scholarly journals Diacerein Versus Chondroitin Sulfate in Treatment of Adult Kashin-Beck Disease: An Intervention Trial in Heilongjiang Province, China

2022 ◽  
Author(s):  
Xianhao Wu ◽  
Luyang Cheng ◽  
Jinjing Jia ◽  
Shili Song ◽  
Tongkun Shi ◽  
...  
Keyword(s):  
Renal Function ◽  
Chondroitin Sulfate ◽  
Side Effect ◽  
Womac Pain ◽  
Primary Efficacy ◽  
End Point ◽  
Group A ◽  
Efficacy Parameters ◽  
Group B ◽  
Beck Disease

Abstract Background: Kashin-Beck disease (KBD) is a special type of osteoarthritis and has disabled and stunted the growth of hundreds of people in China. It also can affect patients' ability to work and live. So, how to conduct effective treatment for adult KBD patients has become a major public health problem in current KBD endemic areas. In this trial, therapeutic effects of diacerein and chondroitin sulfate on adult KBD was to evaluate and compare so that we can screen out more suitable drug. Methods: 308 KBD patients were divided into two groups and received chondroitin sulphate (Group A) and diacerein (Group B) for 24 weeks, respectively. Data were collected at 0 week (baseline), 12 weeks (primary end point) and 24 weeks (secondary end point) to calculate the proportion of patients with effective therapeutic effect and overall improvement rate (primary efficacy parameters), WOMAC pain and stiffness scores (secondary efficacy parameters). Blood sample was collected to measure liver and renal function indexes. All indexes and parameters were analysed with SPSS software and intent-to-treat (ITT) analysis was applied. Results: Two primary efficacy parameters in group B at primary end point were significantly higher than those in group A (P=0.021, P=0.007), but no statistical differences were seen in these two primary efficacy parameters between two groups at secondary end point or between primary and secondary end points in same group (all P>0.05). In both groups, with the prolongation of treatment time, WOMAC pain and stiffness scores decreased significantly (all P<0.001), but no significant differences were seen between primary and secondary end points (all P>0.05). In addition, in both groups, the occurrences of total adverse events were relatively low and no side effect on liver function was seen. Diacerein also had no side effect on renal function. Conclusion: For treatment of adult KBD, both diacerein and chondroitin sulfate were effective, and diacerein might work stronger than chondroitin sulfate. Taking into account both efficacy and safety, the optimal intervention time of diacerein was 12 weeks. Trial registration: The trial was registered complementally on 31/10/2020, and the registration number in the Chinese Clinical Trial Registry is ChiCTR2000039600 (http://www.chictr.org.cn).

Efficacy and safety of nivolumab and trabectedin in pretreated patients with advanced soft tissue sarcomas (STS): Preliminary results of a phase II trial of the German Interdisciplinary Sarcoma Group (GISG-15, NitraSarc) for the non-L sarcoma cohort.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 11545-11545
Author(s):  
Daniel Pink ◽  
Dimosthenis Andreou ◽  
Anne Flörcken ◽  
Alexander Golf ◽  
Stephan Richter ◽  
...  
Keyword(s):  
Phase Ii ◽  
Single Agent ◽  
Primary Efficacy ◽  
Primary Efficacy Endpoint ◽  
Efficacy And Safety ◽  
Disease Stabilization ◽  
Group A ◽  
Pretreated Patients ◽  
Grade 3 ◽  
Group B

11545 Background: Single-agent PD-1 inhibitors have modest activity in the treatment of most STS. Potential strategies to increase efficacy include combination therapies targeting the tumor microenvironment. Considering that apart from direct growth inhibition and death of malignant cells, trabectedin (Tr) also induces macrophage depletion and/or different immunologic effects, suggesting a possible synergistic effect of combined Tr plus anti-PD-1 treatment. We therefore aimed to evaluate the efficacy and safety of combined Tr and nivolumab (Ni) as a second-line treatment in STS. Methods: The prospective, explorative, two group, non-randomized phase II NiTraSarc trial enrolled pretreated patients (pt) with advanced STS (Group A: lipo- or leiomyosarcomas, Group B: non-L-sarcomas). Pt were initially treated with 3 cycles of Tr 1.5 mg/m2, followed by the combination of Tr 1.5 mg/m2 + Ni 240 mg (“late combination cohort” (LCC)) for up to 16 cycles. After positive results of a preplanned interim analysis, pt received the combination therapy starting with cycle 2 (“early combination cohort” (ECC)). 92 pt were recruited to the trial (55 in Group A, 37 in Group B). Primary efficacy endpoint is progression-free survival rate after 6 months (PFSR6) according to RECIST v.1.1. This is a first analysis of the primary efficacy endpoint in Group B based on a modified intention-to-treat (mITT) population of evaluable 36 pt: 23 and 13 pt from the LCC and ECC, respectively. Results: The most common Group B subtypes comprised undifferentiated pleomorphic/not otherwise specified sarcoma (UPS/NOS, 13pt) and fibromyxoid sarcoma (FMS, 6pt). After a median follow-up of 5 months (m) PFSR6 was 13.9% for all pt, 8.7% in LCC and 23.1% in ECC. Median duration of disease stabilization (DoDS) was 4m in all pt, the LCC and the ECC. Two pt had a partial response (PR), 10 had disease stabilization (SD), while 13 pt progressed, and 11 had missing data. By subtype: PR- UPS/NOS=2 (DoDS 12.7m/12.5m). SD: UPS/NOS=3, epithelioid=2, synovial=2, FMS=1, fibrosarcoma=1, other=1. All 36 pt experienced at least one adverse event (AE) reaching a total of 579 AEs, 141 (24.4%) of which were considered to be grade ≥3 treatment-related AEs. The main grade ≥3 AEs were: leukopenia (47.2% of pt), neutropenia (41.7% of pt), thrombocytopenia (33.3% of pt), increased ALT (30.6% of pt), and anemia (27.8% of pt). Conclusions: Tr+Ni was well tolerated and showed activity in at least some patients with non-L-sarcomas (mostly UPS/NOS) especially in the ECC. Analyses of the collected data, including PD-L1 expression profile, with the goal to establish whether Tr+Ni should be further pursued in these patients, are ongoing. ClinicalTrials.gov Identifier: NCT03590210; EudraCT: 2017-001083-38. Clinical trial information: NCT03590210.

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.

P1722A new predictive score for mortality and cardiogenic shock in patients with ST-elevation myocardial infarction

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
B Picarra ◽  
J A Pais ◽  
A R Santos ◽  
M Carrington ◽  
D Bras ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Hospital Mortality ◽  
Cardiogenic Shock ◽  
High Rate ◽  
Predictive Score ◽  
Predictive Capacity ◽  
End Point ◽  
Group A ◽  
St Elevation ◽  
Group B

Abstract Introduction Acute Myocardial Infarction with ST elevation (STEMI) presents a high rate of potentially fatal complications and in-hospital mortality. Objective To test the predictive capacity for Cardiogenic Shock (CS) and In-hospital Mortality (MIH) of a new risk score in patients (Pts) with STEMI. Population and methods Evaluated 5765 Pts with STEMI without CS at admission. The new score, was derived by previous studies in this population, and was calculated according to the following criteria: age ≥65 years (1 point), heart rate ≥100bpm (2 points), systolic blood pressure <100mmHg (2 points), blood glucose at admission above 180 mg/dL (1 point) and creatinine at admission >1.5mg/dL (2 points). The population was divided into three subgroups: group A low score (0–2 points), group B intermediate score (3–5 points) and group C score (6–8 points). The endpoints defined were CS during hospitalization, in-hospital mortality and combined end-point of MIH and CS. The relationship between each of the possible scores (from 0 to 8) and the various end-points was determined, and the sensitivity and specificity of the score as a predictor of MIH and CS was defined as the area under the ROC curve (ASC). Results After the application of the score, 3 subgroups were obtained: group A with 4819 Pts (83,6%), group B with 884 Pts (15,3%) and group C 62 Pts (1,1%). Patients of group C had a higher MIH (Group C: 45,2% vs B: 11,4% vs A: 2,0%, p<0,001), higher CS (C: 29,5% vs B: 12,0% vs A: 2,3%, p<0,001) and a higher combined end-point of MIH and CC (C: 53,2% vs B: 17,8% vs A: 3,4%, p<0,001) during hospitalization. The proposed score revealed a high predictive capacity of MIH (ASC 0,802, 95% CI 0,775–0,830, p=0,001), of CS (ASC 0,763, 95% CI 0,731–0,795, p=0,001) and for the combined endpoint (MIH and CC) ASC 0,781, 95% CI 0,756–0,806, p=0,001). The logistic regression models showed that Pts with a high score (group C) presented a 41-fold higher risk of MIH (OR 41,3; p<0,001) and 18-fold higher CS (OR 18,0; p<0.001) than patients with low score (group A). It was also found that the risk associated with an increase in one point score unit was 100% (OR 2,0 p<0.001) for MIH and 82% (OR 1,82, p<0,001) for CS. Conclusion This new score, with the use of practical and friendly variables, demonstrated a high predictive capacity of MIH and CS.

Residual Renal Function Affects Lipid Profile in Patients Undergoing Continuous Ambulatory Peritoneal Dialysis

1997 ◽  
Vol 17 (3) ◽  
pp. 243-249 ◽  
Author(s):  
Alexander Kagan ◽  
Eti Elimalech ◽  
Zvi Lerner ◽  
Aaron Fink ◽  
Yaacov Bar-Khayim
Keyword(s):  
Renal Function ◽  
Peritoneal Dialysis ◽  
Lipid Profile ◽  
Continuous Ambulatory Peritoneal Dialysis ◽  
Density Lipoprotein ◽  
Serum Levels ◽  
Residual Renal Function ◽  
Lipoprotein Cholesterol ◽  
Group A ◽  
Group B

Objective To determine whether lipoprotein abnormalities associated with continuous ambulatory peritoneal dialysis (CAPD) are influenced by residual renal function (RRF). Design Open, non randomized prospective and com -parative study. Setting Single university teaching hospital dialysis unit and outpatient clinic. Patients Twenty adult patients on standard CAPD (1 -38 months) were divided into two groups: group A (RRF ≤ 0.8 mL/min, n = 10) and group B (RRF ≥ 1.1 mL/ min, n = 10). Patients in the two groups were matched for age, time on dialysis, body weight, body mass index, serum urea and albumin levels, peritoneal and urinary albumin losses, and peritoneal transport characteristics such as overnight 8hour peritoneal creatinine and β2-microglobulin clearances and overnight 8-hour effluent glucose concentrations. Results The degree of uremia in patients with preserved RRF (group B) was obviously lower than in patients with negligible RRF (group A), that is, patients in group B had significantly lower serum creatinine and β2-microglobulin levels and significantly higher weekly KTN than group A patients. Despite the prevalence of allele 4 of apolipoprotein E genotype in group A patients, their levels of serum total cholesterol, low-density lipoprotein cholesterol, lipoprotein (a) [Lp(a)], apolipoprotein B (ApoB), and apolipoprotein A1 (ApoA1) were significantly lower than those of patients with preserved RRF (group B). The two groups did not differ significantly in the serum levels of triglyceride or high-density lipoprotein cholesterol. Serum concentrations of Lp(a) and ApoA1, as well as ratios of ApoA1 to ApoB, were correlated significantly with RRF (r = 0.63, r = 0.51, and r = 0.61, respectively). Conclusions The findings suggest that RRF affects the lipid profile of CAPD patients, especially serum levels of cholesterol-rich lipoproteins.

scholarly journals 13 Amending Admission Protocol to Reduce Proton Pump Inhibitor-Induced Hyponatraemia on A Specialist Hip Fracture Unit

2020 ◽  
Vol 49 (Supplement_1) ◽  
pp. i1-i8
Author(s):  
R Darnell ◽  
B Clements ◽  
E Reeve ◽  
N Singh
Keyword(s):  
Hip Fracture ◽  
Proton Pump Inhibitor ◽  
Elderly Patients ◽  
Proton Pump ◽  
Side Effect ◽  
Sodium Concentration ◽  
Improvement Project ◽  
Number Of Patients ◽  
Group A ◽  
Group B

Abstract Introduction Hyponatraemia is a common electrolyte disturbance amongst elderly patients. Defined as a sodium concentration below 135 mmol/L, the BNF cites hyponatraemia as a ‘rare’ side effect of Omeprazole, a common proton pump inhibitor (PPI). In elderly patients, hyponatraemia can have significant morbidity. On our Hip Fracture Unit (HFU) at St Helier Hospital, all patients are commenced on Omeprazole on admission. We conducted a quality improvement project to reduce the incidence of PPI-induced hyponatraemia by altering standard protocol from Omeprazole to Ranitidine. Methods Phase 1: Retrospective analysis identifying incidence of PPI-induced hyponatraemia, defined as sodium concentration below 133mmol/L on two consecutive readings and resolving on switching to Ranitidine (Group A: n=86). Phase 2: Identifying incidence of hyponatraemia following administration of Ranitidine from admission (Group B: n=62). Exclusion criteria: Patients already on gastric protection or hyponatraemic on presentation. Chi squared analysis to establish statistical significance for risk of hyponatraemia associated with omeprazole. Results Total number of patients was 148. Age range 60-101 years (median 82 years). Incidence of PPI-induced hyponatraemia in Group A was 10.5% (9 cases). All resolved on switching to ranitidine. Following change in admission protocol to Ranitidine (Group B), incidence of hyponatraemia was 1.6% (1 case). The chance of developing hyponatraemia with Omeprazole was significantly higher than with ranitidine (P=0.0454). Conclusions 10.5% of admissions to the HFU experienced PPI-induced hyponatraemia. The European Medicines Agency defines side effects occurring at greater than 10% as very common. Whilst 45% of patients were on medication associated with hyponatraemia on admission, the absence of hyponatraemia at presentation and biochemical response when switching to ranitidine, demonstrates this is a significant side effect of PPIs. Given the increased morbidity associated with hyponatraemia, particularly in frail, elderly patients, amending protocol to ranitidine for gastric protection has the potential to reduce harm and improve patient outcomes.

Reversibility of Renal Failure in Newly Diagnosed Patients with Multiple Myeloma and the Role of Novel Agents.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 955-955 ◽  
Author(s):  
Maria Roussou ◽  
Efstathios Kastritis ◽  
Dimitrios Christoulas ◽  
Magdalini Migkou ◽  
Maria Gavriatopoulou ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Renal Function ◽  
Renal Impairment ◽  
High Dose ◽  
Newly Diagnosed ◽  
Agent Based ◽  
Renal Response ◽  
Group A ◽  
Group B ◽  
Novel Agent

Abstract Abstract 955 Renal impairment (RI) is a common complication of multiple myeloma (MM) and is associated with increased mortality. High dose dexamethasone-based regimens have been extensively used for the initial management of patients with MM presenting with RI. Recently, novel agent-based regimens have been introduced in the frontline management of MM. The purpose of our analysis was to assess the effect of novel agent-based regimens on the rate of RI improvement and compare their efficacy with conventional chemotherapy (CC) plus dexamethasone (Dexa) in newly diagnosed MM patients. Over the last decade, 82 patients with newly diagnosed MM and RI, defined as creatinine clearance (CrCI) <50ml/min, received frontline treatment in our Center. Patients were divided into three groups: group A: 28 patients who received CC plus Dexa-based regimens (VAD, VAD-like regimens, melphalan plus Dexa); group B: 38 patients who received IMiDs-based regimens (thalidomide or lenalidomide with high dose Dexa and/or cyclophosphamide or melphalan) and group C: 16 patients who received bortezomib-based regimens with Dexa. Renal complete response (RCR) was defined as a sustained increase of baseline CrCI to >60ml/min. Renal partial response (RPR) was defined as an increase of CrCI from<15 to 30-50ml/min. Renal minor response (RMR) was defined as sustained improvement of baseline CrCI of<15ml/min to 15-29 ml/min, or, if baseline CrCI was 15-29 ml/min, improvement to 30-59 ml/min. Patients in group B were older than those of groups A and C (p=0.01) while more patient in group C had light chain only MM than in groups A and B (p=0.04). There were no significant differences in the severity of RI, Bence Jones proteinuria, hypercalcemia or ISS stage among the three groups. Improvement of renal function, recorded as RMR or better, was achieved more frequently in patients treated with novel agents (group B: 87% and in group C: 94%) than in patients treated with CC plus Dexa-based regimens (64%, p=0.024). Among 9 patients who required renal dialysis 3 became independent of this procedure after treatment. We subsequently focused our analysis in major renal responses (RPR or RCR), because this endpoint is clinically more relevant. RCR was achieved in 43% of patients in group A, in 50% in group B and in 69% of patients in group C (p=0.2) and RCR+RPR rates were 50% and 57% and 81% for groups A, B and C respectively (p=0.1). Creatinine clearance <30 ml/min was associated with a significantly lower probability of RCR or RPR only in patients treated with CC plus Dexa- or with IMiDs-based regimens (p<0.01), but not in patients treated with bortezomib (p=0.529). The probability of RPR+RCR was similar for patients treated with IMiDs compared to CC plus Dexa-based regimens (p=0.619). In multivariate analysis bortezomib–based regimens (p=0.02, OR: 7, 95% CI 1.5-25) and CrCl>30 ml/min (p=0.002, OR: 6.1, 95% CI 2.5-22.5) were independently associated with a higher probability of RCR+RPR. The median time to RPR was similar for patients treated with IMiDs compared to CC plus Dexa-based regimens (2.2 months for Group A, 1.5 months for Group B, p=0.587) but it was significantly shorter for Group C (0.7 months, p=0.017). Other factors associated with a shorter time to ≥RPR included CrCl>30 ml/min (p=0.039) and age<75 (p=0.089). In multivariate analysis bortezomib–based regimens (p=0.004, OR: 3 95% CI 1.6-6.7) and CrCl>30 ml/min (p=0.006, OR: 2.5 95% CI 1.3-4.5) were independently associated with a shorter time to ≥RPR. In landmark analysis (time was one month in order to reduce bias due to early deaths), rapid improvement of renal function (≤1 month) was associated with a trend for a longer survival compared to patients who achieved renal response later (>1 month) (47 vs. 21 months, p=0.19). Myeloma response to treatment was 58%, 68% and 79% for the three treatment groups respectively and was associated with renal response (p=0.024), though less strongly with a major renal response (p=0.061). Our data indicate that novel agent-based regimens can improve renal function in most patients; furthermore bortezomib-based regimens improve renal function to a higher degree and significantly more rapidly than CC plus Dexa-based or IMiD-based regimens even in patients with severe renal impairment. We conclude that bortezomib-based regimens may be the preferred treatment for newly diagnosed myeloma patients who present with renal impairment. Disclosures: Dimopoulos: JANSSEN-CILAG: Honoraria; CELGENE: Honoraria.

Reversal of Renal Function and Its Prognostic Impact in Patients with Multiple Myeloma in the Era of Novel Agents

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 3056-3056
Author(s):  
Kentaro Narita ◽  
Yoshiaki Usui ◽  
Yasuhito Suehara ◽  
Kota Fukumoto ◽  
Manabu Fujisawa ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Renal Function ◽  
Mortality Rate ◽  
Light Chain ◽  
Reduction Rate ◽  
Prognostic Impact ◽  
Median Serum ◽  
Before And After ◽  
Group A ◽  
Group B

Abstract Aim and Background: Renal impairment (RI) is common feature in patients with multiple myeloma (MM) and is considered as a poor prognostic factor. Improvement of renal function can lead to the improved survival in patients with MM, however little is known on the prognostic impact of reversal of RI compared to that of the patients without RI at diagnosis in the novel agent era. To address this issue, we retrospectively analyzed the impact of RI on survival of newly diagnosed multiple myeloma (NDMM) patients with or without RI seen at our Department over the past 15 years. Patients and Methods: The study population included all patients diagnosed as MM and treated during May 2000 to March 2015 at Kameda Medical Center, Kamogawa-shi, Japan. We reviewed and retrospectively analyzed the medical records of the Department of Hematology/Oncology. All statistical analyses were performed with EZR, which is a graphical user interface for R ver. 3.2.1. Results: We identified 258 patients with NDMM during this period. RI was defined as eGFR<50ml/min/1.73m2. The median age of patients at diagnosis was 72 years (range 42-90), and 144 patients (55.6%) were male. The median follow-up period for the entire group was 37 months, median serum creatinine at diagnosis was 2.01mg/dL (range 0.4-15) and median eGFR was 52.4ml/min/1.73m2 (range: 2.11-136). RI was observed 122 patients (47.2%). Median serum creatinine of patients with and without RI at diagnosis was 2.07 mg/dL (range: 0.80-4.2) and 0.75mg/mL (range: 0.4-1.1), respectively (p<0.001). Patients with RI had significantly higher proportion of light-chain only disease (39.3% vs 12.5%, p<0.001), International Staging System (ISS) stage 3 (76.2%, vs 31.6%, p=0.001), and lower hemoglobin concentration (Hb<8.5mg/dL: 44.2% vs 21.3%, p<0.001). Bortezomib use, high risk cytogenetics, sex, serum LDH, age at diagnosis, amount of involved immunoglobulin, light chain subtype, and urine albumin at diagnosis were not different between patients with and without RI. Median overall survival (OS) for patients with (n=122) and without (n= 136) RI were 39 months and 57 months, respectively (p=0.16). The median OS for patients with or without RI before and after December 2006, when bortezomib became available in Japan, were 28 months and 41 months (p= 0.66), and 46 months and 71 months (p=0.01), respectively. To evaluate the prognostic impact of renal improvement on survival, patients were divided into 3 groups according to the eGFR and subsequent renal response: Group A; eGFR ≥ 50ml/min/1.73m2 at diagnosis, Group B; eGFR < 50 ml/min/1.73m2 at diagnosis but improved to >50ml/min/1.73m2, Group C; eGFR < 50 ml/min/1.73m2 at diagnosis, and remained <50 ml/min/1.73m2. Median OS of patients with Group A, B, and C was 57 months (n=136), 41 months (n=73), and 25 months (n=49), respectively (p=0.02) (Figure 1). When patients were analysed before and after 2006, the median OS of patients with group A, B, and C before 2006 were 41months (n=59), 38months (n=25) and 19months (n=15) (p=0.02), and those of after 2006 were 71 months (n=77), 46 months (n=48) and not reached (n=34) (p=0.03), respectively. On landmark analysis, median OS at 6 months in each group (Group A, B, and C) were 66 months (n=122), 43 months (n=42), 62 months (n=54), respectively (p= 0.74). Early mortality rate (within 6 months from diagnosis) was significantly higher in patients with group C (16%) compared to other groups (8.5% for group A and 8% for group B, respectively, p=0.03). Patients with group C has significantly higher proportion of mortality rate of infectious disease (26.9%) compared to other groups (7.6% for group A and 11.5% for group B, respectively, p=0.04). Reversal of RI was associated with free light chain (FLC) reduction rate >95% at day 21, age<70years, and treatment response ≥VGPR on univariate analysis, but only FLC reduction rate>95% at day 21 retained its significance on multivariate analysis Conclusions: Patients with MM with RI showed poor prognosis compared to those without RI. FLC reduction > 95% at day 21 was the independent prognostic predictor for reversal of RI. The higher mortality rate within 6 month of diagnosis observed in patients with RI without renal recovery might attribute to the inferior survival in patients with RI. Although patients with RI with improved renal function had superior survival compared to those without, it remains inferior to the patients without RI at diagnosis Figure 1. mOS of group A, B, and C Figure 1. mOS of group A, B, and C Disclosures No relevant conflicts of interest to declare.

scholarly journals A comparative prospective open label randomized controlled 8 week study in patients of depression treated with vilazodone and sertraline

2020 ◽  
Vol 7 (4) ◽  
pp. 643
Author(s):  
Nirmal Arya ◽  
Anuradha Nischal ◽  
Anil Nischal ◽  
Manu Agarwal
Keyword(s):  
Side Effect ◽  
Rating Scale ◽  
Sexual Experience ◽  
Open Label ◽  
Randomized Controlled ◽  
Parallel Group ◽  
Treatment Of Depression ◽  
Group A ◽  
Hamilton Anxiety Rating Scale ◽  
Group B

Background: Depression is a mood disorder treated with various antidepressant such as SSRIs due to lesser toxicity and improved safety profile.Methods: This was an eight week randomised active controlled parallel group study. 54 patients were allocated in two group. Group A received vilazodone while group B received sertraline. Assessment done at baseline, 2, 4 and 8 weeks on the basis of clinical efficacy, sexual dysfunction, side effects and weight gain using Hamilton Depression Rating Scale (HAM-D), Hamilton Anxiety Rating Scale (HAM-A), Arizona Sexual Experience Scale (ASEX) and UKU Side Effect Rating Scale.Results: HAM-D score of group A was 18.78±1.78 and 7.67±1.66 while in group B was 19.04±2.12 and 8.15±1.77 at baseline and 8 weeks respectively. HAM-A score of group A was 15.44±1.50 and 6.63±1.39 while in group B was 15.26±1.83 and 7.07±1.14 at baseline and 8 weeks. ASEX total score of group A was 15.63±1.28 and 14.63±1.33 while group B was 15.52±1.37 and 16.41±1.12 at baseline and 8 weeks. ASEX desire score of group A was 9.63±0.93 and 8.67±0.88 while of group B was 9.59±0.93 and 10.07±0.92 at baseline and 8 weeks. UKU side effect rating at 2 and 8 weeks of group A was 0.22±0.42, 1.04±0.76 while in group B was 0.37±0.49, 1.89±0.85.Conclusions: Vilazodone and Sertraline are equally efficacious in treatment of depression and associated anxiety. When side effect profile were compared Vilazodone is found superior to Sertraline

scholarly journals Lenalidomide and Low Dose Dexamethasone in Previously Treated Multiple Myeloma Patients with Impaired Renal Function: Efficacy Analysis of PrE1003, a Precog Study

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 5712-5712
Author(s):  
Joseph Mikhael ◽  
Judi Manola ◽  
Sagar Lonial ◽  
Brendan M Weiss ◽  
Kurt Oettel ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Renal Function ◽  
Renal Insufficiency ◽  
Research Funding ◽  
Impaired Renal Function ◽  
Response Rate ◽  
Phase 2 ◽  
25Mg Daily ◽  
Group A ◽  
Group B

Abstract Introduction: Lenalidomide (Len) and dexamethasone (dex) has proven to be a highly effective treatment for multiple myeloma (MM) and serves as the basis of other combinations in relapsed disease. However, nearly 1/3 of myeloma patients have renal insufficiency, and the optimal use of Len in this population is not well known. We undertook this study in 3 cohorts of pts: Group A had creatinine clearance (CrCl) of 30-60 ml/min, Group B with CrCl < 30 ml/min, and Group C, with CrCl < 30 ml/min and requiring dialysis. The Phase I component of the trial has been previously reported (ASCO 2014) demonstrating that full dose Len (25mg daily 21/28 days) can be given to all patients despite renal insufficiency, even when on dialysis. We now present data on response to treatment. Methods: In the Phase 2 component accrual was slow and the trial was terminated. However, prior to termination a modified exploratory analysis plan was established, including all 34 patients treated at the recommended phase 2 dose. This plan would declare the treatment worthy of further study if 18 or more of the 34 patients responded to treatment. This design had 84% power to distinguish a response rate of 60% from a null rate of 40%, using a 1-sided test with 10% type I error. Results: The Phase 2 efficacy cohort accrued 34 patients, consisting of 20 patients from Group A, 9 patients from Group B, and 5 patients from Group C. Response of PR or greater was seen in 17 patients, resulting in a 50% overall response rate (CI 37-63%). Treatment was well tolerated with expected adverse events; the most common adverse events were anemia, diarrhea, and fatigue. Eleven episodes of Grade 3 and one Grade 4 pneumonia were reported for 10 patients across all cohorts and dose levels; 3 were considered possibly related to treatment. Seventeen patients have remained on treatment for more than 12 cycles. In the exploratory analyses, median PFS was 7.5 months (95% CI, 3.6 - 19.7 months) and median OS was 19.7 months (95% CI, 10.4 - 42.5 months). Conclusions: Len Dex can be safely administered to patients with impaired renal function at full dose of 25mg daily 21/28 days, and is associated with a 50% response rate. Further investigation into other combinations with Len Dex in patients with renal impairment should be considered. Table Table. Disclosures Mikhael: Onyx: Research Funding; Sanofi: Research Funding; Abbvie: Research Funding; Celgene: Research Funding. Lonial:Merck: Consultancy; Novartis: Consultancy; Onyx: Consultancy; BMS: Consultancy; Onyx: Consultancy; Celgene: Consultancy; BMS: Consultancy; Novartis: Consultancy; Celgene: Consultancy; Janssen: Consultancy; Millenium: Consultancy; Janssen: Consultancy. Weiss:Novartis: Consultancy.

scholarly journals Comparison Of Diacerein-Ginger With Diacerein Alone In Treating Knee Osteoarthritis

2019 ◽  
Vol 09 (04) ◽  
pp. 308-311
Author(s):  
Mehtab Munir ◽  
Shahid Mustafa Memon ◽  
Sajid Abbas Jaffri ◽  
Khalid Mustafa Memon
Keyword(s):  
Knee Osteoarthritis ◽  
P Value ◽  
Womac Pain ◽  
Test Results ◽  
Knee Oa ◽  
Significant Difference ◽  
Group A ◽  
Insignificant Difference ◽  
Group B ◽  
Pain At Rest

Objective: To compare clinical efficacy of diacerein-ginger with diacerein alone in treating knee osteoarthritis. Duration and place of study: It was a randomized clinical trial conducted from 21st September 2018 to 31stMarch 2019, in medical OPD of a private hospital in Karachi. Methodology: 60 diagnosed patients of knee osteoarthritis were included in this study. Male and female patients 50 years of age, fulfilling the inclusion criteria and after written informed consent experienced a wash-out period of 72 hours. These patients were systematically randomized into 2 groups each having 30 members. Group A received capsule Diacerein 50mg + capsule Ginger 550 mg twice daily and group B received capsule Diacerein 50mg twice daily, for 12 weeks. Parameters checked at 0, 6 and 12 weeks were: Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index, pain at rest and movement (Visual Analogue Scale). Comparison of the two groups was done by independent t-test. Results: Among 60 patients; 20 (33.33 %) were males and 40 (66.66%) were females. 4 patients in group A and 4 in B, dropped out during the study. Comparison of group A with group B in WOMAC and pain (at rest and movement) scores showed insignificant difference at day 0 before prescription of the drugs. However comparison showed highly significant difference (P-value < 0.001) between the two groups in WOMAC, pain at rest and movement scores at the end of 6th and 12th weeks of intervention. Conclusion: Diacerein-Ginger is clinically more efficacious for management of knee OA than Diacerein alone

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