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Article ; Online: Relationship between quantitative strength and functional outcomes in the phase 2 FORTITUDE-ALS trial.

Shefner, Jeremy M / Jacobsen, Bill / Kupfer, Stuart / Malik, Fady I / Meng, Lisa / Wei, Jenny / Wolff, Andrew A / Rudnicki, Stacy A

Amyotrophic lateral sclerosis & frontotemporal degeneration

2023 Volume 25, Issue 1-2, Page(s) 162–169

Abstract: Objective: To assess the relationship among measurements of strength, function, and quality of life in an amyotrophic lateral sclerosis (ALS) clinical trial.: Methods: In the FORTITUDE-ALS clinical trial (NCT03160898), 456 participants in the full- ... ...

Abstract	Objective: To assess the relationship among measurements of strength, function, and quality of life in an amyotrophic lateral sclerosis (ALS) clinical trial. Methods: In the FORTITUDE-ALS clinical trial (NCT03160898), 456 participants in the full-analysis set were treated with either Results: Upper-extremity muscle strength and hand grip were highly correlated with ALSFRS-R fine motor scores and the ALSAQ-5 hand function question. Similarly, lower-extremity strength correlated well with ALSFRS-R gross motor domain and the ALSAQ-5 walking question. For SVC, correlation was poor with the ALSFRS-R respiratory domain, but stronger with the total score, potentially reflecting the insensitivity of the respiratory questions in the scale. Upper- and lower-extremity strength were both strong predictors of ALSFRS-R domain scores. Conclusions: In this analysis of data from an ALS clinical trial, muscle strength quantified by dynamometry was strongly correlated with functional capacity. These results suggest that muscle strength directly relates to specific functions of importance to people with ALS.
MeSH term(s)	Humans ; Amyotrophic Lateral Sclerosis/diagnosis ; Amyotrophic Lateral Sclerosis/drug therapy ; Hand Strength ; Quality of Life ; Surveys and Questionnaires ; Muscle Strength ; Disease Progression
Language	English
Publishing date	2023-08-29
Publishing country	England
Document type	Clinical Trial, Phase II ; Journal Article
ZDB-ID	2705049-X
ISSN	2167-9223 ; 2167-8421
ISSN (online)	2167-9223
ISSN	2167-8421
DOI	10.1080/21678421.2023.2252468
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Article ; Online: Health utilities and quality-adjusted life years for patients with amyotrophic lateral sclerosis receiving

Gebrehiwet, Paulos / Meng, Lisa / Rudnicki, Stacy A / Sarocco, Phil / Wei, Jenny / Wolff, Andrew A / Butzner, Michael / Chiò, Adriano / Andrews, Jinsy A / Genge, Angela / Hughes, Dyfrig A / Jackson, Carlayne E / Lechtzin, Noah / Miller, Timothy M / Shefner, Jeremy M

Journal of medical economics

2023 Volume 26, Issue 1, Page(s) 488–493

Abstract: Aims: To estimate the health utilities and quality-adjusted life years (QALYs) in patients with amyotrophic lateral sclerosis (ALS) receiving : Materials and methods: We performed a post hoc analysis of clinical trial data from FORTITUDE-ALS ( ... ...

Abstract	Aims: To estimate the health utilities and quality-adjusted life years (QALYs) in patients with amyotrophic lateral sclerosis (ALS) receiving Materials and methods: We performed a post hoc analysis of clinical trial data from FORTITUDE-ALS (NCT03160898). This Phase IIb, double-blind, randomized, dose-ranging, placebo-controlled, parallel-group, 12-week trial evaluated Results: The full analysis set consisted of 456 patients ( Conclusions: This post hoc analysis of FORTITUDE-ALS suggests that Clinicaltrials.gov identifier: NCT03160898.
MeSH term(s)	Humans ; Amyotrophic Lateral Sclerosis/drug therapy ; Quality-Adjusted Life Years ; Surveys and Questionnaires ; Double-Blind Method ; Quality of Life
Chemical Substances	reldesemtiv (4S0HBYW6QE)
Language	English
Publishing date	2023-03-17
Publishing country	England
Document type	Randomized Controlled Trial ; Journal Article
ZDB-ID	2270945-9
ISSN	1941-837X ; 1369-6998
ISSN (online)	1941-837X
ISSN	1369-6998
DOI	10.1080/13696998.2023.2192588
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Article ; Online: MiToS and King's staging as clinical outcome measures in ALS: a retrospective analysis of the FORTITUDE-ALS trial.

Gebrehiwet, Paulos / Meng, Lisa / Rudnicki, Stacy A / Sarocco, Phil / Wei, Jenny / Wolff, Andrew A / Chiò, Adriano / Andrews, Jinsy A / Genge, Angela / Jackson, Carlayne E / Lechtzin, Noah / Miller, Timothy M / Shefner, Jeremy M

Amyotrophic lateral sclerosis & frontotemporal degeneration

2022 Volume 24, Issue 3-4, Page(s) 304–310

Abstract: Objective: To evaluate the Milano-Torino staging (MiToS) and King's staging systems as potential outcome measures for clinical trials in amyotrophic lateral sclerosis (ALS) by assessing these outcomes in FORTITUDE-ALS.: Methods: This was a : ... ...

Abstract	Objective: To evaluate the Milano-Torino staging (MiToS) and King's staging systems as potential outcome measures for clinical trials in amyotrophic lateral sclerosis (ALS) by assessing these outcomes in FORTITUDE-ALS. Methods: This was a Results: The full analysis set consisted of 456 patients randomized 3:1 ( Conclusion: This exploratory analysis showed the feasibility of MiToS and King's staging as potential outcome measures in ALS. Additional studies of these staging systems are needed to further explore their utility in ALS clinical trials.
MeSH term(s)	Humans ; Amyotrophic Lateral Sclerosis/diagnosis ; Amyotrophic Lateral Sclerosis/drug therapy ; Retrospective Studies ; Disease Progression ; Outcome Assessment, Health Care
Chemical Substances	reldesemtiv (4S0HBYW6QE)
Language	English
Publishing date	2022-12-12
Publishing country	England
Document type	Randomized Controlled Trial ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2705049-X
ISSN	2167-9223 ; 2167-8421
ISSN (online)	2167-9223
ISSN	2167-8421
DOI	10.1080/21678421.2022.2154678
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Article ; Online: Developments in Exercise Capacity Assessment in Heart Failure Clinical Trials and the Rationale for the Design of METEORIC-HF.

Lewis, Gregory D / Docherty, Kieran F / Voors, Adriaan A / Cohen-Solal, Alain / Metra, Marco / Whellan, David J / Ezekowitz, Justin A / Ponikowski, Piotr / Böhm, Michael / Teerlink, John R / Heitner, Stephen B / Kupfer, Stuart / Malik, Fady I / Meng, Lisa / Felker, G Michael

Circulation. Heart failure

2022 Volume 15, Issue 5, Page(s) e008970

Abstract: Heart failure with reduced ejection fraction (HFrEF) is a highly morbid condition for which exercise intolerance is a major manifestation. However, methods to assess exercise capacity in HFrEF vary widely in clinical practice and in trials. We describe ... ...

Abstract	Heart failure with reduced ejection fraction (HFrEF) is a highly morbid condition for which exercise intolerance is a major manifestation. However, methods to assess exercise capacity in HFrEF vary widely in clinical practice and in trials. We describe advances in exercise capacity assessment in HFrEF and a comparative analysis of how various therapies available for HFrEF impact exercise capacity. Current guideline-directed medical therapy has indirect effects on cardiac performance with minimal impact on measured functional capacity. Omecamtiv mecarbil is a novel selective cardiac myosin activator that directly increases cardiac contractility and in a phase 3 cardiovascular outcomes study significantly reduced the primary composite end point of time to first heart failure event or cardiovascular death in patients with HFrEF. The objective of the METEORIC-HF trial (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure) is to assess the effect of omecamtiv mecarbil versus placebo on multiple components of functional capacity in HFrEF. The primary end point is to test the effect of omecamtiv mecarbil compared with placebo on peak oxygen uptake as measured by cardiopulmonary exercise testing after 20 weeks of treatment. METEORIC-HF will provide state-of-the-art assessment of functional capacity by measuring ventilatory efficiency, circulatory power, ventilatory anaerobic threshold, oxygen uptake recovery kinetics, daily activity, and quality-of-life assessment. Thus, the METEORIC-HF trial will evaluate the potential impact of increased myocardial contractility with omecamtiv mecarbil on multiple important measures of functional capacity in ambulatory patients with symptomatic HFrEF. Registration: URL: https://clinicaltrials.gov; Unique identifier: NCT03759392.
MeSH term(s)	Exercise Tolerance ; Heart Failure/diagnosis ; Heart Failure/drug therapy ; Humans ; Multicenter Studies as Topic ; Myocardial Contraction ; Oxygen ; Stroke Volume ; Ventricular Dysfunction, Left
Chemical Substances	Oxygen (S88TT14065)
Language	English
Publishing date	2022-03-03
Publishing country	United States
Document type	Journal Article ; Review ; Research Support, Non-U.S. Gov't
ZDB-ID	2429459-7
ISSN	1941-3297 ; 1941-3289
ISSN (online)	1941-3297
ISSN	1941-3289
DOI	10.1161/CIRCHEARTFAILURE.121.008970
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Article ; Online: Effect of Omecamtiv Mecarbil on Exercise Capacity in Chronic Heart Failure With Reduced Ejection Fraction: The METEORIC-HF Randomized Clinical Trial.

Lewis, Gregory D / Voors, Adriaan A / Cohen-Solal, Alain / Metra, Marco / Whellan, David J / Ezekowitz, Justin A / Böhm, Michael / Teerlink, John R / Docherty, Kieran F / Lopes, Renato D / Divanji, Punag H / Heitner, Stephen B / Kupfer, Stuart / Malik, Fady I / Meng, Lisa / Wohltman, Amy / Felker, G Michael

JAMA

2022 Volume 328, Issue 3, Page(s) 259–269

Abstract: Importance: Exercise limitation is a cardinal manifestation of heart failure with reduced ejection fraction (HFrEF) but is not consistently improved by any of the current guideline-directed medical therapies.: Objective: To determine whether ... ...

Abstract	Importance: Exercise limitation is a cardinal manifestation of heart failure with reduced ejection fraction (HFrEF) but is not consistently improved by any of the current guideline-directed medical therapies. Objective: To determine whether omecamtiv mecarbil, a novel direct myosin activator that improves cardiac performance and reduces the risk for cardiovascular death or first HF event in HFrEF, can improve peak exercise capacity in patients with chronic HFrEF. Design, setting, and participants: Phase 3, double-blind, placebo-controlled randomized trial of patients with HFrEF (left ventricular ejection fraction ≤35%), New York Heart Association class II-III symptoms, N-terminal pro-B-type natriuretic peptide level of 200 pg/mL or greater, and baseline peak oxygen uptake (V̇o2) of 75% or less of predicted. Patients were randomized in a 2:1 ratio (omecamtiv mecarbil to placebo) between March 2019 and May 2021 at 63 sites in North America and Europe, with the last patient visit occurring on November 29, 2021. Interventions: Omecamtiv mecarbil (n = 185) or matching placebo (n = 91), given orally twice daily at a dose of 25 mg, 37.5 mg, or 50 mg based on target plasma levels, for 20 weeks. Main outcomes and measures: The primary end point was a change in exercise capacity (peak V̇o2) from baseline to week 20. Secondary end points included total workload, ventilatory efficiency, and daily physical activity as determined by accelerometry. Results: Among 276 patients who were randomized (median age, 64 years; IQR, 55-70 years; 42 women [15%]), 249 (90%) completed the trial. The median left ventricular ejection fraction was 28% (IQR, 21-33) and the median baseline peak V̇o2 was 14.2 mL/kg/min (IQR, 11.6-17.4) in the omecamtiv mecarbil group and 15.0 mL/kg/min (IQR, 12.0-17.2) in the placebo group. Mean change in peak V̇o2 did not differ significantly between the omecamtiv mecarbil and placebo groups (mean, -0.24 mL/kg/min vs 0.21 mL/kg/min; least square mean difference, -0.45 mL/kg/min [95% CI, -1.02 to 0.13]; P = .13). Adverse events included dizziness (omecamtiv mecarbil: 4.9%, placebo: 5.5%), fatigue (omecamtiv mecarbil: 4.9%, placebo: 4.4%), heart failure events (omecamtiv mecarbil: 4.9%, placebo: 4.4%), death (omecamtiv mecarbil: 1.6%, placebo: 1.1%), stroke (omecamtiv mecarbil: 0.5%, placebo: 1.1%), and myocardial infarction (omecamtiv mecarbil: 0%, placebo: 1.1%). Conclusions and relevance: In patients with chronic HFrEF, omecamtiv mecarbil did not significantly improve exercise capacity over 20 weeks compared with placebo. These findings do not support the use of omecamtiv mecarbil for treatment of HFrEF for improvement of exercise capacity. Trial registration: ClinicalTrials.gov Identifier: NCT03759392.
MeSH term(s)	Aged ; Cardiovascular Agents/adverse effects ; Cardiovascular Agents/pharmacology ; Cardiovascular Agents/therapeutic use ; Chronic Disease ; Double-Blind Method ; Exercise Tolerance/drug effects ; Exercise Tolerance/physiology ; Female ; Heart Failure/drug therapy ; Heart Failure/physiopathology ; Humans ; Male ; Middle Aged ; Stroke Volume/drug effects ; Stroke Volume/physiology ; Urea/adverse effects ; Urea/analogs & derivatives ; Urea/pharmacology ; Urea/therapeutic use ; Ventricular Dysfunction, Left/drug therapy ; Ventricular Dysfunction, Left/physiopathology ; Ventricular Function, Left/drug effects ; Ventricular Function, Left/physiology
Chemical Substances	Cardiovascular Agents ; omecamtiv mecarbil (2M19539ERK) ; Urea (8W8T17847W)
Language	English
Publishing date	2022-07-19
Publishing country	United States
Document type	Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial
ZDB-ID	2958-0
ISSN	1538-3598 ; 0254-9077 ; 0002-9955 ; 0098-7484
ISSN (online)	1538-3598
ISSN	0254-9077 ; 0002-9955 ; 0098-7484
DOI	10.1001/jama.2022.11016
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Article ; Online: Aficamten for Drug-Refractory Severe Obstructive Hypertrophic Cardiomyopathy in Patients Receiving Disopyramide: REDWOOD-HCM Cohort 3.

Journal of cardiac failure

2023 Volume 29, Issue 11, Page(s) 1576–1582

MeSH term(s)	Humans ; Disopyramide/adverse effects ; Sequoia ; Heart Failure/drug therapy ; Anti-Arrhythmia Agents ; Cardiomyopathy, Hypertrophic/drug therapy
Chemical Substances	Disopyramide (GFO928U8MQ) ; Anti-Arrhythmia Agents
Language	English
Publishing date	2023-07-18
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1281194-4
ISSN	1532-8414 ; 1071-9164
ISSN (online)	1532-8414
ISSN	1071-9164
DOI	10.1016/j.cardfail.2023.07.003
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Zs.A 4340: Show issues

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Article ; Online: The relationship between tirasemtiv serum concentration and functional outcomes in patients with ALS.

Shefner, Jeremy M / Wolff, Andrew A / Meng, Lisa

Amyotrophic lateral sclerosis & frontotemporal degeneration

2013 Volume 14, Issue 7-8, Page(s) 582–585

Abstract: Tirasemtiv is a fast skeletal muscle activator that increases efficiency of muscle contraction. Both single and repeated dose studies suggested beneficial effects on measures of function, muscle strength and endurance. As the outcomes measured were ... ...

Abstract	Tirasemtiv is a fast skeletal muscle activator that increases efficiency of muscle contraction. Both single and repeated dose studies suggested beneficial effects on measures of function, muscle strength and endurance. As the outcomes measured were identical in previous studies and the duration of all studies was 21 days or less, we pooled data from all studies and assessed the relationship between outcomes and plasma tirasemtiv concentration to assess consistency of observations as well as to increase sensitivity. We pooled data for ALSFRS-R, three pulmonary function measures, quantitative muscle strength, and submaximal handgrip endurance. Up to 855 values from 143 patients were plotted against tirasemtiv concentrations. Linear associations between tirasemtiv concentrations and changes from baseline of clinical measures were estimated using a repeated-measures mixed model. Trends toward improvement were noted in all measures except for vital capacity, despite the fact that time was not included as a factor so that any time-related decline acted to reduce the magnitude of any noted trend. In conclusion, tirasemtiv appears to have concentration-dependent beneficial effects on both function and measures of strength and endurance when administered for up to 21 days, even when time is eliminated as a cofactor. These findings further support the development of this agent in ALS.
MeSH term(s)	Aged ; Amyotrophic Lateral Sclerosis/blood ; Amyotrophic Lateral Sclerosis/drug therapy ; Amyotrophic Lateral Sclerosis/physiopathology ; Drug Administration Schedule ; Female ; Humans ; Imidazoles/blood ; Imidazoles/therapeutic use ; Male ; Middle Aged ; Muscle Strength/drug effects ; Muscle Strength/physiology ; Pyrazines/blood ; Pyrazines/therapeutic use ; Recovery of Function/drug effects ; Recovery of Function/physiology ; Treatment Outcome
Chemical Substances	CK-2017357 ; Imidazoles ; Pyrazines
Language	English
Publishing date	2013-12
Publishing country	England
Document type	Clinical Trial, Phase II ; Journal Article ; Randomized Controlled Trial
ZDB-ID	2705049-X
ISSN	2167-9223 ; 2167-8421
ISSN (online)	2167-9223
ISSN	2167-8421
DOI	10.3109/21678421.2013.817587
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Zs.A 5874: Show issues

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Article ; Online: Noninvasive ventilation use by patients enrolled in VITALITY-ALS.

Rudnicki, Stacy A / Andrews, Jinsy A / Bian, Amy / Cockroft, Bettina M / Cudkowicz, Merit E / Hardiman, Orla / Malik, Fady I / Meng, Lisa / Wolff, Andrew A / Shefner, Jeremy M

Amyotrophic lateral sclerosis & frontotemporal degeneration

2021 Volume 22, Issue 7-8, Page(s) 486–494

Abstract: Objectives: ...

Abstract	Objectives:
MeSH term(s)	Amyotrophic Lateral Sclerosis ; Humans ; Noninvasive Ventilation ; Respiratory Insufficiency ; Sleep ; Time Factors ; Vital Capacity
Language	English
Publishing date	2021-04-01
Publishing country	England
Document type	Journal Article ; Randomized Controlled Trial
ZDB-ID	2705049-X
ISSN	2167-9223 ; 2167-8421
ISSN (online)	2167-9223
ISSN	2167-8421
DOI	10.1080/21678421.2021.1904993
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Article ; Online: Profile of medical care costs in patients with amyotrophic lateral sclerosis in the Medicare programme and under commercial insurance.

Meng, Lisa / Bian, Amy / Jordan, Scott / Wolff, Andrew / Shefner, Jeremy M / Andrews, Jinsy

Amyotrophic lateral sclerosis & frontotemporal degeneration

2017 Volume 19, Issue 1-2, Page(s) 134–142

Abstract: Objective: To determine amyotrophic lateral sclerosis (ALS)-associated costs incurred by patients covered by Medicare and/or commercial insurance before, during and after diagnosis and provide cost details.: Methods: Costs were calculated from the ... ...

Abstract	Objective: To determine amyotrophic lateral sclerosis (ALS)-associated costs incurred by patients covered by Medicare and/or commercial insurance before, during and after diagnosis and provide cost details. Methods: Costs were calculated from the Medicare Standard Analytical File 5% sample claims data from Parts A and B from 2009, 2010 and 2011 for ALS Medicare patients aged ≥70 years (monthly costs) and ≥65 years (costs associated with disability milestones). Commercial insurance patients aged 18-63 years were selected based on the data provided in the Coordination of Benefits field from Truven MarketScan® in 2008-2010. Results: Monthly costs increased nine months before diagnosis, peaked during the index month (Medicare: $10,398; commercial: $9354) and decreased but remained high post-index. Costs generally shifted from outpatient to inpatient and private nursing after diagnosis; prescriptions and durable medical equipment costs were much higher for commercial patients post-diagnosis. Patients appeared to progress to disability milestones more rapidly as their disease progressed in severity (14.4 months to non-invasive ventilation [NIV] vs. 16.6 months to hospice), and their costs increased accordingly (NIV: $58,973 vs. hospice: $76,179). Conclusions: For newly diagnosed ALS patients in the U.S., medical costs are substantial and increase rapidly and substantially with each disability milestone.
MeSH term(s)	Age Factors ; Aged ; Amyotrophic Lateral Sclerosis/economics ; Amyotrophic Lateral Sclerosis/therapy ; Female ; Health Care Costs/statistics & numerical data ; Humans ; Insurance, Health/economics ; Male ; Medicare/economics ; Middle Aged ; Noninvasive Ventilation/economics ; United States
Language	English
Publishing date	2017-09-11
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2705049-X
ISSN	2167-9223 ; 2167-8421
ISSN (online)	2167-9223
ISSN	2167-8421
DOI	10.1080/21678421.2017.1363242
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Article ; Online: Prescription and acceptance of durable medical equipment in FORTITUDE-ALS, a study of

Rudnicki, Stacy A / Andrews, Jinsy A / Genge, Angela / Jackson, Carlayne / Lechtzin, Noah / Miller, Timothy M / Cockroft, Bettina M / Malik, Fady I / Meng, Lisa / Wei, Jenny / Wolff, Andrew A / Shefner, Jeremy M

Amyotrophic lateral sclerosis & frontotemporal degeneration

2021 Volume 23, Issue 3-4, Page(s) 263–270

Abstract: ... ...

Abstract	Objective
MeSH term(s)	Humans ; Amyotrophic Lateral Sclerosis/drug therapy ; Disease Progression ; Double-Blind Method ; Durable Medical Equipment ; Prescriptions
Chemical Substances	reldesemtiv (4S0HBYW6QE)
Language	English
Publishing date	2021-07-05
Publishing country	England
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	2705049-X
ISSN	2167-9223 ; 2167-8421
ISSN (online)	2167-9223
ISSN	2167-8421
DOI	10.1080/21678421.2021.1946083
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