Headache prevalence, characteristics and impact in adults were measured using a cross-sectional general population survey in North Staffordshire, UK. A postal survey was mailed out to 4885 adults (aged > or = 18 years) with an adjusted response rate of 56% (n = 2662). Of respondents 93% reported headache ever and 70% in the last 3 months. Women and younger people reported higher headache prevalences. Of those reporting headache in the last 3 months, 23% experienced headache at least weekly and 16% experienced severe headache pain. Headaches affected work, home or social activities in 43% of sufferers and 20% reported at least moderate headache-related disability. Higher levels of disability were associated with higher levels of pain, 61% with severe disability reporting severe pain compared with 13% who had mild or moderate disability. In the total adult population sample headache affected more than two-thirds in the last 3 months and 14% of all adults reported headache-related disability of at least moderate level, which translates to a large burden in the general population.
Objective. This phase III, 52-week study compared fostamatinib with placebo (for 24 weeks) in patients with active rheumatoid arthritis (RA) and an inadequate response to methotrexate (MTX) therapy.Methods. Patients taking MTX were randomized(1:1:1) to receive fostamatinib 100 mg twice daily for 52 weeks (group A), fostamatinib 100 mg twice daily for 4 weeks and then 150 mg once daily (group B), or placebo for 24 weeks and then fostamatinib 100 mg twice daily (group C). At week 24, the co-primary end points were change from baseline in the American College of Rheumatology 20% (ACR20) improvement response rates and change in the modified total Sharp/van der Heijde score of radiographic damage (SHS).Results. In this study, 918 patients were randomized and received >1 dose of study drug (fostamatinib or placebo); the demographic and baseline clinical characteristics were well balanced. Following treatment with both fostamatinib regimens, a statistically significant difference in the ACR20 improvement response was achieved at week 24 as compared with that in patients receiving placebo (49.0% [group A] and 44.4%, [group B] versus 34.2%; P < 0.001 and P ؍ 0.006, respectively), but there was no statistically significant difference in the SHS between either fostamatinib group and placebo (P ؍ 0.25 and P ؍ 0.17, respectively). The most common adverse events in patients in groups A, B, and C were hypertension (15.8%, 15.1%, and 3.9%, respectively) and diarrhea (13.9%, 15.1%, and 3.9%, respectively). Elevated blood pressure (>140/90 mm Hg) occurred at >1 visit in 44.2%, 41.6%, and 19.3% of patients in each respective group.Conclusion. With the use of either fostamatinib regimen in patients with RA, statistically significant, but not clinically significant, improvements in the ACR20 improvement response over placebo were achieved at ClinicalTrials.gov identifier: NCT01197521.
The objective of this study was to determine predictors of onset of new headache episodes and recovery from headache over one year. A population-based cohort study was conducted, comprising a baseline postal survey to a random sample of adults aged>or=18 years, with follow-up survey after 1 year. Risk factor data at baseline were compared with headache status at follow-up in two groups: (i) those free of recent headache at baseline and (ii) those with a recent headache at baseline. In respondents free of recent headache at baseline, previous headache [risk ratio (RR) 4.15], the presence of other pain at baseline (RR 1.43), severe sleep problems (RR 1.67) and drinking caffeine (RR 1.99) increased the risk of a new headache episode during the follow-up year. In respondents with recent headache at baseline, less severe headaches at baseline predicted recovery during the follow-up year, as did the absence of anxiety [recovery ratio (ReR) 2.84] and of sleep problems (ReR 2.77). Risks for increased headache-related disability reflected those for onset of a new episode and these risks increased in strength for large increases in disability. Sleep problems and caffeine consumption increase the risk of developing headache and thus provide targets for prevention. Low levels of anxiety, sleep problems and the absence of other pain improve the likelihood of recovering and remaining free from headache.
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