scholarly journals REGEN-COV Antibody Cocktail in Outpatients with Covid-19

2021 ◽  
Author(s):  
David Weinreich ◽  
Sumathi Sivapalasingam ◽  
Thomas Norton ◽  
Shazia Ali ◽  
Haitao Gao ◽  
...  
Keyword(s):  
Viral Load ◽  
Relative Risk ◽  
Phase 1 ◽  
Serum Antibody ◽  
Weighted Average ◽  
Baseline Viral Load ◽  
Double Blind ◽  
Group 2 ◽  
Antibody Cocktail ◽  
Group 1

Background: REGEN-COV (casirivimab and imdevimab) antibody cocktail reduced SARS-CoV-2 viral load in descriptive analyses of the first 275 Covid-19 outpatients in the phase 1/2 portion of an ongoing double-blind, seamless phase 1/2/3 trial. Methods: This final analysis of the phase 1/2 portion includes 799 patients: 275 (group-1) and 524 (group-2). Patients were randomized (1:1:1) to placebo, 2400mg REGEN-COV, or 8000mg REGEN-COV, and characterized at baseline for endogenous immune response against SARS-CoV-2 (serum antibody-positive/negative). Efficacy was assessed in patients with a positive baseline RT-qPCR result; safety was assessed in all treated patients. Prespecified hierarchical analyses of virologic endpoints in group-2 were performed to confirm previously reported descriptive analyses from group-1. The proportion of patients with ≥1 Covid-19-related medically-attended visit (MAV) through day 29 was assessed in group-1+2. Results: Time-weighted average reduction in viral load (log10 copies/ml) through day 7 was significantly greater with REGEN-COV (combined 2400mg+8000mg dose groups) versus placebo in patients with baseline viral load >107 copies/ml (prespecified primary endpoint): -0.68 (95% CI, -0.94 to -0.41; P<0.0001). This reduction was -0.73 (P<0.0001) in serum antibody-negative patients and -0.36 (P=0.0003) in the overall population. Proportions of patients with ≥1 Covid-19-related MAV were 2.8% (12/434) with REGEN-COV versus 6.5% (15/231) with placebo (P=0.024; relative risk reduction=57%), with greater relative risk reductions in MAVs in patients with ≥1 risk factor for hospitalization (71%). Adverse events were similar across groups. Conclusions: REGEN-COV treatment of outpatients significantly reduced SARS-CoV-2 viral load and Covid-19-related medically-attended visits. (Funded by Regeneron Pharmaceuticals and the Biomedical and Advanced Research and Development Authority of the Department of Health and Human Services; ClinicalTrials.gov number, NCT04425629.)

scholarly journals SAT0140 SAFETY OF TOFACITINIB THERAPY IN HBSAG CARRIERS WITH RHEUMATOID ARTHRITIS: A PROSPECTIVE STUDY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1008.2-1008
Author(s):  
L. Fang ◽  
Z. Lin ◽  
Z. Liao ◽  
O. Jin ◽  
Y. Pan ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Viral Load ◽  
Hepatitis B Virus ◽  
Hepatitis B ◽  
Hbv Infection ◽  
Hbsag Carriers ◽  
B Virus ◽  
Group 2 ◽  
A Prospective Study ◽  
Group 1

Background:Targeted synthetic DMARDs (ts-DMARDs) are becoming more available and affordable in developing countries, where the prevalence of hepatitis B virus (HBV) infection is still an important public health issue. The safety of ts-DMARDs therapy in terms of the reactivation of hepatitis B virus (HBV) infection need more concern. Rare data from a prospective study focus on the use of ts-DMARDs in patients with concurrent rheumatoid arthritis (RA) and HBV infection were available by now.Objectives:To evaluate the influence of tofacitinib on reactivation of HBV infection in HBsAg carriers with RA.Methods:In this 52 weeks observation, HBsAg carriers with active RA (DAS28>5.1) despite failed combined treatment with MTX and other non-biological DMARDs were enrolled. Patients must have normal liver function prior to study. All patients received therapy with tofacitinib (5mg twice daily) and concomitant MTX (10-12.5mg/w). Entecavir was prescribed preventively for patients who had a baseline HBV load >2000 copy/ml (group 1), and Lamivudin for patients with HBV load ≤ 2000 copy/ml (group 2). Liver enzymes (AST/ALT) and HBV viral load were monitored every 4 weeks. Increased viral load and abnormal liver function were managed according to expert opinion.Results:Thirteen patients (10 female) were recruited. Nine patients had a baseline viral load >2000 copy/ml (group 1, with preventive Entecavir), and the other 4 patients had a viral load ≤ 2000 copy/ml (group 2, with preventive Lamivudin). Two patients from group 1 discontinued tofacitinib at week 12 due to ineffectiveness, and both continued taking Entecavir for another 3 months after the discontinuation of tofacitinib.No reactivation of hepatitis B was observed in patients from group 1. One patients (female, 54 years old) from group 2 underwent a mild increase of both ALT and AST (67 and 56 IU/L, respectively) at week 16. An elevated viral load (4.9e6 copies/ml, baseline 1.4e3) and a HBV YMDD mutant was also found. The tofacitinib treatment continued. After prescription of Adefovir (combined with the pre-existing Lamivudin), both liver enzyme and viral load decreased to normal range in 8 weeks and remained normal throughout the study.Conclusion:An aggressive Tofacitinib + MTX therapy may be a safe option for HBsAg carriers with cs-DMARDs refractory RA. More active and effective prophylaxis strategy may be recommended to reduce the risk of HBV reactivation during the treatment.References:[1]Chen YM, Huang WN, Wu YD, et al. Reactivation of hepatitis B virus infection in patients with rheumatoid arthritis receiving tofacitinib: a real-world study. Ann Rheum Dis 2018; 77:780-2.Disclosure of Interests: :None declared

scholarly journals INJECTABLE COPPER AND ZINC FOR GRAZING YEARLING STEERS

1987 ◽  
Vol 67 (4) ◽  
pp. 1033-1041
Author(s):  
F. A-R. SANKOH ◽  
R. J. BOILA
Keyword(s):  
Body Weight ◽  
Dry Matter ◽  
Phase 1 ◽  
Sole Source ◽  
The Body ◽  
Mineral Supplements ◽  
Copper Zinc ◽  
Group 2 ◽  
Cu And Zn ◽  
Group 1

Injectable Cu and Zn were evaluated as mineral supplements using 37 purebred Herefords (Group 1) and 23 Angus-Charolais-North Devon crosses (Group 2). The 60 steers were carried through a 113-d grazing phase. This was followed by a 79-d finishing phase for all steers of Group 1 and seven steers of Group 2. Treatments were combinations of the non-dosing (0Cu, 0Zn) and dosing (+Cu, +Zn) of steers with injectable Cu or Zn at the start of the grazing phase: (1) 0Cu, 0Zn; (2) +Cu, 0Zn; (3) 0Cu, +Zn; and (4) +Cu, +Zn. Injectables were the sole source of supplementary Cu and Zn during grazing and finishing phases. Means (SE) for Cu and Zn, respectively, in forages as milligrams per kilogram dry matter (DM) during the grazing phase were: grasses, 4.4 (0.17), 15.7 (0.46); alfalfa, 6.9 (0.18), 16.5 (1.49); and birdsfoot trefoil 5.0 (0.76), 15.0 (3.41). Injectable Cu did not influence (P > 0.05) body weight during the grazing phase. Body weight responses were lower (P < 0.05) for +Cu steers in the finishing phase, when dietary Cu was low, but steers could not be classified as Cu-deficient based on liver Cu. Liver Cu increased to means greater than 140 mg kg−1 DM in all steers, but was higher (P < 0.05) in +Cu steers during the grazing phase. Serum Cu varied widely during the grazing phase, but was higher (P < 0.05) for +Cu steers only on day 84 of the grazing phase. Neither liver Cu nor serum Cu was influenced (P > 0.05) by injectable Zn. Injectable Zn decreased growth rates in the latter part of the grazing phase but did not affect (P > 0.05) the body weight response during the finishing phase. The concentrations of Zn in liver and serum were not influenced (P > 0.05) by injectable Cu or Zn. Key words: Cattle, grazing, copper, zinc, injectable copper, injectable zinc

scholarly journals Safety, pharmacokinetics and antiviral activity of PGT121, a broadly neutralizing monoclonal antibody against HIV-1: a randomized, placebo-controlled, phase 1 clinical trial

2021 ◽  
Author(s):  
Kathryn E. Stephenson ◽  
Boris Julg ◽  
C. Sabrina Tan ◽  
Rebecca Zash ◽  
Stephen R. Walsh ◽  
...  
Keyword(s):  
Viral Load ◽  
T Cell ◽  
Adverse Events ◽  
Antiviral Activity ◽  
Controlled Trial ◽  
Phase 1 ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Cell Counts ◽  
Hiv 1

AbstractHuman immunodeficiency virus (HIV)-1-specific broadly neutralizing monoclonal antibodies are currently under development to treat and prevent HIV-1 infection. We performed a single-center, randomized, double-blind, dose-escalation, placebo-controlled trial of a single administration of the HIV-1 V3-glycan-specific antibody PGT121 at 3, 10 and 30 mg kg–1 in HIV-uninfected adults and HIV-infected adults on antiretroviral therapy (ART), as well as a multicenter, open-label trial of one infusion of PGT121 at 30 mg kg–1 in viremic HIV-infected adults not on ART (no. NCT02960581). The primary endpoints were safety and tolerability, pharmacokinetics (PK) and antiviral activity in viremic HIV-infected adults not on ART. The secondary endpoints were changes in anti-PGT121 antibody titers and CD4+ T-cell count, and development of HIV-1 sequence variations associated with PGT121 resistance. Among 48 participants enrolled, no treatment-related serious adverse events, potential immune-mediated diseases or Grade 3 or higher adverse events were reported. The most common reactions among PGT121 recipients were intravenous/injection site tenderness, pain and headache. Absolute and relative CD4+ T-cell counts did not change following PGT121 infusion in HIV-infected participants. Neutralizing anti-drug antibodies were not elicited. PGT121 reduced plasma HIV RNA levels by a median of 1.77 log in viremic participants, with a viral load nadir at a median of 8.5 days. Two individuals with low baseline viral loads experienced ART-free viral suppression for ≥168 days following antibody infusion, and rebound viruses in these individuals demonstrated full or partial PGT121 sensitivity. The trial met the prespecified endpoints. These data suggest that further investigation of the potential of antibody-based therapeutic strategies for long-term suppression of HIV is warranted, including in individuals off ART and with low viral load.

scholarly journals Pharmacokinetics and safety of XAV-19, a swine glyco-humanized polyclonal anti-SARS-CoV-2 antibody, for COVID-19-related moderate pneumonia: a randomized, double-blind, placebo-controlled, phase IIa study

2021 ◽  
Author(s):  
Benjamin Gaborit ◽  
Eric Dailly ◽  
Bernard Vanhove ◽  
Régis Josien ◽  
Karine Lacombe ◽  
...  
Keyword(s):  
Adverse Events ◽  
High Serum ◽  
Serum Concentrations ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Good Tolerability ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Objective: We assessed the pharmacokinetics and safety of XAV-19, a swine glyco-humanized polyclonal antibody against SARS-CoV-2, in COVID-19-related moderate pneumonia. To evaluate the optimal dose and safety of XAV-19 during this first administration to patients with COVID-19-related moderate pneumonia. Methods : In this phase 2a trial, adults with COVID-19-related moderate pneumonia of ≤10 days duration were randomized to infusion of XAV-19 0.5mg/kg at day 1 and day 5 (group 1), 2mg/kg at day 1 and day 5 (group 2), 2mg/kg at day 1 (group 3) or placebo. Results : Eighteen patients (n=7 for group 1, n=1 for group 2, n=5 for group 3, and n=5 for placebo) were enrolled. Baseline characteristics were similar across groups, XAV-19 serum concentrations (μg/mL, median, range) at C max and at day 8 were 9.1 (5.2-18.1) and 6.4 (2.8-11.9), 71.5 and 47.2, and 50.4 (29.1-55.0) and 20.3 (12.0-22.7) for groups 1, 2 and 3, respectively (p=0.012). Terminal half-life (median, range) was estimated at 11.4 (5.5-13.9) days for 2 mg/kg of XAV-19 at day 1. Serum XAV-19 concentrations were above the target concentration of 10 μg/mL (tow fold the in vitro 100% inhibitory concentration [IC 100 ]) from the end of perfusion to more than 8 days for XAV-19 2 mg/kg at day 1. No hypersensitivity or infusion-related reactions were reported during treatment, there was no discontinuation for adverse events and no serious adverse events related to study drug. Conclusions : Single intravenous dose of 2mg/kg of XAV-19 demonstrated high serum concentrations, predictive of potent durable neutralizing activity with good tolerability. Trial registration: ClinicalTrials.gov Identifier: NCT04453384

Adding herbal extracts to silicone gel on post-sternotomy scar: a prospective randomised double-blind study

2020 ◽  
Vol 29 (Sup4) ◽  
pp. S36-S42
Author(s):  
Palakorn Surakunprapha ◽  
Kengkart Winaikosol ◽  
Bowornsilp Chowchuen ◽  
Kriangsak Jenwitheesuk ◽  
Kamonwan Jenwitheesuk
Keyword(s):  
Aloe Vera ◽  
Median Sternotomy ◽  
Centella Asiatica ◽  
Herbal Extract ◽  
Double Blind Study ◽  
Herbal Extracts ◽  
Double Blind ◽  
Silicone Gel ◽  
Group 2 ◽  
Group 1

Objective: Silicone gel has been shown effective in improving healing post-sternotomy scars. It remains to be determined whether adding herbal extracts to the gel would augment the healing effect. Method: After median sternotomy, patients were randomised into two groups. Group 1: topical silicone gel plus herbal extract gel (Allium cepa, Centella Asiatica, Aloe vera and Paper Mulberry) and Group 2: silicone gel. Patients were treated for six months. The postoperative scars were assessed at three and six months by plastic surgeons using the Vancouver Scar Scale (VSS) and the patient assessment scar scale. Results: Each group comprised 23 patients (n=46 in total). The VSS was significantly lower in Group 1 than in Group 2 (p=0.018 and p=0.051, respectively). In Group 1, the four differences from baseline were vascularity scores at three and six months (–0.391, p=0.025; –0.435, p=0.013, respectively), and pigmentation scores at three and six months (–0.391, p=0.019; –0.609, p=0.000, respectively). In Group 2, differences from baseline were the pigmentation and vascularity score at six months (–0.6609, p=0.000; –0.348, p=0.046, respectively). Conclusion: Our results suggest, post-sternotomy scars trend to have better vascularity and pigmentation when treated with silicone gel plus herbal extracts.

scholarly journals Treatment of Optic Canal Decompression Combined with Umbilical Cord Mesenchymal Stem (Stromal) Cells for Indirect Traumatic Optic Neuropathy: A Phase 1 Clinical Trial

2020 ◽  
Vol 64 (3) ◽  
pp. 398-404
Author(s):  
Jia Li ◽  
Xu Bai ◽  
Xiaoyue Guan ◽  
Hongfeng Yuan ◽  
Xiang Xu
Keyword(s):  
Visual Acuity ◽  
Adverse Events ◽  
Phase 1 ◽  
Optic Canal ◽  
Traumatic Optic Neuropathy ◽  
Corrected Visual Acuity ◽  
Group 2 ◽  
Best Corrected Visual Acuity ◽  
Group 1

<b><i>Purpose:</i></b> This study was aimed to investigate the safety and feasibility of umbilical cord-derived mesenchymal stem cell (MSC) transplantation in patients with traumatic optic neuropathy (TON). <b><i>Methods:</i></b> This is a single-center, prospective, open-labeled phase 1 study that enrolled 20 patients with TON. Patients consecutively underwent either optic canal decompression combined with MSC local implantation treatment (group 1) or only optic canal decompression (group 2). Patients were evaluated on the first day, seventh day, first month, third month, and sixth month postoperatively. Adverse events, such as fever, urticarial lesions, nasal infection, and death, were recorded at each visit. The primary outcome was changes in best-corrected visual acuity. The secondary outcomes were changes in color vision, relative afferent pupillary defect, and flash visual evoked potential. <b><i>Results:</i></b> All 20 patients completed the 6-month follow-up. None of them had any systemic or ocular complications. The change in best-corrected visual acuity at follow-up was not significantly different between group 1 and group 2 (<i>p</i> &#x3e; 0.05); however, group 1 showed better visual outcome than group 2. Both groups showed significant improvements in vision compared with the baseline (<i>p</i> &#x3c; 0.05); however, there were no statistically significant differences between the groups (<i>p</i> &#x3e; 0.05). In addition, no adverse events related to local transplantation were observed in the patients. <b><i>Conclusions:</i></b> A single, local MSC transplantation in the optic nerve is safe for patients with TON.

scholarly journals Prospective randomized double blind comparison of analgesic efficacy of single shot epidural bupivacaine with or without dexamethasone in patients undergoing lower abdominal surgeries

2015 ◽  
Vol 2 (2) ◽  
pp. 46-51
Author(s):  
Anuj Jung Rayamajhi ◽  
Balbrishna Bhattarai ◽  
Birendra Prasad Shah
Keyword(s):  
Analgesic Efficacy ◽  
Epidural Injection ◽  
Saline Group ◽  
Epidural Block ◽  
Single Shot ◽  
Double Blind ◽  
Perioperative Analgesia ◽  
Balanced Anesthesia ◽  
Group 2 ◽  
Group 1

Background: Epidural block with local anaesthetic with or without additives is being used for perioperative analgesia. Various additives have been used to enhance the effect of regional blocks including epidural blocks. This study aimed to investigate the effect of adding a single shot epidural dexamethasone to bupivacaine on postoperative analgesia and dose of rescue analgesics used.Methods: A prospective, randomized, double blinded study was conducted in 90 adult patients undergoing lower abdominal surgery. The patients were randomized into two groups. Group 1 received 9ml of 0.5% bupivacaine plain with 1 ml of normal saline. Group 2 received 9ml of 0.5% bupivacaine plain 9 ml with 1 ml of dexamethasone (4mg). After standard balanced anesthesia technique, patients were observed in postoperative period for pain and hemodynamic variables accordingly.Results: Our study showed significantly longer duration of analgesia of 468 minutes (almost 8 hours) when dexamethasone was added to bupivacaine for single shot epidural injection compared to 271 minutes (approximately 4 and half hours) when bupivacaine alone was used (p<0.001). Consumption of rescue analgesic, Tramadol, was significantly lower in dexamethasone group in 24 hours (169.31±50.82 mg in Group 1 and 114.77±60.59mg in Group 2, p<0.001). No adverse events were noted.Conclusion: Addition of dexamethasone to bupivacaine for single shot epidural block almost doubled the duration of analgesia. Single shot epidural block using bupivacaine with addition of dexamethasone provides effective post operative analgesia and significantly reduced the postoperative rescue analgesic requirement.Journal of Society of Anesthesiologists of Nepal 2015; 2(2): 46-51

scholarly journals EFFICACY OF MOUTH RINSE FORMULATION BASED ON CETYLPYRIDINIUM CHLORIDE 0.1% IN THE CONTROL OF DENTAL CALCULUS BUILDUP

2017 ◽  
Vol 9 ◽  
pp. 176 ◽  
Author(s):  
Diah Ayu Maharani ◽  
Alia Ramadhani ◽  
Melissa Adiatman ◽  
Yuniardini Septorini Wimardhani ◽  
Linda Kusdhany ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cetylpyridinium Chloride ◽  
Positive Control ◽  
Negative Control ◽  
Mouth Rinse ◽  
Dental Calculus ◽  
Double Blind ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Objective: This study aimed at comparing the antiplaque, anticalculus, and antigingivitis potentials of a mouth rinse containing essential oil, alcohol,zinc, and fluoride with a mouth rinse containing cetylpyridinium chloride (CPC) 0.1% over 1-, 2-, and 3-month periods.Methods: This study was a double-blind, parallel randomized clinical trial with a 3-day run-in phase. Respondents were asked to gargle twice dailywith 15 ml of mouth rinse for 30 seconds after brushing teeth. Respondents were 80 females with a mean age of 21 years, and a single dental examinerwas employed throughout the study to decrease the variance. Prophylaxis was performed for all respondents before the intervention. Three mouthrinses were tested: Group 1 with the mouth rinse containing CPC 0.1%, Group 2 as the negative control, and Group 3 as the positive control with amouth rinse containing alcohol. Evaluations were conducted by plaque index, gingival index, calculus index, and CariScreen examinations.Results: The clinical trial showed that the mouth rinse with alcohol and the mouth rinse containing CPC 0.1% were effective in inhibiting bacterialbuildup (antiplaque) and have anticalculus properties, but with no statistically significant antigingivitis effect.Conclusion: It was found that the mouth rinse containing alcohol has similar effectiveness with CPC 0.1% mouth rinse, but side effects, such as aburning sensation, were reported in the alcohol-containing mouth rinse.

scholarly journals 2775. Safety and Immunogenicity of a Seasonal Influenza Vaccine and Ad26.RSV.preF Vaccine With and Without Co-Administration: A Randomized, Double-Blind, Placebo-Controlled Phase 2a Study in Adults Aged ≥ 60 Years

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S979-S979
Author(s):  
Christy Comeaux ◽  
Arangassery Rosemary Bastian ◽  
Els De Paepe ◽  
Edmund Omoruyi ◽  
Wouter Haazen ◽  
...  
Keyword(s):  
Influenza Vaccine ◽  
Neutralizing Antibody ◽  
Severe Illness ◽  
Tolerability Profile ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Antibody Titers ◽  
Group 2 ◽  
Tract Infections ◽  
Group 1

Abstract Background Influenza and RSV can cause respiratory tract infections leading to severe illness, hospitalization and mortality in at-risk populations, particularly the elderly. The seasonality of influenza and RSV present the potential to co-administer vaccines. This study aimed to demonstrate the non-inferiority of co-administration of the experimental RSV vaccine Ad26.RSV.preF with an influenza vaccine (Fluarix) vs. Fluarix alone in terms of immunogenicity against influenza. Methods This was a single-center, randomized, double-blind, placebo-controlled Phase 2a study (NCT03339713) in healthy adults ≥60 years old. Volunteers were randomized 1:1 to receive Fluarix + 1 × 1011 vp Ad26.RSV.preF on Day 1 and placebo on Day 29 (Group 1), or Fluarix + placebo on Day 1 and 1 × 1011 vp Ad26.RSV.preF on Day 29 (Group 2). Blood samples were taken prior to each vaccination and at Day 57. The primary endpoints were geometric mean titers (GMTs) of hemagglutination inhibition (HI) antibody titers against Fluarix strains (A/Michigan, A/Hong Kong, B/Brisbane and B/Phuket) and the safety and tolerability of Ad26.RSV.preF administered with or without Fluarix. A key secondary endpoint was neutralizing antibody titers to RSV A2. Results Volunteers (N = 180) were included in Group 1 (n = 90) or Group 2 (n = 90). Most volunteers were white (89%) and female (63%), with a median age of 65 years. Both groups exhibited an increase from baseline in HI antibody response on Day 29. The 95% one-sided upper confidence limit of all GMT ratios were below the non-inferiority margin of 2. The frequency of solicited adverse events (AE) after Ad26.RSV.preF vaccination was similar with and without influenza co-administration. Solicited AEs were mainly of Grade 1 and 2 and of transient duration. Most unsolicited AEs were considered unrelated to the study vaccination and were Grade 1 or 2. There were no serious AEs related to the study vaccine and there were no discontinuations due to AEs. RSV neutralizing antibody titers 29 days post- Ad26.RSV.preF immunization were similar in both groups (1404, Group 1; 1690, Group 2). Conclusion Co-administration of Ad26.RSV.preF with Fluarix was non-inferior to Fluarix alone in terms of immunogenicity against influenza and had an acceptable tolerability profile. Disclosures All authors: No reported disclosures.

scholarly journals Prevention of Delayed Nausea: A University of Rochester Cancer Center Community Clinical Oncology Program Study of Patients Receiving Chemotherapy

2012 ◽  
Vol 30 (27) ◽  
pp. 3389-3395 ◽  
Author(s):  
Joseph A. Roscoe ◽  
Charles E. Heckler ◽  
Gary R. Morrow ◽  
Supriya G. Mohile ◽  
Shaker R. Dakhil ◽  
...  
Keyword(s):  
Statistical Significance ◽  
Cancer Center ◽  
Double Blind ◽  
Group 4 ◽  
Community Clinical Oncology Program ◽  
Delayed Nausea ◽  
Group 3 ◽  
Group 2 ◽  
Mean Differences ◽  
Group 1

Purpose We conducted a double-blind randomized clinical trial of the following four regimens for controlling delayed nausea (DN): group 1: palonosetron + dexamethasone on day 1 with prochlorperazine on days 2 and 3; group 2: granisetron + dexamethasone on day 1 with prochlorperazine on days 2 and 3; group 3: aprepitant + palonosetron + dexamethasone on day 1 with aprepitant + dexamethasone on days 2 and 3; and group 4: palonosetron + dexamethasone on day 1 with prochlorperazine + dexamethasone on days 2 and 3. Patients and Methods Chemotherapy-naive patients received doxorubicin, epirubicin, cisplatin, carboplatin, or oxaliplatin. The primary end point was average nausea assessed four times daily on days 2 and 3. Primary analyses were whether nausea control would be improved by using palonosetron versus granisetron on day 1 (group 1 v group 2); by adding dexamethasone on days 2 and 3 (group 1 v group 4); and by using aprepitant versus prochlorperazine (group 3 v group 4). Statistical significance was set at P = .017. Results Two hundred thirty-four, 234, 241, and 235 evaluable patients were accrued to groups 1, 2, 3, and 4, respectively. Adjusted mean differences for the three planned analyses were as follows: palonosetron versus granisetron: −0.01 (95% CI, −0.23 to 0.20; P = .72); adding dexamethasone on days 2 and 3: 0.20 (95% CI, −0.02 to 0.41; P = .01); and using aprepitant versus prochlorperazine: −0.03 (95% CI, −0.24 to 0.19; P = .56). Conclusion The addition of dexamethasone on days 2 and 3 reduced DN. Palonosetron and granisetron have similar effects on DN. The beneficial effect of adding aprepitant for control of DN was the same as adding prochlorperazine.

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