Telmisartan as Monotherapy or add-on Therapy in African Hypertensive Patients
Background: There is a paucity of information on the effectiveness of angiotensin II-receptor antagonists in lowering blood pressure (BP) in black African hypertensive patients. This study was conducted to evaluate the antihypertensive effect, tolerability and safety profile of telmisartan, an angiotensin II-receptor antagonist, when given alone or as add- on therapy to adult African subjects with mild to moderate essential hypertension for a period of 12- 48 weeks. Methods: This study was part of a multicentre, multinational, open – labeled non-comparative trial of the efficacy and safety of telmisartan in controlling blood pressure of hypertensive patients. 30 adult Black African hypertensive patients were recruited into the study and after a 2 week placebo washout period, were given either 40mg or 80mg telmisartan once daily (OD) for a period of 48 weeks. Subjects whose BP was not controlled on the 80mg dose at 12 weeks were given either 2.5mg bendrofluazide OD or 50mg atenolol twice daily (BID). Primary study end –point was to determine the percentage of controlled responders using trough seated BP after 12 weeks. Systolic BP <140 mmHg and diastolic BP< 90mmHg defined controlled responders. Results: After 12 weeks of treatment the percentage of controlling responders was 50.0% with 95.8% being systolic responders and 83.8% diastolic responders. Mean change from baseline in mean seated trough systolic blood pressure (SBP) was -35.34 mmHg in the intent to treat population. Corresponding mean change in diastolic blood pressure (BDP) was -18.0mmHg. Both changes were statistically significant (p<0.05). After 48 weeks 54.2% were controlled responders, 87.5% systolic and 75.0% diastolic responders. In patients with mild hypertension, 53.8% were controlled after 12 weeks and 69.2% after 48 weeks. 43.3% of the patients experienced adverse events with peripheral oedema (16.6%) being the most frequently observed. Oedema was not dose- dependent though drug- related occurring more frequently with the lower 40mg dose. Conclusion: Telmisartan caused a significant decrease in both SBP and DBP after 12 weeks of treatment. This decrease was clinically relevant and observed up to 48 weeks. The 80mg dose appears to be required in most patients with moderate hypertension. The long term effect indicates telmisartan to be safe and effective treatment in the black African hypertensive population. The BP lowering effect is further enhanced when combined with other classes of antihypertensive drugs.
Keywords: Telmisartan, angiotensin II – receptor antagonist, essential hypertension, monotherapy, add-on therapy, controlled responders.
NQJHM Vol. 14 (2) 2004: pp. 169-174