Efficacy and safety of losartan 100 mg or losartan 100 mg plus hydrochlorothiazide 25 mg in the treatment of patients with essential arterial hypertension and CV risk factors: observational, prospective study in primary care.

BACKGROUND: Patients with high cardiovascular risk are prevalent in ambulatory care. To achieve adequate blood pressure control, such patients require higher drug doses and/or combination therapy. We aimed to assess the efficacy and safety of losartan 100 mg as monotherapy or in fixed-dose combination with hydrochlorothiazide 25 mg.

DESIGN AND METHODS: Multicentre, prospective, open observational study over 13 weeks in patients with essential hypertension, whose blood pressure was not adequately controlled despite pretreatment. Main outcome parameters were the systolic (SBP) and diastolic (DBP) blood pressure reduction, the rate of normalized patients at study end compared to baseline, and the number and type of adverse events (AEs).

RESULTS: Of the 7702 documented patients, 53.1% (N = 4088) were men, with a mean age of 63.5 +/- 10.7 years. Comorbidities were frequent (diabetes mellitus in 57.4% [N = 4418], coronary heart disease in 30.3% [N = 2330], left ventricular hypertrophy in 28.2% [N = 2172], heart failure in 14.0% [N = 1079], and peripheral arterial disease in 9.0% [N = 690]). Patients received losartan 100 mg in 45.7% (N = 3521), losartan/HCTZ in 53.8% (N = 4143); additional antihypertensive drugs were given in 45.5% (N = 3505). Physicians reported somewhat lower target values than those stipulated by the guidelines (irrespective of age, gender, and concomitant diseases except for diabetes). Mean SBP/DBP decreased from a baseline value of 158/93 mmHg by 24/12 mmHg at study end. The BP lowering effect was similar in subgroups by treatment or comorbidity, respectively, however target attainment rates were substantially higher in non-diabetic patients. Metabolic and renal parameters (fasting glucose, HbA(1c), serum creatinine and albumin in urine) showed trends for improvement. Tolerability was very good, as only 0.43% (N = 33) experienced an AE (in 0.31% [N = 24] serious AEs), and 0.08% (N = 6) discontinued therapy due to reasons related to study drug.

CONCLUSION: In high-risk patients, treatment with losartan 100 mg or losartan/HCTZ 100/25 mg was effective and well tolerated, irrespective of comorbidity. These findings from a real-life setting are in line with those from randomized controlled trials.