Comorbid pain and migraine chronicity: The Chronic Migraine Epidemiology and Outcomes Study.

OBJECTIVE: To identify patterns of noncephalic pain comorbidity in people with episodic migraine (EM; <15 headache-days per month) and chronic migraine (CM; ≥15 headache-days per month) and to examine whether the presence of noncephalic pain is an indicator for the 3-month onset or persistence of CM. METHODS: Data from the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study, a prospective, web-based study with cross-sectional modules embedded in a longitudinal design, were analyzed at baseline and the 3-month follow-up. Relationships between the number of noncephalic pain sites and 3-month onset of CM or persistent CM were assessed. RESULTS: Of 8,908 eligible respondents, 8,139 (91.4%) had EM and 769 (8.6%) had CM at baseline. At 3 months, the incidence of CM among those with baseline EM was 3.4%. When adjusted for demographics and headache-day frequency, the odds of CM onset among those with baseline EM increased by 30% (95% confidence interval [CI] 1.21-1.40, p < 0.001) for each additional noncephalic pain site at baseline. Among those with CM at baseline, 50.1% had persistent CM at the 3-month follow-up. After adjustment for demographics, individuals with CM were 15% (95% CI 1.07-1.25, p < 0.001) more likely to have persistent CM for each additional noncephalic pain site at baseline. CONCLUSIONS: These results suggest that noncephalic pain may be a marker for headache chronicity that could be used to identify people with EM at risk of the onset of CM and people with CM at risk of persistent CM.

Gepirone extended-release treatment of anxious depression: evidence from a retrospective subgroup analysis in patients with major depressive disorder.

OBJECTIVE: To evaluate the efficacy and tolerability of gepirone extended-release (ER) tablets in patients with major depressive disorder (MDD) and high ratings of anxiety (anxious depression). METHOD: This subgroup analysis was derived from an 8-week, double-blind, placebo-controlled study of gepirone ER in patients with MDD. Male and female patients 18 to 69 years of age who met DSM-IV criteria for MDD and had high ratings of anxiety (Hamilton Rating Scale for Depression [HAM-D-17] total score > or = 20 and HAM-D-17 factor I [anxiety/somatization] score > 6) were included in this subgroup analysis. Eligible patients with anxious depression were randomly assigned to receive either placebo or gepirone ER, 20 mg to 80 mg daily. Patient assessments were performed at weeks 1, 2, 3, 4, 6, and 8. Treatment efficacy was evaluated by mean HAM-D-17 total scores and mean changes from baseline in (1) HAM-D-17 total scores, (2) HAM-D-17 factor I (anxiety/somatization) scores, and (3) HAM-D-17 item 12 (anxiety, psychic) scores. All statistical tests were 2-sided and considered statistically significant if the p value was <.05. Between-group comparisons were analyzed using least-squares analysis of variance on the change from baseline at each visit with the last observation carried forward (LOCF). The Cochran-Mantel-Haenszel test adjusting for center was also performed on the percentage of patients in each treatment group at each visit (LOCF) who met the response criterion on the HAM-D-17 (> or = 50% decrease from baseline) or remission criterion (HAM-D-17 total score < or = 7). RESULTS: Gepirone ER-treated patients (N = 58) experienced a statistically significant (p <.05) reduction in mean HAM-D-17 total score at week 3, 6, and 8 compared with placebo-treated patients (N = 75). A statistically significant effect (p <.05) in favor of gepirone ER was observed in mean change from baseline in HAM-D-17 total scores and for HAM-D factor I (anxiety/somatization) scores from week 2 onward. A statistically significant (p < or =.01) effect in favor of gepirone ER was observed in HAM-D-17 item 12 (anxiety, psychic) scores throughout the 8-week trial. There were significantly more patients in the gepirone ER group compared with the placebo group who were HAM-D-17 responders (p <.05) at endpoint and who met the criteria for HAM-D-17 remission at week 3 (p <.05) and weeks 6 and 8 (p <.01). Overall, gepirone ER was well tolerated, with rates of weight gain and sexual dysfunction comparable to placebo. Adverse events were generally mild to moderate. The most commonly reported adverse events were dizziness and nausea. CONCLUSIONS: Gepirone ER is an effective and well-tolerated treatment for patients with anxious depression.