PMC:7507645 / 25949-28290 JSONTXT

{"project":"TEST0","denotations":[{"id":"32958075-238-243-1506680","span":{"begin":1103,"end":1104},"obj":"[\"21464078\"]"},{"id":"32958075-216-222-1506681","span":{"begin":1323,"end":1325},"obj":"[\"20164501\"]"},{"id":"32958075-220-226-1506682","span":{"begin":1327,"end":1329},"obj":"[\"27615418\"]"}],"text":"Notable differences were observed between patients with and without MO at baseline, including several differences in disease characteristics. By definition, monthly number of days using acute headache medication differed between subgroups. The defining feature of the subgroups may also underlie the differences in monthly number of headache days of at least moderate severity and migraine days, because a day with acute migraine-specific medication use to treat a headache of any severity or duration was included in the count for these variables. Disease characteristics that did not notably differ at baseline included levels of disability, quality of life, and depression as measured by HIT-6, MSQoL domain, and PHQ-9 scores, respectively. Previous studies have shown that patients with chronic daily headache (CDH; an umbrella term that encompasses CM) and MO have more disability and quality-of-life impairment compared with patients with CDH without MO; however, because these studies looked at MO in a heterogenous group of headache disorders, they may not be generalizable to patients with CM [1]. Similarly to CM, medication overuse headache, a secondary headache attributable to MO, is associated with psychiatric comorbidities such as depression, although whether it could be a cause or an effect is not known [23, 24]. Baseline characteristics in this study suggest that MO does not increase the severity of depression in patients with CM. The impact of fremanezumab on disability, quality of life, and depression was positive in patients with and without MO, with significant differences from placebo observed for HIT-6 and MSQoL domain scores. PHQ-9 scores were reduced from baseline; however, only the reduction among patients without MO in the fremanezumab quarterly group reached statistical significance. A greater difference over placebo may not have been observed due to the majority of patients (69.1% to 79.2%) already having PHQ-9 scores in the no to minimal depression range (R.B. Lipton, unpublished data, 2019), creating a floor effect. In a separate subgroup analysis of patients in this population with moderate to severe depression, reductions in mean PHQ-9 scores were numerically greater, although not statistically significant, potentially due to the modest sample size (R.B. Lipton, unpublished data, 2019)."}

{"project":"2_test","denotations":[{"id":"32958075-21464078-60560887","span":{"begin":1103,"end":1104},"obj":"21464078"},{"id":"32958075-20164501-60560888","span":{"begin":1323,"end":1325},"obj":"20164501"},{"id":"32958075-27615418-60560889","span":{"begin":1327,"end":1329},"obj":"27615418"}],"text":"Notable differences were observed between patients with and without MO at baseline, including several differences in disease characteristics. By definition, monthly number of days using acute headache medication differed between subgroups. The defining feature of the subgroups may also underlie the differences in monthly number of headache days of at least moderate severity and migraine days, because a day with acute migraine-specific medication use to treat a headache of any severity or duration was included in the count for these variables. Disease characteristics that did not notably differ at baseline included levels of disability, quality of life, and depression as measured by HIT-6, MSQoL domain, and PHQ-9 scores, respectively. Previous studies have shown that patients with chronic daily headache (CDH; an umbrella term that encompasses CM) and MO have more disability and quality-of-life impairment compared with patients with CDH without MO; however, because these studies looked at MO in a heterogenous group of headache disorders, they may not be generalizable to patients with CM [1]. Similarly to CM, medication overuse headache, a secondary headache attributable to MO, is associated with psychiatric comorbidities such as depression, although whether it could be a cause or an effect is not known [23, 24]. Baseline characteristics in this study suggest that MO does not increase the severity of depression in patients with CM. The impact of fremanezumab on disability, quality of life, and depression was positive in patients with and without MO, with significant differences from placebo observed for HIT-6 and MSQoL domain scores. PHQ-9 scores were reduced from baseline; however, only the reduction among patients without MO in the fremanezumab quarterly group reached statistical significance. A greater difference over placebo may not have been observed due to the majority of patients (69.1% to 79.2%) already having PHQ-9 scores in the no to minimal depression range (R.B. Lipton, unpublished data, 2019), creating a floor effect. In a separate subgroup analysis of patients in this population with moderate to severe depression, reductions in mean PHQ-9 scores were numerically greater, although not statistically significant, potentially due to the modest sample size (R.B. Lipton, unpublished data, 2019)."}