Search

The efficacy, safety and tolerability of the 5-HT1B/D receptor agonist eletriptan (40 mg and 80 mg) in acute treatment of migraine was evaluated in a multinational, randomized, double-blind, parallel-group, placebo-controlled, three-attack study treating 1153 patients. In the initial attack, significantly more eletriptan patients reported headache relief and complete pain relief at 2 h vs. placebo (40 mg 62% and 32%, 80 mg 65% and 34%, placebo 19% and 3%; P < 0.0001). Headache relief occurred faster after eletriptan, with more patients at both doses reporting relief 30 min (P < 0.01) and 1 h (P < 0.0001) after treatment than after placebo. There was a significantly lower recurrence rate with eletriptan 80 mg compared with placebo (P < 0.01). Adverse events for all treatments were generally mild or moderate and self-limiting. Eletriptan 40 mg and eletriptan 80 mg both appear to be effective and well-tolerated acute migraine treatments. [ABSTRACT FROM AUTHOR]

Sumatriptan nasal spray is a single-dose device that delivers 5 mg, 10 mg, or 20 mg of sumatriptan (dosage availability dependent upon country) in a 0.1 ml aqueous solution to one nostril. The efficacy and tolerability of sumatriptan nasal spray have been assessed in a number of studies. It has been demonstrated that administering sumatriptan as a divided dose in both nostrils confers no advantage over administration in a single nostril. It appears from these studies that sumatriptan nasal spray is rapidly effective (with an onset of efficacy as early as 15 min postdose). The 20 mg dose is superior to the lower doses (5 mg, 10 mg) in terms of both time to onset of efficacy and the extent of migraine symptom relief. Sumatriptan nasal spray is consistently effective in the treatment of multiple migraine attacks (with 67% of patients treated with the 20 mg dose responding in at least two of three treated attacks) and with long-term use for up to 1 year. Apart from a bitter taste, the adverse event profile of sumatriptan nasal spray is comparable to that of placebo. [ABSTRACT FROM AUTHOR]

The ability of tonabersat to relieve the symptoms of migraine attacks with or without aura was evaluated in a randomized, double-blind, placebo-controlled, multicentre, parallel-group study. Patients received 20 or 40 mg of tonabersat, or 50 mg of sumatriptan (positive control), or placebo at the onset of a moderate or severe attack. Headache intensity, relief and recurrence were recorded for 24 h after dosing. On the basis of primary or secondary efficacy measures, tonabersat did not provide a clinically or statistically significant advantage over placebo. Tonabersat generally was well tolerated and had no effect on vital signs, electrocardiogram recordings or laboratory values. The lack of efficacy may be a function of the slow absorption of tonabersat. As a consequence of slow absorption, daily administration of tonabersat as prophylaxis for migraine attacks is under investigation in ongoing studies. [ABSTRACT FROM AUTHOR]

A meta-analysis of pooled individual patient data from four randomized, placebo-controlled, double-blind trials comparing several doses of almotriptan ( n = 1908) with placebo ( n = 386) was used to investigate the efficacy, speed of onset and tolerability of almotriptan in the acute treatment of migraine. As early as 30 min after dosing, almotriptan 12.5 mg was significantly more effective than placebo for pain relief (14.9% vs. 8.2%; P < 0.05) and pain free (2.5% vs. 0.7%; P < 0.05). At 2 h, pain-relief rates were 56.0%, 63.7% and 66.0% for almotriptan 6.25, 12.5 and 25 mg, respectively, compared with 35% for placebo; 2-h pain-free rates were 26.7%, 36.4% and 43.4% compared with 13.9% for placebo. All almotriptan dosages were significantly more effective than placebo in eliminating migraine-associated symptoms ( P < 0.05) and in achieving sustained pain relief up to 24 h ( P < 0.05). The incidence of adverse events after almotriptan 6.25 mg and 12.5 mg was not significantly different from that of placebo. This meta-analysis confirms the findings of individual clinical trials, while demonstrating for the first time, significant pain-free efficacy at 30 min compared with placebo. [ABSTRACT FROM AUTHOR]

Editorial. Comments on the assessment of patients in migraine treatment. Evaluation of the patient preferences on information of the efficacy of the tests; Factors influencing the patient preferences for the guidance of physicians; Advantages of preference trials on real-life perspective of medication.

A randomly selected sample of 1668 individuals (782 women and 886 men) aged 18–74 years was interviewed by telephone using a standardized questionnaire including the International Headache Society (IHS) criteria for migraine. The survey was performed by SIFO, the national public opinion poll agency. The results obtained demonstrate that 21% of the Swedish population had suffered from severe headaches during the past year. A majority of these headache sufferers (61%) fulfilled the IHS-criteria for migraine. The 1-year prevalence of migraine in Sweden was found to be 13.2 ± 1.9% (16.7% among women and 9.5% among men). The prevalence of migraine in this Swedish population did not differ between the northern, middle and southern part of Sweden, or between urban and rural areas or different income groups. Only about half (49%) of the migraineurs had been diagnosed by a physician. Among the individuals who fulfilled the IHS criteria for migraine the mean attack-frequency was 1.3 per month and the mean attack-duration was 19 h. If the duration of the attack was disregarded as a strict criterion for migraine (attacks < 4 h and > 72 h were included), the prevalence increased to 17.0 ± 1.9% without affecting the sex distribution. With this amendment, 92% of those who considered their headaches to be migraine or migraine-like in fact fulfilled the alternative criteria for migraine. However, only 76% of those who believed that they had migraine or migraine-like headaches fulfilled the strict IHS criteria for migraine. An extension of the time window from 4 to 72 h may be reasonable both from a pragmatic and from a rational clinical point of view. [ABSTRACT FROM AUTHOR]

Subcutaneous injection of sumatriptan is an effective treatment for attacks of cluster headache with a short onset of action. This open, randomized study evaluates whether sumatriptan nasal spray at its highest commercially available dose (20 mg/dose) is equally effective. In 26 patients, four consecutive attacks were treated alternately with nasal spray and subcutaneous injection. Treatment was given within 5 min of onset of pain, and the time interval for the start and completeness of pain relief, provided these occurred within 15 min of administration, were recorded by the patient. After completion of the study, the patients were also asked to indicate which treatment they preferred, based on efficacy, side effects, and handling of the preparation. Forty-nine of the 52 treatments with injection resulted in complete relief of pain within 15 min, with a mean of 9.6 min. The remaining three attacks were reduced by a mean of 86.7% at 15 min. Only 7 of the 52 treatments with nasal spray in the nostril ipsilateral to pain resulted in complete relief within this time period, with a mean of 13.0 min. In 18 of these treatments pain was reduced by a mean of 42.2% at 15 min, whereas no effect on pain was obtained at this time in the remaining 27 treatments. The effect was almost identical when the nasal spray was administered in the nostril on the non-painful side. As an overall judgement, only 2 of the 26 patients preferred nasal spray to injection. We conclude that sumatriptan nasal spray 20 mg/dose is less effective than subcutaneous injection in relieving pain in the great majority of cluster headache sufferers. [ABSTRACT FROM AUTHOR]

Presents several guidelines on the controlled trial of drugs used for treating migraines. Selection of patients; Role of health-related quality of life measures; Checklists for acute and prophylactic treatments.

Chronic daily headache (CDH) associated with long-term misuse of headache medication is a common clinical problem which is refractory to most treatments. The present study is a retrospective analysis of the effect of drug withdrawal therapy in patients with CDH and frequent long-term use of headache symptomatic medication. One hundred and one adult patients (74 women and 27 men, aged between 16 and 72 years, mean age 43 years) were evaluated 1-3 months after drug withdrawal therapy had been initiated. The mean headache frequency at baseline was 26.9+/-4.0 days per month. Fifty-seven (56%) patients were significantly improved (defined as at least 50% reduction in number of headache days) after a period of drug withdrawal therapy. Based on the outcome of the drug withdrawal therapy, the patients were divided into three categories: group I, those who had between 0 and 10 headache days per month (n = 41), group II, those who had 11-20 days (n = 37), and group III, those who had 21-30 days (n = 23). The mean headache frequencies in groups I, II and III were 5.6+/-2.8 days, 15.7+/-2.5 days and 28.7+/-2.4 days, respectively. Treatment with amitriptyline was offered to patients in whom no improvement had been achieved. Ten of those 22 patients (36%) experienced a significant (> or = 50%) reduction of headache days. It is concluded that out-patient drug withdrawal therapy is the treatment of choice in patients with CDH and frequent long-term use of headache symptomatic medication, and that about one quarter of these CDH patients do not respond to drug withdrawal therapy only. [ABSTRACT FROM AUTHOR]

Presents author's view on introduction of serotonin 5-HT[subIB/ID] agonists in clinical practice for the treatment of patients with migraine. Effect of the drug almotriptan on migraine headache; Tolerance and clinical safety of almotriptan usage.

Presents information on a study which assessed and compared health-related quality of life in headache patients, using the SF-36 generic questionnaire. Association of migraine with other illnesses.

Comments on a study on the economic impact of migraine. Direct costs of migraine; Indirect costs of migraine for women.

Tolerability of a drug should be regarded as important as its efficacy. In all four phases of drug development evaluation of adverse events is important. Recommendations for assessment of adverse events in acute and prophylactic clinical drug trials in migraine are given. Tolerability may be indirectly assessed using measures of general well-being and eight such tools are presented. Finally, recommendations for reporting of adverse events are given. [ABSTRACT FROM AUTHOR]

This study was designed to document prospectively and explore scientifically the natural course of untreated migraine attacks in detail. A new, integrated, time-intensity method for self-assessment of the intensity of symptoms was tested on 18 adult International Headache Society migraineurs who volunteered to refrain from treatment during one attack. The area under the curves (AUC) during 72 h of untreated attacks was compared with attacks treated with a triptan. Migraine attacks are heterogeneous both inter- and intra-individually. In untreated attacks, the pain can stabilize and fluctuate around a plateau with a wavelength of hours. In general, the symptoms of each separate migraine attack follow a similar temporal course, with only moderate deviations. In some cases photo- and/or phonophobia (hyperexcitability) were not experienced at all, despite severe pain and nausea. Moreover, there was sometimes no nausea despite severe pain and hyperexcitability. Vomiting does not always correlate to the intensity of nausea and is not always followed by decreased headache intensity. Treatment with a triptan usually only temporarily distorts the basic pattern of attacks. Hyperexcitability can respond before pain to treatment. These genuine findings of the classic symptoms of migraine attacks support the notion of a mutual underlying pathophysiological mechanism. [ABSTRACT FROM AUTHOR]

Over the years the paradigm of treating early during the migraine attack has become well established in clinical practice. It is also recommended that the 5-HT1B/1D agonists be administered early during the migraine attack for efficacy. This is because it has been proposed that most migraineurs are less responsive to delayed treatment, owing to the development of central sensitization of the pain transmission. The main objective of this prospective, cross-over study at a specialist clinic was to evaluate if these recommendations should also apply to the subcutaneous formulation of sumatriptan. Results are based on 20 adult International Headache Society migraineurs. Two attacks ( n = 40) were treated with 6 mg subcutaneous sumatriptan as early as possible after the onset of migraine headache and two attacks ( n = 40) as late as the patients could bear. The median intra-individual difference between the two strategies in time from first occurrence of pain to injection was 5.7 h and the median intra-individual difference in pain intensity at the time of injection was 29 visual analogue units. No significant differences were found in time to freedom from pain, pain severity at 1 and 2 h, area under the curves from injection to pain free or in headache recurrence after injection. At the end of the study, most of the patients claimed that their medication was as effective when given early as when given late in the course of the attack. The discrepancy between our present findings and retrospective analyses of trials on oral triptans probably has more to do with the less disturbed pharmacokinetics early during the migraine attack than with central sensitization. Consequently, we recommend nonoral formulations of triptans, which do not necessarily have to be administered early during the migraine attack to provide efficacy. In conclusion, it is reassuring for migraineurs that it is worthwhile taking their medication in an appropriate formulation even if they have not been able to do so early in the course of the attack. [ABSTRACT FROM AUTHOR]

Oral triptans are effective and well tolerated acute treatments for migraine, but clinical differences between them are small and difficult to measure in conventional clinical trials. Patient preference assesses a global measure of efficacy and tolerability, and may be a more sensitive means of distinguishing between these drugs. In a series of studies, patients consistently expressed a clear preference for triptans over their usual non-triptan acute medications, e.g., analgesics and ergotamine. Direct comparator studies of patient preference with oral triptans showed that patients could distinguish between different triptans, and between different formulations of the same triptan. Patients could even distinguish between the three oral doses of sumatriptan. The most frequently provided reasons for preference were speed of response and overall effectiveness. Patient preference is a sensitive clinical trial endpoint and physicians should consider using it when reviewing the efficacy of acute migraine medications. [ABSTRACT FROM AUTHOR]

Topiramate (TPM) has shown efficacy in migraine prophylaxis in two large placebo–controlled, dose–ranging trials. We conducted a randomised, doubleblind, multicentre trial to evaluate the efficacy and safety of two doses of topiramate vs placebo for migraine prophylaxis, with propranolol (PROP) as an active control. Subjects with episodic migraine with and without aura were randomised to TPM 100 mg/d, TPM 200 mg/d, PROP 160 mg/d (active control), or placebo. The primary efficacy measure was the change in mean monthly migraine frequency from the baseline phase relative to the double–blind treatment phase. Five hundred and seventy–five subjects were enrolled from 61 centres in 13 countries. TPM 100 mg/d was superior to placebo as measured by reduction in monthly migraine frequency, overall 50% responder rate, reduction in monthly migraine days, and reduction in the rate of daily rescue medication use. The TPM 100 mg/d and PROP groups were similar with respect to reductions in migraine frequency, responder rate, migraine days, and daily rescue medication usage. TPM 100 mg/d was better tolerated than TPM 200 mg/d, and was generally comparable to PROP. No unusual or unexpected safety risks emerged. These findings demonstrate that TPM 100 mg/d is effective in migraine prophylaxis. TPM 100 mg/d and PROP 160 mg/d exhibited similar efficacy profiles. [ABSTRACT FROM AUTHOR]

To determine the tolerability and efficacy of eletriptan in patients who had discontinued oral sumatriptan due to lack of efficacy or intolerable adverse events (AEs) during previous clinical treatment (not a controlled trial). Eletriptan is a potent, selective 5-HT1B/1D receptor agonist with beneficial pharmacokinetic properties compared with sumatriptan. In a double-blind, parallel group, placebo-controlled multicentre study, patients with and without aura (n = 446) were randomized to 40 mg eletriptan (E40, n = 188), 80 mg eletriptan (E80, n = 171) or placebo (n = 87) for treatment of up to three migraine attacks. Two-hour headache response, based on first-dose, first-attack data, was 59% for eletriptan 40 mg, 70% for eletriptan 80 mg, and 30% for placebo (P < 0.0001 for both doses of eletriptan vs. PBO; P < 0.05 for E80 vs. E40). Onset of action was rapid, with 1-h headache response rates significantly superior for E40 and E80 vs. placebo (40%, 48%, 15%; P < 0.0005). Both E40 and E80 were significantly superior to placebo, based on first-dose, first-attack data, for 2-h pain-free response (35%, 42%, and 7%; P < 0.0001). Both E40 and E80 demonstrated significant consistency of response, with headache relief rates at 2 h on at least two of three attacks in 66% and 72% vs. 15% on placebo (P < 0.001). AEs were mild to moderate in severity and dose related. The most commonly reported AEs included nausea, vomiting, asthenia, and chest symptoms. E40 and E80 produce an effective response in patients who had previously discontinued treatment with sumatriptan due to lack of efficacy or side-effects. [ABSTRACT FROM AUTHOR]

This article reviews the pathophysiology and pharmacology of emesis in relation to migraine pathogenesis. Also, the place of antiemetic and gastrointestinal prokinetic agents in current and future acute migraine treatment strategies is reviewed. The mechanisms of action of current and novel acute migraine therapies are considered with respect to the neurogenic and vascular hypothesis. Control of migraine-associated nausea and vomiting is often achieved with the benzamide dopamine D2 receptor antagonist metoclopramide. This drug also has 5HT3 receptor antagonist activity and reproducibly stimulates gastric motility to increase the availability of orally administered drugs. Other antiemetic and gastroprokinetic agents with potential value for the treatment of migraine-associated nausea and vomiting could speed absorption of oral antimigraine therapies without central nervous system side effects. Domperidone, a dopamine D2 receptor antagonist that does not cross the blood brain barrier is relatively free of the central side-effect liability of metoclopramide. Cisapride, a benzamide 5HT4 receptor agonist gastrointestinal prokinetic drug, lacks dopamine antagonist activity. A controlled comparison of these agents as migraine co-therapies could provide information on the importance of peripheral and central mechanisms in migraine-associated nausea and vomiting and improve antimigraine treatment options. [ABSTRACT FROM AUTHOR]

Objective: To compare almotriptan and zolmitriptan in the treatment of acute migraine. Methods: This multicentre, double-blind trial randomized adult migraineurs to almotriptan 12.5 mg ( n = 532) or zolmitriptan 2.5 mg ( n = 530) for the treatment of a single migraine attack. The primary end point was sustained pain free plus no adverse events (SNAE); other end points included pain relief and pain free at several time points, sustained pain free, headache recurrence, use of rescue medication, functional impairment, time lost because of migraine, treatment acceptability, and overall treatment satisfaction. Results: No significant difference was seen in SNAE (almotriptan 29.2% vs zolmitriptan 31.8%) or the other efficacy end points measured. The incidence of triptan-associated AEs and triptan-associated central nervous system AEs was significantly lower for patients receiving almotriptan compared to zolmitriptan. Conclusions: Almotriptan and zolmitriptan were associated with similar efficacy and overall tolerability in the treatment of acute migraine. Almotriptan was associated with a significantly lower rate of triptan-associated AEs. [ABSTRACT FROM AUTHOR]

Linde M, Fjell A, Carlsson J&Dahlöf C. Role of the needlingper sein acupuncture as prophylaxis for menstrually related migraine: a randomized placebo-controlled study. Cephalalgia 2004. London. ISSN 0333-1024The objectives were to introduce a new method for controlled trials of acupuncture in the field of headache research and to examine the role of needlingper se. Women with menstrually related migraine were randomized to three months of treatment with verum or placebo needles. Three standard size casts were moulded to secure the placebo needles in the head. No significant differences were found between the verum group (n = 15) and the placebo group (n = 13) during treatment or follow up three and six months later, either in the attack frequency or in the number of days per month with migraine, headache intensity or drug-use. The casts held the needles exactly in place despite movements of the head, and are validated as practical, hygienic and extremely durable. This method is satisfactory for controlled studies of acupuncture in headache. It is possible that the positive results in earlier clinical trials on acupuncture in migraine are attributable to other mechanisms than needling of subcutaneous tissue. [ABSTRACT FROM AUTHOR]

Background: Migraine and other severe headaches can cause suffering and reduce functioning and productivity. Patients are the best source of information about such impact.Objective: To develop a new short form (HIT-6) for assessing the impact of headaches that has broad content coverage but is brief as well as reliable and valid enough to use in screening and monitoring patients in clinical research and practice.Methods: HIT-6 items were selected from an existing item pool of 54 items and from 35 items suggested by clinicians. Items were selected and modified based on content validity, item response theory (IRT) information functions, item internal consistency, distributions of scores, clinical validity, and linguistic analyses. The HIT-6 was evaluated in an Internet-based survey of headache sufferers (n = 1103) who were members of America Online (AOL). After 14 days, 540 participated in a follow-up survey.Results: HIT-6 covers six content categories represented in widely used surveys of headache impact. Internal consistency, alternate forms, and test-retest reliability estimates of HIT-6 were 0.89, 0.90, and 0.80, respectively. Individual patient score confidence intervals (95%) of app. +/-5 were observed for 88% of all respondents. In tests of validity in discriminating across diagnostic and headache severity groups, relative validity (RV) coefficients of 0.82 and 1.00 were observed for HIT-6, in comparison with the Total Score. Patient-level classifications based in HIT-6 were accurate 88.7% of the time at the recommended cut-off score for a probability of migraine diagnosis. HIT-6 was responsive to self-reported changes in headache impact.Conclusions: The IRT model estimated for a 'pool' of items from widely used measures of headache impact was useful in constructing an efficient, reliable, and valid 'static' short form (HIT-6) for use in screening and monitoring patient outcomes. [ABSTRACT FROM AUTHOR]

Randomized placebo-controlled clinical trials have been the 'golden standard' during the last decades in the development of new drug therapies. This scientifically valid approach has recently been questioned in the fifth revised version of the Declaration of Helsinki, which states that the use of placebo-controlled clinical trials is only acceptable when no proven treatment exists for the studied disease. The World Medical Association further claims that no national ethical, legal or regulatory requirements should be allowed to reduce or eliminate any of the statements in the declaration. In spite of this, the document is not generally accepted as the world ethical standard, as demonstrated by its lack of adoption by many professional associations. In the evaluation process for a drug to be approved in many countries today, clinical investigators at the hospitals and researchers at the pharmaceutical companies are obliged to use study protocols that would be rejected if the new declaration were to be fully adopted. Adherence to the clinical trial guidelines of the International Headache Society could also mean violation of the new Helsinki declaration of ethics. Some ethics committees have already adopted the new declaration, which has caused concern among clinical investigators, who find this document to be vastly out of the line with common practice. At the moment, the situation is unclear and debated with increasing polarity concerning the scientific and ethical issues regarding the use of placebo in clinical trials. [ABSTRACT FROM AUTHOR]

This double-blind, placebo-controlled, parallel-group, multicentre, multinational, phase-III trial was designed to assess the efficacy and safety of a single subcutaneous injection of placebo, 2 doses of alniditan (1.4 mg and 1.8 mg) and 6 mg of sumatriptan in subjects with acute migraine. A total of 114 investigators from 13 different countries screened 2021 subjects. In total 924 patients were treated with placebo (157), alniditan 1.4 mg (309), alniditan 1.8 mg (141) and sumatriptan 6 mg (317). The lower number of subjects in the alniditan 1.8 mg group is due to the termination of this trial arm after the incidence of a serious adverse event and a subsequent protocol amendment. The number of subjects who were pain free at 2 h (primary endpoint) was: 22 (14.1%) with placebo, 174 (56.3%) with alniditan 1.4 mg, 87 (61.7%) with alnditan 1.8 mg and 209 (65.9%) with sumatriptan 6 mg. Alniditan 1.4 mg was significantly better (P < 0.001) than placebo and sumatriptan was significantly better (P = 0.015) than alniditan 1.4 mg. The number of responders (reduction of headache severity from moderate or severe headache before treatment to mild or absent at 2 h), was 59 (37.8%) on placebo, 250 (80.9%) on alniditan 1.4 mg, 120 (85.1%) on alniditan 1.8 mg, and 276 (87.1%) on sumatriptan. Response was significantly higher (P < 0.001) with alniditan 1.4 mg than with placebo, and significantly lower (P = 0.036) with alniditan 1.4 mg than with sumatriptan. Recurrence rates were: 22 (37.3%) with placebo, 87 (34.8%) with alniditan 1.4 mg, 35 (29.2%) with alniditan 1.8 mg and 108 (39.1%) with sumatriptan. Adverse events occurred in 577/924 (62.4%) subjects, i.e. in 62/157 (39.5%) with placebo, 214/309 (69.3%) with alniditan 1.4 mg, 91/141 (64.5%) with alniditan 1.8 mg and 210/317 (66.2%) with sumatriptan 6 mg. Sumatriptan was significantly better than alniditan 1.4 mg for pain free at 2 h. The difference, however, was small and clinically not important. For alniditan, a... [ABSTRACT FROM AUTHOR]

The aim of the study was to evaluate the prevalence of subjective perception of dry mouth in an adult population and to determine the prevalence of pharmacotherapy in this population. An additional aim was to assess a possible co-morbidity between symptoms of dry mouth and continuing pharmacotherapy. Four-thousand-two-hundred persons were selected at random from the national census register of the adult population of the southern part of the province of Halland, Sweden. The sample was stratified according to age and sex, and 300 men and an equal number of women aged 20, 30, 40, 50, 60, 70 and 80, were included. A newly developed questionnaire was mailed to each individual. In addition to questions about subjective perception of dry mouth, the subjects were asked to report on present diseases and continuing pharmacotherapy. Three-thousand-three-hundred and thirteen (80.5%) evaluable questionnaires were returned. The estimated prevalence of xerostomia in the population was 21.3% and 27.3% for men and women, respectively. This difference between the sexes was statistically significant. In non-medicated subjects, women tended to report a higher prevalence of xerostomia compared with men, 18.8% vs. 14.6%, and also among medicated subjects the estimated prevalence of dry mouth was higher for women than for men, 32.5% vs. 28.4%. There was a strong association between xerostomia and increasing age and also between xerostomia and continuing pharmacotherapy. The average prevalence of dry mouth among medicated and non-medicated subjects was 32.1% and 16.9%, respectively, the difference being statistically significant. There was also a strong association between xerostomia and the number of medications. In a logistic regression, the probability of reporting mouth dryness was significantly greater in older subjects and in women, and the probability increased with the number of medications taken. [ABSTRACT FROM AUTHOR]

Migraineurs (94F, 24M) with previous experience of subcutaneous sumatriptan and/or sumatriptan tablets were asked their opinion on sumatriptan nasal spray treatment particularly with respect to onset of action, total efficacy, tolerability, and user friendliness. The information was obtained by means of a self-administered questionnaire handed out at the time of prescription of the nasal spray. The results are based on the patients' cumulative experience of having treated at least two migraine attacks with the spray (20 mg). Sumatriptan nasal spray (20 mg) was perceived to have a faster onset of action and, with the exception of a bad taste, to have a better tolerability than the tablets. Compared with subcutaneous sumatriptan, the nasal spray was claimed to be less effective in reducing symptoms of migraine attacks but to cause fewer adverse events. A bitter taste was the most commonly reported side effect of sumatriptan nasal spray--reported by 68% (80 out of 118) of the migraineurs. The user friendliness of sumatriptan nasal spray was rated better than that of subcutaneous sumatriptan and/or sumatriptan tablets. The overall impression of sumatriptan nasal spray was reported to be better or equal to that of the tablet and the injection by 57% and 46%, respectively. It is concluded that the results obtained in clinical practice are very much in line with those obtained in controlled clinical trials. The overall impression of sumatriptan nasal spray is that it is user friendly and useful in the acute treatment of migraine attacks of moderate intensity. [ABSTRACT FROM AUTHOR]

Alniditan is a new 5HT1D receptor agonist, belonging to a different chemical class from sumatriptan and other indole derivatives used or being developed for the treatment of acute migraine. In a multinational double-blind randomized parallel-groups dose-finding trial, alniditan was given subcutaneously in hospital to patients with migraine headache of moderate or severe intensity at doses of 0.8 mg (n = 44), 1.0 mg (n = 42), 1.2 mg (n = 46) and 1.4 mg (n = 39). Efficacy, tolerability and safety of each dose were compared with those of placebo (n = 41). At 2 h after injection, headache was absent or mild in 83% and 82% of patients receiving alniditan 1.2 and 1.4 mg respectively compared with 39% for placebo (p < or = 0.002). Complete relief from headache was achieved in 72% (1.4 mg). Time to onset of relief decreased with increasing alniditan dose, and there was a dose-dependent reduction in headache recurrence rate: 25% of patients receiving 1.4 mg had responded by 15 min and headache recurred within 24 h in only 16% of the patients who initially responded to alniditan 1.4 mg, significantly less than for placebo (p = 0.018). Alniditan was superior to placebo in reducing the associated symptoms of nausea, phonophobia and photophobia, and in increasing patients' functional ability. The use of rescue medication was reduced when compared with placebo, and up to 87% of patients said that they would use the drug again if available. No clinically relevant cardiovascular effects were seen, nor consistent changes in clinical laboratory findings. Adverse effects, mainly head pressure, paraesthesia, and hot flushes, were reported by 34% of placebo-treated patients and up to 70% of patients receiving alniditan, but all doses were very well tolerated and no clear relationship with dose was established. Comparison with published findings suggests that alniditan 1.4 mg sc may have advantages over sumatriptan 6 mg sc in providing complete relief from acute migraine headache, and may be associated with fewer headache recurrences within 24 h. Both of these suggestions warrant further and larger trials of alniditan in acute migraine. [ABSTRACT FROM AUTHOR]