Diuretics In the Management of Essential Hypertension (DIME) Study

Kyoto University

Status and phase

Completed

Phase 4

Conditions

Hypertension

Treatments

Drug: No diuretics

Drug: Thiazide diuretics

Study type

Interventional

Funder types

Other

Identifiers

NCT00131846

H15-choju-003

Details and patient eligibility

About

The purpose of DIME is to evaluate the safety (i.e. new onset of diabetes and other metabolic adverse events), efficacy and cost-effectiveness of antihypertensive treatment with low dose diuretics. The researchers' hypothesis is that use of low dose thiazide diuretics is metabolically safe when used with other appropriate antihypertensives, effective in reduction of blood pressure and cheaper than treatment without diuretics. Therefore, this study is an equivalence trial.

Full description

There has been substantial evidence from clinical trials to support the rationale of use of thiazide diuretics in patients with essential hypertension. Diuretics may be more effective in reduction of blood pressure in Japanese patients than Caucasian because of higher salt intake. Moreover, given a large number of hypertensive population here, diuretics may be the most cost-effective antihypertensive agent. Japanese physicians, however, tend to avoid diuretics even in elderly hypertensive patients because of much concern over metabolic adverse events including new onset diabetes, which is deemed to increase cardiovascular risk. Although it is unlikely that use of low dose (12.5 mg of HCTZ or less) diuretics is associated with metabolic adverse events when they are given with any other appropriate antihypertensive agents (e.g. Ca antagonist, ACE inhibitor, ARB, K sparing diuretics) other than β-blockers, the researchers have to confirm the safety of low dose diuretics in terms of new onset diabetes in Japanese, who are assumed to be "diabetes prone" based upon thrifty gene hypothesis.

Enrollment

1,130 patients

Sex

All

Ages

30 to 79 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Aged 30 to 79 years
With blood pressure being >150/>90 if they are not on any antihypertensive treatment
With blood pressure being >140/>90 if they are already on antihypertensive drugs
No history of type 2 diabetes
No history of gout

Exclusion criteria

With supine blood pressure being >200/>120
Patients already on antihypertensive treatment if duration of treatment and drugs used are not identified
Patients already on thiazide diuretics
With type 2 diabetes
With gout or hyperuricaemia (>8.0 mg/dl)
With hypokalemia（<3.5mmol/L）
With erectile dysfunction
With renal dysfunction (s-creatinine > 2.0 mg/dL)
With history of serious adverse reaction to thiazide diuretics
With history of stroke or myocardial infarction within 6 months
With history of percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) within 6 months or in whom these interventions are planned
With heart failure or left ventricular dysfunction (ejection fraction<40%)
Patients who should be on thiazide diuretics
With history of malignant tumor within 5 years
Pregnant, possibility of pregnancy, or during breast feeding
Patients who are deemed not eligible for this study for any reason