Vnitr Lek 2008, 54(11):1031-1038

The safety of long-term administration of losartan in current clinical practice: a non-intervention NCT-CZ 14/04/LOZ study

J. Krupička^1,*, K. Ceypová², P. Kristenová², T. Hauser²

¹ Kardiochirurgické oddělení Nemocnice Na Homolce Praha, přednosta prim. MUDr. Štěpán Černý, CSc.

² Korporátní oddělení Klinické studie a vývoj, Zentiva a.s., Praha, vedoucí MUDr. Tomáš Hauser

Introduction:
Losartan is the longest used angiotensin II receptor blocker in clinical practice [1]. It is one of the first-line drugs for the treatment of hypertensive disease and there is enough data available today about its use in the treatment of the disease, including some specific situations (left ventricular hypertrophy, cerebrovascular accidents) and cases when the hypertension disease combines with another disease (e. g. diabetic nephropathy) [2]. The primary objective of the non-intervention multicentre prospective observational open clinical assessment NCT-CZ 14/04/LOZ was to verify on a large sample of patients the safety of Lozap® and Lozap H® in current clinical practice.


Material and method:
The six-month clinical study enrolled patients with recently diagnosed hypertension and/or poorly controlled hypertension [blood pressure ≥ 140/90 mm Hg: 4 432 patients (96%); blood pressure: ≤ 139/89 mm Hg 84 patients (2%); value unspecified: 83 patients (2%)]. A standard form was used for data acquisition. A total of 4,599 patients was enrolled (of which 2,386 women, i.e. 51.9%) with mean age 61 ± 12 years (18-95 years; median 60 years) with additional risk factors (cardiovascular diseases in 48%, diabetes mellitus in 33%, lipid metabolism disorder in 42%, obesity in 45% and smoking in 26% of cases, respectively). 2,631 patients (57%) had previously diagnosed hypertension. The average blood pressure (BP) at enrolment in the study was 159/95 mm Hg (median 160/95 mm Hg), and the average heart rate was 76 strokes/min (median 76).

Results:
The most frequently used dose was 50 mg of losartan (Lozap® or Lozap H®) - in 4,006 patients (87%) at enrolment in the study and in 3,982 patients (87%) at the end of the study. Adverse effects related to the treatment during the study were reported in a total of 9 patients (0.2%). The therapy was assessed as well tolerated in 96% of patients (4,409), as fairly tolerated in 3% of patients (131) and as poorly tolerated in 0.1% of patients (4). Systolic and diastolic blood pressure decreased by 23 mm Hg and 14 mm Hg respectively to a mean value of 136/81 mm Hg (median 135/80 mm Hg) (P < 0.001 for both systolic and diastolic BP). Improvement in patient status was recorded in 93% of cases (4,254 patients) and no change was recorded in 6% of cases (294 patients).

Conclusion:
Losartan in the form of Lozap® or Lozap® is a safe and effective treatment of patients with hypertensive disease. It is effective and safe beginning with the dose of 50 mg and its combination with a diuretic represents a good and safe therapy in patients with insufficient BP response to a 50 mg dose of losartan alone. In case of poor blood pressure response the dose has to be titrated to 100 mg.

Keywords: losartan; hypertensive disease; non-interventional study; adverse effects

Received: December 11, 2007; Accepted: July 4, 2008; Published: November 1, 2008  Show citation