One-year prevalence of migraine in Spain: a nationwide population-based survey.

AIM: The purpose of the study was to estimate the one-year prevalence of migraine among a population-based sample of Spanish adults. METHOD: Men and women aged 18-65 years were selected at random according to quotas for age, sex, size of habitat (<10,000 inhabitants, 10,001-50,000 inhabitants, 50,001-200,000 inhabitants and >200,000 inhabitants) and residence proportional to the population size of the geographical location. A random-digit-dial, computer-assisted telephone interview (CATI) survey was conducted between April and July 2006. The 2004 International Headache Society operational diagnostic criteria were applied. RESULTS: From a total of 70,692 telephone calls and 26,255 (31.7%) valid contacts, 5,668 (21.6%) respondents completed the CATI survey. A total of 476 subjects (8.4%, 95% confidence interval [CI] 7.7-9.1%) with strict migraine and 236 with probable migraine (4.2%, 95% CI 3.7-4.7%) were recorded. The 1-year prevalence of total migraine (N = 712) was 12.6% (95% CI 11.6-13.6) (17.2% in females, 8.0% in males). The prevalence rates showed significant geographic variations, from 7.6% in Navarra to 18% in the Canary Islands. One-half of the subjects had migraine with aura. One-third of subjects were never diagnosed for migraine. CONCLUSIONS: The one-year prevalence of migraine in Spain is 12.6%, with a prevalence of migraine with and without aura of 8.4% and probable migraine of 4.2%. These findings add data to the current understanding of migraine.

Responsiveness of migraine-ACT and MIDAS questionnaires for assessing migraine therapy.

BACKGROUND: Migraine is frequently undertreated. The 4-item Migraine Assessment of Current Therapy (Migraine-ACT) questionnaire is a simple and reliable tool to identify patients requiring a change in current acute migraine treatment. OBJECTIVE: To investigate the responsiveness of the Migraine-ACT tool, and compare it with that of the Migraine Disability Assessment (MIDAS) questionnaire, for patients with migraine at 1100 primary care sites in Spain. METHODS: Patients eligible for this open-label, 2-visit prospective study reported migraine for >1 year and >or=1 migraine attack per month and were new to the clinic or on follow-up care for <6 months. Validated Spanish versions of the Migraine-ACT and MIDAS questionnaires were administered, and patient satisfaction with treatment was recorded, at baseline and at 3 months. RESULTS: A total of 3272 patients, 78% female, were enrolled, and 2877 (88%) returned for the 3-month visit. Investigators changed baseline migraine treatment for 72% of returning patients; 85% and 80% of these patients had improved Migraine-ACT and MIDAS scores at 3 months, respectively. Patients who reported being completely or very satisfied with migraine treatment numbered 492 (15%) at baseline and 1406 (49%) at 3 months. Migraine-ACT and MIDAS score agreement for improvement at 3 months was poor (kappa = 0.339). Both the mean MIDAS score and the distribution of Migraine-ACT scores improved over the course of 3 months; however, Migraine-ACT scores were significantly (P < .001) more sensitive (83% vs 75%) and specific (72% vs 58%) than MIDAS scores. The area under the curve in the receiver-operating characteristic analysis was significantly (P < .0001) greater for Migraine-ACT (0.82) as compared with the MIDAS (0.70) questionnaire. CONCLUSIONS: These results suggest that the Migraine-ACT questionnaire can be used more reliably than the MIDAS questionnaire for detecting improvements in treatment of new and follow-up patients with migraine.

Predictive model for the Migraine-ACT questionnaire in primary care.

BACKGROUND: Migraine is frequently under-treated. The 4-item Migraine Assessment of Current Therapy (Migraine-ACT) questionnaire is a simple, patient-friendly tool to identify patients requiring change in acute migraine treatment. OBJECTIVE: To establish a predictive model for the Migraine-ACT questionnaire in primary care. RESEARCH DESIGN AND METHODS: This open-label, prospective, two-visit study at 1100 primary care sites enrolled patients reporting migraine for > 1 year and > or = 1 migraine attack/month. Predictive validity of the Migraine-ACT questionnaire was evaluated using a logistic regression model adjusted for baseline disability, diagnosis, sex, age, attack frequency, attack duration, baseline treatment change, treatment(s) for the study period and baseline Migraine-ACT score. RESULTS: A total of 3272 patients, 78% female, entered the study and 2877 patients (88%) returned at 3 months. Investigators changed baseline migraine treatment for 72% of returning patients. Percentages of patients who were completely or very satisfied with migraine therapy increased from 15% at baseline to 49% at 3 months. The adjusted logistics regression model yielded sensitivity of 86% and specificity of 85% to detect > or = 1-point change in Migraine-ACT score at 3 months (p < 0.001). The model yielded 77% sensitivity and 95% specificity to detect > or = 1-point improvement in patient satisfaction at 3 months among patients who improved > or = 1 point in the Migraine-ACT score (adjusted odds ratio, 2.63; 95% confidence interval, 1.97-3.51; p < 0.001). CONCLUSIONS: The Migraine-ACT questionnaire is a simple but sensitive and specific tool to predict improvements at 3 months resulting from changes in migraine treatment and can be used to detect patients with suboptimal migraine management and to monitor treatment effectiveness.

Rizatriptan 10-mg wafer versus usual nontriptan therapy for migraine: analysis of return to function and patient preference.

BACKGROUND: More than half of patients with migraine suffer moderate to severe functional disability during migraine attacks. OBJECTIVE: To compare effects on functional disability at 2 hours after treating a migraine with rizatriptan 10-mg wafer versus usual nontriptan therapy for triptan-naïve patients with migraine. DESIGN: Open-label, prospective, two-attack study conducted at 111 neurology clinics. METHODS: Adult patients with migraine treated two migraine attacks, the first with their usual nontriptan therapy (nonsteroidal anti-inflammatory drugs, 57%; analgesics, 27%; or ergot derivatives, 16%) and the second with rizatriptan 10-mg wafer. Patients recorded pain intensity and functional disability at the start, and functional disability at 2 hours, as well as the time of return to normal function. RESULTS: A total of 1353 patients, 76% of them female, completed the study and were considered evaluable. During first and second migraine attacks, 55% and 63% of patients, respectively, reported severe disability or requiring bed rest. At 2 hours after treatment, the likelihood of experiencing any disability was more than five times greater after usual nontriptan therapy than after rizatriptan (odds ratio, 5.68; 95% confidence interval (CI), 4.66 to 6.94; P < .001). Rizatriptan was twice as likely to return patients to normal function than usual nontriptan therapy after adjusting for confounding factors (adjusted hazard ratio, 2.08; 95% CI, 1.92 to 2.25; P < .001). Assessed over all time points up to 6 hours, the speed of return to normal function was 52% faster after rizatriptan therapy (P < .001). Significantly more patients preferred rizatriptan than usual nontriptan therapy (78.8% vs. 21.2%; P < .001). The most common reasons cited for preference for rizatriptan were faster relief of headache pain and faster return to normal function. CONCLUSIONS: Patients in this study were more likely to experience a return to normal function at 2 hours after receiving rizatriptan than after their usual nontriptan therapy for migraine. The results of this study, using patient-oriented, clinically relevant endpoints such as functional disability and preference, will help to guide practitioners in making recommendations for acute migraine treatment.

Almotriptan versus rizatriptan in patients with migraine in Spain.

OBJECTIVES: To compare patient-reported use of rizatriptan 10 mg with that of almotriptan 12.5 mg per migraine attack (24 hours) in a Spanish population. METHODS: One hundred twenty Spanish community pharmacies recruited patients with migraine to whom they had dispensed almotriptan and rizatriptan. No other selection criteria were used. Patients kept diaries for baseline pain intensity, the number of triptan tablets used, additional medication taken per attack, and their degree of satisfaction with the medication 2 hours after the initial dose. Patients recorded details for a maximum of 3 attacks. Analysis of variance or the Student t test and chi-squared or Fisher exact tests were used for univariate comparisons. A generalized estimating equation method was used to correct for within-subject variability. Adjusted odds ratios (ORs) and 95% confidence intervals (CIs) were calculated. RESULTS: One hundred twenty-six patients (85% women) recorded data for 318 migraine attacks. Rizatriptan was used to treat 122 attacks, almotriptan was used to treat 110 attacks, and a nontriptan medication was used in the initial treatment of 86 attacks. Triptan use (adjusted mean, 95% CI) per attack in this study was lower for rizatriptan (1.19 tablets; 95% CI, 1.06 to 1.32) than for almotriptan (1.43 tablets; 95% CI, 1.30 to 1.56; P=.003). The use of a triptan and additional medication per attack increased with baseline pain severity. Rizatriptan was used to treat more attacks with only one tablet (78%) than almotriptan (58%). Treatment of attacks with almotriptan was more than twice as likely to involve the use of more than one tablet per attack (24 hours) than those treated with rizatriptan (adjusted OR, 2.42; 95% CI, 1.37 to 4.30; P=.003). Patient satisfaction with treatment response at 2 hours was more than 2-fold greater for rizatriptan (85%) than for almotriptan (68%) (adjusted OR, 2.55; 95% CI, 1.11 to 5.87; P=.03). CONCLUSIONS: In this prescription-selected Spanish population, a significantly lower number of rizatriptan tablets were required to treat migraine attacks compared with almotriptan. Further, patients were more than twice as likely to use more than one tablet or additional medication (or both) for attacks treated with almotriptan than for those treated with rizatriptan. Although these data suggest that rizatriptan may be a more effective treatment for migraine than almotriptan, further randomized studies are required to confirm this conclusion.

Migraine treatment patterns and patient satisfaction with prior therapy: a substudy of a multicenter trial of rizatriptan effectiveness.

BACKGROUND: Migraine is a common, chronic, often disabling neurologic condition that is underdiagnosed and undertreated. OBJECTIVE: We undertook this questionnaire-based study as a substudy of a multicenter trial of rizatriptan effectiveness. Our goal was to assess the history of acute migraine medication use and the relationship between different migraine medication regimens and patient satisfaction with prior therapy. METHODS: This study was conducted at 85 neurology clinics throughout Spain from March Lo December 2001. It was planned prospectively as part of the screening visit for a multicenter trial of the effectiveness of rizatriptan therapy for migraine. Male and female patients >/=18 years of age were eligible for the primary trial, and hence for this study, if they had a history of migraine attacks and did not have a contraindication for triptan use. At the screening visit for the primary trial, a questionnaire was used by clinicians to record past and current use, and duration and order of use, of analgesics, nonsteroidal anti-inflammatory drugs (NSAIDs), ergot derivatives, and triptans; satisfaction with treatment was scored on a 5-point scale ranging from "very dissatisfied" to "very satisfied." RESULTS: Of 712 patients completing the questionnaire (mean [SD] age, 34 [10] years; range, 18-69 years), 75% were women and 94% experienced moderate or severe functional disability during migraine attacks. Analgesics were used by the majority of patients (81%) and for the longest mean [SD] duration (8.8 [7.6] years) but were associated with the least satisfaction (10% of patients "very satisfied" or "somewhat satisfied"). Triptans were used by the fewest patients (32%) and for the shortest mean duration (18 [1.6] years) but were associated with the highest rate of satisfaction (66%) compared with NSAIDs (27%) and ergot derivatives (31%). Regardless of duration or order of drug use, or sex or age of the patient, the likelihood of satisfaction with triptans was significantly greater (P < 0.001) than with nontriptan regimens, with an adjusted odds ratio (95% CI) of 16.8 (11.4-24.9) versus analgesics, 5.1 (3.6-7.1) versus NSAIDs, and 4.1 (2.8-6.0) versus ergot derivatives. CONCLUSIONS: Our results showed that analgesics, NSAIDs, and ergot derivatives were used for long durations but provided low satisfaction among patients. Triptans were rarely used as a first treatment choice; however, patients reported the highest treatment satisfaction scores after triptan therapy compared with ergot derivatives, NSAIDs, or analgesics.

Comparison of triptan tablet consumption per attack: a prospective study of migraineurs in Spain.

OBJECTIVES: To compare patient self-reported tablet consumption of rizatriptan 10 mg per attack (24 hours) with that of sumatriptan 50 mg, zolmitriptan 2.5 mg, and naratriptan 2.5 mg on an unselected, prescription-based, Spanish migraine population. METHODS: One hundred twenty community pharmacies recruited patients with migraine, who used their pharmacies, to fill a triptan prescription. In diaries, patients recorded baseline pain intensity and the number of triptan tablets and additional medication taken per attack. Patients treated a maximum of three attacks. Analysis of variance or the Student t test and chi-square or Fisher exact tests were used for univariate comparisons. Hochberg corrections were used for multiple-group comparisons. A generalized estimating equation method was used to correct for within-subject correlation. Adjusted odds ratios (ORs) and 95% confidence intervals (CIs) were calculated. RESULTS: Two hundred thirty-one patients (84% women) treated 589 evaluable migraine attacks (sumatriptan, n = 135; naratriptan, n = 90; zolmitriptan, n = 149; rizatriptan, n = 149). Triptan tablet consumption per attack (mean +/- SD) for rizatriptan (1.24 +/- 0.56) was significantly lower than that of sumatriptan (1.75 +/- 1.2; P< .05), zolmitriptan (1.61 +/- 0.86; P < .05), or naratriptan (1.46 +/- 0.62; P= .05). The average number of triptan tablets taken and additional medication use increased according to baseline pain severity. More attacks were treated with one tablet of rizatriptan (81.2%) than with one tablet of sumatriptan (51.9%), zolmitriptan (55.7%), or naratriptan (60%). The probability of using more than one triptan tablet per attack (24 hours) was more than three times greater for sumatriptan (adjusted OR = 3.71; CI, 2.05 to 6.7; P = .001) and zolmitriptan (adjusted OR = 3.32; CI, 1.82 to 6.17; P = .001), and more than two times greater for naratriptan (adjusted OR = 2.66; CI, 1.36 to 5.21; P =.004) than for rizatriptan. CONCLUSIONS: Rizatriptan was associated with significantly lower triptan tablet use and additional medication use per attack than the other triptans. Additional randomized studies are needed to confirm the conclusions of this study.

Factors influencing cyclosporine blood concentration-dose ratio.

OBJECTIVE: To analyze the trough cyclosporine concentration-dose ratio (CDR) and its relationship to some commonly available factors such as cyclosporine dosage, patient age, grade of obesity, posttransplant days, serum creatinine, serum bilirubin, and serum cholesterol by multiple linear regression. METHODS: The study was performed on 866 samples from 90 transplant recipients (25 kidney, 25 heart, 17 bone marrow, 13 liver, 10 simultaneous pancreas-kidney). RESULTS: The results show differences between transplants both in cyclosporine CDR variability (expressed by the coefficients of variation) and in the capability of those factors to explain this variability (expressed by the coefficient of determination). Coefficients of variation were 41% for the 866 samples (from 34% in heart to 55% in pancreas-kidney transplantation) and 28% for the 90 patients' CDR mean values (from 24% in heart to 32% in pancreas-kidney transplantation). All factors, except for the grade of obesity, were related to the cyclosporine CDR for all transplants as a whole. However, differences in the influence of each factor on each transplant were observed. The coefficient of determination based on significant factors was R2 = 0.25 for all samples (from 0.18 in pancreas-kidney to 0.52 in liver transplantation) and R2 = 0.53 for the patients' CDR means (from 0.39 in heart to 0.83 in kidney transplantation). CONCLUSIONS: We have quantified the cyclosporine CDR, its variability, and its relationship with some commonly available factors and found significant differences between transplant types. The equations of regression obtained might improve trough cyclosporine CDR estimation as a first step in cyclosporine dosage adjustment in kidney and liver transplant recipients.