OnabotulinumtoxinA in Migraine: A Review of the Literature and Factors Associated with Efficacy.
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ABSTRACT:
SUBMITTER: Ray JC
PROVIDER: S-EPMC8269087 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:An intramuscular formulation of onabotulinumtoxinA (onabotA; Botox®) is currently the only therapy specifically approved for the prevention of headaches in adults with chronic migraine (CM) in the EU and North America. This article provides a narrative review of relevant data on the drug in this indication from an EU perspective. OnabotA was originally approved on the basis of pooled data from two phase III studies (PREEMPT 1 and 2). In these pivotal studies, injection of up to five cycles of onabotA (155-195 U/cycle) at 12-week intervals was generally well tolerated and effective in producing statistically significant and clinically meaningful improvements in headache symptoms, acute headache pain medication usage, headache impact and health-related quality of life in adults with CM, of whom approximately two-thirds were acute medication overusers and approximately one-third had failed to respond to???3 prior oral prophylactic therapies. More recently, the efficacy and tolerability of onabotA over a period of 1 year in the PREEMPT programme has been substantiated and extended by the results of a long-term phase IV study (COMPEL), in which patients received up to nine treatment cycles over a period of 2 years, and by findings from several real-world clinical practice studies from Europe, including the prospective multinational REPOSE and CM-PASS studies. In conclusion, the totality of evidence from clinical trials and real-world studies indicates that onabotA is an effective and generally well tolerated option for the prevention of CM that may be particularly useful for patients who have previously failed to respond to or are intolerant of commonly prescribed oral prophylactics.
| S-EPMC5915521 | biostudies-other
Project description:To analyze the predictors of therapeutic efficacy after intravesical botulinum toxin A injection for overactive bladder syndrome (OAB) refractory to antimuscarinic therapy.All consecutively OAB patients, who visited the urologic outpatient clinics of a medical center and refractory to antimuscarinic treatment, were prospectively enrolled. All enrolled patients received intravesical injection of 100 U onabotulinumtoxinA (Botox). The Global Response Assessment (GRA) score ? 2 at 3 months after Botox injection was defined as a successful treatment, otherwise failed.Overall, 89 patients received intravesical injection. Eighty patients, including 42 men and 38 women, had received follow-up at 3 months. The overall success rate was 63.8%. The global response assessment, urgency severity score, urgency, urgency urinary incontinence and frequency episodes, and functional bladder capacity improved after treatment. However, post-void residual volume (PVR) increased, and voiding efficiency (VE) decreased after treatment. Female gender (odds ratio = 3.75) was the only independent factor associated with the success. Female gender (coefficient = 0.74), low baseline overactive bladder symptoms score (coefficient = -0.12) and the presence of OAB-wet (coefficient = 0.79) were independent factors associated with therapeutic efficacy (i.e., GRA score). VE (odds ratio = 0.062) was the only predictor for a large PVR at 3 months. The optimum cutoff value of VE was <87% with the area under the ROC curve being 0.64 (sensitivity = 63.8%, specificity = 57.1%).The therapeutic effects of Botox can persist till 6 months after treatment. Female gender, low overactive bladder symptoms score and OAB-wet are associated better therapeutic efficacy, and low baseline VE is associated with large PVR. These findings can serve as an initial guide or assist in consultation regarding the treatment of OAB patients with Botox injection.ClinicalTrials.gov NCT01657409.
| S-EPMC4732812 | biostudies-literature
Project description:ObjectiveThis systematic review was performed to elucidate dosing practices, dosing conversions, and related outcomes from randomized controlled trials that directly compared onabotulinumtoxinA (ONA) and abobotulinumtoxinA (ABO) at various dose conversion ratios for therapeutic use in movement disorders.MethodsA systematic review of 3 medical literature databases (PubMed, the Cochrane Library, and EMBASE) was performed to identify relevant comparative clinical studies, systematic reviews, and meta-analyses published in the English language between January 1991 and January 2015. Studies that met predefined inclusion criteria were selected for formal data extraction and quality assessment.ResultsA total of 182 manuscripts were identified, of which 4 were included for analysis. Targeted clinical applications included neurological disorders. The studies compared ONA to ABO dose conversion ratios of 1:2.5 (n=1), 1:3 (n=2), and 1:4 (n=2). One study compared both 1:3 and 1:4 ratios. An ONA:ABO conversion factor of 1:2.5 was associated with similar efficacy and side effects. An ONA:ABO ratio of 1:3 provided similar or higher efficacy but an increased rate of adverse effects, and an ONA:ABO ratio of 1:4 was associated with higher efficacy but with an excessive rate of intolerable side effects.ConclusionA dose conversion ratio of ONA to ABO between 1:2.5 and 1:3.0 provides comparable safety and efficacy for therapeutic movement disorders chemodenervation procedures.
| S-EPMC4836618 | biostudies-literature
Project description:BackgroundOnabotulinumtoxinA has demonstrated significant benefit in adult focal spasticity. This study reviews the injection patterns (i.e., muscle distribution, dosing) of onabotulinumtoxinA for treatment of adult spasticity, as reported in published studies.MethodsA systematic review of clinical trials and observational studies published between 1990 and 2011 reporting data on muscles injected with onabotulinumtoxinA in adult patients treated for any cause of spasticity.Results28 randomized, 5 nonrandomized, and 37 single-arm studies evaluating 2,163 adult patients were included. The most frequently injected upper-limb muscles were flexor carpi radialis (64.0% of patients), flexor carpi ulnaris (59.1%), flexor digitorum superficialis (57.2%), flexor digitorum profundus (52.5%), and biceps brachii (38.8%). The most frequently injected lower-limb muscles were the gastrocnemius (66.1% of patients), soleus (54.7%), and tibialis posterior (50.5%). The overall dose range reported was 5-200 U for upper-limb muscles and 10-400 U for lower-limb muscles.ConclusionsThe reviewed evidence indicates that the muscles most frequently injected with onabotulinumtoxinA in adults with spasticity were the wrist, elbow, and finger flexors and the ankle plantar flexors. OnabotulinumtoxinA was injected over a broad range of doses per muscle among the studies included in this review, but individual practitioners should be mindful of local regulatory approvals and regulations.
| S-EPMC3848723 | biostudies-literature
Project description:Large-scale transcriptome and methylome data analyses obtained by high-throughput technologies have been enabling the identification of novel imprinted genes. We investigated genome-wide DNA methylation patterns in multiple human tissues, using a high-resolution microarray to uncover hemimethylated CpGs located in promoters overlapping CpG islands, aiming to identify novel candidate imprinted genes. Using our approach, we recovered ~30% of the known human imprinted genes, further 168 candidates were identified, 61 of which with at least three hemimethylated CpGs shared by more than two tissue types. Thirty-four of these candidate genes are members of the protocadherins cluster on 5q31.3; in mice, protocadherin genes have non-imprinted monoallelic randomic expression, which might be the case in humans. Among the remaining 27 genes, ZNF331 was recently validated as an imprinted gene, and six of them have been reported as candidates, supporting our prediction. Five candidates (CCDC166, ARC, PLEC, TONSL and VPS28) map to 8q24.3, and might constitute a novel imprinted cluster. Additionally, we performed a comprehensive compilation of known human and mice imprinted genes from literature and databases, and a comparison among high-throughput imprinting studies in humans. The screening for hemimethylated CpGs shared by multiple human tissues, together with the extensive review, appears as a useful approach to reveal candidate imprinted genes.
2017-09-26 | GSE103413 | GEO
Project description:OnabotulinumtoxinA is approved for the prevention of headache in those with chronic migraine (CM); however, more clinical data on the risk-benefit profile for treatment beyond one year is desirable.The Chronic Migraine OnabotulinuMtoxinA Prolonged Efficacy open Label (COMPEL) Study ( ClinicalTrials.gov , NCT01516892) is an international, multicenter, open-label long-term prospective study. Adults with CM received 155 U of onabotulinumtoxinA (31 sites in a fixed-site, fixed-dose paradigm across 7 head/neck muscles) every 12 weeks (±7 days) for 9 treatment cycles (108 weeks). The primary outcome was headache day reductions at 108 weeks; secondary outcomes were headache day reductions at 60 weeks and change in the 6-item Headache Impact Test (HIT-6) score. Safety and tolerability were assessed by reviewing the frequency and nature of adverse events (AEs). AEs were determined at each visit through patient self-report, general non-directed and, for specific AEs, directed questioning, and physical examination. Subgroup analyses for safety and efficacy included, but were not limited to, patients with/without concomitant oral preventive treatment and acute medication overuse at baseline.Enrolled patients (N?=?716) were 18-73 years old and most were female (n?=?607, 84.8%). At baseline, patients reported an average 22.0 (SD?=?4.8) headache days per month. 52.1% of patients (n?=?373) completed the study. By 60 and 108 weeks, a significant reduction in headache days (-?9.2 days and -?10.7 days, respectively, P?<?0.0001) was observed. Significant improvements (P?<?0.0001) in HIT-6 scores (-?7.1 point change at week 108) were also demonstrated. 131 patients (18.3%) reported ?1 treatment-emergent adverse events; most frequently reported was neck pain (n?=?29, 4.1%). One patient reported a serious treatment-related adverse event (rash). No deaths were reported.The COMPEL Study provides additional clinical evidence for the consistency of the efficacy and for the long-term safety and tolerability of onabotulinumtoxinA for the prevention of headache in those with CM who have been treated with onabotulinumtoxinA every 12 weeks over 2 years (9 treatments) with the fixed-site, fixed-dose injection paradigm.Trial registration number: NCT01516892 . Name of registry: clinicaltrials.gov . Date of registration: January 20 2012. Date of enrollment of first patient: December 2011.
| S-EPMC5799088 | biostudies-literature
Project description:INTRODUCTION:The phase 3 PREEMPT trials demonstrated efficacy and tolerability of onabotulinumtoxinA for headache prevention in adults with chronic migraine. OnabotulinumtoxinA significantly reduced headache frequency from baseline vs. placebo at 24 weeks; however, this measure may not fully capture the benefits of treatment. We evaluated the impact of onabotulinumtoxinA on patient-reported outcomes according to headache responder status. METHODS:A post hoc analysis pooled 24-week data from the placebo-controlled, randomized, double-blind treatment phases of the PREEMPT trials. Patients were stratified by randomized treatment (onabotulinumtoxinA vs. placebo) and headache day responder status (responder vs. nonresponder). Headache day responders had a???50% headache day reduction from baseline measured at weeks 21-24. Outcomes evaluated were patient-reported reductions in moderate-to-severe headache days, Headache Impact Test, and Migraine-Specific Quality of Life Questionnaire. Missing values were estimated using a modified last-observation-carried-forward approach. RESULTS:In the pooled analysis population (N?=?1384; onabotulinumtoxinA, n?=?688; placebo, n?=?696), headache day responder rates were 308/688 (45%) for onabotulinumtoxinA- and 238/696 (34%) for placebo-treated patients. At 24 weeks compared with baseline, onabotulinumtoxinA nonresponders showed significantly (all P?<?0.01) greater mean (standard error) reductions vs. placebo nonresponders in moderate-to-severe headache days (- 3.5 [0.2] vs. -?2.4 [0.2]) and Headache Impact Test scores (- 2.3 [0.3] vs. - 0.8 [0.2]), and greater mean improvements in Migraine-Specific Quality of Life Questionnaire domains (Restrictive, 8.8 [1.0] vs. 2.9 [0.8]; Preventive, 6.0 [1.0] vs. 1.8 [0.8]; Emotional, 8.5 [1.3] vs. 2.8 [1.1]). Moderate-to-severe headache day and headache impact differences between nonresponder groups were evident at week 4 and sustained through week 24. CONCLUSIONS:Relative to placebo nonresponders, onabotulinumtoxinA nonresponders experienced significant reductions in moderate-to-severe headache days and disability and improvement in quality of life, implying that the full benefits of onabotulinumtoxinA are not captured by headache day reduction. TRIAL REGISTRATION:ClinicalTrials.gov identifiers, NCT00156910 (PREEMPT 1) and NCT00168428 (PREEMPT 2).
| S-EPMC7648816 | biostudies-literature
Project description:Excessive gestational weight gain (EGWG) places women at increased risk for complications during pregnancy and also increases the likelihood that they will remain overweight after pregnancy. The Institute of Medicine (IOM) has recommended weight gain guidelines based on pre-pregnancy body mass index (BMI), but evidence-based strategies to achieve these goals are limited.This review discusses factors associated with EGWG with the goal of identifying targets for future intervention.A search was performed using the PubMed database to identify all English-language papers published between 1995 and 2014 related to excessive weight gain in pregnancy. Papers were grouped by theme: preconception BMI, sociodemographics, diet and exercise, psychosocial characteristics, and type of prenatal care.Studies found that women who were overweight or obese at the time of conception were at higher risk of EGWG and that increased physical activity protected against EGWG. Studies on diet and sociodemographic characteristics were inconclusive. Psychological factors, specifically accurate perceptions of BMI, also appear to play a role in EGWG. Limited studies on methods of prenatal care delivery did not show improvement of weight parameters with group compared to one-on-one visits.Pre-pregnancy BMI is most strongly associated with EGWG, indicating that healthy weight habits throughout adult life may be especially important in periods of expected weight change, such as pregnancy. To decrease EGWG, providers should focus on improving pre-conception BMI through appropriate counseling on healthy eating and increased physical activity as well as encouraging pregnant women to continue moderate exercise during pregnancy when appropriate.
| S-EPMC4756783 | biostudies-other
Project description:The diagnosis of Meniere's disease (MD) and vestibular migraine (VM) is primarily based on clinical criteria and their differentiation is often difficult. Currently, there are no known definitive diagnostic tests that can reliably distinguish the two conditions. Patients with MD and patients with VM are treated differently, therefore improving the diagnosis of these two pathologies should avoid errors in management. A systematic review was conducted according to PRISMA guidelines. Medline-Ovid and Embase databases were used to conduct a thorough search of English-language publications dating from 1948 to March 2016. The primary search objective was to identify all papers explicitly comparing MD and VM in order to clarify and validate the diagnosis of these two diseases. A total of 13 articles out of 831 were reviewed. Among other differences, MD showed later age of onset, more hearing loss, tinnitus, aural fullness, abnormal nystagmus, abnormal caloric testing results, abnormal vestibular evoked myogenic potential and endolymphatic hydrops. VM showed more headaches, photophobia, vomiting and aura. Even though differences were noted between the two diseases, only one study focused on assessing the differences between VM, MD and patients fulfilling both diagnostic criteria (MDVM). This study showed no difference between the three groups. Since the introduction of the new International Headache Society and Barany Society criteria for VM, no studies have focused on comparing these three groups. We strongly encourage authors to focus on comparing MD and VM from MDVM in future studies to help adequately distinguish the diagnosis of both diseases.
| S-EPMC5544477 | biostudies-literature
Project description:AimsTo provide an overview of the parental, child, and socio-contextual factors related to general parenting self-efficacy (PSE) in the general population.DesignSystematic review.Data sourcesMedline Ovid, Web of Science, Embase, and PsycINFO Ovid were systematically searched for studies published between January 1980-June 2020.Review methodsStudies were included if they described associations between factor(s) and PSE among parents of children aged 0-18 years old in the general population, and published in an English language peer-reviewed journal. Studies with participants from specific populations, studies describing the development of instruments for PSE, qualitative studies, reviews, theses, conference papers and book chapters were excluded. Belsky's process model of parenting guided the data synthesis.ResultsOf 3,819 articles, 30 articles met the inclusion criteria. Eighty-nine factors were identified. There was evidence of associations between child temperament, maternal parenting satisfaction, parenting stress, maternal depression, household income, perceived social support and PSE. Evidence was inconsistent for an association of educational level, parity, number of children in the household and PSE in mothers. There was no evidence of an association for child gender, age, marital status and PSE in both mothers and fathers; ethnicity, age, employment status in mothers; household income in fathers; and educational level, parenting fatigue in parents.ConclusionA range of factors studied in relation to PSE was identified in this systematic review. However, the majority of the factors was reported by one or two studies often implementing a cross-sectional design.ImpactThere is some evidence for an association between some potentially modifiable factors and PSE in the general population, this information may be used by health and social professionals supporting child health and well-being. Future longitudinal studies are recommended to study parental, child and socio-contextual factors associated with PSE to inform the development of intervention strategies.
| S-EPMC8248335 | biostudies-literature