[Diltiazem 180 mg in delayed release formulation in mild and moderate arterial hypertension]. 1995

L Serra-Pinto, and A Baptista, and E Rocha
Serviço de Cardiologia, Hospital Distrital de Setúbal.

BACKGROUND Having acknowledge the need to treat arterial Hypertension concomitantly effective, safe and easy to comply with. These issues are the mainstay for a good adherence to a treatment that is long. OBJECTIVE This clinical trial addresses the efficacy and safety of an extended release tablet of 180 mg of diltiazem, once daily, to treat mild to moderate hypertension. METHODS Forty-five patients with mild to moderate hypertension were included in a multicentric, open trial consisting of three periods: washout (one week), placebo (one week) and a treatment period of four weeks with 180 mg slow-release tablets of diltiazem. Arterial Blood Pressure (BP) was measured through ambulatory blood pressure monitoring (ABPM) at the end of the first, second and sixth weeks. The therapeutic response was evaluated in terms of decrease in mmHg and in terms of systolic and diastolic loads. Treatment was considered successful when there was a drop in the medium diastolic BP to 90 mmHg or less and/or a decrease of at least 10 mmHg. RESULTS Twenty-three patients completed the trial. There was a significant decrease (p < 0.0001) in the medium diastolic and systolic 24-hour BP values. The efficacy parameters were met in 62.5% of the patients, nonetheless there was a drop of at least 5 mmHg in 82.6%. There was a statistically more significant response during the diurnal versus the nocturnal periods, according to both criteria. CONCLUSIONS Diltiazem, 180 mg extended-release tablet taken one daily, proved to be effective, over 24 hours, in controlling Hypertension in 62.5% of the enrolled patients while decreasing the medium diastolic BP by at least 5 mmHg in 82.5%.

UI MeSH Term Description Entries
D006973 Hypertension Persistently high systemic arterial BLOOD PRESSURE. Based on multiple readings (BLOOD PRESSURE DETERMINATION), hypertension is currently defined as when SYSTOLIC PRESSURE is consistently greater than 140 mm Hg or when DIASTOLIC PRESSURE is consistently 90 mm Hg or more. Blood Pressure, High,Blood Pressures, High,High Blood Pressure,High Blood Pressures
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D003692 Delayed-Action Preparations Dosage forms of a drug that act over a period of time by controlled-release processes or technology. Controlled Release Formulation,Controlled-Release Formulation,Controlled-Release Preparation,Delayed-Action Preparation,Depot Preparation,Depot Preparations,Extended Release Formulation,Extended Release Preparation,Prolonged-Action Preparation,Prolonged-Action Preparations,Sustained Release Formulation,Sustained-Release Preparation,Sustained-Release Preparations,Timed-Release Preparation,Timed-Release Preparations,Controlled-Release Formulations,Controlled-Release Preparations,Extended Release Formulations,Extended Release Preparations,Slow Release Formulation,Sustained Release Formulations,Controlled Release Formulations,Controlled Release Preparation,Controlled Release Preparations,Delayed Action Preparation,Delayed Action Preparations,Formulation, Controlled Release,Formulations, Controlled Release,Prolonged Action Preparation,Release Formulation, Controlled,Release Formulations, Controlled,Sustained Release Preparation,Timed Release Preparation,Timed Release Preparations
D004110 Diltiazem A benzothiazepine derivative with vasodilating action due to its antagonism of the actions of CALCIUM ion on membrane functions. Aldizem,CRD-401,Cardil,Cardizem,Dilacor,Dilacor XR,Dilren,Diltiazem Hydrochloride,Diltiazem Malate,Dilzem,Tiazac,CRD 401,CRD401
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults
D000368 Aged A person 65 years of age or older. For a person older than 79 years, AGED, 80 AND OVER is available. Elderly
D012720 Severity of Illness Index Levels within a diagnostic group which are established by various measurement criteria applied to the seriousness of a patient's disorder. Illness Index Severities,Illness Index Severity

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