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Mr Josep Redon
Dr. Takahisa Sawada
Presenter | see Discussant report
Takahisa Sawada (Japan)
Presentation webcastPresentation slides
List of Authors: Sawada T, Koide M, Shiraishi J, Yamada H, Matsubara H
Purpose: Chronic renal dysfunction is an independent risk factor for the development of cardiovascular disease, and the interaction is bidirectional between chronic kidney disease (CKD) and cardiovascular disease. The KYOTO HEART Study showed an additional beyond blood pressure lowering benefit of valsartan on cardio- or cerebrovascular (CV) events in Japanese high-risk hypertensive patients (Eur Heart J 2009;30: 2461). We here updated the analysis for cardiovascular protective effects of valsartan in high-risk hypertensive patients with chronic kidney disease. Methods and results: The KYOTO HEART Study is a multicenter, two-arm parallel treatment group comparison study with response-dependent dose titration scheme. High-risk Japanese patients with uncontrolled hypertension (n=3031) were randomized to receive either additional valsartan or conventional non-ARB therapies. The primary endpoint was a composite of defined CV events such as stroke, myocardial infarction, heart failure, angina pectoris, doubling of creatinine or induction of hemodyalysis. In the updated analysis, the study patients were divided into five stages of CKD by estimated glomerular filtration rate (eGFR) at the study entry. The number of CKD-1(eGFR>=90 mL/min/1.73 m2) was 358, CKD-2(60-89) 1590, CKD-3(30-59) 930, CKD-4(15-29) 40 and CKD-5(<15) 11, respectively. The results were as follows; 1) The patients who developed CKD at the entry (eGFR <60) showed significantly higher CV event than patients without CKD (11% vs 6%, HR 1.71, 95%CI:1.34-2.19). 2) Compared to CKD-1, the primary endpoint significantly stepped up in CKD-4 (30% vs 7%, OR 5.96, p=0.0001) and CKD-5 (27% vs 7%, OR 5.22, p=0.02), but not significant in CKD-2 and CKD-3. 3) In the patients with CKD (stage 3,4,5), valsartan add-on treatment showed lower primary events than non-ARB treatment (8% vs 14%, HR 0.53, 95%CI:0.36-0.77), in which the occurrences of heart failure (p=0.009) and renovascular events (doubling of creatinine or induction of hemodyalysis) (p=0.036) were significantly reduced. Conclusions: CKD was significantly associated with CV events in high-risk hypertensive patients, and the event rate stepped up between CKD-3 and CKD-4. Valsartan was even effective in high-risk hypertensive patients with CKD, and the beneficial effects of valsartan were mainly due to prevention of heat failure and renovascular diseases.
Discussant | see Presenter abstract
Josep Redon (Spain)Presentation webcastPresentation slides
The KYOTO HEART STUDY (Sawada, 2009) assessed the add-on effect of valsartan on top of the conventional treatment for high-risk hypertension in terms of the morbidity and mortality in a prospective Randomised Open Blinded Endpoint (PROBE) design. The main conclusion is that Valsartan prevented more cardiovascular events than conventional non-ARB treatment. These benefits seem to be that cannot be entirely explained by a difference in blood pressure control. In this meeting, the authors present a post-hoc analysis of subjects with Chronic Kidney Disease (CKD). The main conclusions of the study were:
Five are the main comments concerning the study: 1. The data, patients with CKD have more cardiovascular risk and valsartan-based treatment reduced risk to develop type 2 diabetes, are confirmatory of previous studies. 2. Limitations of the main study are carried to the post-hoc analysis. The main outcome had too many soft endpoints, angina (27% of the events) and congestive heart failure (16% of the events). The consideration that congestive heart failure is a soft endpoint is based in the definition in the study. It is considered as event when “… new occurrence or exacerbation…” The PROBE design also had limitations but these increases when the impact of the soft endpoints is as high. 3. Limitations of the post-hoc analysis: a) Subgroups were not randomized and may not have been comparable in terms of baseline characteristics: CHF (V 7% vs n-ARB 13%) Diabetes (V 26% vs n-ARB 30%); b) The numbers of patients (981) and outcome events (107) in the subgroup was small, resulting in low statistical power; c) Soft endpoints with large impact in the main outcome: Angina 22%, CHF 16% (the only non-renal significant); d) The renal outcome, doubling sCr or dialysis, was achieved with few numbers (V 0.6% 3 patients vs non-ARB 2.4% 12 patients) and in parallel with more congestive heart failure; e) Results were reported without adjustment for multiple comparisons. 4. Can we support that the results are BP-independent without 24-hour ABPM? 5. Can the results be generalized to other ethnic groups? BIBLIOGRAPHY Sawada T, Yamada H, Dahlöf B, Matsubara H; KYOTO HEART Study Group. Effects of valsartan on morbidity and mortality in uncontrolled hypertensive patients with high cardiovascular risks: KYOTO HEART Study. Eur Heart J. 2009;30:2461-9.
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Clinical Trial Update I - Drug treatment