Efficacy of galcanezumab in patients with migraine and history of failure to 3–4 preventive medication categories: subgroup analysis from CONQUER study

Abstract Background Chronic migraine (CM) and episodic migraine (EM) are associated with substantial headache-related disability, poor quality of life and global societal burden. In this subgroup analysis from the CONQUER study, we report efficacy outcomes from a pre-specified analysis of galcanezumab versus placebo in patients with CM or EM and 3–4 prior preventive medication category failures due to inadequate efficacy (after at least 2 months at maximum tolerated dose), or safety or tolerability reasons. The patient population is of particular interest due to evidence of decreased quality of life and increased economic burden among patients with migraine that is inadequately managed and is of interest to decision-makers globally. Methods Key outcomes included overall mean change from baseline in monthly migraine headache days and proportions of patients achieving ≥30% (CM), ≥50%, and ≥ 75% reduction (response rates) in monthly migraine headache days across Months 1–3. Patient functioning and disability were evaluated at Month 3. Results Of the 462 randomized patients, 186 (40.3%) had a history of 3–4 preventive category failures. Galcanezumab versus placebo resulted in significantly (P ≤ .001) larger overall mean reduction in monthly migraine headache days (total: − 5.49 versus − 1.03; CM: − 6.70 versus − 1.56; EM: − 3.64 versus − 0.65). Similarly, the ≥50% response rate was significantly (P ≤ .001) higher with galcanezumab versus placebo (total: 41.0 versus 12.7; CM: 41.5 versus 8.4; EM: 41.1 versus 16.5). In the CM group, the ≥30% response rate was significantly higher in the galcanezumab group than the placebo group (CM, 57.5 versus 19.8, P ≤ .0001) as was the ≥75% response rate (13.3 versus 2.6, P ≤ .05). Galcanezumab also resulted in significant (P < .0001) improvements in patient functioning and reductions in disability. Conclusions Galcanezumab was effective in a difficult-to-treat population of patients with CM or EM who had failed 3–4 prior preventive medication categories. Trial registration CONQUER. Clinicaltrials.gov identifier: NCT03559257.

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Shift from high-frequency to low-frequency episodic migraine in patients treated with Galcanezumab: results from two global randomized clinical trials

The Journal of Headache and Pain ◽

10.1186/s10194-021-01222-w ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Jakub Jedynak ◽

Eric Eross ◽

Astrid Gendolla ◽

Mallikarjuna Rettiganti ◽

Virginia L. Stauffer

Keyword(s):

Quality Of Life ◽

Migraine Headache ◽

Disease Burden ◽

Randomized Clinical Trials ◽

Low Frequency ◽

Episodic Migraine ◽

Double Blind ◽

Link Type ◽

Post Hoc

Abstract Background Patients with episodic migraine (EM) with a higher-frequency of migraine headache days (HFEM: 8–14 migraine headache days/month) have a greater disease burden and a higher risk of progressing to chronic migraine (CM) with associated acute treatment overuse versus those with low-frequency EM (LFEM: 4–7 migraine headache days/month). In this post hoc analysis, we assessed the proportions of patients who shifted from HFEM to LFEM and to very low-frequency EM (VLFEM: 0–3 migraine headache days/month) status following treatment with galcanezumab versus placebo. Methods EVOLVE-1 and EVOLVE-2 were double-blind, Phase 3 studies in patients with EM. Patients (18–65 years) were randomized (2:1:1) to subcutaneous monthly injections of placebo, galcanezumab 120 mg (240 mg loading dose) or 240 mg, for up to 6 months. Data were pooled and endpoints were change from baseline in number of migraine headache days/month and patients who shifted from HFEM to LFEM or VLFEM status. Impact of change in HFEM status on migraine headache days/month, quality of life and disability was also assessed. Results A total of 66% (1176/1773) patients from EVOLVE studies had HFEM status at baseline and were included in this analysis; placebo: 592, galcanezumab 120 mg: 294 and galcanezumab 240 mg: 290. At each month, both doses of galcanezumab resulted in a higher proportion of patients who shifted to 0–7 monthly headache days/month (VLFEM or LFEM status). Patients who shifted from HFEM at baseline to VLFEM status at Month 3, a relatively larger proportion of patients on galcanezumab 120 mg versus placebo remained at VLFEM status at Months 4–6; Months 4–5 for galcanezumab 240 mg versus placebo. Among the galcanezumab-treated patients who did-not-shift or shifted to LFEM or VLFEM status for ≥3 consecutive months until the end of the study, patients who shifted from HFEM to VLFEM status experienced the largest reduction in migraine headache days/month and the largest clinically meaningful improvements in daily functioning (MSQ-RFR) and disability (MIDAS). Conclusions In patients with HFEM, treatment with galcanezumab (120 mg and 240 mg) significantly reduced migraine headache days/month, maintained remission status at subsequent months until the end of the study, and improved patients’ quality of life versus placebo. Trial registration ClinicalTrials.gov Identifier: EVOLVE-1, NCT02614183; EVOLVE-2, NCT02614196.

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Preoperative Falls and Their Association with Functional Dependence and Quality of Life

Anesthesiology ◽

10.1097/aln.0000000000001167 ◽

2016 ◽

Vol 125 (2) ◽

pp. 322-332 ◽

Cited By ~ 5

Author(s):

Vanessa L. Kronzer ◽

Rose D. Tang ◽

Allison P. Schelble ◽

Arbi Ben Abdallah ◽

Troy S. Wildes ◽

...

Keyword(s):

Quality Of Life ◽

Odds Ratio ◽

Response Rate ◽

Elective Surgery ◽

Functional Dependence ◽

Age Groups ◽

Poor Quality ◽

Aged Patients ◽

History Of

Abstract Background No study has rigorously explored the characteristics of surgical patients with recent preoperative falls. Our objective was to describe the essential features of preoperative falls and determine whether they are associated with preoperative functional dependence and poor quality of life. Methods This was an observational study involving 15,060 surveys from adult patients undergoing elective surgery. The surveys were collected between January 2014 and August 2015, with a response rate of 92%. Results In the 6 months before surgery, 26% (99% CI, 25 to 27%) of patients fell at least once, and 12% (99% CI, 11 to 13%) fell at least twice. The proportion of patients who fell was highest among patients presenting for neurosurgery (41%; 99% CI, 36 to 45%). At least one fall-related injury occurred in 58% (99% CI, 56 to 60%) of those who fell. Falls were common in all age groups, but surprisingly, they did not increase monotonically with age. Middle-aged patients (45 to 64 yr) had the highest proportion of fallers (28%), recurrent fallers (13%), and severe fall-related injuries (27%) compared to younger (18 to 44 yr) and older (65+ yr) patients (P < 0.001 for each). A fall within 6 months was independently associated with preoperative functional dependence (odds ratio, 1.94; 99% CI, 1.68 to 2.24) and poor physical quality of life (odds ratio, 2.18; 99% CI, 1.88 to 2.52). Conclusions Preoperative falls might be common and are possibly often injurious in the presurgical population, across all ages. A history of falls could enhance the assessment of preoperative functional dependence and quality of life.

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Pharmacotherapy of migraine prevention based on the assessment of headache

Journal of Korean Medical Association ◽

10.5124/jkma.2020.63.10.644 ◽

2020 ◽

Vol 63 (10) ◽

pp. 644-649

Author(s):

Hee-Ji Im ◽

Soo-Jin Cho

Keyword(s):

Quality Of Life ◽

Preventive Intervention ◽

Beta Blockers ◽

Position Statement ◽

Episodic Migraine ◽

Reproductive Age ◽

Migraine Prevention ◽

Improve Quality ◽

Preventive Medication

Migraine as a recurrent, relapsing, and chronic disease is one of the most disabling disorders globally. Most patients are women in their reproductive age and their migraines are classified as episodic migraine. Although less than half of the episodic and most chronic migraineurs require preventive intervention, early discontinuation rates are high, owing to poor tolerability and insufficient awareness about migraine. This article aims to review the recent update of migraine prevention based on the practice guidelines for the prevention of episodic migraine published by the Korea Headache Society and the position statement of the American Headache Society in 2019. The goal of migraine prevention is to reduce migraine attack frequency by at least 50 %, the number of migraine days, and the attack severity to ultimately improve quality of life. The guidelines recommend considering the initiation of preventive medication when recurring migraines significantly interfere with daily life or when acute treatment is contraindicated or inappropriate. Preventive medications should be determined based on various qualified assessments. Pharmacologic treatments are recommended for migraine prophylaxis include antidepressant (amitriptyline), anti-epileptic drugs (topiramate, divalproex sodium), beta-blockers (propranolol, metoprolol), calcium channel blocker (flunarizine), and intramuscular injection of onabotulinumtoxin A. Furthermore subcutaneous or intravenous injection of calcitonin gene-related peptide monoclonal antibodies was recently approved as a new therapy for migraine prevention. Migraine is a chronic debilitating disorder. The initiation of evidence-based preventive management is necessary and management methods should be individually selected to improve quality of life.

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Faculty Opinions recommendation of Measuring quality of life in women with endometriosis: tests of data quality, score reliability, response rate and scaling assumptions of the Endometriosis Health Profile Questionnaire.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.1058951.510906 ◽

2007 ◽

Author(s):

Thomas d'Hooghe

Keyword(s):

Quality Of Life ◽

Data Quality ◽

Response Rate ◽

Quality Score ◽

Health Profile ◽

Score Reliability

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Faculty Opinions recommendation of Late complications and long-term quality of life for survivors (>5 years) with history of head and neck cancer.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.717952796.793457670 ◽

2012 ◽

Author(s):

Giulio Cantu ◽

Madia Pompilio ◽

Paolo Formillo

Keyword(s):

Quality Of Life ◽

Head And Neck Cancer ◽

Head And Neck ◽

Neck Cancer ◽

Late Complications ◽

History Of

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Patients With a History of Oronasal Fistula Repair Exhibit Lower Oral Health Measured With Patient-Centric Outcomes Measures

The Cleft Palate-Craniofacial Journal ◽

10.1177/1055665620981331 ◽

2020 ◽

pp. 105566562098133

Author(s):

Alyssa Fritz ◽

Diana S. Jodeh ◽

Fatima Qamar ◽

James J. Cray ◽

S. Alex Rottgers

Keyword(s):

Quality Of Life ◽

Oral Health ◽

Cleft Palate ◽

Fistula Repair ◽

Old Patients ◽

Oronasal Fistula ◽

Patient Reported ◽

History Of ◽

The Impact

Introduction: Oronasal fistulae following palatoplasty may affect patients’ quality of life by impacting their ability to eat, speak, and maintain oral hygiene. We aimed to quantify the impact of previous oronasal fistula repair on patients’ quality of life using patient-reported outcome psychometric tools. Methods: A cross-sectional study of 8- to 9-year-old patients with cleft palate and/or lip was completed. Patients who had a cleft team clinic between September 2018 and August 2019 were recruited. Participants were divided into 2 groups (no fistula, prior fistula repair). Differences in the individual CLEFT-Q and Child Oral Health Impact Profile-Short Form 19 (COHIP-SF 19) Oral Health scores between the 2 groups were evaluated using a multivariate analysis controlling for Veau classification and syndromic diagnosis. Results: Sixty patients with a history of cleft palate were included. Forty-two (70%) patients had an associated cleft lip. Thirty-two (53.3%) patients had no history of fistula and 28 (46.7%) patients had undergone a fistula repair. CLEFT-Q Dental, Jaw, and Speech Function were all higher in patients without a history of a fistula repair; however, none of these differences were statistically significant. The COHIP-SF 19 Oral Health score demonstrated a significantly lower score in the fistula group, indicating poorer oral health ( P = .05). Conclusions: One would expect that successful repair of a fistula would result in improved function and patient satisfaction, but the consistent trend toward lower CLEFT-Q scores and significantly increased COHIP-SF 19 Oral Health scores in our study group suggests that residual effects linger and that the morbidity of a fistula may not be completely treated with a secondary correction.

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Health-related quality of life in tension-type headache: a population-based study

Scandinavian Journal of Pain ◽

10.1515/sjpain-2020-0166 ◽

2021 ◽

Vol 0 (0) ◽

Cited By ~ 1

Author(s):

Sait Ashina ◽

Dawn C. Buse ◽

Jakob B. Bjorner ◽

Lars Bendtsen ◽

Ann C. Lyngberg ◽

...

Keyword(s):

Quality Of Life ◽

Episodic Migraine ◽

Tension Type Headache ◽

Eysenck Personality Questionnaire ◽

Health Related Quality ◽

Self Rated Health ◽

Related Quality ◽

Health Related ◽

Type Headache

Abstract Objectives Tension-type headache (TTH) is the most prevalent primary headache disorder. We assessed the cross-sectional impact of TTH on health related quality of life (HRQoL) in a general population. We also examined the association of HRQoL scores with headache frequency, disability, medication overuse, poor self-rated health, psychiatric comorbidity, and pain sensitivity in individuals with TTH. Methods A sample of 547 subjects completed a headache diagnostic interview, the SF-12 to calculate physical (PCS) and mental (MCS) health component scores, depression (major depression inventory [MDI]) and neuroticism (Eysenck Personality Questionnaire) measures. We defined the following headache diagnosis categories: pure TTH, pure migraine, and coexistent headache (TTH + migraine). Cases were further classified into chronic (≥15) or episodic (<15 headache days/month). Results Using generalized linear models (GLM) adjusted for age, sex and education, both PCS-12 and MCS-12 scores varied in groups distinguished by migraine and TTH status; scores were lower for individuals with coexistent headache (TTH + migraine; n=83), followed by pure TTH (n=97) and pure migraine (n=43) compared to the no headache group (n=324) (p≤0.001). In analyses considering chronicity, PCS-12 scores were lower in chronic coexistent headache followed by pure chronic TTH (CTTH), episodic migraine +/− episodic TTH (ETTH) and pure ETTH than in the no headache group (p≤0.001). MCS-12 scores were lower in pure CTTH, followed by chronic coexistent headache, episodic migraine +/− ETTH and pure ETTH compared to the no headache group (p≤0.001). Multiple regression models showed that in TTH, lower PCS-12 scores were associated with age (p=0.04), female sex (p=0.02), and poor self-rated health (p≤0.001). Lower MCS-12 scores in TTH were associated with depression (p≤0.001). Conclusions In a population sample, TTH, and to higher degree CTTH, are associated with decreased HRQoL.

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Efficacy and safety of Si-Jun-Zi-Tang-based therapies for functional (non-ulcer) dyspepsia: a meta-analysis of randomized controlled trials

BMC Complementary Medicine and Therapies ◽

10.1186/s12906-020-03176-z ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Yaping Wang ◽

Bin Liu ◽

Xiuqiong Fu ◽

Tiejun Tong ◽

Zhiling Yu

Keyword(s):

Relapse Rate ◽

Large Scale ◽

Primary Outcome ◽

Response Rate ◽

Meta Analysis ◽

Risk Of Bias ◽

Efficacy And Safety ◽

History Of ◽

Non Ulcer Dyspepsia

Abstract Background The traditional Chinese medicine formula Si-Jun-Zi-Tang (SJZT) has a long history of application in the treatment of functional dyspepsia (non-ulcer dyspepsia, FD)-like symptoms. SJZT-based therapies have been claimed to be beneficial in managing FD. This study aimed to assess the efficacy and safety of SJZT-based therapies in treating FD by meta-analysis. Methods Systematic searches for RCTs were conducted in seven databases (up to February 2019) without language restrictions. Data were analyzed using Cochrane RevMan software version 5.3.0 and Stata software version 13.1, and reported as relative risk (RR) or odds ratio (OR) with 95% confidence intervals (CIs). The primary outcome was response rate and the secondary outcomes were gastric emptying, quality of life, adverse effects and relapse rate. The quality of evidence was evaluated according to criteria from the Cochrane risk of bias. Results A total of 341 potentially relevant publications were identified, and 12 RCTs were eligible for inclusion. For the response rate, there was a statically significant benefit in favor of SJZT-based therapies (RR = 1.23; 95% CI 1.17 to 1.30). However, the benefit was limited to modified SJZT (MSJZT). The relapse rate of FD patients received SJZT-based therapies was lower than that of patients who received conventional medicines (OR = 0.23; 95% CI 0.10 to 0.51). No SJZT-based therapies-related adverse effect was reported. Conclusion SJZT-based prescriptions may be effective in treating FD and no serious side-effects were identified, but the effect on response rate appeared to be limited to MSJZT. The results should be interpreted with caution as all the included studies were considered at a high risk of bias. Standardized, large-scale and strictly designed RCTs are needed to further validate the benefits of SJZT-based therapies for FD management. Trial registration Systematic review registration: [PROSPERO registration: CRD42019139136].

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