An open-label study investigating the efficacy and safety of 12-96 weeks of telmisartan treatment in patients with hypertension.
This open-label, multicentre, multinational trial evaluated the efficacy and safety of telmisartan used alone or as add-on therapy in 2121 adults with mild-to-moderate essential hypertension. Patients received telmisartan 40-80 mg once daily for 12 weeks and could participate in the study for up to 96 weeks, or until a marketed supply of telmisartan became available. Mean change from baseline in mean seated trough diastolic blood pressure (DBP) after 12 weeks' treatment, the primary endpoint, was -11.8 mmHg in the intent-to-treat population. The corresponding mean change in mean seated trough systolic blood pressure (SBP) was -20.2 mmHg. Both changes were statistically significant. Mean DBP and SBP reductions were apparent from week 4 and maintained throughout the treatment period. Telmisartan was well tolerated; the most common adverse events were headache (6%) and dizziness (3%), and 10% of adverse events were considered drug-related. In conclusion, telmisartan is an effective and well-tolerated drug when used as monotherapy or add-on treatment in this broad population of patients.
Ingino
C
C
Hospital Militar Central, Buenos Aires, Argentina.
Farsang
C
C
Laucevicius
A
A
Bergovec
M
M
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D001565:Benzoates / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D004244:Dizziness / Q000139:chemically induced; D005260:Female; D006261:Headache / Q000139:chemically induced; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D000077333:Telmisartan
D000806:Angiotensin-Converting Enzyme Inhibitors; D001562:Benzimidazoles; D001565:Benzoates; D000077333:Telmisartan