Stephen H. Landy

Selective serotonin reuptake inhibitors for migraine prophylaxis.

The objective of this study was to assess the efficacy of sertraline in migraine prophylaxis. Other selective serotonin reuptake inhibitors have been studied for migraine prophylaxis, but this is the first report with sertraline. Twenty‐seven subjects were enrolled and baseline assessment of migraine frequency and severity were measured over a 4‐week period. Subjects were then randomized to receive placebo or sertraline in a double‐blind fashion with headache frequency and severity measured over an 8‐week period. Subjects completed a daily diary reporting the occurrence, severity, and degree of impairment associated with migraine.

Fixed-Dose Sumatriptan and Naproxen in Poor Responders to Triptans With a Short Half-Life

Objective.— To evaluate efficacy and tolerability of a single, fixed‐dose tablet of sumatriptan 85 mg/naproxen sodium 500 mg (sumatriptan/naproxen sodium) vs placebo in migraineurs who had discontinued treatment with a short‐acting triptan because of poor response or intolerance.

Clarification of developing and established clinical allodynia and pain-free outcomes

Objective.—The aim of this study was to determine whether clinical indicators of cutaneous allodynia predict the success of migraine therapy with sumatriptan using a brief questionnaire.

Assessing the impact of migraine onset on work productivity.

Objective: Examine the impact of migraine on work productivity, and particularly the association between time of migraine onset and lost productivity as measured by absenteeism and presenteeism. Methods: A total of 509 people with migraine completed one online baseline survey and a diary survey after each of their next three migraines. All subjects were 18 or older and employed full time. Results: Sixty-four percent of migraines occurred on a workday. Of these, 68% resulted in some work productivity impact in the form of absenteeism or presenteeism. Migraines occurring during usual sleeping hours or prior to the start of work had the greatest impact on productivity. Conclusions: Findings indicate that absenteeism and presenteeism are both substantial contributors to work productivity loss. Primary factors associated with lost productivity include pain severity, migraine symptoms, and sleep disturbance.

Oral Transmucosal Fentanyl Citrate for the Treatment of Migraine Headache Pain in Outpatients: A Case Series

Background.—Migraine headache pain that does not respond to traditional antimigraine medications frequently requires treatment in the emergency department (ED) with parenteral opioids. Rapid onset of pain relief in an outpatient setting for migraine headache is the primary objective of patients and clinicians. Oral transmucosal fentanyl citrate (OTFC®; ACTIQ®) is a novel opioid product designed to deliver rapid analgesia to patients who experience breakthrough pain (BTP).

Pilot Study Evaluating Preference for 3‐mg Versus 6‐mg Subcutaneous Sumatriptan

Background.—Subcutaneous sumatriptan (6 mg) is undeniably an excellent treatment of migraine. However, some patients have avoided using 6 mg sumatriptan because of unpleasant or unwanted side effects.

Fixed-dose Sumatriptan/Naproxen Sodium Compared with each Monotherapy Utilizing the Novel Composite Endpoint of Sustained Pain-free/no Adverse Events.

A novel composite endpoint, sustained pain-free/no adverse events, was recently proposed as a more rigorous means of capturing in a single measure the attributes of migraine pharmacotherapy that patients consider most important: rapid and sustained pain-free response with no side-effects. Using pooled data from two replicate randomized, double-blind, parallel-group, placebo-controlled studies, this post hoc analysis compared the fixed-dose combination tablet sumatriptan/naproxen sodium (n = 726) with sumatriptan monotherapy (n = 723), naproxen sodium monotherapy (n = 720), and placebo (n = 742) with respect to sustained pain-free/no adverse events and closely related composite measures. Sustained pain-free/no adverse events was defined as having both a sustained pain-free response from 2 through 24 hours post-dose with no use of rescue medication and having no adverse events within up to 5 days after dosing with study medication. The percentage of patients with sustained pain-free/no adverse events was 16% with sumatriptan/naproxen sodium compared with 11%, 9% and 7% for sumatriptan, naproxen sodium and placebo, respectively (p50.01 sumatriptan/naproxen sodium versus each other treatment). Sumatriptan/naproxen sodium was also significantly more effective than sumatriptan, naproxen sodium, and placebo for other composite endpoints including the percentages of patients with (1) sustained pain-free/no adverse events within 1 day; (2) sustained pain-free/no drug-related adverse events within up to 5 days; (3) sustained pain-free/no drug-related adverse events within 1 day; (4) sustained pain relief/no adverse events within up to 5 days; and (5) sustained pain relief/no adverse events within 1 day. The results demonstrate the superiority of sumatriptan/naproxen sodium to sumatriptan monotherapy, naproxen sodium monotherapy and placebo with respect to the rigorous and clinically relevant endpoint of sustained pain-free/no adverse events and reinforce the usefulness of utilizing this new composite endpoint.

An Open‐Label Trial of a Sumatriptan Auto‐Injector for Migraine in Patients Currently Treated With Subcutaneous Sumatriptan

To assess the ability of patients, during an acute migraine attack, to successfully self‐inject a single dose of sumatriptan using a novel sumatriptan auto‐injector (Alsuma®), and to evaluate the safety, tolerability, and effectiveness of this sumatriptan auto‐injector during an acute migraine attack.

Consistency of eletriptan in treating migraine: Results of a randomized, within-patient multiple-dose study

Objective The current study evaluated the consistency of eletriptan response. Methods Using a within-patient crossover design, patients with migraine completed a three-attack, open-label, lead-in period, before being treated, double-blind for four attacks, with either eletriptan 40 mg (ELE-40; N = 539) or eletriptan 80 mg (ELE-80; N = 432); placebo was randomly substituted for the treatment of one attack. Results On an a priori analysis of within-patient consistency, double-blind treatment was associated with similar 2 hour headache response rates using a ≥2/3 response criterion for ELE-40 (77%) and ELE-80 (73%), and using a 3/3 response criterion for ELE-40 (46%) and ELE-80 (47%). Within-patient consistency in achieving pain-free status at 2 hours using a ≥2/3 criterion was slightly higher on ELE-40 (42%) compared with ELE-80 (38%), and was similar using the 3/3 criterion (18% on ELE-40, 17% on ELE-80). On a repeated measures logistic regression analysis across all treated attacks, the probability of achieving a headache response at 2 hours ranged from 71% to 74% on ELE-40 vs. 17% to 28% on placebo (p < 0.0001), and from 66% to 74% on ELE-80 vs. 21% to 27% on placebo (p < 0.0001). The incidence, per attack, of adverse events was low for both ELE-40 and ELE-80. Few adverse events occurred with incidence ≥10% on ELE-40 (asthenia, 5.0%) or ELE-80 (asthenia, 10%; nausea, 5.8%). Discontinuations because of adverse events were 0.2% on ELE-40, and 1.6% on ELE-80 Conclusion In this multiple attack study, eletriptan was well-tolerated and demonstrated consistent and significant efficacy in the treatment of migraine. Clinicaltrials.Gov Identifier: NCT01859481

Sumatriptan–Naproxen Migraine Efficacy in Allodynic Patients: Early Intervention

Objective.— This study evaluated the effectiveness of a single fixed‐dose tablet of sumatriptan 85 mg/naproxen sodium 500 mg (sumatriptan–naproxen) using a very early treatment paradigm in migraine patients whose attacks were historically accompanied by cutaneous allodynia.