Pharmacologic prevention of migraine.
Ontology highlight
ABSTRACT:
SUBMITTER: Tzankova V
PROVIDER: S-EPMC9904820 | biostudies-literature | 2023 Feb
REPOSITORIES: biostudies-literature
Publications
Pharmacologic prevention of migraine.
Tzankova Velina V Becker Werner J WJ Chan Tommy L H TLH
CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne 20230201 5
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Project description:ObjectivesSystematic review of preventive pharmacologic treatments for community-dwelling adults with episodic migraine.Data sourcesElectronic databases through May 20, 2012.Eligibility criteriaEnglish-language randomized controlled trials (RCTs) of preventive drugs compared to placebo or active treatments examining rates of ?50 % reduction in monthly migraine frequency or improvement in quality of life.Study appraisal and synthesis methodsWe assessed risk of bias and strength of evidence and conducted random effects meta-analyses of absolute risk differences and Bayesian network meta-analysis.ResultsOf 5,244 retrieved references, 215 publications of RCTs provided mostly low-strength evidence because of the risk of bias and imprecision. RCTs examined 59 drugs from 14 drug classes. All approved drugs, including topiramate (9 RCTs), divalproex (3 RCTs), timolol (3 RCTs), and propranolol (4 RCTs); off-label beta blockers metoprolol (4 RCTs), atenolol (1 RCT), nadolol (1 RCT), and acebutolol (1 RCT); angiotensin-converting enzyme inhibitors captopril (1 RCT) and lisinopril (1 RCT); and angiotensin II receptor blocker candesartan (1 RCT), outperformed placebo in reducing monthly migraine frequency by ?50 % in 200-400 patients per 1,000 treated. Adverse effects leading to treatment discontinuation (68 RCTs) were greater with topiramate, off-label antiepileptics, and antidepressants than with placebo. Limited direct evidence as well as frequentist and exploratory network Bayesian meta-analysis showed no statistically significant differences in benefits between approved drugs. Off-label angiotensin-inhibiting drugs and beta-blockers were most effective and tolerable for episodic migraine prevention.LimitationsWe did not quantify reporting bias or contact principal investigators regarding unpublished trials.ConclusionsApproved drugs prevented episodic migraine frequency by ?50 % with no statistically significant difference between them. Exploratory network meta-analysis suggested that off-label angiotensin-inhibiting drugs and beta-blockers had favorable benefit-to-harm ratios. Evidence is lacking for long-term effects of drug treatments (i.e., trials of more than 3 months duration), especially for quality of life.
| S-EPMC3744311 | biostudies-literature
Project description:BackgroundHealth economic models are critical tools to inform reimbursement agencies on health care interventions. Many clinical trials report outcomes using the frequency of an event over a set period of time, for example, the primary efficacy outcome in most clinical trials of migraine prevention is mean change in the frequency of migraine days (MDs) per 28 days (monthly MDs [MMD]) relative to baseline for active treatment versus placebo. Using these cohort-level endpoints in economic models, accounting for variation among patients is challenging. In this analysis, parametric models of change in MMD for migraine preventives were assessed using data from erenumab clinical studies.MethodsMMD observations from the double-blind phases of two studies of erenumab were used: one in episodic migraine (EM) (NCT02456740) and one in chronic migraine (CM) (NCT02066415). For each trial, two longitudinal regression models were fitted: negative binomial and beta binomial. For a thorough comparison we also present the fitting from the standard multilevel Poisson and the zero inflated negative binomial.ResultsUsing the erenumab study data, both the negative binomial and beta-binomial models provided unbiased estimates relative to observed trial data with well-fitting distribution at various time points.ConclusionsThis proposed methodology, which has not been previously applied in migraine, has shown that these models may be suitable for estimating MMD frequency. Modelling MMD using negative binomial and beta-binomial distributions can be advantageous because these models can capture intra- and inter-patient variability so that trial observations can be modelled parametrically for the purposes of economic evaluation of migraine prevention. Such models have implications for use in a wide range of disease areas when assessing repeated measured utility values.
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| S-EPMC4977344 | biostudies-literature
Project description:ObjectiveTo examine the cardiovascular, cerebrovascular, and peripheral vascular safety of erenumab across migraine prevention studies.MethodsVascular adverse events (AEs) and blood pressure data were integrated across 4 double-blind, placebo-controlled studies of erenumab and their open-label extensions in patients with chronic or episodic migraine. Subgroup analyses were conducted by acute migraine-specific medication use and number of vascular risk factors at baseline. Standardized search terms were used to identify vascular AEs (cardiovascular, cerebrovascular, or peripheral). An independent committee adjudicated whether targeted events were vascular in origin.ResultsIn placebo-controlled studies, 2,443 patients received placebo (n = 1,043), erenumab 70 mg (n = 893), or erenumab 140 mg (n = 507) subcutaneously once monthly. Regardless of acute migraine-specific medication use or vascular risk factors at baseline, AE incidence was similar across the placebo and erenumab treatment groups. Hypertension AEs were reported for 0.9% (placebo), 0.8% (erenumab 70 mg), and 0.2% (erenumab 140 mg) of patients. Vascular AEs, which were similar across double-blind and open-label treatment, generally were confounded, with plausible alternative etiologies. In 18 patients with events reviewed by the independent committee, 4 events were positively adjudicated as cardiovascular in origin: 2 deaths and 2 vascular events. All 4 positively adjudicated cardiovascular events occurred during open-label erenumab treatment.ConclusionSelective blockade of the canonical calcitonin gene-related peptide receptor with erenumab for migraine prevention had a vascular safety profile comparable to that of placebo over 12 weeks, with no increased emergence of events over time. Further study of long-term safety of erenumab in patients with migraine is needed.Clinicaltrialsgov identifiersNCT02066415, NCT02456740, NCT01952574, NCT02483585, NCT02174861, and NCT01723514.Classification of evidenceThis analysis provides Class II evidence that for patients with migraine, erenumab does not increase the risk of vascular AEs.
| S-EPMC7080286 | biostudies-literature
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:IntroductionThis interactive didactic session is designed for first-year medical students to explore the common clinical symptom of headache and its various management strategies. The session provides an opportunity to cover a variety of drugs, mechanisms of action, drug-drug interactions, and routes of administration in a single 50-minute time frame.MethodsUsing a modified case-based approach, we designed an interactive session for 41 first-year medical students. Students prepared for the session using basic learning objectives and a table of drugs that treat headache pain. In class, we distributed a patient scenario and a series of discussion questions to explore headache management. We assessed student performance using questions purchased from the National Board of Medical Examiners and student perceptions using both qualitative and quantitative data collected from faculty and end-of-block evaluations.ResultsStudent performance on purchased questions related to content was significantly increased when compared to the national average (n = 5; 90.6% ± 6.0% vs. 82.6% ± 8.5%; p = .0052). Student perceptions of the overall quality of the faculty, content presentation, and material were positive (4.4 out of 5.0). Two themes emerged in the end-of-block evaluations: Students commented positively on the prereading materials, and students commented on the need to address underlying physiology associated with the discussed pharmacology.DiscussionThis flexible activity can be delivered in a short time (50 minutes) by a single faculty member in a variety of curricular structures. Our data demonstrate strong student performance and suggest that incorporating additional content would enhance delivery.
| S-EPMC7012313 | biostudies-literature
Project description:BACKGROUND:Vestibular migraine is a common cause of episodic vertigo. Many preventive treatments have been proposed for this condition, including calcium antagonists, beta-blockers, antidepressants, anticonvulsants, selective 5-HT1 agonists, serotonin antagonists and non-steroidal anti-inflammatory drugs (NSAIDs). OBJECTIVES:To assess the effects of pharmacological agents for the prevention of vestibular migraine. SEARCH METHODS:The Cochrane Ear, Nose and Throat Disorders Group (CENTDG) Trials Search Co-ordinator searched the CENTDG Trials Register; Central Register of Controlled Trials (CENTRAL 2015, Issue 5); PubMed; EMBASE; CINAHL; Web of Science; Clinicaltrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 5 June 2015. SELECTION CRITERIA:Randomised controlled trials (RCTs) in adults (over 18 years) with a diagnosis of vestibular migraine orprobable vestibular migraine according to the Bárány Society/International Headache Society (IHS) criteria, treated in any setting, comparing pharmacological treatments used in the prevention of vestibular migraine, including beta-blockers, calcium antagonists, anticonvulsants, antidepressants, serotonin antagonists and non-steroidal anti-inflammatory drugs (NSAIDs) against placebo or no treatment. DATA COLLECTION AND ANALYSIS:We used the standard methodological procedures expected by The Cochrane Collaboration. MAIN RESULTS:Our literature search identified 558 reports, however only 11 were sufficiently relevant for further assessment. We excluded two studies because they did not use the IHS diagnostic criteria for vestibular migraine. We excluded a further eight studies for various reasons related to their design (e.g. lack of placebo or no treatment comparator), aim (e.g. treatment of vestibular migraine rather than prevention) or conduct (e.g. early termination). We identified one ongoing study comparing metoprolol to placebo. The results of this study are awaited; recruitment of the last patient is expected by the end of 2016. AUTHORS' CONCLUSIONS:We found no evidence from RCTs to answer the question set out in the review objectives. This review has identified the need for well-designed randomised controlled trials to answer questions about the efficacy of current and new treatments.
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Project description:Retinopathy of prematurity (ROP), a significant morbidity in prematurely born infants, is the most common cause of visual impairment and blindness in children and persists till adulthood. Strict control of oxygen therapy and prevention of intermittent hypoxia are the keys in the prevention of ROP, but pharmacologic interventions have decreased risk of ROP. Various drug classes such as methylxanthines (caffeine), VEGF inhibitors, antioxidants, and others have decreased ROP occurrence. The timing of pharmacologic intervention remains unsettled, but early prevention rather than controlling disease progression may be preferred. These drugs act through different mechanisms, and synergistic approaches should be considered to maximize efficacy and safety.
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Project description:ObjectiveWe sought to determine the target populations and drug efficacy, toxicity, cost, and initiation age thresholds under which a pharmacologic regimen for knee osteoarthritis (OA) prevention could be cost-effective.DesignWe used the Osteoarthritis Policy (OAPol) Model, a validated state-transition simulation model of knee OA, to evaluate the cost-effectiveness of using disease-modifying OA drugs (DMOADs) as prophylaxis for the disease. We assessed four cohorts at varying risk for developing OA: (1) no risk factors, (2) obese, (3) history of knee injury, and (4) high-risk (obese with history of knee injury). The base case DMOAD was initiated at age 50 with 40% efficacy in the first year, 5% failure per subsequent year, 0.22% major toxicity, and annual cost of $1,000. Outcomes included costs, quality-adjusted life expectancy (QALE), and incremental cost-effectiveness ratios (ICERs). Key parameters were varied in sensitivity analyses.ResultsFor the high-risk cohort, base case prophylaxis increased quality-adjusted life-years (QALYs) by 0.04 and lifetime costs by $4,600, and produced an ICER of $118,000 per QALY gained. ICERs >$150,000/QALY were observed when comparing the base case DMOAD to the standard of care in the knee injury only cohort; for the obese only and no risk factors cohorts, the base case DMOAD was less cost-effective than the standard of care. Regimens priced at $3,000 per year and higher demonstrated ICERs above cost-effectiveness thresholds consistent with current US standards.ConclusionsThe cost-effectiveness of DMOADs for OA prevention for persons at high risk for incident OA may be comparable to other accepted preventive therapies.
| S-EPMC4006219 | biostudies-literature