A048: Effects of candesartan cilexetil as add-on therapy in hypertensive patients uncontrolled on background therapy: a clinical experience trial

• Published in: American journal of hypertension Vol. 13; no. S2; p. 128A
• Main Authors: Weir, M.R., Weber, M.A., Neutel, J.M., Vendetti, J., Harris, S., Michelson, E.L., Wang, R.
• Format: Journal Article
• Language: English
• Published: Oxford Oxford University Press 01.04.2000
• Subjects: add-on; angiotensin receptor blocker; Candesartan cilexetil; hypertension
• ISSN: 0895-7061; 1879-1905; 1941-7225
• DOI: 10.1016/S0895-7061(00)00581-1

Many patients with hypertension (HBP) require more than one agent for effective BP control. This 8-week, multicenter, open-label, not placebo-controlled, single-arm, practice-based trial evaluated the use of candesartan cilexetil (CC) 16 mg titrated to 32 mg as needed for BP control, either alone or as add-on treatment in patients uncontrolled on background BP therapy. The 6465 patients (mean age 58, baseline BP = 156/95 mmHg, 52% female, 16% black) included n = 5446 with essential HBP (DBP 90–109 mmHg) and n = 1014 with isolated systolic HBP (ISH) (SBP 140–179 mmHg, DBP <90 mmHg). CC 16 mg to 32 mg once daily resulted in an overall BP control rate of 67% (71% for patients with essential HBP, DBP <90 mmHg; 47% for patients with ISH, SBP <140 mmHg). CC as monotherapy reduced BP by 19/13 mmHg in essential HBP (n = 2514) and by 17/4 in ISH (n = 330). The additional mean changes from baseline to Week 8 by adding CC to background medications were: (See Table) Essential HBP ISH CC as add-on N BP N BP w/Diuretic 1066 −18/12 278 −17/5 w/Calcium antagonist 1065 −17/11 277 −16/4 w/Beta blocker (BB) 755 −17/10 197 −14/5 w/ACE inhibitor (ACEI) 473 −15/10 127 −13/4 w/Alpha blocker 249 −16/10 65 −12/5 w/BB + diuretic 150 −16/11 26 −20/8 w/ACEI + Ca antagonist 49 −12/10 14 −15/4 w/ACEI + diuretic 42 −14/8 12 −13/5 Overall tolerability was well maintained with the addition of CC. Only 7% withdrew due to AE. Postural hypotension was rare (0.6%). In conclusion, in this clinical experience trial, CC 16 mg to 32 mg once daily was an effective and well-tolerated antihypertensive agent either alone or as add-on to a wide variety of background BP therapies in uncontrolled patients with essential HBP or ISH.