of medicines, anticholinergic burden and potentially inappropriate medications at admission and discharge were assessed as outcome variables. Anticholinergic burden and potentially inappropriate medications were assessed using the Anticholinergic Cognitive Burden scale and the EU(7)-PIM List, respectively. One-sample t-tests were used to compare the mean values of the outcome variables. A four-way ANOVA was used to test the association between background and outcome variables. Partial eta squared (η2) was used to measure the effect size.
RESULTS: A total of 1366 patients were studied. All outcome variables showed a statistically significant increase at discharge compared with admission. The presence of a pharmacist was statistically significant in improving the number of medicines (p<0.001) and the anticholinergic burden score (p<0.001), while no statistically significant value was reached on potentially inappropriate medications (p=0.642). Small effect size values were obtained for the impact of the pharmacist on the number of medicines and anticholinergic burden scores (η2=0.021 and η2=0.011, respectively).
CONCLUSION: These findings suggest that the presence of a long-term care pharmacist can positively impact the use of medication associated with poor health outcomes. An integrated interprofessional approach is needed to address potentially inappropriate medications, anticholinergic burden and polypharmacy in long-term care settings, particularly at the time of discharge.
PMID:37758319 | DOI:10.1136/ejhpharm-2023-003908
Is alternate day dosing of oral iron an effective option for iron-deficiency anaemia?
Drug Ther Bull. 2023 Oct;61(10):149-150. doi: 10.1136/dtb.2023.000046.
ABSTRACT
Commentary on: Kaundal R, Bhatia P, Jain A, et al. Randomized controlled trial of twice-daily versus alternate-day oral iron therapy in the treatment of iron-deficiency anemia. Ann Hematol. 2020;99:57-63. Series Editor: Dr Teck Khong, DTB Associate Editor, Clinical Pharmacology, St George's, University of London, UK.
PMID:37758277 | DOI:10.1136/dtb.2023.000046
Sodium-glucose co-transporter 2 inhibitors & glucagon-like peptide-1 receptor agonists, efficacy & safety in diabetic kidney transplant recipients
Clin Transplant. 2023 Sep 27:e15144. doi: 10.1111/ctr.15144. Online ahead of print.
ABSTRACT
INTRODUCTION: Cardiovascular and renal complications define the outcomes of diabetic kidney transplant recipients (KTRs). The new diabetes medications have changed the management of diabetes. However, transplant physicians are still reluctant to use sodium-glucose cotransporter 2 inhibitors (SGLT2i) and Glucagon-like peptide-1 receptor agonists (GLP-1RA) post kidney transplantation due to fear of drug related complications and lack of established guidelines.
PATIENTS AND METHODS: We collected 1-year follow-up data from records of 98 diabetic KTRs on SGLT2I, 41 on GLP- 1RA and 70 on standard-of-care medicines. Patients were more than 3 months post-transplant with a minimum estimated glomerular filtration rate (eGFR) of 25 ml/min/1.73 m2 . Demographic data were similar except for a slightly lower HbA1c in the control group and higher albuminuria in SGLT2i group.
RESULTS: HbA1c dropped significantly by .4% in both SGLT2i and GLP-1RA compared to .05% in the control group. A significant decrease in BMI by .32 in SGLT2i and .34 in GLP-1RA was observed compared to an increase by .015 in control group. A tendency for better eGFR in study groups was observed but was non-significant except for the SGLT2i group with an eGFR above 90 (p = .0135). The usual dip in eGFR was observed in the SGLT2i group at 1-3 months. Albuminuria was significantly reduced in both study groups. Adverse events were minimal with comparable safety in all groups.
CONCLUSION: The use of SGLT2i and GLP-1RA appears to be effective and safe in diabetic KTRs with good outcomes. Randomized control trials are required to confirm these findings and establish guidelines.
PMID:37755118 | DOI:10.1111/ctr.15144
Efficacy, Safety, and Durability of Brolucizumab: An 8-Month Post-Marketing Surveillance Analysis
Clin Ophthalmol. 2023 Sep 20;17:2791-2802. doi: 10.2147/OPTH.S425709. eCollection 2023.
ABSTRACT
IMPORTANCE: Brolucizumab (Beovu®) is an anti-vascular endothelial growth factor (anti-VEGF) agent approved for the treatment of neovascular age-related macular degeneration (nvAMD). Brolucizumab was marketed for its noninferiority to aflibercept and its potential for greater durability. However, post-marketing utilization has been tempered by safety concerns.
OBJECTIVE: We evaluate the visual and anatomic efficacy of brolucizumab, examine changes in treatment intervals after switching to brolucizumab, and estimate the incidence of drug-related adverse events in the real world.
DESIGN SETTING AND PARTICIPANTS: This was a retrospective consecutive case series of 626 eyes (543 patients) with nvAMD treated with 1438 brolucizumab injections at a single retina practice between 10/1/2019 and 5/15/2020.
MAIN OUTCOMES AND MEASURES: Changes in visual acuity (VA); anatomic outcomes assessed by optical coherence tomography (OCT) including central subfield thickness (CST), macular volume (MV), presence of intraretinal fluid (IRF), subretinal fluid (SRF), and serous pigment epithelial detachment (sPED) on foveal line scans; treatment intervals before and after receiving brolucizumab; and the incidence of brolucizumab-related adverse events.
RESULTS: The majority of eyes (N = 531, 89.7%) had received prior anti-VEGF therapy with aflibercept, ranibizumab, and/or bevacizumab. VA improved in treatment-naïve eyes (+3.7 letters, p = 0.04), and was maintained in previously treated eyes. There were significant improvements in all anatomic outcomes in both groups (p < 0.001). We observed a 4.8% incidence of intraocular inflammation (IOI) and a 0.6% incidence of retinal vasculitis. The average treatment interval increased from 6.3 to 6.8 weeks (p = 0.001).
CONCLUSIONS AND RELEVANCE: Brolucizumab treatment was associated with VA improvement in naïve eyes and maintenance of VA in previously treated eyes. Switching to brolucizumab was associated with improved anatomic outcomes and extended treatment intervals in most eyes. We observed a similar incidence of IOI and a lower incidence of retinal vasculitis compared to the Safety Review Committee's analysis of HAWK and HARRIER.
PMID:37753246 | PMC:PMC10518423 | DOI:10.2147/OPTH.S425709
Mindfulness-Based Mobile Health to Address Unhealthy Eating Among Middle-Aged Sexual Minority Women With Early Life Adversity: Mixed Methods Feasibility Trial
J Med Internet Res. 2023 Sep 26;25:e46310. doi: 10.2196/46310.
ABSTRACT
BACKGROUND: Sexual minority women (lesbian, gay, bisexual, pansexual, queer, and other nonheterosexual women) remain considerably underrepresented in health research despite being at a higher risk for diabetes and obesity as well as stigma and psychological distress than their heterosexual peers. In addition, early life adversity (ELA) is prevalent among sexual minority women, which further increases risks for obesity, psychological distress, and poor cardiovascular health. App-based mindfulness interventions are potentially promising for this group in mitigating the adverse health effects of ELA, reducing food craving and unhealthy eating, addressing the risks associated with obesity.
OBJECTIVE: This mixed methods feasibility trial aimed to test a mindfulness-based mobile health approach for middle-aged sexual minority women (aged 30-55 years) with ELA and overweight or obesity (BMI ≥25 kg/m2) to improve health outcomes.
METHODS: The single-arm trial was advertised on social media and various lesbian, gay, bisexual, transgender, and queer web-based groups. At baseline, after the intervention (2 months), and at the 4-month follow-up, participants completed assessments of primary outcomes (food craving, emotional eating, and weight via a mailed scale) and secondary outcomes (depression, anxiety, mindfulness, and emotion dysregulation). A standardized weight measure was mailed to participants for weight reporting. Feasibility and acceptability were assessed after the intervention via surveys and semistructured exit interviews.
RESULTS: We screened 442 individuals, among which 30 eligible sexual minority women (mean age 40.20, SD 7.15 years) from various US regions were enrolled in the study. At baseline, 86% (26/30) and 80% (24/30) of participants had elevated depressive and anxiety symptoms, respectively. Among the 30 enrolled participants, 20 (66%) completed all intervention modules, 25 (83%) were retained at the 2-month follow-up, and 20 (66%) were retained at the 4-month follow-up. None reported adverse effects. From baseline to the 4-month follow-up, large effects were found in food craving (Cohen d=1.64) and reward-based eating (Cohen d=1.56), whereas small effects were found with weight (Cohen d=0.20; 4.21 kg on average). Significant improvements were also found in the secondary outcomes (depression, Cohen d=0.98; anxiety, Cohen d=0.50; mindfulness, Cohen d=0.49; and emotion dysregulation, Cohen d=0.44; all P<.05). Participants with higher levels of parental verbal and emotional abuse were particularly responsive to the intervention. Participants reported that the program aligned with their goals and expectations, was easy to use, and facilitated changes in eating behavior and mental health. Barriers to engagement included the need for diverse teachers, individualized support, and body positive language.
CONCLUSIONS: This early phase feasibility trial provides proof-of-concept support for a mindfulness mobile health approach to improve obesity-related outcomes among sexual minority women and warrants a larger randomized controlled trial in the future. The findings also suggest the need to address trauma and psychological health when addressing weight-related outcomes among sexual minority women.
PMID:37751273 | DOI:10.2196/46310
Autoinflation for otitis media with effusion (OME) in children
Cochrane Database Syst Rev. 2023 Sep 26;9(9):CD015253. doi: 10.1002/14651858.CD015253.pub2.
ABSTRACT
BACKGROUND: Otitis media with effusion (OME) is an accumulation of fluid in the middle ear cavity, common amongst young children. The fluid may cause hearing loss. When persistent, it may lead to behavioural problems and a delay in expressive language skills. Management of OME includes watchful waiting, medical, surgical and mechanical treatment. Autoinflation is a self-administered technique, which aims to ventilate the middle ear and encourage middle ear fluid clearance by providing a positive pressure of air in the nose and nasopharynx (using a nasal balloon or other handheld device). This positive pressure (sometimes combined with simultaneous swallow) encourages opening of the Eustachian tube and may help ventilate the middle ear.
OBJECTIVES: To assess the efficacy (benefits and harms) of autoinflation for the treatment of otitis media with effusion in children.
SEARCH METHODS: The Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 20 January 2023.
SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-randomised trials in children aged 6 months to 12 years with unilateral or bilateral OME. We included studies that compared autoinflation with either watchful waiting (no treatment), non-surgical treatment or ventilation tubes.
DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were determined following a multi-stakeholder prioritisation exercise and were: 1) hearing, 2) OME-specific quality of life and 3) pain and distress. Secondary outcomes were: 1) persistence of OME, 2) other adverse effects (including eardrum perforation), 3) compliance or adherence to treatment, 4) receptive language skills, 5) speech development, 6) cognitive development, 7) psychosocial skills, 8) listening skills, 9) generic health-related quality of life, 10) parental stress, 11) vestibular function and 12) episodes of acute otitis media. We used GRADE to assess the certainty of evidence for each outcome. Although we included all measures of hearing assessment, the proportion of children who returned to normal hearing was our preferred method to assess hearing, due to challenges in interpreting the results of mean hearing thresholds.
MAIN RESULTS: We identified 11 completed studies that met our inclusion criteria (1036 participants). The majority of studies included children aged between 3 and 11 years. Most were carried out in Europe or North America, and they were conducted in both hospital and community settings. All compared autoinflation (using a variety of different methods and devices) to no treatment. Most studies required children to carry out autoinflation two to three times per day, for between 2 and 12 weeks. The outcomes were predominantly assessed just after the treatment phase had been completed. Here we report the effects at the longest follow-up for our main outcome measures. Return to normal hearing The evidence was very uncertain regarding the effect of autoinflation on the return to normal hearing. The longest duration of follow-up was 11 weeks. At this time point, the risk ratio was 2.67 in favour of autoinflation (95% confidence interval (CI) 1.73 to 4.12; 85% versus 32%; number needed to treat to benefit (NNTB) 2; 1 study, 94 participants), but the certainty of the evidence was very low. Disease-specific quality of life Autoinflation may result in a moderate improvement in quality of life (related to otitis media) after short-term follow-up. One study assessed quality of life using the Otitis Media Questionnaire-14 (OMQ-14) at three months of follow-up. Results were reported as the number of standard deviations above or below zero difference, with a range from -3 (better) to +3 (worse). The mean difference was -0.42 lower (better) for those who received autoinflation (95% CI -0.62 to -0.22; 1 study, 247 participants; low-certainty evidence; the authors report a change of 0.3 as clinically meaningful). Pain and distress caused by the procedure Autoinflation may result in an increased risk of ear pain, but the evidence was very uncertain. One study assessed this outcome, and identified a risk ratio of 3.50 for otalgia in those who received autoinflation, although the overall occurrence of pain was low (95% CI 0.74 to 16.59; 4.4% versus 1.3%; number needed to treat to harm (NNTH) 32; 1 study, 320 participants; very low-certainty evidence). Persistence of OME The evidence suggests that autoinflation may slightly reduce the persistence of OME at three months. Four studies were included, and the risk ratio for persistence of OME was 0.88 for those receiving autoinflation (95% CI 0.80 to 0.97; 4 studies, 483 participants; absolute reduction of 89 people per 1000 with persistent OME; NNTB 12; low-certainty evidence).
AUTHORS' CONCLUSIONS: All the evidence we identified was of low or very low certainty, meaning that we have little confidence in the estimated effects. However, the data suggest that autoinflation may have a beneficial effect on OME-specific quality of life and persistence of OME in the short term, but the effect is uncertain for return to normal hearing and adverse effects. The potential benefits should be weighed against the inconvenience of regularly carrying out autoinflation, and the possible risk of ear pain.
PMID:37750500 | PMC:PMC10521168 | DOI:10.1002/14651858.CD015253.pub2
Long-Term Safety Profiles Macrolides and Tetracyclines: A Systematic Review and Meta-analysis
J Clin Pharmacol. 2023 Sep 26. doi: 10.1002/jcph.2358. Online ahead of print.
ABSTRACT
Macrolides and tetracyclines are antibiotics that have a range of anti-inflammatory properties beyond their microbial capabilities. Although these antibiotcs have been in widespread use, the long-term safety profiles are limited. We performed a systematic review and meta-analysis of randomized clinical trials (RCTs) that compared macrolides or tetracyclines with placeboes to provide long-term safety information. We searched Medline and EMBASE from inception to October 2022 and identified studies that reported study-drug-related death, serious adverse events (SAEs), or withdrawal rates, and common adverse effects of each drug. Relative risk (RR) and number needed to harm (NNH) were calculated. Of the 52 RCTs included, there are 3,151 participants on doxycycline, 2,519 participants on minocycline, 3,049 participants on azithromycin, 763 participants on clarithromycin, 262 participants on erythromycin, and 100 participants on roxithromycin. There was no death related to any study drugs and rates of SAE were not significantly different from placebo in any drug. Overall withdrawal rates were slightly higher than placebo in doxycycline (RR, 1.30; 95% CI, 1.12-1.52) and minocycline (RR, 1.29; 95% CI, 1.15-1.46). Withdrawal rates due to adverse events were higher in doxycycline (RR, 2.82; 95% CI, 1.88-4.22), minocycline (RR, 1.48; 95% CI, 1.09-1.98), and azithromycin (RR, 1.53; 95% CI, 1.13-2.08). Gastrointestinal (GI) disturbances are the most common tolerable adverse effects for every drug. Photosensitivity and rash are the second most common for doxycycline and minocycline. We found no evidence that long-term use up to 2 years of macrolides or tetracyclines was associated with increased risk of SAEs. This article is protected by copyright. All rights reserved.
PMID:37751595 | DOI:10.1002/jcph.2358
Week 240 Efficacy and Safety of Fostemsavir Plus Optimized Background Therapy in Heavily Treatment-Experienced Adults with HIV-1
Infect Dis Ther. 2023 Sep 26. doi: 10.1007/s40121-023-00870-6. Online ahead of print.
ABSTRACT
INTRODUCTION: Efficacy and safety of the attachment inhibitor fostemsavir + optimized background therapy (OBT) were evaluated through 48 and 96 weeks in the phase 3 BRIGHTE trial in heavily treatment-experienced (HTE) adults failing their current antiretroviral regimen. Here, we report 240-week efficacy and safety of fostemsavir + OBT in adults with multidrug-resistant human immunodeficiency virus (HIV)-1 in BRIGHTE.
METHODS: Heavily treatment-experienced adults failing their current regimen entered the randomized cohort (RC; 1-2 fully active antiretrovirals available) or non-randomized cohort (NRC; no fully active antiretrovirals available) and received open-label fostemsavir + OBT (starting Day 8 in RC and Day 1 in NRC). Endpoints included proportion with virologic response (HIV-1 RNA < 40 copies/mL, Snapshot), immunologic efficacy, and safety.
RESULTS: At Week 240, 45% and 22% of the RC and NRC, respectively, had virologic response (Snapshot); 7% of the RC and 5% of the NRC had missing data due to coronavirus disease 2019 (COVID-19)-impacted visits. In the observed analysis, 82% of the RC and 66% of the NRC had virologic response. At Week 240, mean change from baseline in CD4+ T-cell count was 296 cells/mm3 (RC) and 240 cells/mm3 (NRC); mean CD4+/CD8+ ratio increased between Weeks 96 and 240 (RC 0.44 to 0.60; NRC 0.23 to 0.32). Between Weeks 96 and 240, four participants discontinued for adverse events, one additional participant experienced a drug-related serious adverse event, and six deaths occurred (median last available CD4+ T-cell count, 3 cells/mm3). COVID-19-related events occurred in 25 out of 371 participants; all resolved without incident.
CONCLUSION: Through ~5 years, fostemsavir + OBT demonstrated durable virologic and immunologic responses with no new safety concerns between Weeks 96 and 240, supporting this regimen as a key therapeutic option for HTE people with multidrug-resistant HIV-1.
TRIAL REGISTRATION: ClinicalTrials.gov, NCT02362503.
PMID:37751019 | DOI:10.1007/s40121-023-00870-6
Adverse physiological effects of smoking cessation on the gastrointestinal tract: A review
Medicine (Baltimore). 2023 Sep 22;102(38):e35124. doi: 10.1097/MD.0000000000035124.
ABSTRACT
Smoking cessation is known to have numerous health benefits, but it can also induce adverse physiological effects, including those affecting the gastrointestinal tract (GIT). Understanding the adverse physiological effects of smoking cessation on the GIT is critical for healthcare professionals and smokers attempting to quit, as it enables them to anticipate and manage potential challenges during the smoking cessation process. Although the detrimental effects of smoking on the GIT have been well established, there is a gap in the literature regarding the specific physiological reactions that may occur upon smoking cessation. This mini-review summarizes the current literature on the predisposing factors, pathophysiology, clinical presentation, and treatment options for adverse physiological effects of smoking cessation on the GIT. We aimed to raise awareness among busy clinical professionals about these adverse effects, empowering them to effectively support individuals striving to quit smoking and maintain their cessation. By consolidating the existing knowledge in this field, this review offers practical implications for smokers, healthcare providers, and policymakers to optimize smoking cessation interventions and support strategies to improve health outcomes.
PMID:37747027 | PMC:PMC10519547 | DOI:10.1097/MD.0000000000035124
Patterns and outcomes of paracetamol poisoning management in Hamad Medical Corporation, Qatar: A retrospective cohort study
Medicine (Baltimore). 2023 Sep 22;102(38):e34872. doi: 10.1097/MD.0000000000034872.
ABSTRACT
We aimed to investigate the characteristics and clinical outcomes of paracetamol poisoning and paracetamol overdose in Qatar. This retrospective cohort study included patients admitted to the emergency department (ED). We included patients who presented with excessive paracetamol ingestion, between December 2018 and September 2019. The primary outcomes were describing the characteristics and outcomes of paracetamol overdose (from a suicidal overdose or accidental overdose, dose ≤ 150 mg/kg, when serum levels of <60 mmol/L) or dose ingested (≤75 mg/kg) with staggered ingestion poisoning due to suicidal attempt or accidental attempt, defined as the dose ingested (>150 mg/kg), acute ingestion, nomogram level more than the treatment line, or dose ingested (>75 mg/kg) with staggered ingestion, and assessing the management of excessive paracetamol ingestion. Secondary outcomes included evaluation of the time difference between ingestion and time of administration, hospitalization, and adverse drug events. Significant differences were detected between patients who presented with paracetamol overdose and those who presented with paracetamol toxicity. A total of 69 patients were analyzed, of whom 43 received paracetamol overdose (mean age 27.5 ± 11.1 years) and 26 had paracetamol poisoning (mean age 25 ± 6.22 years). Paracetamol poisoning was identified in 26% of the patients with a 24.3% history of psychiatric illness, compared to 18.6% with paracetamol overdose. More patients presented with paracetamol toxicity in the time between ingestion and obtaining serum levels compared to the overdose group. A significantly longer length of hospitalization was observed in the toxicity group. A significantly higher number of patients in the toxicity group received N-acetylcysteine (NAC). More hypotension and rashes were observed among those who received NAC in the toxicity group. Patients presenting to the ED due to paracetamol toxicity are not uncommon, and most cases occur in young adults, and few in patients with a history of psychiatric illness, suggesting that preventive approaches are highly required.
PMID:37746996 | PMC:PMC10519564 | DOI:10.1097/MD.0000000000034872
Case studies of multi-disciplinary team management of atypical gastric cancer: challenges and lessons learned (about two cases)
Pan Afr Med J. 2023 Jun 30;45:113. doi: 10.11604/pamj.2023.45.113.38579. eCollection 2023.
ABSTRACT
There is a paradigm shift towards adopting a multidisciplinary team (MDT) model in the care of cancer patients, with increasing evidence to support its effectiveness. Cancers are biologically distinct, patients present in diverse ways and require, different therapeutic approaches in their management. Patient symptoms and treatment side-effects as well as physical and psychological impact vary according to cancer location and treatment plan. The varied clinical scenarios cancer patients present further buttress the need for MDT practice in hospitals to improve the quality of patient care, in contrast to the outdated concept of holistic treatment offered by a single physician. Unlike Europe, United States of America and Australia which have implemented successful MDT cancer care programs, Nigeria is just coming on board. We present two cases of gastric cancer (seen two months apart) with atypical presentation and the role of MDT in their evaluation and management. These case studies highlight the role of MDT in the management of cancer patients in Nigeria lending credence to the urgent need to implement this model of care in our cancer patients in a bid to improve the quality of care and outcome.
PMID:37745919 | PMC:PMC10516756 | DOI:10.11604/pamj.2023.45.113.38579
Comparative efficacy of intraoperative radiotherapy and external boost irradiation in early-stage breast cancer: a systematic review and meta-analysis
PeerJ. 2023 Sep 18;11:e15949. doi: 10.7717/peerj.15949. eCollection 2023.
ABSTRACT
External boost radiotherapy (EBRT) and intraoperative radiotherapy (IORT) are shown to be effective in patients with early-stage breast cancer. However, the difference between IORT and EBRT for patients' prognosis remains to be elucidated. The purpose of this meta-analysis is to investigate differences in local recurrence (LR), distant metastases, disease free survival (DFS), and overall survival (OS) between these two therapies. We searched the Cochrane Library, PubMed, Web of Science and Embase, from inception to Jan 10th, 2022. We used The Cochrane risk-of-bias assessment tool to assess the risk of bias of the included studies, and the STATA15.0 tool was used for the meta-analyses. Eight studies were ultimately included. Meta-analysis demonstrated that there was an inconsistent finding in the long-term risk of LR between the two radiotherapies, and there was no significant difference in short-term risk of LR, the metastasis rate, DFS, and OS IORT would be more convenient, less time-consuming, less costly, and more effective at reducing side effects and toxicity. However, these benefits must be balanced against the potential for increased risk of LR in the long term.
PMID:37744215 | PMC:PMC10512934 | DOI:10.7717/peerj.15949
Recent updates from the <em>BNF</em> (<em>BNF 86</em>)
Drug Ther Bull. 2023 Sep 25:dtb-2023-000050. doi: 10.1136/dtb.2023.000050. Online ahead of print.
ABSTRACT
The BNF is jointly published by the Royal Pharmaceutical Society and BMJ. BNF is published in print twice a year and interim updates are issued and published monthly in the digital versions. The following summary provides a brief description of some of the key changes that have been made to BNF content.
PMID:37748845 | DOI:10.1136/dtb.2023.000050
Coroners' reports, medicines and preventable deaths
Drug Ther Bull. 2023 Sep 25:dtb-2023-000048. doi: 10.1136/dtb.2023.000048. Online ahead of print.
NO ABSTRACT
PMID:37748844 | DOI:10.1136/dtb.2023.000048
Clinical pharmacy interventions in an Austrian hospital: a report highlights the need for the implementation of clinical pharmacy services
Eur J Hosp Pharm. 2023 Sep 25:ejhpharm-2023-003840. doi: 10.1136/ejhpharm-2023-003840. Online ahead of print.
ABSTRACT
BACKGROUND: Clinical pharmacy services face challenges in Austria due to limited implementation and acceptance, outdated legislation and a lack of guidelines and training, despite the evidence from global studies of the positive impact of clinical pharmacists on patient care.
OBJECTIVES: First, to identify the necessary types of clinical pharmacy interventions required at a 360-bed hospital located in Austria. Second, to evaluate the extent to which physicians accept the suggestions made by clinical pharmacists.
METHODS: Over a period of 27 months, a clinical pharmacist made a series of interventions, which were evaluated using a six-point clinical significance scale. To determine the inter-rater reliability, a subset of 25 interventions was assessed for their clinical significance by four independent internal medicine physicians.
RESULTS: A total of 1064 interventions were made by the pharmacist. Clinical pharmacy input was deemed necessary for 986 out of 1364 (72.3%) patients, with an average of 1.08 interventions per patient. The prompt acceptance rate of these interventions by physicians was 83.5% (888/1064), while 12.9% (137/1064) were considered by physicians but not immediately acted upon. The average clinical significance intervention rating was 2.15. The inter-rater reliability agreement between the four MDs and between the four MDs and the pharmacist was classified as 'good' to 'moderate'.
CONCLUSION: This study in a secondary care Austrian hospital demonstrates the requirement for clinical pharmacy services, which are highly valued by other healthcare professionals. The clinical pharmacist is a key member of the multidisciplinary ward team, playing a vital role in reducing drug-related problems and enhancing patient safety. This work should now be scaled and tested in other Austrian hospitals.
PMID:37748843 | DOI:10.1136/ejhpharm-2023-003840
Incidence, risk factors, and management of alpelisib-associated hyperglycemia in metastatic breast cancer
Cancer. 2023 Sep 25. doi: 10.1002/cncr.34928. Online ahead of print.
ABSTRACT
PURPOSE: The combination of fulvestrant with alpelisib, a PI3K inhibitor, improves progression-free survival in metastatic hormone receptor-positive, PIK3CA-mutant breast cancer. This study describes the incidence, risk factors, and treatment of alpelisib-associated hyperglycemia.
METHODS: Patients with metastatic breast cancer who received alpelisib from 2013 to 2021 at Memorial Sloan Kettering Cancer Center were included in this retrospective study. Alpelisib prescription dates and patient/tumor characteristics were abstracted from medical records. Risk factors associated with hyperglycemia and alpelisib dose reduction/discontinuation were evaluated using Pearson's χ2 tests.
RESULTS: Among 247 patients, baseline median body mass index was 25.4 kg/m2 and median hemoglobin A1c (HbA1c) was 5.5%. A total of 152 patients (61.5%) developed any-grade hyperglycemia and 72 patients (29.2%) developed grade 3-4 hyperglycemia; median time to onset was 16 days. A total of 100 patients (40.5%) received alpelisib on a clinical trial; rates of hyperglycemia were significantly higher in patients treated as standard care versus on a clinical trial (any-grade hyperglycemia 80.3% vs. 34.0%, grade 3-4 hyperglycemia 40.2% vs. 13.0%, p < .001). Baseline HbA1c was significantly associated with development of hyperglycemia (p < .001) and alpelisib dose reduction/discontinuation (p = .015). Among those who developed hyperglycemia, 101 (40.9%) received treatment, most commonly with metformin. A total of 49 patients (19.8%) were referred to an endocrinologist, which was associated with SGLT2 inhibitor prescription (p = .007).
CONCLUSIONS: Rates of hyperglycemia among patients treated with alpelisib as standard care were significantly higher than patients treated on clinical trials. Elevated baseline HbA1c is associated with alpelisib-induced hyperglycemia and requiring dose modification. Optimization of glycemic status before alpelisib initiation should become routine practice.
PMID:37743730 | DOI:10.1002/cncr.34928
Long-acting family planning switching and associated factors among revisit women in Toke Kutaye district of West Shoa Zone, Oromia Region public health facilities, Ethiopia: a mixed methods study
BMC Womens Health. 2023 Sep 25;23(1):512. doi: 10.1186/s12905-023-02664-x.
ABSTRACT
BACKGROUND: Switching from a long-acting family planning (LAFP) method to another could lead to an unintended pregnancy. However, the proportions of LAFP method switching and predictable factors are not well addressed. Therefore, the aim of this study was to determine the magnitude of LAFP method switching and associated factors among revisit women. The study also explored the reasons for the LAFP method switching among the revisited women.
METHOD: A mixed methods study was conducted among 377 reproductive age women attending public health facilities in Toke Kutaye district, West Shoa, Zone, Ethiopia, from 20 May 2021 to 28 July 2021. A systematic random sampling for quantitative and purposive sampling technique for qualitative study was used to select the study participants. A pretested structured questionnaire and in-depth interview were used to determine and explore long-acting family planning switching among revisit women. Data were analysed by Statistical Package for the Social Sciences (SPSS) version 21. Binary logistic regression was conducted to identify the dependent and independent variables at p-value < 0.05 along with 95% Confidence Interval (CI) and Adjusted Odds Ratio (AOR). The qualitative data were analysed using thematic analysis.
RESULTS: The magnitude of long-acting family planning method switching was 53.3%. Switching from an implant to other short-acting method was 39.8%, and switching from an intrauterine contraceptive device (IUCD) to other short-acting method was 13.5%. A formal education (AOR, 10.38, 95% CI: 3.48, 30.95), birth spacing (AOR, 5.52, 95% CI: 1.31, 23.33) and perceived infertility (AOR, 11.16, 95% CI: 5.55, 22.45) were factors associated with LAFP switching. The qualitative findings revealed that fear of side effects, lack of adequate information, religion, and misconceptions hinder users from maintaining the LAFP.
CONCLUSIONS: The study finds that the proportion of women switching from long-acting family planning was relatively higher than in other studies. The main reasons for LAFP switching were fear of side effects, lack of adequate information specific to LAFP and misconceptions. Therefore, the provision of quality contraceptive counselling by the service providers may mitigate the concern of IUD and implant switching. Furthermore, future prospective research at a larger sample size is needed.
PMID:37743477 | PMC:PMC10518956 | DOI:10.1186/s12905-023-02664-x
Influence of side effect information on patient willingness to take medication: consequences for informed consent and medication adherence
Intern Med J. 2023 Sep;53(9):1692-1696. doi: 10.1111/imj.16220.
ABSTRACT
Medication side effect information can create negative patient expectations of side effects, but such information is considered crucial to informed consent. The current study investigated the effect of informing participants of different numbers of medication side effects. Willingness to take the medication was highest for those informed of one or four compared with none or 26 side effects, and memory of side effects was also more accurate. Findings suggest that informing patients of some, but not several, side effects may optimise both medication adherence and accuracy of informed consent.
PMID:37743238 | DOI:10.1111/imj.16220