THE OPEN-LABEL MULTICENTRAL STUDY OF ANTIHYPERTENSIVE FIXED-DOSE COMBINATION EFFECTIVENESS IN UKRAINE

Abstract

Objective: The aim of this study was to evaluate the effectiveness of new 2- or 3-component fixed-dose combinations (FDC) with Olmesartan in comparison with general clinical practice antihypertensive treatment. Design and method: 72 physicians were involved in the multicenter open-label study. They included patients with uncontrolled systolic (SBP)/diastolic(DBP) blood pressure in spite of at least one-month therapy and without exclusion criteria. The one group(n = 604) was treated by Olmesartan/HTC or Olmesatan/HTC/Amlodipin (with up-titration). The other group(n = 311) was treated according to general clinical practice. The physicians were asked to use the FDC more frequently. The follow-up period was 3 months. Results: There were included 1055 patients (59.9 ± 0.5 yr), but only 915 (SBP/DBP–164.9 ± 4.2/93.3 ± 0.3mmHg) were examined at 3 month, the others were lost of follow up. 62.5% at baseline and 94% at the end were on FDC therapy. Baseline 56.7% missed the pills vs 9% at the end of study (P < 0.001). The main reasons were forgetfulness, consideration of not need taking due to BP normalization, not convenient regime, unwilling - 35.5, 30.9, 10.7 and 12.4% at baseline vs 8.1, 0.3,1.4 and 1.4% at the end of study (P < 0.001). 48.6% at baseline vs 9.5% at the end considered the missing of one or more pills could not influence on treatment results and 35.4 vs 3.4% receptively considered they take a lot of pills. Baseline in the group of non-FDC treatment the not-compliant, partly compliant, compliant patients consist 68.1, 11.3 and 20.8% vs 63.4, 18.5 and 18.1% (NS) in the group of FDC therapy. At the end of study there were 59.7, 6,5 and 33.9 vs 17.7, 25.9 and 58 % respectively (P < 0.05).  SBP/DBP was -48/23, 44/21 and 28/14 mmHg (P < 0.001/0.039) in Olmesartan 2-, 3-component FDC and in other therapy groups. The target BP (<140/90mmHg) was achieved in 83.5% of Olmesartan FDC group vs 71.2% (P < 0.05) in other therapy group. Conclusions: Only 62.5% of hypertensive patients are on FDC therapy in Ukraine. More frequently use of FDC was associated with improving patient compliance. The 2- or 3-component Olmesartan based FDCs were more effective in BP decreasing than routine antihypertensive therapy.