Efficacy of candesartan cilexetil as add-on therapy in hypertensive patients uncontrolled on background therapy: A clinical experience trial

A large-scale, 8-week, open-label, clinical experience trial evaluated the efficacy of the angiotensin II receptor (AT, subtype) blocker candesartan c ilexetil (16 to 32 mg once daily) either alone or as add-on therapy in 6465 hypertensive patients. The: study population was 52% female and 16% Africa n American with a mean age of 58 years. It included 5446 patients who had e ssential hypertension (HBP) and 1014 patients who had isolated systolic hyp ertension (ISH). These patients had either untreated or uncontrolled hypert ension (systolic blood pressure [SBP] 140 to 179 mm Hg or diastolic blood p ressure [DBP] 90 to 109 mm Hg inclusive at baseline) despite a variety of a ntihypertensive medications including diuretics, calcium antagonists, angio tensin converting enzyme (ACE) inhibitors, and alpha- or beta -blockers, ei ther singly or in combination. The mean baseline blood pressure for the HBP group was 156/97 mm Hg. Candesartan cilexetil as monotherapy (in 51% of HB P patients) reduced mean SBP/DBP by 18.7/13.1 mm Hg. As add-on therapy (in 49% of HBP patients) to various background therapies, candesartan cilexetil consistently reduced mean SBP/DBP further, irrespective of the background therapy: diuretics (17.8/11.3 mm Hg), calcium antagonists (16.6/11.2 mm Hg) , beta -blockers (16.5/10.4 mm Hg), ACE inhibitors (15.3/10.0 mm Hg), ct-bl ockers (16.4/10.4 mm Hg). The mean baseline blood pressure for the ISH grou p was 158/81 mm Hg, Candesartan cilexetil, as monotherapy (in 34% of ISH pa tients), reduced SBP/DBP by 17.0/4.4 mm HE. As add-on therapy (in 66% of IS H patients) to various background therapies, candesartan cilexetil consiste ntly reduced mean SBP/DBP further, irrespective of the background therapy: diuretics (17.4/5.1 mm Hg), calcium antagonists (15.6/3.6 mm Hg), beta -blo ckers (14.0/4.8 mm Hg), ACE inhibitors (13.4/4.3 mm Hg), and alpha -blocker s (11.6/4.5 mm Hg). The further blood pressure lowering effects of candesar tan cilexetil as add-on therapy were seen regardless of age, sex, and race. Overall, 6.8% of the 6465 patients withdrew because of adverse events, mos t commonly headache (6.3%) and dizziness (5.0%). Orthostatic hypotension wa s infrequent; 0.2% with candesartan cilexetil alone, and 0.8% with candesar tan cilexetil as add-on therapy. Thus, candesartan cilexetil either alone o r as add-on therapy was highly effective for the control of systolic or dia stolic hypertension regardless of demographic background when used in typic al clinical practice settings. (C) 2001 American Journal of Hypertension, L td.