The study was designed to compare the response to almotriptan in migraine patients who take medication early in the course of the attack with that when medication is taken after pain has become moderate or severe. A randomized, four-arm, multicentre, multinational, double-blind, placebo-controlled trial of almotriptan (12.5 mg) comparing treatment administration when pain intensity was mild and within 1 h of headache onset vs. pain that had become moderate or severe was conducted. Of 491 migraineurs enrolled, 403 were evaluable [intention-to-treat population (ITT)]. Their mean age was 38 years, 84% were female and they had a mean of 3.7 attacks/month. Of these patients, 10% did not take medication according to their randomly allocated basal pain intensity (mild or moderate/severe) and were subsequently reassigned to that group for this analysis-'Act when Mild (AwM)' group. In the almotriptan arms, 53% of mild basal pain and 38% of moderate/severe basal pain patients were pain free at 2 h (P = 0.03; primary end-point). Corresponding proportions in the placebo groups were 25% and 17% (statistically significant vs. respective almotriptan arms). Secondary end-points (ITT) were also significantly in favour of early intervention with almotriptan, both between and across treatment groups, such as sustained pain free: 45.6% vs. 30.5% (P = 0.02). Adverse events were reported in < 5% of treated patients in all groups (NS), with no serious events. Treatment with almotriptan while migraine pain is still mild provides statistically significant and clinically relevant enhancements in efficacy compared with treatment when pain has reached higher severity levels.
Abstract:The objective was to compare the incidence of adverse reactions reported with three nonsteroidal anti-inflammatory drugs with different cyclo-oxygenase (COX)-2 selectivity. All spontaneous adverse reaction notifications in the pharmacovigilance database of the World Health Organisation Collaborating Centre for International Drug Monitoring with aceclofenac, meloxicam, and rofecoxib that were recorded during the first year of marketing were included. The incidence rate (adverse reactions/10 6 defined daily dose) and 95% confidence interval for total adverse reactions was 8.7 (6.1-12.0) for aceclofenac, 24.8 (23.1-26.6) for meloxicam, and 52.6 (49.9-55.4) for rofecoxib. Aceclofenac had a lower incidence of gastrointestinal bleeding, abdominal pain, and arterial hypertension than meloxicam and a lower incidence of gastrointestinal bleeding, abdominal pain, liver toxicity, thromboembolic cardiovascular events, arterial hypertension, and edema than rofecoxib. The incidence of total and gastrointestinal adverse reactions was significantly lower with aceclofenac than with meloxicam or rofecoxib, thus raising doubts about the hypothetical advantage of COX-2 selective inhibitors.
The objective of this study was to evaluate the impact of allodynia on treatment outcomes in the patients with acute migraine treated in the "Act when Mild" (AwM) study. AwM, a randomized placebo-controlled trial, studied almotriptan 12.5 mg in the early treatment (within 1 hr) of acute migraine when the pain was still mild, and investigated clinical outcomes in the presence or absence of allodynia, which was prospectively recorded using patient questionnaires. Of the total population, 39% (n = 404) reported allodynia that did not alter the efficacy of almotriptan administered for early/mild pain in terms of 2-hr pain-free rates (53.9% for allodynic patients vs. 52.5% for nonallodynic patients). Similarly, sustained pain-free rates were 47.2% versus 45.5%, and migraine duration 1.40 versus 1.54 hr, respectively. However, allodynia impaired the effectiveness of almotriptan in the patients with moderate/severe pain in terms of longer migraine duration, fewer patients achieving pain-free status, and more requiring rescue medication. In conclusion, the lack of effect of allodynia on the efficacy of almotriptan given for early/mild migraine pain might help explain the improved outcomes associated with the early-treatment strategy in AwM. Moreover, the data suggest that pain intensity is the main driver of triptan response, and not the presence or absence of allodynia.
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