Addition of the Oral NK1 Antagonist Aprepitant to Standard Antiemetics Provides Protection Against Nausea and Vomiting During Multiple Cycles of Cisplatin-Based Chemotherapy

2003 ◽  
Vol 21 (22) ◽  
pp. 4105-4111 ◽  
Author(s):  
R. de Wit ◽  
J. Herrstedt ◽  
B. Rapoport ◽  
A.D. Carides ◽  
G. Carides ◽  
...  
Keyword(s):  
Standard Therapy ◽  
Therapy Group ◽  
Rescue Therapy ◽  
Complete Response ◽  
Nausea And Vomiting ◽  
Cumulative Probability ◽  
Pharmacokinetic Data ◽  
Standard Therapy Group ◽  
Nk1 Antagonist ◽  
Multiple Cycles

Purpose: This analysis evaluated whether the antiemetic efficacy of the NK1 receptor antagonist aprepitant (EMEND™, Merck, Whitehouse Station, NJ) plus standard antiemetics could be sustained for up to six cycles of cisplatin-based chemotherapy. Patients and Methods: Patients receiving cisplatin ≥ 70 mg/m2 were blindly assigned to receive one of the following three regimens: (1) aprepitant 375 mg 1 hour before cisplatin on day 1 and aprepitant 250 mg on days 2 to 5 (n = 35); (2) aprepitant 125 mg before cisplatin and aprepitant 80 mg on days 2 to 5 (n = 81); or (3) placebo before cisplatin on days 2 to 5 (n = 86). All groups received ondansetron 32 mg and dexamethasone 20 mg before cisplatin, and dexamethasone 8 mg on days 2 to 5. The primary end point was complete response (no emesis and no rescue therapy) over 5 days following cisplatin in up to six cycles. A cumulative probability analysis using a model for transitional probabilities was used to analyze the data. The aprepitant 375/250-mg regimen was discontinued early in light of new pharmacokinetic data. Results: In the first cycle, 64% of patients in the aprepitant group and 49% in the standard therapy group had a complete response. Thereafter, complete response rates for the aprepitant group were still 59% by cycle 6, but decreased to 34% by cycle 6 for the standard therapy group. Reasons for discontinuation were similar across treatment groups. Conclusion: Compared with patients who received standard therapy, those who received only the aprepitant regimen had better and more sustained protection against chemotherapy-induced nausea and vomiting over multiple cycles.

The Oral Neurokinin-1 Antagonist Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting: A Multinational, Randomized, Double-Blind, Placebo-Controlled Trial in Patients Receiving High-Dose Cisplatin—The Aprepitant Protocol 052 Study Group

2003 ◽  
Vol 21 (22) ◽  
pp. 4112-4119 ◽  
Author(s):  
Paul J. Hesketh ◽  
Steven M. Grunberg ◽  
Richard J. Gralla ◽  
David G. Warr ◽  
Fausto Roila ◽  
...  
Keyword(s):  
Standard Therapy ◽  
Therapy Group ◽  
Rescue Therapy ◽  
Controlled Trial ◽  
Complete Response ◽  
Nausea And Vomiting ◽  
Phase Iii ◽  
High Dose ◽  
Double Blind ◽  
Double Blind Placebo

Purpose: In early clinical trials with patients receiving highly emetogenic chemotherapy, the neurokinin antagonist aprepitant significantly enhanced the efficacy of a standard antiemetic regimen consisting of a type-three 5-hydroxytryptamine antagonist and a corticosteroid. This multicenter, randomized, double-blind, placebo-controlled phase III study was performed to establish definitively the superiority of the aprepitant regimen versus standard therapy in the prevention of chemotherapy-induced nausea and vomiting (CINV). Patients and Methods: Patients receiving cisplatin ≥ 70 mg/m2 for the first time were given either standard therapy (ondansetron and dexamethasone on day 1; dexamethasone on days 2 to 4) or an aprepitant regimen (aprepitant plus ondansetron and dexamethasone on day 1; aprepitant and dexamethasone on days 2 to 3; dexamethasone on day 4). Patients recorded nausea and vomiting episodes in a diary. The primary end point was complete response (no emesis and no rescue therapy) on days 1 to 5 postcisplatin, analyzed by a modified intent-to-treat approach. Treatment comparisons were made using logistic regression models. Tolerability was assessed by reported adverse events and physical and laboratory assessments. Results: The percentage of patients with complete response on days 1 to 5 was significantly higher in the aprepitant group (72.7% [n = 260] v 52.3% in the standard therapy group [n = 260]), as were the percentages on day 1, and especially on days 2 to 5 (P < .001 for all three comparisons). Conclusion: Compared with standard dual therapy, addition of aprepitant was generally well tolerated and provided consistently superior protection against CINV in patients receiving highly emetogenic cisplatin-based chemotherapy.

scholarly journals Comparison of acute and delayed antiemetic effect of adding Aprepitant to Odansitron ‎and Dexamethasone regimen ‎in patients with Hodgkin lymphoma receiving highly emetogenic chemotherapy

2019 ◽  
Vol 10 (2) ◽  
pp. 1397-1404
Author(s):  
Dara Abdulla Mohammed ◽  
Esraa Ghazy Jabar ◽  
May Siddik Al-Sabbagh ◽  
Hayder Adnan Fawzi
Keyword(s):  
Hodgkin Lymphoma ◽  
Therapy Group ◽  
Rescue Therapy ◽  
The Body ◽  
Nausea And Vomiting ◽  
Controlled Clinical Trial ◽  
Random Allocation ◽  
Standard Therapy Group ◽  
Standard Regimen ◽  
Antiemetic Effect

Cancer is a class of ‎disease in which group of cells show out of control growth, invasions ‎and ‎sometimes metastasis to different parts of the body. Few side effects of cancer treatment are ‎more feared by the patient than nausea and vomiting. Although nausea and emesis (vomiting ‎and retching) can result from surgery or radiation therapy, chemotherapy-induced nausea ‎and vomiting (CINV) are potentially the most severe and most distressing. A randomized, single-blind controlled clinical trial conducted in Hiwa ‎Center for Cancer in Sulaimani city for the period ‎from January to December 2015. A total of 70 Hodgkin lymphoma patients presented to ‎Hiwa ‎Center for Cancer and treated with ABVD chemotherapy regimen ‎were selected. The patient's ‎received either the treatment (Aprepitant, ‎Odansitron and Dexamethasone) or the standard ‎regimen (Odansitron, ‎Dexamethasone) in a 1:1 ratio, ‎computer-generated, random allocation ‎schedule. A total of sixty-three Hodgkin lymphoma patients were included in ‎the present study ‎with a mean age was 47.8±14.4 years; 34.9 % of them were ‎ageing 60 years and more. Nausea and vomiting score was significantly higher in the treatment group from 2nd day to 4th days; the number of rescue therapy was significantly higher in the standard therapy group. In conclusion, the use of Aprepitant, Odansitron and Dexamethasone regimen ‎showed superior and valuable results in the prevention of cancer ‎induced nausea and vomiting by patients on chemotherapy.

scholarly journals The Effects of Synbiotic “Bifidobacterium lactisB94 plus Inulin” Addition on Standard Triple Therapy ofHelicobacter pyloriEradication in Children

2017 ◽  
Vol 2017 ◽  
pp. 1-6 ◽  
Author(s):  
Gonca Handan Ustundag ◽  
Halime Altuntas ◽  
Yasemin Dilek Soysal ◽  
Furuzan Kokturk
Keyword(s):  
Triple Therapy ◽  
Standard Therapy ◽  
Therapy Group ◽  
Symptom Relief ◽  
Standard Therapy Group ◽  
Bifidobacterium Lactis ◽  
Standard Triple Therapy ◽  
H Pylori ◽  
Intent To Treat ◽  
Infection Eradication

Aim. The aim of this study is to evaluate the effects of the synbioticBifidobacterium lactisB94 plus inulin addition to the standard triple therapy onHelicobacter pylori (H. pylori)infection eradication rates.Methods. Children aged 6–16 years who had biopsy provenH. pyloriinfection were randomly classified into two groups. The first group received the standard triple therapy consisting of amoxicillin + clarithromycin + omeprazole. The second group was treated with the standard triple therapy andBifidobacterium lactisB94 (5 × 109 CFU/dose) plus inulin (900 mg) for 14 days, concurrently. Eradication was determined by14C-urea breath test 4–6 weeks after therapy discontinuation.Results. From a total of 69H. pyloriinfected children (F/M = 36/33; mean ± SD = 11.2 ± 3.0 years), eradication was achieved in 20/34 participants in the standard therapy group and 27/35 participants in the synbiotic group. The eradication rates were not significantly different between the standard therapy and the synbiotic groups [intent-to-treat, 58.8% and 77.1%, resp.,p= 0.16; per-protocol, 64.5% and 81.8%, resp.,p= 0.19]. There was no difference between the groups in terms of symptom relief (p= 0.193). The reported side effects were ignorable.Conclusion. Considering the eradication rates, synbiotic addition to therapy showed no superiority over the standard triple therapy conducted alone. This trial is registered withNCT03165253.

Efficacy of Atorvastatin Plus Pegylated Interferon and Ribavirin Versus Pegylated Interferon and Ribavirin Alone in Chronic Hepatitis C Patients with Genotype-3a

2019 ◽  
Vol 2 (1) ◽  
Author(s):  
Waqas Gulzar ◽  
Zafar Niaz ◽  
Sami Ullah Mumtaz ◽  
Somia Iqtadar ◽  
Tayyeba Komal ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis C ◽  
Chronic Hepatitis C ◽  
Standard Therapy ◽  
Therapy Group ◽  
Pegylated Interferon ◽  
Rapid Virological Response ◽  
Standard Therapy Group ◽  
The Mean ◽  
Genotype 3A

Chronic hepatitis C infection has created a huge burden of disease causing serious healtheffects. The combination therapy used to treat hepatitis C virus (HCV) infection includes Pegylatedinterferon and Ribavirin. As cholesterol biosynthesis plays a pivotal role in HCV replication, the use ofvarious statins has been associated with higher sustained viral response Objective: To compare theefficacy of atorvastatin plus pegylated interferon and ribavirin versus pegylated interferon and ribavirinalone in patients of chronic hepatitis C with genotype-3a Methods: This Randomized controlled trial wasconducted at outpatient department, Mayo Hospital Lahore for six months i.e. May to November 2017.After ethical approval, 60 patients of ages 25 to 55 years of either gender with chronic hepatitis C withgenotype 3a were included in the study. Informed consent was taken from all patients. Then patients wererandomly allocated into two groups “A” and “B” using random number table. Patients in Group A receivedstandard of care treatment for chronic hepatitis C i.e. pegylated interferon and ribavirin while the patientsin Group B also received tab atorvastatin along with the standard treatment. Patients were follow up for 4week. Blood samples were collected and HCV RNA detection. All this information were entered inproforma Results: In standard therapy group, the mean age of patients was 39.50±8.39years. Inatorvastatin plus standard therapy group, the mean age of patients was 34.30±6.78years. In standardtherapy group, there were 25 (83.3%) males and 5 (16.7%) females. In atorvastatin plus standard therapygroup, there were 16 (53.3%) males and 14 (46.7%) females. After 4 weeks, Rapid Virological Response(RVR) was achieved in 4 (13.3%) patients in standard therapy group while in 14 (46.7%) in atorvastatin plusstandard therapy group. The difference was significant (p<0.05) Conclusions: Atorvastatin incombination with Pegylated interferon and ribavirin have better efficacy as compared to Pegylatedinterferon & ribavirin alone in chronic hepatitis C-3a.

Treatment of chemotherapy-induced breakthrough nauea and vomiting

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e20536-e20536 ◽  
Author(s):  
R. M. Navari ◽  
S. E. Gray
Keyword(s):  
Serotonin Receptor ◽  
Rescue Therapy ◽  
Performance Status ◽  
Complete Response ◽  
Nausea And Vomiting ◽  
Ecog Performance Status ◽  
Difficult Situation ◽  
Serotonin Receptor Antagonists ◽  
Drug Classes ◽  
To Receive

e20536 Background: Patients may experience breakthrough nausea and vomiting (BNV) despite adequate prophylaxis for chemotherapy-induced nausea and vomiting (CINV). BNV presents a difficult situation as treatment of ongoing nausea and vomiting is challenging. We investigated three different drug classes for the treatment of BNV: phenothiazines (prochlorperazine)(Pro), dopamine-serotonin receptor antagonists (metoclopramide) (Meto), and a corticosteroid-thiobenzodiazepine combination (dexamethasone plus atypical antipsychotic olanzapine) (Dex-Olan). Methods: Adult patients, receiving moderately emetogenic chemotherapy and CINV prophylaxis with a 5-hydroxytryptamine-3 receptor antagonist and Dex pre-chemotherapy and Dex post-chemotherapy according to ASCO guidelines, who experienced BNV during the five days post-chemotherapy were randomized to receive Pro, 10 mg IV, and 10 mg, po, bid for three days; Meto, 20 mg IV, and 10 mg, po, bid for 3 days; or Dex, 20 mg IV and Olan, 5 mg, po, bid for three days. All patients also received at least one liter of IV fluids during the IV phase of their treatment. Patients were excluded if they had undergone rescue therapy with any of the study agents. Beginning with the first day of treatment for BNV (day 1) and daily through day 5, patients recorded episodes of vomiting/retching, nausea, other symptoms utilizing the M.D. Anderson Symptom Inventory, and the utilization of any additional rescue therapy. One hundred six patients (median age 61, range 37 - 85, 60 males, ECOG performance status ≤ 2) consented to the protocol and 100 were evaluable. Results: A complete response (no emesis, no additional rescue) for the five days post-initiation of BNV treatment was recorded for 7 of 35 patients (20%) in the Pro regimen, 12 of 33 patients (36%) receiving the Meto regimen, and 21 of 32 patients (66%) receiving the Dex-Olan regimen. There were no Grade III or IV treatment related toxicities. Conclusion: The combination of Dex-Olan was an effective treatment for BNV and was significantly more effective than Pro or Meto alone. No significant financial relationships to disclose.

scholarly journals Telavancin versus Standard Therapy for Treatment of Complicated Skin and Skin Structure Infections Caused by Gram-Positive Bacteria: FAST 2 Study

2006 ◽  
Vol 50 (3) ◽  
pp. 862-867 ◽  
Author(s):  
Martin E. Stryjewski ◽  
Vivian H. Chu ◽  
William D. O'Riordan ◽  
Brian L. Warren ◽  
Lala M. Dunbar ◽  
...  
Keyword(s):  
Standard Therapy ◽  
Clinical Success ◽  
Therapy Group ◽  
Success Rates ◽  
Standard Therapy Group ◽  
Gram Positive ◽  
Double Blind ◽  
Skin Structure ◽  
Complicated Skin ◽  
Cure Rates

ABSTRACT Telavancin is a bactericidal lipoglycopeptide with a multifunctional mechanism of action. We conducted a randomized, double blind, active-control phase II trial. Patients ≥18 years of age with complicated skin and skin structure infections caused by suspected or confirmed gram-positive organisms were randomized to receive either telavancin at 10 mg/kg intravenously every 24 h (q24h) or standard therapy (antistaphylococcal penicillin at 2 g q6h or vancomycin at 1 g q12h). A total of 195 patients were randomized and received at least one dose of study medication. Clinical success rates were similar in all analysis populations at test of cure. In microbiologically evaluable patients with Staphylococcus aureus at baseline (n = 91), 96% of the telavancin group and 90% of the standard-therapy group were cured. Among patients with methicillin-resistant S. aureus (MRSA) at baseline (n = 45), clinical cure rates were also 96% for telavancin and 90% for standard therapy. Microbiologic eradication in patients with S. aureus infection was better with telavancin compared to standard therapy (92% versus 78%, P = 0.07) and significantly better in patients with MRSA (92% versus 68%; P = 0.04). Therapy was discontinued for an adverse event (AE) in 6% and 3% of the patients receiving telavancin and standard therapy, respectively. Except for two cases of rash in the telavancin group, these AEs were similar in type and severity in the two groups. The overall incidences and severities of AEs and laboratory abnormalities were similar between the two groups. These data support the ongoing studies assessing the efficacy and safety of telavancin in the treatment of serious gram-positive infections, particularly involving MRSA.

scholarly journals Standard therapy potentiation of patients with Stable Angina FC III with concomitant Hypertension through nitric oxide donator L-arginine administration

2018 ◽  
pp. 83-86
Author(s):  
N. V. Zozuliak ◽  
Z. V. Zozuliak ◽  
V. Ye. Neiko ◽  
I. B. Romash ◽  
I. R. Romash ◽  
...  
Keyword(s):  
Nitric Oxide ◽  
Stable Angina ◽  
Standard Therapy ◽  
Therapy Group ◽  
Reactive Hyperemia ◽  
Antioxidant Properties ◽  
Stiffness Index ◽  
Standard Therapy Group ◽  
Oxidation Stress ◽  
Group I

The purpose of the study was to improve treatment of patients with Stable Angina  functional class III (FC) with concomitant arterial hypertension (AH) through a combination of standard therapy with L-arginine. There were examined63 patients with Stable Angina III FK with AH. All patients in the clinic were analyzedby the test with reactive hyperemia, were measured levels of cardio-ankle vascular index, pulse wave velocity, aortic stiffness index and the thickness of the complex "intima-media". It has been established that in studied patients with L-arginine significantly improves endothelium dependent vasodilatation, presumably due to the supply of substrate for the synthesis of nitric oxide, as well as due to antioxidant properties, which prevents the excessive formation of toxic peroxynitrite in conditions of high oxidation stress. Endothelial-independent vasodilation in the standard therapy group was significantly lowered, while in the L-arginine group, the incidence of changes was unreliable, which may indicate a decrease in sensitivity to nitrates in Group I. Thus, the inclusion to antianginal and antihypertensive therapyof L-arginine is more pronouncedaffects subclinical parameters of arterial rigidity, than in the background of treatment with standard therapy.

scholarly journals Controlled randomized clinical trial on using Ivermectin with Doxycycline for treating COVID-19 patients in Baghdad, Iraq

2020 ◽  
Author(s):  
Hashim A. Hashim ◽  
Mohammed F. Maulood ◽  
Anwar M. Rasheed ◽  
Dhurgham F. Fatak ◽  
Khulood K. Kabah ◽  
...  
Keyword(s):  
Mortality Rate ◽  
Standard Therapy ◽  
Therapy Group ◽  
Group Versus ◽  
Controlled Study ◽  
Control Group ◽  
Advanced Stage ◽  
Standard Therapy Group ◽  
Curative Therapy ◽  
Critical Patients

AbstractObjectivesCOVID-19 patients suffer from the lack of curative therapy. Hence, there is an urgent need to try repurposed old drugs on COVID-19.MethodsRandomized controlled study on 70 COVID-19 patients (48 mild-moderate, 11 severe, and 11 critical patients) treated with 200ug/kg PO of Ivermectin per day for 2-3 days along with 100mg PO doxycycline twice per day for 5-10 days plus standard therapy; the second arm is 70 COVID-19 patients (48 mild-moderate and 22 severe and zero critical patients) on standard therapy. The time to recovery, the progression of the disease, and the mortality rate were the outcome-assessing parameters.Resultsamong all patients and among severe patients, 3/70 (4.28%) and 1/11 (9%), respectively progressed to a more advanced stage of the disease in the Ivermectin-Doxycycline group versus 7/70 (10%) and 7/22 (31.81%), respectively in the control group (P>0.05). The mortality rate was 0/48 (0%), 0/11 (0%), and 2/11 (18.2%) in mild-moderate, severe, and critical COVID-19 patients, respectively in Ivermectin-Doxycycline group versus 0/48 (0%), and 6/22 (27.27%) in mild-moderate and severe COVID-19 patients, respectively in standard therapy group (p=0.052). Moreover, the mean time to recovery was 6.34, 20.27, and 24.13 days in mild-moderate, severe, and critical COVID-19 patients, respectively in Ivermectin-Doxycycline group versus 13.66 and 24.25 days in mild-moderate and severe COVID-19 patients, respectively in standard therapy group (P<0.01).ConclusionsIvermectin with doxycycline reduced the time to recovery and the percentage of patients who progress to more advanced stage of disease; in addition, Ivermectin with doxycycline reduced mortality rate in severe patients from 22.72% to 0%; however, 18.2% of critically ill patients died with Ivermectin and doxycycline therapy. Taken together, the earlier administered Ivermectin with doxycycline, the higher rate of successful therapy.

Comparison of the Sequential High-Dose Chemotherapy Followed by Autologous Stem Cell Support with and without Rituximab in Relapsed and Refractory Aggressive Non-Hodgkin’s Lymphoma.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 919-919
Author(s):  
Michal Sieniawski ◽  
Jan Oliver Staak ◽  
Helena Scheuss ◽  
Jan Peter Glossmann ◽  
Volker Diehl ◽  
...  
Keyword(s):  
Stem Cell ◽  
Standard Therapy ◽  
Response Rate ◽  
Therapy Group ◽  
High Dose Chemotherapy ◽  
Hodgkin's Lymphoma ◽  
High Dose ◽  
Standard Therapy Group ◽  
Stem Cell Support ◽  
Cell Support

Abstract Introduction: Combination chemotherapy can cure patients (pts) with Non-Hodgkin’s lymphoma (NHL), but those with relapse still have a poor prognosis. High-dose chemotherapy (HDCT) with autologous stem cell support (ASCT) can improve the outcome of these pts. Rituximab demonstrated encouraging activity in aggressive NHL and showed low toxicity in the setting of combined immunochemotherapy. To investigate the influence of addition of rituximab to the intensified salvage program followed by a final myeloablative course with stem cell reinfusion we compared the group of patients treated with this program - immuntherapy group (IT) with the standard therapy group (ST) of patients treated with the same program without rituximab. Patients and methods: Eligibility criteria for both groups were as follows: age 18–67 years, eligibility for HDCT, histologically proven CD20+ relapsed or progressive NHL. Treatment program starts with two cycles DHAP (dexamethasone, cytarabine, cisplatin); pts with PR or CR receive cyclophosphamide (4g/m2) followed by PBSC harvest; methotrexate 8g/m2 and vincristine 1,4mg/m2; and etoposide 2g/m2. The final myeloablative course is BEAM followed by ASCT. Pts in IT received additionally rituximab (375mg/m²) to the each chemotherapy cycle. Results: In the immuntherapy and standard therapy group were enrolled 23 and 57 pts, respectively. There were 18 (78%) IT and 34 (60%) ST pts with relapsed and 5 (22%) IT and 23 (40%) ST pts with refractory disease. The majority of pts in both groups received CHOP-like regimens as first line treatment (91% IT vs. 79% ST). The response rate at the final evaluation for all patients was in IT 61% (52% CR and 9% PR) and in ST 43% (32% CR and 11% PR). The overall response rate (OR) for patients who responded to 2 cycles DHAP was in IT 83% (71% CR and 12% PR) and in ST 59% (44% CR and 15% PR). The therapy toxicity was tolerable and comparable in both groups. Conclusion: The preliminary results suggest better therapy outcome in patient with sequential high-dose chemotherapy with rituximab compared to pts treated with the same therapy regimen without additional antibody. The combination regimen allows effective mobilization of stem cells. The tolerability of the final myeloablative BEAM was in both groups not affected by rapid sequential administration of DHAP and high doses of cyclophosphamide, methotrexate, etoposide and rituximab. The toxicity was tolerable in both groups. The full results of match pair and multivariate analysis as well as OS and FF2F will be presented.

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