Int Wound J. 2022 Jan 27. doi: 10.1111/iwj.13760. Online ahead of print.

ABSTRACT

Ozonated water and oil are emerging as potential dermatologic therapeutics, particularly for the treatment of various wounds. However, the safety of these liquids has not been extensively studied. The aim of this systematic review was to evaluate the risks of ozonated liquids to human skin tissue based on the available literature. We completed a structured search of five scientific databases and identified 378 articles for consideration. Based on pre-established inclusion/exclusion criteria, nine studies were included in this review. Two studies specifically evaluated the cytotoxicity of ozonated liquids on human cells, five studies evaluated ozonated liquids in randomised controlled trials (RCTs), one was a post-market surveillance study, and one was a crossover study in humans. None of the included studies found any significant human dermatologic risks associated with ozonated water or liquid. Because of the small sample size, however, additional short- and long-term RCTs specifically designed to evaluate the dermatological risks of ozonated liquids are recommended.

PMID:35083865 | DOI:10.1111/iwj.13760

Front Surg. 2022 Jan 10;8:747463. doi: 10.3389/fsurg.2021.747463. eCollection 2021.

ABSTRACT

Trigeminal neuralgia (TN) is a debilitating neuropathic pain involving the fifth cranial nerve. There has been no study investigating the clinical and socioeconomical characteristics of patients with TN in Indonesia. A total of 100 patients were included in this study. Symptoms indicating a later stage of the illness, namely, involvement of all the trigeminal nerve branches, numbness, and concomitant persistent pain, were the common presentations found in our cohort. Only one TN diagnosis was made by a general practitioner (GP). None were immediately referred to a neurosurgeon following their diagnosis. Access to our clinic took as long as 4.7 ± 5.1 years (mean ± SD) from the onset. Older age was a significant predictor of an increased likelihood of not knowing their illness upon the referral (21.9%, p = 0.008). Upon their first presentation, 25.5% of patients had experienced drug-related side effects due to prolonged medication. Only 50% of patients were compensated by the universal health coverage (UHC) system. Seven patients spent ≥ 50 million rupiahs and eight patients had already lost their jobs. In conclusion, early contact with a neurosurgeon contributes to better management of TN, both for the patients and healthcare system in Indonesia. A refined understanding of TN nature is still needed in this country.

PMID:35083268 | PMC:PMC8784373 | DOI:10.3389/fsurg.2021.747463

Case Rep Oncol. 2021 Nov 25;14(3):1671-1676. doi: 10.1159/000520126. eCollection 2021 Sep-Dec.

ABSTRACT

Drug-induced interstitial lung disease (DILD) has been occasionally reported with various causative drugs. In the context of breast cancer, anthracycline infrequently causes pulmonary adverse events. We report a 67-year-old woman with cT2N0M0 triple-negative breast cancer who received neoadjuvant chemotherapy with anthracycline-combined chemotherapy with pegfilgrastim. She developed fever, cough, and shortness of breath after 21 days of the scheduled fourth cycle of anthracycline. Computed tomography revealed drug-induced interstitial pneumonia. Prednisolone (1 mg/kg) was administrated and gradually decreased. Thereby, interstitial pneumonia quickly improved. Partial resection of the left breast and sentinel lymph node biopsy were performed, and we diagnosed ypT1bN0. The patient received 4 cycles of taxane and hypofractional radiotherapy and survived without any recurrences over the following 37 months. We report a rare case of DILD due to anthracycline-combined chemotherapy. Twenty-five cases of DILD with breast cancer after administration of anthracycline have been reported so far. However, 14 cases occurred during taxane. Most of the cases had remission by steroid treatment. The patients with respiratory symptoms during chemotherapy should be suspicious of not only infection but also DILD.

PMID:35082624 | PMC:PMC8740208 | DOI:10.1159/000520126

BMJ Case Rep. 2022 Jan 25;15(1):e244581. doi: 10.1136/bcr-2021-244581.

ABSTRACT

Sulfonamides have been related to drug-induced acute angle closure of the eye, but scarce reports exist concerning furosemide. We describe the second case of acute chamber narrowing (ACN) during furosemide exposure. A 65-year-old man with a renal transplant presented with ACN, after 3 months of furosemide intake. Finally, the patient required a bilateral iridotomy and right lens replacement. ACN has been associated with drugs containing sulfonamide derivatives, but an evaluation with pharmacovigilance scales for adverse drug reaction (ADR)-standardised causality assessment has not been provided. We use this case to illustrate how medicines and an ADR should be evaluated and reported. The spreading of pharmacovigilance information on what should be a rare and unexpected condition related to a drug could mean that other reports emerge about ADR with this drug and regulatory agencies perform consequently, as happened with topiramate.

PMID:35078871 | DOI:10.1136/bcr-2021-244581

Clin Infect Dis. 2022 Jan 25:ciac036. doi: 10.1093/cid/ciac036. Online ahead of print.

ABSTRACT

BACKGROUND: Switching to dolutegravir/lamivudine (DTG/3TC) was non-inferior to continuing tenofovir alafenamide (TAF)-based regimens for maintaining virologic suppression at Week 48 of the TANGO study. Here we present Week 144 outcomes (efficacy, safety, weight, and biomarkers).

METHODS: TANGO is a randomized (1:1, stratified by baseline third agent class), open-label, non-inferiority phase 3 study. Virologically suppressed (>6 months) adults with HIV-1 switched to once-daily DTG/3TC or continued TAF-based regimens.

RESULTS: 741 participants received study treatment (DTG/3TC, n=369; TAF-based regimen, n=372). At Week 144, proportion of participants with HIV-1 RNA ≥50 copies/mL (primary endpoint, Snapshot, intention-to-treat-exposed population) after switching to DTG/3TC was 0.3% (1/369) vs 1.3% (5/372) of those continuing TAF-based regimens, demonstrating non-inferiority (adjusted treatment difference, -1.1; 95% CI, -2.4, 0.2), and favored DTG/3TC in the per-protocol analysis (adjusted treatment difference, -1.1; 95% CI, -2.3, -0.0; P=0.044). Few participants met confirmed virologic withdrawal criteria (DTG/3TC, n=0; TAF-based regimen, n=3), with no resistance observed. Drug-related adverse events were more frequent with DTG/3TC (15%; 4% led to discontinuation) than TAF-based regimens (5%; 1% led to discontinuation) through Week 144 and were comparable post-Week 48 (4%; 1% led to discontinuation in both groups). Change from baseline in lipids generally favored DTG/3TC; no clinical impact on renal function and comparable changes in inflammatory and bone biomarkers across groups were observed.

CONCLUSIONS: Switching to DTG/3TC demonstrated non-inferior and durable efficacy vs continuing TAF-based regimens in treatment-experienced adults with HIV-1, with good safety and tolerability, and no resistance through 144 weeks.

PMID:35079789 | DOI:10.1093/cid/ciac036

Isr Med Assoc J. 2022 Jan;24(1):9-10.

ABSTRACT

The Oxford-AstraZeneca vaccine ChAdOx1 (AZD1222, Vaxzevria) is playing a crucial role in counteracting the coronavirus disease-2019 (COVID-19) pandemic [1]. Since March 2021, reports of unexpected thrombotic events associated with thrombocytopenia and vaccination have been published [2]. To the best of our knowledge there is only one report about vaccination-associated myasthenia gravis (MG) occurring after a second dose of BNT162b2 (Pfizer-BioNTech).

PMID:35077038

Arch Osteoporos. 2022 Jan 24;17(1):22. doi: 10.1007/s11657-022-01066-0.

ABSTRACT

In this study, we found that patients with hypoparathyroidism had a problem with calcium medication compliance, and this problem increased with the duration of the disease. We also showed that patients are concerned about the possible side effects of drugs.

INTRODUCTION: In this study, we aimed to evaluate adherence to active vitamin D and calcium replacement in patients with post-surgical hypoparathyroidism.

METHODS: To elucidate the medication adherence, we performed a questionnaire survey using the six-item "Medication adherence questionnaire"(MAQ). The first, second, and sixth questions reflect the motivation status of the patients whereas the third, fourth, and fifth questions reflect the knowledge about the medication that is received. The responses are scored and patients are classified regarding their motivation to and knowledge about the particular drug.

RESULTS: Totally, 64 patients (male: 12/female: 52; mean age 48.6±11.6 years) who had post-operative hypoparathyroidism were included in our study. Median disease durance was 60 months (min-max: 12-295 months). We found that motivation score of calcium usage was significantly lower compared to vitamin D usage (p<0.001). The calcium motivation score was reversely correlated with disease duration (r= -0.256 and p=0.046). The most common worry about calcium usage was nephrotoxicity, and the most common worries about calcitriol treatment were kidney damage and polyuria. One-third of the patients were taking oral calcium and calcitriol less than the recommended dose.

CONCLUSION: One-third of patients lack motivation to use calcium whereas half of the patients experiences anxiety about drug-related side effects. This is a preliminary study showing that vital calcium and active vitamin D intake may be interrupted due to side effect anxiety.

PMID:35072832 | DOI:10.1007/s11657-022-01066-0

Ann Transl Med. 2021 Dec;9(23):1745. doi: 10.21037/atm-21-3768.

ABSTRACT

Hepatocellular carcinoma (HCC) is the third most frequent source of deaths associated with cancer after lung cancer in the world despite recent innovative treatment techniques. Liver transplantation, hepatic resection, and percutaneous ablation techniques hold great promise as potentially curative treatments for patients at early stages. Nevertheless, most of the patients are not suitable for these curative treatments due to their advanced disease stages at the time of diagnosis. Food and Drug Administration (FDA) approved tyrosine kinase inhibitor, sorafenib is a standard therapy for advanced-stage HCC patients which extends overall survival for several months. However, its therapeutic efficacy is restricted by adverse events and drug resistance which limits the number of patients benefiting from this systemic chemotherapeutic drug. During the last decade, novel approaches including but not limited to immunotherapies, ablation methods, and chemotherapeutic drugs were proposed to enhance sensitivity to sorafenib, improve therapeutic efficacy, and prohibit adverse events through novel delivery routes, utilization of nanoparticle carriers, and combination with other therapeutic agents. However, studies are still being conducted to optimize the efficiency of sorafenib and reduce its adverse events. In this review paper, we examine research studies evaluating novel delivery methods to reduce drug-related cytotoxicity to improve patient tolerance to sorafenib and its therapeutic efficacy in patients with HCC. Moreover, therapeutic approaches with the synergistic potential to combine with sorafenib are briefly summarized.

PMID:35071439 | PMC:PMC8743717 | DOI:10.21037/atm-21-3768

Cureus. 2021 Dec 16;13(12):e20455. doi: 10.7759/cureus.20455. eCollection 2021 Dec.

ABSTRACT

The coronavirus disease 2019 (COVID-19) has led to a global health crisis. Its clinical manifestations are well-documented, and severe complications among patients who survived the infection are being continuously reported. Several vaccines with well-established efficacies and excellent safety profiles have also been approved. To date, few side effects of vaccines have been reported. Drug-induced hepatotoxicity is an extremely rare side effect of these vaccines, with few reported instances. In this case report, we describe a patient who experienced hepatotoxicity after receiving the COVID-19 vaccine from Pfizer BioNTech.

PMID:35070524 | PMC:PMC8760787 | DOI:10.7759/cureus.20455

Ann Med Surg (Lond). 2022 Jan 11;74:103248. doi: 10.1016/j.amsu.2022.103248. eCollection 2022 Feb.

ABSTRACT

INTRODUCTION: and Importance: Metoclopramide is a frequently used anti-emetic medication for the treatment of vomiting secondary to medical conditions or chemotherapy. Metoclopramide is known to cause extrapyramidal symptoms (drug-induced movement disorder). While the dystonic reaction is an acute condition that may emerge after a single dose of metoclopramide, Tardive dyskinesia and Parkinsonism are generally seen after prolonged use. These reactions are more frequent in patients receiving high doses of metoclopramide especially in female patients, children, and older patients.

CASE PRESENTATION: A 61-year-old male hypertensive patient was admitted into the internal medicine ward following persistent epigastric pain and vomiting. Initial laboratory and imaging assessments were insignificant, Upper GI endoscopy revealed features of gastritis. PPI and metoclopramide 10 mg 3 times daily were started. After 2 days, the patient developed an acute dystonic reaction. The drug was discontinued and anticholinergic biperiden was given. The dystonic reaction was controlled after the third dose. The patient was discharged following recovery.

CONCLUSION: Metoclopramide can cause unpredictable acute dystonic reactions. This can be life-threatening and should be detected early. Extrapyramidal side effects should be monitored in patients on metoclopramide since a single dose can cause these symptoms. This case highlights an acute dystonic reaction following the administration of a metoclopromide injection.

HIGHLIGHTS: A 61-year old man became sensitive to Metoclopromide administration. He developed an acute dystonic reaction following the administration of a metoclopromide injection. He was treated with biperiden 5 mg IV after the condition was diagnosed, and he responded well.

PMID:35070292 | PMC:PMC8761935 | DOI:10.1016/j.amsu.2022.103248

World J Hepatol. 2021 Dec 27;13(12):1828-1849. doi: 10.4254/wjh.v13.i12.1828.

ABSTRACT

Hepatobiliary disorders are among the most common extraintestinal manifestations in inflammatory bowel diseases (IBD), both in Crohn's disease and ulcerative colitis (UC), and therefore represent a diagnostic challenge. Immune-mediated conditions include primary sclerosing cholangitis (PSC) as the main form, variant forms of PSC (namely small-duct PSC, PSC-autoimmune hepatitis overlap syndrome and IgG4-related sclerosing cholangitis) and granulomatous hepatitis. PSC is by far the most common, presenting in up to 8% of IBD patients, more frequently in UC. Several genetic foci have been identified, but environmental factors are preponderant on disease pathogenesis. The course of the two diseases is typically independent. PSC diagnosis is based mostly on typical radiological findings and exclusion of secondary cholangiopathies. Risk of cholangiocarcinoma is significantly increased in PSC, as well as the risk of colorectal cancer in patients with PSC and IBD-related colitis. No disease-modifying drugs are approved to date. Thus, PSC management is directed against symptoms and complications and includes medical therapies for pruritus, endoscopic treatment of biliary stenosis and liver transplant for end-stage liver disease. Other non-immune-mediated hepatobiliary disorders are gallstone disease, whose incidence is higher in IBD and reported in up to one third of IBD patients, non-alcoholic fatty liver disease, pyogenic liver abscess and portal vein thrombosis. Drug-induced liver injury (DILI) is an important issue in IBD, since most IBD therapies may cause liver toxicity; however, the incidence of serious adverse events is low. Thiopurines and methotrexate are the most associated with DILI, while the risk related to anti-tumor necrosis factor-α and anti-integrins is low. Data on hepatotoxicity of newer drugs approved for IBD, like anti-interleukin 12/23 and tofacitinib, are still scarce, but the evidence from other rheumatic diseases is reassuring. Hepatitis B reactivation during immunosuppressive therapy is a major concern in IBD, and adequate screening and vaccination is warranted. On the other hand, hepatitis C reactivation does not seem to be a real risk, and hepatitis C antiviral treatment does not influence IBD natural history. The approach to an IBD patient with abnormal liver function tests is complex due to the wide range of differential diagnosis, but it is of paramount importance to make a quick and accurate diagnosis, as it may influence the therapeutic management.

PMID:35069993 | PMC:PMC8727201 | DOI:10.4254/wjh.v13.i12.1828

J Clin Exp Hepatol. 2022 Jan-Feb;12(1):216-221. doi: 10.1016/j.jceh.2021.03.003. Epub 2021 Mar 11.

ABSTRACT

The modified derivatives of testosterone, termed as androgenic steroids are indicated in the management of hypogonadism, visceral obesity and metabolic disorders. Anabolic androgenic steroids (AASs) however are surreptitiously used by athletes and body builders for cosmetic purpose owing to their anabolic effects on muscle mass and strength. The unsurveilled use of AASs subjects these users to various side effects involving multiple systems such as the endocrine, genitourinary, hepatobiliary, central nervous, musculoskeletal and psychosocial system. The liver is a hormone-sensitive organ owing to abundance of androgen receptors and is vulnerable to a wide array of hepatotoxicity ranging from asymptomatic liver enzyme elevation to life-threatening subacute liver failure. The type of drug-induced liver injury (DILI) due to AASs can be hepatocellular injury, cholestasis, fatty liver disease, chronic vascular injury and neoplastic disease. Herein, we report three cases of AAS-related DILI associated with AAS abuse.

PMID:35068803 | PMC:PMC8766528 | DOI:10.1016/j.jceh.2021.03.003

J Oncol Pharm Pract. 2022 Jan 24:10781552221075541. doi: 10.1177/10781552221075541. Online ahead of print.

ABSTRACT

INTRODUCTION: Drug-induced acute pancreatitis (AP) is uncommon and represents 0.1 to 2% of all AP cases. Chemotherapy-induced AP is very rare. Docetaxel monotherapy-induced AP has been reported only once in the literature. Herein we report the second case of docetaxel-related AP and the first case of necrotic AP induced by this agent.

CASE REPORT: We describe the case of a severe docetaxel-induced AP classified as stage E Balthazar in a 55-year-old female treated with adjuvant docetaxel for localized breast cancer. Symptoms occurred five hours following the first infusion of docetaxel.

MANAGEMENT AND OUTCOME: The patient was hospitalized for 15 days for appropriate management. According to the CTCAE (Common Terminology Criteria for Adverse Events) version 5.0 this was a grade 4 toxicity and chemotherapy was withdrawn thereafter. Drug rechallenge was not possible because of the severity of the presentation.

DISCUSSION: Medical oncologists should be aware that docetaxel may induce severe pancreatitis. Therefore, they should prompt testing of serum lipase when patients consult for unusual abdominal pain following chemotherapy infusion. Recognizing this entity is paramount to allow early and appropriate management.

PMID:35068260 | DOI:10.1177/10781552221075541

Stud Health Technol Inform. 2022 Jan 14;289:144-147. doi: 10.3233/SHTI210879.

ABSTRACT

Pharmacovigilance is the science and activities related to the detection, evaluation, understanding and prevention of adverse drug reactions or any other possible drug-related problems. In our tropics, this discipline is in an embryonic state. The availability of a management system capable of responding to pharmacovigilance activities is the main objective of our study. The coding was done on the DJANGO Framework. Signal detection was done using the ROR method. We designed three modules which are the notification module, the analysis module and the statistics module. This study has allowed us to launch the basis for a computerization of the pharmacovigilance information system and partly meets our objective. However, it could lead to the integration of the dictionary of adverse effects such as MedDRA as well as the International Classification of Medicines (ATC, EphMRA).

PMID:35062112 | DOI:10.3233/SHTI210879

Stud Health Technol Inform. 2022 Jan 14;289:61-64. doi: 10.3233/SHTI210859.

ABSTRACT

Polypharmacy in elderly is a public health problem with both clinical (increase of adverse drug events) and economic issues. One solution is medication review, a structured assessment of patients' drug orders by the pharmacist for optimizing the therapy. However, this task is tedious, cognitively complex and error-prone, and only a few clinical decision support systems have been proposed for supporting it. Existing systems are either rule-based systems implementing guidelines, or documentary systems presenting drug knowledge. In this paper, we present the ABiMed research project, and, through literature reviews and brainstorming, we identified five candidate innovations for a decision support system for medication review: patient data transfer from GP to pharmacists, use of semantic technologies, association of rule-based and documentary approaches, use of machine learning, and a two-way discussion between pharmacist and GP after the medication review.

PMID:35062092 | DOI:10.3233/SHTI210859

Epilepsy Behav. 2022 Jan 18;127:108554. doi: 10.1016/j.yebeh.2022.108554. Online ahead of print.

ABSTRACT

INTRODUCTION: The steadily increasing impact of health-related quality of life (HRQOL) on reasonable diagnostic and therapeutic decisions makes the correct mapping of HRQOL indispensable in modern epileptology. The aim of this study was to address the reliability of the often-used generic HRQOL screening questionnaire EuroQOL 5-dimension, 3-level (EQ-5D-3L) by comparing its normalized index value (calculated via the time trade-off method) and visual analog scale (VAS) to the gold standard of the extensive Quality of Life in Epilepsy Inventory (QOLIE-31). QOLIE-10 scores were compared with the extensive QOLIE-31 and EQ-5D-3L TTO.

METHODS: We conducted a retrospective analysis of a monocentric study of 184 patients with epilepsy. Bivariate Spearman correlation analysis and Fisher's r-to-z transformation were used to compare the strengths of correlations of EQ-5D-3L, QOLIE-10 and QOLIE-31 with different epilepsy-specific domains (disease severity, drug interactions, emotional well-being, stigmatization, seizure-related anxiety, cognitive impairment).

RESULTS: The different metrics of EQ-5D-3L, QOLIE-10 and QOLIE-31 showed moderate to very strong intra- and inter-metric correlations for overall HRQOL. Quality of Life in Epilepsy Inventory-31 VAS and EQ-5D-3L VAS did not show any significantly different strengths of correlations with respect to the domains studied. In contrast, the correlation strength of the normalized EQ-5D-3L index value differed significantly from the QOLIE-31 T-score for several domains, for example, for drug-related adverse events, neuropsychological deficits, symptoms of depression and seizure worry. In seizure-free patients, EQ-5D-3L VAS and EQ-5D-3L index values correlated significantly less with the domain of "cognitive impairment" than the QOLIE-31 T-score. In patients without relevant neuropsychological deficits, the strengths of correlations with the assessed domains did not differ significantly between EQ-5D-3L metrics and the QOLIE-31 T-score. The HRQOL mapping probability of QOLIE-10 was inferior to QOLIE-31 and comparable to EQ-5D-3L regarding the analyzed domains.

CONCLUSION: In contrast to the EQ-5D-3L VAS, EQ-5D-3L index values do not adequately map health-related quality of life in severely affected patients with epilepsy and therefore should not be used as screening tools. The QOLIE-31 T-score remains the gold standard for HRQOL assessment in patients with epilepsy.

PMID:35063789 | DOI:10.1016/j.yebeh.2022.108554

Medicina (Kaunas). 2022 Jan 8;58(1):94. doi: 10.3390/medicina58010094.

ABSTRACT

Background and Objectives: The occurrence of rheumatological side effects in a patient after receiving immunotherapy for cancer is becoming increasingly common. Oncologists often fail to diagnose and refer affected patients to rheumatologists. This paper presents the various rheumatological adverse events that occur after immunotherapy in patients as well as their treatment and evolution. Materials and Methods: A total of 36 patients were monitored between November 2018 and March 2020. The oncologist monitoring the immunotherapy-treated patients identified the occurrence of musculoskeletal side effects. The grading of toxicities was performed by both the oncologist and the rheumatologist using common terminology criteria for adverse events (CTCAE). Rheumatological treatment was administered, and for some patients, immunotherapy was discontinued. Results: The clinical presentations of the patients varied. Mild side effects (grade 1-2) were reported in a higher proportion than severe side effects (grade 3-5). Therefore, thirty-one patients had mild-to-moderate side effects, and five patients had severe side effects. Adverse reactions occurred, on average, 10 weeks after the initiation of immunotherapy; this indicated that the severity of the toxicity was dose dependent. Patients were treated with NSAIDs or prednisone, depending on the severity of the side effects, and for patients with severe manifestations, immunotherapy was discontinued. The remission of rheumatic manifestations varied depending on the grade of the manifestations. Conclusions: The clinical, biological, and ultrasound presentations of the patients with adverse events followed by cancer treatments differed from classic rheumatological manifestations. Thorough examinations of these patients by both oncologists and rheumatologists are needed in order to correctly diagnose and treat rheumatological adverse events. Multiple studies that include a larger number of participants are needed in order to better understand the pathogenesis and clinical evolution of these patients under different treatment conditions.

PMID:35056402 | DOI:10.3390/medicina58010094

Clin Drug Investig. 2022 Jan 21. doi: 10.1007/s40261-021-01112-8. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVES: DS-1040 is a novel inhibitor of the activated form of thrombin-activatable fibrinolysis inhibitor that may have therapeutic potential in thromboembolic diseases, such as acute ischemic stroke (AIS) or pulmonary embolism. We undertook a Phase I clinical trial to investigate the safety, pharmacokinetics, and pharmacodynamics of DS-1040 in Japanese patients who were eligible for thrombectomy following AIS.

METHODS: The trial enrolled patients with AIS due to large vessel occlusion, who were planned for thrombectomy within 8 h of symptom onset. Subjects were randomized to receive a single intravenous infusion of placebo or DS-1040 (0.6, 1.2, 2.4 or 4.8 mg) in a sequential-cohort design. The primary endpoints were the incidence of intracranial hemorrhage (ICH) and major extracranial bleeding within 36 and 96 h, respectively, of treatment initiation. Treatment-emergent adverse events (TEAEs) and pharmacokinetic/pharmacodynamic parameters were also assessed.

RESULTS: Nine patients received placebo and 32 patients received DS-1040. There were no cases of symptomatic ICH or major extracranial bleeding with either placebo or DS-1040 after 36 and 96 h. One patient, who received DS-1040 0.6 mg, experienced a subarachnoid hemorrhage that was considered to be drug-related. Three patients died (2 placebo, 1 DS-1040), but no deaths were adjudicated as study drug-related. In vivo exposure to DS-1040 increased in proportion to dosage, but no clear dose-response relationship was seen for D-dimer levels and thrombin-activatable fibrinolysis inhibitor activity.

CONCLUSIONS: Single doses of DS-1040 0.6-4.8 mg were well tolerated in Japanese patients with AIS undergoing thrombectomy.

CLINICAL TRIAL REGISTRATION NUMBER: NCT03198715; JapicCTI-163164.

PMID:35061236 | DOI:10.1007/s40261-021-01112-8

J Oncol Pharm Pract. 2022 Jan 21:10781552221075809. doi: 10.1177/10781552221075809. Online ahead of print.

ABSTRACT

INTRODUCTION: Osimertinib is an approved therapy for patients with a Thr790met (T790M) mutation diagnosed with non-small cell lung cancer (NSCLC) that progresses during epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) therapy. However, in 7-13% of patients, drug-related side effects lead to discontinuation of osimertinib treatment. In such cases, osimertinib desensitization is a treatment option that can be considered.

CASE REPORT: A 59-year-old female patient, who was followed up with the diagnosis of stage 4 NSCLC, was consulted to the allergy clinic because of urticaria. The patient developed urticaria plaques 20 h after the third dose of osimertinib tablet.

MANAGEMENT & OUTCOME: With the diagnosis of osimertinib-induced urticaria, desensitization was planned for the patient. Treatment was started with a dose of 0.1 mg/day osimertinib. The procedure was completed in approximately 50 days, and a dose of 80 mg/day was reached with antihistamine suppression.

DISCUSSION: Here, a successful osimertinib desensitization in a patient with a history of osimertinib-related type 1 allergic reaction is reported. Osimertinib desensitization is a treatment option that should be considered in cases where treatment has to be ceased due to drug-related side effects.

PMID:35060790 | DOI:10.1177/10781552221075809

J Cosmet Dermatol. 2022 Jan 21. doi: 10.1111/jocd.14790. Online ahead of print.

ABSTRACT

Drug-induced angioedema often affects elderly patients with chronic drug use. Proper diagnosis and prompt with effective treatment reduce mortality. With the increasing use of favipravir, many side effects, especially increased alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels due to liver toxicity, and also skin lesions are reported. First patient oral favipravir treatment on the second day, was admitted to the hospital with rash and swelling on the eyelids. Second patient suffered from significant swelling on the upper lip and displayed angioedema. In this cases, angioedema findings regressed after rapid diagnosis and parenterally administered antihistamine and steroid treatment. Although there is no effective drug therapy in the treatment of COVID-19, favipravir is also included in the treatment protocols in many countries. Clinicians should be careful about the side effects and possible skin manifestations, especially including angioedema, related to the use of favipravir.

PMID:35060267 | DOI:10.1111/jocd.14790