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David W Dodick - One of the best experts on this subject based on the ideXlab platform.
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effect of cgrp inhibition with tev 48125 on cardiovascular parameters as a function of Triptan use among individuals with chronic migraine i3 011
Neurology, 2016Co-Authors: Juliana Vanderpluym, David W Dodick, Marcelo E BigalAbstract:Objective: To evaluate the effect of TEV-48125 on cardiovascular parameters as a function of Triptan use. Background: TEV-48125 is a monoclonal antibody against calcitonin gene-related peptide (CGRP) shown to be effective and tolerable in a preventive treatment trial for chronic migraine (CM). CGRP is a potent systemic vasodilator, and as such there are concerns regarding potential cardiovascular effects with its inhibition. Furthermore, there are concerns regarding potential cardiovascular effects of co-administration of CGRP antagonists with Triptans, which are known vasoconstrictive medications. Methods: The current study represents a post-hoc analysis conducted as part of a Phase 2b trial. A multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel-group study tested once monthly injections of TEV-48125 675/225 mg or 900 mg, or placebo. Participants were men or women aged 18 to 65 years with CM. Systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) were measured at pre-specified visits. Information on Triptan consumption was obtained daily during the baseline phase and for the duration of the study. Participants were not limited in their Triptan consumption. Results: In the overall sample (n=264), there were no relevant changes in blood pressure or other vital signs. SBP, DBP, and HR were similar regardless of the level of Triptan use. The mean values of SBP, DBP, and HR at the end of study, when participants had received three months of CGRP inhibition via TEV-48125, remained similar. Conclusions: Inhibition of CGRP withTEV-48125 was not associated with hemodynamic changes among individuals with CM using Triptans in the context of a 3-month study. This is an important finding given the concerns surrounding potential cardiovascular effects of CGRP inhibition, particularly in the setting of other vasoconstrictive medications like Triptans. Study Supported by: Teva Pharmaceuticals, Netanya Israel Disclosure: Dr. VanderPluym has nothing to disclose. Dr. Dodick has received personal compensation for activities with Allergan, Amgen, Alder, Merck Serono, ENeuro, Eli Lilly, Autonomic Technologies, Boston Scientific, Novartis, Tonix, Teva, Trigemina as a consultant and for activities with SAGE Publishing, Dr. Bigal holds stock and/or stock option in Teva which sponsored research in which Dr. Bigal was involved as an investigator.
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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 W 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, David W Dodick, Rebecca Erwin Wells, Jelena M Pavlovic, Carrie E Robertson, Kathleen B Mullin, Larry Charleston, 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, David W Dodick, Joseph G. Hentz, Paul Mathew, Rashmi B. Halker, 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.
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antimigraine efficacy of telcagepant based on patient s historical Triptan response
Headache, 2011Co-Authors: Tony W Ho, David W Dodick, Jes Olesen, James Kost, Christopher Lines, Michel D FerrariAbstract:(Headache 2011;51:64-72) Objective.— To evaluate whether the same or different patients respond to Triptans and telcagepant. Background.— Telcagepant is an oral calcitonin gene-related peptide receptor antagonist with acute antimigraine efficacy comparable to oral Triptans. It is currently unknown whether migraine patients who cannot be adequately helped with Triptans might benefit from treatment with telcagepant. Methods.— Post-hoc analysis of data from a randomized, controlled trial of telcagepant (150 mg, 300 mg) zolmiTriptan 5 mg, or placebo for a moderate/severe migraine. Responder rates were analyzed according to patients' self-reported historical Triptan response (HTR): (1) good HTR (N = 660): response in 75-100% of attacks; (2) intermediate HTR (N = 248): response in 25-74% of attacks; (3) poor HTR/no use (N = 407): response in <25% of attacks, or patient did not take Triptans. A limitation of the analysis is that the last subgroup comprised mainly (91%) patients who reported that they did not take Triptans, but it was not known whether these patients were Triptan-naive or had previously used Triptans and stopped taking them. Results.— For zolmiTriptan, 2-hour pain relief rates were higher in the good HTR subgroup (116/162, 72%) than in the intermediate (29/62, 47%) and poor/no use (44/111, 40%) HTR subgroups. The 2-hour pain relief rates were similar across HTR subgroups for telcagepant 150 mg (48-58%), 300 mg (52-58%), and placebo (26-31%). In the poor/no use HTR subgroup, more patients receiving telcagepant 300 mg (56/98, 57.1%) had 2-hour pain relief than those receiving zolmiTriptan (44/111, 39.6%; odds ratio = 2.11 [95% CI: 1.20,3.71], P = .009); the percentage for telcagepant 150 mg (57/119, 47.9%) was not significantly different from zolmiTriptan (odds ratio = 1.41 [95% CI: 0.82, 2.40], P = .211). Conclusions.— This suggests that different patients may respond to Triptans or telcagepant 300 mg. Caution should be exercised in interpreting the results because of the post-hoc nature of the analysis (clinical trial registry: NCT00442936).
Richard B Lipton - One of the best experts on this subject based on the ideXlab platform.
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post hoc subanalysis of two randomized controlled phase 3 trials evaluating diclofenac potassium for oral solution impact of migraine associated nausea and prior Triptan use on efficacy
Headache, 2017Co-Authors: Richard B Lipton, Peter C Schmidt, Hanschristoph DienerAbstract:OBJECTIVE: To determine whether baseline nausea or prior Triptan treatment for migraine impact the effectiveness of diclofenac potassium for oral solution in treating acute migraine. BACKGROUND: A great deal of variability exists in patients' response to migraine medications. Migraine-associated nausea is common and debilitating and can reduce the effectiveness of oral medications. It may cause patients to delay taking oral medications, which is known to diminish therapeutic outcomes, or to avoid taking them altogether. Gastroparesis, which may be associated with nausea, also inhibits drug absorption, resulting in lower bioavailability. Studies have shown that having nausea at the time of drug administration predicts a poorer response to Triptan treatment. It is of interest to understand how effective other migraine medications are in patients with a poor response to Triptans. METHODS: Data from two randomized, double-blind, placebo controlled trials were pooled and post hoc subgroup analyses were performed in patients with and without nausea at baseline, and in patients with and without prior Triptan treatment. Efficacy assessments included the percentage of patients who, at 2 hours postdosing, were headache pain-free (2hPF, primary endpoint), without photophobia, without phonophobia, without nausea, or without a severe degree of disability. A Cochran-Mantel-Haenszel test, stratified by analysis center was used to evaluate treatment effect. Effects of nausea or prior Triptan use were determined using logistic regression with factors of treatment group, analysis center, nausea or prior Triptan use at time of dosing, and interaction of treatment group by nausea or prior Triptan use at time of dosing. RESULTS: The modified intent to treat population consisted of 1272 patients, 644 on active drug and 628 on placebo. The majority of patients (85%) were female. At the time of dosing, 783 (62%) patients reported nausea with the treated attack. Prior Triptan use was recorded in 570 (45%). For headache pain, nausea, photophobia, and phonophobia, patients in the active treatment group had a statistically significantly better response than those receiving placebo, regardless of whether they had nausea at baseline. In logistic regression analysis only treatment group predicted a response for these parameters with no detectable group interaction. Baseline nausea, as well as treatment group, predicted whether patients recorded severe disability at 2 hours. While patients in the active treatment group were significantly more likely to be headache pain-free at 2 hours after dosing, whether or not they had previously been treated with Triptan, more Triptan-naive patients (30%) than Triptan-experienced patients (20%) were headache pain-free. Interestingly, in the placebo groups, Triptan-naive patients were also more likely to be PF (14% vs 7%). In the logistic regression analysis, treatment group predicted a headache pain response, Triptan use predicted a lack of response, and there was no interaction between the two. Prior Triptan use did not predict any of the other outcome measures. CONCLUSIONS: Nausea at the time of dosing does not diminish the effectiveness of diclofenac potassium for oral solution. The rapid absorption profile may enhance the effectiveness in patients with nausea. Prior Triptan use predicted poorer headache response at 2 hours postdose, suggesting the possibility of a subset of patients who are more likely to be refractory to both Triptans and diclofenac. Diclofenac potassium for oral solution is effective in Triptan-naive patients but no reliable inference can be made from this study as to about how to order treatment.
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adding additional acute medications to a Triptan regimen for migraine and observed changes in headache related disability results from the american migraine prevalence and prevention ampp study
Headache, 2015Co-Authors: Dawn C Buse, Daniel Serrano, Michael L Reed, Shashi H Kori, C Cunanan, Aubrey Manack Adams, Richard B LiptonAbstract:Background Though Triptans are the most widely used acute treatments for migraine, response to treatment is sometimes suboptimal. Triptan therapy is often augmented by the addition of other acute treatments. The benefits of this practice have not been examined in large-scale, real-world observational studies. Objectives To assess changes in headache-related disability associated with adding additional acute treatments to a Triptan regimen by category of added treatment including: a second Triptan, nonsteroidal anti-inflammatory drugs (NSAID), opioids or barbiturates. Methods Subjects were participants in the American Migraine Prevalence and Prevention study, a longitudinal, US population-based study of individuals with “severe” headache. Respondents who met International Classification of Headache Disorders 3 beta criteria for migraine were on Triptan therapy per respondent self-report, used the same Triptan, and provided headache-related disability data for at least 2 consecutive years. Subjects were divided based on headache days per month into 3 groups: low-frequency episodic migraine (LFEM, 0-4), moderate-frequency episodic migraine (MFEM, 5-9), and high-frequency episodic migraine/chronic migraine (HFEM/CM, ≥ 10 headache days per month). HFEM and CM were combined into a single group for analyses because of sample size limitations. Patterns of acute treatment for migraine were monitored from one year to the next over the following couplets of years (2005-2006, 2006-2007, 2007-2008, and 2008-2009). The first eligible couplet was analyzed for each respondent. Medication regimens studied included: (1) maintaining current Triptan use (consistent group); (2) adding a different Triptan; (3) adding an NSAID; or (4) adding a combination analgesic containing opioids or barbiturates. We assessed change in Migraine Disability Assessment (MIDAS) score from the first to the second year of a couplet, contrasting scores of participants with consistent use with those who added an acute treatment to their Triptan regimen. Results The study sample (N = 2128) included 111 individuals who added another Triptan, 118 who added an opioid or barbiturate, and 69 who added an NSAID, with referent groups of approximately 600 cases in each group who remained consistent. In general, MIDAS scores were higher among those who made changes from one year to the next compared with those who did not make changes in therapy. In fully adjusted models, adding Triptans or NSAIDs was associated with increased disability for HFEM/CM cases at follow-up but decreased disability at follow-up for MFEM cases, resulting in significant interaction effects for both adding Triptans and NSAIDs, respectively (15.88, 95% confidence interval [CI] 0.75, 31.01, 38.52, 95% CI 12.43, 64.61). Conclusions While the effects of adding vs staying consistent on the outcome of headache-related disability varied by medication type added and headache frequency strata, in general, these results suggest that for individuals with migraine, adding acute therapies to current Triptan use is generally not associated with reductions in headache-related disability. The results were strongest among persons with HFEM and CM. These results identify important unmet medical needs in current migraine management, especially among patients with high-frequency migraine, and suggest that alternative treatment strategies are needed to improve patient outcomes.
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impact of nsaid and Triptan use on developing chronic migraine results from the american migraine prevalence and prevention ampp study
Headache, 2013Co-Authors: Richard B Lipton, Dawn C Buse, Daniel Serrano, Robert A Nicholson, Chris M Runken, Michael L ReedAbstract:Objectives To assess the influence of Triptan or nonsteroidal anti-inflammatory drug (NSAID) use on the likelihood of developing chronic migraine (CM) among persons with episodic migraine (EM). Background CM is common in tertiary headache care, and relative to EM, CM is associated with a number of deleterious outcomes, including higher headache-related disability, reduced health-related quality of life, and increased direct and indirect costs. Symptomatic medication use has emerged as an important risk factor for the development of CM. Limited evidence based on a single year of follow up suggests that the association between NSAID and Triptan use with the onset of CM varies in a dose-dependent manner that interacts with headache frequency. However, this interaction has never been explicitly studied. Herein, we evaluate results from a large-scale, 5-year, population-based observational study to characterize these relationships and test the hypothesis that NSAID use may modify the effect of Triptan use on CM onset. Methods In the American Migraine Prevalence and Prevention (AMPP) study, 11,249 participants had EM in 2005 and provided up to 5 years of annual follow-up data. We analyzed the characteristics of persons with EM 1 year that predicted new onset CM in the subsequent year, focusing on treatment with NSAIDs and Triptans as exposures. These adjacent years of data provide the basis for analysis and are termed “couplets.” Repeated measures logistic regression with a subject-specific random intercept was used to model the likelihood of transition from EM to CM as a function of NSAID or Triptan dose while controlling for a number of covariates including headache features, use of other medications, and the number of couplets per individual. Results The analysis included 9031 individuals with EM contributing up to 5 years of data and up to 4 couplets each. Results indicated that on average, 55% of the participants used NSAIDs in any given year and 2% transitioned to CM over subsequent years. Among the 20% using Triptans, 3% per year transitioned to CM. Among persons with less than 10 headache days per month, frequency of NSAID use was associated with dose-dependent reductions in risk of CM onset. Among those with 10-14 headache days per month, increasing days per month of NSAID use was associated with increasing risk of CM onset. Increasing days per month of Triptan use was associated with increased risk of transitioning to CM. Combination use of NSAIDs and Triptans was not protective against transition to CM, but was also not statistically significantly associated with increased risk of CM onset. Conclusion Triptan use in EM is associated with an increased risk of CM onset that increases with days of medication use. For NSAIDs, effects depend on headache days per month. NSAIDs are protective in individuals with less than 10 headache days per month but associated with increased risk with 10 or more headache days per month. Combining a Triptan and NSAID was not associated with a statistically significant increased risk of CM onset, whereas increased risk of CM onset was significantly associated with Triptan monotherapy.
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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, Marcelo E Bigal, Daniel Serrano, 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, Ya Ting Chen, Dawn C Buse, Wendy Golden, Daniel Serrano, 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.
Paul Williams - One of the best experts on this subject based on the ideXlab platform.
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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, David W Dodick, F M Cutrer, Peter J Goadsby, Michel D Ferrari, Douglas C Mccrory, J N Liberman, 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, David W Dodick, Richard B Lipton, Peter J Goadsby, Michel D Ferrari, Douglas C Mccrory, 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 J Goadsby, David W Dodick, Michel D Ferrari, Douglas C Mccrory, 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.
Hedvig Nordeng - One of the best experts on this subject based on the ideXlab platform.
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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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longitudinal changes in neurodevelopmental outcomes between 18 and 36 months in children with prenatal Triptan exposure findings from the norwegian mother and child cohort study
BMJ Open, 2016Co-Authors: Mollie Wood, Hedvig Nordeng, Jean A Frazier, Kate L LapaneAbstract:Objective This study sought to determine whether changes in neurodevelopmental outcomes between 18 and 36 months of age were associated with prenatal exposure to Triptan medications, a class of 5-HT receptor agonists used in the treatment of migraine. Method Using data from the Norwegian Mother and Child Cohort Study, a prospective birth cohort that includes nearly 40% of all pregnancies in Norway from 1999 to 2008, we identified 50 469 mother–child dyads who met inclusion criteria and were present for at least one follow-up assessment at 18 or 36 months postpartum. Neurodevelopment was assessed using the Child Behaviour Checklist, the Emotionality, Activity, and Shyness Questionnaire, and the Ages and Stages Questionnaire. We used generalised estimating equations to evaluate change from 18 to 36 months for children prenatally exposed to Triptans, relative to contrast groups, and used marginal structural models with inverse probability of treatment and censoring weights to address time-varying exposure and confounding as well as loss to follow-up. Results Among eligible participants (n=50 469), 1.0% used a Triptan during pregnancy, 2.0% used Triptans prior to pregnancy only, 8.0% reported migraine without Triptan use and 89.0% had no history of migraine. Children with prenatal Triptan exposure had greater increases in emotionality (r-RR 2.18, 95% CI 1.03 to 4.53) and activity problems (r-RR 1.70, 95% CI 1.02 to 2.8) compared to children born to mothers who discontinued Triptan use prior to pregnancy. Conclusion Prenatal Triptan exposure was associated with changes over time in externalising-type behaviours such as emotionality and activity, but not with internalising-type behaviours.
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prenatal Triptan exposure and parent reported early childhood neurodevelopmental outcomes an application of propensity score calibration to adjust for unmeasured confounding by migraine severity
Pharmacoepidemiology and Drug Safety, 2016Co-Authors: Mollie Wood, Hedvig Nordeng, Jean A Frazier, Kate L LapaneAbstract:Purpose Triptan medications are serotonin agonists used to treat migraine, a chronic pain condition highly prevalent in women of reproductive age. Data on the safety of Triptans during pregnancy are scant. We sought to quantify the association of prenatal Triptan exposure on neurodevelopment in 3-year-old children. Methods Using data from the Norwegian Mother and Child Cohort Study, we used propensity score matching to examine associations between prenatal Triptan exposure and psychomotor function, communication, and temperament. We used an external validation study to perform propensity calibration to adjust effect estimates for confounders unmeasured in the main study (migraine severity, type, and maternal attitudes towards medication use). Results We identified 4204 women who reported migraine headache at baseline, of which 375 (8.9%) reported using a Triptan greater than or equal to once during pregnancy. Children with prenatal Triptan exposure had 1.37-fold greater unadjusted odds of fine motor problems (95% confidence interval (CI): 1.06–1.77), which decreased after propensity score matching (odds ratio (OR): 1.29, 95%CI 0.97–1.73) and was further attenuated after calibration (OR: 1.25, 95%CI 0.89–1.74). We observed no increased risk for gross motor or communication problems, and no differences in temperament. Adjustment for migraine severity using propensity score calibration had a moderate impact on effect estimates, with percent changes ranging from 2.4% to 50%. Conclusions Prenatal Triptan exposure was not associated with psychomotor function, communication problems, or temperament in 3-year-old children. Adjustment for migraine severity reduced effect estimates and should be considered in future studies of the safety of Triptans during pregnancy. Copyright © 2015 John Wiley & Sons, Ltd.
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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.
Michel D Ferrari - One of the best experts on this subject based on the ideXlab platform.
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antimigraine efficacy of telcagepant based on patient s historical Triptan response
Headache, 2011Co-Authors: Tony W Ho, David W Dodick, Jes Olesen, James Kost, Christopher Lines, Michel D FerrariAbstract:(Headache 2011;51:64-72) Objective.— To evaluate whether the same or different patients respond to Triptans and telcagepant. Background.— Telcagepant is an oral calcitonin gene-related peptide receptor antagonist with acute antimigraine efficacy comparable to oral Triptans. It is currently unknown whether migraine patients who cannot be adequately helped with Triptans might benefit from treatment with telcagepant. Methods.— Post-hoc analysis of data from a randomized, controlled trial of telcagepant (150 mg, 300 mg) zolmiTriptan 5 mg, or placebo for a moderate/severe migraine. Responder rates were analyzed according to patients' self-reported historical Triptan response (HTR): (1) good HTR (N = 660): response in 75-100% of attacks; (2) intermediate HTR (N = 248): response in 25-74% of attacks; (3) poor HTR/no use (N = 407): response in <25% of attacks, or patient did not take Triptans. A limitation of the analysis is that the last subgroup comprised mainly (91%) patients who reported that they did not take Triptans, but it was not known whether these patients were Triptan-naive or had previously used Triptans and stopped taking them. Results.— For zolmiTriptan, 2-hour pain relief rates were higher in the good HTR subgroup (116/162, 72%) than in the intermediate (29/62, 47%) and poor/no use (44/111, 40%) HTR subgroups. The 2-hour pain relief rates were similar across HTR subgroups for telcagepant 150 mg (48-58%), 300 mg (52-58%), and placebo (26-31%). In the poor/no use HTR subgroup, more patients receiving telcagepant 300 mg (56/98, 57.1%) had 2-hour pain relief than those receiving zolmiTriptan (44/111, 39.6%; odds ratio = 2.11 [95% CI: 1.20,3.71], P = .009); the percentage for telcagepant 150 mg (57/119, 47.9%) was not significantly different from zolmiTriptan (odds ratio = 1.41 [95% CI: 0.82, 2.40], P = .211). Conclusions.— This suggests that different patients may respond to Triptans or telcagepant 300 mg. Caution should be exercised in interpreting the results because of the post-hoc nature of the analysis (clinical trial registry: NCT00442936).
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Antimigraine efficacy of telcagepant based on patient's historical Triptan response.
Headache, 2010Co-Authors: Tony W Ho, David W Dodick, Jes Olesen, James Kost, Christopher Lines, Michel D FerrariAbstract:(Headache 2011;51:64-72) Objective.— To evaluate whether the same or different patients respond to Triptans and telcagepant. Background.— Telcagepant is an oral calcitonin gene-related peptide receptor antagonist with acute antimigraine efficacy comparable to oral Triptans. It is currently unknown whether migraine patients who cannot be adequately helped with Triptans might benefit from treatment with telcagepant. Methods.— Post-hoc analysis of data from a randomized, controlled trial of telcagepant (150 mg, 300 mg) zolmiTriptan 5 mg, or placebo for a moderate/severe migraine. Responder rates were analyzed according to patients' self-reported historical Triptan response (HTR): (1) good HTR (N = 660): response in 75-100% of attacks; (2) intermediate HTR (N = 248): response in 25-74% of attacks; (3) poor HTR/no use (N = 407): response in
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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, David W Dodick, F M Cutrer, Peter J Goadsby, Michel D Ferrari, Douglas C Mccrory, J N Liberman, 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, David W Dodick, Richard B Lipton, Peter J Goadsby, Michel D Ferrari, Douglas C Mccrory, 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 J Goadsby, David W Dodick, Michel D Ferrari, Douglas C Mccrory, 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.
