Diabetes with hypertension medical therapy

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-In-Chief: Priyamvada Singh, M.B.B.S. [2]; Cafer Zorkun, M.D., Ph.D. [3]

## Overview

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Hypertension is a common co-morbidity associated with patients of diabetes, especially type 2 diabetes. Co-existence of these conditions strongly predispose patients to both renal as well as cardiovascular (CV) injury. Diabetes is the most common cause of end-stage renal disease in the United States. The 1994 Working Group Report on Hypertension and Diabetes, has recommended the original blood pressure goals of less than 130/85 mmHg to preserve renal function and reduce cardiovascular events in these groups of patients.

## Treatment

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The preferred treatment of the diabetic with hypertension includes:

* ACE inhibitors which may provide benefits above and beyond control of hypertension including delaying progression of renal disease.
* Calcium channel blockers
* Low dose diuretics

## Supportive Trial Data

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### Study Name: LIFE Study, 2002 [1]

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* Study design: Double blinded, randomised, parallel-group trial
* Sample size: 1195 patients with diabetes, hypertension, left ventricular hypertrophy (on electrocardiograms)
* Study drugs: Losartan or Atenolol
* Study period: 4 years
* Study results: Losartan was found to be more effective than atenolol in reducing composite endpoints like cardiovascular morbidity and all causes mortality in patients with hypertension, diabetes, and left-ventricular hypertrophy.

### Study Name: Candesartan and Lisinopril Microalbuminuria (CALM) Study, 2000 [2]

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* Study design: Double blinded, prospective, randomised, parallel-group, multicenteric (4 countries, 37 centers) trial
* Sample size: 199 patients with diabetes & hypertension
* Study drugs: Candesartan or lisinopril
* Study period:
* Placebo run in period-4 weeks
* 12 weeks Candesartan or lisinopril
* Followed by 12 weeks' monotherapy or combination treatment
* Study question: Compare the effects of candesartan or lisinopril, or both, on blood pressure and urinary albumin excretion , hypertension, and type 2 diabetes.
* Study results: Candesartan was found to be as effective as lisinopril in reducing blood pressure and microalbuminuria in hypertensive type 2 diabetics. Combination treatment (Candesartan+lisinopril) was well tolerated and more effective in reducing blood pressure compared to either drugs alone.

### Study Name: Fosinopril Versus Amlodipine Cardiovascular Events Randomized Trial, (FACET), 1998 [3]

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* Study design: Open label, randomized trial
* Sample size: 380 hypertensive diabetics patient
* Study drugs: Fosinopril (20 mg/day) or amlodipine (10 mg/day)
* Study period: 3.5 years
* Inclusion criteria\- NIDDM and hypertension (SBP > 140 mmHg or DBP > 90 mmHg).
* Exclusion criteria\- History of coronary heart disease or stroke, serum creatinine > 1.5 mg/dl, albuminuria > 40 micrograms/min, and use of lipid-lowering drugs, aspirin, or antihypertensive agents other than beta-blockers or diuretics.
* Study results: Fosinopril lowered the risk of the composite endpoints of acute myocardial infarction, stroke, or hospitalization due to angina more compared to amlodipine (hazards ratio = 0.49, 95% CI = 0.26-0.95). However, no significant difference in total serum cholesterol, HDL cholesterol, HbA1c, fasting serum glucose, or plasma insulin was found.

### Hypertension/ Blood Pressure Control

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"1. Screening and diagnosis: Blood pressure should be measured at every routine visit. Patients found to have elevated blood pressure should have blood pressure confirmed on a separate day. (Level of Evidence: B)"

"2. Goals:

* People with diabetes and hypertension should be treated to a systolic blood pressure goal of <140 mmHg. (Level of Evidence: B)"
* Lower systolic targets, such as <130 mmHg, may be appropriate for certain individuals, such as younger patients, if it can be achieved without undue treatment burden. (Level of Evidence: C)"
* Patients with diabetes should be treated to a diastolic blood pressure <80 mmHg.. (Level of Evidence: B)"

"3. Treatment:

* Patients with a blood pressure <120/ 80 mmHg should be advised on life- style changes to reduce blood pressure. (Level of Evidence: B)"
* Patients with confirmed blood pressure ≥140/80 mmHg should, in addition to lifestyle therapy, have prompt initiation and timely subsequent titration of pharmacological therapy to achieve blood pressure goals. (Level of Evidence: B)"
* Lifestyle therapy for elevated blood pressure consists of weight loss, if overweight; Dietary Approaches to Stop Hypertension (DASH)-style dietary pattern including reducing sodium and increasing potassium intake; moderation of alcohol intake; and increased physical activity. (Level of Evidence: B)"
* Pharmacological therapy for patients with diabetes and hypertension should be with a regimen that includes either an ACE inhibitor or an angiotensin receptor blocker (ARB). If one class is not tolerated, the other should be substituted. (Level of Evidence: C)"
* Multiple-drug therapy (two or more agents at maximal doses) is generally required to achieve blood pressure targets. (Level of Evidence: B)"
* Administer one or more antihypertensive medications at bedtime. (Level of Evidence: A)"
* If ACE inhibitors, ARBs, or diuretics are used, serum creatinine/estimated glomerular filtration rate (eGFR) and serum potassium levels should be monitored. (Level of Evidence: E)"
* In pregnant patients with diabetes and chronic hypertension, blood pressure target goals of 110–129/65–79 mmHg are suggested in the interest of long- term maternal health and minimizing impaired fetal growth. ACE inhibitors and ARBs are contraindicated during pregnancy. (Level of Evidence: E)"

## References

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1. ↑ Lindholm LH, Ibsen H, Dahlöf B, Devereux RB, Beevers G, de Faire U; et al. (2002). "Cardiovascular morbidity and mortality in patients with diabetes in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): a randomised trial against atenolol". Lancet. 359 (9311): 1004–10. doi:10.1016/S0140-6736(02)08090-X. PMID 11937179.CS1 maint: Explicit use of et al. (link) CS1 maint: Multiple names: authors list (link)  Review in: ACP J Club. 2002 Nov-Dec;137(3):87
2. ↑ Mogensen CE, Neldam S, Tikkanen I, Oren S, Viskoper R, Watts RW; et al. (2000). "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. 321 (7274): 1440–4. PMC 27545. PMID 11110735.CS1 maint: Explicit use of et al. (link) CS1 maint: Multiple names: authors list (link) CS1 maint: PMC format (link)
3. ↑ Tatti P, Pahor M, Byington RP, Di Mauro P, Guarisco R, Strollo G; et al. (1998). "Outcome results of the Fosinopril Versus Amlodipine Cardiovascular Events Randomized Trial (FACET) in patients with hypertension and NIDDM". Diabetes Care. 21 (4): 597–603. PMID 9571349.CS1 maint: Explicit use of et al. (link) CS1 maint: Multiple names: authors list (link)

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