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• W2050052977 abstract "We are concerned that the best interests of the patients were not kept in mind in the design of the trial by Scott Solomon and colleagues1Solomon SD Janardhanan R Verma A et al.Effect of angiotensin receptor blockade and antihypertensive drugs on diastolic function in patients with hypertension and diastolic dysfunction: a randomised trial.Lancet. 2007; 369: 2079-2087Summary Full Text Full Text PDF PubMed Scopus (293) Google Scholar on valsartan in patients with hypertension and diastolic dysfunction.In the placebo group, 12% of the patients had diabetes mellitus, but we are not given information about diabetic nephropathy. Patients were not permitted to receive angiotensin-converting-enzyme (ACE) inhibitors during the trial, although they are of proven efficacy for the prevention of the progression of proteinuria in diabetic patients.2Bohlen L de Courten M Weidmann P Comparative study of the effect of ACE-inhibitors and other antihypertensive agents on proteinuria in diabetic patients.Am J Hypertens. 1994; 7: 84S-92SPubMed Google Scholar Furthermore, there is no information available on renal function and proteinuria.We feel that it is no longer ethical to prevent patients with diabetes from receiving ACE inhibitors in trials involving angiotensin-receptor blockers (ARBs). Since trials are now required to be registered in advance, we suggest that those involving ARBs versus placebo and not ACE inhibitors should not be approved for registration.We declare that we have no conflict of interest. We are concerned that the best interests of the patients were not kept in mind in the design of the trial by Scott Solomon and colleagues1Solomon SD Janardhanan R Verma A et al.Effect of angiotensin receptor blockade and antihypertensive drugs on diastolic function in patients with hypertension and diastolic dysfunction: a randomised trial.Lancet. 2007; 369: 2079-2087Summary Full Text Full Text PDF PubMed Scopus (293) Google Scholar on valsartan in patients with hypertension and diastolic dysfunction. In the placebo group, 12% of the patients had diabetes mellitus, but we are not given information about diabetic nephropathy. Patients were not permitted to receive angiotensin-converting-enzyme (ACE) inhibitors during the trial, although they are of proven efficacy for the prevention of the progression of proteinuria in diabetic patients.2Bohlen L de Courten M Weidmann P Comparative study of the effect of ACE-inhibitors and other antihypertensive agents on proteinuria in diabetic patients.Am J Hypertens. 1994; 7: 84S-92SPubMed Google Scholar Furthermore, there is no information available on renal function and proteinuria. We feel that it is no longer ethical to prevent patients with diabetes from receiving ACE inhibitors in trials involving angiotensin-receptor blockers (ARBs). Since trials are now required to be registered in advance, we suggest that those involving ARBs versus placebo and not ACE inhibitors should not be approved for registration. We declare that we have no conflict of interest. The VALIDD study – Authors' replyWe appreciate the comments of Jaewon Oh and Seok-Min Kang on the importance of N-terminal pro-brain natriuretic peptide (NT-proBNP) and its correlation with indices of left-ventricular filling, especially in patients with heart failure. Although we intend to report a detailed assessment of biomarkers in VALIDD subsequently, the mean NT-proBNP concentrations of patients enrolled in VALIDD at baseline were 101 ng/L (SD 104) in the valsartan group and 122 ng/L (176) in the placebo group (p=0·31); after 38 weeks of follow-up the corresponding values were 124 ng/L (168) and 105 ng/L (125), respectively (p=0·48). Full-Text PDF" @default.
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• W2050052977 title "The VALIDD study" @default.
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• W2050052977 doi "https://doi.org/10.1016/s0140-6736(07)61434-2" @default.
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