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- Teerlink, John R., et al.
(författare)
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Cardiac Myosin Activation with Omecamtiv Mecarbil in Systolic Heart Failure
- 2021
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Ingår i: New England Journal of Medicine. - Waltham, MA, United States : MASSACHUSETTS MEDICAL SOC. - 0028-4793 .- 1533-4406. ; 384:2, s. 105-116
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Tidskriftsartikel (refereegranskat)abstract
- Among patients with heart failure and a reduced ejection fraction, those who received the cardiac myosin activator omecamtiv mecarbil had a lower incidence of a composite of heart-failure events or cardiovascular death at a median of 22 months than those who received placebo. Background The selective cardiac myosin activator omecamtiv mecarbil has been shown to improve cardiac function in patients with heart failure with a reduced ejection fraction. Its effect on cardiovascular outcomes is unknown. Methods We randomly assigned 8256 patients (inpatients and outpatients) with symptomatic chronic heart failure and an ejection fraction of 35% or less to receive omecamtiv mecarbil (using pharmacokinetic-guided doses of 25 mg, 37.5 mg, or 50 mg twice daily) or placebo, in addition to standard heart-failure therapy. The primary outcome was a composite of a first heart-failure event (hospitalization or urgent visit for heart failure) or death from cardiovascular causes. Results During a median of 21.8 months, a primary-outcome event occurred in 1523 of 4120 patients (37.0%) in the omecamtiv mecarbil group and in 1607 of 4112 patients (39.1%) in the placebo group (hazard ratio, 0.92; 95% confidence interval [CI], 0.86 to 0.99; P=0.03). A total of 808 patients (19.6%) and 798 patients (19.4%), respectively, died from cardiovascular causes (hazard ratio, 1.01; 95% CI, 0.92 to 1.11). There was no significant difference between groups in the change from baseline on the Kansas City Cardiomyopathy Questionnaire total symptom score. At week 24, the change from baseline for the median N-terminal pro-B-type natriuretic peptide level was 10% lower in the omecamtiv mecarbil group than in the placebo group; the median cardiac troponin I level was 4 ng per liter higher. The frequency of cardiac ischemic and ventricular arrhythmia events was similar in the two groups. Conclusions Among patients with heart failure and a reduced ejection, those who received omecamtiv mecarbil had a lower incidence of a composite of a heart-failure event or death from cardiovascular causes than those who received placebo. (Funded by Amgen and others; GALACTIC-HF ClinicalTrials.gov number, ; EudraCT number, 2016-002299-28.)
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- Teerlink, John R., et al.
(författare)
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Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction: GALACTIC-HF baseline characteristics and comparison with contemporary clinical trials
- 2020
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Ingår i: European Journal of Heart Failure. - : WILEY. - 1388-9842 .- 1879-0844. ; 22:11, s. 2160-2171
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Tidskriftsartikel (refereegranskat)abstract
- Aims The safety and efficacy of the novel selective cardiac myosin activator, omecamtiv mecarbil, in patients with heart failure with reduced ejection fraction (HFrEF) is being tested in the Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure (GALACTIC-HF) trial. Here we describe the baseline characteristics of participants in GALACTIC-HF and how these compare with other contemporary trials. Methods and results Adults with established HFrEF, New York Heart Association (NYHA) functional class >= II, ejection fraction <= 35%, elevated natriuretic peptides and either current hospitalization for heart failure or history of hospitalization/emergency department visit for heart failure within a year were randomized to either placebo or omecamtiv mecarbil (pharmacokinetic-guided dosing: 25, 37.5, or 50 mg bid). A total of 8256 patients [male (79%), non-white (22%), mean age 65 years] were enrolled with a mean ejection fraction 27%, ischaemic aetiology in 54%, NYHA class II 53% and III/IV 47%, and median N-terminal pro-B-type natriuretic peptide 1971 pg/mL. Heart failure therapies at baseline were among the most effectively employed in contemporary heart failure trials. GALACTIC-HF randomized patients representative of recent heart failure registries and trials with substantial numbers of patients also having characteristics understudied in previous trials including more from North America (n = 1386), enrolled as inpatients (n = 2084), systolic blood pressure <100 mmHg (n = 1127), estimated glomerular filtration rate <30 mL/min/1.73 m(2) (n = 528), and treated with sacubitril/valsartan at baseline (n = 1594). Conclusions GALACTIC-HF enrolled a well-treated, high-risk population from both inpatient and outpatient settings, which will provide a definitive evaluation of the efficacy and safety of this novel therapy, as well as informing its potential future implementation.
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- Alexander, M S, et al.
(författare)
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International standards to document remaining autonomic function after spinal cord injury.
- 2008
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Ingår i: Spinal cord : the official journal of the International Medical Society of Paraplegia. - : Springer Science and Business Media LLC. - 1362-4393. ; 47:1, s. 36-43
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Tidskriftsartikel (refereegranskat)abstract
- STUDY DESIGN: Experts opinions consensus. OBJECTIVE: To develop a common strategy to document remaining autonomic neurologic function following spinal cord injury (SCI). BACKGROUND AND RATIONALE: The impact of a specific SCI on a person's neurologic function is generally described through use of the International Standards for the Neurological Classification of SCI. These standards document the remaining motor and sensory function that a person may have; however, they do not provide information about the status of a person's autonomic function. METHODS: Based on this deficiency, the American Spinal Injury Association (ASIA) and the International Spinal Cord Society (ISCoS) commissioned a group of international experts to develop a common strategy to document the remaining autonomic neurologic function. RESULTS: Four subgroups were commissioned: bladder, bowel, sexual function and general autonomic function. On-line communication was followed by numerous face to face meetings. The information was then presented in a summary format at a course on Measurement in Spinal Cord Injury, held on June 24, 2006. Subsequent to this it was revised online by the committee members, posted on the websites of both ASIA and ISCoS for comment and re-revised through webcasts. Topics include an overview of autonomic anatomy, classification of cardiovascular, respiratory, sudomotor and thermoregulatory function, bladder, bowel and sexual function. CONCLUSION:This document describes a new system to document the impact of SCI on autonomic function. Based upon current knowledge of the neuroanatomy of autonomic function this paper provides a framework with which to communicate the effects of specific spinal cord injuries on cardiovascular, broncho-pulmonary, sudomotor, bladder, bowel and sexual function.
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- Baunsgaard, C. B., et al.
(författare)
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EXOSKELETON GAIT TRAINING AFTER SPINAL CORD INJURY: AN EXPLORATORY STUDY ON SECONDARY HEALTH CONDITIONS
- 2018
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Ingår i: Journal of Rehabilitation Medicine. - : Medical Journals Sweden AB. - 1650-1977 .- 1651-2081. ; 50:9, s. 806-813
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To explore changes in pain, spasticity, range of motion, activities of daily living, bowel and lower urinary tract function and quality of life of individuals with spinal cord injury following robotic exoskeleton gait training. Methods: Three training sessions per week for 8 weeks using an Ekso GT robotic exoskeleton (Ekso Bionics). Included were individuals with recent (<1 year) or chronic (>1 year) injury, paraplegia and tetraplegia, complete and incomplete injury, men and women. Results: Fifty-two participants completed the training protocol. Pain was reported by 52% of participants during the week prior to training and 17% during training, but no change occurred longitudinally. Spasticity decreased after a training session compared with before the training session (p< 0.001), but not longitudinally. Chronically injured participants increased Spinal Cord Independence Measure (SCIM III) from 73 to 74 (p= 0.008) and improved life satisfaction (p= 0.036) over 8 weeks of training. Recently injured participants increased SCIM III from 62 to 70 (p<0.001), but no significant change occurred in life satisfaction. Range of motion, bowel and lower urinary function did not change over time. Conclusion: Training seemed not to provoke new pain. Spasticity decreased after a single training session. SCIM III and quality of life increased longitudinally for subsets of participants.
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- Irgens, I., et al.
(författare)
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Telehealth for people with spinal cord injury: a narrative review
- 2018
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Ingår i: Spinal Cord. - : Springer Science and Business Media LLC. - 1362-4393 .- 1476-5624. ; 56:7, s. 643-655
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Tidskriftsartikel (refereegranskat)abstract
- Study design Narrative review. Objectives To find and discuss what has been published about the use of telehealth, on people with spinal cord injury (teleSCI). Method Cochrane Library, Ovid Medline, EMBASE and CINAHL, from 1996 till June 2017 have been searched. Searches in PsycINFO, from 1996 till September 2017, were included afterwards. Extracted data include studies in English language, containing information about spinal cord injury and disorders, and telehealth. Literature reviews, systematic reviews, and studies containing other types of neurological disorders, were excluded. Studies were grouped based on how and to whom telehealth was offered. Results Twenty nine studies were included in the review. They were categorized according to the way teleSCI was provided, and to what modality was used. Some studies utilized more than one modality. TeleSCI seems to be favorable concerning treatment and follow-up, as well as favorable socioeconomically and environmentally. The studies spanned across several aims and outcomes. There was also heterogeneity in number of participants, the differences in modalities, and in the level of evidence. Thus it was challenging to compare studies and make future recommendations. Conclusions TeleSCI can be used for examination and guiding purposes. Further research is warranted to evaluate optimal utilization, methodology and efficacy.
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- Tibaek, S., et al.
(författare)
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The effect of pelvic floor muscle training on sexual function in men with lower urinary tract symptoms after stroke
- 2015
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Ingår i: Topics in Stroke Rehabilitation. - 1074-9357. ; 22:3, s. 185-193
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Tidskriftsartikel (refereegranskat)abstract
- Background: Erectile dysfunction and lower urinary tract symptoms (LUTS) are common sequelae in men after stroke. Objective: The objective of this study was to evaluate the effect of pelvic floor muscle training (PFMT) on measured erectile function as an indicator of sexuality in men with LUTS after stroke. Method: A sample of 516 men with stroke was invited to participate in this single-blinded, randomized controlled trial according to in- and exclusion criteria. This resulted in 31 participants who were randomized to either a Treatment Group (n=16) or a Control Group (n=15). The intervention included 12weeks of PFMT. The effect was measured on the International Index of Erectile Function (IIEF-5) questionnaire. Results: Thirty participants (median age: 68 years; interquartile range: 60-74 years) completed the study, 15 in each group. The results of the IIEF-5 sum score showed a significant improvement (P<0.04) from pre-test to post-test in the Treatment Group, but not in the Control Group. Within pre-test and 6-month follow-up, the median sum score decreased in both groups, worsened in the Control Group [ Treatment Group, 3 (17%) versus Control Group, 5 (31%)]. There were differences between the groups at post-test and at follow-up, but they were not statistically significant. Conclusion: The results showed that, as measured by erectile function in men with LUTS after stroke, PFMT may have short-term and long-term effect, although no statistically significant effect was demonstrated between the groups.
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