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Dual blockade with candesartan cilexetil and lisinopril in hypertensive patients with diabetes mellitus: rationale and design
Niels H Andersen
Department of Internal Medicine, Diabetes & Endocrinology, Aarhus University Hospital, Denmark, holmark{at}iekf.au.dk
Søren T Knudsen
Department of Internal Medicine, Diabetes & Endocrinology, Aarhus University Hospital, Denmark
Per L Poulsen
Department of Internal Medicine, Diabetes & Endocrinology, Aarhus University Hospital, Denmark
Steen H Poulsen
Department of Cardiology, Aarhus University Hospital, Denmark
Kjeld Helleberg
Department of Internal Medicine, Viborg County Hospital, Denmark
Hans Eiskjær
Department of Cardiology, Aarhus University Hospital, Denmark
Klaus W Hansen
Department of Internal Medicine, Silkeborg Hospital, Denmark
Toke Bek
Department of Ophthalmology, Aarhus University Hospital, Denmark
Carl E Mogensen
Department of Internal Medicine, Diabetes & Endocrinology, Aarhus University Hospital, Denmark
Background
Blood pressure (BP) reduction is the key to risk reduction of cardiovascular disease or renal failure in hypertensive patients with diabetes mellitus. Inhibition of the renin-angiotensin system by an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB) provides efficient BP reduction and renal protection in hypertensive diabetes patients. But, despite this, the recommended BP levels can be difficult to achieve and dual blockade therapy might be a possible way of obtaining efficient BP reduction in hypertensive patients with diabetes.
Dual blockade treatment is based on a principle of obtaining the broadest and most efficient blockade of angiotensin II, by using the combination of an ACE-inhibitor and an ARB.
Methods
The Candesartan And Lisinopril Microalbuminuria (CALM II) study is a one centre, one observer, double-blind, randomised, active-controlled, parallel-group study, investigating the efficacy and tolerability of candesartan cilexetil in combination with lisinopril, compared with the maximum recommended dose of lisinopril in hypertensive patients with diabetes mellitus.
The study design consists of two treatment arms with either 16 mg candesartan cilexetil or 20 mg lisinopril added to concomitant treatment with 20 mg lisinopril. It comprises 80 patients with a minimum of 35 patients in each group and statistical power of 90% to detect a difference in systolic BP reduction of 6.5 mmHg.
Conclusion
The CALM II study aims to investigate the effects of dual blockade on systolic BP, albuminuria, left ventricular mass and function, and retinopathy in hypertensive patients with diabetes mellitus.
Key Words: diabetes mellitus • hypertension • ACE-inhibitor • angiotensin II receptor blocker • echocardiography
References
- Hilgers KF, Mann JF ACE Inhibitors versus AT(1) receptor antagonists in patients with chronic renal disease. J Am Soc Nephrol 2002;13:1100-08.[Free Full Text]
- Hebert LA, Falkenhain ME, Nahman NS, Jr, Cosio FG, O'Dorisio TM Combination ACE inhibitor and angiotensin II receptor antagonist therapy in diabetic nephropathy. Am J Nephrol 1999;19:1-6.[Medline]
[Order article via Infotrieve]
- Rossing K., Christensen PK, Jensen BR, Parving HH Dual blockade of the renin-angiotensin system in diabetic nephropathy: a randomised double-blind crossover study. Diabetes Care 2002;25:95-100.[Abstract/Free Full Text]
- Jacobsen P.,Andersen S., Rossing K., Hansen BV, Parving HH Dual blockade of the renin-angiotensin system in type 1 patients with diabetic nephropathy. Nephrol Dial Transplant 2002;17:1019-24.[Abstract/Free Full Text]
- Mogensen CE, Neldam S., Tikkanen I. et al. Randomised controlled trial of dual blockade of renin-angiotensin system in patients with hypertension, microalbuminuria, and non-insulin dependent diabetes: the candesartan and lisinopril microalbuminuria (CALM) study. BMJ 2000;321(7274):1440-4.[Abstract/Free Full Text]
- O'Brien E., Mee F., Atkins N., O'Malley K. Accuracy of the SpaceLabs 90207 determined by the British Hypertension Societyprotocol.JHypertens 1991;9:573-4.[Web of Science][Medline]
[Order article via Infotrieve]
- Schiller NB, Shah PM, Crawford M. et al.Recommendations for quantitation of the left ventricle by two-dimensional echocardiography. American Society of Echocardiography Committee on Standards, Subcommittee on Quantitation of Two-Dimensional Echocardiograms. J Am Soc Echocardiogr 1989;2:358-67.[Medline]
[Order article via Infotrieve]
- Little WC, Ohno M., Kitzman DW, Thomas JD, Cheng CP Determination of left ventricular chamber stiffness from the time for deceleration of early left ventricular filling. Circulation 1995;92:1933-9.[Abstract/Free Full Text]
- Takatsuji H., Mikami T., Urasawa K. et al.A new approach for evaluation of left ventricular diastolic function: spatial and temporal analysis of left ventricular filling flow propagation by color M-mode Doppler echocardiography. J Am Coll Cardiol 1996;27:365-71.[Abstract]
- Mogensen CE, Vestbo E., Poulsen PL et al. Microalbuminuria and potential confounders. A review and some observations on variability of urinary albumin excretion. Diabetes Care 1995;18:572-81.[Web of Science][Medline]
[Order article via Infotrieve]
- Mogensen CE, Chachati A., Christensen CK et al. Microalbuminuria: an early marker of renal involvement in diabetes. Uremia Invest 1985;9:85-95.[Web of Science][Medline]
[Order article via Infotrieve]
- Mogensen CE, Keane WF, Bennett PH et al. Prevention of diabetic renal disease with special reference to microalbuminuria. Lancet 1995;346(8982):1080-4.[CrossRef][Web of Science][Medline]
[Order article via Infotrieve]
- Grading diabetic retinopathy from stereoscopic color fundus photographs-an extension of the modified Airlie House classification. ETDRS report number 10. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology 1991;98(5 suppl):786-806.[Web of Science][Medline]
[Order article via Infotrieve]
- Klein R., Klein BE, Moss SE, Davis MD, DeMets DL The Wisconsin epidemiologic study of diabetic retinopathy. II. Prevalence and risk of diabetic retinopathy when age at diagnosis is less than 30 years. Arch Ophthalmol 1984;102:520-6.[Abstract/Free Full Text]
- Fundus photographic risk factors for progression of diabetic retinopathy. ETDRS report number 12. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology 1991;98(5 suppl):823-33.[Web of Science][Medline]
[Order article via Infotrieve]
- Andersen NH, Mogensen CE Inhibition of the reninangiotensin system, with particular reference to dual blockade treatment. JRAAS 2001;2:146-52.[Medline]
[Order article via Infotrieve]
- Hansen KW, Schmitz A., Pedersen MM Ambulatory blood pressure measurement in type 2 diabetic patients: methodological aspects. Diabet Med 1991;8:567-72.[Web of Science][Medline]
[Order article via Infotrieve]
Journal of Renin-Angiotensin-Aldosterone System, Vol. 4, No. 2,
96-99 (2003)
DOI: 10.3317/jraas.2003.019
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