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The Oncologist Dec 2019A dexamethasone-sparing regimen consisting of palonosetron plus 1-day dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV) has been... (Meta-Analysis)
Meta-Analysis
One-Day Versus Three-Day Dexamethasone in Combination with Palonosetron for the Prevention of Chemotherapy-Induced Nausea and Vomiting: A Systematic Review and Individual Patient Data-Based Meta-Analysis.
BACKGROUND
A dexamethasone-sparing regimen consisting of palonosetron plus 1-day dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV) has been studied previously. Here, we evaluate the noninferiority of the dexamethasone-sparing regimen in overall antiemetic control using a meta-analysis based on individual patient data (IPD).
MATERIALS AND METHODS
We conducted a systematic review for randomized trials reporting CINV outcomes for the comparison of palonosetron plus 1-day dexamethasone (d1 arm) versus the same regimen followed by dexamethasone on days 2-3 after chemotherapy (d3 arm) in chemotherapy-naïve adult patients undergoing either moderately emetogenic chemotherapy (MEC) or anthracycline plus cyclophosphamide (AC)-containing chemotherapy. PubMed and MEDLINE were searched electronically. A manual search was also conducted. The primary endpoint was complete response (CR; no emesis and no rescue medication) in the overall 5-day study period. The noninferiority margin was set at -8.0% (d1 arm-d3 arm).
RESULTS
Five studies ( = 1,194) were eligible for analysis and all IPD was collected. In the overall study period, the d1 arm showed noninferiority to the d3 arm for CR as well as complete control (pooled risk difference in CR rate - 1.5%, 95% confidence interval [CI] -7.1 to 4.0%, I = 0%; in complete control rate - 2.4%, 95% CI -7.7 to 2.9%, I = 0%). There was no significant interaction between dexamethasone regimen and risk factors (type of chemotherapy, sex, age, and alcohol consumption).
CONCLUSION
This IPD meta-analysis indicates that the dexamethasone-sparing regimen is not associated with a significant loss in overall antiemetic control in patients undergoing MEC or AC-containing chemotherapy, irrespective of known risk factors for CINV.
IMPLICATIONS FOR PRACTICE
Although dexamethasone in combination with other antiemetic agents has been used to prevent chemotherapy-induced nausea and vomiting (CINV), it is of clinical importance to minimize total dose of dexamethasone in patients undergoing multiple cycles of emetogenic chemotherapy. This individual-patient-data meta-analysis from five randomized controlled trials (1,194 patients) demonstrated a noninferiority of the dexamethasone-sparing regimen for complete response and complete control of CINV. The outcomes were comparable across patients with different characteristics. These findings thus help physicians minimize use of the steroid and further reduce the burden of dexamethasone-related side effects in patients undergoing multiple consecutive courses of emetogenic chemotherapy.
Topics: Dexamethasone; Drug Dosage Calculations; Female; Humans; Male; Middle Aged; Nausea; Palonosetron; Vomiting
PubMed: 31217343
DOI: 10.1634/theoncologist.2019-0133 -
Sao Paulo Medical Journal = Revista... 2021Considering the disruptions imposed by lockdowns and social distancing recommendations, coupled with overwhelmed healthcare systems, researchers worldwide have been... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Considering the disruptions imposed by lockdowns and social distancing recommendations, coupled with overwhelmed healthcare systems, researchers worldwide have been exploring drug repositioning strategies for treating severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
OBJECTIVE
To compile results from randomized clinical trials on the effect of dexamethasone, compared with standard treatment for management of SARS-CoV-2.
DESIGN AND SETTING
We conducted a systematic review and meta-analysis in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines in a Brazilian public university.
METHODS
We sought to compile data from 6724 hospitalized patients with confirmed or suspected SARS-CoV-2 infection.
RESULTS
Treatment with dexamethasone significantly reduced mortality within 28 days (risk ratio, RR: 0.89; 95% confidence interval, CI: 0.82-0.97). Dexamethasone use was linked with being discharged alive within 28 days (odds ratio, OR: 1.20; 95% CI: 1.07-1.33).
CONCLUSIONS
This study suggests that dexamethasone may significantly improve the outcome among hospitalized patients with SARS-CoV-2 infection and associated severe respiratory complications. -Further studies need to consider both dose-dependent administration and outcomes in early and later stages of the disease.
PROSPERO PLATFORM
CRD42021229825.
Topics: Communicable Disease Control; Dexamethasone; Humans; SARS-CoV-2; COVID-19 Drug Treatment
PubMed: 34644768
DOI: 10.1590/1516-3180.2021.0120.R1.30062021 -
IET Nanobiotechnology Dec 2018To study the development, characterisation, and drug release of one- and two-layered thin films based on organic polymers [poly(D,L-lactide--glycolide) lactide:glycolide...
To study the development, characterisation, and drug release of one- and two-layered thin films based on organic polymers [poly(D,L-lactide--glycolide) lactide:glycolide (65:35), poly(D,L-lactide--glycolide) lactide:glycolide (75:25), and polycaprolactone] and dexamethasone. To examine their applicability for intraocular lenses (IOLs) and function in intraocular drug delivery systems. Four series of thin films, single and double-layer, were prepared by the spin-coating method on a silicon substrate. The films were studied using atomic force microscopy and spectroscopic ellipsometry. The release rate of dexamethasone was studied for a period of ten weeks. Series A and C demonstrated the formation of large dexamethasone aggregates. The monolayer films of series C and D formed pores, in agreement with previous findings. The spectroscopic ellipsometry study demonstrated that the samples were transparent. The drug release study demonstrated that dexamethasone was released during the first 6 weeks at a desirable rate. The films exhibited properties suitable for use in intraocular drug delivery systems. The single-layer thin films demonstrated a sufficient encapsulation of dexamethasone and appropriate release of the therapeutic substance. Further studies are necessary to investigate the possibility of developing the films directly on the surface of the IOL.
Topics: Dexamethasone; Drug Delivery Systems; Drug Liberation; Lenses, Intraocular; Models, Chemical; Ophthalmic Solutions; Polyesters; Polylactic Acid-Polyglycolic Acid Copolymer; Prosthesis Design
PubMed: 30964016
DOI: 10.1049/iet-nbt.2018.5151 -
Pain Physician 2015Transforaminal epidural steroid injections (TFESI) are widely used for the conservative treatment of radicular pain. The use of dexamethasone in TFESIs is relatively... (Observational Study)
Observational Study
BACKGROUND
Transforaminal epidural steroid injections (TFESI) are widely used for the conservative treatment of radicular pain. The use of dexamethasone in TFESIs is relatively new; therefore, immediate and acute adverse effects that it may cause are not fully updated.
OBJECTIVE
To evaluate immediate and acute adverse effects following TFESI with dexamethasone.
STUDY DESIGN
Prospective, observational study.
SETTING
A spine center affiliated with a rehabilitation hospital.
METHODS
One hundred fifty consecutive patients receiving TFESI for the management of radicular and axial spinal pain at the cervical, lumbar, and sacral levels with dexamethasone using fluoroscopic guidance with digital subtraction technology were enrolled. The occurrence of adverse effects in patients in the 2-week time period following interventions was monitored through a set of questionnaires followed up by phone calls scheduled for 1 day, day 3, and day 14. Intensity and duration of side effects were recorded.
RESULTS
Of the 150 patients enrolled, 31 patients (19.5%) experienced adverse effects within the first 30 minutes following the intervention. The most common adverse effects were numbness and tingling in the limb, which developed in 19 patients (11.95%) followed by perineal pruritus that occurred in 7 cases (4.4%). Patients also reported experiencing adverse effects within the 3 days following intervention; most complained of headaches, insomnia, hiccups, flushing, and increased radicular pain. No major complications were noted.
LIMITATIONS
The sample size enrolled might be too small to perceive possible rare side effects related to the procedure. The 2-week follow-up period is a limitation for evaluating late side effects.
CONCLUSIONS
This study offers provision to interventionalists that TFESI with dexamethasone when performed by experienced hands and with proper technique has minor self-limited transient adverse effects that can be easily managed. Patients should be made aware of these adverse effects and their management. Further larger studies are needed to validate the safe use of dexamethasone and the safety of transforaminal epidural injections.
Topics: Adult; Aged; Analgesia, Epidural; Anti-Inflammatory Agents; Dexamethasone; Epidural Space; Female; Fluoroscopy; Follow-Up Studies; Humans; Injections, Epidural; Male; Middle Aged; Pain Management; Prospective Studies; Surveys and Questionnaires
PubMed: 26000671
DOI: No ID Found -
Annual Review of Microbiology 2006The Roseobacter lineage is a phylogenetically coherent, physiologically heterogeneous group of alpha-Proteobacteria comprising up to 25% of marine microbial communities,... (Review)
Review
The Roseobacter lineage is a phylogenetically coherent, physiologically heterogeneous group of alpha-Proteobacteria comprising up to 25% of marine microbial communities, especially in coastal and polar oceans, and it is the only lineage in which cultivated bacteria are closely related to environmental clones. Currently 41 subclusters are described, covering all major marine ecological niches (seawater, algal blooms, microbial mats, sediments, sea ice, marine invertebrates). Members of the Roseobacter lineage play an important role for the global carbon and sulfur cycle and the climate, since they have the trait of aerobic anoxygenic photosynthesis, oxidize the greenhouse gas carbon monoxide, and produce the climate-relevant gas dimethylsulfide through the degradation of algal osmolytes. Production of bioactive metabolites and quorum-sensing-regulated control of gene expression mediate their success in complex communities. Studies of representative isolates in culture, whole-genome sequencing, e.g., of Silicibacter pomeroyi, and the analysis of marine metagenome libraries have started to reveal the environmental biology of this important marine group.
Topics: Anti-Bacterial Agents; Carbon Monoxide; Dexamethasone; Ecology; Environment; Genome, Bacterial; Phosphorylation; Photosynthesis; Quorum Sensing; Roseobacter; Sulfur; Symbiosis
PubMed: 16719716
DOI: 10.1146/annurev.micro.60.080805.142115 -
BMC Musculoskeletal Disorders Dec 2018The purpose of this study was to investigate the efficacy and safety of multiple low-dose dexamethasones in primary total knee arthroplasty (TKA). (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
The purpose of this study was to investigate the efficacy and safety of multiple low-dose dexamethasones in primary total knee arthroplasty (TKA).
METHODS
One hundred fifty patients were equally randomized into 3 groups: Group A (n = 50) received 2 doses of normal saline only; Group B (n = 50) received with 1 dose of intravenous dexamethasone and 1 dose of normal saline; Group C (n = 50) received with 2 doses of intravenous dexamethasone. The clinical outcomes and complications were assessed.
RESULTS
The CRP and IL-6 were significantly lower in Group C and B than Group A at 24, 48, and 72 h postoperatively (P < 0.001 for all). The intensity of postoperative nausea and vomiting (PONV) in Group C was lower than Group A at 24 (P < 0.001, P = 0.002), 48 (P = 0.005, P = 0.041) and 72 h (P = 0.017, P = 0.031) postoperatively and Group B at 24 h (P = 0.027, P = 0.019) postoperatively. Pain were significantly less in Group C than Group A at 24 (P < 0.001), 48 h (P = 0.037) postoperatively and Group B 24 h (P = 0.030) postoperatively. Patients in Group C had better range of motion (ROM) and satisfaction than Group A (P < 0.001, P = 0.002) and B (P = 0.001, P = 0.043). No differences were found in complications.
CONCLUSIONS
The administration of 10 mg dexamethasone 1 h before the surgery, and repeated at 6 h postoperatively can significantly reduce the level of postoperative CRP and IL-6 and the incidence of PONV, relieve pain, achieve an additional analgesic effect, and improve the early ROM compared with the other two groups in TKA.
LEVEL OF EVIDENCE
Therapeutic Level I.
TRIAL REGISTRATION
The Chinese Clinical Trial Registry ( ChiCTR1800017036 ). Registered on July 9, 2018.
Topics: Administration, Intravenous; Aged; Analgesics; Anti-Inflammatory Agents; Antiemetics; Arthroplasty, Replacement, Knee; Biomarkers; C-Reactive Protein; Dexamethasone; Double-Blind Method; Drug Administration Schedule; Female; Humans; Interleukin-6; Length of Stay; Male; Middle Aged; Pain, Postoperative; Patient Satisfaction; Perioperative Care; Postoperative Nausea and Vomiting; Range of Motion, Articular
PubMed: 30501618
DOI: 10.1186/s12891-018-2359-1 -
Lancet (London, England) May 2023
Topics: Humans; COVID-19; COVID-19 Drug Treatment; Hypoxia; Respiration Disorders; Dexamethasone
PubMed: 37060914
DOI: 10.1016/S0140-6736(23)00587-1 -
International Journal of Molecular... Dec 2022As the mediator between the mother and fetus, the placenta allows the most appropriate environment and optimal fetal growth. The placenta of one sex sometimes has a...
As the mediator between the mother and fetus, the placenta allows the most appropriate environment and optimal fetal growth. The placenta of one sex sometimes has a greater ability over the other to respond to and protect against possible maternal insults. Here, we characterized sex differences in the placenta’s morphological features and antioxidant status following dexamethasone (Dx) exposure. Pregnant rats were exposed to Dx or saline. The placenta was histologically and stereologically analyzed. The activity of the antioxidant enzymes, lipid peroxides (TBARS), superoxide anion and nitric oxide (NO) was measured. The decrease in placental zone volumes was more pronounced (p < 0.05) in female placentas. The volume density of PCNA-immunopositive nuclei was reduced (p < 0.05) in both sexes. The reduced (p < 0.05) antioxidant enzyme activities, enhanced TBARS and NO concentration indicate that Dx exposure triggered oxidative stress in the placenta of both fetal sexes, albeit stronger in the placenta of female fetuses. In conclusion, maternal Dx treatment reduced the size and volume of placental zones, altered placental histomorphology, decreased cell proliferation and triggered oxidative stress; however, the placentas of female fetuses exerted more significant responses to the treatment effects. The reduced placental size most probably reduced the transport of nutrients and oxygen, thus resulting in the reduced weight of fetuses, similar in both sexes. The lesser ability of the male placenta to detect and react to maternal exposure to environmental challenges may lead to long-standing health effects.
Topics: Animals; Female; Male; Pregnancy; Rats; Antioxidants; Dexamethasone; Maternal Exposure; Oxidation-Reduction; Placenta; Thiobarbituric Acid Reactive Substances
PubMed: 36613982
DOI: 10.3390/ijms24010540 -
Journal of Ocular Pharmacology and... Dec 2014Dexamethasone intravitreal implant (DEX implant, Ozurdex(®); Allergan, Inc.) is used to treat noninfectious posterior uveitis and macular edema associated with retinal...
PURPOSE
Dexamethasone intravitreal implant (DEX implant, Ozurdex(®); Allergan, Inc.) is used to treat noninfectious posterior uveitis and macular edema associated with retinal vein occlusion and diabetic retinopathy. Two recently published reports of DEX implant fragmentation shortly after injection have raised concerns about the potential for faster implant dissolution and elevated ocular dexamethasone concentrations. This study compared the in vivo release profile and pharmacokinetic behavior of intact and fragmented DEX implants.
METHODS
DEX implant was surgically implanted as a single unit or fragmented into 3 pieces in the posterior segment of opposing eyes of 36 New Zealand white rabbits. The release of dexamethasone over time from 1-piece and 3-piece fragmented implants dissolved in solution in vitro was compared with that from the 1-piece and 3-piece fragmented implants placed in the rabbit eyes. In addition, dexamethasone concentrations in the vitreous and aqueous humors of each eye were measured at 3 h and days 1, 7, 14, 21, and 28. High-performance liquid chromatography and liquid chromatography-tandem mass spectrometry were used for assays.
RESULTS
Dexamethasone release from the 1-piece and 3-piece DEX implants in vivo was not different and was consistent with the in vitro release pattern. Moreover, the concentration profile of dexamethasone in the vitreous and aqueous humors was similar for the 1-piece and 3-piece DEX implants at each time point measured.
CONCLUSIONS
DEX implant fragmentation neither accelerated its dissolution nor increased the dexamethasone concentration delivered at a given time. Accordingly, DEX implant fragmentation is unlikely to have clinically significant effects in patients.
Topics: Animals; Aqueous Humor; Chromatography, High Pressure Liquid; Dexamethasone; Drug Implants; Eye; Glucocorticoids; Intravitreal Injections; New Zealand; Rabbits; Tandem Mass Spectrometry; Vitreous Body
PubMed: 25411827
DOI: 10.1089/jop.2014.0082 -
Transplantation and Cellular Therapy Apr 2023While the role of autologous stem cell transplant (ASCT) in the first line therapy for newly diagnosed multiple myeloma is well established, efficacy of ASCT for...
Daratumumab, pomalidomide, and dexamethasone (DPd) followed by high dose chemotherapy-Autologous Stem Cell Transplantation leads to superior outcomes when compared to DPd-alone for patients with Relapsed Refractory Multiple Myeloma.
BACKGROUND AND OBJECTIVES
While the role of autologous stem cell transplant (ASCT) in the first line therapy for newly diagnosed multiple myeloma is well established, efficacy of ASCT for patients with relapsed refractory multiple myeloma (RRMM) in the era of novel therapeutic agents remains unknown. In this single center retrospective analysis, we evaluated and compared the efficacy and safety outcomes of patients with RRMM treated with daratumumab pomalidomide dexamethasone (DPd) alone versus (vs) DPd followed by ASCT.
METHODS
A total of 83 patients with RRMM who were treated with and achieved at least partial response (PR) with DPd were evaluated by electronic medical records. All patients who responded to DPd and were deemed eligible for ASCT proceeded with high dose melphalan followed by autologous stem cell infusion (DPd + ASCT group). Remaining patients continued DPd until disease progression or intolerable toxicities (DPd-alone group). Responses were evaluated using the International Myeloma Working Group response criteria and toxicities were graded using National Cancer Institute Common Terminology Criteria for Adverse Events. Patient and disease characteristics, as well as efficacy and safety outcomes were summarized using descriptive statistics. Kaplan-Meier analyses were used to estimate progression-free survival (PFS) and overall survival (OS).
RESULTS
A total of 21/83 (25%) patients with RRMM who achieved at least PR to DPd underwent ASCT (DPd + ASCT group) while the remaining 62/83 (75%) continued DPd without ASCT (DPd-alone group). For the entire patient population, median age was 66 years (42-81), 49 (59%) patients were male, 54 (65%) patients had IgG isotype, 21 (25%) patients had R-ISS stage III disease, 51 (61%) patients had high-risk cytogenetics, and 17 (20%) patients had extramedullary disease. Patient age, disease stage, cytogenetic risk profile were well balanced between two groups. A stringent complete response was seen in 10 (16%) and 12 (57%) patients in the DPd-alone and DPd + AST groups, respectively. Median PFS was 17.5 months in the DPd-alone vs 42.2 months (p=0.006) in the DPd + ASCT group. Median OS was 38.1 months in the DPd-alone group vs not reached in the DPD + ASCT group (p=0.009). The most common grade 3 or 4 treatment-related adverse events (TRAE) were myelosuppression and gastrointestinal toxicities, more commonly seen in the DPd + ASCT group. No treatment-related mortalities were observed in either group.
CONCLUSION
Patients with RRMM who responded to DPd and underwent HDT-ASCT demonstrated superior depth and duration of remission compared to those who received DPd-alone. Although DPd followed by ASCT is associated with more cytopenias and gastrointestinal toxicities, this treatment appears to be overall safe for patients with RRMM.
Topics: Humans; Male; Aged; Female; Multiple Myeloma; Hematopoietic Stem Cell Transplantation; Retrospective Studies; Transplantation, Autologous; Stem Cell Transplantation; Dexamethasone
PubMed: 36682468
DOI: 10.1016/j.jtct.2023.01.013