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F D Sheftell

Publications and source records attributed to F D Sheftell.

14 recordsLinked to original sources
PubMed2001

Differentiating the efficacy of 5-HT(1B/1D) agonists.

OBJECTIVE: To examine, for a set of published clinical trials of serotonin (5-HT(1B/1D)) agonists as acute treatments for migraine, whether transformation of efficacy data into therapeutic gain (TG) or number needed to treat (NNT) is useful. BACKGROUND: Pivotal clinical trials of 5-HT(1B/1D) agonists in migraine use a primary end point of change in pain score from 3 or 2 to 1 or 0. Placebo response rates among such studies are variable. Meta-analytic comparisons of 5-HT(1B/1D) agonists often employ TG and NNT as efficacy measures. METHODS: Data from US product labeling or published sources were converted into TG (TG = active response rate [%] - placebo response rate [%]) and NNT (NNT = 1/TG). Pivotal clinical trial data were compared before and after transformation. RESULTS: Therapeutic gain ranged from 17.5% to 51%. The transformation of TG into NNT yielded no clinically significant difference in efficacy estimate for the range of 17.5% to 47% (N = 29 clinical trials). However, NNT and TG had a nonlinear relationship for some secondary end points. When the relationship between the standard primary and secondary end points was compared, the correlation of TG with clinical disability (Pearson coefficient R = 0.93) was stronger than for NNT. Placebo response rates correlated more strongly with NNT (R = 0.66) than active response rates (R = 0.42; N = 29 clinical trials), although both TG and NNT were sensitive to placebo response rate. CONCLUSIONS: Transforming efficacy rates into TG or NNT adds no new information to placebo-controlled trials. The variables, TG and NNT, should not be used to compare members of this class of drugs. Migraine therapies can only be compared using well-designed head-to-head studies and not by meta-analysis. Broader measures of efficacy should be used to describe and compare 5-HT(1B/1D) efficacy.

Acute Disease↗
PubMed2000

Acute migraine treatment outcome measures: a clinician's view.

The efficacy of acute therapies for migraine can be measured in many ways. Traditional endpoints (such as reduction in pain from moderate or severe to mild or absent) are used for regulatory purposes, but do not reflect all components of the migraine syndrome, nor, necessarily, what is most valued by patients and clinicians. There is also a pharmacokinetic-pharmacodynamic disconnection for these traditional types of endpoint, suggesting that they teach us little about how these drugs work. More rigorous, but nonetheless pain-score based, endpoints are reviewed. The biases that can attach to measures such as therapeutic gain and number needed to treat, in the context of migraine therapy, and the limitations of these measures for use in meta-analysis, are discussed. The clinical subtleties of these endpoints are numerous: understanding patients' ability to distinguish between multiple headache types, the best timing of treatment relative to the start of an attack, and measuring clinical outcome may be statistically difficult, but yet may also provide more clinical utility than pain-score analyses. The three therapeutic strategies (Step, Stepped-within-attack, and Stratified care) are reviewed and the place of 5HT(1B/1D) agonists within them, based on the currently best available evidence, is identified. Consideration should be given to more real-life studies, to measuring drug efficacy after early administration during onset of headache, and to greater sophistication in our approach to the necessarily gestalt measures of patient satisfaction and treatment preference.

Humans↗
PubMed1999

Rizatriptan in the treatment of migraine.

Rizatriptan is a selective 5-hydroxytriptamine1B/1D receptor agonist that was launched in 1998 for the acute treatment of migraine in adults. Based on data from 6 large clinical trials in patients > or =18 years of age in whom migraine was diagnosed according to International Headache Society criteria, the marketed 10-mg and 5-mg oral doses of rizatriptan are effective in relieving headache pain and associated migraine symptoms. The 10-mg dose is more effective than the 5-mg dose. At 2 hours after dosing, up to 77% of patients taking rizatriptan 10 mg had pain relief compared with 37% of those taking placebo, up to 44% were completely pain free compared with 7% of those taking placebo, and up to 77% were free of nausea compared with 58% of those taking placebo (P < 0.05 for all 3 comparisons). Both doses of rizatriptan are generally well tolerated. In placebo-controlled studies involving treatment of a single migraine attack, the most common side effects (incidence > or =2%) occurred in <10% of patients, typically were transitory (2 to 3 hours), and were mild or moderate. Rizatriptan is an effective and well-tolerated acute treatment for migraine.

Administration, Oral↗
PubMed1998

[Clinical characteristics of migraine without aura].

A detailed study of the clinical characteristics of migraine without aura (MOA) reveals some interesting data. A questionnaire was returned by 200 patients who met the International Headache Society criteria for MOA. The peak of onset of migraine was between 10 and 19 years of age. The headache was side-locked in 19%. It was exclusively bilateral in 9%. The majority (86.2%) of the patients who described headaches in only one site located them in the fronto-temporal area. Neck pain was associated with migraine attacks in 70.5% and face pain in 73.5%. A pounding quality was noted by 81%. Every patient described the headache as moderate to severe. Only 55% stated that it was aggravated by routine physical activity. Nausea occurred in 91%, photo and phonophobia in 77%, and vomiting in 50%. This close look at MOA uncovers a great complexity of symptoms.

Adult↗
PubMed1997

Role and impact of over-the-counter medications in the management of headache.

The use of nonprescription medication for primary headache in the general population is highly prevalent. The trend toward self-care is likely to increase in the era of health care reform. Physicians may underestimate the efficacy of nonprescription products because most patients who seek consultation have not had good result with their use. The vast majority of people with headache pain find relief from self-treatment with OTS products and are not involved in ongoing care. All nonprescription analgesics are potentially effective and safe; benefits include cost-effective treatment, and liabilities include ineffective treatment, unnecessary suffering, and inappropriate use that results in a variety of side effects. Such side effects include overuse that contributes to chronic daily headache. Patients and physicians need to recognize that nonprescription medication is medication and regard it as such. Physician inquiries during history taking must include the use of OTS medication because patients are confronted with a wide array of choices and often select such agents randomly or on the basis of advertising claims. Patients need to be educated about ingredients, efficacy, safety, side effects, drug interactions, and appropriate use. Physician recommendations regarding dosing and frequency help to avoid overuse syndromes and adverse events. A step-care approach in managing the acute headache is helpful, starting with the simple analgesics, moving to combination products, and finally to prescription products. All this is best done in the climate of a physician/patient partnership characterized by mutuality of effort and responsibility.

Headache↗
PubMed1997

Characteristics of migraine visual aura.

Visual auras (VAs) of 100 patients with migraine with aura were studied by questionnaire. Visual auras accompanied the patients' first headache (HA) in 39% of patients. Only 19% had VAs with every attack. Patients with VAs over the entire HA history had a high frequency (greater than 50%) of attacks with VA; patients with VA during only part of the HA history had a low frequency (less than 50%) of attacks with VA. The auras occurred exclusively prior to the HA in 57%. The free interval between the end of the VA and the start of the HA was usually (75%) shorter than 30 minutes. Most (59%) patients had VAs that lasted from 1 to 30 minutes. They started in the periphery of the visual fields in 56%. The most common phenomena described were: small bright dots (42%), flashes of light (39%), "blind spots" (32%), and "foggy vision" (27%). Fortification spectra was reported by only 20%. Although most (65%) patients had a combination of phenomena, the majority (72%) had only one uniform constellation of manifestations. There was no clear-cut relationship between side of VA and side of HA. Migraine VA is a pleomorphic and complex symptom. Many patients not qualifying for the diagnostic criteria of migraine with aura, as proposed by the International Headache Society (IHS), unequivocally present with visual phenomena that strongly suggest this diagnosis.

Adolescent↗
PubMed1996

Early and transient side effects of repetitive intravenous dihydroergotamine.

Side effects associated with administration of repetitive intravenous dihydroergotamine (DHE) were prospectively studied in 72 patients with chronic daily headache who were hospitalized in a dedicated inpatient headache treatment program. All patients received 11 consecutive doses of DHE, starting with 0.25 mg and increasing by 0.25 mg up to a maximum dose of 1.25 mg, depending on side effects and/or headache relief. The adverse events were recorded after each dose administered. The great majority of patients (91.6%) reported at least one side effect. The most common were: nausea (72.2%), increase in previous headache (47.2%), lightheadedness (33.3%), "new" headache (27.8%), and leg cramps (23.6%). The overall number of side effect complaints did not increase proportionally with the strength of the dose of DHE administered. These complaints declined from the earlier to the later doses of DHE, except for leg cramps, which were more common with the later doses. Side effects determined the strength of subsequent doses of DHE in only 18.1% of patients. Only four patients had to have a decrease in dosage and none required termination of DHE due to side effects. Although repetitive intravenous DHE causes frequent side effects, they are usually mild and transient and decrease with subsequent doses, even at higher doses.

Adolescent↗
PubMed1994

Subcutaneous sumatriptan in a clinical setting: the first 100 consecutive patients with acute migraine in a tertiary care center.

The first 100 consecutive patients at our center receiving subcutaneous sumatriptan (6 mg) were evaluated over a total of 455 migraine attacks. Parameters included overall efficacy, average time to relief, recurrence rate, average time to recurrence, adverse events, comparison to previous abortive agents, and subjective global ratings. Overall efficacy (defined as headache severity reduction from severe or moderate to mild or none) was 84%. Average time to relief was 40 minutes. Nine percent failed to respond at all. Recurrence rate was 46.5% with 36% of patients having no recurrence. Fourteen percent of patients reported 100% recurrence (minimum 3 attacks; average 5.4 attacks). Time to recurrence varied widely, but averaged 9.1 hours. Eighty-one percent rated the drug better or much better than previous abortive medications in terms of sumatriptan's ability to abort the attack. Seventy-seven percent reported some adverse event (generally mild and transient) with 23% reporting no adverse events. Sixty-nine percent reported a global rating of Good to Excellent and 31% rated Poor or Fair. The rate of recurrence and average time to recurrence were the most significant factors affecting the global ratings. These parameters were further evaluated with respect to a variety of subgroups: 1) migraine alone 2) migraine with co-existent tension-type headache 3) drug-induced headache (analgesic rebound headache) 4) posttraumatic headache 5) preventive versus no preventive medication 6) presence or absence of adverse events 7) presence or absence of recurrence and 8) average duration of migraine with no medication.

Acute Disease↗
PubMed1993

Pharmacologic therapy, nondrug therapy, and counseling are keys to effective migraine management.

A recent study on the epidemiology of migraine showed migraine to be present in 17.6% of females and 5.7% of males. The survey results suggested that both patients and physicians believe migraine treatment is elusive and that patients are becoming increasingly frustrated and dissatisfied with treatment outcomes. With increased knowledge of headache and a variety of treatment options, family practice physicians can better educate, counsel, and treat patients.

Counseling↗
PubMed1992

Chronic daily headache.

Earlier definitions of migraine and tension-type headache assumed knowledge of pathophysiology. These definitions were system specific and simplistically defined migraine as vascular in origin and tension-type headache as muscular. These definitions were vague and have led to lack of precision in diagnosis. Newer understandings of the pathophysiology of headache suggest that there may be a relationship between the two disorders based on central mechanisms. Overuse of analgesics and ergotamines has also been found to contribute to chronic daily headache through the phenomenon of rebound pain. These mechanisms have important implications in the treatment of primary headache disorders.

Analgesics↗
PubMed1988

Fiorinal with codeine in the treatment of tension headache--the contribution of components to the combination drug.

The contribution of the Fiorinal and codeine phosphate components to the effectiveness of the Fiorinal with Codeine combination in the treatment of tension headache symptoms was evaluated in a randomized, placebo-controlled, multicenter double-blind study. Patients admitted to the trial took two capsules of Fiorinal with Codeine, Fiorinal alone, codeine alone, or placebo during each of two tension headache attacks. Immediately before and at intervals up to four hours after drug ingestion, patients rated pain severity, pain relief, the tense and uptight feeling, and muscle stiffness. The response to treatment was evaluated in 154 patients. Despite a high placebo response, a factor known to obscure the contribution of components, Fiorinal and codeine were each found to contribute significantly to the therapeutic effect of the Fiorinal with Codeine combination. Statistical or borderline superiority of the combination drug over Fiorinal alone was seen most frequently at the early evaluations, a finding that reflected the rapid onset of action of codeine. Statistically significant differences between Fiorinal with Codeine and codeine alone seen principally at the later assessments reflected the long duration of action of the Fiorinal component. The frequency of adverse reactions did not differ significantly among the four study groups.

Adolescent↗
PubMed1983

Geriatric headaches.

Headaches, although common occurrences in the elderly, can be the symptoms of a serious problem. Specific headaches found in this population need careful consideration and diagnosis. When the diagnosis is elusive, or the headache is sudden, severe, and incapacitating, a neurologist or neurosurgeon should be consulted.

Aged↗