A placebo-controlled comparison of the efficacy and tolerability of candesartan cilexetil, 8 mg, and losartan, 50 mg, as monotherapy in patients with essential hypertension, using 36-h ambulatory blood pressure monitoring

Abstract

This double-blind, randomised, controlled study compared the efficacy of candesartan cilexetil 8 mg (n = 87) and losartan 50 mg (n = 89), once daily for 6 weeks, relative to placebo (n = 80) in patients with mild-to-moderate essential hypertension (diastolic blood pressure (DBP): 95-115 mmHg). Ambulatory BP measurements were done every 15 min over 36 h. At the end of the 6-week treatment, the mean change in DBP between the baseline and the 0-24-h period after the last dose of study medication was greater in patients receiving candesartan cilexetil 8 mg (-7.3 mmHg +/- 6.9 mmHg) compared with losartan 50 mg (-5.1 mmHg +/- 4.9 mmHg) (p < 0.05) or placebo (0.3 mmHg +/- 6.5 mmHg) (p < 0.001). The mean change in systolic BP (SBP) during this time was greater in patients receiving candesartan cilexetil 8 mg (-10.8 mmHg +/- 11.3 mmHg), or losartan 50 mg (-8.8 mmHg +/- 8.9 mmHg) than placebo (1.2 mmHg +/- 9.9 mmHg) (p < 0.001). Candesartan cilexetil 8 mg was associated with a greater reduction in DBP and SBP, relative to placebo, when compared with losartan 50 mg, during both daytime and night-time, and between 12 and 24 h after dosing (p < 0.001). Both active treatments were well tolerated. In patients with mild-to-moderate essential hypertension, candesartan cilexetil 8 mg therefore had greater, more consistent antihypertensive efficacy throughout the day and the night, and long-lasting efficacy after the last dose, compared with losartan 50 mg. This greater efficacy is maintained with an excellent tolerability associated with members of the angiotensin Il type 1-receptor blocker class.

Using Routinely Collected Prescribing Data to Determine Drug Persistence for the Purpose of Pharmacovigilance

“…Similarly for simvastatin, 13.0% of patients discontinued within 3 months and 16% within 6 months of starting, figures similar to previous reports suggesting that 16% to 18% of patients prescribed simvastatin suffer an adverse drug event (ADE) and 18% discontinue therapy over a 3‐ to 6‐month period 23 , 24 . In this study, ARBs, a group of drugs widely reported to have an ADR and side effect profile similar to placebo, 33 – 35 had the lowest discontinuation rate with 1 and 2–3 month discontinuation rates of 9.5% and 11.5%, respectively, figures similar to the 8% to 11% previously reported from clinical trial and postmarketing surveys 25 , 26 …”

Comparison of the efficacy of candesartan and losartan: a meta-analysis of trials in the treatment of hypertension

“…[13][14][15][16][17][18][19][20][21][22][23][24][25] A total of 4066 patients were included in the analysis, and the design and patient characteristics of randomized clinical trials included in the meta-analysis are shown in Table 1. The majority of the trials had a randomized, doubleblind, parallel group design.…”

Using Primary Care Prescribing Databases to Determine Drug Switching and Continuation of Care

“…Angiotensin-II receptor blockers. Angiotensin-II receptor blockers are generally viewed as a group of drugs with a good safety profile, reportedly similar to placebos [23][24][25][26][27][28][29][30][31][32][33]. Unlike ramipril and simvastatin, which have a narrow range of switch drugs, discontinuation of an ARB was associated with a switch to a wide range of alternative antihypertensive agents.…”