The association of renal function with safety and efficacy of cisplatin plus S-1 (CS) therapy and docetaxel plus cisplatin plus S-1 (DCS) therapy in patients with advanced gastric cancer (AGC): An additional analysis of JCOG1013.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16035-e16035
Author(s):  
Shuichi Hironaka ◽  
Ryo Sadachi ◽  
Nozomu Machida ◽  
Satoru Iwasa ◽  
Yasuhide Yamada ◽  
...  
Keyword(s):  
Renal Function ◽  
Adverse Events ◽  
Objective Response ◽  
Exploratory Analysis ◽  
Phase Iii ◽  
Fixed Dose ◽  
Hematological Toxicity ◽  
Significant Difference ◽  
Group A ◽  
Group B

e16035 Background: A phase III study, JCOG1013, did not show the superiority of docetaxel plus cisplatin plus S-1 (DCS) to cisplatin plus S-1 (CS) in overall survival (OS) (Yamada Y, Lancet GH 2019). It is known that cisplatin and gimeracil (an inhibitor of dihydropyrimidine dehydrogenase contained in S-1) are excreted in urine. We previously reported (abstr 197, ASCO-GI 2021) exploratory analysis of JCOG1013 which showed creatinine clearance (CrCl) was associated with safety (Grade [G]4 hematological toxicity for CS, and G3-4 non-hematological toxicity for CS and DCS), but not with efficacy in either group. Here, we report the additional detail results of this exploratory analysis. Methods: Among 741 participants in JCOG1013, patients with serum creatinine level < 1.2 mg/dL were included in this analysis and categorized by CrCl and treatment into A1 (CrCl ≥ 80 mL/min, CS), A2 (60 < CrCl < 80, CS), A3 (CrCl < 60, CS), B1 (CrCl > 80, DCS), B2 (60 < CrCl < 80, DCS), and B3 (CrCl < 60, DCS). The dose (mg/m2) of C/S was 60/80 regardless renal function in group A (A1, A2 and A3), and that of D/C/S was adjusted in group B as follows: 40/60/80 in B1, 40/50/80 in B2, and 40/40/65 in B3. Adverse events, OS, progression-free survival (PFS), and objective response rate (ORR) were compared by CrCl in group A (A1 vs. A2 vs. A3) and group B (B1 vs B2 vs B3), respectively. Results: Of 723 pts (169/136/57 in A1/A2/A3 and 170/138/53 in B1/B2/B3), the median CrCl (mL/min) was 94.1/71.9/53.4 in A1/A2/A3 and 98.2/70.0/55.6 in B1/B2/B3. The relative dose intensity of C/S was 90.4/75.3%, 87.8/74.9% and 85.7/72.8% in A1, A2 and A3, and that of D/C/S was 87.5/77.7/74.9%, 85.8/61.2/72.7% and 87.8/49.4/58.3% in B1, B2 and B3. The incidence of G4 white blood cell decreased, G4 neutrophil count decreased, and G3-4 anorexia were 1.2/4.4/9.3% (P < 0.01), 4.8/11.1/18.5% (P < 0.01), 14.4/28.1/28.6% (P < 0.01) in A1/A2/A3, and 1.8/3.0/4.0% (P = 0.36), 27.3/24.8/20.0% (P = 0.28), 22.4/29.3/32.0% (P = 0.11) in B1/B2/B3, respectively. No significant association between CrCl and other adverse events was observed either in CS or in DCS group. The median OS was 15.4/15.5/15.4 months in A1/A2/A3 (P = 0.89) and 15.3/13.7/13.7 months in B1/B2/B3 (P = 0.72). The median PFS was comparable among A1/A2/A3 (7.1/6.8/6.2 months, P = 0.88) and B1/B2/B3 groups (7.5/7.2/7.8 months, P = 0.85). ORR showed no significant difference in A1/A2/A3 (58.9/57.8/46.9%, P = 0.31) and B1/B2/B3 groups (62.0/61.5/51.5%, P = 0.36). Conclusions: Dose modification according to renal function in the DCS arm could control the increase of severe toxicities, which were observed frequently in patients with low renal function in patients receiving fixed dose of CS. Clinical trial information: 000007652.

The association of renal function with safety and efficacy of cisplatin plus S-1 (CS) therapy and docetaxel plus cisplatin plus S-1 (DCS) therapy in patients with advanced gastric cancer (AGC): An exploratory analysis of JCOG1013.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 197-197
Author(s):  
Shuichi Hironaka ◽  
Ryo Sadachi ◽  
Tadayoshi Hashimoto ◽  
Nozomu Machida ◽  
Satoru Iwasa ◽  
...  
Keyword(s):  
Dihydropyrimidine Dehydrogenase ◽  
Objective Response ◽  
Progression Free Survival ◽  
Exploratory Analysis ◽  
Phase Iii ◽  
Hematological Toxicity ◽  
Safety And Efficacy ◽  
Treatment Groups ◽  
Significant Difference ◽  
Group B

197 Background: JCOG1013, a phase III study comparing CS therapy with DCS therapy for AGC, failed to demonstrate the superiority of DCS to CS in overall survival (OS) (Yamada Y, Lancet GH 2019). Because cisplatin and gimeracil (an inhibitor of dihydropyrimidine dehydrogenase contained in S-1) are excreted in urine, it is speculated that renal dysfunction may affect the safety and efficacy of CS and DCS in patients (pts) with AGC. Methods: Among 741 all randomized pts, pts with serum creatinine level < 1.2 mg/dL were included in this study. Pts were categorized by creatinine clearance (CrCl) and treatment into A1 (CrCl ≥ 80 mL/min, CS), A2 (60 < CrCl < 80, CS), A3 (CrCl < 60, CS), B1 (CrCl ≥ 80, DCS), B2 (60 < CrCl < 80, DCS), and B3 (CrCl < 60, DCS). Adverse events, OS, progression-free survival (PFS), objective response rate (ORR) were compared by CrCl in group A (A1 vs. A2 vs. A3) and group B (B1 vs B2 vs B3), respectively, and between the treatment groups according to CrCl (A1 vs. B1, A2 vs. B2, A3 vs. B3). Results: Of 723 pts (169/136/57 in A1/A2/A3 and 170/138/53 in B1/B2/B3), the median CrCl was 94.1/71.9/53.4 mL/min in A1/A2/A3 and 98.2/70.0/55.6 mL/min in B1/B2/B3 group. The incidence of Grade (G) 4 hematological toxicity was 7.8/16.3/25.9% in A1/A2/A3 (P < 0.01), and 29.1/29.3/22.0% in B1/B2/B3 (P = 0.44), and that of G3-4 non-hematological toxicity was 46.1/64.4/64.3% in A1/A2/A3 (P < 0.01) and 54.6/64.7/74.5% in B1/B2/B3 (P < 0.01), respectively. The median OS was 15.4/15.5/15.4 months in A1/A2/A3 (P = 0.89) and 15.3/13.7/13.7 months in B1/B2/B3 (P = 0.72). The median PFS was comparable in A1/A2/A3 (7.1/6.8/6.2 months, P = 0.88) and B1/B2/B3 groups (7.5/7.2/7.8 months, P = 0.85). ORR showed no significant difference in A1/A2/A3 (58.9/57.8/46.9%, P = 0.31) and B1/B2/B3 groups (62.0/61.5/51.5%, P = 0.36). Comparisons between treatment arms according to CrCl (A1 vs. B1, A2 vs. B2, A3 vs. B3) did not show any significant difference in OS (P = 0.88, 0.65, 0.83) and PFS (P = 0.91, 0.63, 0.46). Conclusions: In this exploratory analysis of JCOG1013, CrCl might be associated with safety (G4 hematological toxicity for CS, and G3-4 non-hematological toxicity for CS and DCS), but not with efficacy in either group. Clinical trial information: 000007652.

Randomized phase III clinical study comparing postoperative UFT/LV,UFT+LV/UFT and UFT+LV+PSK/UFT+PSK as adjuvant therapy for curatively resected stage III colorectal cancer HGCSG-CAD study.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 3638-3638
Author(s):  
Toshiaki Shichinohe ◽  
Yoshito Komatsu ◽  
Kohei Akazawa ◽  
Satoshi Yuki ◽  
Hiraku Fukushima ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Adverse Events ◽  
Gastrointestinal Symptoms ◽  
Phase Iii ◽  
Stage Iii ◽  
Lung Cancers ◽  
Fatigue Score ◽  
Significant Difference ◽  
Group A ◽  
Group B

3638 Background: Study showed that the oral anticancer agent UFT/LV is useful as postoperative adjuvant chemotherapy for stage III colorectal cancer. PSK, a protein-bound polysaccharide extracted from the mycelia of Coriolus versicolor, is an immunomodulator widely used in gastric, colorectal and lung cancers. Methods: Patients aged 20-80 years with stage III colorectal cancer registered in 35 facilities were randomized to: group A (UFT/LV 28 days/5 weeks for 6 months); group B (UFT+LV 28 days/5 weeks for 6 months, then UFT for 12 months); and group C (UFT+LV+PSK 28 days/5 weeks for 6 months, then UFT+PSK for 12 months). Treatment was started within 6 months after curative resection. Outcome measures were relapse-free survival (RFS), overall survival (OS), incidence and severity of adverse events, and QOL. Results: Of 342 patients registered, 340 eligible patients were analyzed (84 in group A, 85 in group B, and 171 in group C). At baseline, variation in QOL score was observed but histopathological parameters were not different among 3 groups. Median observation period was 36 months. 3-year RFS was 73.8%, 77.6% and 73.9% in groups A, B, and C [A vs C: hazard ratio (HR) 0.960, 95% confidence interval (CI) 0.575-1.601; B vs C: HR 0.837, CI 0.488-1.433; A vs B: HR 1.151, CI 0.623-2.126]. 3-year OS was 95.2%, 91.8% and 89.9% in groups A, B, and C (A vs C: HR 0.460, CI 0.155-1.367; B vs C: HR 0.814, CI 0.338-1.963 A vs B: HR 0.570, CI 0.167-1.947). Adverse events ≥grade 3 included gastrointestinal symptoms and general status. There was no treatment-related death. Excluding high fatigue score in QOL scale that showed pretreatment variation, stratification analysis showed interaction between family score and group, and efficacy was suggested especially in group C with high score (3-yesr RFS: 66.7%, 68.2% and 88.1% in groups A, B, and C. A vs C: HR 3.289, CI 0.951-11.375, B vs C: HR 3.070, CI 0.973-9.685, A vs B: HR 1.084, CI 0.344-3.417). Conclusions: A significant difference in primary endpoint was not detected. Variation in QOL at treatment initiation probably greatly affected outcome. Clinical trial information: NCT00209742.

scholarly journals Feasibility of Non-Anesthesiologist-Administered Propofol Sedation for Emergency Endoscopic Retrograde Cholangiopancreatography

2015 ◽  
Vol 2015 ◽  
pp. 1-7 ◽  
Author(s):  
Nobuhito Ikeuchi ◽  
Takao Itoi ◽  
Takuji Gotoda ◽  
Chika Kusano ◽  
Shin Kono ◽  
...  
Keyword(s):  
Adverse Events ◽  
Endoscopic Retrograde Cholangiopancreatography ◽  
Acute Cholangitis ◽  
Careful Monitoring ◽  
Endoscopic Retrograde ◽  
Serious Adverse Events ◽  
Significant Difference ◽  
Group A ◽  
Group B ◽  
Technical Safety

Background. The safety of non-anesthesiologist-administered propofol (NAAP) sedation in emergent endoscopic retrograde cholangiopancreatography (ERCP) has not been fully clarified. Thus, the aim of this study was to assess the safety of NAAP sedation in emergent ERCP.Materials and Methods. We retrospectively analyzed 182 consecutive patients who had obstructive jaundice and who underwent ERCP under NAAP sedation. The patients were divided into Group A (with mild acute cholangitis or without acute cholangitis) and Group B (moderate or severe acute cholangitis). And technical safety and adverse events were assessed.Results. The adverse events were hypoxia (31 cases), hypotension (26 cases), and bradycardia (2 cases). There was no significant difference in the rate of each adverse event of hypoxia and bradycardia in either group. Although the rate of transient hypotension associated in Group B was higher than that in Group A, it was immediately improved with conservative treatment. Moreover, there were no patients who showed delayed awakening, or who developed other complications.Conclusions. In conclusion, NAAP sedation is feasible even in emergent ERCP. Although some transient adverse events (e.g., hypotension) were observed, no serious adverse events occurred. Thus, propofol can be used in emergent ERCP but careful monitoring is mandatory.

scholarly journals Short Practical Regimen of Acupuncture for Melasma: A Prospective Cohort Study in a Tertiary Hospital in Thailand

2021 ◽  
Vol 9 ◽  
Author(s):  
Thanan Supasiri ◽  
Nuntida Salakshna ◽  
Krit Pongpirul
Keyword(s):  
Side Effects ◽  
Adverse Events ◽  
Severity Index ◽  
Tertiary Hospital ◽  
Optimal Number ◽  
Significant Difference ◽  
Patient Reported ◽  
Group A ◽  
The Mean ◽  
Group B

Background: Acupuncture shows benefits for patients with melasma, although no optimal number of sessions have been determined.Methods: The prospective observational study was conducted in melasma patients who were treated with acupuncture procedures two times a week and were evaluated after the 5th and the 10th sessions of acupuncture, with a 1-week follow-up after the last session. Participants Groups A and B received five and 10 acupuncture sessions, respectively. Melasma was assessed by using the melanin index (MI), melasma area and severity index (MASI), patient-reported improvement scores, and acupuncture-related adverse events.Results: Out of 113 participants, 67 received five sessions of acupuncture treatment while 39 received 10 sessions. At 1 week after five sessions of acupuncture in Group A, the mean MI decreased by 28.7 (95% CI −38.5 to −18.8, p &lt; 0.001), whereas the median MASI decreased by 3.4 (95% CI −6.9 to −1.2, p &lt; 0.001) points. At 1 week after ten sessions of acupuncture in Group B, the mean MI decreased by 31.3 (95% CI −45 to −17.6, p &lt; 0.001), whereas the median MASI decreased by 5.4 (95%CI −9.9 to −3, p &lt; 0.001) points. The first five sessions of acupuncture had a higher incremental effect than the last five sessions, although there was no statistically significant difference. Twenty-nine participants reported minor side effects. Group B had a risk ratio (RR) of having adverse events 1.8 times (95% CI 1.0–3.4, p = 0.05) compared with Group A.Conclusion: Short acupuncture regimens of 5–10 sessions in melasma seem to be effective and practical with minor side effects.

Ophthalmic artery catheterization for retinoblastoma treatment: does reflux affect tumor response?

2020 ◽  
Vol 12 (9) ◽  
pp. 915-920 ◽  
Author(s):  
Ahmad Sweid ◽  
Batoul Hammoud ◽  
Joshua H Weinberg ◽  
Pavlos Texakalidis ◽  
Vivian Xu ◽  
...  
Keyword(s):  
Adverse Events ◽  
Ophthalmic Artery ◽  
Tumor Response ◽  
Retrospective Chart Review ◽  
Primary Treatment ◽  
Study Cohort ◽  
Significant Difference ◽  
Group A ◽  
Poor Outcomes ◽  
Group B

BackgroundIntra-arterial chemotherapy (IAC) for retinoblastoma (Rb) has been established as a primary treatment for the disease. To determine whether the presence of reflux into the ICA is associated with tumor response or with any other adverse events in pediatric retinoblastoma patients.MethodsA retrospective chart review was performed for patients diagnosed with Rb and managed with ophthalmic artery catheterization (OAC).ResultsThe total study cohort included 205 Rb tumors of 205 eyes in 194 consecutive patients who underwent 624 successful intra-arterial chemotherapy infusions using OAC. Of the 205 eyes, 65 eyes (32.7%) underwent 157 OAC procedures constituted group A (no reflux), 64 eyes (31.2%) underwent 236 OAC procedures constituted group B (variable pattern), and 74 eyes (36.1%) underwent 231 OAC procedures constituted group C (reflux). There was no significant difference in baseline characteristics between the three cohorts. Also, there was no significant difference in tumor characteristics between the three groups, except for genetic status. There was no significant difference between the three groups in terms of tumor response at completion of the treatment regimen. Complete tumor response was achieved at 70.2% in Group A, at 83.3% in Group B, and at 78.5% in group C (P=0.39). Similarly, eye enucleation occurred at 38.5% in group A, 31.8% in group B, and 31.5% in group C. None of the patients in both groups had any neurological adverse events or new onset of seizures.ConclusionsThe presence of reflux, which may complicate the procedure and prolong it, was not associated with poor outcomes in our analysis.

EXPERT study: Randomized phase III trial of radical surgery and postoperative mFOLFOX6 versus perioperative mFOLFOX6 plus cetuximab in patients with KRAS wild-type resectable colorectal liver metastases (CLMs).

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 652-652 ◽  
Author(s):  
Yoshihiro Mise ◽  
Kiyoshi Hasegawa ◽  
Masaru Oba ◽  
Kensei Yamaguchi ◽  
Hiroyuki Uetake ◽  
...  
Keyword(s):  
Liver Metastases ◽  
Medical Information ◽  
Radical Surgery ◽  
University Hospital ◽  
Phase Iii ◽  
Wild Type ◽  
Phase Iii Trial ◽  
Significant Difference ◽  
Group A ◽  
Group B

652 Background: Up-front radical surgery and adjuvant chemotherapy were regarded as one of the standard-of-care (SOC) in patients with resectablecolorectal liver metastases (CLMs), while perioperative chemotherapy plus surgery is also accepted. We conducted a multicenter randomized phase III trial to compare radical surgery and post-operative mFOLFOX6 with peri-operative mFOLFOX6 plus cetuximab in patients with KRAS wild-type resectable CLMs. Methods: Patients who had KRAS wild-type resectable CLMs having one to eight liver nodules without extrahepatic disease, were randomly assigned to groups: Group A (reference), hepatectomy and 12 cycles of post-operative mFOLFOX6: Group B (experimental), six cycles of preoperative mFOLFOX6 plus cetuximab (loading dose with 400mg/m2and thereafter 250mg/m2weekly), hepatectomy and six cycles of postoperative mFOLFOX6 plus cetuximab. Primary endpoint was progression-free survival (PFS). We hypothesized that 3-year PFS in Group B would be 25% with the hazard ratio (HR) being 0.75. Considering 3 year follow-up period with 5% of two-sided alpha error and 80% of power, target number were set as 500 (250 each). Study was registered in the University Hospital Medical Information Network (UMIN000007787). Results: This study was initiated since June 2012. However, the enrollment was terminated according to the recommendation from the monitoring committee on 2015 due to a slow accrual. A total of 77 patients (Group A 37 vs. Group B 40) were analyzed. Baseline characteristics were well-balanced between groups. Median numbers of liver mets were two each, ranging from one to eight. The HRs for PFS and overall survival (OS) showed no significant difference (PFS, HR = 1.18 [0.69-2.01], p = 0.54: OS, HR = 1.03 [0.46 – 2.29], p = 0.95). There were 3-year PFS of 35% in Group A vs. 30% in Group B, and 3-year OS: 86% vs. 74%, respectively. Conclusions: No additional survival benefits adding on peri-operative cetuximab were indicated, of which findings is consistent with the previous clinical studies, although there were small number of enrolled patients. Clinical trial information: UMIN000007787.

Therapeutic Superiority and Safety of Combined Hydroxyurea with Recombinant Human Erythropoietin Over Hydroxyurea in B-Thalassemia Intermedia Patients

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 252-252
Author(s):  
Mohsen Saleh Elalfy ◽  
Amira Adly ◽  
Yassmine Elhanawy
Keyword(s):  
Adverse Events ◽  
Short Form ◽  
Single Agent ◽  
Random Allocation ◽  
Thalassemia Intermedia ◽  
Transfusion Requirements ◽  
Significant Difference ◽  
Group A ◽  
Group B ◽  
Age Range

Abstract Abstract 252 Background: Both Hydroxyurea (HU) as a single agent or in combination with Erythropoietin (rHuEPO) became a therapeutic option for β-Thalassemia intermedia(TI) over last 2 decades. However superiority and safety of combination therapy over HU alone needs further evaluation. Aim: to assess the increase of hemoglobin levels in TI patients by at least 1g/dl above baseline during therapy using combined HUO and rHuEPO compared to single HUO therapy, also to report decline in transfusion requirements, quality of life (QoL), and any drug related adverse events. Patients and methods: An interventional prospective randomized open-labeled study; was approved from the local ethical committee and was registered in the Clinical Trials. Goverment (NCT01624038 ). Eighty Patients 18 years or less will be assigned into one of 2 groups using a random allocation method. Group A: Forty TI patients (age range: 5–18 years) considered as interventional arm 1 and received combined daily HUO (25 mg/kg/day orally) and rHuEPO (1000 IU/kg/week subcutaneously divided in three times/week). Group B: Forty TI patients (age range: 4–18 years) considered as arm 2 (control arm) and received daily single HUO therapy of 25 mg/kg/day. Both groups were followed up both clinically and laboratory for a mean period of one year with assessment of transfusion requirements, blood pressure weekly, liver and renal functions, Hemoglobin (Hb), HbF monthly, basal serum erythropiotin levels and QoL was assessed at study entry and end using the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36). Diagnosis of TI was based on both genetic mutations and absence of transfusion during the 1st 2 years of life. Exclusion criteria were: evidence of active hepatitis (ALT>5 times) or renal impairment. Results: There were a significant improvement in the QoL in 80% and 60% of patients on combined compared to single therapy(p<0.05). There was a significant increase in both Hb and HbF (p <0.001), and the increments were strongly correlated (r =0.84; p <0.001) in both groups more in group A patients. The median Hb level in groups A and B during the study was 9.1 and 7.9 g/dL, respectively (p=0.03). In 68% (n=27) of TI patients group (A) were responded by a 0.5–3 g/dl increase in Hb level. There was significant difference between the 2 groups as only 20% (n=8) of patients in group B show intended improvement in their hemoglobin levels (p<0.01). In studied thalassemics 40%(n=16) of group A compared to 15%(n=6) of group B (p=0.01) became transfusion independent with 20% in group A showed decrease in their transfusion requirements with significant decrease in transfusion index compared to group B thalassemics (p<0.001). There was no significant change in absolute Hb-F, and serum ferritin levels during treatment. splenectomized patients and those with serum EPO less than 500 mU/mL, and intial HbF% > 40% had best response to combined therapy. Side effects from rHuEPO included bone pain in 2 patients, headache in 4 patients, however no uncontrolled hypertension was reported. Gastrointestinal irritation was observed in 3 patients and resolved when the dose was given at bedtime. No renal or hepatic toxicity were reported. A single case of mild neutropenia was reported and recovered within one week of temporary discontinuation Conclusions: Hu was effective in management of TI however combination with erythropiotin had an additive therapeutic effect and was well tolerated with no further serious adverse events. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Real world experience from 1000 patients. Preprocedural DOAC interruption impacts detectable DOAC serum levels but not adverse events after catheter ablation of atrial fibrillation

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Konstantinou ◽  
S Bordignon ◽  
T Tohoku ◽  
S Chen ◽  
F Bologna ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Adverse Events ◽  
Real World ◽  
Patient Characteristics ◽  
Af Ablation ◽  
Patient Profile ◽  
Significant Difference ◽  
Single Pill ◽  
Group A ◽  
Group B

Abstract Introduction Direct oral anticoagulation (DOAC) therapy represents the standard of care in patients with atrial fibrillation (AF) and increased stroke risk. In a real world setting withholding DOAC medication before elective AF ablation is considered to reduce procedural bleeding risks. The aim of this study was to determine the individual DOAC level prior to the ablation procedure, to identify predisposing factors affecting traceable DOAC levels and to screen for associated severe adverse events. Methods Between September 2016 and March 2019 blood samples were obtained from patients on DOAC before an elective AF ablation. Per institutional standard all patients have been instructed to pause DOAC medication prior ablation for one or two doses depending on the patient profile and type of medication. The time interval between ablation and last DOAC intake was calculated in hours. Patient characteristics, procedural data and in-hospital complications were noted from all patients. Results A total of 1000 patients (60% male, age: 68y, GFR 83.25: BMI: 28, CHADSVASC score 3) undergoing AF ablation were included. Two groups were defined. Group A (n=416, 41.6%): patients treated with “single pill” DOAC (Rivaroxaban (n=288, 28.8%) and Edoxaban (n=128, 12.8%)). Group B (n=584, 58.4%): patients treated with twice a day DOAC (Apixaban (n=505, 50.5%) and Dabigatran (n=79, 7.9%)). The only difference in patient characteristics was an increased prior bleeding history in group B. The DOAC pause was significantly longer in group A (mean 40h) compared to group B (mean 32h), p=0.026. In a total of 217 patients (21.7%) DOAC levels where traceable prior to AF ablation. Traceable DOAC levels were significantly more common in group B (n=144/584, 24.7%) compared to group A (n=73/416, 17.5%). Adverse events occurred in 5.7% of patients (0.4% stroke, 0.3% tamponade, 2.5% hematoma, 1.9% AV-fistel, 0.7% pseudoaneurysma). T-Test analysis showed no significant difference in the occurrence of adverse events between both groups. Conclusion Despite of interrupting DOACs before an elective AF ablation therapeutic substance levels can be detected in &gt;20% of patients. The rate of adverse events was not different between “single pill” vs. twice a day DOAC intake. Funding Acknowledgement Type of funding source: None

scholarly journals Clinical Impact of EUS-Guided Fine Needle Biopsy Using a Novel Franseen Needle for Histological Assessment of Pancreatic Diseases

2019 ◽  
Vol 2019 ◽  
pp. 1-8 ◽  
Author(s):  
Takuya Ishikawa ◽  
Hiroki Kawashima ◽  
Eizaburo Ohno ◽  
Hiroyuki Tanaka ◽  
Daisuke Sakai ◽  
...  
Keyword(s):  
Adverse Events ◽  
Diagnostic Accuracy ◽  
Needle Biopsy ◽  
Fine Needle Biopsy ◽  
Pancreatic Diseases ◽  
Fine Needle ◽  
Histological Assessment ◽  
Significant Difference ◽  
Group A ◽  
Group B

Background and Aims. Several studies have shown the benefits of endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) using a Franseen needle for histological assessment. However, studies focusing on pancreatic diseases are limited and the safety of this method has not been well assessed. We aimed to assess the current status and issues of EUS-FNB in the diagnosis of pancreatic diseases. Materials and Methods. We retrospectively reviewed 87 consecutive EUS-FNB specimens using either a 22-gauge Franseen needle (Group A, N = 51) or a conventional 22-gauge fine-needle aspiration needle (Group B, N = 36) for pancreatic diseases, and the diagnostic accuracy and safety were compared. Final diagnoses were obtained based on surgical pathology or a minimum six-month clinical follow-up. Results. Although the diagnostic accuracy for malignancy was 96.1% in Group A versus 88.9% in Group B, with no statistically significant difference (P = 0.19), the median sample area was significantly larger in Group A (4.07 versus 1.31mm2, P < 0.0001). There were no differences between the two needles in the locations from which the specimens were obtained. Adverse events occurred in one case (2%) in Group A (mild pancreatitis) and none in Group B with no statistical significance (P = 0.586). Although there was no case of bleeding defined as adverse events, 2 cases in Group A showed active bleeding during the procedure with increase in the echo-free space, which required CT scanning to rule out extravasation. Eventually, the bleeding stopped spontaneously. Conclusions. Given its guaranteed ability to obtain core specimens and comparable safety, and although the risk of bleeding should be kept in mind, EUS-FNB using a Franseen needle is likely to become a standard procedure for obtaining pancreatic tissue in the near future.

scholarly journals Comparison of clinical outcomes of sitagliptin+metformin combination and glimepiride in the management of uncomplicated type 2 diabetics

2018 ◽  
Vol 8 (1) ◽  
pp. 16
Author(s):  
Jarinabanu Tahashildar ◽  
Ravi Shekhar Singh ◽  
Jameela Tahashildar
Keyword(s):  
Adverse Events ◽  
Clinical Outcomes ◽  
Diabetic Patients ◽  
Open Label ◽  
Type 2 Diabetics ◽  
Significant Difference ◽  
Group A ◽  
Group B

Background: To evaluate the comparison of clinical outcomes of sitagliptin +metformin and glimepride in uncomplicated Type-2 diabetics.Methods: This one year (July 2016 to August 2017) prospective, open label, observational clinical cohort study was carried out on type-2 diabetics. In this study 299 Type-2 diabetics patients were enrolled and were randomly allocated to two groups viz Group A and Group B. Group A received sitaglitin+metformin (50+500) mg/day and Group B received glimepride 1mg/day respectively. The follow up started after 10 days of stabilization of the patient and data recorded on 10th day was considered Zero month data and follow up continued up to Six month in each group. Comparison of FPG, PPG and HbA1c was evaluated between zero and six months within group and at six month between groups. Adverse events were recorded and summarized by treatment group.Results: At the end of six months follow up the patients of Group A who received sitaglitin+metformin (50+500) mg/day had greater reduction in FPG, PPG and HbA1c (all P<0.001) was recorded when compared between zero and six month within group. A significant reduction in FPG, PPG and HbA1c (all P<0.01) also recorded in Group B who received glimepride 1mg/day when compared between zero and six months within group. A statically significant difference (all P<0.05) was recorded at six months between group. The adverse events like hypoglycemic episodes, gastrointestinal adverse events etc were greater in Group B than Group A. Changes in weight also noted in both Groups. Weight loss in Group A and weight gain in Group B was recorded.Conclusions: The present study suggests that a significant difference may be existing in the clinical outcome interm of glycemia control and adverse events between sitagliptin+metformin combination and glimepride in type-2 diabetic patients.

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