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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,130
Any dosage, frequency, and duration
Any antihypertensive regimen other than diuretics
University of the Ryukyus
Nishihara, Okinawa, Japan
New onset type 2 diabetes (WHO criteria 1998)
Time frame: five years
Treatment resistant hypokalemia less than 3.5mEq/L
Time frame: five years
Ischemic and hemorrhagic Strokes excluding transient ischemic attacks and secondary causes
Time frame: five years
Myocardial infarction
Time frame: five years
Hospitalization due to heart failure
Time frame: five years
Arteriosclerosis obliterans (ASO)
Time frame: five years
Total death
Time frame: five years
Blood pressure
Time frame: five years
Lipid profile
Time frame: five years
HbA1c
Time frame: five years
Fasting blood sugar
Time frame: five years
Direct Cost
Time frame: five years
Gout (American College of Rheumatology 1997 criteria C)
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Time frame: five years