scholarly journals The Current Indication for Pacemaker in Patients with Cardioinhibitory Vasovagal Syncope

2016 ◽  
Vol 10 (1) ◽  
pp. 179-187
Author(s):  
Rose Mary Ferreira Lisboa da Silva
Keyword(s):  
Vasovagal Syncope ◽  
Initial Step ◽  
Tilt Test ◽  
Physical Injury ◽  
Implantable Loop Recorder ◽  
Open Label ◽  
Loop Recorder ◽  
Double Blind ◽  
Injury Recurrence

The most frequent cause of syncope is vasovagal reflex. It is associated with worse quality of life, depression, fatigue and physical injury. Recurrence of vasovagal syncope is an aggravating, reaching the rate of 69%. Initial step and pharmacological treatment may not work, especially in patients with recurrent syncope without prodrome. These patients can present cardioinhibitory response with asystole. Studies were designed to analyses the effectiveness of pacemaker for prevention of syncope. In this review, nonrandomized clinical trials, open-label randomized, double-blind randomized, placebo-controlled, and studies based on tilt test or Implantable Loop Recorder findings will be discussed.

scholarly journals Patients with recurrent syncope and implantable loop recorder exhibit better survival than the control group without implantable loop recorder

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
C Perings ◽  
C Wolff ◽  
A Wilk ◽  
A Witthohn ◽  
R Voss ◽  
...  
Keyword(s):  
Life Expectancy ◽  
Control Group ◽  
Funding Source ◽  
Implantable Loop Recorder ◽  
Loop Recorder ◽  
Cardiac Device ◽  
Unexplained Syncope ◽  
Care Costs

Abstract Introduction In 30% of patients with syncope, the underlying cause remains unexplained after clinical investigations. Unexplained syncope tends to recur, significantly impacting patients' quality of life of patients and mortality. Thus, there is a need for timely and more accurate diagnosis to initiate treatment. Dedicated care pathways are recommended by ESC guidelines. Purpose Patients with recurrent syncope were followed over time and patient outcomes with ILR were compared to patients with the same syncope burden, age, gender and mortality risk score who did not receive an ILR. Method A representative database of 4.9 million patients insured by German company statuary health insurances (BKK) was analysed over a time period of 10 years, 2007–17. Patients with recurrent syncope (two times ICD-10 GM diagnosis codes R55), age between 45–84 and no diagnosis code for the syncope were included in the analysis and followed for at least 2 years. Patients with ILR were matched to patients without ILR based on age, gender and Charlson Comorbidity index (CCI) using mahalanobis distances. The index event was the device implant in the ILR group and the second syncope event in the control group. Life expectancy, syncope hospitalisations, fall related injuries, health care costs, diagnoses and treatment rates were compared between the groups. Results A total of 412 patients with ILR for recurrent unexplained syncope were matched to the control group. Overall mean age was 68, mean was CCI 2.7, 42% were females. The risk of death was 2.35 times higher in the control group during follow up as shown in Figure 1 (p-value logrank test <0.0001). Cardiovascular related diagnosis and treatment rates were higher in the ILR group with 69% of patients having a cardiology diagnosis compared to 41% in the control group. Over a quarter (27%) of ILR patients received an implantable cardiac device compared to 5% in the control group. Ablation rates were 7% in the ILR group compared to 0% in the control group. Median health care costs were € 3,847 higher in the ILR group including the costs of the ILR implant, follow up and higher rates of cardiac treatments. These extra costs appear moderate given the substantially higher mortality risk in the control group. Conclusion This study of patients with recurrent unexplained syncope shows a remarkable difference in life expectancy in patients with ILR compared to a matched control group. Two large claim data analysis have recently shown higher rates of cardiovascular death as well as all-cause mortality in patients with unexplained syncope. A more vigilant cardiac workup might be needed to identify a possible underlying cardiac condition. Higher rates of cardiac device therapy in the ILR group were likely to play an important role for their better life expectancy. Cardiac therapies such as pacemakers, defibrillators and ablation have also been shown to significantly improve patients' quality of life. Life Expectancy Comparison Funding Acknowledgement Type of funding source: Private company. Main funding source(s): The data analysis was funded by Medtronic

scholarly journals The effects of pharmacological interventions on quality of life and fatigue in sarcoidosis: a systematic review

2020 ◽  
Vol 29 (155) ◽  
pp. 190057 ◽  
Author(s):  
Roeland Vis ◽  
Ewoudt M.W. van de Garde ◽  
Jan C. Grutters ◽  
Ingrid H.E. Korenromp
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Minimal Important Difference ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Qualitative Synthesis ◽  
Pharmacological Interventions ◽  
Open Label ◽  
Double Blind

AimsMany sarcoidosis patients experience a reduction in health-related quality of life (HRQoL) and a majority of patients report fatigue. Historically, drug trials in sarcoidosis have focused on changes in chest radiographs, lung function parameters and biomarkers, while HRQoL and fatigue have not been the main outcomes examined. We performed a systematic review of the literature to evaluate the existing evidence on the effects of pharmacological interventions on HRQoL and fatigue outcomes.MethodsThe systematic search was performed in Medline and Embase and yielded 15 records covering seven randomised controlled trials and seven single-arm open label studies, which were included in a qualitative synthesis (the results of one study were included in two publications). 12 studies evaluated immunosuppressive and/or immunomodulatory therapies and two studies evaluated stimulants.ResultsNine out of the 14 studies observed positive treatment effects from the interventions on HRQoL and/or fatigue, exceeding the minimal important difference. The risk of bias was generally high with only three studies rated as having a low risk of bias. The results suggest a potential for improvement in HRQoL and/or fatigue in patients with active disease who are either untreated or treated but not yet fully stabilised or therapy refractory.ConclusionMore randomised, double-blind and placebo-controlled trials are needed to expand the evidence base on these important outcome parameters.

scholarly journals Functional improvement and correlations with symptomatic improvement in adults with attention deficit hyperactivity disorder receiving long-acting methylphenidate

2011 ◽  
Vol 42 (1) ◽  
pp. 195-204 ◽  
Author(s):  
J. K. Buitelaar ◽  
M. Casas ◽  
A. Philipsen ◽  
J. J. S. Kooij ◽  
J. A. Ramos-Quiroga ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Attention Deficit Hyperactivity Disorder ◽  
Attention Deficit ◽  
Daily Functioning ◽  
Open Label ◽  
Double Blind ◽  
Hyperactivity Disorder ◽  
Co Morbidity ◽  
Open Label Extension

BackgroundData on the relationship between core symptoms and daily functioning in adults with attention deficit hyperactivity disorder (ADHD) are limited. Daily functioning was assessed as part of an open-label extension, and associations with symptom scores were evaluated.MethodAfter a 5-week double-blind study with adults with ADHD receiving osmotic-controlled release oral delivery system (OROS) methylphenidate (MPH) 18, 36 or 72 mg/day, or placebo, participants were eligible for a 7-week open-label extension in which all patients received OROS MPH. Data for the Conners' Adult ADHD Rating Scale – Observer: Screening Version (CAARS-O:SV) (primary endpoint) have been presented previously. Secondary endpoints included the observer self-reported short version of the CAARS (CAARS-S:S) and the Clinical Global Impressions – Severity Scale (CGI-S). Daily functioning and quality of life were assessed using the Sheehan Disability Scale (SDS) and the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) respectively. In post-hoc analyses, changes in CAARS-O:SV were evaluated in subgroups. Relationships between symptom and functional outcomes were evaluated in a multivariate regression analysis.ResultsA total of 370 patients entered the open-label extension. Significant improvements from baseline in CAARS-O:SV were similar regardless of sex, ADHD subtype, prior treatment or psychiatric co-morbidity. Significant improvements from double-blind baseline were also seen for the CAARS-S:S, CGI-S, SDS and Q-LES-Q. Improvements in the CAARS-O:SV Hyperactivity/Impulsivity subscale were associated with improvements in SDS total and subscale scores, and in the Q-LES-Q score at open-label endpoint. Improvements in CAARS-O:SV Inattention subscale and CGI-S scores were not significantly associated with functional changes.ConclusionsImprovements in ADHD symptoms relating to hyperactivity and impulsivity in adults receiving OROS MPH are associated with improvements in daily functioning and quality of life.

Erenumab (AMG 334) in episodic migraine

Neurology ◽  
2017 ◽  
Vol 89 (12) ◽  
pp. 1237-1243 ◽  
Author(s):  
Messoud Ashina ◽  
David Dodick ◽  
Peter J. Goadsby ◽  
Uwe Reuter ◽  
Stephen Silberstein ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Safety Data ◽  
Preventive Treatment ◽  
Episodic Migraine ◽  
Controlled Clinical Trial ◽  
Open Label ◽  
Double Blind ◽  
Open Label Extension

Objective:To assess long-term safety and efficacy of anti–calcitonin gene-related peptide receptor erenumab in patients with episodic migraine (EM).Methods:Patients enrolled in a 12-week, double-blind, placebo-controlled clinical trial (NCT01952574) who continued in an open-label extension (OLE) study will receive erenumab 70 mg every 4 weeks for up to 5 years. This preplanned interim analysis, conducted after all participants had completed the 1-year open-label follow-up, evaluated changes in monthly migraine days (MMD), achievement of ≥50%, ≥75%, and 100% reductions, Headache Impact Test (HIT-6) score, Migraine-Specific Quality of Life (MSQ), Migraine Disability Assessment (MIDAS), and safety. Data reported as observed without imputation for missing data.Results:Of 472 patients enrolled in the parent study, 383 continued in the OLE with a median exposure to erenumab of 575 days (range 28–822 days). Mean (SD) MMD were 8.8 (2.6) at parent study baseline, 6.3 (4.2) at week 12 (beginning of OLE), and 3.7 (4.0) at week 64 (mean change from baseline [reduction] of 5.0 days). At week 64, 65%, 42%, and 26% achieved ≥50%, ≥75%, and 100% reduction in MMD, respectively. Mean HIT-6 scores were 60.2 (6.3) at baseline and 51.7 (9.2) at week 64. MSQ and MIDAS improvements from baseline were maintained through week 64. Safety profiles during the OLE were similar to those in the double-blind phase, which overall were similar to placebo.Conclusions:One-year efficacy, supported by functional improvements and favorable safety and tolerability profiles, supports further investigation of erenumab as a preventive treatment in patients with EM.Clinicaltrials.gov identifier:NCT01952574.Classification of evidence:This study provides Class IV evidence that for patients with episodic migraine, erenumab reduces long-term MMD and improves headache-related disability and migraine-specific quality of life.

scholarly journals 0740 Quality of Life in Phase 3, Placebo-Controlled, Double-Blind, Randomized Withdrawal Study of JZP-258 in Adults with Narcolepsy with Cataplexy

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A281-A282
Author(s):  
N Foldvary-Schaefer ◽  
M J Thorpy ◽  
Y Dauvilliers ◽  
A Roy ◽  
L Tang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Short Form ◽  
Standard Of Care ◽  
Sodium Oxybate ◽  
Self Report ◽  
Double Blind Study ◽  
Open Label ◽  
Double Blind ◽  
Sf 36

Abstract Introduction Narcolepsy negatively impacts health-related quality of life (HRQoL). Sodium oxybate is a standard of care for the treatment of cataplexy and excessive daytime sleepiness in narcolepsy. JZP-258 is an oxybate product candidate with 92% less sodium. Efficacy and safety of JZP-258 were established in a double-blind randomized withdrawal study in adults with narcolepsy with cataplexy. Methods Participants 18-70 years of age began JZP-258 treatment during a 12-week, open-label, optimized treatment and titration period, followed by a 2-week stable-dose period (SDP). Participants were then randomized to receive placebo or continue JZP-258 treatment during a 2-week, double-blind, randomized withdrawal period (DBRWP). HRQoL assessments included the 36-Item Short Form Health Survey Version 2 (SF-36) and 5-level EuroQoL 5-Dimensions Self-Report Questionnaire (EQ-5D-5L). Results 201 participants enrolled; 134 were randomized and received at least 1 dose of double-blind study medication (efficacy population; placebo, n=65; JZP-258, n=69). Decreased scores (worsening) were observed in participants randomized to placebo compared with participants randomized to continue JZP-258 treatment for the SF-36 physical component summary (median [Q1, Q3], −1.92 [−3.46, 1.73] for placebo and −0.03 [−2.07, 2.41] for JZP-258; nominal P=0.02), SF-36 mental component summary (−1.92 [−6.28, 1.34] for placebo and 1.55 [−1.88, 3.78] for JZP-258; nominal P=0.03), and EQ-5D-5L visual analog scale (−5.00 [−10.0, 5.00] for placebo and 0 [0, 5.00] for JZP-258; nominal P=0.01). No change was observed in the EQ-5D-5L crosswalk index (0 [−0.05, 0.03] for placebo and 0 [−0.01, 0.03] for JZP-258; nominal P=0.39). The overall safety profile of JZP-258 was similar to sodium oxybate. Conclusion HRQoL worsened in those randomized to placebo during DBRWP but remained stable in participants who continued JZP-258 treatment. Support Jazz Pharmaceuticals

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