Patent foramen ovale and migraine: no reason to intervene.
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Heart Septal Defects, Atrial↗
Biomedical subjects
Hans-Christoph Diener
Publications and source records attributed to Hans-Christoph Diener.
Effectiveness and satisfaction with zolmitriptan 5 mg nasal spray for treatment of migraine in real-life practice: results of a postmarketing surveillance study.
OBJECTIVE: Addressing the needs of migraineurs by actively seeking patient feedback on disease-related disability and treatment satisfaction may lead to improved management and treatment outcomes. Patient feedback can be collected in postmarketing surveillance (PMS) studies. The objective of this PMS study was to evaluate the efficacy and tolerability of zolmitriptan 5 mg nasal spray in the acute treatment of migraine attacks. PATIENTS AND METHODS: Patients received zolmitriptan 5 mg nasal spray to treat migraine attacks of any severity and were followed up after a maximum of 4 months. Patients evaluated the efficacy and tolerability of zolmitriptan nasal spray, and were asked whether they wished to continue using zolmitriptan nasal spray and their preference compared with previous treatments. Physicians also assessed the efficacy and tolerability of zolmitriptan nasal spray. RESULTS: A total of 1838 patients (84.8% females) participated in the study. Within 30 minutes of administration of zolmitriptan nasal spray, 85.0% of patients reported improvements in headache pain, with 25.1% reporting an improvement within 10 minutes. At 1 hour post-dose, 57.9% of patients were pain free and 61.7% were able to resume usual daily activities. Most patients (72.9%) rated zolmitriptan nasal spray as 'better' than previous therapy. The majority (88.8%) expressed a wish to continue using zolmitriptan nasal spray. Physicians evaluated the efficacy of zolmitriptan nasal spray as 'excellent' or 'good' in 89.4% of patients. Tolerability was evaluated as 'excellent' or 'good' in 91.6% of patients. CONCLUSIONS: Zolmitriptan 5 mg nasal spray provides favourable efficacy and tolerability in the acute treatment of migraine attacks. Most patients assessed zolmitriptan nasal spray as 'better' than previous treatment, with nearly all wishing to continue using it.
Administration, Intranasal↗
Migraine--the forgotten epidemic: development of the EHF/WHA Rome Declaration on Migraine.
Despite the availability of effective treatments, many migraine sufferers in Europe still do not receive optimal treatment. A panel of specialists, primary-care physicians and patient-group representatives met in Rome on 10-11 June 2005, under the auspices of the European Headache Federation (EHF), the World Headache Alliance (WHA) and the University of Duisburg-Essen, to review the scientific background, management issues, and physician, patient and government perspectives on migraine. The goal of the meeting was to produce the EHF/WHA Rome Declaration on Migraine, a statement of the actions required to improve migraine care and the quality of life of people with migraine. The key recommendation of the EHF/WHA Rome Declaration on Migraine is education of migraine sufferers, health professionals and health-policy makers.
Cooperative Behavior↗
Additional outcomes and subgroup analyses of NXY-059 for acute ischemic stroke in the SAINT I trial.
BACKGROUND AND PURPOSE: NXY-059 is a free radical-trapping neuroprotectant demonstrated to reduce disability from ischemic stroke. We conducted analyses on additional end points and sensitivity analyses to confirm our findings. METHODS: We randomized 1722 patients with acute ischemic stroke to a 72-hour infusion of placebo or intravenous NXY-059 within 6 hours of stroke onset. The primary outcome was disability at 90 days, as measured by the modified Rankin Scale (mRS), a 6-point scale ranging from 0 (no residual symptoms) to 5 (bed-bound, requiring constant care). Additional and exploratory analyses included mRS at 7 and 30 days; subgroup interactions with final mRS; assessments of activities of daily living by Barthel index; and National Institutes of Health Stroke Scale (NIHSS) neurological scores at 7 and 90 days. RESULTS: NXY-059 significantly improved the distribution of the mRS disability score compared with placebo at 7, 30, and 90 days (Cochran-Mantel-Haenszel test P=0.002, 0.004, 0.038, respectively; 90-day common odds ratio 1.20; 95% CI, 1.01 to 1.42). The benefit was not attributable to any specific baseline characteristic, stratification variable or subgroup interaction. Neurological scores were improved at 7 days (odds ratio [OR], 1.46; 95% CI, 1.13, 1.89; P=0.003) and the Barthel index was improved at 7 and 30 days (OR, 1.55; 95% CI, 1.22, 1.98; P<0.0001; OR, 1.27; 95% CI, 1.01, 1.59; P=0.02). CONCLUSIONS: NXY-059 within 6 hours of acute ischemic stroke significantly reduced disability. Benefit on neurological scores and activities of daily living was detectable early but not significant at 90 days; however, our trial was underpowered to measure effects on the neurological examination. The benefit on disability is not confounded by interactions and is supported by other outcome measures.
Aged↗
Pain related potentials by electrical stimulation of skin for detection of small-fiber neuropathy in HIV.
We compared the sensitivity of pain related evoked potentials (PREP), a novel electrophysiological technique, with standard nerve conduction (SNC) testing in the diagnosis of small fiber neuropathy in 47 patients with HIV infection and 31 age matched controls. SNC testing revealed a neuropathy in only 31%, whereas PREP was abnormal in 74% of symptomatic patients. This result hints that PREP is more sensitive in the detection of HIV-associated small fiber neuropathy than standard neurography.
Adult↗
Trials and tribulations of noninferiority: the ximelagatran experience.
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Anticoagulants↗
Unreported financial disclosures in a study of migraine and cardiovascular disease.
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Conflict of Interest↗
Migraine and risk of cardiovascular disease in women.
CONTEXT: Migraine with aura has been associated with an adverse cardiovascular risk profile and prothrombotic factors that, along with migraine-specific physiology, may increase the risk of vascular events. Although migraine with aura has been associated with increased risk of ischemic stroke, an association with cardiovascular disease (CVD) and, specifically, coronary events remains unclear. OBJECTIVE: To evaluate the association between migraine with and without aura and subsequent risk of overall and specific CVD. DESIGN, SETTING, AND PARTICIPANTS: Prospective cohort study of 27,840 US women aged 45 years or older who were participating in the Women's Health Study, were free of CVD and angina at study entry (1992-1995), and who had information on self-reported migraine and aura status, and lipid measurements. This report is based on follow-up data through March 31, 2004. MAIN OUTCOME MEASURES: The primary outcome measure was the combined end point of major CVD (first instance of nonfatal ischemic stroke, nonfatal myocardial infarction, or death due to ischemic CVD); other measures were first ischemic stroke, myocardial infarction, coronary revascularization, angina, and death due to ischemic CVD. RESULTS: At baseline, 5125 women (18.4%) reported any history of migraine; of the 3610 with active migraine (migraine in the prior year), 1434 (39.7%) indicated aura symptoms. During a mean of 10 years of follow-up, 580 major CVD events occurred. Compared with women with no migraine history, women who reported active migraine with aura had multivariable-adjusted hazard ratios of 2.15 (95% confidence interval [CI], 1.58-2.92; P<.001) for major CVD, 1.91 (95% CI, 1.17-3.10; P = .01) for ischemic stroke, 2.08 (95% CI, 1.30-3.31; P = .002) for myocardial infarction, 1.74 (95% CI, 1.23-2.46; P = .002) for coronary revascularization, 1.71 (95% CI, 1.16-2.53; P = .007) for angina, and 2.33 (95% CI, 1.21-4.51; P = .01) for ischemic CVD death. After adjusting for age, there were 18 additional major CVD events attributable to migraine with aura per 10 000 women per year. Women who reported active migraine without aura did not have increased risk of any vascular events or angina. CONCLUSIONS: In this large, prospective cohort of women, active migraine with aura was associated with increased risk of major CVD, myocardial infarction, ischemic stroke, and death due to ischemic CVD, as well as with coronary revascularization and angina. Active migraine without aura was not associated with increased risk of any CVD event.
Cardiovascular Diseases↗
Carotid intima-media thickness in HIV-infected individuals: relationship of premature atherosclerosis to neuropsychological deficits?
BACKGROUND: Intima-media thickness (IMT) measured by extracranial duplex sonography is a surrogate marker for atherosclerosis. It is well known that IMT is greater in HIV patients than in age-matched healthy controls due to HIV- induced endothelial damage and metabolic side-effects of antiretroviral therapy. However, it remains unclear whether atherosclerosis has an additional impact on cognitive function in HIV patients. Therefore, the objective of this study was to investigate the correlation between IMT and neuropsychological deficits in HIV patients. METHODS: 47 HIV patients and 40 age-matched healthy controls were examined by extracranial ultrasound 2 and 3 cm before the flow divider to evaluate differences in IMT. Possible neuropsychological deficits in HIV patients were assessed using a battery of 10 neuropsychological tests. Results of neuropsychological tests and markers of disease severity were correlated with IMT in HIV patients. RESULTS: IMT was significantly greater in patients than in healthy controls (p < 0.001). However, none of the neuropsychological tests correlated significantly with IMT measurements in HIV patients. There was only a weak correlation between deficits in attention and IMT in HIV patients (r = 0.44; p = 0.005), which was non-significant after correction for multiple comparisons. Markers of disease severity (CD4 cell count, HIV load in plasma, duration of HIV disease) did not correlate with IMT either. CONCLUSION: IMT was greater in HIV patients compared to age-matched controls but it appears that premature atherosclerosis has no additional impact on the evolution of neuropsychological deficits in HIV patients. IMT did not correlate with the severity of immunodeficiency.
Adult↗
[Due to cost considerations too few triptans are prescribed].
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Cost Control↗
[Headaches in nonneurologic diseases].
Headaches can be classified into primary and secondary headaches. Typical examples of primary headaches are migraine, tension-type headache and cluster headache. Secondary headaches in internal medicine might be due to hypertensive encephalopathy, lung diseases, metabolic and endocrine diseases and disturbances of electrolytes like increased and decreased serum calcium levels. Ibuprofen, immunoglobulins, and antibiotics might lead to aseptic meningitis. Drug-induced headaches are seen after use of nitroglycerine, calcium channel blockers and immunoglobulins.
Central Nervous System Diseases↗
Development and validation of a prognostic model to predict recovery following intracerebral hemorrhage.
CONTEXT: While several models have been developed to predict mortality following intracerebral hemorrhage (ICH), the functional outcome and its predictors in surviving patients have been poorly investigated so far. OBJECTIVES: To identify predictors and validate a prognostic model for independent functional outcome in patients with acute ICH. DESIGN: An inception cohort was assessed on the National Institutes of Health Stroke Scale (NIH-SS) at admission and followed-up after 100 days. SETTING: 11 neurological departments with an acute stroke unit. PATIENTS: 207 consecutive patients who were neither comatose nor intubated at admission within 6 hours after ICH and with complete follow-up. RESULTS: After 100 days, 40 patients (19.3 %) had died, 78 (37.7%) had regained functional independence (Barthel Index > or = 95) and 89 (43%) had survived but not recovered. In these patients, age and the NIH-SS total score were identified as independent predictors for functional independence after 100 days. With the predefined cut-off value, the prognosis of 79.8% of all patients could be predicted accurately upon validation in an independent data set of 173 non-comatose patients with acute ICH. CONCLUSION: Our study provides a validated prognostic model for prediction of complete recovery following ICH which could be very useful for the design of clinical studies.
Age Factors↗
Improving patient selection for clinical acute stroke trials.
OBJECTIVE: To optimize patient inclusion criteria for clinical acute stroke trials. METHODS: We stratified probabilities of death and complete recovery based on two validated prognostic models using age and the National Institutes of Health Stroke Scale (NIH-SS) at admission. In an independent data set of 1,725 consecutively admitted patients with acute ischemic stroke, computer simulation with various inclusion thresholds was used to calculate the number and percentage of potential treatment responders, i.e. who had not died or spontaneously recovered. RESULTS: Using defined thresholds for recovery and mortality, inclusion and exclusion criteria could be designed to considerably decrease both trial time and study size compared to a fixed inclusion criterion based on the NIH-SS alone. Other thresholds may allow optimization of either trial time or study size. CONCLUSIONS: The resulting models provide a validated approach for an efficient study inclusion of potential treatment responders based on the Barthel Index 100 days after ischemic stroke. These techniques provide the opportunity for improved stroke trials in terms of enrollment speed, treatment effect size or both.
Adolescent↗
NXY-059 for acute ischemic stroke.
BACKGROUND: NXY-059 is a free-radical-trapping agent that is neuroprotective in animal models of stroke. We tested whether it would reduce disability in humans after acute ischemic stroke. METHODS: We conducted a randomized, double-blind, placebo-controlled trial involving 1722 patients with acute ischemic stroke who were randomly assigned to receive a 72-hour infusion of placebo or intravenous NXY-059 within 6 hours after the onset of the stroke. The primary outcome was disability at 90 days, as measured according to scores on the modified Rankin scale for disability (range, 0 to 5, with 0 indicating no residual symptoms and 5 indicating bedbound, requiring constant care). RESULTS: Among the 1699 subjects included in the efficacy analysis, NXY-059 significantly improved the overall distribution of scores on the modified Rankin scale, as compared with placebo (P=0.038 by the Cochran-Mantel-Haenszel test). The common odds ratio for improvement across all categories of the scale was 1.20 (95 percent confidence interval, 1.01 to 1.42). Mortality and rates of serious and nonserious adverse events were each similar in the two groups. NXY-059 did not improve neurologic functioning as measured according to the National Institutes of Health Stroke Scale (NIHSS): the difference between the two groups in the change from baseline scores was 0.1 point (95 percent confidence interval, -1.4 to 1.1; P=0.86). Likewise, no improvement was observed according to the Barthel index (P=0.14). In a post hoc analysis of patients who also received alteplase, NXY-059 was associated with a lower incidence of any hemorrhagic transformation (P=0.001) and symptomatic intracranial hemorrhage (P=0.036). CONCLUSIONS: The administration of NXY-059 within six hours after the onset of acute ischemic stroke significantly improved the primary outcome (reduced disability at 90 days), but it did not significantly improve other outcome measures, including neurologic functioning as measured by the NIHSS score. Additional research is needed to confirm whether NXY-059 is beneficial in ischemic stroke. (ClinicalTrials.gov number, NCT00119626.).
Acute Disease↗
Value of postmarketing surveillance studies in achieving a complete picture of antimigraine agents: using almotriptan as an example.
Randomised controlled trials cannot collect all the data relevant for use in everyday clinical practice because drug exposure is limited, endpoints are restricted and some patient populations are excluded. Postmarketing surveillance (PS) studies can add important information for real-world clinical practice. Acute migraine therapy with almotriptan 12.5 mg was evaluated in 4 PS studies, 2 conducted in Spain, 1 in Germany and 1 in France. Almotriptan was associated with a high rate of treatment response and was well tolerated in all 4 studies. In the Spanish and German studies, 2-hour pain-relief, 2-hour pain-free, and sustained painfree rates were enhanced when patients treated mild pain. Patient satisfaction with almotriptan, assessed in the German and French studies, was high and the majority of patients preferred almotriptan to their previous acute migraine therapy. In conclusion, PS studies augment our knowledge of antimigraine therapy, giving a more complete picture of how such agents work in the general population.
Humans↗
Stroke prevention using the oral direct thrombin inhibitor ximelagatran in patients with non-valvular atrial fibrillation. Pooled analysis from the SPORTIF III and V studies.
BACKGROUND: To show results of a prespecified pooled analysis of the studies SPORTIF III (open-label) and SPORTIF V (double-blind), to assess the homogeneity of the results and to explore subgroup analyses and adverse events. METHODS AND RESULTS: 7,329 patients with atrial fibrillation (AF) and >or=1 additional stroke risk factor were randomized to warfarin (international normalized ratio 2.0-3.0) or ximelagatran (36 mg twice daily). Over 11,346 patient-years (mean 18.5 months/patient), 184 patients developed primary events of stroke and systemic embolism (ximelagatran 1.62 vs. warfarin 1.65%/year; p = 0.94). Heterogeneity between trials with respect to the primary event rate (study-by-treatment interaction p = 0.026) was found. This could not be explained statistically by baseline patient characteristics or by treatment (except perhaps by the better anticoagulation with warfarin in SPORTIF V) and was not evident for secondary end-points. There was no conclusive difference in major bleeding rates (ximelagatran 1.88 vs. warfarin 2.46%/year; p = 0.054), but combined minor plus major bleeding was lower with ximelagatran (31.7 vs. 38.7%/year; p < 0.0001). Elevation of liver enzymes occurred more frequently in patients taking ximelagatran (6.1% vs. warfarin 0.8%; p < 0.0001) and was reversible except in rare cases. CONCLUSIONS: Fixed-dose oral ximelagatran without coagulation monitoring prevented stroke and systemic embolism as effectively as warfarin in patients with AF. Differences in the results of the two trials might relate to consistency of warfarin anticoagulation, different degree of blinding in the two trials, other concomitant therapies or chance. Further investigation is required to explore the long-term safety profile of ximelagatran.
Administration, Oral↗
Distribution and outcome of symptomatic stenoses and occlusions in patients with acute cerebral ischemia.
OBJECTIVE: To describe the distribution of steno-occlusive disease and the associated rate of recurrence in patients with acute cerebral ischemia. DESIGN: An inception cohort was prospectively recruited after an index event and followed up to assess recurrent stroke and death up to 1 year after the event. SETTING: Eleven German departments of neurology with acute stroke units. PATIENTS: A total of 4157 patients who experienced an acute ischemic stroke or a transient ischemic attack and had complete cerebrovascular examination results. Follow-up information could be obtained in 85.3% of these patients. RESULTS: Symptomatic vessel occlusions were associated with a high mortality rate and were found most often in the proximal internal carotid artery (6.5% of patients), the M1 segment of the middle cerebral artery (3.7%), and the vertebral artery (3.0%). Symptomatic stenosis of 50% to 99% of the internal carotid artery was found in 308 patients (7.4%), and 272 patients (6.5%) had symptomatic intracranial stenosis. The highest rates of recurrent stroke during the first 3 days occurred in patients with symptomatic carotid and intracranial occlusions. Overall, 82 (8.0%) of 1027 patients with symptomatic cerebrovascular disease experienced a recurrent stroke between day 4 and 1 year, but no significant differences in recurrent stroke rates could be found when comparing different locations of steno-occlusive disease. CONCLUSIONS: Our study provides representative data on the distribution and outcome of steno-occlusive disease in patients with acute cerebral ischemia. In contrast to prior studies in more selected populations, the rate of recurrent stroke in patients with symptomatic intracranial stenosis was not elevated compared with that of patients without steno-occlusive disease.
Aged↗