Effectiveness of a trandolapril-based treatment regimen in subjects with isolated systolic hypertension in Canada

ABSTRACT

Objective: This report evaluates the effectiveness of a titration-based, escalating dose regimen based on trandolapril in subjects with isolated systolic hypertension (ISH) treated in Canadian clinical practice.

Methods: Substudy of the TRAIL (Trandolapril Regimen Applied In real Life) study; a prospective, open-label, single cohort, multicentre study in 192 Canadian primary care practices. Subjects with ISH received trandolapril therapy, initiated at 1 mg/day (0.5 mg/day in subjects on diuretics) and increased to 2 or 4 mg at 4 and 9 weeks, respectively, in those not achieving blood-pressure (BP) targets, subject to tolerability. If BP was not controlled after 14 weeks of treatment subjects could be put on trandolapril 4 mg/verapamil 240 mg while continuing the diuretic, or verapamil could be added to the existing regimen. The observation period was 26 weeks. The primary outcome measure was the achievement of target BP levels after 14 weeks.

Results: Systolic BP (SBP) was significantly (p < 0.01) reduced from 167.3 ± 8.7 mmHg at baseline to 136.8 ± 14.0 mmHg (means ± SD) at Week 14. The reductions were maintained at Week 26: mean SBP at this time point was 137.4 ± 12.5 mmHg. The target BP levels of ≤140/90 mmHg at Week 14 was reached by 67% of subjects with ISH. Among study limitations were the observational design; the lack of randomisation and control group, and the fact that subjects with ISH represented a comparatively small number of subjects.

Conclusions: A titration-based, escalating-dose regimen based on trandolapril is effective in subjects with ISH under treatment conditions seen in general clinical practice in Canada.

Key words: :

• Combination therapy
• Control rates
• Hypertension
• Observational study
• Tolerability
• Trandolapril

Transparency

Declaration of funding

The TRAIL study was sponsored and funded by Abbott.

Declaration of financial/other relationships

R.H.T. has disclosed that he has received research support from Abbott Laboratories, Canada. L.A. and A.V. have disclosed that they are employees of Abbott. E.B. has disclosed that she is on the speakers' bureau of Abbott.

All peer reviewers receive honoraria from CMRO for their review work. Peer Reviewer 1 disclosed research grant funding from Pfizer and serving as a consultant to Arca Biopharma. Peer Reviewer 2 has disclosed the/she has no relevant financial relationships.

Acknowledgments

The authors thank Dr P. Stolt for assistance with medical writing and editorial matters, which was supported by Abbot.

Notes

* Mavik, Abbott Laboratories, North Chicago, IL 60064, USA