Erratum to: Efficacy and Safety of 5-Fluorouracil 0.5%/Salicylic Acid 10% in the Field-Directed Treatment of Actinic Keratosis: A Phase III, Randomized, Double-Blind, Vehicle-Controlled Trial

We evaluated the efficacy and safety of ciprofloxacin dry powder for inhalation (DPI) in patients with non-cystic fibrosis bronchiectasis, two or more exacerbations in the previous year and pre-defined bacteria in sputum.In this phase III, double-blind, placebo-controlled trial, patients were randomised 2:1 to twice-daily ciprofloxacin DPI 32.5 mg or placebo in two treatment regimens consisting of on/off treatment cycles of 14 or 28 days for 48 weeks. The primary end-points were time to first exacerbation and frequency of exacerbations.A total of 416 patients were randomised to the 14-day on/off regimen (ciprofloxacin DPI (n=137) and placebo (n=68)) or the 28-day on/off regimen (ciprofloxacin DPI (n=141) and placebo (n=70)). Ciprofloxacin DPI 14 days on/off significantly prolonged time to first exacerbationversuspooled placebo (median time >336versus186 days; hazard ratio 0.53, 97.5% CI 0.36–0.80; p=0.0005) and reduced the frequency of exacerbations compared with matching placebo by 39% (mean number of exacerbations 0.6versus1.0; incidence rate ratio 0.61, 97.5% CI 0.40–0.91; p=0.0061). Outcomes for ciprofloxacin DPI 28 days on/off were not statistically significantly different from placebo. The safety profile of ciprofloxacin DPI was favourable.Ciprofloxacin DPI was well tolerated and has the potential to be an effective treatment option in non-cystic fibrosis bronchiectasis.

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Efficacy and Safety of Linaclotide in Patients with Irritable Bowel Syndrome with Constipation: Chinese Sub‐Cohort Analysis of a Phase III , Randomized, Double‐Blind , Placebo‐controlled Trial

Journal of Digestive Diseases ◽

10.1111/1751-2980.13081 ◽

2022 ◽

Author(s):

Lihua Peng ◽

Jingyuan Fang ◽

Ning Dai ◽

Xizhong Shen ◽

Youlin Yang ◽

...

Keyword(s):

Irritable Bowel Syndrome ◽

Controlled Trial ◽

Cohort Analysis ◽

Phase Iii ◽

Efficacy And Safety ◽

Double Blind ◽

Double Blind Placebo ◽

Irritable Bowel

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Efficacy and safety of levetiracetam as adjunctive therapy for refractory focal epilepsy

Arquivos de Neuro-Psiquiatria ◽

10.1590/0004-282x-anp-2020-0082 ◽

2021 ◽

Vol 79 (4) ◽

pp. 290-298

Author(s):

Maria Luiza Giraldes de MANREZA ◽

Tatiane Amaral PAN ◽

Eduardo Quinalha CARBONE ◽

Antonio Carlos Amedeo VATTIMO ◽

Renata HERRERA ◽

...

Keyword(s):

Focal Epilepsy ◽

Controlled Trial ◽

Premature Mortality ◽

Phase Iii ◽

Adverse Event Rate ◽

Control Group ◽

Efficacy And Safety ◽

Double Blind ◽

Good Tolerability ◽

Focal Seizures

ABSTRACT Background: Epilepsy affects about 50 million people worldwide and around 30% of these patients have refractory epilepsy, with potential consequences regarding quality of life, morbidity and premature mortality. Objective: The aim of treatment with antiseizure medications (ASMs) is to allow patients to remain without seizures, with good tolerability. Levetiracetam is a broad-spectrum ASM with a unique mechanism of action that differs it from other ASMs. It has been shown to be effective and safe for treating adults and children with epilepsy. Methods: This was a phase III, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of levetiracetam in children and adults (4-65 years) as an adjuvant treatment for focal-onset seizures. It was conducted among 114 patients undergoing treatment with up to three ASMs. The primary efficacy analysis was based on the proportion of patients who achieved a reduction of ≥ 50% in the mean number of focal seizures per week, over a 16-week treatment period. The patients were randomized to receive placebo or levetiracetam, titrated every two weeks from 20 mg/kg/day or 1,000 mg/day up to 60 mg/kg/day or 3,000 mg/day. Results: Levetiracetam was significantly superior to placebo (p = 0.0031); 38.7% of the participants in the levetiracetam group and 14.3% in the control group shows reductions in focal seizures. Levetiracetam was seen to have a favorable safety profile and an adverse event rate similar to that of placebo. Conclusion: Corroborating the results in the literature, levetiracetam was shown to be effective and safe for children and adults with refractory focal-onset epilepsy.

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