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Stephen D Silberstein

Publications and source records attributed to Stephen D Silberstein.

At least 19 recordsLinked to original sources
PubMed2026

Systematic Review of Pharmacologic Treatment for Migraine Prevention in Adults: Report of the AAN Guidelines Subcommittee and the American Headache Society.

BACKGROUND AND OBJECTIVES: This systematic review (SR) provides updated evidence-based conclusions regarding the use of pharmacologic migraine prevention in adults to inform a new joint American Academy of Neurology (AAN) and American Headache Society practice guideline. METHODS: A multidisciplinary panel conducted an SR following the 2017 AAN Clinical Practice Guideline Process Manual. Randomized controlled trials evaluating pharmacologic preventive treatments for adults with episodic or chronic migraine were included. Searches encompassed MEDLINE, Embase, and ClinicalTrials.gov from database inception through June 6, 2024. Studies were screened in duplicate, with dual independent risk-of-bias assessment. Outcomes included change in monthly headache days, ≥50% responder rate, and validated patient-reported quality of life (QOL) measures. Raw mean differences, standardized mean differences, and risk ratios were calculated. A modified Grading of Recommendations Assessment, Development, and Evaluation process was used to classify certainty of evidence. RESULTS: A total of 217 studies met inclusion criteria. For episodic migraine, high-confidence evidence showed that galcanezumab and erenumab are more effective than placebo in reducing headache frequency. Moderate-confidence evidence supported benefit from atogepant, eptinezumab, fremanezumab, propranolol, topiramate, and valproate. Several additional oral agents including amitriptyline, bisoprolol, flunarizine, fluoxetine, levetiracetam, metoprolol, nifedipine, pizotifen, and telmisartan had low-confidence evidence suggesting possible benefit. For chronic migraine, high-confidence evidence supported reductions in headache frequency with fremanezumab, galcanezumab, and onabotulinumtoxinA. Moderate-confidence evidence supported benefit from atogepant, eptinezumab, erenumab, topiramate and valproate. Across both episodic and chronic migraine populations, erenumab, fremanezumab, galcanezumab, eptinezumab, rimegepant, atogepant, topiramate and onabotulinumtoxinA demonstrated improvements in patient-reported QOL outcomes on validated instruments. Evidence comparing active treatments was limited and generally of low or very low confidence, restricting conclusions about comparative effectiveness. DISCUSSION: This SR provides a comprehensive synthesis of evidence on pharmacologic migraine prevention in adults. High- and moderate-confidence findings confirm the efficacy of several established and newer preventive therapies and demonstrate improvements in patient-reported outcomes across multiple validated measures. These conclusions informed the development of evidence-based recommendations, presented in a companion publication, to guide clinicians in selecting preventive medications for adults with episodic and chronic migraine.

Humans↗
PubMed2006

Preventive treatment of migraine.

Migraine is a common episodic pain disorder, the treatment of which can be acute to stop an attack or preventive to reduce the frequency, duration or severity of attacks. Preventive treatment is used when attacks are frequent or disabling. Many different medication groups are used for preventive treatment, including beta-blockers, antidepressants and antiepileptic drugs. Their mechanisms of action include raising the threshold to migraine activation, enhancing antinociception, inhibiting cortical spreading depression, inhibiting peripheral and central sensitization, blocking neurogenic inflammation and modulating sympathetic, parasympathetic or 5-HT tone. In this article, I review evidence of the effectiveness of migraine preventive drugs. I also discuss the setting of treatment priorities.

Humans↗
PubMed2006

Efficacy and tolerability of topiramate 200 mg/d in the prevention of migraine with/without aura in adults: a randomized, placebo-controlled, double-blind, 12-week pilot study.

BACKGROUND: Several large, randomized, double-blind, placebo-controlled trials have found topiramate (TPM) to be effective and generally well tolerated as a preventive therapy for migraine. OBJECTIVE: This paper evaluates efficacy and safety data from a pilot study of TPM 200 mg/d as preventive therapy in adult subjects with a history of migraine with or without aura. METHODS: The pilot study had a randomized, double-blind, placebo-controlled design. Subjects were randomized in a 2:1 ratio to receive TPM 200 mg/d or placebo. The double-blind treatment phase consisted of an 8-week titration period (25 mg/d for the first week, followed by weekly increases of 25 mg) and a 12-week maintenance period. The primary efficacy measure was the change in mean monthly migraine frequency. Additional measures were the median percent reduction in monthly migraine frequency and the proportion of responders (those with > or =50%, > or =75%, or 100% reduction in monthly migraine frequency). RESULTS: The intent-to-treat (ITT) population included 211 subjects (138 TPM, 73 placebo; mean [SD] mean weight, 76.7 [18.7] kg). Of 45 subjects who discontinued the study in the TPM group, 21 discontinued during the titration period, compared with 3 of 13 subjects who discontinued in the placebo group. When the efficacy data were assessed using the per-protocol, analysis-of-covariance model, TPM 200 mg/d was not associated with a significant reduction in mean monthly migraine frequency compared with placebo. A post hoc analysis using a Poisson regression model in the ITT population suggested that TPM significantly reduced mean monthly migraine frequency compared with placebo (P=0.04). A significantly larger proportion of TPM-treated subjects had a > or =75% reduction in monthly migraine frequency compared with placebo (P=0.03). At least 1 adverse event was reported by 90.0% and 69.9% of the TPM and placebo groups, respectively. Treatment-emergent adverse events (AEs) occurring in > or =10% of subjects in the TPM group were paresthesia (45%), dizziness (16%), fatigue (16%), nausea (14%), and weight loss (14%). Most treatment-emergent AEs were rated mild or moderate in severity. Of 3 serious AEs (depression, abdominal pain, leg pain) occurring during the trial, none were considered related to either TPM or placebo. CONCLUSION: In this pilot study, mean monthly migraine frequency did not differ significantly between TPM and placebo.

Adolescent↗
PubMed2006

Acetaminophen, aspirin, and caffeine in combination versus ibuprofen for acute migraine: results from a multicenter, double-blind, randomized, parallel-group, single-dose, placebo-controlled study.

OBJECTIVE: Compare the effectiveness of a combination analgesic containing acetaminophen, aspirin, and caffeine to that of ibuprofen in the treatment of migraine. METHODS: Multicenter, double-blind, randomized, parallel-group, placebo-controlled, single-dose study. A total of 1555 migraineurs were included in the analysis. No patients were excluded solely because of severity of symptoms or degree of disability. A single 2-tablet dose for each of the 3 treatment groups: a combination product containing acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg per tablet (AAC); ibuprofen 200 mg per tablet (IB); or matching placebo. The primary efficacy endpoint was the weighted sum of pain relief (PAR) scores at 2 hours postdose (TOTPAR2) and an important secondary endpoint was the time to onset of meaningful relief. RESULTS: There were 669 patients in the AAC group, 666 patients in the IB group, and 220 patients in the placebo group. The 3 treatment groups had similar demographic profiles, migraine histories, and baseline symptom profiles. While both active treatments were significantly better than placebo in relieving the pain and associated symptoms of migraine, AAC was superior to IB for TOTPAR2, as well as for PAR, time to onset of meaningful PAR, pain intensity reduction, headache response, and pain free. The mean TOTPAR2 scores for AAC, IB, and placebo were 2.7, 2.4, and 2.0, respectively (AAC vs. IB, P < .03). The median time to meaningful PAR for AAC was 20 minutes earlier than that of IB (P < .036). CONCLUSION: AAC and IB are safe, cost-effective treatments for migraine; AAC provides significantly superior efficacy and speed of onset compared with IB.

Acetaminophen↗
PubMed2006

Acute migraine treatment: patterns of use and satisfaction in a clinical population.

BACKGROUND: The sequence and timing of taking migraine medications, whether prescription or over-the-counter, and the patient's response to their treatment, is unknown. OBJECTIVE: To describe the use of, response to, and satisfaction with acute medications for 1 migraine attack. METHODS: We performed a clinic-based survey of 127 patients at Jefferson Headache Center, Philadelphia. Adult patients who met the International Headache Society criteria for migraine with or without aura were included in the study. Patients were asked to complete a questionnaire. RESULTS: Of 109 participants who met the inclusion criteria, most waited 1 hour or more after the onset of symptoms to take medication. Triptans were most commonly used as first, second, and third medications. Triptan use was associated with higher 2-hour pain-free response rates compared with other agents, whether the triptan was used as the first, second, or third medication. Patients who were treated with medications other than triptans were more likely to have pain at 2 hours (P = .36). NSAIDs had relatively low pain-free and headache relief response rates at 2 hours. Sixty-two participants (56.9%) had to treat a second time and 31 (28.4%) had to treat a third time. Some participants (17.6%) had headache recurrence within 24 hours after becoming headache free following initial medication and some (23.5%) had recurrence after becoming headache free following their second medication. Sixty-six percent of participants reported being very satisfied/satisfied with their initial medication and 33% were somewhat dissatisfied/dissatisfied to some degree. Even though most patients were satisfied with their medication, 88% reported that they would be willing to try a new antimigraine medication. Most patients (60 [55%]) preferred a long-acting agent versus a rapid-onset, short-acting agent (which was preferred by 49 [45%] patients). CONCLUSION: Migraine patients have treatment preferences. They generally want a drug that provides complete headache relief, and they are often satisfied with the current treatment options.

Acetaminophen↗
PubMed2006

The impact of migraine on daily activities: effect of topiramate compared with placebo.

OBJECTIVE: Assess the impact of migraine preventive therapy on patient-reported routine daily activities using the Migraine Specific Questionnaire (MSQ) and the Medical Outcomes Study Short Form-36 (SF-36) in patients with migraine who participated in a 26-week, randomized, double-blind, placebo-controlled trial of topiramate for migraine prevention. METHODS: Patients were required to have 3-12 migraines and < or = 15 headache days/month during the baseline phase. Patients who failed > 2 adequate regimens of migraine preventive therapy were excluded. MSQ and SF-36 data were collected at baseline, weeks 8, 16, and 26 from 469 patients receiving either topiramate 50, 100, or 200 mg/day or placebo. Patients entered a double-blind, 8-week titration period followed by an 18-week maintenance period. Two activity-related MSQ domains (Role Restrictive [RR] and Role Prevention [RP]) and two activity-related SF-36 domains (Role Physical [SF-36-RP] and Vitality [SF-36-VT]) were prospectively designated as the outcome measures. Changes in MSQ and SF-36 scores during the double-blind phase relative to prospective baseline scores were compared between topiramate- and placebo-treated groups. Specifically, a mixed-effect piecewise linear regression model was used to estimate average domain score over time, and areas under the domain-over-time curve (AUC) were compared using a 2-sided t-test, with multiplicity adjustment. RESULTS: In the intent-to-treat population (N = 469), topiramate (all doses) significantly improved mean MSQ-RR domain scores versus placebo (topiramate 50 mg/day, p = 0.035; topiramate 100 mg/day; p < 0.001; topiramate 200 mg/day, p = 0.001). Topiramate-associated improvements in mean MSQ-RP domain scores were significant versus placebo only for topiramate 100 mg/day (p = 0.045). SF-36-RP and SF-36-VT domain scores improved (not significant versus placebo) for topiramate 100 and 200 mg/day. Changes in these MSQ and SF-36 domain scores significantly correlated with changes in mean monthly migraine frequency. CONCLUSION: Improvements in patient-reported outcomes specific for migraine (measured by the MSQ) were significantly better for patients receiving topiramate than for those receiving placebo. Improvements in the prospectively selected MSQ and SF-36 domains were significantly correlated with the decrease in mean monthly migraine frequency observed with topiramate treatment.

Activities of Daily Living↗
PubMed2006

Hormone-related headache: pathophysiology and treatment.

Epidemiological data suggest a link between migraine and the female sex hormones. Indeed, it is known that estrogen affects various brain functions, including pain perception. The prevalence of migraine is similar in boys and girls before puberty, but is 3-fold higher in postpubertal females compared with males. Migraine attacks in women are more likely to occur in the perimenstrual period and occur exclusively so in some women. The acute treatment of menstrual migraine is similar to that of non-menstrually related attacks, but the response to treatment may be less favourable. Perimenstrual prophylaxis, with NSAIDs, triptans or estradiol, is effective in decreasing attack frequency and severity. The use of oral contraceptives (OCs) may change migraine frequency and severity. Since both migraine and hormonal contraceptive use are risk factors for ischaemic stroke, the use of OCs in women who experience migraine should be made only after consideration of the benefit-risk ratio. Migraine typically, but not invariably, improves during the last two trimesters of pregnancy, and may worsen in the postpartum period. When using drugs to treat migraine during pregnancy, potential risks to the mother and fetus should be considered. The prevalence of migraine decreases with advancing age and it improves in many, but not all, women after the menopause. However, in the perimenopausal period, migraine may worsen as a result of fluctuations in estrogen levels. Reducing the estrogen dose and changing the estrogen type or the route of administration of hormone replacement therapy (HRT) from oral to transdermal may reduce headache. Migraine is not a risk factor for stroke in postmenopausal women. When considering symptomatic HRT for postmenopausal migraneurs, the usual indications and contraindications should be applied. HRT may also exacerbate migraine.

Contraceptives, Oral, Hormonal↗
PubMed2005

Headaches in pregnancy.

Most women with migraine improve during pregnancy. Some women have their first attack. Migraine often recurs postpartum and can begin for the first time. Drugs are commonly 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 dose and route of administration and the timing of the exposure relative to the period of foetal development. While medication use should be limited, it is not absolutely contraindicated in pregnancy. Nonpharmacologic treatment is the ideal solution; however, analgesics such as acetaminophen and opioids can be used on a limited basis. Preventive therapy is a last resort.

Analgesics↗
PubMed2005

The Global Campaign (GC) to Reduce the Burden of Headache Worldwide. The International Team for Specialist Education (ITSE).

The social perception of headache, everywhere at low levels in industrialised countries, becomes totally absent in developing ones. Headache disorders came into the World Health Organization's strategic priorities after publication of the 2001 World Health Report. Among the leading causes of disability, migraine was ranked 19th for adults of both sexes together and 12th for females. The Global Campaign (GC) to Reduce the Burden of Headache Worldwide was planned by the major international headache organizations together with WHO in order to identify and remove those cultural, social and educational barriers recognised as responsible factors for the inadequate treatment of headache disorders worldwide. Within the GC activities, the education of the medical body will represents a central pillar. An International Team for Specialist Education (ITSE) has been created to train physicians from all over the world through the acquisition of a university level Master Degree in Headache Medicine. Once trained as headache specialists, physicians will become trainers, offering education in this field to other health care providers in their own countries. In this way they will give life to a cultural chain raising awareness locally of headache, its burden and its medical control.

Education, Medical, Graduate↗
PubMed2005

Topiramate monotherapy in epilepsy and migraine prevention.

OBJECTIVES: The purposes of this review were to assess the efficacy of topiramate as monotherapy for epilepsy and migraine prevention, describe how it should be used, and give clinical advice on how to manage the practical aspects of dosing, titration, and possible adverse events in these 2 indications. METHODS: We searched the PubMed and BIOSIS databases using the key words topiramate, epilepsy, and migraine from the year 1987 onward, and subsequently focused the search on larger controlled trial studies of topiramate as monotherapy. RESULTS: Studies have evaluated the use of topiramate as monotherapy in the treatment of partial-onset and generalized seizures and in the prevention of migraine. In a randomized study, 75% of epilepsy patients treated with 400 mg/d topiramate remained seizure free at 1 year. Patients in the same study treated with a lower dose of topiramate (50 mg/d) also experienced notable seizure reductions, with 59% of patients free of seizures at 1 year. A comparison trial of topiramate (100 or 200 mg/d), valproate, and carbamazepine found that topiramate was associated with a similar time to first posttreatment seizure as the other 2 agents (P = NS). Trials of topiramate monotherapy in migraine prevention found that 100 mg/d was associated with a > or =50% reduction in monthly migraine frequency in 49% to 54% of patients. The migraine prevention trials typically used a starting dose of 25 mg/d, with weekly increases of 25 mg and an initial monotherapy target dose of 100 mg/d. The most common adverse events associated with topiramate are paresthesia, weight loss, and other centrally mediated symptoms, many of which may be ameliorated by proper titration and dosing and by good communication between physician and patient. CONCLUSIONS: Data from controlled trials suggest that 100 mg/d topiramate as monotherapy is effective in the treatment of partial-onset and generalized seizures and in the prevention of migraine.

Anticonvulsants↗
PubMed2005

Preventive treatment of headaches.

PURPOSE OF REVIEW: To review recent advances in preventive headache treatment. RECENT FINDINGS: Migraine may be a progressive disorder. Aggressive treatment may stop progression. Propranolol, the beta-blocker, and the anticonvulsant topiramate are effective for migraine prevention. Feverfew, montelukast and acupuncture have not proven effective. SUMMARY: New drugs and other treatment strategies expand the spectrum of preventive migraine treatments.

Acupuncture Therapy↗
PubMed2005

Removing barriers to appropriate migraine treatment: formulary limitations and triptan package size.

The main goals in the pharmacologic management of migraine headache are to avert or relieve debilitating pain, prevent escalating acute medication use, and improve day-to-day functioning. This review will examine the evidence supporting the early use of acute medication, usually when pain is mild, to enhance patient outcomes. We will also discuss imposed quantity limits as a practical impediment to the implementation of this strategy in the managed care setting, and will identify strategies for overcoming this barrier to effective care. Quantity limits imposed on triptan therapy by health plans can hinder the optimal acute treatment of migraine. A standard triptan quantity limit sufficient to permit early migraine treatment and a movement by manufacturers to provide blister packs consistent with a standard quantity limit should reduce patients costs, permit brand mobility when appropriate, and bolster long-term cost effectiveness by removing an important impediment to the use of triptans when they are most effective, early in the migraine attack when pain is often still mild.

Drug Packaging↗
PubMed2005

Botulinum toxin type a for the prophylaxis of chronic daily headache: subgroup analysis of patients not receiving other prophylactic medications: a randomized double-blind, placebo-controlled study.

OBJECTIVE: To assess the efficacy and safety of botulinum toxin type A (BoNT-A; BOTOX, Allergan, Inc., Irvine, CA) for the prophylaxis of headaches in patients with chronic daily headache (CDH) without the confounding factor of concurrent prophylactic medications. BACKGROUND: Several open-label studies and an 11-month, randomized, double-blind, placebo-controlled study suggest that BoNT-A may be an effective therapy for the prophylaxis of headaches in patients with CDH. DESIGN AND METHODS: This was a subgroup analysis of an 11-month, randomized double-blind, placebo-controlled study of BoNT-A for the treatment of adult patients with 16 or more headache days per 30-day periods conducted at 13 North American study centers. All patients had a history of migraine or probable migraine. This analysis involved data for patients who were not receiving concomitant prophylactic headache medication and who constituted 64% of the full study population. Following a 30-day screening period and a 30-day single-blind, placebo injection, eligible patients were injected with BoNT-A or placebo and assessed every 30 days for 9 months The following efficacy measures were analyzed per 30-day periods: change from baseline in number of headache-free days; change from baseline in headache frequency; proportion of patients with at least 30% or at least 50% decrease from baseline in headache frequency; and change from baseline in mean headache severity. Acute medication use was assessed, and adverse events were recorded at each study visit. RESULTS: Of the 355 patients randomized in the study, 228 (64%) were not taking prophylactic medication and were included in this analysis (117 received BoNT-A, 111 received placebo injections). Mean age was 42.4+/-10.90 years; the mean frequency of headaches per 30 days at baseline was 14.1 for the BoNT-A group and 12.9 for the placebo group (P=.205). After two injection sessions, the maximum change in the mean frequency of headaches per 30 days was -7.8 in the BoNT-A group compared with only -4.5 in the placebo group (P=.032), a statistically significant between-group difference of 3.3 headaches. The between-group difference favoring BoNT-A treatment continued to improve to 4.2 headaches after a third injection session (P=.023). In addition, BoNT-A treatment at least halved the frequency of baseline headaches in over 50% of patients after three injection sessions compared to baseline. Statistically significant differences between BoNT-A and placebo were evident for the change from baseline in headache frequency and headache severity for most time points from day 180 through day 270. Only 5 patients (4 patients receiving BoNT-A treatment; 1 patient receiving placebo) discontinued the study due to adverse events and most treatment-related events were transient and mild to moderate in severity. CONCLUSIONS: BoNT-A is an effective and well-tolerated prophylactic treatment in migraine patients with CDH who are not using other prophylactic medications.

Adult↗
PubMed2005

Neuroleptics in headache.

OBJECTIVES: To review the mechanism of action of neuroleptics, the evidence for their efficacy, and their clinical use in headache treatment. BACKGROUND: Neuroleptics and antiemetics have long been used for headache treatment; however, they have not been widely utilized because of general unfamiliarity with them and concerns about their adverse events. With the recent advent of the atypical neuroleptics and their improved adverse event profile, our armamentarium for headache treatment has expanded. In this review, we explore the mechanism of action of these classes of drugs, their adverse events, and the evidence for their efficacy. We also detail our experience with the different drugs and how we use them as both acute and preventive headache therapy. DESIGN: A review of published literature was obtained through a MEDLINE search on the use of neuroleptics in headache therapy. CONCLUSION: Neuroleptics have widespread evidence supporting their use in headache treatment and present an important part of the armaterium against headache.

Antipsychotic Agents↗
PubMed2005

The headache of SAH responds to sumatriptan.

We report the first case of the headache of subarachnoid hemorrhage (SAH) possibly responding to a triptan. Recent evidence suggests that triptans block transmission from the trigeminal nerve to second-order neurons in the trigeminal nucleus caudalis; thus, any meningeal nociceptive process would be aborted. The triptans and ergots are not specific for migraine, but for any process that activates trigeminal fibers, including migraine, cluster headache, SAH, and meningitis. The failure to respond in the reported cases of meningitis may be due to sensitization.

Fatal Outcome↗