Adjunctive Triamcinolone Acetonide for Ahmed Glaucoma Valve Implantation: A Randomized Clinical Trial

2016 ◽  
Vol 27 (4) ◽  
pp. 411-416 ◽  
Author(s):  
Shahin Yazdani ◽  
Azadeh Doozandeh ◽  
Mohammad Pakravan ◽  
Vahid Ownagh ◽  
Mehdi Yaseri
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Triamcinolone Acetonide ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Final Analysis ◽  
Ahmed Glaucoma Valve ◽  
Hypertensive Phase ◽  
The Difference ◽  
Valve Implantation

Purpose To evaluate the effect of intraoperative sub-Tenon injection of triamcinolone acetonide (TA) as an adjunct to Ahmed glaucoma valve (AGV) implantation. Methods In this triple-blind randomized clinical trial, 104 eyes with refractory glaucoma were randomly assigned to conventional AGV (non-TA group) or AGV with adjunctive triamcinolone (TA group). In the TA group, 10 mg TA was injected in the sub-Tenon space around the AGV plate intraoperatively. Patients were followed for 1 year. The main outcome measure was intraocular pressure (IOP). Other outcome measures included best-corrected visual acuity (BCVA), occurrence of hypertensive phase (HP), peak IOP, number of antiglaucoma medications, and complications. Results A total of 90 patients were included in the final analysis. Mean IOP was lower in the TA group at most follow-up visits; however, the difference was statistically significant only at the first month (p = 0.004). Linear mixed model showed that mean IOP was 1.5 mm Hg lower in the TA group throughout the study period (p = 0.006). Peak postoperative IOP was significantly lower in the TA group (19.3 ± 4.8 mm Hg versus 29 ± 9.2 mm Hg, p = 0.032). Rates of success (defined as 6 < IOP <21 mm Hg) were similar in both groups at 12 months. There was no difference in the occurrence of the HP between the 2 groups (p = 0.123). Loss of BCVA >2 lines was more common in the non-TA group (p = 0.032). Conclusions Adjunctive intraoperative TA injection during AGV implantation can blunt peak IOP levels and reduce mean IOP up to 1 year. Visual outcomes also seem to be superior to standard surgery.

A threshold linear mixed model for identification of treatment-sensitive subsets in a clinical trial based on longitudinal outcomes and a continuous covariate

2020 ◽  
Vol 29 (10) ◽  
pp. 2919-2931
Author(s):  
Xinyi Ge ◽  
Yingwei Peng ◽  
Dongsheng Tu
Keyword(s):  
Clinical Trial ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Likelihood Function ◽  
Specific Treatment ◽  
Likelihood Method ◽  
Simulation Studies ◽  
Longitudinal Outcomes ◽  
Continuous Covariate

Identification of a subset of patients who may be sensitive to a specific treatment is an important problem in clinical trials. In this paper, we consider the case where the treatment effect is measured by longitudinal outcomes, such as quality of life scores assessed over the duration of a clinical trial, and the subset is determined by a continuous baseline covariate, such as age and expression level of a biomarker. A threshold linear mixed model is introduced, and a smoothing maximum likelihood method is proposed to obtain the estimation of the parameters in the model. Broyden-Fletcher-Goldfarb-Shanno algorithm is employed to maximize the proposed smoothing likelihood function. The proposed procedure is evaluated through simulation studies and application to the analysis of data from a randomized clinical trial on patients with advanced colorectal cancer.

Addition of ATRA to the Maintenance Protocol Did Not Improve Disease-Free Survival: Results of the Russian APL Trial.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 4374-4374
Author(s):  
Elena N. Parovichnikova ◽  
Valeri G. Savchenko ◽  
Valentin G. Isaev ◽  
Elena N. Shuravina ◽  
Irina A. Demidova ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Total Dose ◽  
Randomized Clinical Trial ◽  
Maintenance Treatment ◽  
Disease Free Survival ◽  
Final Analysis ◽  
Study Group ◽  
Free Survival ◽  
Multivariant Analysis ◽  
Disease Free

Abstract Russian Leukemia study group is presenting the final analysis of the APL-06.01. randomized clinical trial. The aim of the study was to identify the efficacy of ATRA substitution of each other chemotherapy course while the 2-yrs maintenance after three induction/ consolidation 7+3 with daunorubicin dose of 180 mg/m2 per course and ATRA for 30 days while the first induction. The patients were randomized for two types of maintenance - (I type) rotation of 5-days ARA-C (100 mg/m2 bid) combined with daunorubicin (45 mg/m2 for 2 days, till the total dose of 650 mg/m2) or 6-MP (50mg/m2 p.o.5 days) or CHP (800 mg/m2 i.v.1 day) or (II type) rotation of the same courses of chemotherapy with 5-days 45 mg/m2 ATRA course. The II type of maintenance treatment contained twice less chemotherapy. The intervals between courses were 4 weeks From July, 2001 till January, 2006 114 APL patients from 26 centers were enrolled in the study. In 95% of pts APL was confirmed by cytogenetics or PCR. 102 patients were included in the analysis. CR rate was 85%, ED rate -15%, 4-yrs OS -68,3%, DFS - 77,4%, CCR - 89,5%. Suvival analysis according to randomization did not demonstrate statistical differences, but showed a trend (p=0,06) towards better DFS and CCR in patients maintened with chemotherapy only: 85,2% and 94,3% (I type) and 77,7% and 85,6% (II type). In the multivariant analysis only one factor was defined as statistically significant - the number of the patients randomized by the participating centers. OS and DFS were much higher in the centers randomized 6 and more patients comparing with less than 6 patients: 82,9%and 90,7% vs 48,8% and 63%, respectively (0,003). 1. So we can suggest that maintenance with ATRA alternating with chemotherapy is less effective than chemotherapy only. Whether addition not substitution of ATRA to chemotherapy maintenance will change the results will be checked in the next study.2. The experince of the centers in APL treatment is a cruicial point for survival.

scholarly journals Triamcinolone Acetonide in the Treatment of Perennial Allergic Rhinitis: A post hoc Efficacy Analysis of a Phase III Study Performed in Russia

2021 ◽  
pp. 1-8
Author(s):  
Alexander V. Karaulov ◽  
Natalia I. Ilina ◽  
Natalia Shartanova ◽  
Aleksandr Maslakov ◽  
Luiz Lucio
Keyword(s):  
Allergic Rhinitis ◽  
Triamcinolone Acetonide ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Nasal Symptom ◽  
Phase Iii ◽  
Double Blind ◽  
Post Hoc Analysis ◽  
Post Hoc ◽  
To Receive

<b><i>Introduction:</i></b> Allergic rhinitis (AR) is a disease which affects &#x3e;24% of the population in Russia. Triamcinolone acetonide (TAA) is a corticosteroid used for treating AR. This post hoc analysis assesses the efficacy of intranasal TAA in improving perennial AR (PAR) symptom scores over 4 weeks. <b><i>Methods:</i></b> NASANIF (NCT03317015) was a double-blind, parallel-group, multicenter, prospective, non-inferiority, phase III clinical trial in which patients with PAR were randomized (1:1) to receive TAA or fluticasone propionate (FP) over 4 weeks. Our post hoc analysis evaluates weekly change in PAR symptoms using the reflective Total Nasal Symptom Score (rTNSS), overall and for individual symptoms (sneezing, nasal itching, rhinorrhoea, and nasal obstruction). Proportion of patients and time to achieve a ≥50 or ≥75% reduction in rTNSS were assessed. For rTNSS endpoints, a linear mixed-model methodology was used; for time-to-event endpoints, cumulative incidence functions were estimated using the Kaplan-Meier method, in the per-protocol population. <b><i>Results:</i></b> Of 260 patients, 128 each completed the study and were randomized to receive TAA or FP. From baseline to week 4, the changes in total rTNSS were −7.78 (95% CI: −8.1701 to −7.3967; <i>p</i> &#x3c; 0.001) and −7.52 (−7.9053 to −7.1320; <i>p</i> &#x3c; 0.001) for TAA and FP, respectively. Individual symptoms improved significantly from baseline. The proportion of patients achieving ≥50 and ≥75% reductions in total rTNSS was 88.0 and 67.2%, respectively in the TAA group. No significant differences were observed between the TAA and FP in any analyses. <b><i>Conclusions:</i></b> TAA produced effective and prolonged improvement of PAR symptoms over a 4-week treatment period.

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