Table 2.
Clinical trials of candesartan cilexetil
| Target | Study | Patient population and duration | Treatment added to standard therapy | Primary endpoint | Benefit |
|---|---|---|---|---|---|
| Heart Failure | CHARM–Added16 | CHF, EF < 40% (41 months) | Candesartan + ACEI vs ACEI | Reduction in mortality and morbidity | Confirmed |
| CHARM–Alternative17 | CHF, EF < 40%, intolerant to ACEI (33.7 months) | Candesartan vs placebo | Reduction in mortality and hospital admission | Confirmed | |
| CHARM-Preserved18 | CHF, EF > 40% (36.6 months) | Candesartan vs placebo | Reduction in mortality and hospital admission | Moderate confirmed | |
| High blood pressure | TROPHY19 | Prehypertension (4 years) | Candesartan vs placebo | Prevention HTN | Confirmed |
| Five trials20 | HTN ± DM (12–14 wks) | Candesartan vs placebo | Treatment HTN | Confirmed | |
| Candesartan comparative trial21 | HTN + DM (3 months) | Candesartan vs telmisartan and valsartan | Treatment HTN | As good as the other two | |
| Candesartan comparative trial22 | HTN and CHF Meta-analysis | Candesartan vs losartan | Treatment HTN | Better. Not cost-effective | |
| Arterial elasticity | CALM II23 | HTN + DM (12 months) | Candesartan + 20 mg lisinopril vs 40 mg lisinopril | Reduction in pulse pressure | Confirmed |
| Large and small artery elasticity24 | HTN + DM (6 months) | 32 mg candesartan vs 16 mg candesartan vs placebo | Reduction in arterial elasticity | Confirmed | |
| Renal protection | SECRET25 | Renal graft + HTN (3 years) | Candesartan vs placebo | Reduction in mortality and graft failure | Confirmed |
| CKD stage 4–526 | CKD stage 4–5 and BP < 140/90 mmHg (3 years) | Candesartan vs placebo | Reduction in mortality and hemodialysis prevention | Confirmed | |
| CKD stage 1–327 | CKD stage 1–3, DM, ALB (8 months) | Candesartan vs placebo | Reduction in ALB | Confirmed | |
| Stroke | SCOPE28 | Aged 70–89 years, HTN (3.7 years) | Candesartan vs placebo | Reduction in stroke and cognitive decline | Confirmed for stroke only |
| ACCESS29 | Early stroke, HTN (1 year) | Candesartan vs placebo | Reduction in mortality and morbidity | Confirmed | |
| SCAST30 | Within first 30 hours after stroke (6 months) | Candesartan vs placebo | Better functional outcome | Worse than placebo | |
| Retinal protection | DIRECT-Prevent 131 | No RTP + DM type 1, no HTN, no ALB (4 years) | Candesartan vs placebo | Prevention of RTP | Partially confirmed |
| DIRECT-Protect 131 | RTP + DM type 1, no HTN, no ALB (4 years) | Candesartan vs placebo | Reduction in RTP | Partially confirmed | |
| DIRECT-Protect 232 | RTP+DM type 2, no HTN, no ALB (4 years) | Candesartan vs placebo | Reduction in RTP | Partially confirmed | |
| New-onset diabetes prevention | CASE-J 33,34 | HTN + obesity | Candesartan vs amlodipine | Reduction in new-onset DM and mortality | Confirmed |
| Migraine | Prophylaxis35 | Migraine (12 wks) | Candesartan vs placebo | Reduction in no. of days with headache | Confirmed |
| Atrial fibrillation | J-RHYTHM II36 | Paroxysmal AF + HTN (1 year) | Candesartan vs Amlodipine | Reduction in frequency of AF episodes | Confirmed but not better |
Abbreviations: ACEI, angiotensin-converting enzyme inhibitor; AF, atrial fibrillation; ALB, albuminuria; ARB, angiotensin receptor blocker; BP, blood pressure; CHF, chronic heart failure; CKD, chronic kidney disease; DM, diabetes mellitus; EF, ejection fraction; HTN, hypertension; RTP, retinopathy. Clinical studies: ACCESS, Acute Candesartan Cilexetil Therapy in Stroke Survivors; CALM II, Candesartan and Lisinopril Microalbuminuria Trial II; CASE-J, Candesartan Antihypertensive Survival Evaluation in Japan; CHARM, Candesartan in Heart failure: Assessment of Reduction in Mortality; DIRECT, DIabetic REtinopathy Candesartan Trials; J-RHYTHM II, Japanese Rhythm Management Trial II for Atrial Fibrillation; SCAST, Candesartan for Treatment of Acute Stroke; SCOPE, Study on Cognition and Prognosis in the Elderly; SECRET, Study on Evaluation of Candesartan Cilexetil after Renal Transplantation; TROPHY, Trial of Preventing Hypertension.