Safety and Efficacy of Melatonin in Chronic Tension-Type Headache: A Post-Marketing Real-World Surveillance Program

Abstract Background Rituximab is conditionally approved in Japan for use in patients with refractory nephrotic syndrome. To meet the conditions of approval, an all-case post-marketing surveillance study was conducted to confirm the real-world safety and efficacy of rituximab in patients of all ages with refractory nephrotic syndrome. Methods All patients scheduled to receive rituximab treatment for refractory nephrotic syndrome were eligible to register (registration: August 29, 2014 through April 15, 2016); the planned observation period was 2 years from the initiation of rituximab treatment (intravenous infusion, 375 mg/m2 once weekly for four doses). The study was conducted at 227 hospitals throughout Japan. Adverse drug reactions (ADRs) were collected for safety outcomes. The efficacy outcomes were relapse-free period and the degree of growth in pediatric (< 15 years) patients. Results In total, 997 (447 pediatric) patients were registered; 981 (445) were included in the safety analysis set; 852 (402) completed the 2-year observation period; and 810 (429) were included in the efficacy analysis set. Refractory nephrotic syndrome had developed in childhood for 85.0% of patients, and 54.6% were aged ≥15 years. ADRs were observed in 527 (53.7%) patients, treatment-related infection/infestation in 235 (24.0%) patients, and infusion reactions in 313 (31.9%) patients. The relapse-free period was 580 days (95% confidence interval, 511–664). There was a significant change in height standard deviation score (pediatric patients; mean change, 0.093; standard deviation, 0.637; P = 0.009). Conclusion The safety and efficacy of rituximab treatment in patients with refractory nephrotic syndrome were confirmed in the real-world setting. Clinical trial registration UMIN000014997.

Download Full-text

Exteroceptive Suppression of Temporalis Muscle Activity: Findings in Headache

Cephalalgia ◽

10.1046/j.1468-2982.1993.1301011.x ◽

1993 ◽

Vol 13 (1) ◽

pp. 11-14 ◽

Cited By ~ 16

Author(s):

Thomas-Martin Wallasch ◽

Hartmut Göbel

Keyword(s):

Muscle Activity ◽

Silent Period ◽

Tension Type Headache ◽

Temporalis Muscle ◽

Pharmacological Agents ◽

Chronic Tension Type Headache ◽

Exteroceptive Suppression ◽

Headache Diagnosis ◽

Secondary Phenomenon ◽

Type Headache

Exteroceptive suppression of temporalis muscle activity was proposed by Schoenen and co-workers in 1987 as a tool in headache diagnosis and research. Their finding of a decreased or abolished second silent period (ES2) in chronic tension-type headache sufferers has been confirmed by several independent laboratories during the last five years. Temporalis silent periods have also been studied in various other types of headaches. Their modulation by neuropsychological factors and pharmacological agents has also been investigated as well as their retest reliability. The pathophysiological concept of muscle contraction in tension-type headache has been challenged by studies using temporalis silent periods. The exterocepfive suppression of temporalis muscle activity points unequivocally towards a central pathogenetic mechanism, although it remains unclear whether the abnormalities of temporalis ES2 represent the primary dysfunction or a secondary phenomenon in chronic tension-type headache.

Download Full-text

The Local and Referred Pain From Myofascial Trigger Points in the Temporalis Muscle Contributes to Pain Profile in Chronic Tension-type Headache

Clinical Journal of Pain ◽

10.1097/ajp.0b013e318153496a ◽

2007 ◽

Vol 23 (9) ◽

pp. 786-792 ◽

Cited By ~ 68

Author(s):

César Fernández-de-las-Peñas ◽

Hong-You Ge ◽

Lars Arendt-Nielsen ◽

Maria Luz Cuadrado ◽

Juan A. Pareja

Keyword(s):

Trigger Points ◽

Tension Type Headache ◽

Referred Pain ◽

Temporalis Muscle ◽

Myofascial Trigger Points ◽

Chronic Tension Type Headache ◽

Type Headache

Download Full-text

Variables associated with sleep quality in chronic tension-type headache: A cross-sectional and longitudinal design

PLoS ONE ◽

10.1371/journal.pone.0197381 ◽

2018 ◽

Vol 13 (5) ◽

pp. e0197381 ◽

Cited By ~ 1

Author(s):

Elena Benito-González ◽

Maria Palacios-Ceña ◽

Juan J. Fernández-Muñoz ◽

Matteo Castaldo ◽

Kelun Wang ◽

...

Keyword(s):

Sleep Quality ◽

Longitudinal Design ◽

Tension Type Headache ◽

Cross Sectional ◽

Chronic Tension Type Headache ◽

Type Headache

Download Full-text

Chronic Tension-Type Headache in Children and Adolescents

Cephalalgia ◽

10.1046/j.0333-1024.2001.00275.x ◽

2001 ◽

Vol 21 (8) ◽

pp. 830-836 ◽

Cited By ~ 41

Author(s):

Ishaq Abu-Arafeh

Keyword(s):

Children And Adolescents ◽

Clinical Features ◽

Chronic Daily Headache ◽

Adult Population ◽

Tension Type Headache ◽

Stressful Events ◽

Chronic Tension Type Headache ◽

Daily Headache ◽

Ihs Criteria ◽

Type Headache

In this study, the causes, predisposing factors and clinical features of chronic daily headache in children and adolescents were studied within the population of patients attending a specialist headache. The International Headache Society's (IHS) criteria for the diagnosis of chronic tension type headache (CTTH) were assessed for their applicability in the paediatric age group. Over a period of three years, demographic and clinical data were collected prospectively on all children who attended the clinic and suffered from daily attacks of headache. One hundred and fifteen children and adolescents (32% of all clinic population) had chronic daily headache, of whom 93 patients (81%) fulfilled the IHS criteria for the diagnosis of CTTH. They were between 3-15 years of age (mean: 11.1, SD: 2.3) and their female to male ratio was 1.2: 1. Around one third of the patients also suffered from migraine (mainly migraine without aura). The headache was described as mild in 60.9%, moderate 36.5% and severe 2.6%. Headache was located at the forehead in 53% or over the whole of the head in 29.6%. Pain was described as ‘just sore’ or dull by 73.9%. During attacks of headache, at least half the patients reported light intolerance, noise intolerance, anorexia or nausea. Thirty-two percent of patients had at least one underlying chronic disease that may have contributed to the pathogenesis of the CTTH. Eleven percent had serious stressful events related to family illnesses and in four patients headaches were triggered by family bereavement. Fourteen percent were investigated with neuroimaging and 22% were referred for clinical psychology assessment and management. In conclusion, CTTH is a common cause of headache in children attending a specialist headache clinic. The clinical features closely match those of adult population and the IHS criteria for the diagnosis of CTTH can be adapted for use in children. Predisposing stressful risk factors, physical or emotional, are present in a large proportion.

Download Full-text

Chronic Tension-Type Headache

CNS Drugs ◽

10.2165/00023210-199504020-00002 ◽

1995 ◽

Vol 4 (2) ◽

pp. 90-98 ◽

Cited By ~ 1

Author(s):

Alessandro S. Zagami

Keyword(s):

Tension Type Headache ◽

Chronic Tension Type Headache ◽

Type Headache

Download Full-text

Increased Pericranial Tenderness, Decreased Pressure Pain Threshold, and Headache Clinical Parameters in Chronic Tension-type Headache Patients

Clinical Journal of Pain ◽

10.1097/ajp.0b013e31803b3770 ◽

2007 ◽

Vol 23 (4) ◽

pp. 346-352 ◽

Cited By ~ 57

Author(s):

C??sar Fern??ndez-de-las-Pe??as ◽

Maria Luz Cuadrado ◽

Lars Arendt-Nielsen ◽

Hong-You Ge ◽

Juan A. Pareja

Keyword(s):

Pain Threshold ◽

Pressure Pain Threshold ◽

Tension Type Headache ◽

Clinical Parameters ◽

Pressure Pain ◽

Chronic Tension Type Headache ◽

Type Headache ◽

Headache Patients

Download Full-text

Psychophysical testing in chronic migraine and chronic tension type headache: An observational study

Cephalalgia ◽

10.1177/03331024211060315 ◽

2021 ◽

pp. 033310242110603

Author(s):

Ignacio Elizagaray-García ◽

Gabriela F Carvalho ◽

Tibor M Szikszay ◽

Waclaw M Adamczyk ◽

Gonzalo Navarro-Fernández ◽

...

Keyword(s):

Chronic Migraine ◽

Tension Type Headache ◽

Headache Frequency ◽

Chronic Tension Type Headache ◽

Psychophysical Testing ◽

Pressure Pain Thresholds ◽

Type Headache ◽

Neck Disability ◽

Painful Area

Background Clinical presentation is the key to the diagnosis of patients with migraine and tension-type headache, but features may overlap when both become chronic. Psychophysical parameters may distinguish both conditions. We aimed to compare psychophysical aspects of patients with chronic migraine, chronic tension-type headache and headache-free controls, and to determine whether these can predict headache frequency. Methods An examiner blinded to the diagnosis assessed 100 participants (chronic migraine (n = 38), chronic tension-type headache (n = 31) and controls (n = 31)). Assessed variables included painful area, pressure pain thresholds, temporal summation, cervical range of motion, neck posture, headache and neck impact, quality of life, and kinesiophobia. Comparison between groups was performed with one-way ANOVA and multiple linear regression was used to assess the headache frequency predictors. Results We found differences of both headache groups compared to controls ( p < 0.01), but not between headache groups. Neck disability was a significant predictor of headache frequency for chronic tension-type headache (adjusted R2 = 0.14; β = 0.43; p = 0.03) and chronic migraine (adjusted R2 = 0.18; β = 0.51; p < 0.01). Conclusions Chronic tension-type headache and chronic migraine showed similar psychophysical results, but were significantly worse when compared to controls. The psychophysical examination did not discriminate between headache types. The variable best explaining headache frequency for both headache types was neck disability.

Download Full-text

Abstract 1122‐000142: Safety and Efficacy of Surpass Streamline for Intracranial Aneurysms: A Multicenter US Real‐World Experience (SESSIA)

Stroke: Vascular and Interventional Neurology ◽

10.1161/svin.01.suppl_1.000142 ◽

2021 ◽

Vol 1 (S1) ◽

Author(s):

Juan Vivanco‐Suarez ◽

Alan Mendez‐Ruiz ◽

Farooqui Mudassir ◽

Cynthia B Zevallos ◽

Milagros Galecio‐Castillo ◽

...

Keyword(s):

Real World ◽

Intracranial Aneurysms ◽

The United States ◽

Chromium Alloy ◽

Cobalt Chromium ◽

Anterior Circulation ◽

Safety And Efficacy ◽

Post Marketing ◽

The Mean

Introduction : Flow diversion has established itself as standard treatment of wide complex intracranial aneurysms (IA). Its recognition has been validated with positive occlusion rates and favorable clinical outcomes. The Surpass Streamline (SS) flow diverter (FD) is a braided cobalt/chromium alloy implant with 72 or 96 wires approved by the FDA in 2018. The aim of this study is to determine the safety and efficacy of the SS in a post‐marketing large US cohort. Methods : We performed a multicenter, retrospective study for consecutive patients treated with the SS FD for IA between January 2018 and June 2021 in the United States. Inclusion criteria for participants were: 1. Adults (≥ 18 years) and 2. Treatment with SS FD for IA. Primary safety end point was a major ipsilateral stroke (increase in National Institutes of Health Stroke Scale Score of ≥ 4) or neurological death within 12 months. Primary efficacy was assessed using the 3‐point Raymond‐Roy (RR) occlusion scale on digital subtraction angiography (DSA) at 6‐12‐month follow‐up. Results : A total of 276 patients with 313 aneurysms were enrolled. The median age was 59 years and 199 (72%) were females. The most common comorbidities included hypertension in 156 (57%) subjects followed by hyperlipidemia in 76 (28%) patients. One hundred and twenty‐two (44%) patients were asymptomatic while subarachnoid hemorrhage was present in only 10 (4%) patients. A total of 143 (46%) aneurysms were left‐sided. Aneurysms were located as follows: 274 (88%) were in the anterior circulation with paraophthalmic being the most common in 120 (38%) followed by petrocavernous ICA in 81 (26%); 33 (11%) aneurysms were located in the posterior circulation with basilar trunk being the most common in 14 (5%). The mean maximum aneurysm dome width was 5.77 ± 4.7 mm, neck width 4.22 ± 3.8 mm and dome to neck ratio was 1.63 ± 1.3 mm. The mean number of SS FD implanted per aneurysm was 1.06 (range 1–3) with more than one SS FD implanted in 21 (7%) aneurysms. Modified Rankin Scale (mRS) of 0–2 was present in 206/213 (97%) patients at 6–12 month follow‐up. The complete aneurysm occlusion (RR 1) rate was 145/175 (83%) among subjects who had angiographic follow‐up at 6–12 months. Major stroke and death was encountered in 7 (2%) and 5 (1.8%) of the patients respectively. Conclusions : Our data represent the largest real‐world study using SS FD. These results corroborate its post‐marketing safety and efficacy for the treatment of intracranial aneurysms showing more favorable rates to the initial experience during SCENT trial.

Download Full-text