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Clinical Drug Investigation

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01-05-2010 | Original Research Article

Candesartan Cilexetil/Hydrochlorothiazide Treatment in High-Risk Patients with Type 2 Diabetes Mellitus and Microalbuminuria

The CHILI T2D Study

Authors: Prof. Dr Reinhard Ketelhut, Peter Bramlage

Published in: Clinical Drug Investigation | Issue 5/2010

Abstract

Background: Arterial hypertension complicated by the presence of diabetes mellitus and microalbuminuria is a particularly hazardous risk-factor combination. Blockers of the renin-angiotensin system have been shown to be beneficial with respect to these risk factors in randomized clinical trials.

Objective: To provide proof of effectiveness for a fixed-dose combination such as candesartan cilexetil 16mg/hydrochlorothiazide (HCTZ) 12.5 mg in clinical practice within the context of a variety of concomitant diseases and medications.

Methods: CHILI T2D was a non-interventional, open-label, non-controlled, multicentre study in clinical practice that evaluated 4110 patients with type 2 diabetes, uncontrolled hypertension and microalbuminuria who were being prescribed a fixed-dose combination of candesartan cilexetil 16mg/HCTZ 12.5 mg (Biopress®). Documented outcomes included blood pressure (BP) reductions, metabolic changes, changes in albuminuria, and adverse events throughout the 12-week treatment period.

Results: Patients had a mean ±SD age of 64.0 ±10.3 years, 54.0% were male and the mean ±SD body mass index was 29.6 ±5.8 kg/m². Coronary heart disease (34.3%), diabetic neuropathy (23.8%), retinopathy (18.6%) and heart failure (20.2%) were frequent co-morbidities. The use of candesartan cilexetil 16mg/HCTZ 12.5mg in patients with a mean ±SD baseline BP of 158.5±14.2/92.5 ±9.1 mmHg resulted in a substantial further reduction of office BP by a mean ±SD of −27.1 ±14.4/-13.1±9.5mmHg (p<0.001). The reduction was particularly pronounced in patients with severe hypertension (mean reduction of −44.7/−19.9 mmHg). Glucose (glycosylated haemoglobin [HbA_1c], fasting blood glucose) as well as lipid parameters (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and triglycerides) were significantly improved (p< 0.001). Microalbuminuria, indicative of renal and cardiovascular risk, was significantly reduced by 28.8% (p< 0.001). Tolerability was excellent with only 16 out of 4110 patients experiencing any adverse event, of which six were considered to be serious.

Conclusions: The fixed-dose combination of candesartan cilexetil 16 mg/HCTZ 12.5 mg is highly effective in lowering blood pressure in type 2 diabetic patients with all stages of hypertension and microalbuminuria. The data indicate that low-dose HCTZ can safely be added to an existing drug regimen in this patient group to increase the BP-lowering effect, without compromising tolerability and the favourable metabolic profile of candesartan cilexetil monotherapy.

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Title: Candesartan Cilexetil/Hydrochlorothiazide Treatment in High-Risk Patients with Type 2 Diabetes Mellitus and Microalbuminuria
The CHILI T2D Study
Authors: Prof. Dr Reinhard Ketelhut
Peter Bramlage
Publication date: 01-05-2010
Publisher: Springer International Publishing
Published in: Clinical Drug Investigation / Issue 5/2010
Print ISSN: 1173-2563
Electronic ISSN: 1179-1918
DOI: https://doi.org/10.1007/BF03256905

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Candesartan Cilexetil/Hydrochlorothiazide Treatment in High-Risk Patients with Type 2 Diabetes Mellitus and Microalbuminuria

The CHILI T2D Study

Abstract

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

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