New data from the SHIFT trial show that in addition to the main result of a reduction in death/hospitalization patients on the heart-rate-lowering drug ivabradine (Procoralan, Servier) also experience improvements in quality of life and heart remodeling.
The SHIFT trial, first reported last year, showed an 18% reduction in the primary end point of cardiovascular death/heart-failure hospitalization with ivabradine vs placebo.
New data from two subgroup analyses focusing on quality of life and heart remodeling were presented at the European Society of Cardiology (ESC) 2011 Congress and have been published in the European Heart Journal.
Presenting the quality-of-life substudy, which involved 944 patients, Dr Inger Ekman (Sahlgrenska Academy, Gothenburg, Sweden) reported that ivabradine patients showed a greater improvement in quality of life (as measured by the Kansas City Cardiomyopathy Questionnaire) from baseline to 12 months than the placebo group. And the quality-of-life improvements were correlated with the degree of heart-rate reduction achieved with the drug.
SHIFT: Change in quality-of-life scores on the Kansas City Cardiomyopathy Questionnaire
|
KCCQ score at 12 mo
|
Ivabradine
|
Placebo
|
Difference
|
p
|
|
Change
|
+6.7
|
+4.3
|
2.4
|
<0.001
|
The remodeling data came from the echocardiography substudy of the SHIFT trial, which included 611 patients, making it one of the largest echo substudies on reverse remodeling in heart failure.
Presenting the results, Dr Jean-Claude Tardif (Montreal Heart Institute, QC) noted that cardiac remodeling was central to heart-failure progression and was assessed in this study by measuring left ventricular end-systolic volume index (LVESVI).
SHIFT echo substudy: Change in left ventricular end diastolic volume index
|
Left ventricular end-systolic volume index
|
Ivabradine
|
Placebo
|
Difference
|
p
|
|
Change (mL/m2)
|
-7.0
|
-0.9
|
-5.8
|
0.0002
|
Left ventricular ejection fraction was also increased by 3% in the ivabradine group vs placebo, again a significant result.
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