Drug-induced Adverse Events

Administration of Samital® in children with oral mucositis: a feasibility study

Fri, 2022-12-02 06:00

Eur Rev Med Pharmacol Sci. 2022 Nov;26(22):8576-8581. doi: 10.26355/eurrev_202211_30393.

NO ABSTRACT

PMID:36459038 | DOI:10.26355/eurrev_202211_30393

Categories: Literature Watch

Suanzaoren Decoction for the treatment of chronic insomnia: a systematic review and meta-analysis

Fri, 2022-12-02 06:00

Eur Rev Med Pharmacol Sci. 2022 Nov;26(22):8523-8533. doi: 10.26355/eurrev_202211_30388.

NO ABSTRACT

PMID:36459033 | DOI:10.26355/eurrev_202211_30388

Categories: Literature Watch

Target-controlled infusion during MitraClip procedures in deep-sedation with spontaneous breathing

Fri, 2022-12-02 06:00

Eur Rev Med Pharmacol Sci. 2022 Nov;26(22):8437-8443. doi: 10.26355/eurrev_202211_30379.

NO ABSTRACT

PMID:36459026 | DOI:10.26355/eurrev_202211_30379

Categories: Literature Watch

Clostridium difficile and other adverse events from overprescribed antibiotics for acute upper respiratory infection

Fri, 2022-12-02 06:00

J Intern Med. 2022 Dec 2. doi: 10.1111/joim.13597. Online ahead of print.

NO ABSTRACT

PMID:36460621 | DOI:10.1111/joim.13597

Categories: Literature Watch

Rhabdomyolysis in a male adolescent associated with monotherapy of fluvoxamine

Fri, 2022-12-02 06:00

Eur J Hosp Pharm. 2022 Dec 2:ejhpharm-2022-003533. doi: 10.1136/ejhpharm-2022-003533. Online ahead of print.

NO ABSTRACT

PMID:36460460 | DOI:10.1136/ejhpharm-2022-003533

Categories: Literature Watch

Efficacy and safety of acoziborole in patients with human African trypanosomiasis caused by Trypanosoma brucei gambiense: a multicentre, open-label, single-arm, phase 2/3 trial

Fri, 2022-12-02 06:00

Lancet Infect Dis. 2022 Nov 29:S1473-3099(22)00660-0. doi: 10.1016/S1473-3099(22)00660-0. Online ahead of print.

NO ABSTRACT

PMID:36460027 | DOI:10.1016/S1473-3099(22)00660-0

Categories: Literature Watch

Comparative analysis of anti-relapse treatment regimens in 110 patients with hepatic and pulmonary hydatid echinococcosis

Fri, 2022-12-02 06:00

Eur Rev Med Pharmacol Sci. 2022 Nov;26(22):8591-8598. doi: 10.26355/eurrev_202211_30396.

ABSTRACT

OBJECTIVE: Hydatid echinococcosis is worm disease caused by Echinococcus granulosus, that is primarily detected in the liver and lungs. This study aimed at determining the clinical tolerance and efficacy of albendazole in patients with cystic echinococcosis, depending on the volume of the previous one.

PATIENTS AND METHODS: We retrospectively (from 2016 to 2020 years) analyzed patients who have been treated with two treatment regimens (28-day courses with a 14-day break and continuous drug intake for 60 days), which are used in the Russian Federation. There were 110 patients (after surgery) who had hydatid echinococcosis of the liver and lungs; the diagnosis of these patients was confirmed morphologically (intra-vitam). A retrospective analysis was carried out on the following matters: (1) the duration of anti-relapse chemotherapy depending on the localization of the parasitic cyst; (2) chemotherapy's side effects and long-term relapses after treatment. We evaluated patients' tolerability of albendazole according to the level of blood cells count and hepatic enzymes. The effectiveness of anti-parasitic treatment was evaluated by imaging studies that did not reveal the growth of new parasitic cysts even in the presence of serum antibodies to echinococcal antigens.

RESULTS: A correlation was found between the choice of antiparasitic treatment regimen and the frequency of adverse reactions in lab tests: more often adverse reactions (drug-induced hepatitis, anemia, granulocytopenia) occurred in patients who received a continuous treatment regimen for 60 days (p < 0.05). The frequency of relapses reached 4.5% and was more often observed in patients who received treatment for 28 days with a 14-day break.

CONCLUSIONS: Continuous drug intake for 60 days is the most effective.

PMID:36459040 | DOI:10.26355/eurrev_202211_30396

Categories: Literature Watch

Efficacy and safety of belantamab-mafodotin in triple-refractory multiple myeloma patients: A multicentric real-life experience

Fri, 2022-12-02 06:00

Front Oncol. 2022 Nov 15;12:1026251. doi: 10.3389/fonc.2022.1026251. eCollection 2022.

ABSTRACT

Belantamab-mafodotin is an innovative and selective treatment for multi-refractory/relapsed multiple myeloma (MM) patients; however, available real-life experiences on efficacy and safety are limited. In this real-world multicentric retrospective study, we enrolled 28 MM patients treated in four Hematology units of Campania region, Italy, who received a median of six treatment lines prior to belantamab-mafodotin. The overall response rate (ORR) was 40% (complete remission, CR, 11%; very good partial remission, VGPR, 11%; and partial remission, PR, 18%), with a median progression-free survival (PFS) and overall survival (OS) of 3 and 8 months, respectively. One of the most frequent drug-related adverse events was keratopathy observed in nine (32%) patients, leading to therapy discontinuation in only three (11%) of them. Moreover, 22 out of 28 total patients who were treated with at least two administrations achieved an ORR of 50% (CR, 14%; VGPR, 14%; and PR, 22%) with a median PFS and OS of 5 and 11 months, respectively. In conclusion, our multicentric study confirmed efficacy and safety of belantamab-mafodotin in triple-refractory MM patients even in the real-life setting.

PMID:36457484 | PMC:PMC9705330 | DOI:10.3389/fonc.2022.1026251

Categories: Literature Watch

The pathophysiology of rapid fluctuations in mental status associated with olanzapine: A case report

Thu, 2022-12-01 06:00

Front Psychiatry. 2022 Dec 1;13:1028350. doi: 10.3389/fpsyt.2022.1028350. eCollection 2022.

ABSTRACT

BACKGROUND: Olanzapine toxicity is reported to be a rare but specific phenomenon characterized by rapid fluctuations between somnolence and agitation, which has been referred to as "agitation despite sedation." A similar phenomenon is observed as an adverse reaction of the long-acting injectable olanzapine formulation, which has been referred to as "delirium/sedation syndrome."

CASE PRESENTATION: This case report describes a 48-year-old man diagnosed with schizophrenia who experienced rapid fluctuations between somnolence and agitation during a cross-titration of olanzapine to clozapine. The patient had normal serum levels of both medications and the symptoms resolved with the discontinuation of olanzapine.

CONCLUSION: Rapid fluctuations in mental status between somnolence and agitation are not clearly described among other antipsychotics, and it is possible that this phenomenon may be specific to olanzapine. The findings of this case report suggested that this phenomenon was likely the result of the oversaturation of (H1) and (M1) receptors.

PMID:37082516 | PMC:PMC10111197 | DOI:10.3389/fpsyt.2022.1028350

Categories: Literature Watch

Evaluation of Lung Toxicity With Lenalidomide Using the Pharmacovigilance Database

Thu, 2022-12-01 06:00

Anticancer Res. 2022 Dec;42(12):5917-5925. doi: 10.21873/anticanres.16101.

NO ABSTRACT

PMID:36456140 | DOI:10.21873/anticanres.16101

Categories: Literature Watch

Bullous Sweet syndrome as a presentation of chronic myelogenous leukaemia

Thu, 2022-12-01 06:00

BMJ Case Rep. 2022 Dec 1;15(12):e250755. doi: 10.1136/bcr-2022-250755.

NO ABSTRACT

PMID:36455980 | PMC:PMC9716981 | DOI:10.1136/bcr-2022-250755

Categories: Literature Watch

Immunotherapy for Cancer: Common Gastrointestinal, Liver, and Pancreatic Side Effects and Their Management

Thu, 2022-12-01 06:00

Am J Gastroenterol. 2022 Dec 1;117(12):1917-1932. doi: 10.14309/ajg.0000000000001983. Epub 2022 Aug 22.

NO ABSTRACT

PMID:36455219 | DOI:10.14309/ajg.0000000000001983

Categories: Literature Watch

The adverse effects of trastuzumab-containing regimes as a therapy in breast cancer: A piggy-back systematic review and meta-analysis

Thu, 2022-12-01 06:00

PLoS One. 2022 Dec 1;17(12):e0275321. doi: 10.1371/journal.pone.0275321. eCollection 2022.

NO ABSTRACT

PMID:36454979 | DOI:10.1371/journal.pone.0275321

Categories: Literature Watch

A case of fatal multidrug intoxication involving flualprazolam: distribution in body fluids and solid tissues

Thu, 2022-12-01 06:00

Forensic Toxicol. 2022 Jan;40(1):180-188. doi: 10.1007/s11419-021-00591-w. Epub 2021 Aug 11.

NO ABSTRACT

PMID:36454486 | PMC:PMC9715448 | DOI:10.1007/s11419-021-00591-w

Categories: Literature Watch

Brain targeted intra nasal acyclovir lipid nanoparticles; in-vitro characterization and in-vivo biodistribution studies

Thu, 2022-12-01 06:00

Pak J Pharm Sci. 2022 Sep;35(5):1363-1369.

ABSTRACT

Acyclovir (ACY) is an antiviral class of drugs used to treat herpes simplex virus infections such as herpes simplex encephalitis (HSE). ACY is widely distributed; Systemic exposure of ACY leads to serious adverse effects. Because of its high pH, intravenous ACY may cause phlebitis and local inflammation if extravasation occurs. This study aims to enhance acyclovir delivery to the brain via the intranasal route by formulating ACY nano lipid carriers (ACY-NLCs) to circumvent the side-effects, as mentioned earlier. ACY-NLCs were prepared by emulsification, followed by ultrasonication. A Box-Behnken statistical design with three factors, three levels and 17 runs was selected for the optimization study using Design- Expert Software. Nanoparticles were characterized for particle size, entrapment efficiency and in-vitro drug release. ACY- NLC showed biphasic release pattern i.e. an initial faster release followed by sustained release. Biodistribution study by imaging, Nanoparticles were slowly cleared and biodistributed to the other organs was observed in 2nd and 3rd hr post-administration. From the toxicity studies, NLC formulation is safe and non-toxic for the nasal administration. Rhodamine loaeded NLCs were quickly adsorbed by the olfactory tract and distributed mainly to the lungs through respiratory tract and were also detected in the trachea and olfactory bulb. Biodistribution study of dye loaded NLCs reach brain compared to the Rhodamine-solution.

PMID:36451565

Categories: Literature Watch

Meta analysis of the effect of phloroglucinol combined with progesterone in the treatment of threatened miscarriage before 20 weeks of gestation: A protocol for a systematic review

Thu, 2022-12-01 06:00

Medicine (Baltimore). 2022 Nov 25;101(47):e31885. doi: 10.1097/MD.0000000000031885.

ABSTRACT

BACKGROUND: Threatened miscarriage (TM) is an important factor endangering the health of pregnant women. It not only affects women's physical and mental health, but also destroys family happiness. To treat this disease, it is necessary to find a treatment with better clinical efficacy and fewer side effects. The purpose of this systematic study was to evaluate the efficacy and safety of phloroglucinol (PHL) combined with progesterone in the treatment of TM before 20 weeks of pregnancy.

METHODS: Electronic databases (EMBASE, PubMed, Cochrane Central Register of Controlled Trials, Web of Science, Elsevier, China National Knowledge Infrastructure, Chongqing VIP, and WanFang Data) were searched from inception until September. 2022. Randomized controlled trials of PHL combined with progesterone in the treatment of TM before 20 weeks of gestation will be included, and all articles will be independently screened and collected by 2 reviewers. Revman 5.3.5 software will be used for meta-analysis. The specific process is described in the Cochrane Handbook for Systematic Reviews.

RESULTS: The efficacy and safety of PHL combined with progesterone for the treatment of threatened abortion were comprehensively evaluated in terms of efficacy, efficiency, time of symptom relief, length of hospital stay, and incidence of adverse events.

CONCLUSION: This study provides reliable evidence for the clinical application of PHL combined with progesterone for the treatment of TM.

PMID:36451473 | DOI:10.1097/MD.0000000000031885

Categories: Literature Watch

Prospective Observational Study of Sorafenib in Hepatocellular Carcinoma Patients With Very High Risk of Recurrence After Surgery

Thu, 2022-12-01 06:00

Anticancer Res. 2022 Dec;42(12):6127-6134. doi: 10.21873/anticanres.16126.

ABSTRACT

BACKGROUND/AIM: Surgical resection remains the mainstay of treatment for hepatocellular carcinoma (HCC). However, reducing the risk of postoperative recurrence is urgently needed. We planned a prospective observational study to investigate the efficacy and safety of adding sorafenib in a maintenance setting after surgery in HCC patients with high risk of recurrence.

PATIENTS AND METHODS: Patients with HCC (invasion of the hepatic vein or inferior vena cava or tumor size >7 cm or tumor to nontumor standardized uptake value ratio >2 by fluorodeoxyglucose positron emission tomography) who underwent macroscopically curative resection were eligible. Dose and schedule of sorafenib were set at 800 mg/day for six months after hepatic resection. The primary endpoint was progression-free survival, and the secondary endpoints were overall survival and safety. This study was registered with the UMIN Clinical Trials Registry (UMIN000013089).

RESULTS: Ten patients were evaluated. Six patients completed the pre-planned treatment. Three patients discontinued treatment because of disease progression (lung metastasis in two patients and liver metastasis in one), and one patient discontinued because of pneumonia. The most common drug-related adverse event was increased γ-glutamyl transpeptidase (γGTP). None of the patients suffered grade 4 adverse events. The median progression-free survival was 380 (range=38-1,555) days. The median overall survival was 1000 (range=850-1,705) days. Four patients survived without disease progression for more than 800 days.

CONCLUSION: Although the sample size was limited, this is the first study to demonstrate the safety and efficacy of sorafenib in a maintenance setting after surgery for HCC patients with high risk of recurrence.

PMID:36456121 | DOI:10.21873/anticanres.16126

Categories: Literature Watch

PEOPLE (NCT03447678), a first-line phase II pembrolizumab trial, in negative and low PD-L1 advanced NSCLC: clinical outcomes and association with circulating immune biomarkers

Thu, 2022-12-01 06:00

ESMO Open. 2022 Nov 28;7(6):100645. doi: 10.1016/j.esmoop.2022.100645. Online ahead of print.

ABSTRACT

BACKGROUND: The PEOPLE trial aimed to identify new immune biomarkers in negative and low programmed death-ligand 1 (PD-L1) (0%-49%) advanced non-small-cell lung cancer (aNSCLC) patients treated with first-line pembrolizumab. Here we report the main outcomes and the circulating immune biomarkers analysis.

PATIENTS AND METHODS: The primary endpoint of this phase II trial was the identification of immune biomarkers associated with progression-free survival (PFS). Overall survival (OS), objective response rate (ORR), disease control rate (DCR), duration of response (DoR) and safety were secondary endpoints. Absolute cell counts for 36 subsets belonging to innate and adaptive immunity were determined by multiparametric flow cytometry in peripheral blood at baseline and at first radiologic evaluation. An orthoblique principal components-based clustering approach and multivariable Cox regression model adjusted for clinical variables were used to analyze immune variables and their correlation with clinical endpoints.

RESULTS: From May 2018 to October 2020, 65 patients were enrolled. After a median follow-up of 26.4 months, the median PFS was 2.9 months [95% confidence interval (CI) 1.8-5.6 months] and median OS was 12.1 months (95% CI 8.7-17.1 months). The ORR was 21.5%, DCR was 47.7% and median DoR was 14.5 months (95% CI 6.4-24.9 months). Drug-related grade 3-4 adverse events were 9.2%. Higher T cell and natural killer (NK) cell count at baseline and at the first radiologic evaluation were associated with improved PFS, DCR and OS. On the contrary, higher myeloid cell count at baseline or at the first radiologic evaluation was significantly associated with worse OS and DCR.

CONCLUSIONS: Circulating immune biomarkers can contribute to predict outcomes in negative and low PD-L1 aNSCLC patients treated with first-line single-agent pembrolizumab.

PMID:36455507 | DOI:10.1016/j.esmoop.2022.100645

Categories: Literature Watch

Risk factors for and preventability of drug-related hospital revisits in older patients: a post-hoc analysis of a randomised clinical trial

Thu, 2022-12-01 06:00

Br J Clin Pharmacol. 2022 Dec 1. doi: 10.1111/bcp.15621. Online ahead of print.

ABSTRACT

AIM: To identify older patients' risk factors for drug-related readmissions and 2) to assess the preventability of older patients' drug-related revisits.

METHODS: Post-hoc analysis of a randomised clinical trial with patients aged ≥ 65 years at eight wards within four hospitals in Sweden. 1) The primary outcome was risk factors for drug-related readmission within 12 months post-discharge. A Cox proportional hazards model was made with sociodemographic and clinical baseline characteristics. 2) Four hundred trial participants were randomly selected and their revisits (admissions and emergency department visits) were assessed to identify potentially preventable drug-related revisits, related diseases and causes.

RESULTS: Among 2,637 patients (median age 81 years), 582 (22%) experienced a drug-related readmission within 12 months. Sixteen risk factors (hazard ratio > 1, p < 0.05) related to age, previous hospital visits, medication use, multimorbidity and cardiovascular, liver, lung and peptic ulcer disease were identified. 2) The 400 patients experienced a total of 522 hospital revisits, of which 85 (16%) were potentially preventable drug-related revisits. The two most prevalent related diseases were heart failure (n=24, 28%) and chronic obstructive pulmonary disease (n=13, 15%). The two most prevalent causes were inadequate treatment (n=23, 27%) and insufficient or no follow-up (n=22, 26%).

CONCLUSION: Risk factors for drug-related readmissions in older hospitalised patients were age, previous hospital visits, medication use and multiple diseases. 2) Potentially preventable drug-related hospital revisits are common and might be prevented through adequate pharmacotherapy and continuity of care in older patients with cardiovascular or lung disease.

PMID:36454520 | DOI:10.1111/bcp.15621

Categories: Literature Watch

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