Drug-induced Adverse Events

The impact of pharmacist practice of medication therapy management in ambulatory care: an experience from a comprehensive Chinese hospital

Wed, 2023-02-22 06:00

BMC Health Serv Res. 2023 Feb 21;23(1):176. doi: 10.1186/s12913-023-09164-6.

ABSTRACT

BACKGROUD: With the reform of medical system in China, Beijing municipal hospitals explored a new pharmaceutical care model and set up medication therapy management services (MTMs) in ambulatory care since 2019. We were one of the first hospitals to set up this service in China. At the present, there were relatively few reports about the effect of MTMs in China. In this study, we summarized the implementation of MTMs in our hospital, explore the feasibility of pharmacist-led MTMs in ambulatory care and the impact of MTMs on patients' medical costs.

METHODS: A retrospective study was conducted in a university-affiliated, tertiary comprehensive hospital in Beijing, China. The patients who received at least one MTMs and with complete medical records and pharmaceutical documents from May 2019 to February 2020 were included. Pharmacists provided pharmaceutical care for patients according to the MTMs standards issued by the American Pharmacists Association, identified the numbers and classification of the patients' perceived medication-related demands, identified medication-related problems (MRPs), and developed the medication-related action plans (MAPs). All MRPs found by pharmacists, pharmaceutical interventions, and resolving recommendations were documented, and calculate the cost of treatment drugs that patients can reduce.

RESULTS: A total of 112 patients received MTMs in ambulatory care, among them 81 cases with the completed record were included in this study. 67.9% of patients had five or more diseases, 83% of them co-took over 5 drugs. While performing MTMs, 128 patients' perceived medication-related demands were recorded in all, monitoring and judgment of adverse drug reaction (ADR) (17.19%) was the most common demand. 181 MRPs were found, with an average of 2.55 MPRs per patient. Nonadherence (38%), excessive drug treatment (20%), and adverse drug events (17.12%) were the top three MRPs. Pharmaceutical care (29.77%), adjustment of drug treatment plan (29.10%) and referral to the clinical department (23.41%) were the top three MAPs. Whereby the MTMs provided by pharmacists, the cost-saving of each patient was about $ 43.2 monthly.

CONCLUSION: By participating in the MTMs of outpatients, the pharmacists could identify more MRPs and develop personalized MAPs timely for patients, thereby promoting rational drug use and reducing medical expenses.

PMID:36810022 | DOI:10.1186/s12913-023-09164-6

Categories: Literature Watch

Guillain-Barre Syndrome After the Third BNT162b2 Dose in an Adolescent Without Side Effects After the First and Second Jab

Wed, 2023-02-22 06:00

J Clin Neuromuscul Dis. 2023 Mar 1;24(3):162-163. doi: 10.1097/CND.0000000000000434.

NO ABSTRACT

PMID:36809204 | DOI:10.1097/CND.0000000000000434

Categories: Literature Watch

Acute localized pustular drug reaction to pembrolizumab

Wed, 2023-02-22 06:00

Dermatol Online J. 2022 Oct 15;28(5). doi: 10.5070/D328559261.

NO ABSTRACT

PMID:36809142 | DOI:10.5070/D328559261

Categories: Literature Watch

The use of oral vitamin A in acne management: a review

Wed, 2023-02-22 06:00

Dermatol Online J. 2022 Oct 15;28(5). doi: 10.5070/D328559239.

ABSTRACT

BACKGROUND: Changes to the iPLEDGE platform on December 13, 2021 made isotretinoin virtually inaccessible for many patients. Prior to the FDA approval of isotretinoin, a derivative of vitamin A, in 1982, vitamin A was used for severe acne.

OBJECTIVE: To review the efficacy, safety, affordability, and practicality of vitamin A as a substitute for isotretinoin when the latter is inaccessible.

METHODS: A literature review of PubMed was conducted using the key words: oral vitamin A, retinol, isotretinoin, Accutane, acne, iPLEDGE, hypervitaminosis A, and side effects.

RESULTS: We identified 9 studies (8 clinical trials and one case report); acne improved in 8 studies. Dosages ranged from 36,000IU daily to 500,000IU with 100,000IU as the most common. Mean duration until clinical improvement was 7 weeks to four months after initiation of therapy. Mucocutaneous side effects were most common, along with headaches, which resolved with either continued treatment or cessation.

CONCLUSION: Oral vitamin A is efficacious for the treatment of acne vulgaris, although the available studies have limited controls and outcomes. Side effects are qualitatively similar to those of isotretinoin and avoiding pregnancy for at least three months after stopping treatment is critical; like isotretinoin, vitamin A is a teratogen.

PMID:36809126 | DOI:10.5070/D328559239

Categories: Literature Watch

Multimodal representation learning for predicting molecule-disease relations

Wed, 2023-02-22 06:00

Bioinformatics. 2023 Feb 3;39(2):btad085. doi: 10.1093/bioinformatics/btad085.

ABSTRACT

MOTIVATION: Predicting molecule-disease indications and side effects is important for drug development and pharmacovigilance. Comprehensively mining molecule-molecule, molecule-disease and disease-disease semantic dependencies can potentially improve prediction performance.

METHODS: We introduce a Multi-Modal REpresentation Mapping Approach to Predicting molecular-disease relations (M2REMAP) by incorporating clinical semantics learned from electronic health records (EHR) of 12.6 million patients. Specifically, M2REMAP first learns a multimodal molecule representation that synthesizes chemical property and clinical semantic information by mapping molecule chemicals via a deep neural network onto the clinical semantic embedding space shared by drugs, diseases and other common clinical concepts. To infer molecule-disease relations, M2REMAP combines multimodal molecule representation and disease semantic embedding to jointly infer indications and side effects.

RESULTS: We extensively evaluate M2REMAP on molecule indications, side effects and interactions. Results show that incorporating EHR embeddings improves performance significantly, for example, attaining an improvement over the baseline models by 23.6% in PRC-AUC on indications and 23.9% on side effects. Further, M2REMAP overcomes the limitation of existing methods and effectively predicts drugs for novel diseases and emerging pathogens.

AVAILABILITY AND IMPLEMENTATION: The code is available at https://github.com/celehs/M2REMAP, and prediction results are provided at https://shiny.parse-health.org/drugs-diseases-dev/.

SUPPLEMENTARY INFORMATION: Supplementary data are available at Bioinformatics online.

PMID:36805623 | PMC:PMC9940625 | DOI:10.1093/bioinformatics/btad085

Categories: Literature Watch

Ezetimibe plus moderate-intensity statin versus high-intensity statin

Wed, 2023-02-22 06:00

Drug Ther Bull. 2023 Mar;61(3):38. doi: 10.1136/dtb.2023.000008.

ABSTRACT

Overview of: Kim BK, Hong SJ, Lee YJ, et al Long-term efficacy and safety of moderate-intensity statin with ezetimibe combination therapy versus high-intensity statin monotherapy in patients with atherosclerotic cardiovascular disease (RACING): a randomised, open-label, non-inferiority trial. Lancet 2022;400:380-390.

PMID:36813278 | DOI:10.1136/dtb.2023.000008

Categories: Literature Watch

Safety update: prescribing metolazone

Wed, 2023-02-22 06:00

Drug Ther Bull. 2023 Feb 22:dtb-2023-000010. doi: 10.1136/dtb.2023.000010. Online ahead of print.

ABSTRACT

Overview of: Medicines and Healthcare products Regulatory Agency. Xaqua (metolazone) 5mg tablets: exercise caution when switching patients between metolazone preparations. Drug Safety Update 2023;16:1.

PMID:36813274 | DOI:10.1136/dtb.2023.000010

Categories: Literature Watch

Emicizumab prophylaxis in haemophilia A with inhibitors: Three years follow-up from the UK Haemophilia Centre Doctors' Organisation (UKHCDO)

Wed, 2023-02-22 06:00

Haemophilia. 2023 Feb 22. doi: 10.1111/hae.14762. Online ahead of print.

ABSTRACT

INTRODUCTION: The UK National Haemophilia Database (NHD) collects data from all UK persons with haemophilia A with inhibitors (PwHA-I). It is well-placed to investigate patient selection, clinical outcomes, drug safety and other issues not addressed in clinical trials of emicizumab.

AIMS: To determine safety, bleeding outcomes and early effects on joint health of emicizumab prophylaxis in a large, unselected cohort using national registry and patient reported Haemtrack (HT) data between 01 January 2018 and 30 September 2021.

METHODS: Prospectively collected bleeding outcomes were analysed in people with ≥6 months emicizumab HT data and compared with previous treatment if available. Change in paired Haemophilia Joint Health Scores (HJHS) were analysed in a subgroup. Adverse events (AEs) reports were collected and adjudicated centrally.

RESULTS: This analysis includes 117 PwHA-I. Mean annualised bleeding rate (ABR) was .32 (95% CI, .18; .39) over a median 42 months treatment with emicizumab. Within-person comparison (n = 74) demonstrated an 89% reduction in ABR after switching to emicizumab and an increase in zero treated bleed rate from 45 to 88% (p < .01). In a subgroup of 37 people, total HJHS improved in 36%, remained stable in 46% and deteriorated in 18%, with a median (IQR) within-person change of -2.0 (-9, 1.5) (p = .04). Three arterial thrombotic events were reported, two possibly drug related. Other AEs were generally non-severe and usually limited to early treatment, included cutaneous reactions (3.6%), headaches (1.4%), nausea (2.8%) and arthralgia (1.4%).

CONCLUSIONS: Emicizumab prophylaxis is associated with sustained low bleeding rates and was generally well-tolerated in people with haemophilia A and inhibitors.

PMID:36811304 | DOI:10.1111/hae.14762

Categories: Literature Watch

Safety and Efficacy of Tyrosine Kinase Inhibitors in Immune Thrombocytopenic Purpura: A Systematic Review of Clinical Trials

Wed, 2023-02-22 06:00

J Xenobiot. 2023 Jan 28;13(1):29-41. doi: 10.3390/jox13010005.

ABSTRACT

Immune thrombocytopenic purpura (ITP) is an acquired antibody or cell-mediated platelet damage or decreased platelet production. Steroids, IV immunoglobulins (IVIG), and Rho-anti-D antibodies are the commonly used initial treatments for ITP. However, many ITP patients either do not respond or do not maintain a response to initial therapy. Splenectomy, rituximab, and thrombomimetics are the commonly used second-line treatment. More treatment options include tyrosine kinases inhibitors (TKI), including spleen tyrosine kinase (Syk) and Bruton's tyrosine kinase (BTK) inhibitors. This review aims to assess the safety and efficacy of TKIs. Methods: Literature was searched on PubMed, Embase, WOS, and clinicaltrials.gov using keywords, "tyrosine kinase" and "idiopathic thrombocytopenic purpura". PRISMA guidelines were followed. Results: In total, 4 clinical trials were included with 255 adult patients with relapsed/refractory ITP. In all, 101 (39.6%) patients were treated with fostamatinib, 60 (23%) patients with rilzabrutinib, and 34 (13%) with HMPL-523. Patients treated with fostamatinib achieved a stable response (SR) and overall response (OR) in 18/101 (17.8%) and 43/101 (42.5%) of the patients, respectively, while SR and OR were achieved in 1/49 (2%) and 7/49 (14%) of the patients, respectively, in the placebo group. Patients treated with HMPL-523 (300 mg dose expansion) achieved an SR and OR in 5/20 (25%) and 11/20 (55%) of the patients, respectively, while SR and OR were achieved in 1/11 (9%) of the patients treated with the placebo. Patients treated with rilzabrutinib achieved an SR in 17/60 (28%) patients. Dizziness (1%), hypertension (2%), diarrhea (1%), and neutropenia (1%) were serious adverse events in fostamatinib patients. Rilzabrutinib or HMPL-523 patients did not require a dose reduction due to drug-related adverse effects. Conclusions: Rilzabrutinib, fostamatinib, and HMPL-523 were safe and effective in the treatment of relapsed/refractory ITP.

PMID:36810430 | DOI:10.3390/jox13010005

Categories: Literature Watch

What does the TIME study tell us about morning and evening dosing of antihypertensive medication?

Wed, 2023-02-22 06:00

Drug Ther Bull. 2023 Feb 21:dtb-2023-000002. doi: 10.1136/dtb.2023.000002. Online ahead of print.

ABSTRACT

Commentary on: Mackenzie IS, Rogers A, Poulter NR, et al Cardiovascular outcomes in adults with hypertension with evening vs morning dosing of usual antihypertensives in the UK (TIME study): a prospective, randomised, open-label, blinded-endpoint clinical trial. Lancet 2022;400:1417-25.

PMID:36810303 | DOI:10.1136/dtb.2023.000002

Categories: Literature Watch

Effectiveness and safety of nab-paclitaxel and platinum as first-line chemotherapy for ovarian cancer: a retrospective study

Wed, 2023-02-22 06:00

J Gynecol Oncol. 2023 Feb 6. doi: 10.3802/jgo.2023.34.e44. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the effectiveness and safety of nab-paclitaxel plus platinum as first-line chemotherapy for ovarian cancer (OC).

METHODS: Patients administered platinum combined with nab-paclitaxel as first-line chemotherapy for epithelial OC, fallopian tube cancer, or primary peritoneal cancer from July 2018 to December 2021 were retrospectively evaluated. The primary outcome was progression-free survival (PFS). Adverse events (AEs) were examined. Subgroup analysis was performed.

RESULTS: Seventy-two patients (median age, 54.5 years; range, 20.0-79.0 years) were evaluated, including 12 and 60 administered neoadjuvant therapy and primary surgery with subsequent chemotherapy, respectively. The median follow-up duration was 25.6 months, and the median PFS was 26.7 (95% confidence interval [CI]=24.0-29.3) months in the whole patient population. In the neoadjuvant subgroup, the median PFS was 26.7 (95% CI=22.9-30.5) months vs. 30.1 (95% CI=23.1-37.1) months in the primary surgery subgroup. Twenty-seven patients were administered nab-paclitaxel plus carboplatin and had a median PFS of 30.3 (95% CI=not available [NA]-NA) months. The commonest grade 3-4 AEs included anemia (15.3%), white blood cell decreased (11.1%), and neutrophil count decreased (20.8%). No drug-related hypersensitivity reactions occurred.

CONCLUSION: Nab-paclitaxel plus platinum as first-line treatment in OC was associated with a favorable prognosis and was tolerable in patients with OC.

PMID:36807747 | DOI:10.3802/jgo.2023.34.e44

Categories: Literature Watch

[[Translated article]]RF-Adverse Skin Reaction to Apalutamide: An Emerging Effect

Wed, 2023-02-22 06:00

Actas Dermosifiliogr. 2023 Feb 17:S0001-7310(23)00152-7. doi: 10.1016/j.ad.2021.10.028. Online ahead of print.

NO ABSTRACT

PMID:36806633 | DOI:10.1016/j.ad.2021.10.028

Categories: Literature Watch

Pneumocystis jirovecii pneumonia in a patient treated with trastuzumab-deruxtecan

Wed, 2023-02-22 06:00

BMJ Case Rep. 2023 Feb 20;16(2):e253647. doi: 10.1136/bcr-2022-253647.

ABSTRACT

Trastuzumab-deruxtecan (T-DXd) is a novel antibody drug conjugate that has improved treatment outcomes in patients with ERBB2-positive cancer, including locally advanced or metastatic gastric and gastro-oesophageal junction adenocarcinoma. One of the reported side effects of this medication is drug-induced pneumonitis. We present in this case report, a diagnostic dilemma of a patient presenting with clinical and radiographical features of drug-induced pneumonitis but was found to have pneumocystis jirovecii pneumonia (PJP). Our case is the first of PJP in a patient treated with T-DXd, highlighting the increasing incidence of this opportunistic infection in patients with solid malignancy. It also highlights the clinical and radiographical similarities between the PJP and drug-induced pneumonitis.

PMID:36805876 | DOI:10.1136/bcr-2022-253647

Categories: Literature Watch

Appropriateness of medication prescribing in nursing homes: A collaboration project between pharmacy and geriatric departments

Wed, 2023-02-22 06:00

Rev Esp Geriatr Gerontol. 2023 Feb 17:S0211-139X(23)00009-4. doi: 10.1016/j.regg.2023.01.008. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate the appropriateness of medication prescribing and to analyze interventions carried out in polymedicated elderly patients in nursing homes (NHs).

METHODS: Prospective study of potentially inappropriate medication prescribing in polymedicated older adults living in NHs, implemented via a collaborative project between NHs and the geriatric and pharmacy departments of a university hospital. The pharmacist reviewed patients' active medical prescriptions and prepared an individualized report with proposals aimed at therapeutic optimization that was sent for evaluation to the geriatrician in charge of the NH. The drug-related problems (DRPs) were classified according to the Third Consensus of Granada and the potentially inappropriate prescriptions (PIPs) were identified by explicit criteria (STOPP/START, BEERS, LESS-CHRON), implicit criteria (MAI) and CheckTheMeds® software. It was measured the degree of acceptance of the interventions carried out, and the economic impact was calculated from the direct costs of the discontinued drugs.

RESULTS: Of the 210 patients reviewed by the pharmacy department, 105 patients from 10 NHs were analyzed. A total of 510 prescriptions with possible DRPs were identified (38.5% of all prescribed drugs). According to STOPP/START/BEERS or LESS-CHRON criteria, 41.2% were PIPs. The main DRPs identified were: unfavorable risk-benefit ratio, inappropriate dose/regimen, inappropriate treatment duration, probability of adverse events, medication not indicated, and duplicate therapy. Interventions were proposed for 81.5% of the DRPs detected, of which 73.3% were accepted. This resulted in a 23.1% reduction in the number of drugs prescribed per patient and an economic saving of €16,218 per 6-month period.

CONCLUSION: The appropriateness of medication prescribing in polymedicated older adults living in NHs by the pharmacist has made it possible to reduce DRPs and PIPs and to save costs thanks to the high degree of acceptance by geriatricians.

PMID:36805293 | DOI:10.1016/j.regg.2023.01.008

Categories: Literature Watch

The relationship between area levels of involuntary psychiatric care and patient outcomes: a longitudinal national register study from Norway

Tue, 2023-02-21 06:00

BMC Psychiatry. 2023 Feb 20;23(1):112. doi: 10.1186/s12888-023-04584-4.

ABSTRACT

BACKGROUND: Mental health legislation permits involuntary care of patients with severe mental disorders who meet set legal criteria. The Norwegian Mental Health Act assumes this will improve health and reduce risk of deterioration and death. Professionals have warned against potentially adverse effects of recent initiatives to heighten involuntary care thresholds, but no studies have investigated whether high thresholds have adverse effects.

AIM: To test the hypothesis that areas with lower levels of involuntary care show higher levels of morbidity and mortality in their severe mental disorder populations over time compared to areas with higher levels. Data availability precluded analyses of the effect on health and safety of others.

METHODS: Using national data, we calculated standardized (by age, sex, and urbanicity) involuntary care ratios across Community Mental Health Center areas in Norway. For patients diagnosed with severe mental disorders (ICD10 F20-31), we tested whether lower area ratios in 2015 was associated with 1) case fatality over four years, 2) an increase in inpatient days, and 3) time to first episode of involuntary care over the following two years. We also assessed 4) whether area ratios in 2015 predicted an increase in the number of patients diagnosed with F20-31 in the subsequent two years and whether 5) standardized involuntary care area ratios in 2014-2017 predicted an increase in the standardized suicide ratios in 2014-2018. Analyses were prespecified (ClinicalTrials.gov NCT04655287).

RESULTS: We found no adverse effects on patients' health in areas with lower standardized involuntary care ratios. The standardization variables age, sex, and urbanicity explained 70.5% of the variance in raw rates of involuntary care.

CONCLUSIONS: Lower standardized involuntary care ratios are not associated with adverse effects for patients with severe mental disorders in Norway. This finding merits further research of the way involuntary care works.

PMID:36803444 | DOI:10.1186/s12888-023-04584-4

Categories: Literature Watch

Hepatotoxicity of immune checkpoint inhibitors: What is Currently Known

Tue, 2023-02-21 06:00

Hepatol Commun. 2023 Feb 20;7(3):e0063. doi: 10.1097/HC9.0000000000000063. eCollection 2023 Mar 1.

ABSTRACT

BACKGROUND: This systematic review and network meta-analysis aimed to provide a complete hepatotoxicity profile, hepatotoxicity spectrum, and safety ranking of immune checkpoint inhibitor drugs for cancer treatment.

METHODS: PubMed, Embase, Scopus, CINAHL, Web of Science, psycINFO, Cochrane Library, and ClinicalTrials.gov. websites were searched, and a manual search of relevant reviews and trials up to January 1, 2022, was undertaken. Head-to-head III randomized controlled trials comparing any 2 or 3 of the following treatments or different doses of the same immune checkpoint inhibitor drug were included: programmed death 1 (PD-1), programmed death ligand 1, and cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) inhibitors and conventional therapy. We included 106 randomized trials (n=164,782) containing 17 treatment arms.

RESULTS: The overall incidence of hepatotoxicity was 4.06%. The rate of fatal liver adverse events was 0.07%. The programmed death ligand 1 inhibitor+targeted therapy drug+chemotherapy group had the highest risk of treatment-related increases in all-grade alanine aminotransferase and aspartate aminotransferase levels, and the differences were significant. For immune-related hepatotoxicity, no significant difference was found between PD-1 and CTLA-4 inhibitors for all-grade hepatotoxicity; however, CTLA-4 inhibitors were associated with a higher risk of grade 3-5 hepatotoxicity than PD-1 inhibitors.

CONCLUSIONS: The highest incidence of hepatotoxicity and fatality was observed with triple therapy. The overall incidence of hepatotoxicity was similar between different dual regimens. For immune checkpoint inhibitor monotherapy, the overall risk of immune-mediated hepatotoxicity related to CTLA-4 inhibitors did not differ significantly from that of PD-1 inhibitors. There was no direct relationship between the risk of liver injury and drug dose, whether monotherapy or combination therapy was used.

PMID:36802366 | DOI:10.1097/HC9.0000000000000063

Categories: Literature Watch

A descriptive study of abdominal complications in patients with mild COVID-19 presenting to the emergency department: a single-center experience in Japan during the omicron variant phase

Tue, 2023-02-21 06:00

BMC Gastroenterol. 2023 Feb 19;23(1):43. doi: 10.1186/s12876-023-02681-y.

ABSTRACT

BACKGROUND: COVID-19 is widely known to induce a variety of extrapulmonary manifestations. Gastrointestinal symptoms have been identified as the most common extra-pulmonary manifestations of COVID-19, with an incidence reported to range from 3 to 61%. Although previous reports have addressed abdominal complications with COVID-19, these have not been adequately elucidated for the omicron variant. The aim of our study was to clarify the diagnosis of concomitant abdominal diseases in patients with mild COVID-19 who presented to hospital with abdominal symptoms during the sixth and seventh waves of the pandemic of the omicron variant in Japan.

METHODS: This study was a retrospective, single-center, descriptive study. In total, 2291 consecutive patients with COVID-19 who visited the Department of Emergency and Critical Care Medicine, Kansai Medical University Medical Center, Osaka, Japan, between January 2022 and September 2022 were potentially eligible for the study. Patients delivered by ambulance or transferred from other hospitals were not included. We collected and described physical examination results, medical history, laboratory data, computed tomography findings and treatments. Data collected included diagnostic characteristics, abdominal symptoms, extra-abdominal symptoms and complicated diagnosis other than that of COVID-19 for abdominal symptoms.

RESULTS: Abdominal symptoms were present in 183 patients with COVID-19. The number of patients with each abdominal symptom were as follows: nausea and vomiting (86/183, 47%), abdominal pain (63/183, 34%), diarrhea (61/183, 33%), gastrointestinal bleeding (20/183, 11%) and anorexia (6/183, 3.3%). Of these patients, 17 were diagnosed as having acute hemorrhagic colitis, five had drug-induced adverse events, two had retroperitoneal hemorrhage, two had appendicitis, two had choledocholithiasis, two had constipation, and two had anuresis, among others. The localization of acute hemorrhagic colitis was the left-sided colon in all cases.

CONCLUSIONS: Our study showed that acute hemorrhagic colitis was characteristic in mild cases of the omicron variant of COVID-19 with gastrointestinal bleeding. When examining patients with mild COVID-19 with gastrointestinal bleeding, the potential for acute hemorrhagic colitis should be kept in mind.

PMID:36800938 | DOI:10.1186/s12876-023-02681-y

Categories: Literature Watch

Involvement of regulatory B lymphocytes in susceptibility to autoimmune side effects of cancer immunotherapy

Fri, 2023-02-17 06:00

Med Sci (Paris). 2023 Feb;39(2):101-104. doi: 10.1051/medsci/2023001. Epub 2023 Feb 17.

NO ABSTRACT

PMID:36799742 | DOI:10.1051/medsci/2023001

Categories: Literature Watch

Monoclonal Antibody for the Prevention of Respiratory Syncytial Virus in Infants and Children: A Systematic Review and Network Meta-analysis

Fri, 2023-02-17 06:00

JAMA Netw Open. 2023 Feb 1;6(2):e230023. doi: 10.1001/jamanetworkopen.2023.0023.

ABSTRACT

IMPORTANCE: Respiratory syncytial virus (RSV) is the leading cause of acute lower respiratory infection in children younger than 5 years; effective prevention strategies are urgently needed.

OBJECTIVE: To compare the efficacy and safety of monoclonal antibodies for the prevention of RSV infection in infants and children.

DATA SOURCES: In this systematic review and network meta-analysis, PubMed, Embase, CENTRAL, and ClinicalTrials.gov were searched from database inception to March 2022.

STUDY SELECTION: Randomized clinical trials that enrolled infants at high risk of RSV infection to receive a monoclonal antibody or placebo were included. Keywords and extensive vocabulary related to monoclonal antibodies, RSV, and randomized clinical trials were searched.

DATA EXTRACTION AND SYNTHESIS: The Preferred Reporting Items for Systematic Reviews and Meta-analyses reporting guideline was used. Teams of 2 reviewers independently performed literature screening, data extraction, and risk of bias assessment. The Grading of Recommendations, Assessments, Developments, and Evaluation approach was used to rate the certainty of evidence. A random-effects model network meta-analysis was conducted using a consistency model under the frequentist framework.

MAIN OUTCOMES AND MEASURES: The main outcomes were all-cause mortality, RSV-related hospitalization, RSV-related infection, drug-related adverse events, intensive care unit admission, supplemental oxygen use, and mechanical ventilation use.

RESULTS: Fifteen randomized clinical trials involving 18 395 participants were eligible; 14 were synthesized, with 18 042 total participants (median age at study entry, 3.99 months [IQR, 3.25-6.58 months]; median proportion of males, 52.37% [IQR, 50.49%-53.85%]). Compared with placebo, with moderate- to high-certainty evidence, nirsevimab, palivizumab, and motavizumab were associated with significantly reduced RSV-related infections per 1000 participants (nirsevimab: -123 [95% CI, -138 to -100]; palivizumab: -108 [95% CI, -127 to -82]; motavizumab: -136 [95% CI, -146 to -125]) and RSV-related hospitalizations per 1000 participants (nirsevimab: -54 [95% CI, -64 to -38; palivizumab: -39 [95% CI, -48 to -28]; motavizumab: -48 [95% CI, -58 to -33]). With moderate-certainty evidence, both motavizumab and palivizumab were associated with significant reductions in intensive care unit admissions per 1000 participants (-8 [95% CI, -9 to -4] and -5 [95% CI, -7 to 0], respectively) and supplemental oxygen use per 1000 participants (-59 [95% CI, -63 to -54] and -55 [95% CI, -61 to -41], respectively), and nirsevimab was associated with significantly reduced supplemental oxygen use per 1000 participants (-59 [95% CI, -65 to -40]). No significant differences were found in all-cause mortality and drug-related adverse events. Suptavumab did not show any significant benefits for the outcomes of interest.

CONCLUSIONS AND RELEVANCE: In this study, motavizumab, nirsevimab, and palivizumab were associated with substantial benefits in the prevention of RSV infection, without a significant increase in adverse events compared with placebo. However, more research is needed to confirm the present conclusions, especially for safety and cost-effectiveness.

PMID:36800182 | DOI:10.1001/jamanetworkopen.2023.0023

Categories: Literature Watch

Comparative Evaluation of COVID-19 Associated Mucormycosis (CAM) and Non-COVID-19-associated Mucormycosis (non-CAM)

Thu, 2023-02-16 06:00

J Coll Physicians Surg Pak. 2023 Feb;33(2):153-157. doi: 10.29271/jcpsp.2023.02.153.

ABSTRACT

OBJECTIVE: To compare COVID-19 associated mucormycosis cases (CAM) with non-COVID-19 associated mucormycosis (non-CAM) cases followed as in-patients.

STUDY DESIGN: Observational Study.

PLACE AND DURATION OF STUDY: Department of Infectious Diseases and Clinical Microbiology, Adana City Training and Research Hospital, Health Sciences University (HSU), Adana, Turkey, between January 2018 and March 2022.

METHODOLOGY: Patients with a diagnosis of mucormycosis (proven and probable) were dichotomised as COVID-19 associated mucormycosis and non-COVID-19 associated mucormycosis cases. Both groups were compared for underlying malignancy, chemotherapy, antifungal therapy related side effects and overall survival.

RESULTS: Of the 35 cases enrolled in the study, 17 (48.6%) had CAM and 18 (51.4%) had non-CAM. A statistically significant difference was detected between non-CAM and CAM cases in terms of haematological malignancy, receiving chemotherapy, and antifungal therapy-related side effects (p=0.019, p=0.019, and p=0.027 respectively). Steroid use was found as a risk factor for the diabetic CAM cases (p<0.0001). The difference between the CAM and non-CAM cases in terms of overall survival was not statistically significant (p=0.088).

CONCLUSION: Because of the ongoing COVID-19 pandemic and the increasing number of critical patients, treatment of COVID-19 should be performed cautiously in patients who have the risk of developing CAM, particularly those with diabetes and immunosuppression (haematologic malignancy, receiving steroid or chemotherapy, etc.) and these patients should be monitored closely.

KEY WORDS: Mucormycosis, COVID-19, Mucormycosis associated with COVID-19, Diabetes mellitus, Turkey.

PMID:36797623 | DOI:10.29271/jcpsp.2023.02.153

Categories: Literature Watch

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