Dyazide (Hydrochlorothiazide / Triamterene) - Summary

DYAZIDE SUMMARY

Each Dyazide capsule for oral use, with opaque red cap and opaque white body, contains hydrochlorothiazide 25 mg and triamterene 37.5 mg, and is imprinted with the product name DYAZIDE and SB. Hydrochlorothiazide is a diuretic/antihypertensive agent and triamterene is an antikaliuretic agent.

This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked.

Dyazide is indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone.

Dyazide is also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked.

Dyazide may be used alone or as an adjunct to other antihypertensive drugs, such as beta-blockers. Since Dyazide may enhance the action of these agents, dosage adjustments may be necessary.

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NEWS HIGHLIGHTS

Published Studies Related to Dyazide (Hydrochlorothiazide / Triamterene)

Effect of quinapril and triamterene/hydrochlorothiazide on cardiac and vascular end-organ damage in isolated systolic hypertension. [1998.02]
We compared, in a prospective double-blind randomized study, the effect of the angiotensin-converting enzyme inhibitor quinapril (QUI) with that of triamterene/hydrochlorothiazide (THCT) treatment on cardiovascular end-organ damage in subjects with untreated isolated systolic hypertension (ISH)... Results of LV diastolic function and peripheral vascular resistance were less clear but appear to show less favorable changes in the THCT subjects treatment group.

Pharmacokinetics and pharmacodynamics of triamterene and hydrochlorothiazide and their combination in healthy volunteers. [1997.10]
Although triamterene has been in clinical use for over 30 years, the linearity of triamterene kinetics was not systematically tested. Moreover, although triamterene is mostly applied concomitantly with thiazide-type diuretics the interaction of triamterene (TA) with hydrochlorothiazide (HCT) is subject to a controversial discussion.

Felodipine or hydrochlorothiazide/triamterene for treatment of hypertension in the elderly: effects on blood pressure, hypertensive heart disease, metabolic and hormonal parameters. [1996.05]
The aim of the study was to compare the antihypertensive efficacy of either felodipine or the diuretic combination hydrochlorothiazide/triamterene in a group (n = 65) of elderly (> or = 70 years) hypertensives (office blood pressure > or = 160/95 mmHg) with special regard to ambulatory blood pressure monitoring, hypertensive heart disease and metabolic parameters...

A study of plasma sodium levels in elderly people taking amiloride or triamterene in combination with hydrochlorothiazide. [1993.10]
This study was performed to compare the effect of one month's treatment with hydrochlorothiazide (25 mg) in combination with either amiloride (2.5 mg) or triamterene (50 mg) on plasma sodium levels in elderly people in institutional care. Fifty residents of NHS nursing or social service residential care established on diuretics for congestive cardiac failure and aged 64 years or over were recruited...

A comparison of the anti-hypertensive effectiveness of two triameterene/hydrochlorothiazide combinations: Maxzide versus Dyazide. [1990.08]
The hydrochlorothiazide component of Maxzide (Lederle Laboratories, Pearl River, NY) has been shown to be more bioavailable than the hydrochlorothiazide component of Dyazide (Smith, Kline and French Laboratories, Philadelphia, PA). The authors compared the antihypertensive effectiveness of a half-tablet of Maxzide (25 mg of hydrochlorothiazide and 37.5 mg of triamterene) to one capsule of Dyazide (25 mg of hydrochlorothiazide and 50 mg of triamterene) to determine if the difference in bioavailability would be reflected in differences in blood pressure control and metabolic changes...

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Clinical Trials Related to Dyazide (Hydrochlorothiazide / Triamterene)

Efficacy of Irbesartan/Hydrochlorothiazide Versus Valsartan/Hydrochlorothiazide in Mild to Moderate Hypertension [Recruiting]
The primary objective is to compare the efficacy of irbesartan/hydrochlorothiazide 300/25mg against valsartan/hydrochlorothiazide 160/25mg in reducing mean systolic blood pressure (SBP) as measured by home blood pressure monitoring (HBPM) after 24 weeks compared with baseline.

The secondary objectives are:

- To compare the percentage of patients with normal blood pressure as measured by HBPM and

at the doctor's office at weeks 16 and 24

- To compare the differences in mean Diastolic Blood Pressure (DBP), mean morning and

evening SBP and DBP evaluated by HBPM at weeks 16 and 24

- To compare the difference in mean SBP evaluated by HBPM at week 16

- To compare the differences in mean SBP and DBP evaluated at the doctor's office at weeks

16 and 24

- To determine the incidence and severity of adverse events

Irbesartan/Hydrochlorothiazide and Irbesartan in the Treatment of Mild to Moderate Hypertension [Completed]
Study Objectives :

- To demonstrate the reduction in office Blood Pressure following a 8-week regimen of

irbesartan / hydrochlorothiazide using irbesartan as a reference.

- To demonstrate the reduction in office Blood Pressure after 4-week regimen of irbesartan

/ hydrochlorothiazide using irbesartan as a reference.

- To compare the response rate (defined as office Systolic Blood Pressure/Diastolic Blood

Pressure reduce more than 10mmHg from Week 0) of patients after 4-week and 8-week regimen of irbesartan / hydrochlorothiazide versus irbesartan.

- To compare the proportion of patients requiring titration after 4-week regimen of

irbesartan/hydrochlorothiazide versus irbesartan

- To ascertain the safety and tolerability of irbesartan / hydrochlorothiazide versus

irbesartan when administered once daily

A Randomized, Double-Blind, Placebo-Controlled, Forced-Titration, Phase IV Study Comparing Telmisartan 80 mg + Hydrochlorothiazide 25 mg [Micardis HCT] Versus Valsartan 160 mg + Hydrochlorothiazide 25 mg [Diovan HCT] Taken Orally for Eight Weeks in Patients With Stage 1 and Stage 2 Hypertension. [Completed]

A Comparison of Telmisartan + Hydrochlorothiazide With Amlodipine + Hydrochlorothiazide in the Control of Blood Pressure in Older Patients With Predominantly Systolic Hypertension. (ATHOS Study) [Completed]
The primary objective of this clinical trial was to show that the combination of telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12. 5 mg was not inferior to and was possibly superior to amlodipine 10 mg + HCTZ 12. 5 mg in reducing the systolic blood pressure (SBP) in the last six hours of the 24-hour dose period [as measured by 24-hour ambulatory blood pressure monitoring ( ABPM)] in elderly patients with predominantly systolic hypertension. The primary endpoint was the change from baseline in SBP in the last six hours of the 24-hour dose period (as measured by 24-hour ABPM) at the end-of-study visit.

Efficacy and Safety of Valsartan, Hydrochlorothiazide and Amlodipine Combination Therapy in Hypertension [Completed]
This study is designed to evaluate the efficacy and safety of the combination valsartan with hydrochlorothiazide and amlodipine in hypertensive patients previously treated with valsartan with hydrochlorothiazide and remaining uncontrolled. A naturalistic approach will be taken comparing two different possible ways to achieve the higher dosage of the triple combination, i. e. 160 mg of valsartan and 25 mg of hydrochlorothiazide with amlodipine 10 mg.

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