Safety of ciclesonide in children with asthma: A review of randomized controlled trials

2021 ◽  
Vol 42 (6) ◽  
pp. 471-480 ◽  
Author(s):  
Michael Blaiss ◽  
William Berger ◽  
Bradley Chipps ◽  
Vivian Hernandez-Trujillo ◽  
Wanda Phipatanakul ◽  
...  
Keyword(s):  
Adverse Effects ◽  
Randomized Controlled Trials ◽  
Hpa Axis ◽  
Growth Velocity ◽  
Controlled Trials ◽  
Short Term ◽  
Randomized Controlled ◽  
Children With Asthma ◽  
Asthma In Children

Background: Parental concerns about the adverse effects of asthma medications can lead to nonadherence and uncontrolled asthma in children. Ciclesonide (CIC) is a prodrug, with low oropharyngeal deposition and bioavailability that may minimize the risk of local and systemic adverse effects. CIC is U.S. Food and Drug Administration approved for asthma in children ages ≥ 12 years. Objective: To summarize safety results from the 13 phase II or III randomized controlled trials conducted in children with asthma during CIC clinical development. Methods: Four 12- to 24-week trials compared the safety of once-daily CIC 40, 80, or 160 µg/day with placebo; four 12-week trials compared the safety of CIC 80 or 160 µg/day with either fluticasone or budesonide; one 12-month trial compared the long-term safety of CIC 40, 80, or 160 µg/day with fluticasone; one 12-month trial compared growth velocity of CIC 40 or 160 µg/day with placebo; and three cross-over trials compared short-term growth velocity and hypothalamic-pituitary-adrenal (HPA) axis effects of CIC 40, 80, or 160 µg/day with placebo or fluticasone. Results: In all, 4399 children were treated with CIC. The incidence of treatment-emergent adverse events (AE) was similar among the CIC doses and between CIC and placebo in short-term studies and between CIC and fluticasone in the long-term safety study. No CIC-related serious AEs were reported in any study. The incidence of treatment-related oral candidiasis was low and similar between CIC (≤0.5%) and placebo (≤0.7%) or active controls (≤0.5%) in the short-term studies. There was no clinically relevant HPA axis suppression or reduction in growth velocity associated with CIC. Conclusion: Data from 13 studies demonstrate that CIC is associated with low rates of oropharyngeal AEs, with no indication of clinically relevant systemic effects in children with asthma. The favorable safety profile and demonstrated improvements in asthma control make CIC an ideal inhaled corticosteroid for the treatment of asthma in children.

scholarly journals Gastrointestinal Adverse Effects of Short-Term Aspirin Use: A Meta-Analysis of Published Randomized Controlled Trials

Drugs in R&D ◽  
2013 ◽  
Vol 13 (1) ◽  
pp. 9-16 ◽  
Author(s):  
John A. Baron ◽  
Stephen Senn ◽  
Michael Voelker ◽  
Angel Lanas ◽  
Irene Laurora ◽  
...  
Keyword(s):  
Adverse Effects ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Short Term ◽  
Randomized Controlled

scholarly journals EFFICACY AND SAFETY OF CURCUMA LONGA EXTRACT IN THE TREATMENT OF OSTEOARTHRITIS: A SYSTEMATIC REVIEW

2019 ◽  
pp. 140-145
Author(s):  
ALESSA FAHIRA ◽  
ALLYSA SORAYA ◽  
ARMAND ACHMADSYAH ◽  
RANI WARDANI HAKIM
Keyword(s):  
Adverse Effects ◽  
Randomized Controlled Trials ◽  
Visual Analog Scale ◽  
Curcuma Longa ◽  
Control Group ◽  
Controlled Trials ◽  
Analog Scale ◽  
Randomized Controlled ◽  
Natural Remedies

Objective: Osteoarthritis (OA) is a chronic disease caused by inflammation of the tissue and bony structure of the joint, which affects more than 235 million people worldwide. Due to the adverse effects caused by the long-term use of standard treatment of OA, the attempt to find natural remedies to treat chronic diseases continues to rise. Curcuma longa is known to have anti-inflammatory effects, which may impact the pathophysiology of OA. While many randomized controlled trials show the efficacy of Curcuma longa extract in the treatment of OA, there has been no comprehensive review of this evidence. Methods: We systematically searched PubMed, Cochrane, Scopus, ProQuest, EBSCOhost, and ScienceDirect for randomized controlled trials that evaluated Curcuma longa extract (CE extract) vs. control (placebo or other therapy). Three trials were identified. Data were then extracted from the studies and summarized descriptively. Results: Across all trials, Curcuma longa therapy was proven to reduce Visual Analog Scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores significantly compared to the control group. Adverse effects were less likely to appear in patients treated with Curcuma longa extract compared to other groups. Conclusion: CL extract is beneficial as an alternative medication for OA treatment, shown by the reduced scores of the Visual Analog Scale (VAS) and WOMAC in all studies we reviewed.

scholarly journals Intravitreal corticosteroids for diabetic macular edema: a network meta-analysis of randomized controlled trials

2021 ◽  
Vol 8 (1) ◽  
Author(s):  
Lu Gao ◽  
Xu Zhao ◽  
Lei Jiao ◽  
Luosheng Tang
Keyword(s):  
Confidence Interval ◽  
Randomized Controlled Trials ◽  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Short Term ◽  
Randomized Controlled

Abstract Background To evaluate the efficacy and safety of different intravitreal corticosteroids for treating diabetic macular edema (DME). Methods Four databases were systematically searched for randomized controlled trials comparing different intravitreal corticosteroids for treating DME. The primary outcome was the change in best-corrected visual acuity (BCVA) within 6 months after the first injection (short-term BCVA). Secondary outcomes were the change in BCVA over 1 year (long-term BCVA) and changes in central macular thickness (CMT) and intraocular pressure (IOP) within 6 months after the first injection. Network meta-analysis was performed to aggregate the results from the individual studies. Results Nineteen trials involving 2839 eyes were included. Intravitreal triamcinolone acetonide (TA) injections (≥ 8 mg and 4–8 mg), fluocinolone acetonide (FA) implants (0.5 µg/day) and dexamethasone (DEX) implants (700 µg) improved short-term BCVA (mean changes in logMAR [95% confidence interval] − 0.27 [− 0.40, − 0.15]; − 0.12 [− 0.18, − 0.06]; − 0.10 [− 0.21, − 0.01]; and − 0.06 [− 0.11, − 0.01]). Intravitreal TA injections (4 mg, multiple times), FA implants (0.5 µg/day and 0.2 µg/day), and DEX implants (350 µg) improved long-term BCVA (mean changes in logMAR [95% confidence interval] − 0.11 [− 0.21, − 0.02]; − 0.09 [− 0.15, − 0.03]; − 0.09 [− 0.14, − 0.02]; and − 0.04 [− 0.07, − 0.01]). All intravitreal corticosteroids reduced CMT, and different dosages of TA did not show significant differences in increasing IOP. Conclusions Intravitreal corticosteroids effectively improved BCVA in DME patients, with higher dosages showing greater efficacies. TA was not inferior to FA or DEX and may be considered a low-cost alternative choice for DME patients. The long-term efficacy and safety of different corticosteroids deserve further investigation. Trial registration Prospectively registered: PROSPERO, CRD42020219870

scholarly journals Opioids in Chronic Noncancer Pain: More Faces from the Crowd

2012 ◽  
Vol 17 (4) ◽  
pp. 263-275 ◽  
Author(s):  
C Peter N Watson
Keyword(s):  
Adverse Effects ◽  
Randomized Controlled Trials ◽  
Functional Status ◽  
Present Article ◽  
Controlled Trials ◽  
High Dose ◽  
Chronic Noncancer Pain ◽  
Randomized Controlled ◽  
Noncancer Pain

BACKGROUND: The use of opioids for chronic noncancer pain (CNCP) remains very controversial. There are several randomized controlled trials, mostly in neuropathic pain, reporting efficacy and safety in the short term, but more long-term data are needed. Randomized controlled trials may be limited in providing data about the patients who benefit from often high-dose opioids over the long term. The present article provides details of these patients and adds to a previous case series.METHODS: The present article contains 17 case reports of 11 CNCP conditions (followed to 2011) selected to illustrate specific issues from a survey of 84 patients with intractable CNCP treated with opioids and followed every three months for a median of 11 years. The previous published survey of this group reported outcomes of pain severity, adverse effects, pain relief, satisfaction, mood, problematic opioid use, tolerance, physical dependency, functional status, health-related quality of life (HRQL), immune status and sexual function. The outcome measures for that study included a numerical rating scale for pain, the Hospital Anxiety and Depression Scale, the Brief Pain Inventory Interference Scale, the Pain Disability Index and, for HRQL, the Short-Form Health Survey 12 version 2. Most patients in the total sample reported 50% or greater relief and a moderate improvement in disability. Scores for functional status and HRQL were not severely affected. Problematic use, tolerance and serious adverse effects, including constipation, were not major issues. These selected patient reports were chosen, not to illustrate optimal results, but rather important aspects of the diagnoses, opioids and doses, the paucity of intolerable adverse effects, particular issues (concurrent addiction history, bipolar disorder and combination therapy), disease-specific and other outcomes and duration of follow-up with complex pain problems.RESULTS: Opioids were found to be safe and useful in the long term for these particular patients, as well as in the larger group from which they originated.INTERPRETATION: These 17 reports of patients with intractable CNCP treated with opioids with some success over many years puts a face on more of the participants in the larger survey of 84 subjects, suggesting that this approach is effective and safe for some patients over many years.

LONGITUDINAL TRAJECTORY ANALYSIS OF PLACEBO RESPONSE: SHORT-TERM AND LONG-TERM RANDOMIZED CONTROLLED TRIALS

2010 ◽  
Vol 117 (2-3) ◽  
pp. 496
Author(s):  
Steven Potkin ◽  
Ofer Agid ◽  
Gary Remington ◽  
Shitij Kapur ◽  
Eric Watsky ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Trajectory Analysis ◽  
Placebo Response ◽  
Controlled Trials ◽  
Short Term ◽  
Randomized Controlled

Clinical trials of multiple sclerosis therapies: improvements to demonstrate long-term patient benefit

2009 ◽  
Vol 15 (8) ◽  
pp. 951-958 ◽  
Author(s):  
WM Carroll
Keyword(s):  
Multiple Sclerosis ◽  
Randomized Controlled Trials ◽  
Controlled Trials ◽  
Patient Benefit ◽  
Short Term ◽  
Randomized Controlled ◽  
Long Term Follow Up ◽  
Term Benefit

Background The therapeutic goal for multiple sclerosis (MS) is to achieve a better long-term outcome. However, since available data come from short-term studies, it is important to review the evidence that current therapies provide long-term benefit. Method and results Long-term data from both registry studies and long-term follow-up studies, and efficacy treatment data were reviewed. Registry data show that the course of MS is predictable after a certain level of disability is reached, indicating that short-term efficacy data from randomized, controlled trials provide evidence of long-term benefit. Long-term studies of patients originally enrolled in pivotal randomized, controlled trials consistently show that delayed or discontinued treatment provides less benefit than continuous therapy. The 16-Year Long-Term Follow-Up Study of interferon beta-1b (IFNβ-1b; Betaferon®/Betaseron®) therapy had the highest ascertainment of long-term follow-up efforts of the pivotal trials, which led to the currently approved therapies. Disability scores at the start of treatment were predictive of their current disability scores. In addition, this 16-year study showed an excellent safety profile with no unexpected side effects to IFNβ-1b and a lower mortality rate after 16 years compared with those receiving placebo treatment during the pivotal study (6 deaths vs 20 deaths). Conclusion This article reviews the key data and provides recommendations for optimizing clinical studies in MS to demonstrate long-term patient benefit.

scholarly journals Comparison between Acupuncture and Nicotine Replacement Therapies for Smoking Cessation Based on Randomized Controlled Trials: A Systematic Review and Bayesian Network Meta-Analysis

2021 ◽  
Vol 2021 ◽  
pp. 1-11
Author(s):  
Runjing Dai ◽  
Yongchun Cao ◽  
Hailiang Zhang ◽  
Na Zhao ◽  
Dong Ren ◽  
...  
Keyword(s):  
Acupuncture Therapy ◽  
Bayesian Network ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Short Term ◽  
Randomized Controlled ◽  
Auricular Acupressure ◽  
Significant Difference

Objectives. To evaluate the efficacy and/or safety of acupuncture therapy (AT) in quitting smoking. Methods. Randomized controlled trials (RCTs) were searched in PubMed, Cochrane Library, Embase, Web of Science, and Chinese Biomedical Database (CBM). We used Cochrane Collaborative Quality Assessment to assess the risk of bias. Bayesian network meta-analysis was utilized to evaluate the efficacy and safety of different interventions. Data analyses were conducted using WinBUGS 1.4.3, Stata 14, and RevMan 5.3.5 software. Results. A total of 2706 patients from 23 studies were included, involving 6 treatment arms. Network meta-analysis demonstrated that there was no significant difference in short-term abstinence rates or changes in Fagerstrom test for nicotine dependence (FTND) scores and daily smoking among these groups (AT, sham acupuncture therapy (SAT), auricular acupressure (AA), sham auricular acupressure (SAA), acupuncture plus auricular acupressure (APAA), and nicotine replacement therapy (NRT)). However, there was a significant difference between SAA and AA with risk ratio (RR) of 2.49 (95% CI 1.14, 5.97) in long-term abstinence rate. The probabilistic ranking results showed that APAA and AA were superior to other interventions in the comparison of abstinence rates. There was no obvious inconsistency between the direct comparison and indirect comparison, using the consistency test. Conclusion. AA was superior to SAA in smoke quitting, but there was no difference among other interventions in long-term truncation rates. There was no difference in short-term abstinence rates among these selected groups. We need large sample RCTs to clarify the advantages of interventions such as APAA and AA. In addition, reporting of adverse events that may occur during treatment also should be enhanced to complement evidence-based medicine. The trial is registered with PROSPERO CRD42020164712.

Desmopressin Acetate and Nocturnal Enuresis: How Much Do We Know?

PEDIATRICS ◽  
1993 ◽  
Vol 92 (3) ◽  
pp. 420-425
Author(s):  
M. E.K. Moffatt ◽  
S. Harlos ◽  
A. J. Kirshen ◽  
L. Burd
Keyword(s):  
Prognostic Factors ◽  
Side Effects ◽  
Randomized Controlled Trials ◽  
Dose Response ◽  
Nocturnal Enuresis ◽  
Controlled Trials ◽  
Short Term ◽  
Randomized Controlled ◽  
Term Efficacy

Objectives. Desmopress in acetate (DDAVP) is promoted to treat nocturnal enuresis but indications for its use are unclear. We reviewed all randomized controlled trials to determine (1) short- and long-term efficacy, (2) responders, (3) dose-response curve, (4) side effects, and (5) comparative efficacy with other treatments. Methods. A Medline search of the English language literature from January 1966 to August 1992, supplemented by contact with the drug companies, yielded 18 articles which were true randomized controlled trials (11 cross-over and 7 parallel studies). Results. The 18 randomized controlled trials included 689 subjects for most of whom some other type of treatment had failed. All studies found decreased mean frequency of wetting ranging from 10% to 91%, but only 24.5% of subjects achieved short-term dryness. One study of DDAVP responders directly tested long-term dryness and 21% stayed dry. In three studies that incidentally reported on long-term effects 5.7% stayed dry after stopping DDAVP. There was wide variation in the type of patient included. Seven studies addressed prognostic factors. Children more than 9 years old and with fewer initial wet nights do better. Four studies seem to include almost exclusively monosymptomatic children with nocturnal enuresis (ie, primary nocturnal enuresis, positive family history, and no urinary symptoms). Results were no better than those which included mixed symptoms. Five studies attempted to address the dose-response issue. Despite some methodological issues, there is probably some dose-response effect. Side effects were infrequent in the 589 subjects who received DDAVP as opposed to placebo. No cases of water intoxication and no significant shifts in electrolytes were reported in the four studies which measured them. Nasal stuffiness, headache, epistaxis, and mild abdominal pain seem to be the only side effects noted, and these were uncommon. Only one study compared DDAVP with conditioning alarms. Alarm patients had 10% fewer wet nights and a better long-term result. Conclusions. DDAVP reduces wet nights in children for whom other treatments have failed but it produces complete dryness in a minority, and this is often a temporary effect. The literature focuses on short-term efficacy. The true role of DDAVP will be known when samples are carefully selected, prognostic factors are examined, and more comparisons with other treatments are conducted focusing on long-term outcomes. On the basis of current knowledge, DDAVP is inferior to conditioning alarms as a primary therapy.

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