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A 26-week, prospective, open-label, uncontrolled, multicenter study to evaluate the effect of an escalating-dose regimen of trandolapril on change in blood pressure in treatment-naive and concurrently treated adult hypertensive subjects (TRAIL).

AbstractOBJECTIVE:
This study evaluated the effectiveness of an escalating-dose regimen of trandolapril in subjects with stage 1 or stage 2 hypertension.
METHODS:
This was a 26-week, prospective, open-label,multicenter study in Canadian primary care centers. Subjects with hypertension who were treatment naive or whose disease was uncontrolled on current first-line antihypertensive monotherapy were treated with trandolapril for 26 weeks alone or in addition to their current treatment. Uncontrolled hypertension was defined as systolic/diastolic blood pressure (SBP/DBP) >or=140/90 mm Hg in subjects with no other risk factors or >or=130/80 mm Hg in subjects with diabetes or kidney disease. Trandolapril therapy was initiated at 1 mg/d and was titrated as required to 2 or 4 mg at 4 and 9 weeks after initiation of treatment, respectively, in those not achieving BP targets. At 14 weeks after treatment initiation, subjects not achieving BP targets could receive a combination of trandolapril 4 mg plus a calcium channel blocker (verapamil 240 mg) with or without a diuretic. Primary outcome was the percentage of patients reaching target BP after 14 weeks.
RESULTS:
A total of 1683 subjects from 192 general practice clinics across Canada completed the 14-week trandolapril dose-optimization phase, and 1650 completed the full 26-week follow-up. Mean (SD) age was 56.6 (12.6) years, and 49.2% of the subjects were men. At baseline, 82.4% (1359/1650) of subjects were antihypertensive-treatment naive. At the trial end, 73.4% (95% CI, 70.9-75.9) of subjects achieved a target level of SBP/DBP <140/90 mm Hg. The mean (SD) reductions in SBP and DBP were -21.5 (14.0) and -11.9 (9.1) mm Hg, respectively (P < 0.001), and -22.4 (14.0) and -12.7 (9.0) mm Hg, respectively (P < 0.001), at 26 weeks. A total of 343 predominantly mild, nonserious adverse events were attributed to the study drugs, reported by 252 (15.3%) of the 1650 subjects. The most frequently reported nonserious adverse events were cough (6.3%); gastrointestinal disorders (2.3%), predominantly nausea; and headache (2.1%). No serious adverse events were attributed to the study treatment. Trandolapril was generally well tolerated.
CONCLUSIONS:
A titration-based, escalating-dose regimen of trandolapril was effective and well tolerated in the management of these subjects who were antihypertensive-treatment naive or whose disease was uncontrolled on a diuretic or a calcium channel blocker in this open-label, uncontrolled, multicenter study. Overall, 73.4% of subjects achieved their target blood pressure goal (<140/90 mm Hg).
AuthorsRichard H Tytus, Ellen D Burgess, Linda Assouline, Anita Vanjaka
JournalClinical therapeutics (Clin Ther) Vol. 29 Issue 2 Pg. 305-15 (Feb 2007) ISSN: 0149-2918 [Print] United States
PMID17472822 (Publication Type: Clinical Trial, Phase IV, Journal Article, Multicenter Study)
Chemical References
  • Angiotensin-Converting Enzyme Inhibitors
  • Antihypertensive Agents
  • Calcium Channel Blockers
  • Diuretics
  • Indoles
  • trandolapril
  • Verapamil
Topics
  • Adult
  • Aged
  • Aged, 80 and over
  • Angiotensin-Converting Enzyme Inhibitors (administration & dosage, adverse effects, therapeutic use)
  • Antihypertensive Agents (administration & dosage, adverse effects)
  • Blood Pressure (drug effects)
  • Calcium Channel Blockers (therapeutic use)
  • Canada
  • Diuretics (therapeutic use)
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Female
  • Humans
  • Hypertension (drug therapy)
  • Indoles (administration & dosage, adverse effects)
  • Male
  • Middle Aged
  • Primary Health Care
  • Prospective Studies
  • Verapamil (therapeutic use)

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