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Biomedical subjects

Stephen D Silberstein

Publications and source records attributed to Stephen D Silberstein.

At least 37 records · Page 2Linked to original sources
PubMed2005

Acetaminophen, aspirin, and caffeine versus sumatriptan succinate in the early treatment of migraine: results from the ASSET trial.

OBJECTIVE: To address the need for a rigorous, direct comparison of prescription and over-the-counter (OTC) migraine drugs and to expand the database on early treatment of migraine. BACKGROUND: Most people who experience migraine use OTC medications to treat their symptoms, but no head-to-head clinical trials comparing these agents with prescription migraine therapies have been published. In addition, even though most migraineurs treat early in the attack, few studies have been conducted to reflect this treatment pattern. METHODS: We compared a combination of nonprescription migraine medication (acetaminophen 500 mg, aspirin 500 mg, and caffeine 130 mg) with a prescription migraine product (50 mg sumatriptan) in a randomized, controlled clinical trial in which subjects treated at the first sign of a migraine attack. Subjects who reported vomiting during more than 20% of migraine episodes or who required bedrest during more than 50% of migraine episodes were excluded from the study. Of the 188 subjects randomized, 171 took study medication and were included in the analysis. CONCLUSION: The combination of acetaminophen, aspirin, and caffeine was significantly more effective (P > .05) than sumatriptan in the early treatment of migraine, as shown by superiority in summed pain intensity difference, pain relief, pain intensity difference, response, sustained response, relief of associated symptoms, use of rescue medication, disability relief, and global assessments of effectiveness. An additional, larger clinical trial is needed to confirm these results.

Acetaminophen↗
PubMed2005

Burden of illness and satisfaction with care among patients with headache seen in a primary care setting.

OBJECTIVE: To assess the current level of headache burden and the headache management needs at three diverse clinical sites. BACKGROUND: Headache is a common disabling disorder that is costly for the patient and a management challenge for physicians. The determination of whether and how to intervene to improve headache management depends on both the burden of disease and the characteristics of patients that would likely be targeted. METHODS: Patients from three healthcare organizations were identified by administrative records as having either migraine or tension-type headache and then mailed a survey that addressed demographics, headache type, headache-related disability, depression and anxiety, satisfaction with care, general health, worry about headache, problems with headache management, and healthcare utilization. Comparisons were made across sites and between patients with more and less severe headache-related impairments. RESULTS: Of the 789 patients contacted, 385 (50%) returned a survey. While the socio-demographic characteristics of the patients were diverse, headache-related characteristics were similar. These patients have significant problems with headache management, disability, pain, worry, and dissatisfaction with care. Patients who described higher headache-related impairment experienced significantly greater problems in these areas, perceived themselves to be in worse general health, and had significantly greater use of medical services than those with lower headache severity. CONCLUSIONS: Despite various elements of heterogeneity, we observed across the sites a consistent need for improvement in headache management. Future efforts should be directed at developing and evaluating methods for effectively improving headache management.

Adult↗
PubMed2005

Topiramate in migraine prevention.

The efficacy of topiramate in migraine prevention (prophylaxis) was established in two multicenter, randomized, double-blind, placebo-controlled, pivotal trials. Topiramate has received regulatory approval for use in adults for migraine prophylaxis (prevention) in the US and numerous other countries, including France, Ireland, Switzerland, Brazil, Taiwan, Spain, and Australia. Treatment with 100 or 200 mg per day of topiramate was associated with significant reductions in the frequency of migraine headaches, number of migraine days, and use of acute medications. No increase in efficacy was observed between 100 and 200 mg per day of topiramate. Based on efficacy and tolerability, 100 mg per day of topiramate should be the initial target dose for most patients. The most common adverse events were paresthesia, fatigue, decreased appetite, nausea, diarrhea, weight decrease, and taste perversion. Topiramate is a first-line migraine preventive drug and should especially be considered as a preferred treatment for all patients who are concerned about gaining weight, who are currently overweight, or who have coexisting epilepsy.

Adolescent↗
PubMed2005

Therapeutic options in the management of headache attributed to rhinosinusitis.

Sinus headache is a common diagnosis when patients have facial pain and pressure accompanying their headache. However, acute sinus headache is in fact rare, and the headache must accompany acute bacterial rhinosinusitis (ABRS), a diagnosis which is based both on clinical and radiological evidence. In fact, sinus headache is a misnomer. The only headache related to sinus disease, as recognised by the International Headache Society (IHS), is headache attributed to rhinosinusitis (HARS; section 11.5 of IHS criteria). Many patients who are diagnosed with sinus headache and treated with antibiotics have a primary headache, usually migraine. This is an important distinction and the treatment is very different. This review covers the most recent definitions, epidemiology, pathophysiology, diagnostics and treatment of ABRS and the resulting headache as defined by the IHS.

Analgesics↗
PubMed2005

Botulinum toxin type A for the prophylactic treatment of chronic daily headache: a randomized, double-blind, placebo-controlled trial.

OBJECTIVES: To identify a treatment-responsive population for botulinum toxin type A (BoNTA) and to evaluate the safety and efficacy of 3 different doses of BoNTA as prophylactic treatment of chronic daily headache (CDH). PATIENTS AND METHODS: A randomized, double-blind, placebo-controlled study of BoNTA in patients with CDH was conducted from July 6, 2001, through November 7, 2003, at 28 North American study centers. Eligible patients were injected with BoNTA at 225 U, 150 U, 75 U, or placebo and returned for additional masked treatments at day 90 and day 180. Patients were assessed every 30 days for 9 months. The primary efficacy end point was the mean change from baseline in the frequency of headache-free days at day 180 for the placebo nonresponder group. RESULTS: For this study, 702 patients were enrolled and randomized. The primary efficacy end point was not met. Mean improvements from baseline at day 180 of 6.0, 7.9, 7.9, and 8.0 headache-free days per month were observed in the placebo nonresponder group treated with BoNTA at 225 U, 150 U, 75 U, or placebo, respectively (P=.44). An a priori-defined analysis of headache frequency revealed that BoNTA at 225 U or 150 U had significantly greater least squares mean changes from baseline than placebo at day 240 (-8.4, -8.6, and -6.4, respectively; P=.03 analysis of covariance). Only 27 of 702 patients (3.8%) withdrew from the study because of adverse events, which generally were transient and mild to moderate. CONCLUSIONS: Although the primary efficacy end point was not met, all groups responded to treatment. The 225 U and 150 U groups experienced a greater decrease in headache frequency than the placebo group at day 240. The placebo response was higher than expected. BoNTA was safe and well tolerated. Further study of BoNTA prophylactic treatment of CDH appears warranted.

Adolescent↗
PubMed2005

Chronic daily headache.

Chronic daily headache represents a range of disorders characterized by the occurrence of long-duration headache 15 or more days per month. The classification of these disorders continues to undergo revision to make them more clinically relevant, such as that which has been most controversial, the classification of chronic migraine. The role of medication overuse in what has commonly been known as rebound headache can have a significant influence on these disorders. The diagnosis of the chronic daily headaches, including chronic migraine and chronic tension-type headache, truly cannot be made if patients are having medication-overuse headache. This article reviews the criteria for medication-overuse headache and the subset of headaches making up chronic daily headache, as well as the epidemiologic and therapeutic aspects of these disorders.

Analgesics↗
PubMed2004

A randomized trial of frovatriptan for the intermittent prevention of menstrual migraine.

BACKGROUND: Menstrually associated migraine (MAM) is often prolonged and difficult to manage with conventional therapies. Frovatriptan is a new selective 5HT(1B/1D) receptor agonist indicated for short-term management of migraine. It has a long half-life and good tolerability. These characteristics suggest that frovatriptan may be useful for the intermittent prevention of MAM. METHODS: The study was a randomized, double-blind, placebo-controlled, three-way crossover design. Patients treated each of three perimenstrual periods (PMPs) with placebo, frovatriptan 2.5 mg QD, and frovatriptan 2.5 mg BID. The 6-day treatment started 2 days before the anticipated start of MAM headache. The primary efficacy endpoint was incidence of MAM headache during the 6-day PMP. RESULTS: The population comprised 546 women (mean age, 37.6 years). Use of frovatriptan reduced the occurrence of MAM headache. The incidence of MAM headache during the 6-day PMP was 67% for placebo, 52% for frovatriptan 2.5 mg QD, and 41% for frovatriptan 2.5 mg BID. Both frovatriptan regimens were superior to placebo (p < 0.0001), and the BID regimen was superior to the QD regimen (p < 0.001). Both frovatriptan regimens also reduced MAM severity (p < 0.0001), duration (p < 0.0001), and the use of rescue medication (p < 0.01 QD; p < 0.0001 BID) in a dose-dependent manner. The incidence and type of adverse events for both regimens were similar to placebo and consistent with those reported for short-term migraine management. CONCLUSION: Frovatriptan given prophylactically for 6 days was effective in reducing the incidence of menstrually associated migraine. More than half of patients who used frovatriptan 2.5 mg BID had no menstrually associated migraine headache during the 6-day perimenstrual period. The findings are consistent with the long duration of action and good tolerability of frovatriptan observed in short-term migraine management.

Adult↗
PubMed2004

Migraine.

Migraine is a very common neurobiological headache disorder that is caused by increased excitability of the CNS. It ranks among the world's most disabling medical illnesses. Diagnosis is based on the headache's characteristics and associated symptoms. The economic and societal effect of migraine is substantial: it affects patients' quality of life and impairs work, social activities, and family life. There are many acute and preventive migraine treatments. Acute treatment is either specific (triptans and ergots) or non-specific (analgesics). Disabling migraine should be treated with triptans. Increased headache frequency is an indication for preventive treatment. Preventive treatment decreases migraine frequency and improves quality of life. More treatments are being developed, which provides hope to the many patients whose migraines remain uncontrolled.

Humans↗
PubMed2004

Topiramate in migraine prevention: results of a large controlled trial.

BACKGROUND: Open-label trials and small controlled studies report topiramate's efficacy in migraine prevention. OBJECTIVE: To assess the efficacy and safety of topiramate as a migraine-preventive therapy. DESIGN: A 26-week, randomized, double-blind, placebo-controlled study. SETTING: Outpatient treatment at 49 US clinical centers. Patients Patients were aged 12 to 65 years, had a 6-month International Headache Society migraine history, and experienced 3 to 12 migraines per month, but had 15 or fewer headache days per month during the 28-day baseline period. INTERVENTIONS: Participants were randomized to placebo or topiramate, 50, 100, or 200 mg/d, titrated by 25 mg/wk to the assigned dose or as tolerated in 8 weeks; maintenance therapy continued for 18 weeks. MAIN OUTCOME MEASURES: The primary efficacy assessment was a reduction in mean monthly migraine frequency across the 6-month treatment phase. Secondary end points were responder rate, time to onset of action, mean change in migraine days per month, and mean change in rescue medication days per month. RESULTS: Four hundred eighty-seven patients were randomized, and 469 composed the intent-to-treat population. The mean +/- SD monthly migraine frequency decreased significantly for the 100-mg/d group (from 5.4 +/- 2.2 to 3.3 +/- 2.9; P <.001) and the 200-mg/d group (from 5.6 +/- 2.6 to 3.3 +/- 2.9; P <.001) vs the placebo group (from 5.6 +/- 2.3 to 4.6 +/- 3.0); improvements occurred within the first treatment month. Significantly more topiramate-treated patients (50 mg/d, 35.9% [P =.04]; 100 mg/d, 54.0% [P <.001]; and 200 mg/d, 52.3% [P <.001]) exhibited a 50% or more reduction in monthly migraine frequency than placebo-treated patients (22.6%). Adverse events included paresthesia, fatigue, nausea, anorexia, and taste per version. CONCLUSION: Topiramate, 100 or 200 mg/d, was effective as a preventive therapy for patients with migraine.

Adolescent↗
PubMed2004

Anticonvulsants in migraine.

Migraine is a common, disabling disorder that often requires preventive treatment. The decision to treat migraine preventively generally is based on disability, problems with acute medicines, patient preference, risk of acute medication overuse, special circumstances, and concern that high migraine attack frequency may be a risk factor for chronic daily headache. Migraine and epilepsy are comorbid episodic central nervous system disorders that can have stereotyped symptoms with negative and positive phenomena. Controlled trials have demonstrated the efficacy of anticonvulsants in migraine prevention. Valproic acid, topiramate and, to a lesser extent, gabapentin, have demonstrated efficacy in randomized, placebo-controlled trials. Lamotrigine may be effective at controlling migraine aura, but has not demonstrated effectiveness at controlling migraine headache. Anticonvulsants are a useful option for the preventive treatment of migraine.

Anticonvulsants↗
PubMed2004

Headaches in pregnancy.

Migraine and TTH are primary headache disorders that occur commonly during pregnancy. Migraine sometimes occurs for the first time with pregnancy. The majority of migraineurs improve while pregnant; however, migraine often recurs post partum. Some disorders that produce, headache, such as stroke, cerebral venous thrombosis, eclampsia, and SAH, occur more frequently during pregnancy. Diagnostic testing serves to exclude organic causes of headache, to confirm the diagnosis, and to establish a baseline before treatment. If neurodiagnostic testing is indicated, the study that provides the most information with the least fetal risk is the study of choice. Drugs commonly are used during pregnancy despite insufficient knowledge about their effects on the growing fetus. Most drugs are not teratogenic. Adverse effects, such as spontaneous abortion, developmental defects, and various postnatal effects, depend on the dosage and route of administration and the timing of the exposure relative to the period of fetal development. Although medication use should be limited, it is not absolutely contraindicated in pregnancy. In migraine, the risk for status migrainosus may be greater than the potential risk of the medication used to treat the pregnant patient. Nonpharmacologic treatment is the ideal solution; however, analgesics, such as acetaminophen and narcotics, can be used ona limited basis. Preventive therapy is a last resort.

Adult↗
PubMed2004

Headaches due to nasal and paranasal sinus disease.

Sinus infections are much less common today than they were in the preantibiotic era, but they still are overdiagnosed. Acute sinusitis, a relatively uncommon cause of headache, is the result of infection of one or more of the cranial sinuses. Acute sinusitis usually is characterized by purulent discharge in the nasal passages and a pain profile determined by the site of infection. Sinusitis is overdiagnosed as a cause of headache because of the belief that pain over the sinuses must be related to the sinuses. In fact, frontal head pain more often is caused by migraine and tension-type headache. It should not follow that if a patient fails to respond to treatment for migraine and tension-type headache one should reconsider the diagnosis of sinus disease. Whether or not nasal obstruction can lead to chronic headache is controversial. Paradoxically, sinus disease also tends to be underdiagnosed, as sphenoid sinus infection frequently is missed.

Diagnosis, Differential↗
PubMed2004

Botulinum neurotoxin for the treatment of migraine and other primary headache disorders.

Clinical data and experience to date have demonstrated that BoNT-A is an effective and well-tolerated therapy for the prevention of migraine and other headache disorders. It has a long duration of action that may last over 4 months with no systemic or serious AEs. Several issues remain to be defined, however, including dosing, location, and number of injections; optimal dilution of BoNT-A; specific headache types that respond best to BoNT-A; and long-term efficacy and safety. Data from ongoing well-designed trials that include a larger patient population investigating these issues may confirm a role for BoNT-A as a first-line agent for migraine prevention. Neurotoxin therapy is part of a broader headache management approach. Because the injection techniques for headache are unique and vary depending on the primary headache disorder being treated and the location and pattern of pain referral, the use of BoNT-A for headache is not simply an extension of its use for cosmesis. The use of BoNT-A in the overall management of primary headache disorders should be reserved for medical practitioners who not only have experience with BoNT-A injections, but possess the expertise in the diagnosis and management of complex headache disorders. Educating patients and addressing headache triggers and optimizing acute treatment improve the outcome of any preventive program.

Botulinum Toxins, Type A↗
PubMed2004

Productivity cost benefit to employers of treating migraine with rizatriptan: a specific worksite analysis and model.

Employers in the United States might not be aware of the productivity costs of migraine or the extent to which those costs can be reduced by optimal treatment. An economic model was developed to enable employers to estimate the productivity costs of migraine to their company and the savings that will accrue if those patients who suffer from migraine are treated with rizatriptan. Analyses were run for both a major financial services corporation and a representative U.S. company. The major financial services corporation, with 87,821 employees, is projected to lose 538 person-years annually, at an estimated cost of 23.8 million dollars. A representative U.S. company with 10,000 employees is projected to lose 46.0 person-years of productive effort annually as a result of migraine, valued at approximately 1.94 million dollars. The value of the annual work loss avoided if migraine is treated with rizatriptan is projected at 10.3 million dollars for the financial services corporation and 841,000 dollars for the representative U.S. company. There is a substantial productivity cost burden of migraine from a U.S. employer perspective. These productivity costs can be reduced significantly by treating migraine headaches with rizatriptan.

Absenteeism↗
PubMed2004

Efficacy and tolerability of oral zolmitriptan in menstrually associated migraine: a randomized, prospective, parallel-group, double-blind, placebo-controlled study.

BACKGROUND: Approximately 60% of female migraineurs report experiencing migraine in association with menstruation, while 7% to 25% experience attacks almost exclusively with menstruation. OBJECTIVE: To examine the efficacy and tolerability of oral zolmitriptan in the acute treatment of menstrually associated migraine. In this study, menstrually associated migraine was defined as migraine that consistently occurred from 72 hours before to 5 days after onset of menses. Methods.-Participants were women with regular menstrual cycles, aged 18 to 55 years, who had experienced migraine with at least two thirds of prior menstrual cycles. Subjects were randomized to treat one attack per menstrual cycle for 3 months with either zolmitriptan or placebo. Treatment was intensity based: mild migraines were treated with half of a 2.5-mg zolmitriptan tablet, moderate migraines were treated with zolmitriptan 2.5 mg, and severe migraines were treated with 5 mg (two 2.5-mg tablets) of zolmitriptan, or placebo. RESULTS: Of the 579 women enrolled in the study, 260 were treated with zolmitriptan and 251 were assigned placebo. Twelve hundred thirty-two attacks were treated, and a 2-hour headache response was achieved in 48% of zolmitriptan-treated attacks as compared with 27% of placebo-assigned attacks (P <.0001). Zolmitriptan was superior to placebo in achieving a headache response as early as 30 minutes (18% versus 14%, P=.03) and at 1 hour (33% versus 23%, P <.001). Drug-related adverse events were reported in 16% of subjects receiving zolmitriptan and 9% of subjects receiving placebo. CONCLUSION: Oral zolmitriptan exhibits efficacy and good tolerability in the treatment of menstrually associated migraine. Improvement over placebo was observed as early as 30 minutes following treatment.

Adolescent↗
PubMed2004

Botulinum toxin and other new approaches to migraine therapy.

The number of migraine treatments and our understanding of migraine pathophysiology are both increasing. Newer treatments focus on migraine prevention. Botulinum toxin (BTX) is a potent neurotoxin used primarily to treat diseases associated with increased muscle activity. Recently, BTX was found to have antinociceptive effects that are probably independent of its muscle-relaxant action. Clinical trials support the efficacy of BTX type A (and possibly also type B) in the treatment of migraine. The anticonvulsant topiramate was recently shown to be effective for migraine prevention. At the low doses used for this indication, cognitive side effects are not a major concern. Another new approach to migraine prevention is angiotensin type 1 (AT1) receptor blockade. The high tolerability of the AT1 receptor blocker candesartan warrants further studies to assess its role in migraine prevention.

Angiotensin Receptor Antagonists↗
PubMed2004

Chronic migraine: diagnosis and management strategy.

The case presented underscores the complexities encountered in diagnosing and managing patients with a long-standing history of headache and some of the difficulties in classifying patients according to the new International Headache Society (IHS) criteria. A 42-year-old nurse with 4 children whose headaches began at age 24 years developed continuous headaches of varying intensity, regularly so debilitating that she was unable to get out of bed and occasionally so disabling that she required an injection of meperidine from her physician. Management strategies are presented and the revised IHS criteria are discussed.

Adult↗