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Joel M. Neutel, Christiane Klein, Thomas W. Meinicke, Helmut Schumacher, P-232: Long-term efficacy and tolerability of telmisartan as monotherapy and in combination with other antihypertensive medications, American Journal of Hypertension, Volume 14, Issue S1, April 2001, Page 106A, https://doi.org/10.1016/S0895-7061(01)01422-4
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Abstract
This open-label, multicenter, extension study assessed the efficacy and tolerability of telmisartan 80 mg administered alone or with hydrochlorothiazide (HCTZ) and/or other antihypertensive agents over a maximal 1-year treatment period.
Of the 690 patients with mild-to-moderate hypertension completing the preceding 6-week, randomized study (comparing telmisartan 80 mg with losartan 50 mg/HCTZ 12.5 mg combination therapy), 490 patients (71.0%) continued in this extension study. A fixed-titration regimen was employed: all patients received telmisartan 80 mg initially, with stepwise addition of HCTZ 12.5 mg, HCTZ 25 mg, and/or other antihypertensives to attain DBP control (<90 mmHg).
489 patients received treatment and 483 patients were included in the intent-to-treat analysis. 57.3% (277/483) of patients were maintained on telmisartan 80 mg monotherapy throughout the study and 68.6% (194/283) of them reached DBP control at the final visit. A subgroup analysis by pretreatment (telmisartan 80 mg vs losartan 50 mg + HCTZ 12.5 mg) in the preceding study did not reveal any difference in maintenance rate of telmisartan monotherapy and control rates in the present study. 17.8% (86/483) of patients were titrated to telmisartan 80 mg + HCTZ 12.5 mg and 55.8% (48/86) reached DBP control. 54.7% (47/86) titrated to telmisartan 80 mg + HCTZ 25 mg and 64.7% (22/34) titrated to telmisartan 80 mg + other antihypertensive ± HCTZ (12.5 or 25 mg) reached DBP control. The DBP and SBP reductions observed in the preceding randomized study continued during extension treatment. Overall, a further decrease by a mean of 4.5 (SD ± 10.0) mmHg in DBP and by a mean of 5.7 (SD ± 16.4) mmHg in SBP was observed. Progressively greater blood pressure reductions occurred with the sequential addition of HCTZ and other antihypertensives. Adding HCTZ 12.5 mg to telmisartan 80 mg was particularly effective at enhancing antihypertensive efficacy. All treatments were well tolerated.
In conclusion, telmisartan 80 mg administered alone or with HCTZ (12.5 or 25 mg) and/or other antihypertensives maintains a clinically significant therapeutic effect over the long term in patients with mild-to-moderate hypertension.