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CARDIOLOGY
UPDATE - Landmark Trials
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Prospective, randomised investigation of the safety and efficacy of telmisartan versus ramipril using ambulatory blood pressure monitoring
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Background
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- Blood pressure (BP) follows a circadian pattern with a morning surge that is associated with an increased risk of acute coronary and cerebrovascular events.
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Aim
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- To compare the efficacy and safety of telmisartan and ramipril in reducing ambulatory BP during the last 6 h of the 24-h dosing interval.
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Study design
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- PROBE (Prospective, Randomized, Open-label, Blinded-Endpoint) study
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Study patients
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- 812 patients with mild to moderate hypertension [mean seated diastolic BP ≥ 95 mm Hg and ≤ 109 mm Hg and a 24-h ambulatory BP monitoring (ABPM) diastolic BP ≥ 85 mm Hg].
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Study groups
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- Telmisartan initiated at 40 mg for 2 weeks, up-titrated to 80 mg for 12 weeks.
- Ramipril initiated at 2.5 mg for 2 weeks, titrated to 5 mg for 6 weeks and then to 10 mg for a further 6 weeks.
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Results
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- Telmisartan 80 mg was superior to ramipril 5 mg and 10 mg in reducing the mean ambulatory BP during the last 6 h of dosing interval at 8 and 14 weeks, respectively.

- Significantly and consistently greater reduction with telmisartan 80 mg in controlling 24 h BP than ramipril 5 mg and 10 mg after 8 and 14 weeks of treatment, respectively.

- Greater ambulatory BP response rates in telmisartan-treated patients than among those treated with ramipril 5 mg and 10 mg.

- Significantly greater reductions in morning, daytime and nighttime mean ambulatory BP with telmisartan 80 mg compared to ramipril 5 mg and 10 mg.
- Patients treated with ramipril had a higher incidence of cough than those treated with telmisartan (10.1% vs. 1.5%, respectively).
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Conclusion
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- Telmisartan was consistently and significantly more effective than ramipril in controlling BP during the last 6 h of the dosing interval, a time when patients are at greatest risk of cardiovascular and cerebrovascular events.
- Both drugs were equally well tolerated, but telmisartan was associated with fewer instances of cough.
Am J Hypertens 2006; 19: 104-112
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