Comparison of 26-week efficacy and tolerability of telmisartan and atenolol, in combination with hydrochlorothiazide as required, in the treatment ofmild to moderate hypertension: A randomized, multicenter study

Objective: This study was undertaken to compare the efficacy and tolerabili ty of telmisartan, a novel antihypertensive agent, and atenolol, a well-est ablished beta-blocker, in the treatment of mild to moderate hypertension. Methods: This 26-week, multicenter, randomized, double-blind, double-dummy, parallel-group, titration-to-response study compared doses of telmisartan (40 mg titrated to 80 mg titrated to 120 mg) with atenolol (50 mg titrated to 100 mg) required to achieve diastolic blood pressure (DBP) control (less than or equal to 90 mm Hg or a decrease from baseline of greater than or e qual to 10 mm Hg). Open-label hydrochlorothiazide (HCTZ) 12.5 or 25 mg was added if needed according to a prespecified titration rule. Men and women a ged >18 years with mild to moderate hypertension (morning mean supine DBP [ SDBP] greater than or equal to 95 mm Hg and less than or equal to 114 mm Hg ) were eligible to participate. Patients with significant cardiovascular, m etabolic, hepatic, or renal dysfunction or chronic obstructive pulmonary di sease were excluded. The primary efficacy end point was trough SDBP respons e at 26 weeks; secondary efficacy end points included changes from baseline at trough in both standing and supine DBP and systolic blood pressure (SBP ), and heart rate after 4, 8, 16, and 26 weeks; SEP control (reduction from baseline of greater than or equal to 10 mm HE); normalization of supine SD BP to less than or equal to 90 mm I-Ig; and the need for add-on HCTZ. Chang es in quality of lift: were also examined. Adverse events were obtained fro m spontaneous reporting and recorded. Serious adverse events were reported to the sponsor according to predefined timelines. Results: A total of 533 patients from 49 centers participated. Patients' me an age was 57.9 years (range, 22-79 years); 55.9% (298/533) of the populati on was male and 98.1% (523/533) was white, Of the 533 patients randomly ass igned to treatment and included ill the safety analysis, 520 (97.6%) were i ncluded in the efficacy analysis; 346 received telmisartan and 174 received atenolol. A total of 489 patients (91.7%) completed the study (325 [93.9%] , telmisartan; 164 [94.2%], atenolol). Pull SDBP response (trough SDBP less than or equal to 90 mm Hg and/or a reduction from baseline of greater than or equal to 10 mm Hg) was observed in 84% and 78% of telmisartan- and aten olol-treated patients, respectively; this difference was not statistically significant. Final SBP/DBP reductions of 20.9/14.4 mm Hg were observed for the telmisartan regimen versus 16.7/13.3 mm Hg for the atenolol regimen; on ly the difference in SEP was significant (P = 0.005). Reduction from baseli ne in SEP of greater than or equal to 10 mm Hg was achieved by 80% of telmi sartan-treated and 68% of atenolol-treated patients (P = 0.003). Adverse ev ents were reported by 52.7% of patients given telmisartan and 61.2% of pati ents given atenolol; this difference was not statistically significant. Mos t events were mild or moderate. Although fatigue and male impotence were mo re common in atenolol-treated patients (3.4% and 4.0%, respectively), the i ncidence of these adverse events was too low to differentiate statistically . Conclusions: Telmisartan appears to be at least as effective as atenolol in the treatment of mild to moderate hypertension and may be better tolerated .