Comparison of 26-week efficacy and tolerability of telmisartan and atenolol, in combination with hydrochlorothiazide as required, in the treatment of mild to moderate hypertension: a randomized, multicenter study

• Published in: Clinical therapeutics Vol. 23; no. 1; pp. 108 - 123
• Main Authors: Freytag, Frank, Schelling, Adre, Meinicke, Thomas, Deichsel, Guntram
• Format: Journal Article
• Language: English
• Published: Belle Mead, NJ EM Inc USA 2001; Excerpta Medica
• Subjects: Adrenergic beta-Antagonists - administration & dosage; Adult; Aged; Angiotensin-Converting Enzyme Inhibitors - administration & dosage; Antihypertensive agents; Atenolol - administration & dosage; Atenolol - adverse effects; Benzimidazoles - administration & dosage; Benzimidazoles - adverse effects; Benzoates - administration & dosage; Benzoates - adverse effects; Biological and medical sciences; Cardiovascular system; Diuretics; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Hydrochlorothiazide - administration & dosage; Hypertension - drug therapy; Male; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Sodium Chloride Symporter Inhibitors - administration & dosage; Human; Hypertension; Toxicity; Treatment efficiency; Cardiovascular disease; Atenolol; β-Adrenergic receptor; Telmisartan; Chemotherapy; Treatment; Antihypertensive agent; Angiotensin antagonist; Antagonist; Angiotensin II; Comparative study; Beta blocking agent; Biological receptor
• ISSN: 0149-2918; 1879-114X
• DOI: 10.1016/S0149-2918(01)80034-5

Objective: This study was undertaken to compare the efficacy and tolerability of telmisartan, a novel antihypertensive agent, and atenolol, a well-established beta-blocker, in the treatment of mild to moderate hypertension. Methods: This 26-week, multicenter, randomized, double-blind, double-dummy, parallel-group, titration-to-response study compared doses of telmisartan (40 mg titrated to 80 mg titrated to 120 mg) with atenolol (50 mg titrated to 100 mg) required to achieve diastolic blood pressure (DBP) control (≤90 mm Hg or a decrease from baseline of ≥10 mm Hg). Open-label hydrochlorothiazide (HCTZ) 12.5 or 25 mg was added if needed according to a prespecified titration rule. Men and women aged > 18 years with mild to moderate hypertension (morning mean supine DBP [SDBP] ≥95 mm Hg and ≤114 mm Hg) were eligible to participate. Patients with significant cardiovascular, metabolic, hepatic, or renal dysfunction or chronic obstructive pulmonary disease were excluded. The primary efficacy end point was trough SDBP response at 26 weeks; secondary efficacy end points included changes from baseline at trough in both standing and supine DBP and systolic blood pressure (SBP), and heart rate after 4, 8, 16, and 26 weeks; SBP control (reduction from baseline of ≥10 mm Hg); normalization of supine SDBP to ≤90 mm Hg; and the need for add-on HCTZ. Changes in quality of life were also examined. Adverse events were obtained from spontaneous reporting and recorded. Serious adverse events were reported to the sponsor according to predefined timelines.