LOW DOSE ATORVASTATIN TREATMENT REDUCES AMBULATORY BLOOD PRESSURE IN PATIENTS WITH MILD HYPERTENSION AND HYPERCHOLESTEROLEMIA. A DOUBLE-BLIND, RANDOMIZED, PLACEBO- CONTROLLED STUDY

s e265 Conclusions: OM or OM/HCTZ therapy progressively improved the severity profile of patients with moderate-to-severe hypertension who had not achieved BP control after 8 weeks treatment with OM 40 mg. PP.14.381 EFFICACY AND SAFETY OF THE LOSARTAN/ HYDROCHLOROTHIAZIDE COMBINATION (PREMINENT®) AFTER SWITCHING FROM AN ANGIOTENSIN II RECEPTOR BLOCKER: THE CLINICAL EVALUATION OF COMBINATION THERAPY FOR HYPERTENSIVE PATIENTS IN OMIYA (CONCERTO) STUDY K. Hirata, Y. Sugawara, C. Suga, T. Iijima, S. Saihara, K. Takahashi, T. Hasegawa, Y. Hayakawa, S. Momomura, on behalf of the concerto study investigators group. Department of Cardiology, Jichi Medical University, Saitama Medical Center, Saitama-Japan, Iijima Clinic, Saitama-Japan, Saihara Clinic, Saitama-Japan, Takahashi Clinic, Saitama-Japan, Hasegawa Clinic, Saitama-Japan, Hayakawa Clinic, Saitama-Japan Objective: Clinical studies have shown that intensive blood pressure (BP) control is needed to prevent cardiovascular events. However, since target BP is often not achieved in clinical practice in Japan, more effective pharmacologic treatments are required. Losartan/hydrochlorothiazide, a combination of an angiotensin II receptor blocker (ARB) and a diuretic, exerts synergistic antihypertensive activity. We conducted a multicenter open-label prospective study on the efficacy and safety of this drug in patients treated with an ARB but who failed to achieve target BP. Design and Methods: Patients with essential hypertension who failed to achieve 2004 Japanese Society of Hypertension (JSH) target BP with standard dose ARB treatment for at least 1 month (M) were enrolled at 30 institutions. Treatment was switched to a fixed-dose combination of losartan (50 mg)/ hydrochlorothiazide (12.5 mg). The primary endpoint was changes in BP 3 and 12 M after switching. Secondary endpoints were changes in standard blood test results, brain natriuretic peptide (BNP) concentration, cardiothoracic ratio, and urinary protein concentration at 3 and 12 M; cardiac hypertrophy index on electrocardiogram at 12 M; and safety throughout the study period. Results: Of the 188 patients registered, 171 (mean age, 63.9 ± 11.9 years; 84 men) were included in the analysis after excluding those with protocol violations and/or missing data; 36 had concomitant diabetes, 60 had hyperlipidemia, and 26 had ischemic heart disease. BP was significantly decreased from 156 ± 15/89 ± 11 to 137 ± 14/79 ± 9 (3 M), 135 ± 15/78 ± 10mmHg (12 M) (p < 0.001), with increased success rates for achieving JSH 2004 target systolic/diastolic BP (0.6/33.3 to 35.1/69.6, 42.6/72.2%). BNP concentration (36.8 to 31.3, 32.8 pg/mL, p < 0.001), cardiothoracic ratio (49.5 to 48.5, 48.2%, p < 0.001), and urinary protein concentration (semiquantitative score: 0.27 to 0.16, 0.24, p < 0.05) decreased significantly. Concentrations of potassium, fasting blood glucose, hemoglobin Alc, and serum lipids showed no significant change. Serum sodium concentration decreased (142 to 141, 141 meq/L, p < 0.001) and uric acid concentration increased (5.7 to 5.8, 5.9 mg/dL, p < 0.05) significantly but only slightly. The only adverse event definitely caused by the study drug was one case of solar dermatitis. Good compliance was achieved by all patients, excluding six who dropped out because of adverse events. Conclusions: The losartan/hydrochlorothiazide combination has significant and substantial antihypertensive effects in patients with hypertension uncontrolled by previous treatment including an ARB. The drug showed additional organ protective effects and had good medical compliance, with little influence on glucose/lipid metabolism and few adverse events. Switching ARB to the losartan/hydrochlorothiazide combination is a useful treatment option for achievement of target BP. PP.14.382 FIXED-DOSE COMBINATION OF AZILSARTAN MEDOXOMIL/CHLORTHALIDONE PROVIDES SUPERIOR BP REDUCTION TO MONOTHERAPIES IN STAGE 2 HYPERTENSION D. Sica, G. L. Bakris, W. B. White, M. A. Weber, W. C. Cushman, A. Roberts, C. Cao, S. Kupfer. Virginia Commonwealth University Health System, Richmond-USA, University of Chicago Pritzker School of Medicine, Chicago-USA, University of Connecticut School of Medicine, FarmingtonUSA, New York, New York-USA, University of Tennessee College of Medicine, Memphis-USA, Takeda Global Research & Development Center, Deerfield-USA Background: We compared the efficacy and safety of various fixed-dose combinations (FDCs) of azilsartan medoxomil (AZL-M) and chlorthalidone (CLD) with individual monotherapies in patients with stage 2 hypertension. Objective: This interim analysis evaluates blood pressure reduction and tolerability in hypertensive overweight or obese patients under single pill combination of angiotensin receptor blocker (ARB; valsartan) and a calcium channel blocker (CCB; amlodipine) in Turkish population. Design and Method: A total of 751 patients (62.3% female; mean age: 58.2 ± 11.1 years) under ARB-CCB single pill combination were included in this non-interventional, multi center study at 170 centers in Turkey. The followup visits were at intervals based on the physicians’ initiative. Blood pressure (mmHg; visit 1-3) and adverse event incidence (%; visit 2-3) were compared in terms of body mass index (BMI) classification ( < 25, 25.0-29.9 or ≥ 30 kg/m). Results: At the time of this interim analysis, 612 (81.5%) and 425 (56.6%) patients have attended to the follow-up visits conducted in 34.0 ± 26.0 and 92.0 ± 39.0 days after the initial visit, respectively. The initial BMI (30.4 ± 5.3 kg/m; n = 744) was < 25 kg/m in 14.9% (n = 111; 45.9% females), 25-29.9 kg/ m in 37.1% (n = 276; 50.4% females) and ≥ 30 kg/m in 47.9% (n = 357; 77.0% females) of the patients. A total of 217 (28.9%) patients were ≥ 65 years of age with a mean initial BMI of 29.2 ± 4.9 kg/m. Initial and visit 3 mean systolic blood pressure (SBP) in BMI subgroups ( < 25, 25-29.9, ≥ 30 kg/m ) were as follows respectively: 170.5 ± 22.6 to 129.1 ± 15.6; 164.7 ± 23.0 to 130.8 ± 13.4; and 166.4 ± 22.4 to 131.1 ± 14.7 mmHg. There was no significant difference in blood pressure reduction and the proportion of patients who achieved target SBP < 140 mmHg at visit 3 [48/61 (78.7%), 112/153 (73.2%) and 151/206 (73.3%) in BMI < 25, 25-29.9, ≥ 30 kg/m groups, respectively] with respect to BMI. A total of 76 adverse events (AE) in 60 patients were reported during the course of the study (50 AEs at visit 2 and 26 AEs at visit 3). The proportion of patients who experienced at least one AE was significantly higher among those with BMI > 30 kg/m [(7/111 (6.3%) in BMI < 25 kg/m; 15/276 (5.4%) in BMI 25-29.9 kg/m; and 38/357 (10.6%) in BMI ≥ 30kg/m groups; p = 0.044]. However, only 4 AEs (1, 1 and 3 AEs in BMI groups, respectively) were indicated to be related to valsartan/amlodipine combination. Conclusions: In conclusion, valsartan/amlodipine single pill combination therapy achieved blood pressure control independent of BMI. Although hypertensive patients with highest BMI values seem to be at higher risk with respect to adverse events, the causality with the single pill combination therapy was very low indicating that valsartan/amlodipine single pill is well-tolerated. PP.14.380 OLMESARTAN/HYDROCHLOROTHIAZIDE COMBINATION THERAPY IMPROVES HYPERTENSION GRADE CLASSIFICATION IN UNCONTROLLED HYPERTENSION X. Girerd, L.C. Rump, D. Rosenbaum, B. Ammentorp, J. Schmitt. Hôpital De La Pitié, Paris-France, Heinrich-Heine-University Duesseldorf, Duesseldorf-Germany, Daiichi Sankyo Europe Gmbh, Munich-Germany Objective: To evaluate the effect of olmesartan/hydrochlorothiazide (OM/ HCTZ) 40/12.5, 40/25 and 20/12.5 mg combination therapy in comparison to OM 40 mg monotherapy on BP control by examining hypertension severity in terms of proportions of patients (pts) who fulfilled the BP criteria for the severity categories: normal, high normal, mild, moderate or severe. Design and Methods: This was a post hoc analysis of data from a multinational clinical study (EudraCT 2006-003876-37) which consisted of an 8-week, openlabel period during which pts (N = 1226) received OM 40 mg alone (Weeks 0–8, Period I). Uncontrolled pts (N = 972) were randomised to 8 weeks’ doubleblind treatment with OM 40 mg (N = 274), OM/HCTZ 40/12.5 (N = 278), 40/25 (N = 140) or 20/12.5 mg (N = 280) (Weeks 8 [baseline]–16, Period II). Results: During Period II the proportions of pts with severe, moderate and mild hypertension were reduced from 7.1%, 25.0% and 67.4%, respectively, at baseline to 6.0%, 11.8% and 41.3%, respectively, at Week 16. Moreover, the proportions of pts with normal or high normal BP were increased from 0% and 0.6%, respectively at baseline to 28.3% and 12.6%, respectively at Week 16 (Table). In particular, in the OM/HCTZ 40/25 mg group, the corresponding reductions in the severe, moderate and mild categories were from 6.1%, 24.5% and 68.4%, respectively, to 5.1%, 5.1% and 33.3%, respectively, and the corresponding increases in the normal and high normal BP categories were from 0% and 1.0%, respectively, at baseline to 43.6% and 12.8%, respectively, at Week 16. Patients, total (%) Full analysis set Period I Full analysis set Period II