scholarly journals Efficacy and safety of a flexible extended regimen of ethinylestradiol/drospirenone for the treatment of dysmenorrhea: a multicenter, randomized, open-label, active-controlled study

2017 ◽  
Vol Volume 9 ◽  
pp. 295-305 ◽  
Author(s):  
Mikio Momoeda ◽  
Masami Kondo ◽  
Jörg Elliesen ◽  
Masanobu Yasuda ◽  
Shigetomo Yamamoto ◽  
...  
Keyword(s):  
Controlled Study ◽  
Efficacy And Safety ◽  
Open Label

485 Efficacy and Safety of Once- and Twice-Nightly Dosing of Lower-Sodium Oxybate in Adults With Idiopathic Hypersomnia

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A191-A192
Author(s):  
Isabelle Arnulf ◽  
Anne Marie Morse ◽  
Patricia Chandler ◽  
Rupa Parvataneni ◽  
Dan Chen ◽  
...  
Keyword(s):  
Sodium Oxybate ◽  
Mean Difference ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Open Label ◽  
Double Blind ◽  
Patient Global Impression ◽  
Idiopathic Hypersomnia ◽  
Secondary Endpoints ◽  
Global Impression Of Change

Abstract Introduction Idiopathic hypersomnia (IH) is a rare central hypersomnolence disorder. In a randomized, controlled study of lower-sodium oxybate (LXB; Xywav™) in adults with IH (NCT03533114), significant differences for LXB compared with placebo were observed in Epworth Sleepiness Scale (ESS; primary efficacy endpoint), self-reported Patient Global Impression of Change (PGIc), and IH Severity Scale (IHSS; key secondary endpoints). In this clinical study, investigators were permitted to initiate LXB dosing on a once-nightly or twice-nightly regimen. Methods Eligible participants aged 18–75 years began LXB treatment, administered once or twice nightly during an open-label treatment/titration and optimization period (OLTTOP; 10–14 weeks); dose amount/regimen could be adjusted during this period. Participants next entered a 2-week, open-label, stable-dose period (SDP), then were randomized to placebo or to continue LXB treatment during a 2-week, double-blind, randomized withdrawal period (DBRWP). P values are nominal for this exploratory analysis. Results Of 154 enrolled participants, 40 (26%) initiated LXB treatment on a once-nightly regimen. In the efficacy population (n=115), 27 participants were on a once-nightly regimen during SDP (48.1% of whom initiated treatment once nightly during OLTTOP) and 88 participants were on a twice-nightly regimen during SDP (86.4% of whom initiated treatment twice nightly during OLTTOP). During SDP, median (min, max) LXB total dose was 4.5 (2.5, 6) g/night (once-nightly group) and 7.5 (4.5, 9) g/night (twice-nightly group). ESS scores worsened in participants randomized to placebo vs those continuing LXB in the once-nightly group (n=11 and n=15, respectively; LS mean difference [95% CI]: −4.93 [−7.41, −2.46]; P=0.0004) and twice-nightly group (n=47 and n=41, respectively; LS mean difference [95% CI]: −7.44 [−9.15, −5.72]; P<0.0001). Worsening was also observed in PGIc (once-nightly: 81.8% [placebo] vs 26.7% [LXB]; P=0.0077; twice-nightly: 89.4% [placebo] vs 19.5% [LXB]; P<0.0001) and IHSS score (estimated median difference [95% CI], once-nightly: −9.00 [−16.0, −3.0]; P=0.0028; twice-nightly: −12.00 [−15.0, −8.0]; P<0.0001). Common adverse events included nausea (21.4%), headache (16.2%), anxiety (14.9%), dizziness (11.7%), insomnia (11.7%), and vomiting (10.4%). Conclusion The efficacy and safety of LXB in IH were demonstrated for both once-nightly and twice-nightly regimens. The majority of participants initiated and remained on a twice-nightly regimen. Support (if any) Jazz Pharmaceuticals

scholarly journals Preliminary results of an adaptive randomized open-label controlled study on the efficacy and safety of enisamium iodide for outpatient treatment of the COVID-19 infection

2021 ◽  
Vol 5 (11) ◽  
pp. 705-711
Author(s):  
N.Yu. Pshenichnaya ◽  
◽  
K.V. Zhdanov ◽  
Keyword(s):  
Respiratory Failure ◽  
Adverse Events ◽  
Primary Endpoint ◽  
Outpatient Treatment ◽  
Comparison Group ◽  
Controlled Study ◽  
Study Group ◽  
Efficacy And Safety ◽  
Open Label ◽  
Iodide Film

Aim: to assess the efficacy and safety of enisamium iodide (film-coated tablets, 250 mg) for outpatient treatment of moderate-to-severe COVID-19 infection. Patients and Methods: this adaptive, randomized, open-label controlled study on the efficacy and safety of enisamium iodide enrolled 194 patients. The study group included 97 patients, and the comparison group included 97 patients. Comparison group patients received standard therapy. Study group patients received orally 500 mg of enisamium iodide three times daily for seven days. In addition, pathogenic and symptomatic treatment was prescribed. The first component of the primary endpoint was composite efficiency parameter. The second component of the primary endpoint was the proportion of patients with respiratory failure. Registration of deaths, adverse events and serious adverse events was carried out by standard methods. Results: cohort enrollment into part 1 of the study and treatment of all patients were completed. The mean time of the relief of major COVID-19 symptoms (primary combination endpoint) and differences between the study and comparison groups (8 days and 9 days, respectively, p=0.028) were revealed. The rate of respiratory failure in the study group and comparison group was: 4 (4,12%) versus 8 (8,25%) cases respectively. In addition, the effect of this drug on mortality in the groups was compared (one death in the study group and five deaths in the comparison group). The statistical reliability of these differences will be determined during part 2 of this study that started in September 2021. Conclusions: the efficacy and safety of enisamium iodide (film-coated tablets, 250 mg) for the COVID-19 were evaluated. A significant reduction in the time to clinical recovery (by one day) was reported in patients who received enisamium iodide. In addition, the rate of severe respiratory failure and associated mortality also tends to reduce after therapy that includes enisamium iodide. KEYWORDS: enisamium iodide, antivirals, etiopathogenic treatment, SARS-CoV-2, COVID-19, viral lung damage, pneumonia, randomized controlled study, adaptive study, open-label study. FOR CITATION: N.Yu. Pshenichnaya, Zhdanov K.V. Preliminary results of an adaptive randomized open-label controlled study on the efficacy and safety of enisamium iodide for outpatient treatment of the COVID-19 infection. Russian Medical Inquiry. 2021;5(11):705–711 (in Russ.). DOI: 10.32364/2587-6821-2021-5-11-705-711.

Efficacy and Safety of Adalimumab Treatment in Patients with Moderate to Severe Psoriasis: A Double-Blind, Randomized Clinical Trial

2007 ◽  
Vol 13a (1) ◽  
pp. 4-11 ◽  
Author(s):  
Kenneth B. Gordon ◽  
Robin R. Blum ◽  
Kim A. Papp ◽  
Robert Matheson ◽  
Chantal Bolduc ◽  
...  
Keyword(s):  
Plaque Psoriasis ◽  
Dosage Reduction ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Open Label ◽  
Double Blind ◽  
Necrosis Factor Alpha ◽  
Severe Plaque Psoriasis ◽  
Tnf Α ◽  
Adalimumab Therapy

Background Tumor necrosis factor-alpha (TNF-α) is pivotal in the pathogenesis of psoriasis, an immune-mediated disease. Adalimumab is a fully human, IgG1 monoclonal antibody that inhibits TNF-α. Objectives The aims of this study were to assess the efficacy and safety of adalimumab therapy for patients with moderate to severe plaque psoriasis and evaluate the duration of treatment response after withdrawal from or dosage reduction of adalimumab therapy. Methods In this multicenter, randomized, double-blind, placebo-controlled study, patients with moderate to severe plaque psoriasis received 12-week, open-label therapy with subcutaneous adalimumab, consisting of 80 mg of adalimumab at weeks 0 and 1, followed by 40 mg weekly at weeks 2–11. At week 12, patients who had an improvement in Psoriasis Area and Severity Index (PASI) score of ≥50% were randomized to blinded therapy and received either adalimumab 40 mg every other week (eow) or placebo for an additional 12 weeks. Results A total of 148 patients enrolled. Clinical response was rapid, with a PASI 50 response rate of 28% at week 2 of adalimumab therapy. At week 12, 91.9% (136/148) of patients had achieved ≥50% reduction in PASI (PASI 50) vs. baseline, 76.4% (113/148) had achieved PASI 75, and 47.3% (70/148) had achieved PASI 90. Of patients who were randomized to placebo at week 12, 30.9% (21/68) experienced a relapse (<PASI 50 improvement vs. baseline) by week 24, compared with 16.2% (11/68) of patients who received adalimumab 40 mg eow. In addition, 48.5% (33/68) of patients who were randomized to placebo at week 12 were PASI 75 responded at week 24, compared with 67.6% (46/68) of patients randomized to adalimumab 40 mg eow (p=0.032). And, 27.9% (19/68) of patients who were randomized to placebo at week 12 were PASI 90 responders at week 24, compared with 47.1% (32/68) of patients randomized to adalimumab 40 mg eow (p=0.028). Adalimumab was generally well-tolerated, and the rates of adverse events were comparable between the adalimumab and placebo groups. Conclusions Weekly adalimumab therapy rapidly improved psoriasis during an initial 12-week period. Improvement was sustained in most, but not all patients, despite dosage reduction to every other week. No patients randomized to adalimumab withdrawal (placebo at week 12) experienced rebound, and most maintained >PASI 50 improvement, relative to baseline, during the 3 months following adalimumab discontinuation. Overall, greater efficacy rates at week 24 were observed for patients randomized to continuous adalimumab therapy than for patients who were withdrawn from therapy at week 12.

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