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Background/Aims: Ascertaining the prevalence of isolated nocturnal hypertension (INHT) in the general population and identifying the characteristics of patients with INHT may be important to determine patients who should receive 24- hour ambulatory blood pressure (BP) measurements. This study aimed to evaluate the prevalence and characteristics of INHT in the general population.Methods: Of 1,128 participants (aged 20 to 70 years), we analyzed 823 who had valid 24-hour ambulatory BP measurements and were not on antihypertensive drug treatment.Results: The prevalence of INHT in the study was 22.8%. Individuals with INHT had a higher office, 24-hour, and daytime and nighttime ambulatory systolic and diastolic BPs compared to individuals with sustained day-night normotension. INHT was more prevalent in individuals with masked hypertension (MH) than in those with sustained hypertension (59.8% vs. 15.6%, p < 0.001). Among individuals with INHT, 92.6% had MH. Among individuals with office BP-based prehypertension, 34.5% had both INHT and MH. The prevalence of INHT was highest in individuals with office BP-based prehypertension. INHT was an independent determinant of MH after adjustment for age, sex, body mass index, diabetes, low-density-lipoprotein cholesterol, 24-hour systolic and diastolic BP, systolic and diastolic BP dipping, and systolic and diastolic BP non-dipping.Conclusions: The present study showed that INHT is not uncommon and is a major determinant of MH. Our findings strongly suggest the use of 24-hour ambulatory BP measurement for individuals within the prehypertension range of office BP owing to the high prevalence of INHT and MH in this population.

PURPOSE We investigated whether the combination therapy of low-intensity rosuvastatin and ezetimibe is an useful alternative to moderate-intensity rosuvastatin monotherapy in patients requiring cholesterol-lowering therapy. METHODS This was a multicenter randomized, double-blind study to investigate the safety and efficacy of a fixed-dose combination of rosuvastatin 2.5 mg and ezetimibe 10 mg (R2.5+E10) compared to those of ezetimibe 10 mg monotherapy (E10), rosuvastatin 2.5 mg (R2.5), and rosuvastatin 5 mg monotherapy (R5) in patients with hypercholesterolemia. A total of 348 patients at 15 centers in Korea were screened, and 279 patients were randomized to different groups in the study. Clinical and laboratory examinations were performed at baseline and 4 and 8 weeks after intervention. The primary endpoint was the percentage change of low-density lipoprotein (LDL) cholesterol levels at the 8-week follow-up. FINDINGS Baseline characteristics were similar among the four groups. There were significant changes in lipid profiles at the 8-week follow-up. A greater decrease in the LDL cholesterol levels (primary endpoint) were found in the R2.5+E10 group (-45.7±18.6%) than in the E10 group (-16.7±14.7%, p

Background Optimal antiplatelet monotherapy during the chronic maintenance period in patients who undergo coronary stenting is unknown. We aimed to compare head to head the efficacy and safety of aspirin and clopidogrel monotherapy in this population. Methods We did an investigator-initiated, prospective, randomised, open-label, multicentre trial at 37 study sites in South Korea. We enrolled patients aged at least 20 years who maintained dual antiplatelet therapy without clinical events for 6-18 months after percutaneous coronary intervention with drug-eluting stents (DES). We excluded patients with any ischaemic and major bleeding complications. Patients were randomly assigned (1:1) to receive a monotherapy agent of clopidogrel 75 mg once daily or aspirin 100 mg once daily for 24 months. The primary endpoint was a composite of all-cause death, non-fatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and Bleeding Academic Research Consortium (BARC) bleeding type 3 or greater, in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT02044250. Findings Between March 26, 2014, and May 29, 2018, we enrolled 5530 patients. 5438 (98·3%) patients were randomly assigned to either the clopidogrel group (2710 [49·8%]) or to the aspirin group (2728 [50·2%]). Ascertainment of the primary endpoint was completed in 5338 (98·2%) patients. During 24-month follow-up, the primary outcome occurred in 152 (5·7%) patients in the clopidogrel group and 207 (7·7%) in the aspirin group (hazard ratio 0·73 [95% CI 0·59-0·90]; p=0·0035). Interpretation Clopidogrel monotherapy, compared with aspirin monotherapy during the chronic maintenance period after percutaneous coronary intervention with DES significantly reduced the risk of the composite of all-cause death, non-fatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and BARC bleeding type 3 or greater. In patients requiring indefinite antiplatelet monotherapy after percutaneous coronary intervention, clopidogrel monotherapy was superior to aspirin monotherapy in preventing future adverse clinical events. Funding ChongKunDang, SamJin, HanMi, DaeWoong, and the South Korea Ministry of Health and Welfare.

The potential cancer risk associated with long‐term exposure to angiotensin receptor blockers (ARBs) is still unclear. We assessed the risk of incident cancer among hypertensive patients who were treated with ARBs compared with patients exposed to angiotensin‐converting enzyme inhibitors (ACEIs), which are known to have a neutral effect on cancer development. Using the Korean National Health Insurance Service database, we analyzed the data of patients diagnosed with essential hypertension from January 2005 to December 2012 who were aged ≥40 years, initially free of cancer, and were prescribed either ACEI or ARB (n = 293,962). Cox proportional hazard model adjusted for covariates was used to evaluate the risk of incident cancer. During a mean follow‐up of 10 years, 24,610 incident cancers were observed. ARB use was associated with a decreased risk of overall cancer compared with ACEI use (hazard ratio [HR] 0.76, 95% confidence interval [CI] 0.72‐0.80). Similar results were obtained for lung (HR 0.73, 95% CI 0.64‐0.82), hepatic (HR 0.56, 95% CI 0.48‐0.65), and gastric cancers (HR 0.74, 95% CI 0.66‐0.83). Regardless of the subgroup, greater reduction of cancer risk was seen among patients treated with ARB than that among patients treated with ACEIs. Particularly, the decreased risk of cancer among ARB users was more prominent among males and heavy drinkers (interaction P, In this contemporary cohort involving a population of nearly 0.3 million Koreans, the use of ARBs was associated with a decrease in the risk of overall cancer compared with the use of angiotensin‐converting enzyme inhibitors during a mean follow‐up of 10 years. The current study provides appropriate long‐term safety data, given that more patients were exposed to ARBs.

The objective of this study was to compare the diagnostic accuracy of office blood pressure (BP) threshold of 140/90 and 130/80 mmHg for correctly identifying uncontrolled out‐of‐office BP in apparent treatment‐resistant hypertension (aTRH). We analyzed 468 subjects from a prospectively enrolled cohort of patients with resistant hypertension in South Korea (clinicaltrials.gov: NCT03540992). Resistant hypertension was defined as office BP ≥ 130/80 mmHg with three different classes of antihypertensive medications including thiazide‐type/like diuretics, or treated hypertension with four or more different classes of antihypertensive medications. We conducted different types of BP measurements including office BP, automated office BP (AOBP), home BP, and ambulatory BP. We defined uncontrolled out‐of‐office BP as daytime BP ≥ 135/85 mmHg and/or home BP ≥ 135/85 mmHg. Among subjects with office BP

Purpose We evaluated the efficacy and safety of nebivolol and rosuvastatin combination treatment in patients with hypertension and hyperlipidemia. Patients and Methods Eligible patients, after more than 4 weeks of therapeutic lifestyle change, were randomly assigned to three groups: 5 mg nebivolol plus 20 mg rosuvastatin (NEBI/RSV), 20 mg rosuvastatin (RSV), or 5 mg nebivolol (NEBI). Treatments lasted 8 weeks. Results Efficacy was analyzed using data from 276 patients. Sitting systolic and diastolic blood pressures differed between the NEBI/RSV and RSV groups (LSmean difference = -5.89 and -5.99 mmHg; 95% confidence interval [CI] = -9.88 to -1.90 mmHg and -8.13 to -3.84 mmHg, respectively). Reductions in the two pressures did not differ between the NEB/RSV and NEB groups. The percent reduction in low-density lipoprotein (LDL) cholesterol differed between the NEBI/RSV and NEBI groups (LSmean difference = -47.76%, 95% CI = -52.69 to -42.84%) but not between the NEBI/RSV and RSV groups. The blood pressure (BP) control rate was higher in the NEBI/RSV group than in the RVS group (51.09% vs 29.67%, p = 0.003). The LDL cholesterol goal achievement rate was higher in the NEBI/RSV group than in the NEBI group (85.87% vs 11.83%, p < 0.001). The incidence of adverse drug reactions in the NEBI/RSV, RSV, and NEBI groups was 8.51%, 7.45%, and 8.60%, respectively (p = 0.950). Conclusion Nebivolol plus rosuvastatin treatment is effective in reducing BP and LDL cholesterol levels and is safe in patients with hypertension and hypercholesterolemia without the loss of BP or the LDL cholesterol-lowering effect of each drug. Trial Registration CRIS registration number KCT0002148.

Single risk factors, such as hypertension and dyslipidemia, can combine to exacerbate the development and severity of cardiovascular disease. Treatment goals may be more effectively achieved if multiple disease factors are targeted with combination treatment. We enrolled 202 patients who were randomly divided into the following three groups: telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg, telmisartan 80 mg + rosuvastatin 20 mg, and telmisartan/amlodipine 80/5 mg. The primary efficacy variables were changes from baseline in mean sitting systolic blood pressure (MSSBP) between telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg and telmisartan 80 mg + rosuvastatin 20 mg at 8 weeks, and the percent changes from baseline in low‐density lipoprotein (LDL) cholesterol between telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg and telmisartan/amlodipine 80/5 mg at 8 weeks. The secondary efficacy variables were changes in MSSBP, mean sitting diastolic blood pressure (MSDBP), LDL cholesterol and other lipid levels at 4 weeks and 8 weeks, as well as observed adverse events during follow‐up. There were no significant differences between the three groups in demographic characteristics and no significant difference among the three groups in terms of baseline characteristics for the validity evaluation variables. The mean overall treatment compliance in the three groups was, respectively, 98.42%, 96.68%, and 98.12%, indicating strong compliance for all patients. The Least‐Square (LS) mean (SE) for changes in MSSBP in the two (telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg and telmisartan 80 mg + rosuvastatin 20 mg) groups were −19.3 (2.68) mm Hg and −6.69 (2.76) mm Hg. The difference between the two groups was significant (−12.60 (2.77) mm Hg, 95% CI −18.06 to −7.14, P

BACKGROUND AND OBJECTIVES The relationship between the hospital percutaneous coronary intervention (PCI) volumes and the in-hospital clinical outcomes of patients with acute myocardial infarction (AMI) remains the subject of debate. This study aimed to determine whether the in-hospital clinical outcomes of patients with AMI in Korea are significantly associated with hospital PCI volumes. METHODS We selected and analyzed 17,121 cases of AMI, that is, 8,839 cases of non-ST-segment elevation myocardial infarction and 8,282 cases of ST-segment elevation myocardial infarction, enrolled in the 2014 Korean percutaneous coronary intervention (K-PCI) registry. Patients were divided into 2 groups according to hospital annual PCI volume, that is, to a high-volume group (≥400/year) or a low-volume group (

The authors developed and validated a diagnostic algorithm using the optimal upper and lower cut‐off values of office and home BP at which ambulatory BP measurements need to be applied. Patients presenting with high BP (≥140/90 mm Hg) at the outpatient clinic were referred to measure office, home, and ambulatory BP. Office and home BP were divided into hypertension, intermediate (requiring diagnosis using ambulatory BP), and normotension zones. The upper and lower BP cut‐off levels of intermediate zone were determined corresponding to a level of 95% specificity and 95% sensitivity for detecting daytime ambulatory hypertension by using the receiver operator characteristic curve. A diagnostic algorithm using three methods, OBP‐ABP: office BP measurement and subsequent ambulatory BP measurements if office BP is intermediate zone; OBP‐HBP‐ABP: office BP, subsequent home BP measurement if office BP is within intermediate zone and subsequent ambulatory BP measurement if home BP is within intermediate zone; and HBP‐ABP: home BP measurement and subsequent ambulatory BP measurements if home BP is within intermediate zone, were developed and validated. In the development population (n = 256), the developed algorithm yielded better diagnostic accuracies than 75.8% (95%CI 70.1–80.9) for office BP alone and 76.2% (95%CI 70.5–81.3) for home BP alone as follows: 96.5% (95%CI: 93.4–98.4) for OBP‐ABP, 93.4% (95%CI: 89.6–96.1) for OBP‐HBP‐ABP, and 94.9% (95%CI: 91.5–97.3%) for HBP‐ABP. In the validation population (n = 399), the developed algorithm showed similarly improved diagnostic accuracy. The developed algorithm applying ambulatory BP measurement to the intermediate zone of office and home BP improves the diagnostic accuracy for hypertension.

The objective of this study was to evaluate the association between sodium intake and blood pressure (BP) control in hypertensive patients taking antihypertensive medications by using 24‐hour urine collection and 24‐hour ambulatory BP. This is a cross‐sectional community‐based study and conducted in 2011 and 2012. A total of 1128 participants were recruited from five cities in Korea. Among them, 740 participants who had complete 24‐hour urine collection and valid 24‐hour ambulatory BP data were included in this study. Participants were divided into four groups: normotensives (NT, n = 441), untreated hypertensive patients (UTHT, n = 174), controlled hypertensive patients (CHT, n = 62), and uncontrolled hypertensive patients (UCHT, n = 63). UCHT and CHT groups showed higher mean age than NT and UTHT groups. UCHT and UTHT groups showed higher 24‐hour systolic BP (SBP) and diastolic BP (DBP) than NT and CHT groups. UCHT group had the highest level of 24‐hour urine sodium. Multivariate analysis adjusted with age, gender, body mass index, estimated glomerular filtration rate, and use of diuretics showed higher level of 24‐hour urine sodium in UCHT group than that in CHT group. Multivariate logistic regression analysis revealed independent association of the amount of 24‐hour urine sodium with uncontrolled BP in hypertensive patients on antihypertensive drug treatment. Higher level of 24‐hour urine sodium excretion in uncontrolled hypertensive patients suggests that excessive sodium intake could be associated with blunted BP lowering efficacy of antihypertensive medications.

Aims We investigated the dose–response association of 24-hour urine sodium and potassium with 24-hour ambulatory blood pressure. Design Cross-sectional community-based study. Methods Among the 1128 participants in the community-based cross-sectional survey, 740 participants (aged 20–70 years) with complete 24-hour urine collection and valid 24-hour ambulatory blood pressure monitoring were included in the study. Participants were grouped into younger (Results In the older population, nighttime blood pressure linearly increased with 24-hour urine sodium and the sodium to potassium ratio. For 24-hour urine sodium, adjusted β was 0.171 (95% confidence interval (CI) 0.036–0.305) for nighttime systolic blood pressure and 0.144 (95% CI 0.012–0.276) for nighttime diastolic blood pressure. For the 24-hour urine sodium to potassium ratio, adjusted β was 0.142 (95% CI 0.013–0.270) for nighttime systolic blood pressure and 0.144 (95% CI 0.018–0.270) for nighttime diastolic blood pressure. The 24-hour blood pressure linearly increased with the 24-hour urine sodium to potassium ratio and adjusted β was 0.133 (95% CI 0.003–0.262) for 24-hour systolic blood pressure and 0.123 (95% CI 0.003–0.244) for 24-hour diastolic blood pressure. Daytime blood pressure and 24-hour systolic blood pressure showed a significant but non-linear association with 24-hour urine sodium among the older population. In the younger population, 24-hour urine sodium, potassium and the sodium to potassium ratio were not associated with ambulatory blood pressure. Conclusion In the older population, 24-hour urine sodium and the sodium to potassium ratio showed a linear and positive association with nighttime blood pressure, and 24-hour urine sodium was associated with 24-hour systolic blood pressure and daytime blood pressure in a non-linear fashion.

Soon Jun Hong,1,* Ki-Chul Sung,2,* Sang-Wook Lim,3 Seok-Yeon Kim,4 Weon Kim,5 Jinho Shin,6 Sungha Park,7 Hae-Young Kim,8 Moo-Yong Rhee9,10 On behalf of MH_APOLLO to read: HM_APOLLO1Department of Cardiology, Cardiovascular Center, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Republic of Korea; 2Department of Cardiology, Gangbuk Samsung Hospital, Sungkyunkwan University College of Medicine, Seoul, Republic of Korea; 3Cardiology Division, Cardiac Center, CHA Bundang Medical Center, CHA University, Seongnam, Republic of Korea; 4Department of Cardiology, Seoul Medical Center, Seoul, Republic of Korea; 5Department of Internal Medicine, Kyung Hee University Medical Center, Kyung Hee University, Seoul, Republic of Korea; 6Division of Cardiology, Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Republic of Korea; 7Department of Cardiology, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea; 8Department of Health Policy and Management, College of Health Science & Department of Health Care Science, Graduate School, Korea University, Seoul, Republic of Korea; 9Cardiovascular Center, Dongguk University Ilsan Hospital, Goyang-si, Gyeonggi, Republic of Korea; 10College of Medicine, Dongguk University, Gyeongju-si, Gyeongbuk, Republic of Korea*These authors contributed equally to this workCorrespondence: Moo-Yong RheeCardiovascular Center, Dongguk University Ilsan Hospital, 27 Dongguk-Ro, Ilsandong-Gu, Goyang-si, Gyeonggi-do 10326, Republic of KoreaTel +82 31 961 5775Fax +82 31 961 7786Email mooyong_rhee@dumc.or.krPurpose: We evaluated the dose-responsiveness, efficacy, and safety of low-dose triple antihypertensive combination therapies in patients with mild-to-moderate hypertension.Patients and Methods: After a 1 to 2-week placebo run-in period, 248 patients were randomized to the half-dose triple combination (amlodipine 2.5 mg + losartan 25 mg + chlorthalidone 6.25 mg), third-dose triple combination (amlodipine 1.67 mg + losartan 16.67 mg + chlorthalidone 4.17 mg), quarter-dose triple combination (amlodipine 1.25 mg + losartan 12.5 mg + chlorthalidone 3.13mg), amlodipine 10mg, amlodipine 5mg, losartan 100mg, and placebo groups for 8 weeks. The primary outcome was the mean change in systolic blood pressure (SBP) from baseline to week 8.Results: The placebo-corrected SBP reductions of the half-dose, third-dose, quarter-dose combination, amlodipine 10 mg, amlodipine 5 mg and losartan 100 mg treatments were − 17.2, − 19.5, − 14.9, − 18.5, − 11.3 and − 9.9 mmHg, respectively. The BP control and response rates were significantly higher in the half-dose, third-dose, and quarter-dose combination groups than in the placebo group (all p < 0.01). Despite no intergroup differences in study drug-related adverse events, ankle circumference increased significantly in the amlodipine group compared to those in the combination treatment groups. The quarter-dose combination, amlodipine 5 mg, and losartan 100 mg groups showed similar SBP reduction and BP response rates. The SBP reduction and BP response rate in the third-dose and half-dose combination groups were not significantly different from those in the amlodipine 10 mg group but superior to those in the losartan 100 mg group.Conclusion: Low-dose triple combination therapies could be effective as antihypertensive therapies.Trial Registration: ClinicalTrials.gov identifier NCT03897868.Keywords: hypertension, blood pressure, combination therapy, low-dose, amlodipine, losartan, chlorthalidone

Among the 146 patients enrolled in the Korean FH registry, 83 patients who had undergone appropriate LLT escalation and were followed-up for ≥ 6 months were analyzed for pathogenic variants (PVs). The achieved percentage of expected low-density lipoprotein-cholesterol (LDL-C) reduction (primary variable) and achievement rates of LDL-C 2 = 0.045, p = 0.048). Among evolocumab users, PV-negative patients or those with only defective PVs revealed higher primary variable, whereas patients with at least one null PV showed lower primary variables. The adjusted response of patients with FH to LLT showed significant associations with PV positivity and 4-SNP score. These results may be helpful in managing FH patients with diverse genetic backgrounds.

Home and ambulatory blood pressure (BP) measurements are recommended for the diagnosis of hypertension. However, the clinical characteristics of individuals showing a diagnostic disagreement between their home and ambulatory BP measurements are unclear. Of the 470 individuals who were not on antihypertensive drug treatment with a BP &ge, 140/90 mmHg at an outpatient clinic, 399 who had valid office, home, and ambulatory BP results were included. Hypertension was diagnosed based on an average home BP &ge, 135/85 mmHg and/or an average daytime ambulatory BP &ge, 135/85 mmHg. The participants were divided into three groups: Agree-NT (home and ambulatory BP normotension), Disagree (home BP normotension and ambulatory BP hypertension, or home BP normotension and ambulatory BP hypertension), and Agree-HT (home and ambulatory BP hypertension). Eighty-four individuals (21.1%) were classified as the Disagree group. The mean serum creatinine, triglycerides, and electrocardiogram voltage in the Disagree group were intermediate between those observed in the Agree-NT and the Agree-HT group. In the Disagree group, the mean levels of office and home diastolic BP, all of the components of ambulatory BP, the aortic systolic BP, and the BP variabilities were found to be intermediate between those of the Agree-NT and the Agree-HT groups. These results indicate that individuals showing a diagnostic disagreement between their home and ambulatory BP may have cardiovascular risks that are intermediate between those with sustained home and ambulatory normotension and hypertension.

Our study evaluated whether there were differences in the prevalence of white-coat hypertension (WH) and masked hypertension (MH) based on the 2018 ESC/ESH and 2017 ACC/AHA hypertension guidelines in Korea. The motivation was the lowering of the diagnostic threshold for hypertension in the 2017 ACC/AHA guidelines. Of 319 participants without antihypertensive drug history and with suspected hypertension based on outpatient clinic blood pressure (BP) measured by physicians, 263 participants (51.6 &plusmn, 9.6 years, 125 men) who had valid research-grade office BP and 24-h ambulatory BP measurements were enrolled. WH prevalence based on daytime ambulatory BP among normotensive individuals was lower with the ESC/ESH guidelines than the ACC/AHA guidelines (29.0% vs. 71.4%, p &lt, 0.001). However, MH prevalence based on daytime ambulatory BP among hypertensive individuals was higher based on the ESC/ESH guidelines (21.6% vs. 1.8%, p &lt, 0.001). Seventy percent of WH cases (2017 ACC/AHA guidelines) and 95.2% of MH cases (2018 ESC/ESH guidelines) occurred in individuals with systolic BP of 130&ndash, 139 mmHg and/or diastolic BP of 80&ndash, 89 mmHg. The diagnostic threshold of the 2017 ACC/AHA guidelines yielded a higher prevalence of WH compared to that of the 2018 ESC/ESH guidelines. However, the prevalence of MH was higher with the 2018 ESC/ESH guidelines than with the 2017 ACC/AHA guidelines. The high prevalence of WH and MH in people with a systolic BP of 130&ndash, 139 mmHg or diastolic BP of 80&ndash, 89 mmHg suggests the need for a more active out-of-office BP measurement in this patient group.

Purpose The aim of this study was to evaluate the safety and efficacy of combination treatment of rosuvastatin with ezetimibe in patients with primary hypercholesterolemia. Methods This multicenter, randomized, double-blind study comprised a main study and an extension study. In the main study, the efficacy and safety of a combination of rosuvastatin (5, 10, and 20 mg) with ezetimibe (10 mg) were compared with those of rosuvastatin (5, 10, and 20 mg) alone. The subjects who achieved the National Cholesterol Education Program Adult Treatment Panel III LDL-C goal in the main study and agreed to a further study were enrolled for the extension study. In the extension study, ezetimibe 10 mg was also administered to subjects who had received rosuvastatin (5, 10, and 20 mg) alone in the main study, and the same treatment was continued for subjects who had received a combination of rosuvastatin with ezetimibe in the main study. Findings At the end of the main study (week 8), LDL-C levels were significantly lower in subjects receiving combination therapy than in those receiving rosuvastatin monotherapy. Other lipid profiles also significantly improved in the combination therapy group. These improvements continued in the extension study. The combination therapy of rosuvastatin and ezetimibe was generally well tolerated. At the end of the main study, more subjects achieved the National Cholesterol Education Program Adult Treatment Panel III LDL-C goal in the combination therapy group than in the monotherapy group. The increased dosage of rosuvastatin was also well tolerated in the combination treatment. Implications Combination therapy of ezetimibe 10 mg with varying doses of rosuvastatin that are commonly used in the clinical field improved the lipid profile and allowed more subjects to reach the LDL-C goal in primary hypercholesterolemia compared with rosuvastatin monotherapy. In addition, the efficacy of the combination therapy was maintained for the extended period. Additional beneficial changes were also achieved with combination therapy even in patients who responded well to rosuvastatin monotherapy. ClinicalTrials.gov identifier: NCT03288038.

BACKGROUND: Data on treatment results of lipid‐lowering therapy (LLT) in familial hypercholesterolemia (FH) are limited, particularly in Asian patients. HYPOTHESIS: We sought to evaluate the target achievement rate and associated variables in Korean patients with FH after maximal statin‐based LLT. METHODS: We enrolled 146 patients with heterozygous FH, and 90 patients were finally analyzed. Patients were initially prescribed rosuvastatin 10 mg or atorvastatin 20 mg, and the regimen was adjusted to achieve the low‐density lipoprotein cholesterol (LDL‐C) target of 100 mg/dL. The primary evaluation point was the achievement rate of the LDL‐C targets at 12 months: LDL‐C < 100 mg/dL and ≥50% LDL‐C reduction. The associations between clinical variables and target achievement were also analyzed. RESULTS: At 12 months, 58% of patients were receiving high‐intensity regimens, whereas 46% were receiving combination therapy. The mean pre‐ and post‐treatment LDL‐C levels were 229 and 118 mg/dL, respectively. Twenty‐eight percent of patients achieved LDL‐C < 100 mg/dL, and 47% achieved ≥50% LDL‐C reduction. Pretreatment LDL‐C and high‐intensity regimens indicated a negative tendency toward the attainment of LDL‐C < 100 mg/dL. Conversely, pretreatment LDL‐C and diabetes mellitus were positively associated with a higher rate of ≥50% LDL‐C reduction. CONCLUSIONS: The target achievement of LDL‐C < 100 mg/dL was low, and 50% LDL‐C reduction was moderately achieved in Korean patients with FH receiving maximal statin‐based LLT. Pretreatment LDL‐C levels and diabetes mellitus were associated with target achievement. Our results provide rare and informative data on FH treatment in Asian patients.

Background Differences between the recently suggested outcome-driven diagnostic threshold of home blood pressure (HBP) measurements and the currently recommended diagnostic threshold of HBP measurements may cause a disagreement between 24-hour ambulatory blood pressure (ABP) and HBP measurements in the diagnosis of hypertension. We evaluated the agreement of various HBP diagnostic thresholds (135/85, 130/85, and 130/80 mm Hg) to ABP measurements, as a reference method. Methods Patients who were confirmed to have high BP (≥140/90 mm Hg) at the outpatient clinic were referred. HBP measurement was performed for 7 days in triplicates every morning and evening. The 24-hour ABP measurement was performed on the 8th day. Using 24-hour ABP measurement as a reference method, we analyzed HBP diagnostic thresholds at 135/85, 130/85, and 130/80 mm Hg. Results Among 319 patients, 256 patients (mean age, 51.8 ± 9.7 years; 119 men) with valid HBP measurements and 24-hour ABP measurements were enrolled. The threshold of 130/80 mm Hg showed the highest diagnostic sensitivity (P = 0.001) with diagnostic agreement by Kappa statistics. Using 130/80 mm Hg as a diagnostic threshold of hypertension, the prevalence of masked hypertension was significantly lower than 130/85 and 135/85 mm Hg (7.8, 15.2, and 18.4%, respectively, P = 0.002). Conclusions The present study suggests that lowering the diagnostic thresholds of HBP measurement from 135/85 mm Hg to 130/80 mm Hg may improve diagnostic accuracy for hypertension.

Background and purpose Based on the data of patients who measured office BP (OBP) in controlled condition, home BP (HBP), and 24-hour ambulatory BP (24hABP) for diagnosis of hypertension, we developed and validated a diagnostic algorithm for hypertension. Methods Patients who have high BP (≥140/90 mmHg) at the outpatient clinic were referred to measure OBP in controlled condition, HBP and 24hABP. The OBP was measured three times at each visit for 3 days in controlled condition by using a validated oscillometric device. HBP was measured for 7 days in triplicates every morning and evening. The 24hABP was measured on the 8th day. Same study protocol was used for development and validation population. Results In the development of algorithm, 319 patients were recruited and data of 256 patients (51.8±9.7 years, 119 men) with valid HBP and 24hABP measurements were analyzed. In the validation of algorithm, 300 patients were recruited and data of 257 patients (52.4±9.8 years, 126 men) with valid HBP and 24hABP measurements were analyzed. In the development population, the prevalence of masked hypertension was 19.5% (n=50) and most of them (n=47, 94%) was in the range of 130–139/80–89 mmHg. The BP in the range of 130–144/80–94 mmHg was defined as the grey zone of OBP, because prevalence of white-coat hypertension was lowered to 1.6% from 4.3% with threshold of 145/95 mmHg. The diagnostic sensitivity, specificity, positive and negative predictive value of OBP was improved to 97.4%, 76.5, 96.5% and 81.3% after excluding the grey zone of OBP (n=125). The diagnostic agreement between 24hABP and HBP in the grey zone of OBP was 64%. The diagnostic sensitivity, specificity, positive and negative predictive value of HBP were 88.8%, 74.7, 93.5% and 61.5% after excluding the grey zone of HBP (130–134/80–84 mmHg, n=28). Based upon these results, we developed a diagnostic algorithm for hypertension by using on out-of-office BP measurements to improved diagnostic accuracy of hypertension (Figure). In the validation population, the developed algorithm showed similar diagnostic accuracy. Diagnostic algorithm for hypertension Conclusion For accurate diagnosis of hypertension, OBP measurement according to guidelines and 24hABP measurement to grey zone of OBP is preferred. To improve diagnostic accuracy of HBP measurement, 24hABP measurement to grey zone of HBP is required. Acknowledgement/Funding Part of this study was supported by a grand from Dong-A ST Co. Ltd., Seoul, Korea.

Background Hypertension is an important risk factor for cardiovascular disease, even in the elderly. Fimasartan is a new non-peptide angiotensin II receptor blocker with a selective type I receptor blocking effect. The objective of this study is to confirm the safety and the non-inferiority of the blood pressure–lowering effect of fimasartan compared with those of perindopril, which has been proven safe and effective in elderly patients with hypertension. Methods This is a randomized, double-blind, active-controlled, two-parallel group, optional-titration, multicenter, phase 3 study comparing the efficacy and safety of fimasartan and perindopril arginine. The study population consists of individuals 70 years old or older with essential hypertension. The primary outcome will be a change in sitting systolic blood pressure from baseline after the administration of the investigational product for 8 weeks. The secondary outcomes will be a change in sitting diastolic blood pressure from baseline and changes in sitting systolic blood pressure and diastolic blood pressure from baseline after the administration of the investigational product for 4, 16, and 24 weeks. The sample size will be 119 subjects for each group to confer enough power to test for the primary outcome. Discussion Research to confirm the efficacy and safety of a new medicine compared with those of previously proven anti-hypertensive drugs is beneficial to guide physicians in the selection of therapeutic agents. If it is confirmed that the new drug is not inferior to the existing drug, the drug will be considered as an option in the treatment of hypertension in elderly patients. Trial registration ClinicalTrials.gov Identifier: NCT03246555, registered on July 25, 2017. Electronic supplementary material The online version of this article (10.1186/s13063-019-3466-5) contains supplementary material, which is available to authorized users.

The authors developed an equation to estimate 24‐hour urine sodium (24HUNa) using the average of three spot urine (SU) samples (morning‐first, morning, and evening) from 74 individuals and validated this equation using the average of three SU samples (morning‐first, daytime, and evening) from 174 additional individuals. Compared with previously published equations using a single SU sample, the currently developed equation using the average of three SU samples showed much lower bias from measured 24HUNa (−2.9 vs >10 mmol/24 h). The intraclass and concordance correlation coefficients of the proposed equation using the average of three SU samples were 0.909 and 0.832, respectively. The limits of agreement were −64.1–58.3 mmol/24 h and approximately 100 mmol/24 h for the currently developed and previously published equations, respectively. All equations showed a tendency to overestimate or underestimate 24HUNa in a manner dependent on the level of 24HUNa but irrespective of the number of SU samples considered. Nonetheless, among the currently tested equations, our equation using the average of three SU samples provided the best estimation of 24HUNa at a population level.

SummaryAim We aimed to compare the effects of fixed-dose combinations of ezetimibe plus rosuvastatin to rosuvastatin alone in patients with primary hypercholesterolemia, including a subgroup analysis of patients with diabetes mellitus (DM) or metabolic syndrome (MetS). Method This multicenter eight-week randomized double-blind phase III study evaluated the safety and efficacy of fixed-dose combinations of ezetimibe 10 mg plus rosuvastatin, compared with rosuvastatin alone in patients with primary hypercholesterolemia. Four hundred and seven patients with primary hypercholesterolemia who required lipid-lowering treatment according to the ATP III guideline were randomized to one of the following six treatments for 8 weeks: fixed-dose combinations with ezetimibe 10 mg daily plus rosuvastatin (5, 10, or 20 mg daily) or rosuvastatin alone (5, 10, or 20 mg daily). Results Fixed-dose combination of ezetimibe plus rosuvastatin significantly reduced LDL cholesterol, total cholesterol, and triglyceride levels compared with rosuvastatin alone. Depending on the rosuvastatin dose, these fixed-dose combinations of ezetimibe plus rosuvastatin provided LDL cholesterol, total cholesterol, and triglyceride reductions of 56%–63%, 37%–43%, and 19%–24%, respectively. Moreover, the effect of combination treatment on cholesterol levels was more pronounced in patients with DM or MetS than in non-DM or non-MetS patients, respectively, whereas the effect of rosuvastatin alone did not differ between DM vs non-DM or MetS vs non-MetS patients. Conclusion Fixed-dose combinations of ezetimibe and rosuvastatin provided significantly superior efficacy to rosuvastatin alone in lowering LDL cholesterol, total cholesterol, and triglyceride levels. Moreover, the reduction rate was greater in patients with DM or MetS.

Background We evaluated the association between sodium intake and plasma renin levels in the cross sectional study and meta-analysis of randomized controlled trials, whether there is a persistent elevation of plasma renin by longer-term sodium intake restriction. Methods Plasma renin activity (PRA) and 24-h urine sodium (24HUNa) excretion were measured from individuals randomly selected from a community. Simple and multiple linear regression analyses adjusted for age, 24-h systolic blood pressure, 24-h average heart rate, fasting blood glucose and gender were performed. For meta-analysis, 74 studies published from 1975 to mid-2014 were identified in a systematic literature search using EMBASE, CINAHL, and MEDLINE. Random effects meta-analyses and a meta-regression analysis were performed. Results Among the 496 participants recruited, 210 normotensive and 87 untreated hypertensive subjects were included in the analysis. There was no significant association between PRA and 24HUNa in the total population, or hypertensive and normotensive individuals. In the meta-analysis, the standard mean difference (SMD) of renin level by sodium intake reduction was 1.26 (95% CI: 1.08 to 1.44, Z=12.80, P 2 =87%). In the meta-regression analysis, an increase in a day of intervention was associated with a fall in SMD by −0.04 (95% CI: −0.05 to −0.02, Z=−5.27, P 2 =86%), indicating that longer duration of reduced sodium intake would lead to lesser SMD of renin level. Conclusions The present population based cross-sectional study and meta-analysis suggests that prolonged reduction in sodium intake is very unlikely associated with elevation of plasma renin levels.

Background/objectives Arterial stiffness and endothelial dysfunction are 2 of the independent predictors for cardiovascular disease, while Acanthopanax senticosus Harms (ASH) is a traditional medicinal plant that can improve cardiovascular health. This study aimed to investigate the efficacy of the fruit of ASH on vascular function in apparently healthy subjects. Subjects/methods A 12-week, randomized, double-blind, placebo-controlled design, consisting of healthy adults with at least 2 of the following 3 conditions: borderline high blood pressure (BP; 120 mmHg ≤ systolic BP ≤ 160 mmHg or 80 mmHg ≤ diastolic BP ≤ 100 mmHg), smoking (≥10 cigarettes/day), and borderline blood lipid levels (220 ≤ total cholesterol ≤ 240, 130 ≤ low density lipoprotein cholesterol ≤ 165, or 150 ≤ triglyceride ≤ 220 mg/dL). Randomly assigned 76 subjects who received a placebo or 2 doses of ASH fruit (low, 500 mg/day; high, 1,000 mg/day) completed the intervention. Brachial-ankle pulse wave velocity (baPWV), flow-mediated dilation, carotid intima-media thickness, and BP were measured both at baseline and following the 12-week intervention. Endothelial nitric oxide synthase (eNOS) phosphorylation was assessed by western blotting. Results Compared with the placebo group, the low-dose group showed more significant changes after the 12-week intervention period in terms of systolic BP (0.1 vs. -7.7 mmHg; P = 0.044), baPWV (31.3 vs. -98.7 cm/s; P = 0.007), and the ratio of phospho-eNOS/eNOS (0.8 vs. 1.22; P = 0.037). Conclusions These results suggest that ASH fruit extract at 500 mg/day has the potential to improve BP and arterial stiffness via endothelial eNOS activation in healthy adults with smoking and the tendency of having elevated BP or blood lipid parameters. Trial registration Clinical Research Information Service Identifier: KCT0001072.

BACKGROUND/OBJECTIVES Hypertension is the major risk factor for cardiovascular disease, a leading cause of deaths in Korea. The objective of this study was to evaluate the effect of a nutrition education in reducing sodium intake and increasing potassium intake in hypertensive adults. SUBJECTS/METHODS Subjects who participated in this study were 88 adults (28 males and 60 females) who were pre-hypertension or untreated hypertensive patients aged ≥ 30 yrs in Gyeonggi Province, Korea. These subjects were divided into 2 groups: a low-sodium education (LS) group and a low-sodium high-potassium education (LSHP) group. Nutrition education of 3 sessions for 12 weeks was conducted. Blood pressure, blood and urine components, nutrient intake, and dietary behavior were compared between the two education groups. RESULT Blood pressure was decreased in both groups after the nutrition education (P < 0.05). In the LSHP group, levels of blood glucose (P < 0.05), total cholesterol (P < 0.01), and low-density lipoprotein-cholesterol (P < 0.05) were decreased after the program completion. Sodium intake was decreased in both groups after the nutrition education (P < 0.05). However, Na/K ratio was only decreased in the LS group (P < 0.05). Intake frequency of fish & shellfish was only significantly reduced in the LS group (P < 0.05), while intake frequencies of cooked rice, noodles & dumplings, breads & snacks, stew, kimchi, and fish & shellfish were reduced in the LSHP group (P < 0.05). Total score of dietary behavior appeared to be effectively decreased in both groups after the education program (P < 0.001). CONCLUSIONS This education for reducing sodium intake was effective in reducing blood pressure and sodium intake. The education for enhancing potassium intake resulted in positive changes in blood glucose and serum cholesterol levels.

Introduction Masked uncontrolled hypertension (MUCH) carries an increased risk of cardiovascular (CV) complications and can be identified through combined use of office (O) and ambulatory (A) blood pressure (BP) monitoring (M) in treated patients. However, it is still debated whether the information carried by ABPM should be considered for MUCH management. Aim of the MASked-unconTrolled hypERtension management based on OBP or on ambulatory blood pressure measurement (MASTER) Study is to assess the impact on outcome of MUCH management based on OBPM or ABPM. Methods and analysis MASTER is a 4-year prospective, randomised, open-label, blinded-endpoint investigation. A total of 1240 treated hypertensive patients from about 40 secondary care clinical centres worldwide will be included -upon confirming presence of MUCH (repeated on treatment OBP

Dyslipidemia and hypertension increase the risk for cardiovascular disease. Combination therapy improves patient compliance. This study was conducted to compare the efficacy and tolerability of the combination therapies telmisartan/amlodipine + rosuvastatin, telmisartan/amlodipine, and telmisartan + rosuvastatin in patients with hypercholesterolemia and hypertension.In this Phase III, multicenter, 8-week randomized, double-blind study, participants with hypertension and dyslipidemia (defined as a sitting systolic blood pressure [sitSBP] of ≥140 mm Hg, a low-density lipoprotein-cholesterol [LDL-C] level of ≤250 mg/dL, and a triglyceride level of ≤400 mg/dL) were screened. After a 4-week washout/run-in period involving therapeutic lifestyle changes and telmisartan 80 mg once a day, eligible patients had a sitSBP of ≥140 mm Hg and met the LDL-C level criteria according to the National Cholesterol Education Program Adult Treatment Panel III cardiovascular disease risk category. Patients were randomly assigned to 1 of 3 groups: (1) telmisartan/amlodipine 80/10 mg + rosuvastatin 20 mg (TAR group); (2) telmisartan/amlodipine 80/10 mg (TA group); or (3) telmisartan 80 mg + rosuvastatin 20 mg (TR group). The primary efficacy end points were the percentage changes from baseline in LDL-C in the TAR and TA groups and the mean changes in sitSBP in the TAR and TR groups at week 8 compared to baseline. Continuous variables were compared using the unpaired t test or the Wilcoxon rank sum model, and categorical variables were compared using the χA total of 134 patients were enrolled. The least squares mean percentage changes in LDL-C at 8 weeks after administration of the drug compared to baseline were -51.9% (3.0%) in the TAR group and -3.2% (2.9%) in the TA group (P 0.001). At 8 weeks after baseline, the least squares mean (SE) changes sitSBP were -28.3 (2.4) mm Hg in the TAR group and -10.7 (2.1) mm Hg in the TR group (P 0.001). The prevalence rates of treatment-emergent adverse events were 15.0%, 25.0%, and 12.2% in the TAR, TA, and TR groups, respectively; those of adverse drug reactions were 15.0%, 22.7%, and 10.2%. None of the differences in rates were significant among 3 groups.Triple therapy with TAR can be an effective treatment in patients with dyslipidemia and hypertension. The TAR combination has value for hypertensive patients with hyperlipidemia in terms of convenience, tolerability, and efficacy. ClinicalTrials.gov identifier: NCT03566316.

Background: To determine whether the effectiveness and safety of fixed-dose combinations (FDCs) of amlodipine orotate/valsartan (AML/VAL) 5/160 mg are noninferior to those of valsartan/hydrochlorothiazide (VAL/HCTZ) 160/12.5 mg in hypertensive patients with inadequate response to valsartan 160 mg monotherapy. Methods: This 8-week, active-controlled, parallel-group, fixed-dose, multicenter, double-blind randomized controlled, and noninferiority trial was conducted at 17 cardiovascular centers in the Republic of Korea. Eligible patients had mean sitting diastolic blood pressure (msDBP) ≥90 mm Hg despite monotherapy with valsartan 160 mg for 4 weeks. Patients were randomly assigned to treatment with AML/VAL 5/160 mg FDC (AML/VAL) group or VAL/HCTZ 160/12.5 mg FDC (VAL/HCTZ) group once daily for 8 weeks. A total of 238 patients were enrolled (AML/VAL group, n = 121; VAL/HCTZ group, n = 117), of whom 228 completed the study. Results: At 8 weeks after randomization, msDBP was significantly decreased in both groups (−9.44 ± 0.69 mm Hg in the AML/VAL group and −7.47 ± 0.71 mm Hg in the VAL/HCTZ group, both P

Objective:Masked hypertension has been known to have higher cardiovascular risk than sustained normotension. However, little is known about the risk of masked hypertension in low risk population. We compared the cardiovascular risk factors of masked hypertension to other type of hypertension in low

The objective of this study was to evaluate the efficacy and safety of the lercanidipine/valsartan combination compared with lercanidipine monotherapy in patients with hypertension.Part 1 of this study was the randomized, multicenter, double-blind, parallel group, Phase III, 8-week clinical trial to compare superiority of lercanidipine 10 mg/valsartan 80 mg (L10/V80) and lercanidipine 10 mg/valsartan 160 mg (L10/V160) combinations with lercanidipine 10 mg (L10) monotherapy. At screening, hypertensive patients, whose diastolic blood pressure (DBP) was90 mm Hg after 4 weeks with L10, were randomized to 3 groups of L10, L10/V80, and L10/V160. The primary end point was the change in the mean sitting DBP from baseline (week 0) after 8 weeks of therapy. Patients who were randomly assigned to L10/V160 and whose mean DBP was still ≥ 90 mm Hg in part 1 were enrolled to the up-titration extension study with lercanidipine 20 mg/valsartan 160 mg (L20/V160) (part 2).Of 772 patients screened, 497 were randomized to 3 groups (166 in the L10 group, 168 in the L10/V80 group, and 163 in the L10/V160 group). Mean (SD) age was 55 (9.9) years, and male patients comprised 69%. The mean (SD) baseline systolic blood pressure (SBP)/DBP were 148.4 (15.1)/94.3 (9.5) mm Hg. No significant differences were found between groups in baseline characteristics except the percentages of previous history of antihypertensive medication. The primary end points, the changes of mean (SD) DBP at week 8 from the baseline were -2.0 (8.8) mm Hg in the L10 group, -6.7 (8.5) mm Hg in L10/V80 group, and -8.1 (8.4) mm Hg in L10/V160 group. The adjusted mean difference between the combination groups and the L10 monotherapy group was -4.6 mm Hg (95% CI, -6.5 to -2.6; P0.001) in the L10/V80 group and -5.9 mm Hg (95% CI, -7.9 to -4.0, P0.001) in the L10/V160 group, which had significantly greater efficacy in BP lowering. A total of 74 patients were enrolled in the part 2 extension study. Changes of mean (SD) DBP and SBP from week 8 to week 12 and week 16 were -5.6 (7.9)/-8.0 (12.0) mm Hg and -5.5 (7.0)/-8.5 (11.3) mm Hg, respectively. For evaluation of the safety profile, the frequencies of adverse events between groups were also not significantly different. The most frequently reported adverse events were headache (6 cases, 20.7%) in the L10 group, dizziness (8 cases, 16.3%) in L10/V80 group, and nasopharyngitis (3 cases, 9.4%) in L10/V160 group, and the incidences of adverse events were not different between groups.Treatment of L10/V80 or L10/V160 combination therapy resulted in significantly greater BP lowering compared with L10 monotherapy. Moreover, the L20/V160 high dose combination had additional BP lowering effect compared with nonresponders with the L10/V160 combination. ClinicalTrials.gov: NCT01928628.

Moo-Yong Rhee,1 Sang Hong Baek,2 Weon Kim,3 Chang Gyu Park,4 Seung Woo Park,5 Byung-Hee Oh,6 Sang-Hyun Kim,7 Jae-Joong Kim,8 Joon-Han Shin,9 Byung-Su Yoo,10 Se-Joong Rim,11 Jong-Won Ha,12 Joon Hyung Doh,13Youngkeun Ahn,14 Jei Keon Chae,15 Jeong Bae Park,16 Soon-Kil Kim,17 Cheol Ho Kim18 1Cardiovascular Center, Dongguk University Ilsan Hospital, Goyang, 2Catholic University of Korea, Seoul St Mary’s Hospital, Seoul, 3Cardiovascular Department of Internal Medicine, Kyung Hee University Medical Center, Seoul, 4Division of Cardiology, Guro Hospital, Korea University College of Medicine, Seoul, 5Division of Cardiology, Samsung Medical Center, Seoul, 6Department of Internal Medicine, Seoul National University Hospital, Seoul, 7Division of Cardiology, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, 8Division of Cardiology, Asan Medical Center, Seoul, 9Division of Cardiology, Ajou University Hospital, Suwon, 10Division of Cardiology, Wonju Severance Christian Hospital, Wonju, 11Division of Cardiology, GangNam Severance Hospital, Seoul, 12Division of Cardiology, Severance Hospital, Seoul, 13Division of Cardiology, Inje University Ilsan Hospital, Goyang, 14Department of Cardiology, Chonnam National University Hospital, Gwangju, 15Chonbuk National University Hospital, Jeonju, 16Department of Cardiology, Cheil General Hospital, Dankook University College of Medicine, Seoul, 17Department of Cardiology, Hanyang University Guri Hospital, Guri, 18Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea Background: The study reported here compared the blood pressure (BP)-lowering efficacy of fimasartan alone with that of fimasartan/hydrochlorothiazide (HCTZ) combination in patients whose BP goal was not achieved after 4 weeks of treatment with once-daily fimasartan 60mg.Methods: Patients with sitting diastolic blood pressure (siDBP) ≥90mmHg with 4 weeks of once-daily fimasartan 60mg were randomly assigned to receive either once-daily fimasartan 60mg/HCTZ 12.5mg or fimasartan 60mg for 4 weeks. After 4 weeks, the dose was increased from fimasartan 60mg/HCTZ 12.5mg to fimasartan 120 mg/HCTZ 12.5 mg or from fimasartan 60mg to fimasartan 120 mg if siDBP was ≥90mmHg.Results: Of the 263 randomized patients, 256 patients who had available efficacy data were analyzed. The fimasartan/HCTZ treatment group showed a greater reduction of siDBP compared to the fimasartan treatment group at Week4 (6.88±8.10mmHg vs 3.38±7.33, P=0.0008), and the effect persisted at Week8 (8.67±9.39mmHg vs 5.02±8.27mmHg, P=0.0023). Reduction of sitting systolic BP in the fimasartan/HCTZ treatment group was also greater than that in the fimasartan treatment group (at Week4, 10.50±13.76mmHg vs 5.75±12.18mmHg, P=0.0069 and, at Week8, 13.45±15.15mmHg vs 6.84±13.57mmHg, P=0.0007). The proportion of patients who achieved a reduction of siDBP ≥10mmHg from baseline and/or a mean siDBP&nbsp

Various home blood-pressure (HBP) measurement schedules were compared to determine the optimal schedule of HBP measurement for the diagnosis of hypertension. Out of 319 individuals who were suspected of having hypertension based on office BP measurements and who did not take antihypertensive drugs, 157 individuals who completed 42 HBP measurements over 7 days and who had a valid 24-h ambulatory blood pressure (ABP) measurement were included in this analysis. We evaluated five HBP measurement schedules to determine the optimal HBP measurement schedule for the diagnosis of hypertension. The cumulatively averaged HBP from 5 to 6 measurement days showed a Pearson correlation coefficient of >0.990 compared to HBP averaged for 6 or 7 days depending on the method. The intraclass correlation coefficient of the cumulatively averaged HBP measurements compared with the 24-h ABP measurement was excellent (≥0.75) from the average of three measurement days and increased steadily with increasing averaged days of HBP measurements. Compared with a diagnosis using a 24-h ABP measurement, the diagnostic sensitivity, specificity, and positive and negative predictive values of HBP measurements were not different among the five methods. The diagnostic agreement of cumulatively averaged HBP measurements was nearly perfect (kappa ≥ 0.9) from the average of five measurement days compared with a diagnosis based on HBP measurements averaged for 6 or 7 days and diagnosis based on averaged HBP measurements of previous days. We suggest obtaining HBP measurements over 5 days or more, in the morning and evening, taking two or more measurements per occasion, and averaging all of the readings as the optimal schedule of HBP measurement for the diagnosis of hypertension.

Hypertension and dyslipidemia are 2 risk factors of cardiovascular disease that often present simultaneously. Traditionally, treatment of these multiple conditions required separate medications for each disease, which may result in poor compliance and thus lead to possible treatment failure. Fixed-dose combination (FDC) therapy with a single pill may be a solution in these situations.This multicenter, 8-week, randomized, double-blind, Phase III study evaluated the efficacy and safety of FDC treatment with telmisartan (80 mg) and rosuvastatin calcium (20 mg) in Korean patients with mild to moderate hypertension and dyslipidemia. Patients were randomly assigned to 4 groups: (1) FDC drug (80 mg of telmisartan and 20 mg of rosuvastatin); (2) 80 mg of telmisartan; (3) 20 mg of rosuvastatin; or (4) placebo. After 8 weeks of treatment, the change in mean sitting systolic blood pressure (MSSBP) and mean sitting diastolic blood pressure (MSDBP) between the FDC group and the rosuvastatin group, and the percent change in LDL-C between the FDC group and the telmisartan group, were compared.A total of 210 patients were enrolled in the study (84 in the FDC group, 42 in the rosuvastatin group, 43 in the telmisartan group, and 41 in the placebo group). The reduction in blood pressure was significantly greater in the FDC group than in the rosuvastatin group after 8 weeks of treatment (least squares mean change from baseline, -16.1 [1.6] mm Hg vs -1.7 [2.2] mm Hg [P0.001] for MSSBP; -8.8 [1.0] mm Hg vs -1.6 [1.4] mm Hg [P0.001] for MSDBP). Least squares mean percent change in LDL-C from baseline was also significantly greater in the FDC group compared with the telmisartan group (-49.3% [2.2%] vs 1.5% [3.0%]; P0.001). FDC therapy also had a higher rate of achieving the treatment goal in both blood pressure (60% vs 45%; P = 0.024) and LDL-C (88.8% vs 16.3%; P0.001) compared with rosuvastatin or telmisartan alone, respectively. In regression analysis, higher baseline MSSBP, female sex, and lower body mass index were associated with increased reductions in MSSBP, whereas higher baseline LDL-C level and lower body mass index were associated with greater reductions in LDL-C. There were 48 adverse events in 36 patients (17.3% [36 of 208]), and 17 adverse drug reactions in 12 patients (5.8% [12 of 208]), indicating no significant differences in short-term safety among study groups.Treatment with an FDC drug containing telmisartan and rosuvastatin showed similar efficacy in lowering blood pressure and LDL-C levels compared with that of each single drug. ClinicalTrials.gov identifier: NCT01914432.

The objective of this study was to evaluate the efficacy and tolerability of a triple combination of amlodipine/losartan/rosuvastatin in patients with hypertension and hypercholesterolemia.A randomized, multicenter, double-blind, placebo-controlled study was conducted. Eligible patients with hypertension and a sitting diastolic blood pressure (SiDBP) of90 mm Hg and LDL-C levels250mg/dL were screened. After a 4-week run-in period with therapeutic lifestyle changes and losartan potassium 100mg once daily, patients who met both blood pressure criteria (80 mm Hg ≤ SiDBP110 mm Hg) and the LDL-C level criteria (defined in the National Cholesterol Education Program Adult Treatment Panel III cardiovascular risk categories) were randomized to 1 of 3 groups and treated once daily for 8 weeks: losartan potassium 100mg + rosuvastatin 20mg treatment (L/R 100/20) group, amlodipine camsylate 5mg + losartan potassium 100mg treatment (A/L 5/100) group, and amlodipine 5mg+ losartan potassium 100mg + rosuvastatin 20mg (A/L/R 5/100/20) group. The primary efficacy variables were the percent change in LDL-C in the A/L/R 5/100/20 and A/L 5/100 groups and the mean change of SiDBP in the A/L/R 5/100/20 and L/R 100/20 groups after 8 weeks of treatment, relative to baseline values.A total of 146 patients were enrolled and the demographic characteristics were similar among the 3 treatment groups. After 8 weeks of treatment, the mean (SD) percent change in LDL-C was significantly greater in the A/L/R group than in the A/L group (-48.40% [2.77%] vs -6.70% [3.00%]; P0.0001). Moreover, the mean change in SiDBP was significantly greater in the A/L/R group than in the L/R group (-9.75 [0.92] mm Hg vs -1.73 [1.03] mm Hg; P0.0001). SiDBP and LDL-C reductions in the A/L/R group were comparable to reductions in the A/L and L/R groups, respectively. Ten adverse events were reported in 7 patients (4.83%), and 1 patient from the A/L group (0.69%) experienced 2 adverse drug reactions (tachycardia and face edema), which were mild and resolved without specific treatment. There were no clinically significant tolerability issues during the treatment period.Triple combination therapy with amlodipine/losartan/rosuvastatin can be an effective therapeutic strategy in patients with hypertension combined with dyslipidemia. These findings will form the foundation of the future development of a single-pill triple combination. ClinicalTrials.gov identifier: NCT02899455.

This study was conducted to develop an equation for estimation of 24-h urinary-sodium excretion that can serve as an alternative to 24-h dietary recall and 24-h urine collection for normotensive Korean adults. In total, data on 640 healthy Korean adults aged 19 to 69 years from 4 regions of the country were collected as a training set. In order to externally validate the equation developed from that training set, 200 subjects were recruited independently as a validation set. Due to heterogeneity by gender, we constructed a gender-specific equation for estimation of 24-h urinary-sodium excretion by using a multivariable linear regression model and assessed the performance of the developed equation in validation set. The best model consisted of age, body weight, dietary behavior (‘eating salty food’, ‘Kimchi consumption’, ‘Korean soup or stew consumption’, ‘soy sauce or red pepper paste consumption’), and smoking status in men, and age, body weight, dietary behavior (‘salt preference’, ‘eating salty food’, ‘checking sodium content for processed foods’, ‘nut consumption’), and smoking status in women, respectively. When this model was tested in the external validation set, the mean bias between the measured and estimated 24-h urinary-sodium excretion from Bland-Altman plots was -1.92 (95% CI: -113, 110) mmol/d for men and -1.51 (95% CI: -90.6, 87.6) mmol/d for women. The cut-points of sodium intake calculated based on the equations were ≥4,000 mg/d for men and ≥3,500 mg/d for women, with 89.8 and 76.6% sensitivity and 29.3 and 64.2% specificity, respectively. In this study, a habitual 24-hour urinary-sodium-excretion-estimation model of normotensive Korean adults based on anthropometric and lifestyle factors was developed and showed feasibility for an asymptomatic population.

Background Hypertension and dyslipidemia are major risk factors of cardiovascular disease (CVD) events. The objective of this study was to evaluate the efficacy and safety of the co-administration of fimasartan and rosuvastatin in patients with hypertension and hypercholesterolemia. Methods We conducted a randomized double-blind and parallel-group trial. Patients who met eligible criteria after 4 weeks of therapeutic life change were randomly assigned to the following groups. 1) co-administration of fimasartan 120 mg/rosuvastatin 20 mg (FMS/RSV), 2) fimasartan 120 mg (FMS) alone 3) rosuvastatin 20 mg (RSV) alone. Drugs were administered once daily for 8 weeks. Results Of 140 randomized patients, 135 for whom efficacy data were available were analyzed. After 8 weeks of treatment, the FMS/RSV treatment group showed greater reductions in sitting systolic (siSBP) and diastolic (siDBP) blood pressures than those in the group receiving RSV alone (both p

Objectives Measurement of central blood pressure provides prognostic information beyond conventional peripheral blood pressure (BP). However, few studies have directly compared the effects of antihypertensives on central hemodynamics. This study investigated the effects of a low-dose combination of nifedipine Gastrointestinal Therapeutic System (GITS) and valsartan versus high-dose monotherapy with either agent in reducing central BP in essential hypertension inadequately controlled by low-dose monotherapy. Materials and methods In this prospective, open-label, randomized, active-controlled, multicenter 8-week study, patients not meeting the target BP after 4 weeks of treatment with low-dose monotherapy were randomized to receive nifedipine GITS 30 mg plus valsartan 80 mg (N30+V80), nifedipine GITS 60 mg (N60), or valsartan 160 mg (V160) for a further 4 weeks. Central hemodynamics were measured by applanation tonometry. Results A total of 391 patients were enrolled. Reduction in central systolic BP from baseline to week 8, the primary efficacy variable, was significantly greater in the N30+V80 group (-27.2±14.7 mmHg) and the N60 group (-27.1±16.5 mmHg) compared with V160 group (-14.4±16.6 mmHg). Decrease in the augmentation index in the N60 group was significantly greater compared with V160 alone, without differences between combination therapy and either high-dose monotherapy. Decreases in brachial systolic BP were significantly greater in the N30+V80 and N60 groups than in the V160 group. By multiple regression analysis, most differences in drug effects on central hemodynamics disappeared after controlling for changes in peripheral BP. A low rate of adverse events occurred in all treatment groups. Conclusion A low-dose combination of nifedipine GITS plus valsartan or high-dose nifedipine was more effective in improving central hemodynamics than high-dose valsartan in patients with hypertension, mostly because of the improvement in peripheral (brachial) hemodynamics.

We investigated the effect of Panax ginseng extract, which is rich in the ginsenoside protopanaxatriol (Ginseol K-g1), on blood pressure (BP). Adults over 20 years old with a systolic BP (SBP) between 120 and 159 mm Hg or a diastolic BP (DBP) between 80 and 99 mm Hg were included. At the end of an initial 2-week washout period, the patients were divided into three groups: the control group (placebo), the low-dose Ginseol K-g1 group (100 mg), and the high-dose Ginseol K-g1 (300 mg) group. The primary end point was the difference in seated SBP (seSBP) and seated DBP (seDBP) changes between the placebo and Ginseol K-g1 groups after 8 weeks of treatment. A total of 90 subjects participated in the study (mean age; 55.2 ± 11.8 years, 43 males). At week 8, levels of seSBP and seDBP were significantly decreased from baseline in the high-dose Ginseol K-g1 group (-3.1 mm Hg and -2.3 mm Hg, respectively, p < 0.05). In contrast, there was no significant decrease in seSBP or seDBP in the control or low-dose Ginseol K-g1 groups. No significant difference of seSBP and seDBP was identified among the three treatment groups at week 8. In patients who had a seSBP ≥ 130 mm Hg or an seDBP ≥ 85 mm Hg, the high dose of Ginseol K-g1 decreased the BP compared with the control group at week 4; however, there was no significant difference at week 8. The proportions of patients who experienced adverse events were comparable among the treatment groups. In conclusion, Ginseol K-g1 has a favorable effect on BP after 4 weeks of treatment, especially at a high dose. However, the effect is not maintained over 8 weeks. (Clinical trial registration information is available at http://www.clinicaltrials.gov , identifier: NCT01483430.)

Brachial-ankle pulse wave velocity (baPWV) provides a useful means of assessing cardiovascular events and diabetic complications. However, the nature of associations between baPWV and microalbuminuria (MAU) and its presence in Type 2 diabetes mellitus (Type 2 DM) have rarely been investigated. This study aimed to examine the association between baPWV and MAU coupled with prediction of MAU using baPWV measurement among Type 2 DM patients. In this cross-sectional study, we enrolled 424 Type 2 DM patients who visited the cardiology and endocrinology department at a tertiary level health care facility, Republic of Korea between 1 January 2006 to 31 December 2008. Clinical and laboratory data were collected, and risk factors associated with MAU and prediction of risk for the development of MAU using baPWV measurement. The association between MAU and baPWV was examined using multivariable logistic regression analysis and predicted MAU by using receiver operating characteristic (ROC) curve analysis. Of the 424 Type 2 DM patients, 93 (21.9%) had MAU (20&ndash, 200 &mu, g/min). baPWV (cm/sec) was found to be significantly correlated with MAU levels (ug/min) (r = 0.791, p &lt, 0.001). Further, baPWV was significantly associated MAU with higher odds ratio (adjusted odds ratio (AOR) 10.899, 95% confidence interval (CI) (4.518&ndash, 26.292)). Similarly, smoking (AOR 10.899, 95% CI (4.518&ndash, 26.292)), and low-density lipoprotein (LDL)-cholesterol (mg/dL) (AOR 1.017, 95% CI (1.001&ndash, 1.033)) were also significantly associated with MAU. The appropriate cut-off value for baPWV to predict MAU 20 &mu, g/min in our study was 1700 cm/sec (area under ROC curve = 0.976). This study shows that baPWV, cigarette smoking, and LDL-cholesterol are associated with MAU in Type 2 DM patients and suggests that a baPWV cut-off of 1700 cm/sec could be used to predict the presence of MAU (20 &mu, g/min) in Type 2 DM patients in the Korean community.

Objective:Little is known about the diurnal blood pressure (BP) characteristic of masked hypertension and masked uncontrolled hypertension.Design and method:Among the 1128 participants (age range 20–70 years), 1004 individuals who had valid 24-hour ambulatory BP monitoring were analyzed. Hypertensio

Accurate estimation of sodium intake by a precise and reproducible method is crucial in sodium intake reduction policy. This study tested the feasibility of 24-h urine (24HU) collection method and estimated sodium intake of a major city population from a representative adult sample.A representative population (aged 20-65 years) was selected by list-assisted random-digit dialing method from a city with a population of one million. Sodium and potassium intakes (24HUNa and 24HUK, respectively) were measured with 24HU collection.Of those 496 individuals recruited, 24HU samples from 368 participants were determined to be properly collected and analyzed. The weighted mean of 24HUNa was 166.4 ± 68.1 mmol per day, much lower than 208.2 mmol of 24HUNa measured in Pusan (Korea; 1988 INTERSALT). The 24HUNa was highest in population aged 40-49 years, with a decrease after 50 years. Men had higher 24HUNa than women (182.0 ± 77.6 vs 151.4 ± 55.0 mmol per day). The sodium intake is higher than that found in survey conducted in the United Kingdom/Scotland and Finland, similar to that of Spain and lower than that of Portugal, Slovenia and Turkey. In contrast to 24HUNa, 24HUK increased continuously as age increased.This study enables us to compare sodium intake with the results of other surveys even from other countries, and reinforce the recommended introduction of the 24HU collection method in Korea. Sodium intake of the studied population was higher than the World Health Organization recommendation, suggesting the needs for further efforts to reduce sodium intake.