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David William Dodick - One of the best experts on this subject based on the ideXlab platform.
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Efficacy of ubrogepant based on prior exposure and response to Triptans: A post hoc analysis.
Headache, 2021Co-Authors: Andrew M Blumenfeld, Peter James Goadsby, David William Dodick, Susan Hutchinson, Chengcheng Liu, Michelle Finnegan, Joel M Trugman, Armin SzegediAbstract:To determine the potential efficacy of ubrogepant for acute treatment of migraine based on historical experience with Triptans. Although Triptans have improved migraine treatment, their efficacy and tolerability may limit their utility in some individuals. Ubrogepant is a small-molecule, oral calcitonin gene-related peptide receptor antagonist approved by the Food and Drug Administration for acute treatment of migraine in adults. This post hoc analysis of pooled data from the pivotal trials ACHIEVE I and II, identically designed, randomized, double-blind, phase 3, single-attack trials of ubrogepant in adults with a history of migraine with/without aura, examined the efficacy and tolerability of ubrogepant 50 mg versus placebo based on participants' historical experience with Triptans: triptan responder, triptan-insufficient responder, and triptan naïve. Co-primary efficacy endpoints were pain freedom and absence of most bothersome migraine-associated symptom (MBS) 2 h post initial dose. Adverse events (AEs) within historical triptan experience subgroups were evaluated. In the pooled analysis population (n = 1799), 682 (placebo, n = 350; ubrogepant 50 mg, n = 332), 451 (placebo, n = 223; ubrogepant, n = 228), and 666 (placebo, n = 339; ubrogepant, n = 327) participants were triptan responders, triptan-insufficient responders, and triptan-naïve, respectively. Response rates on co-primary efficacy endpoints were higher for ubrogepant versus placebo across all groups. Treatment-by-subgroup interaction p values based on odds ratios for pain freedom (p = 0.290) and absence of MBS (p = 0.705) indicated no significant impact of historical triptan experience on ubrogepant efficacy. AE incidence for ubrogepant did not differ appreciably across historical triptan experience subgroups. Ubrogepant efficacy and tolerability did not differ for the acute treatment of migraine in participants classified as triptan responders, triptan-insufficient responders, and triptan-naïve based on their historical experience with Triptans. © 2021 The Authors. Headache: The Journal of Head and Face Pain published by Wiley Periodicals LLC on behalf of American Headache Society.
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efficacy of ubrogepant based on prior exposure and response to Triptans a post hoc analysis
Headache, 2021Co-Authors: Andrew M Blumenfeld, Peter James Goadsby, David William Dodick, Susan Hutchinson, Chengcheng Liu, Michelle Finnegan, Joel M Trugman, Armin SzegediAbstract:OBJECTIVE To determine the potential efficacy of ubrogepant for acute treatment of migraine based on historical experience with Triptans. BACKGROUND Although Triptans have improved migraine treatment, their efficacy and tolerability may limit their utility in some individuals. Ubrogepant is a small-molecule, oral calcitonin gene-related peptide receptor antagonist approved by the Food and Drug Administration for acute treatment of migraine in adults. METHODS This post hoc analysis of pooled data from the pivotal trials ACHIEVE I and II, identically designed, randomized, double-blind, phase 3, single-attack trials of ubrogepant in adults with a history of migraine with/without aura, examined the efficacy and tolerability of ubrogepant 50 mg versus placebo based on participants' historical experience with Triptans: triptan responder, triptan-insufficient responder, and triptan naive. Co-primary efficacy endpoints were pain freedom and absence of most bothersome migraine-associated symptom (MBS) 2 h post initial dose. Adverse events (AEs) within historical triptan experience subgroups were evaluated. RESULTS In the pooled analysis population (n = 1799), 682 (placebo, n = 350; ubrogepant 50 mg, n = 332), 451 (placebo, n = 223; ubrogepant, n = 228), and 666 (placebo, n = 339; ubrogepant, n = 327) participants were triptan responders, triptan-insufficient responders, and triptan-naive, respectively. Response rates on co-primary efficacy endpoints were higher for ubrogepant versus placebo across all groups. Treatment-by-subgroup interaction p values based on odds ratios for pain freedom (p = 0.290) and absence of MBS (p = 0.705) indicated no significant impact of historical triptan experience on ubrogepant efficacy. AE incidence for ubrogepant did not differ appreciably across historical triptan experience subgroups. CONCLUSIONS Ubrogepant efficacy and tolerability did not differ for the acute treatment of migraine in participants classified as triptan responders, triptan-insufficient responders, and triptan-naive based on their historical experience with Triptans.
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triptan education and improving knowledge for optimal migraine treatment an observational study
Headache, 2014Co-Authors: Eric P Baron, Shira Y Markowitz, Alyssa Lettich, Eric V Hastriter, Brigitte Lovell, Kavita Kalidas, David William Dodick, Todd J. SchwedtAbstract:Background It is generally felt that patient education and patient knowledge regarding triptan use for acute migraine management are important for successful and safe treatment. It is unclear how knowledgeable triptan users are regarding their triptan, how much education occurs when Triptans are prescribed, and the impact patient education has on actual patient knowledge regarding triptan use. Objective The primary objective was to compare triptan users' self-perceived knowledge and actual knowledge about Triptans in patients who report having received triptan education vs patients who report not having received triptan education. Methods This was a multicenter prospective observational study of 207 migraine patients who were using Triptans for abortive therapy and who were being evaluated as new patients at academic headache specialty clinics in the United States. Patients completed standardized questionnaires regarding their self-perceived knowledge about Triptans, their actual knowledge regarding Triptans, and the perceived education about the triptan that they had received at the time of prescription. Results Although greater than 80% of the subjects reported receiving education about when to take the triptan and the number of doses they could take for headache, only 71.5% reported receiving education about triptan side effects, 64% for the number of triptan doses they could take each week/month, 64% for taking other medications with the triptan, and 49% for medical contraindications to triptan use. Compared with subjects who did not recall receiving education about when to take their triptan, subjects who recalled such education had a statistically significant greater actual knowledge for taking the triptan immediately after a headache begins (91% vs 77%, P = .049; confidence interval [CI]: 0.00–0.33), treating when pain is mild (75% vs 50%, P = .009; CI: 0.04–0.45), understanding that they do not need to fail treatment with over-the-counter medications before taking a triptan (74% vs 42%, P = .001; CI: 0.11–0.51), and recognizing that coronary artery disease is a contraindication to triptan use (40% vs 19%, P = .001; CI: 0.09–0.34). Conclusion This study provides evidence that patients who recall having received education at the time of triptan prescribing have greater knowledge regarding optimal triptan use. Triptan users who recalled having received this education had greater recognition of the importance of taking the triptan immediately at the onset of a headache, treating when pain is mild, not needing to fail treatment with over-the-counter medications before taking a triptan, and understanding that coronary artery disease is a contraindication to triptan use.
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education and decision making at the time of triptan prescribing patient expectations vs actual practice
Headache, 2014Co-Authors: Paul Mathew, Alyssa Lettich, Rebecca Erwin Wells, Jelena M Pavlovic, Carrie E Robertson, Kathleen B Mullin, Larry Charleston, David William Dodick, Todd J. SchwedtAbstract:There are 3 general models for decision making regarding medical treatment: the paternalistic model, the informed model, and the shared model.1 The classic “paternalistic model” is one in which the physician makes medical decisions for the patient without substantial consideration of the patient's preferences. This model has been challenged over time with a push toward models that take the patient's preferences into account. The reasons for this shift in the approach to medical decision making include the rise of consumerism, the passage of legislation focusing on patients' rights, and an increased focus on the principle of autonomy. The “informed model” involves the physician communicating information to the patient regarding treatment options, risks, and benefits. After being provided sufficient information, the patient ultimately makes an informed treatment decision based on their preferences. The “shared model” involves the physician discussing treatment options and preferences with the patient and then both parties actively participate in making a shared medical decision.1 Optimizing patient satisfaction and adherence with treatment plans requires an understanding of patient preferences regarding their role in decision making. Furthermore, informed and shared decision making require that patients be educated about their treatment options. In order to maximize patients' abilities to participate in medical decision making, clinicians must be aware of the educational topics for which patients desire education and must understand how patients want their education to be delivered. Although Triptans are effective migraine-specific acute medications,2 they are underutilized by the migraine population.3,4 There are likely numerous reasons for triptan underutilization, including patients not consulting a healthcare provider for migraine, patients not receiving a migraine diagnosis after they present to a healthcare provider, lack of health insurance, physicians not feeling that the patient's symptoms are sufficiently severe to warrant a triptan, and expense associated with filling the triptan prescription.3-5 In addition, there are high rates of non-adherence and discontinuation of Triptans in those patients prescribed Triptans, with at least one third discontinuing triptan use within 1 year.6 While several studies have investigated patient satisfaction with triptan treatment, barriers to treatment, and predictors of adherence,5,7-9 little is known about patient satisfaction with triptan education and with their role in decision making when a triptan is prescribed. Patient satisfaction with their triptan and adherence to triptan therapy are likely optimized when the patient's role in decision making matches their expectations, and when the education that is provided is consistent with the patient's educational desires. In clinical practice, the extent of patient participation in the decision to initiate treatment with a triptan, as well as the forms and extent of patient education are highly variable. In this observational study, migraine patients who had used Triptans were asked about their expectations for education when a triptan is prescribed and their desire to be involved in the decision-making process regarding whether and which triptan is prescribed. In order to assess the congruence between patient expectations and actual practice, migraineurs were also asked about the actual education that they received and their actual role in the decision-making process when the triptan was prescribed.
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Identifying the factors underlying discontinuation of Triptans.
Headache, 2013Co-Authors: Rebecca Erwin Wells, Eric P Baron, Shira Y Markowitz, Kavita Kalidas, Rashmi B. Halker, Joseph G Hentz, Paul Mathew, David William Dodick, Todd J. SchwedtAbstract:Objective To identify factors associated with triptan discontinuation among migraine patients. Background It is unclear why many migraine patients who are prescribed Triptans discontinue this treatment. This study investigated correlates of triptan discontinuation with a focus on potentially modifiable factors to improve compliance. Methods This multicenter cross-sectional survey (n = 276) was performed at US tertiary care headache clinics. Headache fellows who were members of the American Headache Society Headache Fellows Research Consortium recruited episodic and chronic migraine patients who were current triptan users (use within prior 3 months and for ≥1 year) or past triptan users (no use within 6 months; prior use within 2 years). Univariate analyses were first completed to compare current triptan users to past users for: migraine characteristics, other migraine treatments, triptan education, triptan efficacy, triptan side effects, type of prescribing provider, Migraine Disability Assessment (MIDAS) scores and Beck Depression Inventory (BDI) scores. Then, a multivariable logistic regression model was selected from all possible combinations of predictor variables to determine the factors that best correlated with triptan discontinuation. Results Compared with those still using Triptans (n = 207), those who had discontinued use (n = 69) had higher rates of medication overuse (30 vs 18%, P = .04) and were more likely to have ever used opioids for migraine treatment (57 vs 38%, P = .006) as well as higher MIDAS (mean 63 vs 37, P = .001) and BDI scores (mean 10.4 vs 7.4, P = .009). Compared with discontinued users, current triptan users were more likely to have had their triptan prescribed by a specialist (neurologist, headache specialist, or pain specialist) (74 vs 54%, P = .002) and were more likely to report headache resolution (53 vs 14%, P 24 (2.6, [1.5, 4.6]), BDI >4 (2.5, [1.4, 4.5]), and a history of ever using opioids for migraine therapy (2.2, [1.3, 3.8]). Having a triptan prescribed by a specialist and using at least 1 other abortive medication with the triptan were associated with a decreased likelihood of triptan discontinuation (0.41, [0.2-0.7] and 0.44 [0.3, 0.8], respectively). Conclusions As expected, discontinuation was most correlated with lack of efficacy, but other important factors associated with those who had discontinued use included greater migraine-related disability, depression, and the use of opioids for migraine attacks. Compared with patients who had discontinued Triptans, current triptan users felt more: educated about their triptan, control over their migraine attacks, and confidence in their prescribing provider. Current triptan users had their triptan prescribed by a specialist and used other abortive medications with their triptan more often compared with patients who had discontinued Triptans. Given the cross-sectional nature of this study, we cannot determine if these factors contributed to triptan discontinuation or reflect the impact of such discontinuation. Interventions that address modifiable risk factors for triptan discontinuation may decrease the likelihood of triptan discontinuation and thus improve overall migraine control. Because lack of efficacy was most strongly associated with triptan discontinuation, future research should determine why Triptans are effective for some patients but not others.
Hedvig Nordeng - One of the best experts on this subject based on the ideXlab platform.
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modeling exposures of medications used episodically during pregnancy Triptans as a motivating example
Pharmacoepidemiology and Drug Safety, 2020Co-Authors: Gerd Marie Eskerud Harris, Mollie Wood, Hedvig NordengAbstract:Purpose To assess the validity of dispensed prescription to classify exposure to medications used episodically during pregnancy, and to explore individual trajectories of episodic medication use across pregnancy, using Triptans for migraine as the motivating example. Methods We compared self-reported triptan use during pregnancy in The Norwegian Mother, Father and Child Cohort Study (MoBa) to dispensed prescriptions in The Norwegian Prescription Database and calculated Cohen's kappa coefficient (κ), sensitivity, specificity and predictive values using MoBa as reference standard. We used group-based trajectory modeling to estimate exposure trajectories in MoBa according to probability of triptan use across pregnancy. Results We identified 6051 pregnancies where mothers filled at least one triptan prescription or reported migraine or triptan use in the 6 months before or during pregnancy. Sensitivity of prescribed Triptans during pregnancy was low (39.1%), but specificity was quite high (95.4%). Agreement between the two data sources was fair (κ 0.36). We identified three trajectory groups in MoBa including constant-high, decreasing-medium and decreasing-low probability of triptan use across pregnancy. Conclusions Using dispensed prescriptions rather than self-report to classify exposure to Triptans during pregnancy is likely to result in substantial under-estimation of exposure. In this study, traditional definitions of ever-exposed vs never-exposed failed to capture variations in drug utilization during pregnancy.
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prenatal triptan exposure and neurodevelopmental outcomes in 5 year old children follow up from the norwegian mother and child cohort study
Paediatric and Perinatal Epidemiology, 2018Co-Authors: Gerd Marie Eskerud Harris, Mollie Wood, Eivind Ystrom, Hedvig NordengAbstract:BACKGROUND: Triptans are commonly used to treat migraine headaches, but data on the long-term safety of these medications during pregnancy are sparse. Triptans have a biologically plausible mechanism for effects on the fetal brain through binding to 5-HT1 -receptors, and previous studies show increased risks of externalising behaviour problems in toddlers exposed to Triptans during pregnancy. METHODS: We included 3784 children in the Norwegian Mother and Child Cohort Study, whose mothers returned the 5-year-questionnaire and reported a history of migraine or triptan use; 353 (9.3%) mothers reported use of Triptans during pregnancy, 1509 (39.9%) reported migraine during pregnancy but no triptan use, and 1922 (50.8%) had migraine prior to pregnancy only. We used linear and log-binomial models with inverse probability weights to examine the association between prenatal triptan exposure and internalising and externalising behaviour, communication, and temperament in 5-year-old children. RESULTS: Triptan-exposed children scored higher on the sociability trait than unexposed children of mothers with migraine (β 1.66, 95% confidence interval [0.30, 3.02]). We found no other differences in temperament, or increased risk of behaviour or communication problems. CONCLUSIONS: Contrary to results from previous studies in younger children, we found no increased risk of externalising behaviour problems in 5-year-old children exposed to Triptans in fetal life. Triptan-exposed children did have slightly more sociable temperaments, but the clinical meaning of this finding is uncertain.
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prenatal triptan exposure and internalising and externalising behaviour problems in 3 year old children results from the norwegian mother and child cohort study
Paediatric and Perinatal Epidemiology, 2016Co-Authors: Mollie Wood, Eivind Ystrom, Kate L Lapane, Jean A Frazier, Eric Mick, Hedvig NordengAbstract:Background Triptans are commonly prescribed for migraine, a pain condition that is highly prevalent in women of childbearing age. No prior studies have investigated associations between exposure to Triptans during fetal life and risk of externalising and internalising behaviours in children. Methods This study was set in the Norwegian Mother and Child Cohort study, a prospective birth cohort. A total of 41 173 live, singleton births without major malformations present at 36-month post-partum follow-up were included in this study; 396 used a triptan during pregnancy, 798 used a triptan prior to pregnancy only, 3291 reported migraine without triptan use, and 36 688 reported no history of migraine or triptan use. Marginal structural models were used to analyse the association between timing of triptan exposure and neurodevelopmental outcome. Results Children exposed to Triptans during pregnancy had a 1.39-fold increased risk of externalising behaviours compared with those whose mothers used Triptans prior to pregnancy only (95% CI 0.97, 1.97), a 1.36-fold increased risk compared with the unmedicated migraine group (95% CI 1.02, 1.81), and a 1.41-fold increased risk compared with the population comparison group (95% CI 1.08, 1.85). The greatest risk was associated with first trimester exposure (RR 1.77, 95% CI 0.98, 3.14). Risk differences were small, ranging from 3–6%. Conclusions This study found an increased risk of clinically relevant externalising behaviours in children with prenatal exposure to Triptans, and this risk was highest for first trimester exposure. Absolute risks were small, and the results may be due to confounding by underlying migraine severity.
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triptan safety during pregnancy a norwegian population registry study
European Journal of Epidemiology, 2013Co-Authors: Kateřina Nezvalovahenriksen, Hedvig Nordeng, Olav SpigsetAbstract:Knowledge on triptan safety during pregnancy remains limited to their class effect or studies on sumatriptan. Our aim was to evaluate the individual effect of four most frequently used Triptans on several pregnancy outcomes. We used the Norwegian prescription database to access information on Triptans redeemed by pregnant women living in Norway between 2004 and 2007. This database was linked to the Medical Birth Registry of Norway covering every institutional delivery in Norway and providing information on pregnancy, delivery, maternal and neonatal health. Estimates of associations with pregnancy outcomes were obtained by Generalised Estimation Equations analysis. Of the 181,125 women in our study, 1,465 (0.8 %) redeemed Triptans during pregnancy, and 1,095 (0.6 %) redeemed Triptans before pregnancy only (disease comparison group). The population comparison group comprised the remaining 178,565 women. Using this group as reference, we found no associations between triptan redemption during pregnancy and congenital malformations. Second trimester redemption was associated with postpartum haemorrhage (adjusted OR 1.57; 95 % CI 1.19–2.07). The disease comparison group had an increased risk of major congenital malformations (adjusted OR 1.48; 95 % CI 1.11–1.97), low birth weight (adjusted OR 1.39; 95 % CI 1.08–1.81), and preterm birth (adjusted OR 1.30; 95 % CI 1.06–1.60). The association of Triptans with postpartum hemorrhage could be attributable to decreased platelet agreeability occurring in severe migraine. Likewise, the increased risk of major congenital malformations and other adverse pregnancy outcomes in the disease comparison group might be attributable to migraine severity.
Richard B. Lipton - One of the best experts on this subject based on the ideXlab platform.
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factors associated with triptan use in episodic migraine results from the american migraine prevalence and prevention study
Headache, 2012Co-Authors: Dawn C Buse, Daniel Serrano, Marcelo E. Bigal, Richard B. LiptonAbstract:Background.— Though Triptans are considered the standard of acute therapy for migraine attacks with headache-related disability, they are used by the minority of potentially eligible persons. Understanding the socio-demographic and headache features that predict triptan use may help to clarify barriers to optimal treatment. Objective.— To assess the sociodemographic and headache features associated with triptan use in a US population sample of persons with episodic migraine. Methods.— The American Migraine Prevalence and Prevention Study (AMPP) is a longitudinal study conducted in a representative sample of US headache sufferers. Episodic migraineurs (n = 11,388) who provided treatment data in 2005 were included in the current analyses. We assessed factors associated with triptan use through univariate and multivariate analyses. Multivariate analyses were adjusted for sociodemographic factors, headache-related disability, cutaneous allodynia, depression, and preventive headache medication use. Results.— Among persons with episodic migraine, 18.31% reported current use of Triptans for acute headache treatment. In univariate analyses, triptan use was most common in midlife (ages 30-59), among females, and was more common in Caucasians than in African Americans. Triptan use increased with headache frequency, headache-related disability and allodynia, but decreased among persons with depression. In multivariate analyses, female gender, Caucasian race, age 40-49, higher levels of education (college or higher), annual household income of ≥$40,000, having health insurance, the presence of cutaneous allodynia, greater headache-related disability, and preventive medication use for migraine were significantly associated with triptan use. Conclusions.— Less than 1 in 5 persons with migraine in the United States who were respondents to this survey used Triptans for acute headache treatment over the course of a year. Several markers of severe headache, including disability and allodynia, were associated with increased triptan use. Groups less likely to get Triptans included males, African Americans, older adults, and the uninsured. Predictors of use provide insight into groups with unmet treatment needs.
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rates and predictors of starting a triptan results from the american migraine prevalence and prevention study
Headache, 2010Co-Authors: Marcelo E. Bigal, Dawn C Buse, Wendy Golden, Daniel Serrano, Ya-ting Chen, Richard B. LiptonAbstract:BACKGROUND: Although diagnostic rates for migraine have increased over the past 5 years, the proportion of migraine sufferers using Triptans has remained essentially stable. OBJECTIVES: To assess the rate of onset of new triptan prescriptions among persons with migraine and the predictors of initiating therapy. METHODS: The American Migraine Prevalence and Prevention Study is a longitudinal study conducted in a representative sample of headache sufferers in the US population. Episodic migraineurs not using Triptans in 2005 who continued to have migraine and provided treatment data in 2006 (n=6865) were included. We assessed predictors of triptan use in univariate and multivariate analyses, including 3 nested models. In Model 1, we adjusted for demographic variables. Model 2 added headache-related disability and cutaneous allodynia. Model 3 added depression and use of preventive headache medications. RESULTS: Among individuals not using Triptans in 2005, triptan use in 2006 occurred in 4.9% of the sample. In unadjusted analyses, gender and race were not associated with use of triptan. Use was lower in those aged 60 years or more vs those 18-29 (odds ratio [OR]=0.4, 95% confidence interval [CI]=0.2-0.7, P=.001). Taking individuals with no disability as the reference, mild (OR=1.44, 95% CI=1.03-2.01, P=.03), moderate (OR=1.54, 95% CI=1.1-2.2, P=.01) and severe disability (OR=2.19, 95% CI=1.55-3.09, P<.0001) predicted triptan use. In the adjusted models, age, income, insurance, disability and preventive medication use were associated with triptan use. Gender, race, education and depression were not. CONCLUSIONS: New use of Triptans is low in the population. Because adequacy of care was not assessed, future studies should focus on investigating whether this low rate of triptan start is proper or if it reflects an unmet treatment need.
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triptan use as a function of cardiovascular risk a population based study
Headache, 2010Co-Authors: Marcelo E. Bigal, Dawn C Buse, Wendy Golden, Ya-ting Chen, Richard B. LiptonAbstract:AIM: To estimate the proportion of individuals with migraine using triptan therapy as a function of their cardiovascular (CV) profile and disease severity. METHODS: As a part of the American Migraine Prevalence and Prevention study, we identified migraineurs representative of the U.S. adult population. Triptan use was estimated as a function of presence of CV disease (CVD), of CV risk factors, and by level of migraine-related disability. RESULTS: Our sample consists of 6102 individuals with migraine. Compared with migraineurs without risk factors for CVD, Triptans were significantly less likely to be used in individuals with diabetes (11.5% vs 18.3%, OR = 0.6, 95% CI = 0.5-0.7), hypertension (14.8%, OR = 0.8, 0.7-0.9) and by smokers (12.9%, OR = 0.7, 0.6-0.8). Similar findings were seen for individuals with established CVD. As contrasted to individuals without CVD, those with myocardial infarct (8.5% vs 18.5%, OR = 0.4, 0.3-0.7), stroke (7%, OR = 0.6, 0.3-0.9) and heart surgery (9.3%, OR = 0.5, 0.4-0.7) were less likely to use Triptans. Use of triptan increased as a function of disability regardless of CVD status or presence of CV risk factors. CONCLUSION: Triptan use is lower in those with vs without CV risk, suggesting that doctors and/or patients fear using Triptans in individuals at risk to CVD. Furthermore, triptan use in those with established CVD increases with headache-related disability, suggesting that patients and providers balance risks and benefits. Additional and analytical data are needed on the safety of Triptans in the setting of CVD risk. This study has not assessed adequacy of care.
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Triptan use as a function of cardiovascular risk. A population-based study.
Headache, 2009Co-Authors: Marcelo E. Bigal, Dawn C Buse, Wendy Golden, Ya-ting Chen, Richard B. LiptonAbstract:(Headache 2010;50:256-263) Aim.— To estimate the proportion of individuals with migraine using triptan therapy as a function of their cardiovascular (CV) profile and disease severity. Methods.— As a part of the American Migraine Prevalence and Prevention study, we identified migraineurs representative of the U.S. adult population. Triptan use was estimated as a function of presence of CV disease (CVD), of CV risk factors, and by level of migraine-related disability. Results.— Our sample consists of 6102 individuals with migraine. Compared with migraineurs without risk factors for CVD, Triptans were significantly less likely to be used in individuals with diabetes (11.5% vs 18.3%, OR = 0.6, 95% CI = 0.5-0.7), hypertension (14.8%, OR = 0.8, 0.7-0.9) and by smokers (12.9%, OR = 0.7, 0.6-0.8). Similar findings were seen for individuals with established CVD. As contrasted to individuals without CVD, those with myocardial infarct (8.5% vs 18.5%, OR = 0.4, 0.3-0.7), stroke (7%, OR = 0.6, 0.3-0.9) and heart surgery (9.3%, OR = 0.5, 0.4-0.7) were less likely to use Triptans. Use of triptan increased as a function of disability regardless of CVD status or presence of CV risk factors. Conclusion.— Triptan use is lower in those with vs without CV risk, suggesting that doctors and/or patients fear using Triptans in individuals at risk to CVD. Furthermore, triptan use in those with established CVD increases with headache-related disability, suggesting that patients and providers balance risks and benefits. Additional and analytical data are needed on the safety of Triptans in the setting of CVD risk. This study has not assessed adequacy of care.
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how treatment priorities influence triptan preferences in clinical practice perspectives of migraine sufferers neurologists and primary care physicians
Current Medical Research and Opinion, 2005Co-Authors: Richard B. Lipton, Peter James Goadsby, Douglas C Mccrory, J N Liberman, Michel D. Ferrari, David William Dodick, F. Michael Cutrer, Paul WilliamsAbstract:ABSTRACTBackground: In treating migraine sufferers, physicians can choose from among seven Triptans with different attributes.Objective: To develop a system for selecting an oral triptan based on treatment priorities of migraine sufferers, neurologists, and primary care physicians (PCPs) in the United States, and evidence-based performance of Triptans in clinical trials.Methods: The TRIPSTAR project combines data on the treatment preferences of migraineurs and physicians with results from a meta-analysis of individual Triptans, which evaluated their effectiveness on various clinical endpoints. Telephone interviews with migraine sufferers, neurologists, and PCPs were conducted to elicit individual views on the relative importance of a prespecified set of acute treatment outcomes. Four hundred and fifteen migraine sufferers, both triptan-experienced and triptan-naive, were interviewed. Also, 200 board-certified neurologists and 200 PCPs provided information on migraine patients from their clinical practice....
Peter James Goadsby - One of the best experts on this subject based on the ideXlab platform.
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Efficacy of ubrogepant based on prior exposure and response to Triptans: A post hoc analysis.
Headache, 2021Co-Authors: Andrew M Blumenfeld, Peter James Goadsby, David William Dodick, Susan Hutchinson, Chengcheng Liu, Michelle Finnegan, Joel M Trugman, Armin SzegediAbstract:To determine the potential efficacy of ubrogepant for acute treatment of migraine based on historical experience with Triptans. Although Triptans have improved migraine treatment, their efficacy and tolerability may limit their utility in some individuals. Ubrogepant is a small-molecule, oral calcitonin gene-related peptide receptor antagonist approved by the Food and Drug Administration for acute treatment of migraine in adults. This post hoc analysis of pooled data from the pivotal trials ACHIEVE I and II, identically designed, randomized, double-blind, phase 3, single-attack trials of ubrogepant in adults with a history of migraine with/without aura, examined the efficacy and tolerability of ubrogepant 50 mg versus placebo based on participants' historical experience with Triptans: triptan responder, triptan-insufficient responder, and triptan naïve. Co-primary efficacy endpoints were pain freedom and absence of most bothersome migraine-associated symptom (MBS) 2 h post initial dose. Adverse events (AEs) within historical triptan experience subgroups were evaluated. In the pooled analysis population (n = 1799), 682 (placebo, n = 350; ubrogepant 50 mg, n = 332), 451 (placebo, n = 223; ubrogepant, n = 228), and 666 (placebo, n = 339; ubrogepant, n = 327) participants were triptan responders, triptan-insufficient responders, and triptan-naïve, respectively. Response rates on co-primary efficacy endpoints were higher for ubrogepant versus placebo across all groups. Treatment-by-subgroup interaction p values based on odds ratios for pain freedom (p = 0.290) and absence of MBS (p = 0.705) indicated no significant impact of historical triptan experience on ubrogepant efficacy. AE incidence for ubrogepant did not differ appreciably across historical triptan experience subgroups. Ubrogepant efficacy and tolerability did not differ for the acute treatment of migraine in participants classified as triptan responders, triptan-insufficient responders, and triptan-naïve based on their historical experience with Triptans. © 2021 The Authors. Headache: The Journal of Head and Face Pain published by Wiley Periodicals LLC on behalf of American Headache Society.
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efficacy of ubrogepant based on prior exposure and response to Triptans a post hoc analysis
Headache, 2021Co-Authors: Andrew M Blumenfeld, Peter James Goadsby, David William Dodick, Susan Hutchinson, Chengcheng Liu, Michelle Finnegan, Joel M Trugman, Armin SzegediAbstract:OBJECTIVE To determine the potential efficacy of ubrogepant for acute treatment of migraine based on historical experience with Triptans. BACKGROUND Although Triptans have improved migraine treatment, their efficacy and tolerability may limit their utility in some individuals. Ubrogepant is a small-molecule, oral calcitonin gene-related peptide receptor antagonist approved by the Food and Drug Administration for acute treatment of migraine in adults. METHODS This post hoc analysis of pooled data from the pivotal trials ACHIEVE I and II, identically designed, randomized, double-blind, phase 3, single-attack trials of ubrogepant in adults with a history of migraine with/without aura, examined the efficacy and tolerability of ubrogepant 50 mg versus placebo based on participants' historical experience with Triptans: triptan responder, triptan-insufficient responder, and triptan naive. Co-primary efficacy endpoints were pain freedom and absence of most bothersome migraine-associated symptom (MBS) 2 h post initial dose. Adverse events (AEs) within historical triptan experience subgroups were evaluated. RESULTS In the pooled analysis population (n = 1799), 682 (placebo, n = 350; ubrogepant 50 mg, n = 332), 451 (placebo, n = 223; ubrogepant, n = 228), and 666 (placebo, n = 339; ubrogepant, n = 327) participants were triptan responders, triptan-insufficient responders, and triptan-naive, respectively. Response rates on co-primary efficacy endpoints were higher for ubrogepant versus placebo across all groups. Treatment-by-subgroup interaction p values based on odds ratios for pain freedom (p = 0.290) and absence of MBS (p = 0.705) indicated no significant impact of historical triptan experience on ubrogepant efficacy. AE incidence for ubrogepant did not differ appreciably across historical triptan experience subgroups. CONCLUSIONS Ubrogepant efficacy and tolerability did not differ for the acute treatment of migraine in participants classified as triptan responders, triptan-insufficient responders, and triptan-naive based on their historical experience with Triptans.
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predictors of triptan response in pediatric migraine
Pediatric Neurology, 2016Co-Authors: Hannah Johnson, Peter James Goadsby, Amy A GelfandAbstract:Abstract Background Migraine is common in children and adolescents and can be disabling. Being able to predict which patients will respond to Triptans based on their clinical phenotype would be helpful. Adult data suggest cranial autonomic symptoms and aura predict triptan response. This study examined clinical predictors of triptan response in pediatric migraineurs. Methods This chart review study included all patients less than 18 years old with migraine who were seen at the University of California, San Francisco Headache Center in 2014. Univariate χ 2 analyses were performed, followed by multivariate logistic regression modeling. Results Of 127 pediatric migraineurs, 70 (55%) had chronic migraine and 24 (19%) had aura. The majority (55%) had at least one cranial autonomic symptom. Of 65 with triptan outcome data, 47 (73%) benefitted from a triptan. In univariate analyses, triptan benefit was seen in 65% with chronic migraine versus 88% with episodic migraine ( P = 0.048), 67% with aura versus 74% without ( P = 0.66), and 70% with cranial autonomic symptom versus 74% without ( P = 0.76). In a multivariate logistic regression model, chronic migraine, aura, and cranial autonomic symptom were not statistically significant predictors of triptan benefit: chronic migraine: 0.25 (0.06-1.04); aura: 0.65 (0.09-4.45); cranial autonomic symptom: 0.75 (0.22-2.52). Conclusions In univariate analysis, individuals with chronic migraine were less likely to benefit from Triptans. In contrast to what has been documented in adults, cranial autonomic symptoms and aura did not predict triptan response, although our small sample size limited the study's power. Larger pediatric studies are needed, and future pediatric triptan trials should provide response rates stratified by clinical variables such as aura.
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Triptans in Orgasmic Headache
Cephalalgia : an international journal of headache, 2006Co-Authors: Achim Frese, Peter James Goadsby, Andreas R. Gantenbein, Martin Marziniak, S. EversAbstract:Orgasmic headache (headache associated with sexual activity type 2 according to the International Headache Society classification) is a sudden severe headache which occurs at orgasm. Experiences with triptan therapy are described. Two out of four patients with severe headache continuing for >2 h had a positive response to acute triptan therapy. Two out of three patients using Triptans as short-term prophylaxis reported a reliable response on several occasions. Triptans might be a treatment option to shorten orgasmic headache attacks after the diagnosis is clear and, particularly, subarachnoid haemorrhage has been excluded. In patients who chose to predict their sexual activity, short-term prophylaxis with oral Triptans 30 min before sexual activity might be a therapeutic option in those not responsive to or not tolerating indomethacin.
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how treatment priorities influence triptan preferences in clinical practice perspectives of migraine sufferers neurologists and primary care physicians
Current Medical Research and Opinion, 2005Co-Authors: Richard B. Lipton, Peter James Goadsby, Douglas C Mccrory, J N Liberman, Michel D. Ferrari, David William Dodick, F. Michael Cutrer, Paul WilliamsAbstract:ABSTRACTBackground: In treating migraine sufferers, physicians can choose from among seven Triptans with different attributes.Objective: To develop a system for selecting an oral triptan based on treatment priorities of migraine sufferers, neurologists, and primary care physicians (PCPs) in the United States, and evidence-based performance of Triptans in clinical trials.Methods: The TRIPSTAR project combines data on the treatment preferences of migraineurs and physicians with results from a meta-analysis of individual Triptans, which evaluated their effectiveness on various clinical endpoints. Telephone interviews with migraine sufferers, neurologists, and PCPs were conducted to elicit individual views on the relative importance of a prespecified set of acute treatment outcomes. Four hundred and fifteen migraine sufferers, both triptan-experienced and triptan-naive, were interviewed. Also, 200 board-certified neurologists and 200 PCPs provided information on migraine patients from their clinical practice....
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how treatment priorities influence triptan preferences in clinical practice perspectives of migraine sufferers neurologists and primary care physicians
Current Medical Research and Opinion, 2005Co-Authors: Richard B. Lipton, Peter James Goadsby, Douglas C Mccrory, J N Liberman, Michel D. Ferrari, David William Dodick, F. Michael Cutrer, Paul WilliamsAbstract:ABSTRACTBackground: In treating migraine sufferers, physicians can choose from among seven Triptans with different attributes.Objective: To develop a system for selecting an oral triptan based on treatment priorities of migraine sufferers, neurologists, and primary care physicians (PCPs) in the United States, and evidence-based performance of Triptans in clinical trials.Methods: The TRIPSTAR project combines data on the treatment preferences of migraineurs and physicians with results from a meta-analysis of individual Triptans, which evaluated their effectiveness on various clinical endpoints. Telephone interviews with migraine sufferers, neurologists, and PCPs were conducted to elicit individual views on the relative importance of a prespecified set of acute treatment outcomes. Four hundred and fifteen migraine sufferers, both triptan-experienced and triptan-naive, were interviewed. Also, 200 board-certified neurologists and 200 PCPs provided information on migraine patients from their clinical practice....
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priorities for triptan treatment attributes and the implications for selecting an oral triptan for acute migraine a study of us primary care physicians the tripstar project
Clinical Therapeutics, 2004Co-Authors: Michael F Cutrer, Peter James Goadsby, Douglas C Mccrory, Michel D. Ferrari, Richard B. Lipton, David William Dodick, Paul WilliamsAbstract:BACKGROUND: Physicians treating patients with migraine can now choose from among 7 Triptans, which differ on a range of attributes that may be important for treatment selection. OBJECTIVE: The aims of this study were to determine the relative importance of treatment attributes of the available Triptans and assess their impact on deciding the most appropriate treatment for a particular patient with migraine. METHODS: As part of the TRIPSTAR project, US primary care physicians were surveyed to elicit their views on the relative importance of a prespecified set of treatment attributes for making treatment choices in clinical practice. The treatment attributes assessed were those for which data from controlled clinical trials were available for subsequent comparison. The resulting attribute-importance weights were then combined with data on the performance of individual Triptans across these attributes in a multiattribute decision model to assist selection of an oral triptan. RESULTS: Efficacy attributes were considered more important than tolerability or consistency of effect in selecting an oral triptan. For triptan-naive but not triptan-experienced patients, tolerability was considered significantly more important than consistency (30% [95% CI, 27%-34%] vs 21% [19%-24%]). Sustained pain-free status and freedom from cardiovascular (chest) adverse events were the most important efficacy and tolerability attributes for both patient categories. When the relative importance of the treatment attributes was combined in a multiattribute decision model with meta-analysis data from controlled trials, almotriptan, eletriptan, and rizatriptan were significantly closer to the hypothetical ideal triptan than the reference product, sumatriptan 100 mg. CONCLUSION: Multiattribute decision-making models (such as that used in the TRIPSTAR project) that determine and apply the relative importance of treatment attributes to drug selection have considerable potential value as a decision support tool in the treatment of acute migraine.
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tripstar prioritizing oral triptan treatment attributes in migraine management
Acta Neurologica Scandinavica, 2004Co-Authors: Peter James Goadsby, Douglas C Mccrory, Michel D. Ferrari, David William Dodick, Paul WilliamsAbstract:: Migraine can be associated with severe pain and is often very disabling. Optimal treatment should provide rapid and sustained, complete pain relief, be well tolerated and restore normal function. The seven commercially available Triptans show differences in performance on individual treatment attributes. The TRIPSTAR multiattribute decision model compares the profiles of the oral Triptans, using efficacy and tolerability data weighted for importance, to identify if measurable differences are clinically relevant. Application of the TRIPSTAR model was demonstrated at the Migraine Trust International Symposium 2002, where delegates collectively prioritized treatment attributes according to the needs of a specific patient case history. The TRIPSTAR model identified the preferred Triptans for this patient. These three Triptans, almotriptan 12.5 mg, eletriptan 80 mg and rizatriptan 10 mg, standout in a triptan meta-analysis, three TRIPSTAR surveys and in a demonstration of the TRIPSTAR model at a symposium in the USA. Taken together the findings suggest that some differences amongst Triptans may be relevant in clinical practice.
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priorities for triptan treatment attributes and the implications for selecting an oral triptan for acute migraine a study of us primary care physicians the tripstar project
Clinical Therapeutics, 2004Co-Authors: Michael F Cutrer, Douglas C Mccrory, Michel D. Ferrari, Richard B. Lipton, David William Dodick, Peter J Goadsby, Paul WilliamsAbstract:BACKGROUND: Physicians treating patients with migraine can now choose from among 7 Triptans, which differ on a range of attributes that may be important for treatment selection. OBJECTIVE: The aims of this study were to determine the relative importance of treatment attributes of the available Triptans and assess their impact on deciding the most appropriate treatment for a particular patient with migraine. METHODS: As part of the TRIPSTAR project, US primary care physicians were surveyed to elicit their views on the relative importance of a prespecified set of treatment attributes for making treatment choices in clinical practice. The treatment attributes assessed were those for which data from controlled clinical trials were available for subsequent comparison. The resulting attribute-importance weights were then combined with data on the performance of individual Triptans across these attributes in a multiattribute decision model to assist selection of an oral triptan. RESULTS: Efficacy attributes were considered more important than tolerability or consistency of effect in selecting an oral triptan. For triptan-naive but not triptan-experienced patients, tolerability was considered significantly more important than consistency (30% [95% CI, 27%-34%] vs 21% [19%-24%]). Sustained pain-free status and freedom from cardiovascular (chest) adverse events were the most important efficacy and tolerability attributes for both patient categories. When the relative importance of the treatment attributes was combined in a multiattribute decision model with meta-analysis data from controlled trials, almotriptan, eletriptan, and rizatriptan were significantly closer to the hypothetical ideal triptan than the reference product, sumatriptan 100 mg. CONCLUSION: Multiattribute decision-making models (such as that used in the TRIPSTAR project) that determine and apply the relative importance of treatment attributes to drug selection have considerable potential value as a decision support tool in the treatment of acute migraine.
