scholarly journals Triamcinolone Acetonide in the Treatment of Perennial Allergic Rhinitis: A post hoc Analysis of Quality of Life during a Phase III Study

2021 ◽  
pp. 1-8
Author(s):  
Alexander V. Karaulov ◽  
Natalia Nenasheva ◽  
Yury Smolkin ◽  
Aleksandr Maslakov ◽  
Luiz Lucio
Keyword(s):  
Quality Of Life ◽  
Allergic Rhinitis ◽  
Triamcinolone Acetonide ◽  
Allergic Conjunctivitis ◽  
Phase Iii ◽  
Treatment Groups ◽  
Post Hoc Analysis ◽  
Previous Diagnosis ◽  
Post Hoc

<b><i>Introduction:</i></b> Allergic rhinitis (AR) is a disease that affects ≤24% of people in Russia, significantly impairing quality of life (QoL). Intranasal corticosteroids, such as triamcinolone acetonide (TAA), are considered effective drugs for treatment. A post hoc analysis of data (phase III NASANIF trial) examined weekly QoL changes in patients receiving TAA for the treatment of perennial AR (PAR). <b><i>Methods:</i></b> NASANIF (NCT03317015) was a double-blind, parallel group, multicenter, prospective, noninferiority, phase III clinical trial. Patients with PAR were randomized (1:1) to receive TAA or fluticasone propionate (FP) for 4 weeks. Here, a post hoc analysis measures QoL using a shortened Rhinoconjunctivitis Quality of Life Questionnaire (miniRQLQ). Differences in miniRQLQ score were evaluated using a mixed linear model and descriptive statistics. A subgroup analysis was performed in patients with a previous diagnosis of allergic conjunctivitis. <b><i>Results:</i></b> Of 260 patients eligible for randomization, 128 each completed treatment with TAA or FP. Overall and individual domain scores progressively improved and were significantly different versus baseline at week 4 in both treatment groups: LS mean difference TAA: −30.92 (95% CI [−33.01 to −28.83]), <i>p</i> &#x3c; 0.001, and FP: −31.13 (−33.23 to −29.04), <i>p</i> &#x3c; 0.001. In both arms of the subgroup, there was a significant reduction in eye symptoms. There was no significant difference between the TAA and FP treatment groups in any analyses. <b><i>Conclusions:</i></b> TAA is effective in improving overall and individual domains of QoL in patients with PAR, over 4 weeks. Patients with a previous diagnosis of allergic conjunctivitis experienced significant improvements in QoL related to the resolution of these symptoms.

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.

scholarly journals Quality of life and functional outcomes with tapentadol prolonged release in chronic musculoskeletal pain: post hoc analysis

2020 ◽  
Author(s):  
Cesar Margarit Ferri ◽  
Silvia Natoli ◽  
Paz Sanz-Ayan ◽  
Alberto Magni ◽  
Carlos Guerrero ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Chronic Pain ◽  
Phase Iii ◽  
Prolonged Release ◽  
Post Hoc Analysis ◽  
Three Phase ◽  
Sf 36 ◽  
Phase Iii Trials ◽  
Post Hoc

Aims: To investigate quality of life (QOL) and functionality changes in chronic pain during tapentadol prolonged release (PR) treatment. Patients & methods: Post hoc analysis of data from three Phase III trials in patients with osteoarthritis knee pain or low back pain. QOL and functionality changes were assessed by SF-36 scores. Results: All SF-36 subdomain scores improved progressively to week 3 of tapentadol titration and were sustained during 12-week maintenance treatment. Improvements in SF-36 scores were similar between tapentadol dose groups (e.g., 200 to <300 mg vs ≥500 mg), with no greater effect from higher doses. QOL and functionality improvements were consistently greater with tapentadol PR than oxycodone controlled release. Conclusion: Tapentadol PR provides consistent, clinically relevant improvements in QOL and functionality in chronic pain.

scholarly journals Evaluation of efficacy and safety of montelukast and levocetirizine FDC tablet compared to montelukast and levocetirizine tablet in patients with seasonal allergic rhinitis: a randomized, double blind, multicentre, phase III trial

2020 ◽  
Vol 7 (1) ◽  
pp. 83
Author(s):  
Sagar Panchal ◽  
Saiprasad Patil ◽  
Hanmant Barkate
Keyword(s):  
Quality Of Life ◽  
Allergic Rhinitis ◽  
Seasonal Allergic Rhinitis ◽  
Phase Iii ◽  
Fixed Dose ◽  
Controlled Study ◽  
Global Evaluation ◽  
Double Blind ◽  
Nasal Symptoms

<p class="abstract"><strong>Background:</strong> To evaluate efficacy, safety and tolerability of Montelukast 10 mg+levocetirizine 5 mg  FDC compared to either montelukast 10 mg or levocetirizine 5 mg given alone in seasonal allergic rhinitis (SAR) patients.</p><p class="abstract"><strong>Methods:</strong> Phase III, multicentre, randomized, double blind, parallel group, active controlled study was conducted in 279 SAR patients at 16 sites across India. Efficacy was assessed using daytime nasal symptoms score (Primary efficacy outcome), night-time symptoms score, daytime eye symptom score, patient's global evaluation, physician's global evaluation, rhino-conjunctivitis quality-of-life score.  </p><p class="abstract"><strong>Results:</strong> At end of treatment there was statistically significant evidence from the per protocol analysis that patients on FDC had a greater improvement in change from baseline in daytime nasal symptoms score than patients who received Montelukast (p=0.0266) or Levocetirizine (p=0.0409). These results were consistent with the Intent to treat analysis. Analysis of the secondary efficacy endpoints provided numerically greater improvement in the nighttime symptoms score, daytime eye symptoms score, and rhinoconjunctivitis quality-of-life scores in the FDC group as compared to the Montelukast group or Levocetirizine group. The FDC of Montelukast and Levocetirizine was found to be safe and generally well tolerated. The majority of adverse events were mild in severity, resolved without treatment and were unrelated to study medication.</p><p class="abstract"><strong>Conclusions:</strong> Fixed dose combination of Montelukast and Levocetirizine was safe, generally well tolerated and superior on efficacy compared to Montelukast or Levocetirizine in patients of seasonal allergic rhinitis.</p>

scholarly journals Experience of patisiran with transthyretin stabilizers in patients with hereditary transthyretin-mediated amyloidosis

2020 ◽  
Vol 10 (5) ◽  
pp. 289-300 ◽  
Author(s):  
Hollis Lin ◽  
Madeline Merkel ◽  
Cecilia Hale ◽  
Jing L Marantz
Keyword(s):  
Quality Of Life ◽  
Diabetic Neuropathy ◽  
Phase Ii ◽  
Phase Iii ◽  
Open Label ◽  
Safety And Efficacy ◽  
Impairment Score ◽  
Open Label Extension ◽  
Post Hoc

Aim: Examine safety and pharmacodynamics of patisiran alone or with concomitant transthyretin stabilizers from the Phase II open-label extension study and safety and efficacy of patisiran in patients with prior transthyretin stabilizer use from the Phase III APOLLO study. Patients & methods: Post hoc analyses in patients with hereditary transthyretin-mediated amyloidosis with polyneuropathy. Results: Patisiran safety was consistent regardless of concomitant or prior transthyretin stabilizers. In the Phase II open-label extension (n = 27), transthyretin reduction was similar over 24 months, regardless of concomitant transthyretin stabilizers. In APOLLO (n = 225), patisiran-treated groups showed stabilization or improvements in neurological function (modified Neuropathy Impairment Score +7) and quality of life (Norfolk Quality of Life-Diabetic Neuropathy questionnaire) at 18 months, regardless of prior transthyretin stabilizers. Conclusion: Patients benefit from patisiran regardless of transthyretin stabilizer use.

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