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.

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.

Results in clinical practice in the treatment of severe eosinophilic asthma with mepolizumab: a real-life study

2021 ◽  
pp. 1-7
Author(s):  
Ana Isabel Enríquez-Rodríguez ◽  
Tamara Hermida Valverde ◽  
Pedro Romero Álvarez ◽  
Francisco Julián López-González ◽  
Jose Antonio Gullón Blanco ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Real Life ◽  
Eosinophilic Asthma ◽  
Life Study ◽  
Severe Eosinophilic Asthma ◽  
Real Life Study

scholarly journals Effectiveness of Neck Myofascial Release Techniques and Exercise Therapy on Pain Intensity and Disability in Patients with Chronic Tension-Type Headache

2016 ◽  
Vol 9 (6) ◽  
pp. 47
Author(s):  
Mohammad Hosseinifar ◽  
Razieh Bazghandi ◽  
Zahra Azimi ◽  
Bahareh Khodadadi Bohlouli
Keyword(s):  
Pain Intensity ◽  
Exercise Therapy ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Tension Type Headache ◽  
Control Group ◽  
Myofascial Release ◽  
Headache Intensity ◽  
Headache Disability ◽  
Type Headache

PURPOSE: Tension type headache (TTH) is one of the most prevalent types of headache. TTH is classified as episodic if it occurs on less than 15 days a month and as chronic if it occurs more often. Tension, anxiety and depression are some etiological factors for TTH which leads to work efficiency reduction. Today the interest in non-pharmacological methods is increasing; massage is one of these approaches which has no side effects. Aim of this study was to investigate the effects of neck Myofascial Release (MFR) techniques and exercise therapy on pain intensity and disability in patients with chronic tension-type headache.METHODS: This randomized clinical trial study was investigated on 30 females suffering from TTH. Participants were randomly assigned into two equal groups (n=15). The MFR group received neck MFR massage and exercise therapy four times a week for 3 weeks, each session lasting 45 minutes. Control group had no intervention. Outcomes were headache intensity and disability measured by numerical rating scale (NRS) and headache disability index (HDI), respectively. Data was analysed through independent and pair t-test.RESULTS: Between group comparison showed significant improvement of headache intensity and disability rate in MFR group (p<0.05) than control group (p=0.000).DISCUSSION: This study provides evidences that MFR technique and exercise therapy have significant effect on patients with TTH.

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.

scholarly journals AB0963 HOW OFTEN DO DOCTORS TREAT PATIENTS WITH LOCAL DAMAGE TO THE PERIARTICULAR SOFT TISSUES IN REAL CLINICAL PRACTICE?

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1778.2-1778
Author(s):  
A. Karateev ◽  
A. Lila ◽  
N. Zagorodniy ◽  
E. Pogozheva
Keyword(s):  
Clinical Practice ◽  
Soft Tissues ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Clinical Manifestations ◽  
Treatment Result ◽  
The Third ◽  
Orthopedic Surgeons ◽  
Acute Injuries ◽  
Real Clinical Practice

Background:Damage of the periarticular soft tissues (DPST) - tendinitis, entesitis, bursitis, etc. are one of the most common reasons for patients to contact rheumatologists and orthopedic surgeons.Objectives:To evaluate the frequency and localization of DPST in real clinical practice, as well as the effectiveness of therapy for this pathology in the acute period.Methods:68 outpatient orthopaedic surgeons evaluated the frequency of initial patient recourse due to DPST within one month. The study did not include patients with systemic rheumatic diseases such as spondyloarthritis. The localization of DPST and the dynamics of clinical manifestations were evaluated in 1227 patients (women 42.5%, cf. age 51.3±15.5 years). Non-steroidal anti-inflammatory drugs (NSAIDs), mainly meloxicam, were used as a first-line treatment for DPST. The results of treatment were evaluated after 10-14 days with repeated visits of patients.Results:7766 cases of primary outpatient treatment by orthopedic surgeons were evaluated. DPST was the cause of treatment in 1227 (15.8%) patients. This was the third highest incidence after acute injuries (37.2%) and knee osteoarthritis (20.6%).In patients with DPST, the most common lesions were in the knee area (knee entesopathy, prepatellar bursitis, pes anserinus area tendinitis/bursitis) - 21.2%, the foot (plantar fasciitis) - 16.9%, the shoulder (tendinitis of the rotator cuff) – 16.4%, and the elbow (lateral and medial epicondylitis) - 15.3%. After treatment, there was a significant decrease in the severity of pain during movement – from 6.58±1.61 to 2.48±1.60 points on the numerical rating scale (p<0.001), a decrease in the intensity of pain at rest, at night and during palpation, as well as the severity of functional disorders. The need for local injection of glucocorticoids occurred in 22.1% of patients. Significant improvement was observed in all DPST localities, with 68.1% of patients rating the treatment result as “good” and “excellent”. Adverse reactions were observed in 15.0% of patients, and no serious complications were reported.Conclusion:DPST is the third most frequent reason of recourse to a doctor after acute injuries and osteoarthritis of large joints in the practice of outpatient orthopedic surgeons. The use of NSAIDs in the maximum therapeutic dose for 10-14 days allows for significant improvement in DPST of different localization.Disclosure of Interests:None declared

scholarly journals Daily Practice Managing Resistant Multiple Sclerosis Spasticity With Delta-9-Tetrahydrocannabinol: Cannabidiol Oromucosal Spray: A Systematic Review of Observational Studies

2019 ◽  
Vol 11 ◽  
pp. 117957351983199 ◽  
Author(s):  
Katja Akgün ◽  
Ute Essner ◽  
Cordula Seydel ◽  
Tjalf Ziemssen
Keyword(s):  
Multiple Sclerosis ◽  
Systematic Review ◽  
Clinical Practice ◽  
Real World ◽  
Observational Studies ◽  
Rating Scale ◽  
Real Life ◽  
Daily Practice ◽  
Patient Characteristics ◽  
Numeric Rating Scale

Background/purpose: Spasticity is one of the most common symptoms in people with multiple sclerosis (MS). Conventional anti-spasticity agents have limitations in their efficacy and tolerability. Delta-9-tetrahydrocannabinol: cannabidiol (THC:CBD) spray, a cannabinoid-based medicine, is approved as an add-on therapy for MS spasticity not adequately controlled by other anti-spasticity medications. The results from randomized controlled trials (RCTs) have demonstrated a reduction in the severity of spasticity and associated symptoms. However, RCTs do not always reflect real-life outcomes. We systematically reviewed the complementary evidence from non-interventional real-world studies. Methods: A systematic literature review was conducted to identify all non-RCT publications on THC:CBD spray between 2011 and 2017. Data on study design, patient characteristics, effectiveness, and safety outcomes were extracted from those publications meeting our inclusion criteria. Results: In total, we reviewed 14 real-world publications including observational studies and treatment registries. The proportion of patients reaching the threshold of minimal clinical important difference (MCID), with at least a 20% reduction of the spasticity Numeric Rating Scale (NRS) score after 4 weeks ranged from 41.9% to 82.9%. The reduction in the mean NRS spasticity score after 4 weeks was maintained over 6-12 months. The average daily dose was five to six sprays. Delta-9-tetrahydrocannabinol: cannabidiol was well tolerated in the evaluated studies in the same way as in the RCTs. No new or unexpected adverse events or safety signals were reported in everyday clinical practice. Conclusions: The data evaluated in this systematic review provide evidence for the efficacy and safety of THC:CBD in clinical practice and confirm results obtained in RCTs.

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.

scholarly journals Damage to periarticular soft tissues in real clinical practice: frequency, nature, effectiveness of non - steroidal anti - inflammatory drugs

2019 ◽  
Vol 91 (12) ◽  
pp. 21-28
Author(s):  
A E Karateev ◽  
A M Lila ◽  
N V Zagorodni ◽  
E Yu Pogozheva
Keyword(s):  
Clinical Practice ◽  
Knee Joint ◽  
Soft Tissues ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Clinical Manifestations ◽  
Results Of Treatment ◽  
Inflammatory Drugs ◽  
Anti Inflammatory ◽  
Real Clinical Practice

Damage to periarticular soft tissues is a common pathology that causes severe pain and impaired function of the musculoskeletal system. Aim. To determine the frequency, nature and clinical features of damage to periarticular soft tissues in real clinical practice, as well as the effectiveness of non - steroidal anti - inflammatory drugs (NSAIDs) in the debut of treatment of this pathology. Materials and methods. During the observational study, the frequency of defeat of the periarticular soft tissues in the structure of visits to 68 outpatient orthopedic surgeons in different cities of Russia for 1 month was estimated. Assessed the nature and dynamics of clinical manifestations during treatment in 1227 patients with defeat of the periarticular soft tissues. NSAIDs, mainly the original meloxicam, were used as a “first line” treatment for damage of the periarticular soft tissues. The results of treatment were evaluated after 10-14 days at a repeat visit of patients. Results. The proportion of patients with damage of the periarticular soft tissues was 15.8% of the total number of people who applied for outpatient care. Among 1227 patients (men 57.5%, average age 51.3±15.5 years) who were observed in the dynamics, prevailed were those with damage of the periarticular soft tissues of the knee joint area (knee joint enthesopathy, prepatellar bursitis, tendonitis/ bursitis of the goose foot area) - 21.2%, feet (plantar fasciitis, calcaneal spur) - 16.9%, shoulder (tendonitis of the muscles of the shoulder rotators) - 16.4% and the elbow (lateral and medial epicondylitis) - 15.3%. During treatment, there was a significant decrease in the total severity of pain - from 6.58±1.61 to 2.48±1.60 points on an 11-point numerical rating scale (p

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