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Biomedical subjects

David W Dodick

Publications and source records attributed to David W Dodick.

At least 55 records · Page 3Linked to original sources

Acute treatment of migraine with zolmitriptan 5 mg orally disintegrating tablet.

OBJECTIVE: To determine the speed of onset of headache response and duration of response with zolmitriptan 5 mg orally disintegrating tablet (ODT) in the acute treatment of migraine. BACKGROUND: Rapid pain relief is important for migraine sufferers. The early efficacy (30 minutes) of the 5 mg dose of the zolmitriptan ODT formulation was evaluated. METHODS: In this double-blind, parallel-group trial, 670 patients were randomised to receive either zolmitriptan 5 mg ODT (n=329) or matching placebo (n=341) to treat two migraine headaches of moderate or severe intensity. RESULTS: Zolmitriptan 5 mg ODT was significantly more effective than placebo in achieving a headache response (reduction in migraine headache intensity from moderate or severe to mild or no pain) at 30 minutes (16.5% vs 12.5%; p=0.048; primary endpoint), 1 hour (p <0.0001), and 2 hours (p <0.0001). Significantly more patients achieved a sustained headache response for 24 hours with zolmitriptan 5 mg ODT than with placebo (42.5% vs 16.4%; p <0.0001). Zolmitriptan 5 mg ODT also produced a higher pain-free rate than placebo at all timepoints (0.5, 1 and 2 hours post-dose), with the differences becoming significant at 1 hour. Adverse events were reported by 37.7% of the patients treated with zolmitriptan 5 mg ODT and 18.1% of the patients treated with placebo. Those that occurred most often for the patients treated with zolmitriptan 5 mg ODT were tightness (7.0%), dizziness (6.7%), somnolence (6.7%) and paraesthesias (6.1%). CONCLUSIONS: A significant headache response as early as 30 minutes post-dose and good maintenance of this headache response at 24 hours makes zolmitriptan 5 mg ODT an excellent acute treatment for migraine. Together with the relatively low adverse event rate, these data demonstrate that zolmitriptan 5 mg ODT is a valuable therapy for migraine sufferers.

Acute Disease↗

Migraine in special populations. Treatment strategies for children and adolescents, pregnant women, and the elderly.

Although migraine is a common occurrence in children and adolescents, its diagnosis and treatment present unique challenges. Migraine management in pregnant women and the elderly can also be difficult and requires selection of appropriate and safe medications for patients in these special circumstances. In this article, Drs Gladstone, Eross, and Dodick provide pearls for both abortive and prophylactic treatments for migraine in these populations.

Adolescent↗

Evaluation and management of asymptomatic carotid artery stenosis.

Internal carotid artery stenosis (ICAS) is responsible for approximately 30% of ischemic strokes. Internal carotid artery stenosis of greater than 50% is present in about 4% to 8% of the population aged 50 to 79 years. Natural history studies and clinical trials have shown a small increase in stroke risk in patients with increasing degrees of ICAS, especially in those with greater than 80% reduction in carotid artery diameter. Randomized, prospective multicenter trials have revealed the superiority of carotid endarterectomy (CEA) over medical therapy in recently symptomatic patients with severe ICAS. However, the evidence from several randomized controlled trials of CEA in asymptomatic patients does not support the use of CEA in most of these patients; also, the role of noninvasive screening in this patient population remains uncertain and controversial. Furthermore, there is considerable uncertainty about whether the statistical benefit of avoiding a nondisabling stroke is worth the overall cost and risk of the procedure. Clinicians continue to struggle with treatment decisions for patients with asymptomatic ICAS. Carotid endarterectomy for asymptomatic ICAS should be considered only for medically stable patients with 80% or greater stenosis who are expected to live at least 5 years, and only in centers with surgeons who have a demonstrated low (<3%) perioperative complication rate. We outline the prevalence and natural history of ICAS, the evidence for CEA in patients with asymptomatic ICAS, the roles of screening and monitoring for ICAS, the methods of evaluating ICAS, and the implications for practicing clinicians.

Carotid Artery, Internal↗

Advances in migraine management: implications for managed care organizations.

Migraine headache is a disabling disease that poses a significant societal burden. Stratified care and early intervention are current strategies for migraine management. It has been shown that early treatment with triptans in select patients can improve treatment outcomes. Triptans are selective 5-HT receptor agonists that are specific and effective treatments in the management of migraine, and they meet the acute treatment goal of rapid relief with minimal side effects. Triptans are associated with improved quality of life. Factors such as speed of onset, need for a second triptan dose, and patient satisfaction should be considered in the selection of a specific triptan treatment. Appropriate treatment can decrease costs. The patient's migraine history and response to prior therapy should be considered when selecting acute treatment. Cost-effectiveness models can be used to understand the effect of treatment choices on health care budgets. The direct cost per migraine episode, driven primarily by the need for rescue medications, is important to include in economic models. All aspects of effectiveness (efficacy, tolerability, and cost) should be considered to reduce overall managed care expenditures for migraine treatment. The improved clinical profiles of the triptans provide substantial value to managed care organizations.

Cost-Benefit Analysis↗

Clinical, anatomical, and physiologic relationship between sleep and headache.

The intimate relationship between sleep and headache has been recognized for centuries, yet the relationship remains clinically and nosologically complex. Headaches associated with nocturnal sleep have often been perceived as either the cause or result of disrupted sleep. An understanding of the anatomy and physiology of both conditions allows for a clearer understanding of this complex relationship and a more rational clinical and therapeutic approach. Recent biochemical and functional imaging studies in patients with primary headache disorders has lead to the identification of potential central generators which are also important for the regulation of normal sleep architecture. Medical conditions (e.g. obstructive sleep apnea, depression) that may disrupt sleep and lead to nocturnal or morning headache can often be identified on clinical evaluation or by polysomnography. In contrast, primary headache disorders which often occur during nocturnal sleep or upon awakening, such as migraine, cluster headache, chronic paroxysmal hemicrania, and hypnic headache, can readily be diagnosed through clinical evaluation and managed with appropriate medication. These disorders, when not associated with co-morbid mood disorders or medications/analgesics overuse, seldom lead to significant sleep disruption. Identifying and classifying the specific headache disorder in patients with both headache and sleep disturbances can facilitate an appropriate diagnostic evaluation. Patients with poorly defined nocturnal or awakening headaches should undergo polysomnography to exclude a treatable sleep disturbance, especially in the absence of an underlying psychological disorder or analgesic overuse syndrome. In patients with a well defined primary headache disorder, unless there are compelling historical or examination findings suggestive of a primary sleep disturbance, a formal sleep evaluation is seldom necessary.

Cluster Headache↗

A review of the clinical efficacy and tolerability of almotriptan in acute migraine.

Almotriptan is a serotonin (5-hydroxytryptamine, 5HT)(1B/1D)-receptor agonist approved for the acute treatment of migraine. In 3500 acute migraine patients enrolled in short-term trials and 1500 patients in long-term open-label trials, almotriptan 12.5 mg was effective and well-tolerated. Almotriptan maintains a consistency of response across three attacks and patients continue to respond to almotriptan for up to 1 year. Results from two comparative studies and a meta-analysis of 53 randomised, placebo-controlled studies of oral triptans in > 24,000 patients, confirm that almotriptan 12.5 mg demonstrates comparable efficacy with sumatriptan 50 and 100 mg. The incidence of treatment-related adverse events with almotriptan is comparable to that of placebo and significantly lower than that with sumatriptan. Drug-drug interaction studies indicate that almotriptan may be coadministered with other commonly prescribed drugs without dose modification. Almotriptan can be recommended as first-line treatment for acute migraine.

Acute Disease↗

Paroxysmal sleep as a presenting symptom of bilateral paramedian thalamic infarctions.

Bilateral paramedian thalamic infarctions may result in hypersomnolence, supranuclear palsy, and an amnestic syndrome. We describe an 82-year-old man who presented with recurrent, transient episodes of unresponsiveness secondary to bilateral paramedian thalamic infarctions. Electroencephalography was performed during one of these paroxysmal events and showed an abrupt transition to a stage 2 sleep pattern with spindle formation.

Aged↗

Sustained-release niacin for prevention of migraine headache.

Considerable advances in the diagnosis and treatment of migraine headache have occurred during the past decade, but treatment options for acute migraine attacks have expanded at a faster rate than those for prophylaxis. We describe a patient whose migraine headaches responded dramatically to sustained-release niacin as preventive treatment. Niacin is not generally considered to be effective for migraine prevention. However, low plasma levels of serotonin have been implicated in migraine pathogenesis, and niacin may act as a negative feedback regulator on the kynurenine pathway to shunt tryptophan into the serotonin pathway, thus increasing plasma serotonin levels. Sustained-release niacin merits further study as a potentially useful preventive therapy for migraine headache.

Delayed-Action Preparations↗

Patient-focused migraine management: establishing needs.

Headache disorders represent a serious threat to the sufferer's quality of life and normal day-to-day functioning. Headache generates a substantial disability burden, being classified among the major public health disorders. There is no doubt that the emergence of the triptan class in the early 1990s dramatically advanced the treatment of migraine and has changed the perspective of the migraine sufferer with respect to the treatment. Triptan therapies for migraine relief have been proven to be safe and efficacious in clinical trials. Nevertheless, endpoint-based clinical trials are focused more on specific measures of efficacy and tolerability (e.g., relief, response and adverse event rates), and less on the patient's feelings and quality of life. For instance, in the U.S. only 29% of migraine sufferers are very satisfied with their usual treatment. The principal reasons for their dissatisfaction with therapy are as follows: pain relief takes too long (87%), treatment does not relieve all the pain (87%), treatment does not always work (85%), headache comes back (71%), and too many side effects (35%). Thus, this work is focused on patients' perspectives on migraine therapies attempting to establish their needs and to find better treatment possibilities for restoring patients' overall functionality.

Humans↗

Thunderclap headache.

Thunderclap headache refers to an excruciating headache of instantaneous onset. It occurs as suddenly and unexpectedly as a "clap of thunder." Patients with thunderclap headache may have normal neurologic examination results and normal computed tomographic brain scans, even if they have serious underlying pathology. This has created confusion regarding nosology and the nature and extent of the diagnostic evaluation, which this article discusses.

Diagnosis, Differential↗

Almotriptan increases sustained pain-free outcomes in acute migraine: results from three controlled clinical trials.

OBJECTIVE: Evaluate the effect of almotriptan on sustained pain-free outcome in patients with acute migraine. METHODS: Three randomized, double-blind, placebo-controlled trials of almotriptan for the treatment of acute migraine were examined. Two trials evaluated almotriptan 6.25 mg and 12.5 mg, and the third evaluated almotriptan 12.5 mg and sumatriptan 100 mg. Patients aged 18 to 65 years were instructed to take 1 dose of study medication at the onset of a moderate-to-severe migraine headache. A second dose was allowed for relapse. Sustained pain-free was defined as a decrease in pain severity from moderate or severe at baseline to no pain at 2 hours postdose and without relapse or the use of escape medication between 2 and 24 hours. RESULTS: A total of 1791 adult migraine sufferers were studied. The proportion of patients achieving a sustained pain-free state was significantly (P<.05) higher in the almotriptan 6.25-mg (21.7% to 22.5%) and 12.5-mg (24.6% to 27.6%) groups than in the placebo group (7.5% to 12.1%). The proportion of patients achieving a sustained pain-free state was comparable between almotriptan 12.5 mg (24.6%) and sumatriptan 100 mg (28.5%) and significantly (P<.05) greater than with placebo (12.1%). Among patients with severe baseline pain, a sustained pain-free state was achieved in significantly more patients (P<.05) with almotriptan 12.5 mg (17.3% to 20.9%) than with placebo (3.1% to 3.2%). Among those with moderate baseline pain, a sustained pain-free state was achieved in significantly more patients (P<.01) with almotriptan 12.5 mg (31.3% to 32.0%) than with placebo (10.2% to 16.1%). CONCLUSIONS: Almotriptan 12.5 mg is significantly better than placebo and comparable to sumatriptan 100 mg for achieving a sustained pain-free state.

Acute Disease↗