Drug-induced Adverse Events

Commonly prescribed medications associated with alopecia
J Am Acad Dermatol. 2023 Jun;88(6):1326-1337.e2. doi: 10.1016/j.jaad.2017.01.060.
ABSTRACT
BACKGROUND: The diagnosis and treatment of medication-associated alopecia often challenges patients and physicians. While numerous studies on the topic exist, limited information on the strength and magnitude of these studies exists.
OBJECTIVES: We investigated the most commonly prescribed medications with high levels of evidence to support associations with alopecia.
METHODS: A list of most commonly prescribed medications was compiled using the "Top 100 Prescriptions, Sales" (Intercontinental Marketing Services) and "Top 200 Names Searched" (RxList.com). PubMed, Embase, and Web of Science were searched for "generic drug name" AND "alopecia" and "generic drug name" AND "hair loss." Two reviewers independently reviewed articles for drug, study type and level of evidence, and number of alopecia cases.
RESULTS: A total of 192 unique drugs were investigated, with 110 yielding positive search results. Of these, 13 were associated with alopecia in studies with strong levels of evidence (adalimumab, infliximab, budesonide, interferon β-1α, tacrolimus, enoxaparin, zoster vaccine, lamotrigine, docetaxel, capecitabine, erlotinib, imatinib, and bortezomib).
LIMITATIONS: Only full-length articles available in the English language were included. The methodology used relied on lists of drugs based on their sales rather than number of prescriptions, which likely overrepresented expensive drugs.
CONCLUSIONS: Few studies with high levels of evidence have been conducted on the topic of medication-associated alopecia. The mechanisms of hair loss must be further identified to provide effective management.
PMID:37268392 | DOI:10.1016/j.jaad.2017.01.060
Do Criminal Offenders Have a Right to Neurorehabilitation?
Crim Law Philos. 2023;17(2):429-451. doi: 10.1007/s11572-022-09630-y. Epub 2022 Mar 29.
ABSTRACT
Soon it may be possible to promote the rehabilitation of criminal offenders through neurointerventions (interventions which exert direct physical, chemical or biological effects on the brain). Some jurisdictions already utilise neurointerventions to diminish the risk of sexual or drug-related reoffending. And investigation is underway into several other neurointerventions that might also have rehabilitative applications within criminal justice-for example, pharmacotherapy to reduce aggression or impulsivity. Ethical debate on the use of neurointerventions to facilitate rehabilitation-henceforth 'neurorehabilitation'-has proceeded on two assumptions: that we have instrumental reasons for employing neurorehabilitation (e.g. because it helps protect the public from crime); and that its permissibility depends upon whether its use unjustifiably infringes offenders' rights. This paper defends a different, hitherto neglected thought. I argue we have rights-based reasons to offer neurorehabilitation to offenders-in other words, that offenders have a moral right to neurorehabilitation. I identify three considerations which support a moral right to conventional rehabilitative interventions-(1) as a countermeasure to the debilitating side-effects of punishment; (2) as a derivative right of the right to hope for renewed liberty; and (3) as compensation for structural injustice. I argue these considerations extend to support a moral right to neurorehabilitation in the following instance: when neurorehabilitation would be part of the most effective package for facilitating rehabilitation, and can be carried out at reasonable cost. I then defend my argument against potential objections, including the objection that neurorehabilitation is a bad option for offenders to have and the charge of over-medicalisation.
PMID:37266329 | PMC:PMC10229454 | DOI:10.1007/s11572-022-09630-y
Acute myopericarditis and left shoulder capsulitis following second dose of mRNA SARS-CoV-2 Moderna vaccination
BMJ Case Rep. 2023 Jun 1;16(6):e254110. doi: 10.1136/bcr-2022-254110.
ABSTRACT
Vaccination against mRNA SARS-CoV-2 has been administered on a very large scale and various side effects have been described. The increased risk of myopericarditis is known, and only a few cases of shoulder capsulitis have been reported after vaccination. These two pathologies have never been reported in the same patient after vaccination. Our article presents the history of a man in his 40s who presented with myopericarditis a few days after vaccination against SARS-CoV-2 with mRNA(Messenger RNA) Moderna® vaccine and who at the same time developed shoulder capsulitis. His cardiovascular symptoms resolved rapidly, and his shoulder symptoms improved/resolved within 1 year. This case should make physicians aware of the possibility of several concomitant side effects following vaccination against SARS-CoV-2.
PMID:37263680 | DOI:10.1136/bcr-2022-254110
Economic impact of clinical pharmacist interventions in a general tertiary hospital in Qatar
PLoS One. 2023 Jun 1;18(6):e0286419. doi: 10.1371/journal.pone.0286419. eCollection 2023.
ABSTRACT
BACKGROUND: With an increasingly strained health system budgets, healthcare services need to continually demonstrate evidence of economic benefits. This study sought to evaluate the economic impact of interventions initiated by clinical pharmacists in an adult general tertiary hospital.
METHODS: A retrospective review of clinical pharmacist interventions was carried out throughout follow-up durations in March 2018, July/August 2018, and January 2019 in Hamad General Hospital (HGH) at Hamad Medical Corporation (HMC) in Qatar. The study included clinical pharmacy interventions data of patients admitted to the internal medicine, critical care, and emergency wards. Included interventions were documented by clinical pharmacists or clinical pharmacy specialists, and approved by physicians. Interventions by non-clinical pharmacists or with missing data were excluded. Adopting the perspective of HMC, we calculated the total economic benefit, which is the sum of the cost savings and the cost avoidance associated with the interventions. Cost savings was defined as the reduced cost of therapy associated with therapy changes minus the cost of intervention and cost avoidance was the cost avoided by eliminating the occurrence of adverse drug events (ADEs). Sensitivity analyses were performed to assess the robustness of results against uncertainties.
RESULTS: A total of 852 interventions, based on 340 patients, were included. The analysis projected an annual total benefit of QAR 2,267,036 (USD 621,106) based on a negative cost-savings of QAR-175,139 (USD-47,983) and a positive cost avoidance of QAR741,898 (USD203,260) over the 3-month follow-up period. The uncertainty analysis demonstrated the robustness of outcomes, including a 100% probability of positive economic benefit.
CONCLUSIONS: The clinical pharmacist intervention was associated with an increased cost of resource use, which was overtaken by the cost avoidance generated. The pharmacy intervention, therefore, is an overall economically beneficial practice in HGH, reducing ADEs with considerable consequential positive economic savings.
PMID:37262042 | PMC:PMC10234553 | DOI:10.1371/journal.pone.0286419
Efficacy of radiotherapy in combination with first-line immunotherapy and chemotherapy for advanced lung squamous cell carcinoma: a propensity score analysis
Front Immunol. 2023 May 16;14:1138025. doi: 10.3389/fimmu.2023.1138025. eCollection 2023.
ABSTRACT
AIM: To compare the efficacy and safety of radiotherapy in combination with immunotherapy after achieving disease control from the first-line combination therapy of platinum-based chemotherapy and immunotherapy for advanced lung squamous cell carcinoma (LUSC).
METHODS: This study retrospectively evaluated the patients with advanced LUSC treated with the combination of radiotherapy with immunotherapy and chemotherapy (ICRT group, n = 52) or immunotherapy and chemotherapy (ICT group, n = 63) as the first-line treatment from April 2018 to April 2022. Using propensity score matching (PSM), 50 pairs were created, while the confounders and bias were controlled. The objective response rate (ORR), duration of overall response (DOR), progression-free survival (PFS), overall survival (OS), and adverse events were analyzed in the two groups. The PFS and OS were re-analyzed separately for patients treated with thoracic radiotherapy.
RESULTS: After PSM, the median PFS (12.23 vs. 7.43 months; P <0.001) and median OS (19.7 vs. 12.9 months; P <0.001) were significantly longer in the ICRT group than those in the ICT group. Both the PFS and OS rates were also significantly higher in the ICRT group than those in the ICT group, except for the OS rates in the 6th and 12th months. The mDOR of the ICRT group patients (17.10 vs. 8.27 months; P <0.001) was significantly higher than that of the ICT group patients. The median PFS, median OS, and local control rate were significantly longer in the thoracic radiotherapy group than in the control group. Radiation pneumonia was the most common adverse effect after radiotherapy; however, no treatment-related deaths occurred. The Cox regression analysis showed that ECOG scores 0-1, presence of necrosis in the tumor, radiotherapy, and optimal efficacy better than the stable disease (SD) were independent factors, affecting the PFS, while the patients with recurrent post-operative, pre-treatment NLR, radiotherapy, and optimal efficacy better than SD were the independent factors, affecting the OS.
CONCLUSIONS: The combination of radiotherapy with systematic immunotherapy and chemotherapy for the advanced LUSC was effective with tolerable adverse effects.
PMID:37261356 | PMC:PMC10227428 | DOI:10.3389/fimmu.2023.1138025
Co-use of opioids with cannabis: evaluating risks and benefits
Reg Anesth Pain Med. 2023 Jun 1:rapm-2023-104593. doi: 10.1136/rapm-2023-104593. Online ahead of print.
NO ABSTRACT
PMID:37263746 | DOI:10.1136/rapm-2023-104593
Efficacy and Safety of Eliapixant in Refractory Chronic Cough: The Randomized, Placebo-Controlled Phase 2b PAGANINI Study
Lung. 2023 Jun 1. doi: 10.1007/s00408-023-00621-x. Online ahead of print.
ABSTRACT
INTRODUCTION: The PAGANINI study evaluated the efficacy and safety of the selective P2X3 antagonist eliapixant in patients with refractory chronic cough (RCC).
METHODS: PAGANINI was a randomized, double-blind, parallel-group, placebo-controlled, multicenter, dose-finding, phase 2b study. Adults with RCC lasting ≥ 12 months and cough severity ≥ 40 mm on a visual analog scale at screening were enrolled. Participants were randomized 1:1:1:1 to twice-daily 25 mg, 75 mg, or 150 mg oral eliapixant or placebo for 12 weeks. The primary endpoint was change from baseline in 24-h cough count after 12 weeks of intervention.
RESULTS: Overall, 310 participants were randomized to twice-daily eliapixant 25 mg (n = 75), 75 mg (n = 78), 150 mg (n = 80), or placebo (n = 77). A statistically significant dose-response signal with eliapixant was detected for the primary endpoint (all dose-response models, adjusted p < 0.1; one-sided). Adverse events (AEs) were reported in 39 (51%) participants with placebo and 43-51 (57-65%) participants receiving eliapixant. The most common AE was dysgeusia, occurring in 1% (n = 1) of the placebo group and 1-16% (n = 1-13) of the eliapixant groups in a dose-related manner. One case of a moderate drug-induced liver injury occurred in a participant receiving 150 mg twice-daily eliapixant.
CONCLUSION: Eliapixant demonstrated efficacy and a favorable taste tolerability profile in RCC. However, a drug-induced liver injury contributed to intensified liver monitoring in clinical trials with eliapixant and discontinuation of the entire development program in all indications by Bayer AG.
TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT04562155; registered September 18, 2020.
PMID:37261531 | DOI:10.1007/s00408-023-00621-x
Metformin-Induced Eosinophilic Interstitial Lung Disease
Cureus. 2023 Apr 30;15(4):e38339. doi: 10.7759/cureus.38339. eCollection 2023 Apr.
ABSTRACT
Metformin, a mainstay treatment for type two diabetes mellitus has several side effects, ranging from mild to life-threatening ones. One report has found the combination of metformin/glibenclamide a culprit for interstitial lung disease. Other studies have shown that metformin has a protective effect on the lungs. We report a rare case of a 64-year-old male who presented with progressive dyspnea while he was on metformin alone. He was diagnosed with eosinophilic interstitial lung disease (ILD). This was confirmed by a pulmonary function test (PFT), high-resolution chest computed tomography scan (HRCT), and bronchoscopy with bronchoalveolar lavage (BAL). Known causes for eosinophilic pneumonia were excluded, and the patient's condition improved significantly after withdrawing metformin. We report this case due to the rarity of the condition. In fact, this is the only case in the literature, of metformin as the sole agent causing eosinophilic pneumonitis.
PMID:37261145 | PMC:PMC10228833 | DOI:10.7759/cureus.38339
Longitudinal Gut Microbiota Dysbiosis Underlies Olanzapine-Induced Weight Gain
Microbiol Spectr. 2023 Jun 1:e0005823. doi: 10.1128/spectrum.00058-23. Online ahead of print.
ABSTRACT
Olanzapine is one of the most effective medicines available for stabilizing schizophrenia spectrum disorders. However, it has been reported to show the greatest propensity for inducing body weight gain and producing metabolic side effects, which cause a great burden in patients with psychiatric disorders. Since the gut microbiota has a profound impact on the initiation and development of metabolic diseases, we conducted a longitudinal study to explore its role in olanzapine-induced obesity and metabolic abnormalities. Female Sprague-Dawley rats were treated with different doses of olanzapine, and metabolic and inflammatory markers were measured. Olanzapine significantly induced body weight gain (up to a 2.1-fold change), which was accompanied by hepatic inflammation and increased plasma triglyceride levels (up to a 2.9-fold change), as well as gut microbiota dysbiosis. Subsequently, fuzzy c-means clustering was used to characterize three clusters of longitudinal trajectories for microbial fluctuations: (i) genera continuing to increase, (ii) genera continuing to decrease, and (iii) genera temporarily changing. Among them, Enterorhabdus (r = 0.38), Parasutterella (r = 0.43), and Prevotellaceae UCG-001 (r = 0.52) positively correlated with body weight gain. In addition, two MetaCyc metabolic pathways were identified as associated with olanzapine-induced body weight gain, including the superpathway of glucose and xylose degradation and the superpathway of l-threonine biosynthesis. In conclusion, we demonstrate that olanzapine can directly alter the gut microbiota and rapidly induce dysbiosis, which is significantly associated with body weight gain. This may suggest gut microbiota targets in future studies on metabolic abnormalities caused by olanzapine. IMPORTANCE Olanzapine is one of the most effective second-generation antipsychotics for stabilizing schizophrenia spectrum disorders. However, olanzapine has multiple drug-induced metabolic side effects, including weight gain. This study provides insight to the gut microbiota target in olanzapine-induced obesity. Specifically, we explored the longitudinal gut microbiota trajectories of female Sprague-Dawley rats undergoing olanzapine treatment. We showed that olanzapine treatment causes a dynamic alteration of gut microbiota diversity. Additionally, we identified three genera, Parasutterella, Enterorhabdus, and Prevotellaceae UCG-001, that may play an important role in olanzapine-induced obesity. In this case, the supply or removal of specific elements of the gut microbiota may represent a promising avenue for treatment of olanzapine-related metabolic side effects.
PMID:37260381 | DOI:10.1128/spectrum.00058-23
Selective 5-HT<sub>6</sub> Receptor Ligands (Agonist and Antagonist) Show Different Effects on Antipsychotic Drug-Induced Metabolic Dysfunctions in Rats
Pharmaceuticals (Basel). 2023 Jan 20;16(2):154. doi: 10.3390/ph16020154.
ABSTRACT
It is estimated that in patients taking antipsychotic drugs (APDs), metabolic syndrome occurs 2-3 times more often than in the general population. It manifests itself in abdominal obesity, elevated glucose concentration, and dyslipidemia. Despite the high prevalence of this disorder, only a small percentage of patients receive appropriate and effective treatment, and none of the available methods for preventing or treating APD-induced metabolic side effects is satisfactory. A promising supplement to antipsychotic therapy appears to be ligands of the serotonin 6 (5-HT6) receptor. The present study aimed to examine the chronic effects of the selected APDs (haloperidol, risperidone, olanzapine), administered alone and in combination with a selective 5-HT6 agonist (WAY-181187) or antagonist (SB-742457), on weight gain, food intake, serum lipid profile, glucose level, and a spectrum of hormones derived from adipose (leptin, adiponectin) and gastrointestinal (insulin, ghrelin) tissue in rats. SB-742457 inhibited increased weight gain and alleviated hyperglycemia induced by APDs more strongly than did WAY-181187, but also intensified dyslipidemia. WAY-181187 tended to improve the lipid profile, but increased the glucose level. The greatest benefits were obtained when WAY-181187 or SB-742457 were co-administered with haloperidol. It is difficult to assess whether the modification of the serum levels of insulin, leptin, ghrelin, and adiponectin depended on the treatment applied or other drug-independent factors; therefore, further research is needed.
PMID:37259305 | DOI:10.3390/ph16020154
Evaluation of lung adverse events with nivolumab using the spontaneous reporting system in Japan
Sci Rep. 2023 May 31;13(1):8819. doi: 10.1038/s41598-023-35602-w.
ABSTRACT
This study was conducted to examine times to onset, incidence rates, and outcomes of nivolumab-induced lung adverse events (AEs), using the Japanese Adverse Drug Event Report database. We analysed data for the period between April 2004 and March 2021. Data on lung AEs were extracted, and relative risks of AEs were estimated using the reporting odds ratio. We analysed 5,273,115 reports and found 18,721 reports of nivolumab-related AEs, including 3084 lung AEs. Signals were detected for nine lung AEs: interstitial lung disease; pneumonitis; lung disorder; organising pneumonia; pleural effusion; pneumonia aspiration; pneumonia bacterial; radiation pneumonitis; and infectious pleural effusion. Among these, interstitial lung disease was the most frequently reported (68.7%) and included some fatal cases. A histogram of median times to onset showed AEs occurring from 34 to 79 days after the first dose, but some cases occurred even more than one year after starting administration. In conclusion, we focused on lung AEs caused by nivolumab as post-marketing AEs. Some cases could potentially involve serious outcomes, particularly in interstitial lung disease. Patients should be monitored for signs of the development of these AEs not only at the start of administration, but also over an extended time.
PMID:37258564 | PMC:PMC10232428 | DOI:10.1038/s41598-023-35602-w
A Novel Approach to Analyze the Factors Affecting Adverse Drug Reactions by Combination of Electronic Medical Record Database and Machine Learning Method
Yakugaku Zasshi. 2023;143(6):485-489. doi: 10.1248/yakushi.22-00179-1.
ABSTRACT
Decision tree analysis, a flowchart-like tree framework, is a typical machine learning method that is widely used in various fields. The most significant feature of this method is that independent variables (e.g., with or without concomitant use of vasopressor drugs) are extracted in order of the strength of their relationship with the dependent variable to be predicted (e.g., with or without adverse drug reactions), forming a tree-like model. Specifically, users can easily and quantitatively estimate the proportion of event occurrences considering "interrelationships among multiple combinations of factors" by answering the questions in the constructed flowchart. Previously, we applied the decision tree model to vancomycin-associated nephrotoxicity and demonstrated that this method can be used to analyze the factors affecting adverse drug reactions. However, the number of cases that can be analyzed decreases significantly as the number of branches increases. Thus, many cases are necessary to generate highly accurate findings. In attempt to solve this problem, we combined big data and decision tree analyses. In this review, we present the results of our research combining big data (electronic medical record database) and a machine learning method. Furthermore, we discuss the limitations of these methods and factors to consider when applying the results of big data and machine learning analyses to clinical practice.
PMID:37258180 | DOI:10.1248/yakushi.22-00179-1
Doxycycline to treat levodopa-induced dyskinesias in Parkinson's disease: a preliminary study
Arq Neuropsiquiatr. 2023 May;81(5):460-468. doi: 10.1055/s-0043-1768668. Epub 2023 May 31.
ABSTRACT
BACKGROUND: Levodopa-induced dyskinesia (LID) is a common motor complication of levodopa therapy in patients with Parkinson's disease (PD). Doxycycline is a widely used and inexpensive tetracycline with anti-inflammatory properties.
OBJECTIVE: To evaluate the efficacy and safety of doxycycline in patients with PD and LID.
METHODS: This was an open-label, uncontrolled, single-arm, single-center, phase 2 proof-of-concept study in patients with PD with functional impact of dyskinesia, which used levodopa three times daily, in a movement disorders clinic in Brazil. Participants were treated with doxycycline 200 mg/day for 12 weeks, with evaluations at baseline, week 4, and week 12 of treatment. The primary outcome measure was the change from baseline in the Unified Dyskinesia Rating Scale (UDysRS) total score at week 12, evaluated by two blinded raters. Key secondary outcomes measures were OFF time and ON time with troublesome dyskinesia in the PD home diary.
RESULTS: Eight patients with PD were treated and evaluated. Doxycycline 200 mg/day reduced the UDysRS total score at week 12, compared with baseline (Friedman χ2 = 9.6; p = 0.008). Further, doxycycline reduced the ON time with troublesome dyskinesia (Friedman χ2 = 10.8; p = 0.004) without worsening parkinsonism. There were no severe adverse events, and dyspepsia was the commonest event.
CONCLUSION: In this preliminary, open-label and uncontrolled trial, doxycycline was effective in reducing LID and safe after a 12-week treatment. Further well-designed placebo-controlled clinical trials with a longer duration and a larger number of participants are needed.
CLINICAL TRIAL REGISTRATION: https://ensaiosclinicos.gov.br, identifier: RBR-1047fwbf.
PMID:37257466 | DOI:10.1055/s-0043-1768668
Adverse events with risankizumab in the real world: postmarketing pharmacovigilance assessment of the FDA adverse event reporting system
Front Immunol. 2023 May 15;14:1169735. doi: 10.3389/fimmu.2023.1169735. eCollection 2023.
ABSTRACT
BACKGROUND: Risankizumab, a humanized IgG1 monoclonal antibody that selectively inhibits IL-23, is currently approved for the treatment of moderate-to-severe plaque psoriasis and Crohn's disease. The real-world safety study of risankizumab in a large- sample population is currently lacking. The aim of this study was to evaluate risankizumab-associated adverse events (AEs) and characterize the clinical priority through the data mining of the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS).
METHODS: Disproportionality analyses were performed by calculating the reporting odds ratios (RORs), deemed significant when the lower limit of the 95% confidence interval was greater than 1, to quantify the signals of risankizumab-related AEs from the second quarter (Q2) of 2019 to 2022 Q3. Serious and non-serious cases were compared, and signals were prioritized using a rating scale.
RESULTS: Risankizumab was recorded in 10,235 reports, with 161 AEs associated with significant disproportionality. Of note, 37 PTs in at least 30 cases were classified as unexpected AEs, which were uncovered in the drug label, such as myocardial infarction, cataract, pancreatitis, diabetes mellitus, stress, and nephrolithiasis. 74.68%, 25.32%, and 0% PTs were graded as weak, moderate, and strong clinical priorities, respectively. A total of 48 risankizumab-related AEs such as pneumonia, cerebrovascular accident, cataract, loss of consciousness, cardiac disorder, hepatic cirrhosis, and thrombosis, were more likely to be reported as serious AEs. The median TTO of moderate and weak signals related to risankizumab was 115 (IQR 16.75-305) and 124 (IQR 29-301) days, respectively. All of the disproportionality signals had early failure type features, indicating that risankizumab-associated AEs gradually decreased over time.
CONCLUSION: Our study found potential new AE signals and provided valuable evidence for clinicians to mitigate the risk of risankizumab-associated AEs based on an extensive analysis of a large-scale postmarketing international safety database.
PMID:37256136 | PMC:PMC10225532 | DOI:10.3389/fimmu.2023.1169735
Correspondence on the evaluation of patients with COVID-19 vaccine side effects
Rev Assoc Med Bras (1992). 2023 May 29;69(6):e20230225. doi: 10.1590/1806-9282.20s230225. eCollection 2023.
NO ABSTRACT
PMID:37255089 | DOI:10.1590/1806-9282.20s230225
Risk of chronic kidney disease in children who developed acute kidney injury secondary to nephrotoxic medication exposure in infancy
Ren Fail. 2023 Dec;45(1):2218486. doi: 10.1080/0886022X.2023.2218486.
ABSTRACT
INTRODUCTION: Nephrotoxic medication (NTM) is one of the common causes of acute kidney injury (AKI) in critically ill infants. Current knowledge about the long-term effects of NTM exposure and associated AKI during the neonatal period and early infancy is limited. Hence, we aimed to explore the risk of chronic kidney disease (CKD) after NTM-AKI in this age group.
METHODS: We performed a cross-sectional study including children 2-7 years of age, who had a history of high NTM exposure during NICU hospitalization. Cases and controls were defined as children who developed AKI and who did not develop AKI after NTM exposure, respectively. The primary outcome of interest was to explore the prevalence of composite CKD. In addition, we explored differences in urinary biomarker kidney injury molecule-1 (KIM-1) between the groups.
RESULTS: We enrolled 48 children, 18 cases and 30 controls in which 25/48 (52%) had at least one finding of CKD. The composite CKD outcome tended to be higher in cases vs controls (61.1% vs. 46.6%, odds ratio = 1.79 (95% confidence interval 0.54-5.8)); however, this was not statistically significant. Median urinary KIM-1 value trended higher in controls, 0.367(0.23-0.59) vs. 0.20 (IQR 0.11-0.47), which was not statistically significant.
CONCLUSION: In this study, 52% of children exposed to NTM had at least one marker of CKD at a median age of 5 years. Multicenter, large prospective studies are needed to improve our understanding of the natural course of NTM-AKI and to determine risk factors and strategies to reduce CKD in this high-risk population.
PMID:37254865 | DOI:10.1080/0886022X.2023.2218486
Dapagliflozin in people with chronic kidney disease
Drug Ther Bull. 2023 May 31:dtb-2023-000022. doi: 10.1136/dtb.2023.000022. Online ahead of print.
ABSTRACT
Commentary on: Heerspink HJL, Stefánsson BV, Correa-Rotter R, et al Dapagliflozin in patients with chronic kidney disease. N Engl J Med 2020;383:1436-46.Series Editor: Dr Teck Khong, DTB Associate Editor, Clinical Pharmacology, St George's, University of London, UK.
PMID:37257897 | DOI:10.1136/dtb.2023.000022
Sexual dysfunction is highly prevalent in male survivors of malignant lymphoma
Sex Med. 2023 May 26;11(2):qfad021. doi: 10.1093/sexmed/qfad021. eCollection 2023 Apr.
ABSTRACT
BACKGROUND: With improved survival in patients with lymphoma, long-term toxicity and quality of life (QoL), including sexual health, have become increasingly important.
AIM: We aimed to (1) determine the prevalence of erectile dysfunction (ED) in adult male lymphoma survivors; (2) determine whether testosterone deficiency, comorbidities, or lifestyle factors were associated; and (3) evaluate their impact on QoL.
METHODS: A cross-sectional study including 172 male survivors of Hodgkin lymphoma or diffuse large B cell lymphoma diagnosed in adulthood between 2008 and 2018 was performed. Patients were in complete metabolic remission after first-line treatment and remained in remission at follow-up (3-13 years after diagnosis). Participants completed 3 questionnaires measuring sexual health and general QoL. Serum concentrations of total testosterone were measured and thorough medical history and sociodemographic factors were obtained. The Danish SEXUS Project, European Male Ageing Study, and European Organization of Research and Treatment of Cancer (EORTC) Reference Manual were used as reference values of the general population.
OUTCOMES: Patient reported outcome measures including the 5-item International Index of Erectile Function, EORTC C30, and EORTC 22-item Sexual Health Questionnaire.
RESULTS: ED was reported by 55.2%, which was higher than in an age-matched Danish population cohort (17.5%). Erectile function score (5-item International Index of Erectile Function) was negatively associated with comorbidity, body mass index, smoking, and age and positively with the number of children conceived before treatment and serum concentration of total testosterone. Overt testosterone deficiency in combination with ED was detected in 10 (5.7%) of 176 survivors, including excluded survivors in hormonal treatment, which is higher than for the general population (0.1%-3.2% for men <70 years of age). Mean EORTC C30 global health score for survivors with ED was lower (67.7) than for survivors without ED (80.1) but was comparable to the general population (71.2). Furthermore, a positive association was seen between sexual function and both sexual and general QoL.
CLINICAL IMPLICATIONS: Sexual health is important for QoL and related to comorbidities. The focus on improving QoL requires that both sexual health and comorbidities are addressed in the follow-up of lymphoma patients.
STRENGTHS AND LIMITATIONS: Despite the relatively high number of included survivors, the cross-sectional design of this study warrants longitudinal studies to clarify the specific underlying causes of sexual dysfunction.
CONCLUSION: ED was highly prevalent and associated with comorbidity in lymphoma survivors, and more focus on sexual health and treatment related comorbidity is needed to improve sexual and general QoL.
PMID:37256215 | PMC:PMC10225470 | DOI:10.1093/sexmed/qfad021
Treatment-duration-wise harm profile of insulin-sodium-glucose co-transporter inhibitor co-treatment in type 1 diabetes mellitus patients
J Diabetes Metab Disord. 2023 Feb 15;22(1):673-701. doi: 10.1007/s40200-023-01192-7. eCollection 2023 Jun.
ABSTRACT
BACKGROUND: The treatment duration of insulin-sodium-glucose co-transporter inhibitors (SGLTis) co-treatment of type 1 diabetes mellitus (T1DM) patients in randomized controlled trials (RCTs) varies by 1-52 weeks. Henceforth, treatment duration-wise, we compared the following insulin-treatment adjuncts- mega- versus low-dose SGLTis, SGLTis versus placebo, and different SGLTi dosages.
METHOD: Double-blinded RCTs reporting the above were searched (using terms like insulin-dependent, "juvenile-onset diabetes," and "sodium glucose cotransport*") in the PubMed, Embase, and Scopus databases and appraised using a Cochrane tool. The risks across different SGLTi-dosages were compared using network meta-analysis. Random-effect pairwise meta-analysis was performed for the remaining harm juxtapositions. Meta-analyses were performed for the following treatment durations- < 4 weeks, 4 to < 24 weeks, and ≥ 24 weeks. For meta-analysis and certainty of evidence assessment, we used the Stata statistical software and the GRADE method, respectively.
RESULTS: A total of 15 (low risks of bias) studies sourcing data from about 7,330 T1DM patients were reviewed. Meta-analysis findings of ≥ 24 weeks long trials were- a. SGLTi-insulin co-treatment increased the genital infection (GI) (RR: 3.51; 95% CI: 2.59, 4.77), diabetic ketoacidosis (DKA) and (RR: 3.25; 95% CI:1.29, 8.16), and serious side effects (RR: 1.43; 95% CI: 1.05, 1.94) risk. b. SGLT2i-insulin increased the GI risk (RR: 3.77; 95% CI: 2.31, 6.16; high-quality evidence). c. Sotagliflozin-insulin increased the GI (RR: 3.36; 95% CI: 2.28, 4.96) and DKA (RR: 6.69; 95% CI: 2.75, 16.32) risk (both high-quality evidence). Compared to low-dose, megadose SGLTi treatment for 4 to < 24 weeks increased the GI risk. The remaining analyses were not statistically significantly different.
CONCLUSION: On moderate to long-term treatment (24-52 weeks) of T1DM patients, insulin-SGLT2i co-treatment was associated with GI risk, and insulin-sotagliflozin co-treatment was associated with DKA and GI risk.
SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40200-023-01192-7.
PMID:37255836 | PMC:PMC10225433 | DOI:10.1007/s40200-023-01192-7
Nurse practitioner educational preparation and confidence related to managing antipsychotic medications and associated drug-induced movement disorders
J Am Assoc Nurse Pract. 2023 May 31. doi: 10.1097/JXX.0000000000000899. Online ahead of print.
ABSTRACT
BACKGROUND: Antipsychotic medications (APMs) have been used to treat multiple psychiatric disorders for decades. The conditions to use these medications have expanded from primarily psychotic disorders to Food and Drug Administration-approved uses as first-line mood stabilizers in bipolar disorder and adjunctive pharmacotherapy in unipolar depression. Antipsychotic medications can have serious side effects, including drug-induced movement disorders (DIMDs). Nurse practitioners (NPs) in non-psychiatric-mental health specialties are increasingly managing psychotropic medication regimes. There is a void in peer-reviewed literature capturing the scope of NPs managing APMs, such as whether they received training to prescribe and manage risks of APM, and if so, what type (e.g., continuing education, attending conferences, consulting), and their confidence assessing and managing DIMDs.
PURPOSE: To describe the scope of NP management, knowledge, and confidence related to APMs and associated risks of DIMDs.
METHODOLOGY: Nonexperimental, descriptive, cross-sectional survey. Participants (n = 400) recruited through a professional association membership portal.
RESULTS: Nearly two-thirds of participants reported managing APMs (64%) and receiving training to prescribe and manage risks of APMs (63%). More than half (54%) reported they received training to do so in their NP education program. Thirty-five percent of participants indicated they were either completely (6%) or fairly (29%) confident, whereas most (65%) endorsed being somewhat (26%), slightly (20%), or not (19%) confident in assessing and managing DIMDs.
CONCLUSIONS/IMPLICATIONS: Opportunities exist to broaden NP education in managing APMs and associated risks of DIMDs.
PMID:37255433 | DOI:10.1097/JXX.0000000000000899