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Published Online, 9 November 2004, www.theannals.com, DOI 10.1345/aph.1E182b.
 The Annals of Pharmacotherapy: Vol. 38, No. 12, pp. 2176-2177. DOI 10.1345/aph.1E182b
© 2004 Harvey Whitney Books Company.
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AUTHORS' REPLY:

James D Coyle, PharmD

Assistant Professor of Clinical Pharmacy Division of Pharmacy Practice and Administration College of Pharmacy The Ohio State University Columbus, Ohio

Stephanie F Gardner, PharmD EdD

Professor and Dean College of Pharmacy UAMS Little Rock, Arkansas

C Michael White, PharmD

Associate Professor of Pharmacy School of Pharmacy University of Connecticut 80 Seymour Street Hartford, Connecticut 06102-5037 fax 860/545-2277 cmwhite{at}harthosp.org

Published Online, November 9, 2004. www.theannals.com, DOI 10.1345/aph.1E182b

AUTHORS' REPLY: We thank Dr. Epstein for his comments in response to our review of the renal protective effects of ARBs in patients with type 2 diabetes.1 We would like to address each of his 3 major points.

First, Dr. Epstein suggested that ACE inhibitors are clearly preferred over ARBs for cardiovascular risk reduction in patients with diabetic nephropathy. This position is becoming increasingly difficult to defend. There is a significant, growing body of literature showing that ARBs also decrease cardiovascular risk, that the magnitude of their overall effect is similar to that of ACE inhibitors, and that they have a more favorable adverse effect profile than ACE inhibitors.2-10 For example, VALIANT recently provided a head-to-head comparison of the effects of ARB monotherapy (losartan), ACE inhibitor monotherapy (captopril), and combination ARB and ACE inhibitor therapy (valsartan plus captopril) on mortality in a high-risk patient population with acute myocardial infarction complicated by heart failure, left ventricular systolic dysfunction, or both.10 All-cause mortality, cardiovascular mortality, recurrent myocardial infarction, and hospitalizations for heart failure were similar in all treatment groups, while the lowest incidence of adverse events occurred in the losartan monotherapy treatment group.

Other recent clinical trials also support ARB use to reduce cardiovascular risk without providing a direct comparison with ACE inhibitors.11,12 In our opinion, available data support the use of either ARBs or ACE inhibitors to provide renal and cardiovascular protection in patients with type 2 diabetes as indicated in the treatment algorithm in our manuscript.

Dr. Epstein's second point primarily questions the ability of ARBs to decrease ESRD in clinical practice. Many aspects of his argument regarding specific aspects of individual studies are correct. However, in our opinion, the entire body of evidence regarding the renal protective effects of ARBs and ACE inhibitors strongly suggests that both classes of agents are renoprotective. We refer readers to the K/DOQI Clinical Practice Guidelines on Hypertension and Antihypertensive Agents in Chronic Kidney Disease for a comprehensive summary of current data on this topic.13 The American Diabetes Association's 2004 Clinical Practice Recommendations are also consistent with our view.14

Dr. Epstein's third point questions the appropriateness of good glycemic control as the first step in our treatment algorithm. We agree that strict blood pressure control is more important than strict glycemic control in protecting the kidneys of patients with diabetes. What we intended to convey in our algorithm is that achieving strict glycemic control contributes to the lowering of blood pressure and to renal protection in patients with diabetes. Simultaneously achieving glycemic and blood pressure control should be advocated.

Our review article was narrowly focused on the renal protective effects of ARBs in patients with type 2 diabetes since it was intended to serve as an update to the excellent review of the renoprotective effects of ACE inhibitors (and other drugs) that appeared previously in The Annals.15 We hope that Dr. Epstein's comments and our reply have helped clarify the current status of some potentially controversial issues related to this topic.

References

  1. Coyle JD, Gardner SF, White CM. The renal protective effects of angiotensin II receptor blockers in type 2 diabetes mellitus. Ann Pharmacother 2004;38:1731-8. DOI 10.1345/aph.1E182[Abstract/Free Full Text]
  2. Pitt B, Segal R, Martinez FA, Meurers G, Cowley AJ, Thomas I, et al. Randomised trial of losartan versus captopril in patients over 65 with heart failure (Evaluation of Losartan in the Elderly Study, ELITE).Lancet 1997;349:747-52.[CrossRef][Medline]
  3. Pitt B, Poole-Wilson PA, Segal R, Martinez FA, Dickstein K, Camm AJ, et al. Effect of losartan compared with captopril on mortality in patients with symptomatic heart failure: randomized trial—the Losartan Heart Failure Survival Study, ELITE II. Lancet 2000;355:1582-7.[CrossRef][Medline]
  4. Cohn JN, Tognoni G. A randomized trial of the angiotensin-receptor blocker valsartan in chronic heart failure. N Engl J Med 2001;345:1667-75.[Abstract/Free Full Text]
  5. Maggioni AP, Anand I, Gottlieb SO, Latini R, Tognoni G, Cohn JN. Effects of valsartan on morbidity and mortality in patients with heart failure not receiving angiotensin-converting enzyme inhibitors. J Am Coll Cardiol 2002;40:1414-21.[Abstract/Free Full Text]
  6. Pfeffer MA, Swedberg K, Granger CB, Held P, McMurray JJ, Michelson EL, et al. Effects of candesartan on mortality and morbidity in patients with chronic heart failure: the CHARM-Overall programme. 2003;362:759-66.
  7. McMurray JJ, Ostergren J, Swedberg K, Granger CB, Held P, Michelson EL, et al. Effects of candesartan in patients with chronic heart failure and reduced left-ventricular systolic function taking angiotensin-converting-enzyme inhibitors: the CHARM-Added trial.Lancet 2003;362:767-71.[CrossRef][Medline]
  8. Granger CB, McMurray JJ, Yusuf S, Held P, Michelson EL, Olofsson B, et al. Effects of candesartan in patients with chronic heart failure and reduced left-ventricular systolic function intolerant to angiotensin-converting-enzyme inhibitors: the CHARM-Alternative trial.Lancet 2003;362:772-6.[CrossRef][Medline]
  9. Yusuf S, Pfeffer MA, Swedberg K, Granger CB, Held P, McMurray JJ, et al. Effects of candesartan in patients with chronic heart failure and preserved left-ventricular ejection fraction: the CHARM-Preserved trial.Lancet 2003;362:777-81.[CrossRef][Medline]
  10. Pfeffer MA, McMurray JJ, Velazquez EJ, Rouleau JL, Kober L, Maggioni AP, et al. Valsartan, captopril, or both in myocardial infarction complicated by heart failure, left ventricular dysfunction, or both. N Engl J Med 2003;349:1893-906.[Abstract/Free Full Text]
  11. Dahlof B, Devereux RB, Kjeldsen SE, Julius S, Beevers G, de Faire U, et al. Cardiovascular morbidity and mortality in the losartan intervention for endpoint reduction in hypertension study (LIFE): a randomized trial against atenolol. Lancet 2002;359:995-1003.[CrossRef][Medline]
  12. Papademetriou V, Varsang C, Elmfeldt D, Hofman A, Lithell H, Olofsson B, et al. Stroke prevention with the angiotensin II type 1-receptor blocker candesartan in elderly patients with isolated systolic hypertension: the study on cognition and prognosis in the elderly (SCOPE). J Am Coll Cardiol 2004;44:1175-80.[Abstract/Free Full Text]
  13. National Kidney Foundation. K/DOQI clinical practice guidelines on hypertension and antihypertensive agents in chronic kidney disease. Am J Kidney Dis 2004;43(suppl 1):S1 -290.[Medline]
  14. American Diabetes Association 2004 Clinical Practice Recommendations. Diabetes Care 2004;27(suppl 1):S1 -150.
  15. Vivian EM, Goebig ML. Slowing the progression of renal disease in diabetic patients. Ann Pharmacother 2001;35: 452-63. DOI 10.1345/aph.10067[Abstract]




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