Exploratory randomized trial to evaluate the effect of indisetron tablets for preventing chemotherapy-induced nausea and vomiting (CINV)/acute-onset diarrhea induced by IRIS/FOLFIRI: HGCSG0704.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 624-624
Author(s):  
Sosuke Kato ◽  
Hiraku Fukushima ◽  
Kanji Kato ◽  
Satoshi Yuki ◽  
Kazuaki Harada ◽  
...  
Keyword(s):  
Receptor Antagonist ◽  
Rescue Medication ◽  
Complete Response ◽  
Acute Onset ◽  
Complete Protection ◽  
Primary Endpoints ◽  
Significant Difference ◽  
Secondary Endpoints ◽  
Colorectal Cancer Patients ◽  
Ecog Ps

624 Background: Indisetron is a 5-HT3 receptor antagonist that also antagonizes 5-HT4receptors. Indisetron tablets showed the non-inferiority to ondansetron tablets in terms of efficacy for preventing CINV. Moreover, preclinical data administered with irinotecan showed indisetron significantly reduced stool frequency in mice and inhibited the colonic peristalsis in dogs. We designed a pilot study compared with granisetron in the efficacy and tolerability of indisetron for irinotecan-induced nausea, vomiting and especially in diarrhea. Methods: Advanced colorectal cancer patients treated with FOLFIRI or IRIS (Irinotecan + S-1) with or without bevacizumab were enrolled in this study. Treatment: Arm A: indisetron tablets 8mg po day1. Arm B: granisetron 3mg iv day 1. The primary endpoints were the incidence of acute-onset diarrhea and complete protection from vomiting. Secondary endpoints were tolerability, complete protection from nausea and rate of no rescue medication. Results: Between May 2008 and July 2012, 33 patients (pts) were randomized. The study was closed prematurely due to poor accrual. Arm A: 16 pts, arm B 17 pts. Median age A: 68 y.o., B: 66 y.o.: ECOG PS 0/1: A: 12/4, B: 14/3pts. There was no significant difference of the incidence of acute-onset diarrhea between both groups (18.8% in A vs. 35.3% in B, p = 0.438). The proportion of complete protection from vomiting was 87.5% in A and 88.2% in B (p = 1.000). Similarly, complete protection from nausea, rate of no rescue medication, proportion of patients with a complete response (defined as no emetic episodes and no rescue medication) did not have a significant difference. Severity of nausea/vomiting and AE induced by 5-HT3 receptor antagonist were also similar between two groups. Conclusions: Compared with granisetron, indisetron showed effective and feasible results for preventing CINV induced by FOLFIRI or IRIS. Indisetron had also not improved the incidence of acute-onset diarrhea induced by irinotecan. Clinical trial information: UMIN000010162.

Palbociclib (P) in patients (pts) with soft tissue sarcoma (STS) with CDK4 amplification: Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 11565-11565
Author(s):  
Scott Schuetze ◽  
Michael Rothe ◽  
Pam K. Mangat ◽  
Liz Garrett-Mayer ◽  
Funda Meric-Bernstam ◽  
...  
Keyword(s):  
Treatment Options ◽  
Objective Response ◽  
Progression Free Survival ◽  
Complete Response ◽  
Stage Design ◽  
Secondary Endpoints ◽  
Grade 3 ◽  
Ecog Ps ◽  
Stage 1 ◽  
Anti Tumor Activity

11565 Background: TAPUR is a phase II basket study evaluating anti-tumor activity of commercially available targeted agents in pts with advanced cancers with genomic alterations. Results in a cohort of STS pts with CDK4 amplification treated with P are reported. Methods: Eligible pts had advanced STS, no standard treatment options, measurable disease, ECOG PS 0-2, and adequate organ function. Genomic testing was performed in CLIA-certified, CAP-accredited site selected labs. Pts received P at 125 mg orally once daily for 21 days, followed by 7 days off until disease progression. Pts matched to P had CDK4 amplification and no RB mutations. Simon 2-stage design tested the null disease control (DC) - defined as partial (PR), complete response (CR) or stable disease at 16+ weeks (SD 16+) - rate of 15% vs. 35% (power = 0.85; α = 0.10). If ≥2 of 10 pts in stage 1 have DC, 18 more pts are enrolled. If ≥7 of 28 pts have DC, the null DC rate is rejected. Secondary endpoints are progression-free survival (PFS), overall survival (OS) and safety. Results: 29 pts (66% male) with STS with CDK4 amplification were enrolled from July 2016 to Nov 2019. 1 pt was not evaluable and excluded from efficacy analyses. Demographics and outcomes are summarized in Table. One pt with partial response (PR) and 12 pts with SD16+ were observed for DC and objective response (OR) rates of 48% (95% CI: 31%, 62%) and 3.7% (95% CI: 0.1%, 19%), respectively, and the null DC rate of 15% was rejected (p<0.001). 9/13 pts with DC continued on treatment for >32 weeks. 14 pts had at least one grade 3-4 AE at least possibly related to P with the most common being low WBC/platelets. Other grade 3 AEs included increased alanine aminotransferase, anemia, and fatigue. Conclusions: Monotherapy P demonstrated anti-tumor activity in heavily pre-treated pts with STS with CDK4 amplification. Additional study is warranted to confirm the efficacy of P in pts with STS with CDK4 amplification. Clinical trial information: NCT02693535. [Table: see text]

Clinical evaluation of AI software for rib fracture detection and its impact on junior radiologist performance

2021 ◽  
pp. 028418512110438
Author(s):  
Xiang Liu ◽  
Dijia Wu ◽  
Huihui Xie ◽  
Yufeng Xu ◽  
Lin Liu ◽  
...  
Keyword(s):  
Detection System ◽  
Ct Images ◽  
Diagnostic Efficiency ◽  
Fracture Detection ◽  
Patient Level ◽  
Primary Endpoints ◽  
Significant Difference ◽  
Secondary Endpoints ◽  
Lesion Level ◽  
Missed Diagnosis

Background The detection of rib fractures (RFs) on computed tomography (CT) images is time-consuming and susceptible to missed diagnosis. An automated artificial intelligence (AI) detection system may be helpful to improve the diagnostic efficiency for junior radiologists. Purpose To compare the diagnostic performance of junior radiologists with and without AI software for RF detection on chest CT images. Materials and methods Six junior radiologists from three institutions interpreted 393 CT images of patients with acute chest trauma, with and without AI software. The CT images were randomly split into two sets at each institution, with each set assigned to a different radiologist First, the detection of all fractures (AFs), including displaced fractures (DFs), non-displaced fractures and buckle fractures, was analyzed. Next, the DFs were selected for analysis. The sensitivity and specificity of the radiologist-only and radiologist-AI groups at the patient level were set as primary endpoints, and secondary endpoints were at the rib and lesion level. Results Regarding AFs, the sensitivity difference between the radiologist-AI group and the radiologist-only group were significant at different levels (patient-level: 26.20%; rib-level: 22.18%; lesion-level: 23.74%; P < 0.001). Regarding DFs, the sensitivity difference was 16.67%, 14.19%, and 16.16% at the patient, rib, and lesion levels, respectively ( P < 0.001). No significant difference was found in the specificity between the two groups for AFs and DFs at the patient and rib levels ( P > 0.05). Conclusion AI software improved the sensitivity of RF detection on CT images for junior radiologists and reduced the reading time by approximately 1 min per patient without decreasing the specificity.

Severe-COVID-19 and mortality among patients (pts) with prostate cancer (PCa) receiving androgen deprivation therapy (ADT).

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 39-39
Author(s):  
Matthew D Tucker ◽  
Andrew Lachlan Schmidt ◽  
Chih-Yuan Hsu ◽  
Yu Shyr ◽  
Andrew J. Armstrong ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Mortality Rate ◽  
Propensity Score ◽  
Viral Entry ◽  
Primary Diagnosis ◽  
Significant Difference ◽  
Secondary Endpoints ◽  
Retrospective Nature ◽  
Ecog Ps ◽  
The Impact

39 Background: The presence of progressing cancer, male sex and advanced age have been shown to increase the severity of coronavirus disease 2019 (COVID-19). Given that the androgen regulated gene TMPRSS2 has been implicated in SARS-CoV-2 viral entry, we hypothesized that ADT may improve COVID-19 outcomes. This analysis evaluated clinical outcomes of pts with PCa with concurrent SARS-CoV-2 infection and investigated the impact of ADT on occurrence of severe-COVID-19 and mortality. Methods: Data was obtained via the COVID-19 and Cancer Consortium (CCC19), a multicenter registry including >120 cancer centers with de-identified data from pts with COVID-19 and cancer. Men with confirmed SARS-CoV-2 infection and a primary diagnosis of prostate cancer were included: data cutoff of July 31, 2020. The primary endpoint was the development of severe-COVID-19 (death, ICU admission, or mechanical ventilation) among pts on ADT vs. those not on ADT at time of COVID-19 infection. Secondary endpoints included 30-day mortality based on ADT use. Mortality and development of severe-COVID-19 were assessed in Pts grouped by therapy: 1st generation androgen receptor inhibitor (ARI-1), 2nd generation ARI (darolutamide, enzalutamide, apalutamide, ARI-2), abiraterone/prednisone, and chemotherapy. Propensity score matching was utilized. Logistic regression was utilized to adjust for age, ECOG PS, comorbidities, and race. Results: 589 pts were included; median follow-up was 42 days (IQR 25-90) and 62% (363/589) were hospitalized. Severe-COVID-19 developed in 28% of pts and the all-cause 30-day mortality rate was 19%. There was no significant difference in the development of severe-COVID-19 or 30-day mortality between Pts on ADT vs not on ADT, whether using descriptive statistics with the entire population or using the propensity score matched population (Table). Among the descriptive population, the numerical rates of severe-COVID-19 and mortality were lowest in Pts receiving ARI-2, but sample size was low. Conclusions: The overall 30-day mortality rate and percentage developing severe-COVID-19 were high. There was no statistical difference in the development of severe-COVID-19 or mortality based on receipt of ADT; however, this analysis is limited by the retrospective nature and small N after propensity-matching. [Table: see text]

Prevention of cisplatin-induced emesis: a double-blind multicenter randomized crossover study comparing ondansetron and ondansetron plus dexamethasone.

1991 ◽  
Vol 9 (4) ◽  
pp. 675-678 ◽  
Author(s):  
F Roila ◽  
M Tonato ◽  
F Cognetti ◽  
E Cortesi ◽  
G Favalli ◽  
...  
Keyword(s):  
Side Effects ◽  
Crossover Study ◽  
Receptor Antagonist ◽  
Treatment Preference ◽  
Complete Protection ◽  
Double Blind ◽  
Significant Difference ◽  
Antiemetic Activity ◽  
To Receive ◽  
Randomized Crossover Study

Ondansetron (OND) is a new 5-HT3 receptor antagonist that give complete protection from emesis/nausea in approximately 50% of cisplatin (CDDP)-treated patients. To evaluate if dexamethasone (DEX) added to OND increases antiemetic efficacy, we carried out a double-blind randomized crossover study to compare the antiemetic activity of OND with OND plus DEX. One hundred two chemotherapy-naive patients (44 women and 58 men) scheduled to receive CDDP chemotherapy at doses greater than or equal to 50 mg/m2 entered the study. Eighty-nine patients completed both cycles with the following results: complete protection from emesis/nausea was obtained in 57/59 patients (64.0%/66.3%) with OND and in 81/79 (91.0%/88.8%) with OND plus DEX (P = .0005/P = .0021). At the end of the study, 53% of the patients expressed a treatment preference, and of these, 74% chose OND plus DEX compared with 26% who preferred OND alone, a statistically significant difference (P less than .003). Side effects were very mild and not significantly different between the two treatments. We conclude that OND plus DEX is more efficacious than OND in protecting patients from CDDP-induced emesis and nausea.

Co-administration of ondansetron and casopitant mesylate, a novel NK-1 receptor antagonist, results in augmented anti-emetic activity in the ferret

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 18608-18608 ◽  
Author(s):  
R. C. Gagnon ◽  
A. G. King
Keyword(s):  
Receptor Antagonist ◽  
Complete Response ◽  
Clinical Development ◽  
Phase Iii ◽  
Pharmacokinetic Analysis ◽  
Depression And Anxiety ◽  
Complete Protection ◽  
Highly Emetogenic Chemotherapy ◽  
Phase Iii Trials ◽  
Latency Duration

18608 Background: As monotherapies, ondansetron (a 5HT3 receptor antagonist) and casopitant mesylate ( GW679769 ) are effective anti-emetics in models of chemotherapy-induced nausea and vomiting in the ferret. To demonstrate the potential benefit of combination therapy, suboptimal doses of both ondansetron and casopitant mesylate were administered to ferrets receiving cisplatin. Methods: A 4x4 factorial design was utilized to test for therapeutically synergistic anti-emetic activity. Suboptimal doses (administered as monotherapy, which reduced vomiting and retching by >50% compared to control ferrets but did not result in complete protection) of each compound alone and in combination (0.3, 0.1, and 0.03 mg/kg) were administered 25 minutes prior to injection with cisplatin (10 mg/kg, IP). All emetic events/behaviors were recorded digitally via camera and DVR. Normal behaviors (eating, drinking, urination, defecation), emetic events (vomits, retches), and peri-emetic events (excessive mouth licking, burrowing, eye squinting, backward walking, and body scratching) were recorded temporally. All events were analyzed by finding the cumulative sum of events over time. Therapeutic synergy calculations were determined by analysis of variance. Results: Analysis of emetic events demonstrated the combination of ondansetron and casopitant mesylate resulted in significantly fewer events than either agent alone. Similar activity was demonstrated for vomits, retches, event latency, duration of emesis, water intake, food intake, and complete response. Conclusions: Co-administration of ondansetron and casopitant mesylate results in therapeutically synergistic anti-emetic and potential anti-nausea activity in this cisplatin-induced emesis model in ferrets. Pharmacokinetic analysis indicated no alteration of disposition of either agent. Therefore, we believe the synergy observed between ondansetron and casopitant mesylate is the result of their complementary mechanisms of pharmacologic action. Casopitant mesylate is currently in phase III trials for the prevention of PONV and CINV from moderately and highly emetogenic chemotherapy. It is also in clinical development for depression and anxiety. [Table: see text]

Phase III randomized trial of definitive chemoradiotherapy (CRT) with FOLFOX or cisplatin and fluorouracil in esophageal cancer (EC): Final results of the PRODIGE 5/ACCORD 17 trial.

2012 ◽  
Vol 30 (18_suppl) ◽  
pp. LBA4003-LBA4003 ◽  
Author(s):  
Thierry Conroy ◽  
Marie-Pierre Galais ◽  
Jean Luc Raoul ◽  
Olivier Bouche ◽  
Sophie Gourgou-Bourgade ◽  
...  
Keyword(s):  
Squamous Cell ◽  
Treatment Options ◽  
Complete Response ◽  
Phase Iii ◽  
Eligibility Criteria ◽  
Randomized Phase Ii ◽  
Secondary Endpoints ◽  
Grade 3 ◽  
Ecog Ps

LBA4003 Background: CRT is one of the best treatment options for localized EC. As new combinations are required to improve safety and survival, we launched a randomized phase II study to assess the complete response (CR) rate of CRT with FOLFOX versus 5FU/cisplatin in 97 pts with localized EC (Conroy 2010). The trial having met its objectives, it has been pursued as a phase III trial. Stratified randomization was performed centrally in a 1:1 ratio according to histological type, pretreatment weight loss in the prior 6 months (<10% vs ≥10%), ECOG PS (0 vs 1 vs 2), and center. Methods: Pts with technically unresectable cancer or those with surgical contraindications or who refused to undergo surgery were eligible. Eligibility criteria also included age >18 years (y), PS ≤ 2, previously untreated adenocarcinoma or squamous cell EC (any T, N0 or N1, M0 or M1a). The radiation dose was 50 Gy (2Gy/fr) 5 d/wk for 5 wks in both arms. In Arm A, pts received 6 bimonthly cycles (cy): oxaliplatin 85 mg/m2 d1 and leucovorin 200 mg/m2 followed by 5-FU 400 mg/m2 bolus d1 then 1,600 mg/m2 46h continuous infusion (ci) ; the first 3 cy were delivered during RT, the 3 other after. In Arm B, pts received 4 cy: cisplatin 75 mg/m2 d1 followed by 5FU 1,000 mg/m2/d ci d1-4, the first 2 cy during RT and 2 other after. The primary endpoint was PFS. Main secondary endpoints were OS, grade 3-4 toxicities, and quality of life. A total of 266 pts would provide 90% power to detect a 20% 3y-PFS difference (α=0.05). Results: 267 pts were enrolled between 10/2004 and 08/2011. Treatment cohorts were well balanced: male 81%; median age 61 y; PS 0 53%, squamous cell 85.8%, stage III 52%, IVA 6.0% and IVB 3.0%. Full treatment was delivered to 67.9% and 72.2% of pts in arms A/B, respectively. 7 toxic deaths occurred in each arm. Grade 3/4 toxicities per pt (%) in arms A/B were neutropenia 30.6/31.3, febrile neutropenia 5.3/7.0, anemia 5.4/11.0, asthenia 17.6/10.2, respectively. The median FU time was 25.3 mos. 3y-PFS was 18.2/17.4 % (HR=1.07; 95%CI =0.80-1.43) and median OS was 20.2 /17.5 m (HR=1.06; 95%CI =0.77-1.46). Conclusions: CRT with FOLFOX does not improve PFS compared to cisplatin and 5-FU and has similar toxicities.

Rolapitant for control of chemotherapy-induced nausea and vomiting (CINV) in patients with gynecologic cancer.

2016 ◽  
Vol 34 (26_suppl) ◽  
pp. 223-223 ◽  
Author(s):  
Bernardo Leon Rapoport ◽  
Lee Steven Schwartzberg ◽  
Sujata Arora ◽  
Daniel Powers ◽  
Karin Jordan ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Receptor Antagonist ◽  
Rescue Medication ◽  
Gynecologic Cancer ◽  
Complete Response ◽  
Double Blind ◽  
Neurokinin 1 ◽  
Long Acting ◽  
Type 3 ◽  
And Control

223 Background: Rolapitant, a long-acting neurokinin-1 receptor antagonist, protected against CINV in patients receiving highly or moderately emetogenic chemotherapy (HEC or MEC). Methods: In 3 double-blind phase 3 studies, patients were randomized to receive oral rolapitant 180 mg or placebo before administration of HEC or MEC. All patients received a 5-hydroxytryptamine type 3 receptor antagonist and dexamethasone. In a post hoc analysis of 3 pooled studies (2 HEC and 1 MEC), we assessed the efficacy and safety of rolapitant in patients with gynecologic (ovarian, uterine, or cervical) cancer. Endpoints included complete response (CR; no emesis and no use of rescue medication), no emesis, no nausea (maximum visual analogue scale [VAS] < 5 mm), and complete protection (CP; no emesis, no use of rescue medication, and no significant nausea [maximum VAS < 25 mm]) in the overall (0–120 h), acute (≤ 24 h), and delayed (> 24–120 h) phases. Results: Of 201 patients with gynecologic cancer (60% ovarian, 28% uterine, and 12% cervical cancer), 55% received cisplatin-based HEC and 44% received MEC (99% of whom received carboplatin-based therapy). In the overall and delayed phases, improved rates of CR, no emesis, no nausea, and CP were observed with rolapitant compared with control (Table). The overall incidence of treatment-emergent adverse events was similar in the rolapitant and control groups (45% vs 54%). Conclusions: Rolapitant protected against overall and delayed CINV in patients with gynecologic cancer receiving HEC or MEC. Clinical trial information: NCT01500226, NCT01499849, NCT01500213. [Table: see text]

Activity of durvalumab in advanced endometrial cancer (AEC) according to mismatch repair (MMR) status: The phase II PHAEDRA trial (ANZGOG1601).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 5501-5501 ◽  
Author(s):  
Yoland Catherine Antill ◽  
Peey Sei Kok ◽  
Kristy Robledo ◽  
Elizabeth Barnes ◽  
Michael Friedlander ◽  
...  
Keyword(s):  
Mismatch Repair ◽  
Dna Mismatch Repair ◽  
Single Agent ◽  
Tumour Response ◽  
Complete Response ◽  
Dna Mismatch ◽  
Phase 2 Trial ◽  
Mutation Burden ◽  
Secondary Endpoints ◽  
Ecog Ps

5501 Background: Deficient DNA mismatch repair (dMMR) occurs in approximately 15% of AEC and is associated with a high tumour mutation burden. Expression of PD-1 and PD-L1 has been reported in up to 90% of ECs, including those with proficient DNA mismatch repair (pMMR). We report here preliminary results of PHAEDRA, a single-arm phase 2 trial designed to determine the activity of single-agent durvalumab, an antibody to PD-L1, in 2 cohorts of women with AEC. Methods: Participants (pts) had pMMR AEC progressing after 1-3 lines of chemotherapy, or dMMR AEC progressing after 0-3 lines of chemotherapy, and were treated with durvalumab 1500mg IV Q4W. The primary endpoint was objective tumour response (OTR = complete response [CR] or partial response [PR] by iRECIST). Secondary endpoints included disease control at 16 weeks (DC16w = CR, PR, or stable disease at 16 weeks [SD16w]), immune-related adverse events (irAEs), PD-L1, germline mutations and MLH1 methylation. Other secondary endpoints include: OTR and DC by RECIST1.1, other AE, PFS, OS & quality of life will be reported later. Results: 71 pts with AEC were recruited from Feb 2017 to Sep 2018: 35 dMMR and 36 pMMR. Median follow-up were 8.3 vs 14.8 months in dMMR vs pMMR pts. Median age: 67 (range 36-81); ECOG PS: 0-1 in 68, and 2 in 3. Pathology: endometrioid in 94% and 58%; serous in 0% and 31%; grade: high in 42% and 83% (dMMR and pMMR respectively). Durvalumab was the 1st, 2nd and subsequent line of non-hormonal therapy in 15, 14, and 6 pts with dMMR and 0, 21, and 15 pts with pMMR. Among dMMR pts, the OTR rate was 40% (14/35, 95% CI 26-56), with 4 CR and 10 PR; 7 others had SD 16w for a DC16w rate of 60% (21/35, 95% CI 44-74). OTR rate was 40% as 1st line, 43% as 2nd line, and 33% as subsequent line treatment. Among pMMR pts, the OTR rate was 1/36 (3%, 95% CI 1-14) with 1 PR; 6 others had SD16w for a DC16w rate of 19% (7/36; 95% CI 10-35). IrAEs occurred in 14 pts: hyperthyroidism in 6, hypothyroidism in 6, pneumonitis in 1 and hepatitis in 1. Conclusions: Durvalumab monotherapy showed promising activity and safety in AEC with dMMR regardless of prior lines of chemotherapy, but there was limited evidence of activity in AEC with pMMR. Clinical trial information: ACTRN12617000106336.

Comparison of Tobramycin Pharmacokinetics After Administration by Cris and a Traditional Intravenous Piggyback Infusion

1995 ◽  
Vol 29 (5) ◽  
pp. 465-469
Author(s):  
Vincent F Mauro ◽  
Lori R Jacobs ◽  
Laurie S Mauro ◽  
Rodger D MacArthur ◽  
Donald B White
Keyword(s):  
Maximum Concentration ◽  
Elimination Rate ◽  
Random Order ◽  
Open Label ◽  
Medical College ◽  
Primary Endpoints ◽  
Significant Difference ◽  
Secondary Endpoints ◽  
Open Label Trial ◽  
Infusion System

Objective: To compare the administration pharmacokinetics of a 30-minute intravenous piggyback (ivpb) infusion of tobramycin with those of controlled-release infusion system (CRIS) using a 20-mL vial at rates of 60 and 120 mL/h. Design: Randomized, controlled, crossover, prospective, open-label trial. Setting: Medical college-affiliated hospital. Participants: Eight healthy volunteer men between the ages of 22 and 24 years weighing between 60 and 90 kg. Interventions: Volunteers received, in random order, tobramycin sulfate 2 mg/kg iv on 3 occasions separated by 1 week. The drug was administered using a 50-mL ivpb infusion at 100 mL/h for 30 minutes, and with the CRIS using a 20-mL vial with flow rates of 60 mL/h for 1 hour (slow) and 120 mL/h for 1 hour (fast). Main Outcome Measures: Primary endpoints were area under the time–concentration curve (AUC), time to reach maximum concentration (tmax), and maximum concentration (Cmax). Secondary endpoints were elimination rate constant (ke), clearance (Cl), and half-life (t1/2). Results: Six volunteers successfully completed the trial. The tmax values observed following fast CRIS and ivpb were 28 ± 8 and 32 ± 4 minutes, respectively, and not significantly different from each other. Both occurred significantly earlier than the tmax associated with slow CRIS (44 ± 7 min). The Cmax values observed following ivpb (11.2 ± 1.5 mg/L) and slow CRIS (10.9 ± 0.9 mg/L) administration were not significantly different from each other, but both were significantly lower than that of fast CRIS (13.4 ± 1.5 mg/L). The AUCs of slow and fast CRIS were 29.8 ± 4.8 and 31.2 ± 3.8 mg/L•h, respectively, and were not significantly different from each other. The AUC of fast CRIS was significantly greater than that observed with ivpb (27.4 ± 4.3 mg/L•h). No significant difference in ke (fast CRIS 0.32 ± 0.03 h-1; slow CRIS 0.33 ± 0.04 h-1; ivpb 0.34 ± 0.0 h-1) was observed among any of the methods. Conclusions: CRIS administration of tobramycin resulted in higher AUCs than did ivpb administration. Compared with ivpb, fast CRIS resulted in a higher Cmax, but the tmax values of fast CRIS and ivpb administration were not statistically different. Compared with ivpb, slow CRIS resulted in a more delayed tmax, but the Cmax values of slow CRIS and ivpb were not statistically different.

scholarly journals Post-streptokinase PCI in STEMI patients exceeding the 24-h guidelines

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
El-Zahraa M. Esmat Sultan ◽  
Khaled R. Abdel Meguid ◽  
Hesham B. Mahmoud
Keyword(s):  
End Point ◽  
Timi Flow ◽  
Primary Endpoints ◽  
Significant Difference ◽  
Close Observation ◽  
Secondary Endpoints ◽  
Group 2 ◽  
Group 1 ◽  
The Ideal

Abstract Background Due to delay in obtaining approval from insurance institution, performing PCI after successful reperfusion using streptokinase was postponed for ˃24 h-1 week. The study was conducted to investigate safety and efficacy of such delay in comparison to the ideal guidelines of PCI (≤ 24 h) in 129 STEMI patients received streptokinase followed by PCI. Patients were divided into two groups: (group 1 = 57; early PCI ≤ 24 h.) and (group 2 = 72; late PCI > 24 h.). Results Primary end point was death, congestive heart failure and reinfarction up to 30 days. Secondary end point was TIMI flow < G3, ischemic stroke, intracranial hemorrhage and non-intracranial bleeding. No statistical significant difference was found between both groups regarding LVEF, dimensions and myocardium wall preservation and incidence of complications and TIMI flow. No primary endpoints were detected. Five patients had secondary endpoints in early PCI and four in the late PCI. Suction device and IV Eptifibatide were used more in early PCI (p = 0.003). Conclusions The study suggests that relatively late PCI (> 24 h–1wk) after successful reperfusion using streptokinase in STEMI patients seems to be safe and effective in 30-day follow-up, provided that patients received DAPT and were subjected to close observation. The results seem safely applicable when we are forced to this choice; however lack of more investigations to this hypothesis is considered a limitation.

Sign in / Sign up

Export Citation Format

Share Document