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| Name | Class |
|---|---|
| University of the Ryukyus | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Diuretics use |
|
| 2 | Active Comparator | No diuretics use |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thiazide diuretics | Drug | Any dosage, frequency, and duration |
| |
| No diuretics |
| Measure | Description | Time Frame |
|---|---|---|
| New onset type 2 diabetes (WHO criteria 1998) | five years |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment resistant hypokalemia less than 3.5mEq/L | five years | |
| Ischemic and hemorrhagic Strokes excluding transient ischemic attacks and secondary causes | five years | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shinichiro Ueda, MB, ChB, PhD | Department of Clinical Pharmacology & Therapeutics, University of the Ryukyus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of the Ryukyus | Nishihara | Okinawa | 903-0215 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25031188 | Derived | Ueda S, Morimoto T, Ando S, Takishita S, Kawano Y, Shimamoto K, Ogihara T, Saruta T; DIME Investigators. A randomised controlled trial for the evaluation of risk for type 2 diabetes in hypertensive patients receiving thiazide diuretics: Diuretics In the Management of Essential hypertension (DIME) study. BMJ Open. 2014 Jul 16;4(7):e004576. doi: 10.1136/bmjopen-2013-004576. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D000075222 | Essential Hypertension |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
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| ID | Term |
|---|---|
| D049993 | Sodium Chloride Symporter Inhibitors |
| ID | Term |
|---|---|
| D049990 | Membrane Transport Modulators |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| Drug |
Any antihypertensive regimen other than diuretics |
|
| Myocardial infarction |
| five years |
| Hospitalization due to heart failure | five years |
| Arteriosclerosis obliterans (ASO) | five years |
| Total death | five years |
| Blood pressure | five years |
| Lipid profile | five years |
| HbA1c | five years |
| Fasting blood sugar | five years |
| Direct Cost | five years |
| Gout (American College of Rheumatology 1997 criteria C) | five years |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D004232 | Diuretics |
| D045283 | Natriuretic Agents |
| D045505 | Physiological Effects of Drugs |