scholarly journals Fremanezumab in the Prevention of High-Frequency Episodic and Chronic Migraine: A 12-Week, Multicenter, Real-Life, Cohort Study (The FRIEND Study).

2021 ◽  
Author(s):  
Piero Barbanti ◽  
Gabriella Egeo ◽  
Cinzia Aurilia ◽  
Florindo d'Onofrio ◽  
Maria Albanese ◽  
...  
Keyword(s):  
Chronic Migraine ◽  
High Frequency ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Real Life ◽  
Drug Effects ◽  
Episodic Migraine ◽  
Primary Study ◽  
Life Study ◽  
Younger Age

Abstract Background Fremanezumab has demonstrated to be effective, safe, and tolerated in the prevention of episodic or chronic migraine (CM) in randomized, placebo-controlled trials (RCTs). Real-life studies are needed to explore drug effects in unselected patients in routine circumstances and to provide higher generalizability results. This study explores the effectiveness, safety, and tolerability of fremanezumab in a real-life population of individuals affected by high-frequency episodic (HFEM: 8-14 days/month) or CM. Methods This is a 12-week multicenter, prospective, cohort, real-life study. We considered all consecutive patients affected by HFEM or CM visited at 9 Italian headache centers from 28/07/2020 to 11/11/2020. Eligible patients were given subcutaneous fremanezumab at the doses of 225 mg monthly or 675 mg quarterly, according to their preference. Primary study endpoints were the change in monthly migraine days (MMDs) in HFEM and monthly headache days (MHDs) in CM patients at weeks 9-12 compared to baseline. Secondary endpoints encompassed variation in monthly analgesic intake (MAI), Numerical Rating Scale (NRS), HIT-6 and MIDAS scores, and ≥50%, ≥75% and 100% responder rates at the same time intervals. Results 67 migraine patients had received ≥1 subcutaneous fremanezumab dose and were considered for safety analysis, while 53 patients completed 12 weeks of treatment and were included also in the effectiveness analysis. Fremanezumab was effective in both HFEM and CM, inducing at week 12 a significant reduction in MMDs (-4.6, p<0.05), MHDs (-9.4, p<0.001), MAI (-5.7, p<0.05; -11.1, p<0.001), NRS (-3.1, p<0.001; -2.5, p<0.001), and MIDAS scores (-58.3, p<0.05; -43.7; p<0.001). HIT-6 was significantly reduced only in HFEM patients (-18.1, p<0.001). Remission from CM to episodic migraine and from MO to no-MO occurred in 75% and 67.7% of the patients. The ≥50%, ≥75% and 100% responder rates at week 12 were 76.5%, 29.4% and 9.9% in HFEM and 58.3%, 25% and 0% in CM. Younger age emerged as a positive response predictor (OR=0.91; 95% CI 0.85-0.98, p=0.013). Treatment-emergent adverse events were uncommon (5.7%) and mild. No patient discontinued fremanezumab for any reason. Conclusions Fremanezumab seems more effective in real-life than in RCTs. Younger age emerges as a potential response predictor.

scholarly journals Galcanezumab for the prevention of high frequency episodic and chronic migraine in real life in Italy: a multicenter prospective cohort study (the GARLIT study)

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Fabrizio Vernieri ◽  
◽  
Claudia Altamura ◽  
Nicoletta Brunelli ◽  
Carmelina Maria Costa ◽  
...  
Keyword(s):  
Cohort Study ◽  
Chronic Migraine ◽  
High Frequency ◽  
Randomized Clinical Trials ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Real Life ◽  
Episodic Migraine ◽  
Normal Weight ◽  
Link Type

Abstract Background The clinical benefit of galcanezumab, demonstrated in randomized clinical trials (RCTs), remains to be quantified in real life. This study aimed at evaluating the effectiveness, safety and tolerability of galcanezumab in the prevention of high-frequency episodic migraine (HFEM) and chronic migraine (CM) in a real-life setting. Methods This multicenter prospective observational cohort study was conducted between November 2019 and January 2021 at 13 Italian headache centers. Consecutive adult HFEM and CM patients clinically eligible were enrolled and treated with galcanezumab subcutaneous injection 120 mg monthly with the first loading dose of 240 mg. The primary endpoint was the change in monthly migraine days (MMDs) in HFEM and monthly headache days (MHDs) in CM patients after 6 months of therapy (V6). Secondary endpoints were the Numerical Rating Scale (NRS), monthly painkiller intake (MPI), HIT-6 and MIDAS scores changes, ≥50% responder rates (RR), the conversion rate from CM to episodic migraine (EM) and Medication Overuse (MO) discontinuation. Results One hundred sixty-three patients (80.5% female, 47.1 ± 11.7 years, 79.8% CM) were included. At V6, MMDs reduced by 8 days in HFEM and MHDs by 13 days in CM patients (both p < .001). NRS, MPI, HIT-6 and MIDAS scores significantly decreased (p < .001). Ten patients (6.1%) dropped out for inefficacy and classified as non-responders. Patients with ≥50%RRs, i.e. responders, were 76.5% in the HFEM and 63.5% in the CM group at V6. Among CM patients, the V6 responders presented a lower body mass index (p = .018) and had failed a lower number of preventive treatments (p = .013) than non-responders. At V6, 77.2% of CM patients converted to EM, and 82.0% ceased MO. Adverse events, none serious, were reported in up to 10.3% of patients during evaluation times. Conclusions Galcanezumab in real life was safe, well tolerated and seemed more effective than in RCTs. Normal weight and a low number of failed preventives were positively associated with galcanezumab effectiveness in CM patients. Trial registration ClinicalTrials.govNCT04803513.

scholarly journals Conversion From Chronic To Episodic Migraine In Patients Treated With Erenumab: Real-Life Data From An Italian Region

2020 ◽  
Author(s):  
Raffaele Ornello ◽  
Alfonsina Casalena ◽  
Ilaria Frattale ◽  
Valeria Caponnetto ◽  
Amleto Gabriele ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Central Italy ◽  
Real Life ◽  
Episodic Migraine ◽  
Main Body ◽  
Life Study ◽  
Headache Intensity ◽  
Acute Medication

Abstract Background. Most patients treated with erenumab in clinical practice have chronic migraine (CM). We assessed the rate and possible predictors of conversion from CM to episodic migraine (EM) in a real-life study.Main body. We performed a subgroup analysis of patients treated with erenumab from January 2019 to February 2020 in the Abruzzo region, central Italy. Treatment was provided according to current clinical practice. For the purpose of the present study, we included patients fulfilling the definition of CM for the three months preceding erenumab treatment and with at least 6 months of follow-up after treatment. We assessed the rate of conversion to EM from baseline to Months 4-6 of treatment and during each month of treatment. To test the clinical validity of conversion to EM, we also assessed the decrease in monthly headache days (MHDs), acute medication days, and median headache intensity on a Numerical Rating Scale (NRS). We included in our study 91 patients with CM. At Months 4-6, 62 patients (68.1%) converted from CM to EM; the proportion of converters increased from Month 1 to Month 5. In the overall group of patients, median MHDs decreased from 26.5 (IQR 20-30) to 7.5 (IQR 5-16; P<0.001) compared with baseline, while median acute medication days decreased from 21 (IQR 16-30) to 6 (IQR 3-10; P<0.001) and median NRS scores decreased from 8 (IQR 7-9) to 6 (IQR 4-7; P<0.001). Significant decreases were found both in converters and in non-converters. We found no significant predictors of conversion to EM among the patients’ baseline characteristics.Conclusions. In our study, two thirds of patients with CM converted to EM during 6 months of treatment with erenumab. MHDs, acute medication use, and headache intensity decreased regardless of conversion from CM to EM.

scholarly journals Conversion From Chronic to Episodic Migraine in Patients Treated With Erenumab: Real-life Data From an Italian Region

2020 ◽  
Author(s):  
Raffaele Ornello ◽  
Alfonsina Casalena ◽  
Ilaria Frattale ◽  
Valeria Caponnetto ◽  
Amleto Gabriele ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Central Italy ◽  
Real Life ◽  
Episodic Migraine ◽  
Headache Intensity ◽  
Acute Medication ◽  
Numerical Rating ◽  
Definition Of

Abstract BackgroundMost patients treated with erenumab in clinical practice have chronic migraine (CM). We assessed the rate and possible predictors of conversion from CM to episodic migraine (EM) in a real-life study.Main bodyWe performed a subgroup analysis of patients treated with erenumab from January 2019 to February 2020 in the Abruzzo region, central Italy. Treatment was provided according to current clinical practice. For the purpose of the present study, we included patients fulfilling the definition of CM for the three months preceding erenumab treatment and with at least 6 months of follow-up after treatment. We assessed the rate of conversion to EM from baseline to Months 4–6 of treatment and during each month of treatment. To test the clinical validity of conversion to EM, we also assessed the decrease in monthly headache days (MHDs), acute medication days, and median headache intensity on a Numerical Rating Scale (NRS). We included in our study 91 patients with CM. At Months 4–6, 62 patients (68.1%) converted from CM to EM; the proportion of converters increased from Month 1 to Month 5. In the overall group of patients, median MHDs decreased from 26.5 (IQR 20–30) to 7.5 (IQR 5–16; P < 0.001) compared with baseline, while median acute medication days decreased from 21 (IQR 16–30) to 6 (IQR 3–10; P < 0.001) and median NRS scores decreased from 8 (IQR 7–9) to 6 (IQR 4–7; P < 0.001). Significant decreases were found both in converters and in non-converters. We found no significant predictors of conversion to EM among the patients’ baseline characteristics.ConclusionsIn our study, two thirds of patients with CM converted to EM during 6 months of treatment with erenumab. MHDs, acute medication use, and headache intensity decreased regardless of conversion from CM to EM.

Acupuncture for Low Back Pain in Pregnancy – a Prospective, Quasi- Randomised, Controlled Study

2004 ◽  
Vol 22 (2) ◽  
pp. 60-67 ◽  
Author(s):  
João Bosco Guerreiro da Silva ◽  
Mary Uchiyama Nakamura ◽  
José Antonio Cordeiro ◽  
Luiz Kulay
Keyword(s):  
Pelvic Pain ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Real Life ◽  
Acupuncture Group ◽  
Controlled Study ◽  
Control Group ◽  
Study Group ◽  
Low Back ◽  
Average Pain

This study was undertaken to investigate the effects of acupuncture in low back and pelvic pain during pregnancy under real life conditions, as compared with patients undergoing conventional treatment alone. A total of 61 conventionally treated pregnant women were allocated randomly into two groups to be treated or not by acupuncture. Twenty-seven patients formed the study group and 34 the control group. They reported the severity of pain using a Numerical Rating Scale from 0 to 10, and their capacity to perform general activities, to work, and to walk. We also assessed the use of analgesic drugs. Women were followed up for eight weeks and interviewed five times, at two-week intervals. All women completed the study. In the study group the average pain during the study period showed a larger reduction (4.8 points) than the control group (−0.3 points) (P<0.0001). Average pain scores decreased by at least 50% over time in 21 (78%) patients in the acupuncture group and in five (15%) patients in the control group (P<0.0001). Maximum pain and pain at the moment of interview were also less in the acupuncture group compared with the control group. The capacity to perform general activities, to work and to walk was improved significantly more in the study group than in the control group (P<0.05). The use of paracetamol was lower in the acupuncture group (P<0.01). These results indicate that acupuncture seems to alleviate low back and pelvic pain during pregnancy, as well as to increase the capacity for some physical activities and to diminish the need for drugs, which is a great advantage during this period.

The clinical and public health implications and risks of widening the definition of chronic migraine

Cephalalgia ◽  
2019 ◽  
Vol 40 (4) ◽  
pp. 407-410 ◽  
Author(s):  
Martina Guglielmetti ◽  
Alberto Raggi ◽  
Raffaele Ornello ◽  
Simona Sacco ◽  
Domenico D’Amico ◽  
...  
Keyword(s):  
Public Health ◽  
Chronic Migraine ◽  
High Frequency ◽  
Episodic Migraine ◽  
Headache Frequency ◽  
Allocation Of Resources ◽  
Independent Entity ◽  
Definition Of ◽  
The Impact

Background The definition of chronic migraine has long been debated. Recently, it was suggested to define subjects with at least 8/migraine days as chronic migraine; that is, incorporating so-called high frequency episodic migraine (eight or more migraine days but less than 15 headache days per month). Methods We addressed the possible problems that might arise based on this proposal accounting for clinical, pathophysiological, impact and public health aspects. Results and conclusions Defining chronic migraine on the basis of headache frequency alone does not account for clinical and pathophysiological aspects, as well as for the impact of chronic migraine in terms of disability and quality of life. Moreover, it is potentially harmful for patients in terms of allocation of resources. These issues are discussed in the present manuscript, and we support the idea of defining high frequency episodic migraine as an independent entity as a viable path to follow.

When does chronic migraine strike? A clinical comparison of migraine according to the headache days suffered per month

Cephalalgia ◽  
2016 ◽  
Vol 37 (2) ◽  
pp. 104-113 ◽  
Author(s):  
M Torres-Ferrús ◽  
M Quintana ◽  
J Fernandez-Morales ◽  
J Alvarez-Sabin ◽  
P Pozo-Rosich
Keyword(s):  
Chronic Migraine ◽  
High Frequency ◽  
Daily Life ◽  
Low Frequency ◽  
Episodic Migraine ◽  
Predictive Capacity ◽  
The Poor ◽  
Clinical Comparison ◽  
Current Classification ◽  
Poor Outcomes

Introduction According to the IHCD-3β classification, chronic migraine (CM) is headache occurring on 15 or more days/month. Episodic migraine (EM) can be divided into low frequency (LFEM) and high frequency (HFEM) depending on the headache days suffered per month. Methods We performed a clinical comparison of migraine characteristics according to monthly headache days suffered. Patients were divided into three groups: LFEM (1–9 headache days/month), HFEM (10–14 headache days/month) and CM (≥15 headache days/month). Results The analysis included 1109 patients. Previously reported differences between EM and CM were replicated. However, there were three times more clinical differences between LFEM and HFEM than between HFEM and CM (15 vs. 6). A new model that takes 10 headache days as a cut-off value for CM would have a minimally higher predictive capacity (72.8%) and no statistical differences (71.8%) when comparing it to the current classification. Conclusions HFEM patients have few clinical differences compared with CM patients. This includes the poor outcomes regarding headache-related disability and impact on daily life. According to these findings, neurologists and headache specialists should consider that the emotional and functional impact in HFEM patients could be as disabling as in those with CM.

Acupuncture for Insomnia in Pregnancy – a Prospective, Quasi-Randomised, Controlled Study

2005 ◽  
Vol 23 (2) ◽  
pp. 47-51 ◽  
Author(s):  
João Bosco Guerreiro da Silva ◽  
Mary Uchiyama Nakamura ◽  
José Antonio Cordeiro ◽  
Luiz Kulay
Keyword(s):  
Pregnant Women ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Real Life ◽  
Controlled Study ◽  
Control Group ◽  
Study Group ◽  
Randomised Controlled Study ◽  
Numerical Rating ◽  
Randomised Controlled

Objective This study was undertaken to test the effects of acupuncture on insomnia in a group of pregnant women under real life conditions, and to compare the results with a group of patients undergoing conventional treatment alone (sleep hygiene). Methods A total of 30 conventionally treated pregnant women were allocated at random into groups with or without acupuncture. Seventeen patients formed the study group and 13 the control group. The pregnant women scored the severity of insomnia using a Numerical Rating Scale from 0 to 10. Women were followed up for eight weeks and interviewed five times, at two-week intervals. Results Eight women dropped out, five in the study group and three in the control group. The study group reported a larger reduction on insomnia rating (5.1) than the control group (0.0), a difference which was statistically significant (P=0.0028). Average insomnia scores decreased by at least 50% over time in nine (75%) patients in the study group and in three (30%) of the control group. Conclusion The results of this study suggest that acupuncture alleviates insomnia during pregnancy and further research is justified.

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