This site is intended for U.S. Healthcare Professionals only.
For patients with NYHA class II–III
obstructive HCM,
To achieve the primary composite functional endpoint, patients needed to achieve either ≥1 NYHA class improvement and an increase of ≥1.5 mL/kg/min in peak oxygen consumption (pVO2) or no worsening NYHA class and an increase of ≥3.0 mL/kg/min in pVO2.1,2
At week 30, 37% (n=45/123) of patients taking CAMZYOS® achieved the primary composite functional endpoint vs 17% (n=22/128) with placebo (95% CI: 9, 30; P=0.0005).1,2
Guideline-based threshold for surgery consideration (>50 mmHg)2
Guideline-based diagnostic criteria for obstruction (>30 mmHg)2
Data based on all randomized patients who received ≥1 dose of study treatment. LVOT gradient was analyzed with all available data without imputation.2
CI=confidence interval; LVOT=left ventricular outflow tract obstruction; SD=standard deviation.
ADVERSE REACTIONS
In the EXPLORER-HCM trial, adverse reactions occurring in >5% of patients and more commonly in the CAMZYOS group than in the placebo group were dizziness (27% vs 18%) and syncope (6% vs 2%).
Effects on Systolic Function
In the EXPLORER-HCM trial, mean (SD) resting LVEF was 74% (6) at baseline in both treatment groups. Mean (SD) absolute change from baseline in LVEF was -4% (8) in the CAMZYOS group and 0% (7) in the placebo group over the 30-week treatment period. At Week 38, following an 8-week interruption of trial drug, mean LVEF was similar to baseline for both treatment groups. In the EXPLORER-HCM trial, 7 (6%) patients in the CAMZYOS group and 2 (2%) patients in the placebo group experienced reversible reductions in LVEF <50% (median 48%: range 35-49%) while on treatment. In all 7 patients treated with CAMZYOS, LVEF recovered following interruption of CAMZYOS.
Please see additional Important Safety Information below, including Boxed WARNING.
Exploratory endpoints: proportion of patients achieving post-exercise LVOT peak gradient <50 mmHg or <30 mmHg at week 302
74% (n=75/101) of patients on CAMZYOS had
a post-exercise LVOT gradient <50 mmHg
and 21% (n=22/106) in the placebo arm2*
57% (n=64/113) of patients on CAMZYOS had
a post-exercise LVOT gradient <30 mmHg
and 7% (n=8/114) in the placebo arm2†
While these exploratory endpoints were prespecified, they were not powered for significance.3
ADVERSE REACTIONS
In the EXPLORER-HCM trial, adverse reactions occurring in >5% of patients and more commonly in the CAMZYOS group than in the placebo group were dizziness (27% vs 18%) and syncope (6% vs 2%).
Effects on Systolic Function
In the EXPLORER-HCM trial, mean (SD) resting LVEF was 74% (6) at baseline in both treatment groups. Mean (SD) absolute change from baseline in LVEF was -4% (8) in the CAMZYOS group and 0% (7) in the placebo group over the 30-week treatment period. At Week 38, following an 8-week interruption of trial drug, mean LVEF was similar to baseline for both treatment groups. In the EXPLORER-HCM trial, 7 (6%) patients in the CAMZYOS group and 2 (2%) patients in the placebo group experienced reversible reductions in LVEF <50% (median 48%: range 35-49%) while on treatment. In all 7 patients treated with CAMZYOS, LVEF recovered following interruption of CAMZYOS.
Please see additional Important Safety Information below, including Boxed WARNING.
For patients with NYHA class II–III
obstructive HCM,
To achieve the primary composite functional endpoint, patients needed to achieve either ≥1 NYHA class improvement and an increase of ≥1.5 mL/kg/min in peak oxygen consumption (pVO2) or no worsening NYHA class and an increase of ≥3.0 mL/kg/min in pVO2.1,2
At week 30, 37% (n=45/123) of patients taking CAMZYOS® achieved the primary composite functional endpoint vs 17% (n=22/128) with placebo (95% CI: 9, 30; P=0.0005).1,2
Mean change in pVO2 from baseline to week 30 was 1.4 mL/kg/min (SD, 3.1) for patients taking CAMZYOS and -0.1 mL/kg/min (SD, 3.0) for patients taking placebo.1
pVO2 measures peak oxygen consumption during cardiopulmonary exercise testing. Data based on all randomized patients who received ≥1 dose of study treatment.2,3
CI=confidence interval; SD=standard deviation.
ADVERSE REACTIONS
In the EXPLORER-HCM trial, adverse reactions occurring in >5% of patients and more commonly in the CAMZYOS group than in the placebo group were dizziness (27% vs 18%) and syncope (6% vs 2%).
Effects on Systolic Function
In the EXPLORER-HCM trial, mean (SD) resting LVEF was 74% (6) at baseline in both treatment groups. Mean (SD) absolute change from baseline in LVEF was -4% (8) in the CAMZYOS group and 0% (7) in the placebo group over the 30-week treatment period. At Week 38, following an 8-week interruption of trial drug, mean LVEF was similar to baseline for both treatment groups. In the EXPLORER-HCM trial, 7 (6%) patients in the CAMZYOS group and 2 (2%) patients in the placebo group experienced reversible reductions in LVEF <50% (median 48%: range 35-49%) while on treatment. In all 7 patients treated with CAMZYOS, LVEF recovered following interruption of CAMZYOS.
Please see additional Important Safety Information below, including Boxed WARNING.
For patients with NYHA class II–III
obstructive HCM,
To achieve the primary composite functional endpoint, patients needed to achieve either ≥1 NYHA class improvement and an increase of ≥1.5 mL/kg/min in peak oxygen consumption (pVO2) or no worsening NYHA class and an increase of ≥3.0 mL/kg/min in pVO2.1,2
At week 30, 37% (n=45/123) of patients taking CAMZYOS® achieved the primary composite functional endpoint vs 17% (n=22/128) with placebo (95% CI: 9, 30; P=0.0005).1,2
At baseline, approximately 73% of the randomized patients were NYHA class II and 27% were NYHA class III.1
Data based on all randomized patients who received ≥1 dose of study treatment. Missing NYHA class data at week 30 were imputed with the week 26 value for NYHA response. Patients with a nonevaluable NYHA secondary endpoint were considered nonresponders.2
ADVERSE REACTIONS
In the EXPLORER-HCM trial, adverse reactions occurring in >5% of patients and more commonly in the CAMZYOS group than in the placebo group were dizziness (27% vs 18%) and syncope (6% vs 2%).
Effects on Systolic Function
In the EXPLORER-HCM trial, mean (SD) resting LVEF was 74% (6) at baseline in both treatment groups. Mean (SD) absolute change from baseline in LVEF was -4% (8) in the CAMZYOS group and 0% (7) in the placebo group over the 30-week treatment period. At Week 38, following an 8-week interruption of trial drug, mean LVEF was similar to baseline for both treatment groups. In the EXPLORER-HCM trial, 7 (6%) patients in the CAMZYOS group and 2 (2%) patients in the placebo group experienced reversible reductions in LVEF <50% (median 48%: range 35-49%) while on treatment. In all 7 patients treated with CAMZYOS, LVEF recovered following interruption of CAMZYOS.
Please see additional Important Safety Information below, including Boxed WARNING.
The data below were used to calculate the secondary endpoint related to NYHA class but were exploratory in nature and not evaluated for significance to compare between the treatment groups.2,3
CI=confidence interval; NYHA=New York Heart Association.
ADVERSE REACTIONS
In the EXPLORER-HCM trial, adverse reactions occurring in >5% of patients and more commonly in the CAMZYOS group than in the placebo group were dizziness (27% vs 18%) and syncope (6% vs 2%).
Effects on Systolic Function
In the EXPLORER-HCM trial, mean (SD) resting LVEF was 74% (6) at baseline in both treatment groups. Mean (SD) absolute change from baseline in LVEF was -4% (8) in the CAMZYOS group and 0% (7) in the placebo group over the 30-week treatment period. At Week 38, following an 8-week interruption of trial drug, mean LVEF was similar to baseline for both treatment groups. In the EXPLORER-HCM trial, 7 (6%) patients in the CAMZYOS group and 2 (2%) patients in the placebo group experienced reversible reductions in LVEF <50% (median 48%: range 35-49%) while on treatment. In all 7 patients treated with CAMZYOS, LVEF recovered following interruption of CAMZYOS.
Please see additional Important Safety Information below, including Boxed WARNING.
For patients with NYHA class II–III
obstructive HCM,
To achieve the primary composite functional endpoint, patients needed to achieve either ≥1 NYHA class improvement and an increase of ≥1.5 mL/kg/min in peak oxygen consumption (pVO2) or no worsening NYHA class and an increase of ≥3.0 mL/kg/min in pVO2.1,2
At week 30, 37% (n=45/123) of patients taking CAMZYOS® achieved the primary composite functional endpoint vs 17% (n=22/128) with placebo (95% CI: 9, 30; P=0.0005).1,2
Mean baseline KCCQ-23 CSS (SD) was 71 (16) for the CAMZYOS group (n=99) and 71 (19) for the placebo group (n=97).1
KCCQ-23 TSS: change from baseline to week 30, mean (SD) was 12 (15) for CAMZYOS and 5 (16) for placebo.1
KCCQ-23 PL: change from baseline to week 30, mean (SD) was 15 (17) for CAMZYOS and 4 (15) for placebo.1
The KCCQ-23–CSS is composed of the physical limitations and total symptom burden scores of the KCCQ-23. The Clinical Summary Score ranges from 0 to 100, with higher scores representing less severe symptoms and/or physical limitations.1
Missing data were not imputed to summarize the baseline and change from baseline to week 30 values. Difference in mean change from baseline between treatment groups was estimated using a mixed model for repeated measures.1
Patient-reported outcomes were analyzed with all available data. Sensitivity analyses were conducted to assess the effect of the missing data. When missing data were imputed with unfavorable results for the CAMZYOS group, the estimated treatment effects of KCCQ-CSS remained significant (P<0.05).2
KCCQ-23–CSS=Kansas City Cardiomyopathy Questionnaire (23-item version)–Clinical Summary Score; LS=least squares; PL=physical limitations; SD=standard deviation; SE=standard error; TSS=total symptom score.
The Kansas City Cardiomyopathy Questionnaire (KCCQ) has been used to capture and quantify patient-reported outcomes in a disease-specific fashion.3
ADVERSE REACTIONS
In the EXPLORER-HCM trial, adverse reactions occurring in >5% of patients and more commonly in the CAMZYOS group than in the placebo group were dizziness (27% vs 18%) and syncope (6% vs 2%).
Effects on Systolic Function
In the EXPLORER-HCM trial, mean (SD) resting LVEF was 74% (6) at baseline in both treatment groups. Mean (SD) absolute change from baseline in LVEF was -4% (8) in the CAMZYOS group and 0% (7) in the placebo group over the 30-week treatment period. At Week 38, following an 8-week interruption of trial drug, mean LVEF was similar to baseline for both treatment groups. In the EXPLORER-HCM trial, 7 (6%) patients in the CAMZYOS group and 2 (2%) patients in the placebo group experienced reversible reductions in LVEF <50% (median 48%: range 35-49%) while on treatment. In all 7 patients treated with CAMZYOS, LVEF recovered following interruption of CAMZYOS.
Please see additional Important Safety Information below, including Boxed WARNING.
Mean baseline HCMSQ-SoB domain score (SD) was 5 (3) for both CAMZYOS (n=108) and placebo (n=109) groups.1The HCMSQ-SoB domain score measures the frequency and severity of shortness of breath. The HCMSQ-SoB scale score ranges from 0 to 18 with lower scores representing less shortness of breath.1 Missing data were not imputed to summarize the baseline and change from baseline to week 30 values. Difference in mean change from baseline between treatment groups was estimated using a mixed model for repeated measures.1 Patient-reported outcomes were analyzed with all available data. Sensitivity analyses were conducted to assess the effect of the missing data. When missing data were imputed with unfavorable results for the CAMZYOS group, the treatment effects of HCMSQ-SoB remained significant (P<0.05).2
The HCMSQ-SoB is an assessment created expressly for the EXPLORER-HCM
study that measures the frequency and severity of shortness of breath.4
ADVERSE REACTIONS
In the EXPLORER-HCM trial, adverse reactions occurring in >5% of patients and more commonly in the CAMZYOS group than in the placebo group were dizziness (27% vs 18%) and syncope (6% vs 2%).
Effects on Systolic Function
In the EXPLORER-HCM trial, mean (SD) resting LVEF was 74% (6) at baseline in both treatment groups. Mean (SD) absolute change from baseline in LVEF was -4% (8) in the CAMZYOS group and 0% (7) in the placebo group over the 30-week treatment period. At Week 38, following an 8-week interruption of trial drug, mean LVEF was similar to baseline for both treatment groups. In the EXPLORER-HCM trial, 7 (6%) patients in the CAMZYOS group and 2 (2%) patients in the placebo group experienced reversible reductions in LVEF <50% (median 48%: range 35-49%) while on treatment. In all 7 patients treated with CAMZYOS, LVEF recovered following interruption of CAMZYOS.
Please see additional Important Safety Information below, including Boxed WARNING.
For patients with NYHA class II–III
obstructive HCM,
To achieve the primary composite functional endpoint, patients needed to achieve either ≥1 NYHA class improvement and an increase of ≥1.5 mL/kg/min in peak oxygen consumption (pVO2) or no worsening NYHA class and an increase of ≥3.0 mL/kg/min in pVO2.1,2
At week 30, 37% (n=45/123) of patients taking CAMZYOS® achieved the primary composite functional endpoint vs 17% (n=22/128) with placebo (95% CI: 9, 30; P=0.0005).1,2
The reduction in NT-proBNP was 80% greater with CAMZYOS than for placebo. The clinical significance of these findings is unknown.1,2
While this endpoint was prespecified, it was not powered for significance.3
NT-proBNP is a marker for negative cardiac outcomes in patients with obstructive hypertrophic cardiomyopathy.4
CI=confidence interval; NT-proBNP=N-terminal pro B-type natriuretic peptide.
ADVERSE REACTIONS
In the EXPLORER-HCM trial, adverse reactions occurring in >5% of patients and more commonly in the CAMZYOS group than in the placebo group were dizziness (27% vs 18%) and syncope (6% vs 2%).
Effects on Systolic Function
In the EXPLORER-HCM trial, mean (SD) resting LVEF was 74% (6) at baseline in both treatment groups. Mean (SD) absolute change from baseline in LVEF was -4% (8) in the CAMZYOS group and 0% (7) in the placebo group over the 30-week treatment period. At Week 38, following an 8-week interruption of trial drug, mean LVEF was similar to baseline for both treatment groups. In the EXPLORER-HCM trial, 7 (6%) patients in the CAMZYOS group and 2 (2%) patients in the placebo group experienced reversible reductions in LVEF <50% (median 48%: range 35-49%) while on treatment. In all 7 patients treated with CAMZYOS, LVEF recovered following interruption of CAMZYOS.
Please see additional Important Safety Information below, including Boxed WARNING.
This website is best viewed
using the horizontal display
on your tablet device.
This website is best viewed
using the vertical display
on your mobile device.
References: