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Antihypertensives and Statin Therapy for Primary Stroke Prevention: A Secondary Analysis of the HOPE-3 Trial.
Bosch, J, Lonn, EM, Dagenais, GR, Gao, P, Lopez-Jaramillo, P, Zhu, J, Pais, P, Avezum, A, Sliwa, K, Chazova, IE, et al
Stroke. 2021;(8):2494-2501
Abstract
BACKGROUND AND PURPOSE The HOPE-3 trial (Heart Outcomes Prevention Evaluation–3) found that antihypertensive therapy combined with a statin reduced first stroke among people at intermediate cardiovascular risk. We report secondary analyses of stroke outcomes by stroke subtype, predictors, treatment effects in key subgroups. METHODS Using a 2-by-2 factorial design, 12 705 participants from 21 countries with vascular risk factors but without overt cardiovascular disease were randomized to candesartan 16 mg plus hydrochlorothiazide 12.5 mg daily or placebo and to rosuvastatin 10 mg daily or placebo. The effect of the interventions on stroke subtypes was assessed. RESULTS Participants were 66 years old and 46% were women. Baseline blood pressure (138/82 mm Hg) was reduced by 6.0/3.0 mm Hg and LDL-C (low-density lipoprotein cholesterol; 3.3 mmol/L) was reduced by 0.90 mmol/L on active treatment. During 5.6 years of follow-up, 169 strokes occurred (117 ischemic, 29 hemorrhagic, 23 undetermined). Blood pressure lowering did not significantly reduce stroke (hazard ratio [HR], 0.80 [95% CI, 0.59–1.08]), ischemic stroke (HR, 0.80 [95% CI, 0.55–1.15]), hemorrhagic stroke (HR, 0.71 [95% CI, 0.34–1.48]), or strokes of undetermined origin (HR, 0.92 [95% CI, 0.41–2.08]). Rosuvastatin significantly reduced strokes (HR, 0.70 [95% CI, 0.52–0.95]), with reductions mainly in ischemic stroke (HR, 0.53 [95% CI, 0.37–0.78]) but did not significantly affect hemorrhagic (HR, 1.22 [95% CI, 0.59–2.54]) or strokes of undetermined origin (HR, 1.29 [95% CI, 0.57–2.95]). The combination of both interventions compared with double placebo substantially and significantly reduced strokes (HR, 0.56 [95% CI, 0.36–0.87]) and ischemic strokes (HR, 0.41 [95% CI, 0.23–0.72]). CONCLUSIONS Among people at intermediate cardiovascular risk but without overt cardiovascular disease, rosuvastatin 10 mg daily significantly reduced first stroke. Blood pressure lowering combined with rosuvastatin reduced ischemic stroke by 59%. Both therapies are safe and generally well tolerated. REGISTRATION URL: https://www.clinicaltrials.gov; Unique identifier: NCT00468923.
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Risk Factors Control and Early Recurrent Cerebral Infarction in Patients with Symptomatic Intracranial Atherosclerotic Disease.
Del Brutto, VJ, Liebeskind, DS, Romano, JG, Campo-Bustillo, I, Cotsonis, G, Nizam, A, Prabhakaran, S, ,
Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association. 2021;(9):105914
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BACKGROUND The risk of early recurrent cerebral infarction (RCI) is high in patients with symptomatic intracranial atherosclerotic disease (IAD). We sought to determine the relationship between risk factor control and early RCI risk among patients with symptomatic IAD. METHODS We analyzed participants with symptomatic IAD in the multi-center prospective observational MYRIAD study. Risk factor control was assessed at 6-8-week follow-up. Optimal risk factor control was defined by target systolic blood pressure, being non-smoker, target physical activity, and antiplatelet and antilipidemic therapy compliance. Age-adjusted associations were calculated between risk factor control and RCI determined by MRI-evident new infarcts in the territory of the stenotic vessel at 6-8 weeks from the index event. RESULTS Among 82 participants with clinical and brain MRI information available 6-8 weeks after the index event (mean age 63.5 ±12.5 years, 62.2% men), RCI occurred in 21 (25.6%) cases. At 6-8-week follow-up, 37.8% had target systolic blood pressure, 92.7% were non-smokers, 51.2% had target physical activity, and 98.8% and 86.6% were compliant with antiplatelet and antilipidemic therapy, respectively. Optimal risk factor control increased from 4.9% at baseline to 19.5% at 6-8-week follow-up (p=0.01). None of the participants with optimal risk factor control at follow-up had RCI (0% vs. 31.8%, p<0.01). CONCLUSIONS Only one-fifth of MYRIAD participants had optimal risk factor control during early follow-up. Approximately half and two-thirds had physical inactivity and uncontrolled systolic blood pressure, respectively. These risk factors may represent important therapeutic targets to prevent early RCI in patients with symptomatic IAD.
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Epidemiological and clinical profile of hypertensive octogenarian patients and factors associated with uncontrolled hypertension: observational study of 346 patients.
Bahloul, A, Hammami, R, Charfeddine, S, Triki, S, Bouattour, N, Abid, L, Kammoun, S
The Pan African medical journal. 2021;:202
Abstract
INTRODUCTION hypertension (HTN) is the main risk factor for most morbidities of elderly subjects. The objective of this study was to identify the epidemiological and clinical characteristics of hypertension in octogenarians and to identify the factors associated with uncontrolled hypertension in this population. METHODS we used data collected in the outpatient cardiology department of the University Hospital of Sfax between 15th April 2019 and 15th May 2019 as part of the National Tunisian Registry of Hypertension. We included in our study patients aged 80 years or more with hypertension. We described the epidemiological and clinical profile of this population, and we studied the associations between uncontrolled hypertension and socio-demographic, lifestyle, clinical and therapeutic factors using logistic regression models. RESULTS we included 346 subjects (45.1% (n=156) male and 54.9% (n=190) female), with a mean age of 84.36 (SD 4.01) years. More than half of them had uncontrolled hypertension. Dyslipidemia was the most common cardiovascular risk factor found in 43.6 % (n=151) of patients followed by diabetes (35.5%, n=122). One-third of patients had a history of coronary artery disease and/or stroke. Renal failure and kalemia disorders were observed, respectively, in 12.1% (n=42) and 25.2% (n=40) of patients. In multivariate analysis, factors associated with uncontrolled hypertension (HTN) were male sex (adjusted odds ratio (aOR): 1.663, 95% confidence interval (CI): 1.045-2.647; p=0.032), diabetes (aOR: 1.66, 95%CI: 1.031-2.688; p=0.037,) and poor adherence to blood pressure (BP) medications (aOR: 1.960, 95%CI: 1.195-3.214; p=0.008). CONCLUSION our results showed that more than half of octogenarian hypertensive patients did not reach the BP target and that poor adherence to BP medications was the main factor of uncontrolled HTN. In this population, the presence of other comorbidities and poor adherence to BP medications are very common. Systematic research for behaviors suggesting poor medication adherence should be a priority for physicians caring for these patients.
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Effect of the Million Hearts Cardiovascular Disease Risk Reduction Model on Initiating and Intensifying Medications: A Prespecified Secondary Analysis of a Randomized Clinical Trial.
Peterson, GG, Pu, J, Magid, DJ, Barterian, L, Kranker, K, Barna, M, Conwell, L, Rose, A, Blue, L, Markovitz, A, et al
JAMA cardiology. 2021;(9):1050-1059
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IMPORTANCE The Million Hearts Cardiovascular Disease (CVD) Risk Reduction Model pays provider organizations for measuring and reducing Medicare patients' cardiovascular risk. OBJECTIVE To assess whether the model increases the initiation or intensification of antihypertensive medications or statins among patients with blood pressure or low-density lipoprotein (LDL) cholesterol levels above guideline thresholds for treatment intensification. DESIGN, SETTING, AND PARTICIPANTS This prespecified secondary analysis of a cluster-randomized, pragmatic trial included primary care and cardiology practices, health care centers, and hospital-based outpatient departments across the US. Participants included Medicare patients who were enrolled into the model in 2017 by participating organizations and who were at high risk and at medium risk of a myocardial infarction or stroke in 10 years. Patient outcomes were analyzed for 1 year postenrollment (through December 2018) using an intent-to-treat design. Analysis began November 2019. INTERVENTIONS US Centers for Medicare & Medicaid Services paid organizations for risk stratifying Medicare patients and reducing CVD risk among high-risk patients through discussing risk scores, developing individualized risk reduction plans, and following up with patients twice yearly. MAIN OUTCOMES AND MEASURES Initiating or intensifying statin or antihypertensive therapy within 1 year of enrollment, measured in Medicare Part D claims, and LDL cholesterol and systolic blood pressure levels approximately 1 year after enrollment, measured in usual care and reported to Centers for Medicare & Medicaid Services via a data registry (data complete for 51% of high-risk enrollees). The study's primary outcome (incidence of first-time myocardial infarction and stroke) is not reported because the trial is ongoing. RESULTS A total of 330 primary care and cardiology practices, health care centers, and hospital-based outpatient departments and 125 436 Medicare patients were included in this analysis. High-risk patients in the intervention group had a mean (SD) age of 74 (4.1), 15 213 (63%) were male, 21 657 (90%) were receiving antihypertensive medication at baseline, and 16 558 (69%) were receiving statins. Almost all (21 791 [91%]) high-risk intervention group patients had above-threshold systolic blood pressure level (>130 mm Hg), LDL cholesterol level (>70 mg/dL), or both. Patients in the intervention group with these risk factors were more likely than control patients (8127 [37.3%] vs 4753 [32.4%]; adjusted difference in percentage points, 4.8; 95% CI, 2.9-6.7; P < .001) to initiate or intensify statins or antihypertensive medication. Centers for Medicare & Medicaid Services did not pay for CVD risk reduction for medium-risk enrollees, but initiation or intensification rates for these enrollees were also higher in the intervention vs control groups (12 668 [27.9%] vs 7544 [24.8%]; adjusted difference in percentage points, 3.1; 95% CI, 1.9-4.3; P < .001). Among high-risk enrollees with clinical data approximately 1 year after enrollment, LDL cholesterol level was slightly lower in the intervention vs control groups (mean [SD], 89 [31.8] vs 91 [32.1] mg/dL; adjusted difference in percentage points, -1.8; 95% CI, -2.9 to -0.6; P = .002), as was systolic blood pressure (mean [SD], 133 [15.7] vs 135 [16.4] mm Hg; adjusted difference in percentage points, -1.7; 95% CI, -2.8 to -0.6; P = .003). CONCLUSIONS AND RELEVANCE In this study, a pay-for-performance model led to modest increases in the use of CVD medications in a range of organizations, despite high medication use at baseline.
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Implications of Guideline Updates for the Management of Apparent Treatment Resistant Hypertension in the United States (A NCDR Research to Practice [R2P] Project).
Maw, AM, Thompson, LE, Ho, PM, Kennedy, KF, Maddox, TM, Valle, JA, Sandhu, A, Masoudi, FA, Messerli, FH, Daugherty, SL
The American journal of cardiology. 2020;(1):63-67
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The 2018 resistant hypertension scientific statement offers new treatment recommendations. To determine the implications of these changes, we sought to ascertain the prevalence of apparent treatment resistant hypertension (aTRH) and the therapies used to treat it in an US national ambulatory cardiovascular registry before these recent developments. Using the PINNACLE Registry from 2013 to 2014, we identified all patients receiving treatment for hypertension and then determined the proportion with aTRH as those who met the following criteria over ≥2 consecutive visits: (1) 3 blood pressure medication classes including a diuretic and blood pressure >140/90, OR (2) ≥4 blood pressure medications. Among those with aTRH, we examined past use of therapies now recommended in guidelines including: (1) first-line therapy with an angiotensin-converting enzyme inhibitor or angiotensin-II receptor blocker, calcium channel blocker and a thiazide diuretic, (2) use of chlorthalidone, and (3) use of a mineralocorticoid receptor antagonist (MRA) for those requiring a 4th medication. Of 84,624 patients on treatment for hypertension, 11,147 (13.1%) met criteria for prevalent aTRH. Among these patients: (1) Of those on 3 antihypertensive agents (n = 1,255), 315 (25%) were on the first-line regimen now recommended in guidelines, (2) 520 (6.7%) of the 7,930 patients on thiazides were using chlorthalidone, and (3) 3061 (27%) were using a MRA; another 4,523 (40.6%) were eligible for its addition. In conclusion, our findings of low historic use of therapies now recommended in guidelines suggest opportunities to improve care among patients with aTRH.
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Poor adherence to medication and salt restriction as a barrier to reaching blood pressure control in patients with hypertension: Cross-sectional study from 12 sub-Saharan countries.
Macquart de Terline, D, Kramoh, KE, Bara Diop, I, Nhavoto, C, Balde, DM, Ferreira, B, Houenassi, MD, Hounsou, D, Ikama, MS, Kane, A, et al
Archives of cardiovascular diseases. 2020;(6-7):433-442
Abstract
BACKGROUND Sub-Saharan Africa is experiencing a rising burden of hypertension. Antihypertensive medications and diet are the cornerstone of effective hypertension control. AIMS To assess adherence to medication and salt restriction in 12 sub-Saharan countries, and to study the relationship between adherence and blood pressure control in patients with hypertension. METHODS We conducted a cross-sectional survey in urban clinics in twelve sub-Saharan countries. Data were collected on demographics, treatment and adequacy of blood pressure control in patients with hypertension attending the clinics. Adherence was assessed by questionnaires completed by the patients. Hypertension grades were defined according to European Society of Cardiology guidelines. Association between adherence and blood pressure control was investigated using multilevel logistic regression analysis, adjusting for age, sex and country. RESULTS Among the 2198 patients, 77.4% had uncontrolled blood pressure, 34.0% were poorly adherent to salt restriction, 64.4% were poorly adherent to medication and 24.6% were poorly adherent to both. Poor adherence to salt restriction (odds ratio [OR] 1.33, 95% confidence interval [CI] 1.03-1.72), medication (OR 1.56, 95% CI 1.25-1.93) or both (OR 1.91 1.39-2.66) was related to uncontrolled blood pressure. Moreover, poor adherence to both medication and salt restriction was related to a 1.52-fold (95% CI 1.04-2.22), 1.8-fold (95% CI 1.22-2.65) and 3.08-fold (95% CI 2.02-4.69) increased likelihood of hypertension grade 1, 2 and 3, respectively. CONCLUSIONS High levels of poor adherence to salt restriction and medication were noted in this urban sub-Saharan study; both were significantly associated with uncontrolled blood pressure, representing major opportunities for intervention to improve hypertension control in sub-Saharan Africa.
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A randomized, double-blind clinical trial to evaluate the efficacy and safety of a fixed-dose combination of amlodipine/rosuvastatin in patients with dyslipidemia and hypertension.
Kim, W, Chang, K, Cho, EJ, Ahn, JC, Yu, CW, Cho, KI, Kim, YJ, Kang, DH, Kim, SY, Lee, SH, et al
Journal of clinical hypertension (Greenwich, Conn.). 2020;(2):261-269
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This multicenter, randomized, double-blind, parallel-group phase III clinical trial aimed to investigate the efficacy and safety of a rosuvastatin + amlodipine combination compared with that of rosuvastatin or amlodipine monotherapy in hypertensive patients with dyslipidemia. A total of 106 patients of 15 institutions in Korea were randomly assigned to 1 of 3 treatment groups: rosuvastatin 20 mg + amlodipine 10 mg, amlodipine 10 mg, or rosuvastatin 20 mg. After 8 weeks of treatment, the mean ± SD of change in mean sitting systolic blood pressure (msSBP) was -22.82 ± 12.99 mm Hg in the rosuvastatin + amlodipine group, the most decreased among the treatment groups. The percentage of patients whose msSBP decreased ≥20 mm Hg or msDBP decreased ≥10 mm Hg was also highest in this group (74.29%). The mean ± SD percentage change in low-density lipoprotein cholesterol (LDL-C) level from baseline after 8 weeks was -52.53% ± 11.21% in the rosuvastatin + amlodipine group, the most decreased among the treatment groups. More patients in the rosuvastatin + amlodipine group achieved their target LDL-C goal at 8 weeks, compared with the other treatment groups (97.14%). No serious adverse events or adverse drug reactions were observed in all groups. In hypertensive patients with dyslipidemia, combination treatment with rosuvastatin 20 mg + amlodipine 10 mg effectively reduced blood pressure and LDL-C levels while maintaining safety.
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Relation between baseline LDL-cholesterol and cardiovascular outcomes in high cardiovascular risk hypertensive patients: A post-hoc SPRINT data analysis.
Nguyen, LS, Procopi, N, Salem, JE, Squara, P, Funck-Brentano, C
International journal of cardiology. 2019;:159-161
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BACKGROUND Patients at increased cardiovascular (CV) risk, noticeably hypertensive patients, have multiple CV risk factors which may be treatment targets. LDL-cholesterol is one of such targets. Using the SPRINT cohort, studying the cardiovascular outcomes of hypertensive patients at increased CV risk, this post-hoc study aimed to assess the association of LDL-C with CV outcomes. METHODS Clinical outcomes were those defined in SPRINT a composite of various CV outcomes, all-cause mortality, and CV mortality. Association between LDL-C and the primary outcome was analyzed using survival regression adjusted on confounding factors (age, sex, body-mass index, active smoking status, eGFR-estimated kidney function, history of CV disease, Framingham risk score, SPRINT treatment arm (intensive or control), baseline high-density-lipoprotein-bound cholesterol, and co-treatments by aspirin and statins). RESULTS LDL-C was not associated with the primary outcome in the overall cohort (n = 9631). Among patients in secondary prevention (i.e. with a previous history of CV disease) (n = 1562), LDL-C was marginally associated with the incidence of the primary outcome (adjusted hazard-ratio 1.005 (95% CI = 1.002-1.009), p = 0.005 (per 1 mg/dl increase)) however, discrimination was poor with a ROC AUC of 0.54, p = 0.087. There was no association between LDL-C and the primary outcome in other subgroup analyses (those under statin or not, and those in primary prevention). CONCLUSION This post-hoc analysis of SPRINT indicates that LDL-C levels do not influence cardiovascular events over a period of 3 years in a large cohort of hypertensive patients at increased risk of cardiovascular events but without previous history of clinical cardiovascular disease other than stroke.
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Clinical Effectiveness of the Cardiovascular Polypill in a Real-Life Setting in Patients with Cardiovascular Risk: The SORS Study.
Castellano, JM, Verdejo, J, Ocampo, S, Rios, MM, Gómez-Álvarez, E, Borrayo, G, Ruiz, E, Ibáñez, B, Fuster, V, ,
Archives of medical research. 2019;(1):31-40
Abstract
BACKGROUND The cardiovascular disease pandemic has promoted the cardiovascular polypill as one of the most scalable public health strategies to improve cardiovascular risk by increasing accessibility and adherence to treatments. Data from randomized clinical trials has shown that the polypill strategy significantly improves adherence as well as risk factor control (cholesterol and blood pressure), however, to date, no information from phase IV registries has been available. METHODS We conducted a multicentre, observational and prospective registry of a polypill-based treatment strategy. A total of 1193 patients in Mexico were included. Patient demographics, clinical history, blood pressure, analysis of blood lipids and the Framingham risk score were measured at baseline and after 12 months of treatment with the CNIC-Ferrer polypill. RESULTS At one year with the polypill, systolic blood pressure (SBP) and diastolic blood pressure (DBP) levels changed from mean 146.9 mmHg to 128 mmHg (p <0.001), and from 89.1 mmHg to 80.4 mmHg (p <0.001) respectively. LDLc levels were significantly reduced 132.5-107.6 mg/dL (p <0.001). The 10 year Framingham cardiovascular disease risk was also reduced in the high-risk group (33.7 + 22.0 vs. 21.2 + 14.8; p <0.001) and in the intermediate risk group (23.7 + 14.8 vs. 12.7 + 11.4; p <0.001). CONCLUSIONS To our knowledge, the results of the current study constitute the first real life data on the impact of a polypill therapy on cardiovascular risk factor control. The results show major improvements on the primary outcome, above and beyond those presented previously in the setting of randomized clinical trials.
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Multicentre cohort study of antihypertensive and lipid-lowering therapy cessation after bariatric surgery.
Thereaux, J, Lesuffleur, T, Czernichow, S, Basdevant, A, Msika, S, Nocca, D, Millat, B, Fagot-Campagna, A
The British journal of surgery. 2019;(3):286-295
Abstract
BACKGROUND Few studies have assessed changes in antihypertensive and lipid-lowering therapy after bariatric surgery. The aim of this study was to assess the 6-year rates of continuation, discontinuation or initiation of antihypertensive and lipid-lowering therapy after bariatric surgery compared with those in a matched control group of obese patients. METHODS This nationwide observational population-based cohort study used data extracted from the French national health insurance database. All patients undergoing gastric bypass or sleeve gastrectomy in France in 2009 were matched with control patients. Mixed-effect logistic regression models were used to analyse factors that influenced discontinuation or initiation of treatment over a 6-year interval. RESULTS In 2009, 8199 patients underwent primary gastric bypass (55·2 per cent) or sleeve gastrectomy (44·8 per cent). After 6 years, the proportion of patients receiving antihypertensive and lipid-lowering therapy had decreased more in the bariatric group than in the control group (antihypertensives: -40·7 versus -11·7 per cent respectively; lipid-lowering therapy: -53·6 versus -20·2 per cent; both P < 0·001). Gastric bypass was the main predictive factor for discontinuation of therapy for hypertension (odds ratio (OR) 9·07, 95 per cent c.i. 7·72 to 10·65) and hyperlipidaemia (OR 11·91, 9·65 to 14·71). The proportion of patients not receiving treatment at baseline who were subsequently started on medication was lower after bariatric surgery than in controls for hypertension (5·6 versus 15·8 per cent respectively; P < 0·001) and hyperlipidaemia (2·2 versus 9·1 per cent; P < 0·001). Gastric bypass was the main protective factor for antihypertensives (OR 0·22, 0·18 to 0·26) and lipid-lowering medication (OR 0·12, 0·09 to 0·15). CONCLUSION Bariatric surgery is associated with a good discontinuation of antihypertensive and lipid-lowering therapy, with gastric bypass being more effective than sleeve gastrectomy.