- Email: [email protected]
Efficacy and safety of fixed-dose combination of rosuvastatin and irbesartan in patients with dyslipidemia and hypertension
e264
Abstracts / Atherosclerosis 235 (2014) e192–e301
67 - Blood pressure lowering therapies EAS-0908. EFFECTS OF COMBINATIONS OF VALSARTAN WITH AMLODIPINE OR HYDROCHLOROTHIAZIDE ON RENAL FUNCTION AND PROTEINURIA IN HYPERTENSIVE PATIENTS WITH METABOLIC SYNDROME L. Christogiannisa, M. Kostapanosa, C. Kostarab, F. Barkasa, A. Liontosa, T. Panagiotopouloua, E. Bairaktarib, M. Elisafa a Department of Internal Medicine, University Hospital of Ioannina, Ioannina, Greece; b Laboratory of Clinical Chemistry, Medical School University of Ioannina, Ioannina, Greece
Objectives: Albuminuria may independently predict vascular events. Hypertensive nephrosclerosis is a complication of chronic hypertension affecting both kidney glomeruli and tubules. Microalbuminuria is commonly observed in patients with metabolic syndrome (MetS). Data are limited regarding the effect of antihypertensive drug combinations on proteinuria in hypertensive patients with MetS. We assessed the effects of fixed combinations of valsartan with amlodipine or hydrochlorothiazide on renal function and proteinuria in hypertensive patients with MetS. Methods: Drug-naïve patients with stage II/III hypertension and MetS were randomized to fixed combinations of valsartan with amlodipine (160/5 mg/day, V-A) or hydrochlorothiazide (160/12.5 mg/day, V-H). At baseline as well as 16 weeks post-treatment serum creatinine (SCr) levels as well as the estimated glomerular filtration rate (eGFR) were assessed. Also, the renal excretions of albumin and a1 microglobulin, as surrogates of glomerular and tubular proteinuria respectively, were determined. Results: Fifty patients were included; 25 in each treatment group. Blood pressure was effectively reduced in both groups at similar levels. No significant differences between groups were noted regarding baseline renal function or proteinuria. SCr levels and eGFR did not change from baseline in either treatment group. At baseline the renal excretion of albumin was increased in both groups: median values of 74 vs 81 mg/g creatinine in the V-H vs V-A group respectively (p ¼ NS for the comparison between groups). V-A significantly reduced albuminuria by 25.1% (p < 0.05). This remained unchanged in the V-H group (p < 0.05 for the comparison between groups). No statistically significant change in a1 microglobulin renal excretion was noted in either treatment group. Conclusion: Despite comparable antihypertensive effects, V-A, but not V-H, may effectively reduce albuminuria without affecting a1 microglobulin renal excretion in hypertensive patients with MetS. This finding may imply extra protective effects of V-A combination on renal glomeruli. 67 - Blood pressure lowering therapies EAS-0905. EFFECT OF VALSARTAN/HYDROCHLOROTHIAZIDE COMBINATION ON LOW-DENSITY-LIPOPROTEIN PARTICLE SIZE AND PLASMA LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2 ACTIVITY IN HYPERTENSIVE PATIENTS WITH METABOLIC SYNDROME L. Christogiannisa, M. Kostapanosa, A. Agouridisa, F. Barkasa, E. Klourasa, C. Tellisb, A. Tselepisb, M. Elisafa a Department of Internal Medicine, University Hospital of Ioannina, Ioannina, Greece; b Laboratory of Biochemistry, Department of Chemistry University of Ioannina, Ioannina, Greece
Objectives: Elevated plasma lipoprotein-associated phospholipase A2 (LpPLA2) activity and small size of low-density-lipoproteins (LDL) activity may predict atherosclerotic vascular events. Data are limited on the effect of antihypertensive drugs on these parameters in hypertensive patients with MetS. We assessed the effect of valsartan+hydrochlorothiazide fixed combination on plasma LpPLA2 activity as well as on LDL particle size in hypertensive patients with MetS. Methods: Drug-naïve patients with stage II/III hypertension were prescribed valsartan+hydrochlorothiazide (160/12.5 mg/day, V-H). At baseline
as well as 16 weeks post-treatment plasma LpPLA2 activity was determined by the trichloroacetic acid precipitation procedure using [3H]-PAF as a substrate. Also, LDL particle size was determined electrophoretically. Results: Sixty patients were included; 25 met the criteria for the diagnosis of MetS (MetS group), while 35 did not (control group). BP was effectively reduced in both groups at similar levels. As expected, baseline triglycerides (TG) were increased, while high density lipoprotein cholesterol (HDL-C) levels were reduced compared with the control group (p<0.05 for the comparison between groups). Treatment raised TG levels (by 22.1%, p<0.05) in the MetS and the cholesterol concentration of small-dense LDL particles (by 11.2%, p<0.05) in the MetS, but not in the control group. This resulted in a small though significant reduction in the mean LDL size in MetS patients (from 2572 Å at baseline to 2552 Å on week 16, p<0.05).. This variable remained unchanged in the control group (p<0.05 for the comparison with the control group). Plasma LpPLA2 activity was significantly increased (by 18.9%, p<0.05) in the MetS group. In contrast, this activity was significantly reduced in the control group (by 16.1%, p<0.05, p<0.01 for the comparison between groups). Conclusion: V-H fixed combination may adversely or beneficially affect LDL size and plasma LpPLA2 activity in hypertensive patients with or without MetS respectively. 67 - Blood pressure lowering therapies EAS-0367. EFFICACY AND SAFETY OF FIXED-DOSE COMBINATION OF ROSUVASTATIN AND IRBESARTAN IN PATIENTS WITH DYSLIPIDEMIA AND HYPERTENSION S.H. Kima, H.L. Leeb, H.L. Kima, J.B. Seoa, W.Y. Chunga, J.H. Zoa, M.A. Kima, B.H. Ohc a
Internal Medicine Cardiology, Seoul Boramae Hospital, Seoul, Korea; Internal Medicine, Seoul Bukbu Hospital, Seoul, Korea; c Internal Medicine cardiology, Seoul National University Hospital, Seoul, Korea
b
Objectives: Hypertension and dyslipidemia are important major risk factors of cardiovascular disease. These are components of metabolic syndrome and are usually co-morbid and not so easy to achieve treatment goals with non-pharmaocological and pharmacological therapy. This study was designed to evaluate the efficacy and safety of fixed dose combination of irbesartan and rosuvastatin and compare its characteristics with those of monotherapy with rosuvastatin or irbesartan. Methods: This is the prospective randomized double blind, multicenter trial of fixed dose combination. We enrolled the patients in 10 centers including Boramae hospital. Antihypertensive efficacy of fixed dose combination of rosuvastatin/irbesartan was compared with that of rosuvastatin. Primary evaluation points were 1) percent reduction of low-density lipoprotein cholesterol (LDL-C) in the rosuvastatin/irbesartan combination and irbesartan monotherpay after 8 weeks' treatment, and 2) percent reduction of sitting diastolic blood pressure (siDBP) in the rosuvastatin/ irbesartan combination and rosuvastatin monotherapy after 8 weeks' treatment. Secondary evaluation points were other lipid profile, systolic blood pressure and safety profile. Results: Of 186 patients with hypertension and hypercholesterolemia, each 31 patient were randomized into 6 groups 1) rosuvastatin 10mg, 2) irbesartan 300mg, 3) rosuvastatin 10mg / irbesartan 150 mg, 4) rosuvastatin 10mg/irbesartan 300mg, 5) rosuvastatin 20mg / irbesartan 150 mg , 6) rosuvastatin 20mg/irbesartan 300mg). After 8 weeks' treatment, LDL-C level decreased significantly in rosuvastatin 10mg / irbesartan 300 mg and rosuvastatin 20mg/irbesartan 300mg compared with that of irbesartan 300mg monotherapy (-47.8% and -51.8% vs -2.7%, p<0.001). After 8 weeks' treatment, siDBP decreased significantly in rosuvastatin 10mg / irbesartan 150 mg and rosuvastatin 10mg/irbesartan 300mg compared with that of rosuvastatin 10mg monotherapy (-9.5 % and -11.7% vs -3.4%, p<0.05). There was no significant difference in the adverse event rates between groups. Conclusion: Fixed dose combination of rosuvastatin/irbesartan was more effective in lowering LDL-C level and blood pressure than monotherapy groups. There was no significant difference in the safety between groups.
Abstracts / Atherosclerosis 235 (2014) e192–e301
67 - Blood pressure lowering therapies EAS-0908. EFFECTS OF COMBINATIONS OF VALSARTAN WITH AMLODIPINE OR HYDROCHLOROTHIAZIDE ON RENAL FUNCTION AND PROTEINURIA IN HYPERTENSIVE PATIENTS WITH METABOLIC SYNDROME L. Christogiannisa, M. Kostapanosa, C. Kostarab, F. Barkasa, A. Liontosa, T. Panagiotopouloua, E. Bairaktarib, M. Elisafa a Department of Internal Medicine, University Hospital of Ioannina, Ioannina, Greece; b Laboratory of Clinical Chemistry, Medical School University of Ioannina, Ioannina, Greece
Objectives: Albuminuria may independently predict vascular events. Hypertensive nephrosclerosis is a complication of chronic hypertension affecting both kidney glomeruli and tubules. Microalbuminuria is commonly observed in patients with metabolic syndrome (MetS). Data are limited regarding the effect of antihypertensive drug combinations on proteinuria in hypertensive patients with MetS. We assessed the effects of fixed combinations of valsartan with amlodipine or hydrochlorothiazide on renal function and proteinuria in hypertensive patients with MetS. Methods: Drug-naïve patients with stage II/III hypertension and MetS were randomized to fixed combinations of valsartan with amlodipine (160/5 mg/day, V-A) or hydrochlorothiazide (160/12.5 mg/day, V-H). At baseline as well as 16 weeks post-treatment serum creatinine (SCr) levels as well as the estimated glomerular filtration rate (eGFR) were assessed. Also, the renal excretions of albumin and a1 microglobulin, as surrogates of glomerular and tubular proteinuria respectively, were determined. Results: Fifty patients were included; 25 in each treatment group. Blood pressure was effectively reduced in both groups at similar levels. No significant differences between groups were noted regarding baseline renal function or proteinuria. SCr levels and eGFR did not change from baseline in either treatment group. At baseline the renal excretion of albumin was increased in both groups: median values of 74 vs 81 mg/g creatinine in the V-H vs V-A group respectively (p ¼ NS for the comparison between groups). V-A significantly reduced albuminuria by 25.1% (p < 0.05). This remained unchanged in the V-H group (p < 0.05 for the comparison between groups). No statistically significant change in a1 microglobulin renal excretion was noted in either treatment group. Conclusion: Despite comparable antihypertensive effects, V-A, but not V-H, may effectively reduce albuminuria without affecting a1 microglobulin renal excretion in hypertensive patients with MetS. This finding may imply extra protective effects of V-A combination on renal glomeruli. 67 - Blood pressure lowering therapies EAS-0905. EFFECT OF VALSARTAN/HYDROCHLOROTHIAZIDE COMBINATION ON LOW-DENSITY-LIPOPROTEIN PARTICLE SIZE AND PLASMA LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2 ACTIVITY IN HYPERTENSIVE PATIENTS WITH METABOLIC SYNDROME L. Christogiannisa, M. Kostapanosa, A. Agouridisa, F. Barkasa, E. Klourasa, C. Tellisb, A. Tselepisb, M. Elisafa a Department of Internal Medicine, University Hospital of Ioannina, Ioannina, Greece; b Laboratory of Biochemistry, Department of Chemistry University of Ioannina, Ioannina, Greece
Objectives: Elevated plasma lipoprotein-associated phospholipase A2 (LpPLA2) activity and small size of low-density-lipoproteins (LDL) activity may predict atherosclerotic vascular events. Data are limited on the effect of antihypertensive drugs on these parameters in hypertensive patients with MetS. We assessed the effect of valsartan+hydrochlorothiazide fixed combination on plasma LpPLA2 activity as well as on LDL particle size in hypertensive patients with MetS. Methods: Drug-naïve patients with stage II/III hypertension were prescribed valsartan+hydrochlorothiazide (160/12.5 mg/day, V-H). At baseline
as well as 16 weeks post-treatment plasma LpPLA2 activity was determined by the trichloroacetic acid precipitation procedure using [3H]-PAF as a substrate. Also, LDL particle size was determined electrophoretically. Results: Sixty patients were included; 25 met the criteria for the diagnosis of MetS (MetS group), while 35 did not (control group). BP was effectively reduced in both groups at similar levels. As expected, baseline triglycerides (TG) were increased, while high density lipoprotein cholesterol (HDL-C) levels were reduced compared with the control group (p<0.05 for the comparison between groups). Treatment raised TG levels (by 22.1%, p<0.05) in the MetS and the cholesterol concentration of small-dense LDL particles (by 11.2%, p<0.05) in the MetS, but not in the control group. This resulted in a small though significant reduction in the mean LDL size in MetS patients (from 2572 Å at baseline to 2552 Å on week 16, p<0.05).. This variable remained unchanged in the control group (p<0.05 for the comparison with the control group). Plasma LpPLA2 activity was significantly increased (by 18.9%, p<0.05) in the MetS group. In contrast, this activity was significantly reduced in the control group (by 16.1%, p<0.05, p<0.01 for the comparison between groups). Conclusion: V-H fixed combination may adversely or beneficially affect LDL size and plasma LpPLA2 activity in hypertensive patients with or without MetS respectively. 67 - Blood pressure lowering therapies EAS-0367. EFFICACY AND SAFETY OF FIXED-DOSE COMBINATION OF ROSUVASTATIN AND IRBESARTAN IN PATIENTS WITH DYSLIPIDEMIA AND HYPERTENSION S.H. Kima, H.L. Leeb, H.L. Kima, J.B. Seoa, W.Y. Chunga, J.H. Zoa, M.A. Kima, B.H. Ohc a
Internal Medicine Cardiology, Seoul Boramae Hospital, Seoul, Korea; Internal Medicine, Seoul Bukbu Hospital, Seoul, Korea; c Internal Medicine cardiology, Seoul National University Hospital, Seoul, Korea
b
Objectives: Hypertension and dyslipidemia are important major risk factors of cardiovascular disease. These are components of metabolic syndrome and are usually co-morbid and not so easy to achieve treatment goals with non-pharmaocological and pharmacological therapy. This study was designed to evaluate the efficacy and safety of fixed dose combination of irbesartan and rosuvastatin and compare its characteristics with those of monotherapy with rosuvastatin or irbesartan. Methods: This is the prospective randomized double blind, multicenter trial of fixed dose combination. We enrolled the patients in 10 centers including Boramae hospital. Antihypertensive efficacy of fixed dose combination of rosuvastatin/irbesartan was compared with that of rosuvastatin. Primary evaluation points were 1) percent reduction of low-density lipoprotein cholesterol (LDL-C) in the rosuvastatin/irbesartan combination and irbesartan monotherpay after 8 weeks' treatment, and 2) percent reduction of sitting diastolic blood pressure (siDBP) in the rosuvastatin/ irbesartan combination and rosuvastatin monotherapy after 8 weeks' treatment. Secondary evaluation points were other lipid profile, systolic blood pressure and safety profile. Results: Of 186 patients with hypertension and hypercholesterolemia, each 31 patient were randomized into 6 groups 1) rosuvastatin 10mg, 2) irbesartan 300mg, 3) rosuvastatin 10mg / irbesartan 150 mg, 4) rosuvastatin 10mg/irbesartan 300mg, 5) rosuvastatin 20mg / irbesartan 150 mg , 6) rosuvastatin 20mg/irbesartan 300mg). After 8 weeks' treatment, LDL-C level decreased significantly in rosuvastatin 10mg / irbesartan 300 mg and rosuvastatin 20mg/irbesartan 300mg compared with that of irbesartan 300mg monotherapy (-47.8% and -51.8% vs -2.7%, p<0.001). After 8 weeks' treatment, siDBP decreased significantly in rosuvastatin 10mg / irbesartan 150 mg and rosuvastatin 10mg/irbesartan 300mg compared with that of rosuvastatin 10mg monotherapy (-9.5 % and -11.7% vs -3.4%, p<0.05). There was no significant difference in the adverse event rates between groups. Conclusion: Fixed dose combination of rosuvastatin/irbesartan was more effective in lowering LDL-C level and blood pressure than monotherapy groups. There was no significant difference in the safety between groups.