-
1.
Vascular effects of combined enriched Korean Red ginseng (Panax Ginseng) and American ginseng (Panax Quinquefolius) administration in individuals with hypertension and type 2 diabetes: A randomized controlled trial.
Jovanovski, E, Lea-Duvnjak-Smircic, , Komishon, A, Au-Yeung, F, Zurbau, A, Jenkins, AL, Sung, MK, Josse, R, Vuksan, V
Complementary therapies in medicine. 2020;:102338
Abstract
BACKGROUND Type 2 diabetes is known to abrogate the vascular response. Combination of two commonly consumed ginseng species, American ginseng (AG) and a Korean Red ginseng (KRG), enriched with ginsensoide Rg3, was shown to concomitantly improve glucemic control and blood pressure. We evaluated the hypothesis that improvements in central hemodynamics, vascular function and stiffness markers are involved in observed benefits of co-administration. METHODS In this randomized, placebo controlled, two-center trial, patients with type 2 diabetes and hypertension were assigned to either 2.25 g ginsenoside Rg3-enriched KRG&AG co-administration or a control 3 times daily for 12-weeks, treated by standard of care. The effects on central hemodynamics, pulse wave velocity (PWV) and endothelial function over the 12-week administration were analyzed. RESULTS In intent-to-treat analysis of 80 individuals, a reduction in central systolic BP (-4.69 ± 2.24 mmHg, p = 0.04) was observed with co-administration of Rg3-KRG + AG relative to control at 12-weeks, which was characterized by a decrease in end-systolic pressure (-6.60 ± 2.5 mmHg, p = 0.01) and area under the systolic/diastolic BP curve (-132.80 ± 65.1, p = 0.04, 220.90 ± 91.1, p = 0.02, respectively). There was no significant change in reactive hyperemia index (0.09 ± 0.11, p = 0.44), PWV (-0.40 ± 0.28 %, p = 0.17), and other related pulse wave analysis components. CONCLUSION Co-administration of complementary ginseng species improved central systolic BP and components of pulse waveform without a direct effect on endothelial function, when added to background pharmacotherapy in individuals with diabetes. These data support potential utility of ginseng for modest blood pressure benefit to broaden its role in diabetes management.
-
2.
Serum bicarbonate and cardiovascular events in hypertensive adults: results from the Systolic Blood Pressure Intervention Trial.
Dobre, M, Pajewski, NM, Beddhu, S, Chonchol, M, Hostetter, TH, Li, P, Rahman, M, Servilla, K, Weiner, DE, Wright, JT, et al
Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association. 2020;(8):1377-1384
-
-
Free full text
-
Abstract
BACKGROUND Low serum bicarbonate level is associated with increased mortality, but its role as a predictor of cardiovascular disease (CVD) is unclear. This study evaluates the association between serum bicarbonate concentration and CVD and whether the effect of intensive blood pressure (BP) lowering on CVD outcomes is modified by serum bicarbonate level. METHODS The Systolic Blood Pressure Intervention Trial (SPRINT) randomized participants to a systolic BP target <120 mmHg (intensive treatment) or <140 mmHg (standard treatment). The primary CVD outcome was a composite of nonfatal myocardial infarction (MI), acute coronary syndrome not resulting in MI, stroke, acute decompensated heart failure and CVD death. Cox proportional hazards models adjusted for demographic, clinical and laboratory characteristics were used to evaluate the association of interest in 9334 SPRINT participants (ClinicalTrials.gov: NCT01206062). RESULTS Over a median follow-up of 3.33 years (interquartile range 2.87-3.87 years), 618 (6.6%) participants experienced a primary CVD outcome. Participants with serum bicarbonate <22 mEq/L had a significantly higher risk of the primary CVD outcome (hazard ratio 1.54; 95% confidence interval 1.11-2.14, P = 0.01), compared with participants with bicarbonate 22-26 mEq/L. The magnitude of the CVD risk reduction with intensive BP lowering was similar across bicarbonate strata (P-value for interaction = 0.97). CONCLUSIONS In hypertensive individuals, serum bicarbonate level <22 mEq/L was associated with an increased CVD risk. The effect of intensive BP lowering on CVD outcomes was not modified by the serum bicarbonate level.
-
3.
Regional variability in Canadian routine care of type 2 diabetes, hypercholesterolemia, and hypertension: Results from the The Cardio-Vascular and metabolic treatments in Canada: Assessment of REal-life therapeutic value (CV-CARE) registry.
Goldenberg, R, Bell, A, Cheng, W, Paron, E, Fils-Aimé, N, Burrows, M, Blavignac, J, Barakat, M
Journal of cardiology. 2020;(4):385-394
Abstract
BACKGROUND Regional differences in the profile and treatment strategies of patients with cardiometabolic diseases have been studied in several different countries. The Cardio-Vascular and metabolic treatments in Canada: Assessment of REal-life therapeutic value (CV-CARE) registry was designed to evaluate patient profiles and medical management of cardiometabolic diseases in routine clinical care settings across Canada. Primary objectives were to (1) evaluate regional variability of patient profiles with cardiometabolic disease(s) and (2) assess treatment differences of patients treated for type 2 diabetes (T2D), hypercholesterolemia (HCh), and hypertension (HTN) across Canada. METHODS CV-CARE is a multi-center, observational, prospective registry that enrolled Canadian patients treated with metformin-extended release (MetER) for T2D, colesevelam (C) for HCh, azilsartan (AZI) for mild-to-moderate essential HTN and azilsartan/chlorthalidone (AZI/CHL) for severe, essential HTN. Patient characteristics and treatments were assessed at baseline. RESULTS The registry enrolled 6960 patients, with a total of 4194 patients making up the primary analysis population [MetER (n=995); C (n=1639); AZI (n=1364); AZI/CHL (n=498)]. First-line use of MetER was more common in British Columbia (BC; 45.5%) compared to Ontario (ON; 29.8%), and Quebec (QC; 12.9%). C treatment for HCh was used as monotherapy most readily in BC (68.7%) compared with QC (59.7%) and ON (35.8%). Dual action of low-density lipoprotein cholesterol and hemoglobin A1c reduction was the predominant reason for C add-on therapy (46.8%), with highest usage seen in ON (62.9%). AZI treatment for HTN was most frequently used in BC (43.8%), and AZI/CHL was most commonly used in ON (12.0%). First-line use of AZI was more common in QC (50%) vs. ON (34.9%) and BC (24.1%). The primary reason for switching to AZI and AZI/CHL from prior treatment was lack of efficacy across provinces. CONCLUSION This is the first regional description of the CV-CARE cohort. Significant variations in both baseline profile and treatments were observed which could have an impact on long-term outcomes.
-
4.
Comparison of Cardiovascular and Safety Outcomes of Chlorthalidone vs Hydrochlorothiazide to Treat Hypertension.
Hripcsak, G, Suchard, MA, Shea, S, Chen, R, You, SC, Pratt, N, Madigan, D, Krumholz, HM, Ryan, PB, Schuemie, MJ
JAMA internal medicine. 2020;(4):542-551
-
-
Free full text
-
Abstract
IMPORTANCE Chlorthalidone is currently recommended as the preferred thiazide diuretic to treat hypertension, but no trials have directly compared risks and benefits. OBJECTIVE To compare the effectiveness and safety of chlorthalidone and hydrochlorothiazide as first-line therapies for hypertension in real-world practice. DESIGN, SETTING, AND PARTICIPANTS This is a Large-Scale Evidence Generation and Evaluation in a Network of Databases (LEGEND) observational comparative cohort study with large-scale propensity score stratification and negative-control and synthetic positive-control calibration on databases spanning January 2001 through December 2018. Outpatient and inpatient care episodes of first-time users of antihypertensive monotherapy in the United States based on 2 administrative claims databases and 1 collection of electronic health records were analyzed. Analysis began June 2018. EXPOSURES Chlorthalidone and hydrochlorothiazide. MAIN OUTCOMES AND MEASURES The primary outcomes were acute myocardial infarction, hospitalization for heart failure, ischemic or hemorrhagic stroke, and a composite cardiovascular disease outcome including the first 3 outcomes and sudden cardiac death. Fifty-one safety outcomes were measured. RESULTS Of 730 225 individuals (mean [SD] age, 51.5 [13.3] years; 450 100 women [61.6%]), 36 918 were dispensed or prescribed chlorthalidone and had 149 composite outcome events, and 693 337 were dispensed or prescribed hydrochlorothiazide and had 3089 composite outcome events. No significant difference was found in the associated risk of myocardial infarction, hospitalized heart failure, or stroke, with a calibrated hazard ratio for the composite cardiovascular outcome of 1.00 for chlorthalidone compared with hydrochlorothiazide (95% CI, 0.85-1.17). Chlorthalidone was associated with a significantly higher risk of hypokalemia (hazard ratio [HR], 2.72; 95% CI, 2.38-3.12), hyponatremia (HR, 1.31; 95% CI, 1.16-1.47), acute renal failure (HR, 1.37; 95% CI, 1.15-1.63), chronic kidney disease (HR, 1.24; 95% CI, 1.09-1.42), and type 2 diabetes mellitus (HR, 1.21; 95% CI, 1.12-1.30). Chlorthalidone was associated with a significantly lower risk of diagnosed abnormal weight gain (HR, 0.73; 95% CI, 0.61-0.86). CONCLUSIONS AND RELEVANCE This study found that chlorthalidone use was not associated with significant cardiovascular benefits when compared with hydrochlorothiazide, while its use was associated with greater risk of renal and electrolyte abnormalities. These findings do not support current recommendations to prefer chlorthalidone vs hydrochlorothiazide for hypertension treatment in first-time users was found. We used advanced methods, sensitivity analyses, and diagnostics, but given the possibility of residual confounding and the limited length of observation periods, further study is warranted.
-
5.
A Prospective Noninterventional, Observational Study to Describe the Effectiveness and Safety of Trandolapril and Verapamil Single-Pill Combination in the Management of Patients with Hypertension and Type 2 Diabetes Mellitus: A Harvest TR Study.
Atalar, E, Eskin, F, Tugtekin, HB, Karabulut, A, Kanyilmaz, S, Kirbiyik, H, Ozyildiz, AG
BioMed research international. 2020;:2123601
Abstract
Maintaining regular blood pressure control usually requires multidrug regimens rather than monotherapy. The objective of this study was to describe the effectiveness and safety of an angiotensin-converting enzyme inhibitor and a nondihydropyridine calcium channel blocker in a single-tablet combination in patients with hypertension, a heart rate higher than 70 beats/min, and type 2 diabetes mellitus (T2DM). This study was conducted in Turkey as a prospective, noninterventional, observational study. At 22 clinical sites, the data of 200 patients with hypertension were used for efficacy analysis; however, 262 patients received at least one dose of trandolapril/verapamil fixed-dose combination at two dose strengths. Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate, PR interval, glycated haemoglobin (HbA1c), and albumin/creatinine ratios were recorded during 8 weeks of treatment. With treatment, the mean (±SD) SBP that was recorded as 162.8 (±14.642) mm Hg at baseline was reduced to 131.7 ± 11.1 mm Hg at week 8 (p < 0.05). Similarly, the mean DBP was reduced from 93.76 ± 9.16 mm Hg to 77.6 ± 7.6 mm Hg (p < 0.001). Following 8 weeks of treatment, SBP and DBP values were reduced below 140 mm Hg and 90 mm Hg in most patients (81.5%), respectively. The mean heart rate as evaluated using electrocardiography measurements was reduced to 78.25 beats/min at week 8 as compared with baseline during trandolapril/verapamil single-pill combination treatment (p < 0.001). Treatment with trandolapril and verapamil was well tolerated over 8 weeks with no unexpected safety signals. In conclusion, the single-pill combination of trandolapril and verapamil was considered effective in reducing and controlling blood pressure in patients with hypertension and T2DM. There was a significant improvement in HbA1c and ACR levels in a smaller subgroup of the patient cohort. The trandolapril/verapamil combination was evaluated as being safe and well-tolerated following a treatment period of 8 weeks. This trial was registered with NCT02298556.
-
6.
Association of self-reported sleep duration and quality with BaPWV levels in hypertensive patients.
Hu, H, Li, H, Huang, X, Bao, H, Song, Y, Wang, B, Liu, C, Xu, R, Liu, L, Wang, X, et al
Hypertension research : official journal of the Japanese Society of Hypertension. 2020;(12):1392-1402
-
-
Free full text
-
Abstract
The association between sleep conditions and arterial stiffness remains inconclusive. We aimed to investigate the relationship of sleep duration and quality with brachial-ankle pulse-wave velocity (baPWV) in hypertensive patients. A total of 14,485 hypertensive adults were included in this cross-sectional analysis. Information about sleep duration and quality was obtained via questionnaire. A baPWV level ≥1800 cm/s was defined as indicative of arterial stiffness. Compared with participants with a sleep duration <8 h per day, participants with a sleep duration ≥8 h per day had a significantly higher baPWV level (β = 13.7 cm/s; 95% CI: 3.9, 23.5) and a nonsignificantly higher prevalence of arterial stiffness (39.7% vs. 33.0%; OR, 1.08; 95% CI: 0.99-1.19). Similarly, compared with participants with good or medium sleep quality, participants with poor sleep quality had a significantly higher baPWV level (β = 16.3 cm/s; 95% CI: 0.1, 32.6) and a nonsignificantly greater prevalence of arterial stiffness (36.6% vs. 35.3%; OR, 1.13; 95% CI: 0.97-1.32). When sleep duration and quality were examined jointly, participants with a sleep duration ≥8 h and/or poor sleep quality had a significantly higher baPWV level (β = 14.4 cm/s; 95% CI: 5.3, 23.4) and a greater prevalence of arterial stiffness (38.8% vs. 32.7%; OR, 1.10; 95% CI: 1.01-1.20) than those with a sleep duration <8 h and good/medium sleep quality. In summary, among hypertensive patients, a longer sleep duration (≥8 h per day) and poor sleep quality were associated with higher baPWV levels and a higher prevalence of arterial stiffness.
-
7.
Dose-dependent effects of lifestyle interventions on blood lipid levels: Results from the PREMIER trial.
Dudum, R, Juraschek, SP, Appel, LJ
Patient education and counseling. 2019;(10):1882-1891
-
-
Free full text
-
Abstract
OBJECTIVE To assess the effects of comprehensive lifestyle modification on low-density lipoprotein cholesterol (LDL-C) levels and whether greater participation in counseling sessions was associated with greater LDL-C reductions. METHODS Multicenter trial of Pre- or Stage 1 hypertensive adults randomized to: (1)Advice alone, (2)'Established' lifestyle intervention implementing physical activity, sodium reduction, and weight loss, if overweight, or (3)'Established + DASH' lifestyle intervention with DASH diet counseling. Both intervention groups received behavioral counseling. We used generalized estimating equations to model the intervention's effects on lipid outcomes. Analyses of number of sessions and lipids were adjusted for demographics and medical history. RESULTS Among 756 participants (mean age 49.7, 63.2% women, 34.7% black), both lifestyle interventions reduced LDL-C, triglycerides, and total cholesterol (TC) at six months. Compared to the 'Advice' arm, net mean lipid changes in the Established group were: LDL-C of -5.6 mg/dL (p=0.001) and TC of -7.3 mg/dL (p<0.001). Similarly, changes in the 'Established + DASH' group were: LDL-C of -4.0 mg/dL (p=0.03) and TC of -5.7 mg/dL (p=0.006). In dose-response analyses, for every 10-session increase, LDL-C changed by -6.2 mg/dL (p=0.003). CONCLUSIONS Comprehensive lifestyle modification lowers LDL-C with greater benefit among persons who attend more counseling sessions. PRACTICE IMPLICATIONS Patient engagement is a critical aspect of effective lifestyle interventions.
-
8.
Efficacy and Safety of Triple Therapy With Telmisartan, Amlodipine, and Rosuvastatin in Patients With Dyslipidemia and Hypertension: The Jeil Telmisartan, Amlodipine, and Rosuvastatin Randomized Clinical Trial.
Hong, SJ, Jeong, HS, Cho, JM, Chang, K, Pyun, WB, Ahn, Y, Hyon, MS, Kang, WC, Lee, JH, Kim, HS
Clinical therapeutics. 2019;(2):233-248.e9
Abstract
PURPOSE Fixed-dose combination therapy with telmisartan, amlodipine, and rosuvastatin is needed in patients with hypertension and dyslipidemia for better adherence and cost-effectiveness than free-equivalent combination therapies. This study aimed to compare the efficacy and safety of combination therapy with telmisartan, amlodipine, and rosuvastatin versus telmisartan plus amlodipine or telmisartan plus rosuvastatin in patients with hypertension and dyslipidemia. METHODS The Jeil Telmisartan, Amlodipine, and Rosuvastatin Randomized Clinical Trial (J-TAROS-RCT) was an 8-week, multicenter, randomized, double-blind, parallel, Phase III clinical trial conducted at 9 hospitals in Korea. After a run-in period of >4 weeks, patients who fulfilled the criteria of the National Cholesterol Education Program Adult Treatment Panel III guidelines were eligible for randomization to receive 1 of 3 treatments for 8 weeks: (1) telmisartan/amlodipine 80 mg/10 mg plus rosuvastatin 20 mg, (2) telmisartan/amlodipine 80 mg/10 mg, or (3) telmisartan 80 mg plus rosuvastatin 20 mg. The primary end point was efficacy evaluation of combination therapy with telmisartan/amlodipine/rosuvastatin by comparing the change in mean sitting systolic blood pressure (msSBP) and mean percentage change in LDL-C from baseline after 8 weeks of treatment. Adverse events (AEs), clinical laboratory data, and vital signs were assessed in all patients. FINDINGS Among 148 patients, the changes in msSBP from baseline after 8 weeks of treatment were a mean (SD) of -24.41 (2.38) versus -9.31 (2.36) mm Hg in the telmisartan/amlodipine/rosuvastatin and telmisartan/rosuvastatin groups, respectively. Significantly more participants achieved the target BP at week 8 in the telmisartan/amlodipine/rosuvastatin group (41 patients [87.2%]) than in the telmisartan/rosuvastatin group (24 [50.0%], P < 0.001). The changes in mean (SD) LDL-C at 8 weeks compared with baseline values were -57.59% (11.59%) versus 6.08% (20.98%) in the telmisartan/amlodipine/rosuvastatin and telmisartan/amlodipine groups, respectively. The percentages of patients who achieved the target LDL-C according to their risk factors after 8 weeks of treatment were 97.87% vs 6.12% in the telmisartan/amlodipine/rosuvastatin and the telmisartan/amlodipine groups (P < 0.0001), respectively. No significant differences were found in the incidence of overall AEs and adverse drug reactions, and serious AEs were comparable among 3 groups. IMPLICATIONS Fixed-dose combinations of telmisartan, amlodipine, and rosuvastatin decreased BP and LDL-C in patients with hypertension and dyslipidemia. The safety and tolerability profiles of fixed-dose telmisartan, amlodipine, and rosuvastatin combination therapy were comparable with those of telmisartan plus amlodipine or telmisartan plus rosuvastatin. ClinicalTrials.gov identifier: NCT03088254.
-
9.
Self-management and blood pressure control in China: a community-based multicentre cross-sectional study.
Qu, Z, Parry, M, Liu, F, Wen, X, Li, J, Zhang, Y, Wang, D, Li, X
BMJ open. 2019;(3):e025819
Abstract
OBJECTIVES This study explored the relationship between self-management and blood pressure (BP) control in China. DESIGN A cross-sectional study. SETTING Eight community health centres from four cities in the Northeast (Shenyang), Northwest (Xi'an), Southwest (Chengdu) and South (Changsha) of China. PARTICIPANTS A total of 873 adults with hypertension, including 360 men and 513 women. Hypertension was defined as systolic BP ≥140 mm Hg and/or diastolic BP ≥90 mm Hg. OUTCOME MEASUREMENTS BP control was the primary outcome variable. This was categorised as good control if individuals with hypertension reduced their BP to <140/90 mm Hg, otherwise, it was categorised as poor control. Secondary outcomes included self-management, defined as: (1) context or condition-specific factors or physical/social environments (eg, age, sex, marital status, education, personal income and health insurance) and (2) process or knowledge/beliefs, self-regulation skills/abilities and social facilitation (eg, treatment, diet, exercise and risk factor management). Data were analysed using logistic regression models using SPSS V.20. RESULTS A total of 67.1% (n=586) participants had poor BP control. Limited outpatient care benefits in mainly rural residents (OR 2.26, 95% CI 1.06 to 4.81) and longer disease duration (OR 1.03, 95% CI 1.01 to 1.04) were associated with poor BP control. Self-management practices reduced the odds of having poor BP control (OR 0.98, 95% CI 0.97 to 0.99). CONCLUSIONS The individual and family self-management theory can serve as an effective theory for understanding the key contexts, processes and outcomes essential for BP control in China. Future research should evaluate the effect of a self-management intervention (eg, self-monitoring, medication adherence, regular and routine doctor visits, and social supports) for BP control in China using a multisite cluster randomised controlled trial. Sex and gender difference, cost and patient-reported outcomes should also be examined.
-
10.
The "Hypertension Approaches in the Elderly: a Lifestyle study" multicenter, randomized trial (HAEL Study): rationale and methodological protocol.
Umpierre, D, Santos, LP, Botton, CE, Wilhelm, EN, Helal, L, Schaun, GZ, Ferreira, GD, De Nardi, AT, Pfeifer, LO, da Silveira, AD, et al
BMC public health. 2019;(1):657
Abstract
BACKGROUND Hypertension is a clinical condition highly prevalent in the elderly, imposing great risks to cardiovascular diseases and loss of quality of life. Current guidelines emphasize the importance of nonpharmacological strategies as a first-line approach to lower blood pressure. Exercise is an efficient lifestyle tool that can benefit a myriad of health-related outcomes, including blood pressure control, in older adults. We herein report the protocol of the HAEL Study, which aims to evaluate the efficacy of a pragmatic combined exercise training compared with a health education program on ambulatory blood pressure and other health-related outcomes in older individuals. METHODS Randomized, single-blinded, multicenter, two-arm, parallel, superiority trial. A total of 184 subjects (92/center), ≥60 years of age, with no recent history of cardiovascular events, will be randomized on a 1:1 ratio to 12-week interventions consisting either of a combined exercise (aerobic and strength) training, three times per week, or an active-control group receiving health education intervention, once a week. Ambulatory (primary outcome) and office blood pressures, cardiorespiratory fitness and endothelial function, together with quality of life, functional fitness and autonomic control will be measured in before and after intervention. DISCUSSION Our conceptual hypothesis is that combined training intervention will reduce ambulatory blood pressure in comparison with health education group. Using a superiority framework, analysis plan prespecifies an intention-to-treat approach, per protocol criteria, subgroups analysis, and handling of missing data. The trial is recruiting since September 2017. Finally, this study was designed to adhere to data sharing practices. TRIAL REGISTRATION NCT03264443 . Registered on 29 August, 2017.