Bleeding risk with rivaroxaban compared with vitamin K antagonists in patients aged 80 years or older with atrial fibrillation.

OBJECTIVE: Direct oral anticoagulants have been evaluated in the general population, but proper evidence for their safe use in the geriatric population is still missing. We compared the bleeding risk of a direct oral anticoagulant (rivaroxaban) and vitamin K antagonists (VKAs) among French geriatric patients with non-valvular atrial fibrillation (AF) aged ≥80 years. METHODS: We performed a sequential observational prospective cohort study, using data from 33 geriatric centres. The sample comprised 908 patients newly initiated on VKAs between September 2011 and September 2014 and 995 patients newly initiated on rivaroxaban between September 2014 and September 2017. Patients were followed up for up to 12 months. One-year risks of major, intracerebral, gastrointestinal bleedings, ischaemic stroke and all-cause mortality were compared between rivaroxaban-treated and VKA-treated patients with propensity score matching and Cox models. RESULTS: Major bleeding risk was significantly lower in rivaroxaban-treated patients (7.4/100 patient-years) compared with VKA-treated patients (14.6/100 patient-years) after multivariate adjustment (HR 0.66; 95% CI 0.43 to 0.99) and in the propensity score-matched sample (HR 0.53; 95% CI 0.33 to 0.85). Intracerebral bleeding occurred less frequently in rivaroxaban-treated patients (1.3/100 patient-years) than in VKA-treated patients (4.0/100 patient-years), adjusted HR 0.59 (95% CI 0.24 to 1.44) and in the propensity score-matched sample HR 0.26 (95% CI 0.09 to 0.80). Major lower bleeding risk was largely driven by lower risk of intracerebral bleeding. CONCLUSIONS: Our study findings indicate that bleeding risk, largely driven by lower risk of intracerebral bleeding, is lower with rivaroxaban than with VKA in stroke prevention in patients ≥80 years old with non-valvular AF.

Blood pressure-lowering efficacy of indapamide SR/amlodipine combination in older patients with hypertension: A post hoc analysis of the NESTOR trial (Natrilix SR vs Enalapril in Hypertensive Type 2 Diabetics With Microalbuminuria).

To examine the antihypertensive efficacy and safety of indapamide sustained-release (SR)/amlodipine compared with enalapril/amlodipine in patients 65 years and older with uncontrolled blood pressure (BP) on monotherapy, a post hoc analysis of the NESTOR trial (Natrilix SR vs Enalapril in Hypertensive Type 2 Diabetics With Microalbuminuria) was conducted. NESTOR randomized 570 patients (n=197, aged ≥65 years) with hypertension (systolic BP 140-180/diastolic BP <110 mm Hg) to indapamide SR 1.5 mg or enalapril 10 mg. If target BP (<140/85 mm Hg) was not achieved at 6 weeks, amlodipine 5 mg was added with uptitration to 10 mg if required. A total of 107 patients aged 65 years and older received dual therapy (53 indapamide SR/amlodipine and 54 enalapril/amlodipine). Amlodipine uptitration occurred in 22 and 24 patients, respectively. At 52 weeks, mean systolic BP (±SE) reduction was significantly greater with indapamide SR/amlodipine vs enalapril/amlodipine 6.2±2.7 mm Hg (P=.02). Indapamide SR/amlodipine was also associated with a greater BP response rate (88% vs 75%, respectively). Both regimens were well tolerated. Indapamide SR/amlodipine may be more effective than enalapril/amlodipine for lowering systolic BP in patients with hypertension aged 65 years and older.

Treatment of Hypertensive Patients With Diabetes and Microalbuminuria With Combination Indapamide SR/Amlodipine: Retrospective Analysis of NESTOR.

BACKGROUND: Combination treatments for hypertension most often include a renin-angiotensin-aldosterone system (RAAS) inhibitor. However, systolic blood pressure (SBP) remains difficult to control. Non-RAAS-inhibiting strategies such as calcium channel blocker/thiazide-like diuretic combinations may offer effective alternatives. METHODS: Hypertensive diabetic patients with microalbuminuria were included in this retrospective, post-hoc analysis of the Natrilix SR Versus Enalapril Study in Hypertensive Type 2 Diabetics With MicrOalbuminuRia (NESTOR) trial if they were uncontrolled on monotherapy (indapamide slow release (SR) 1.5 mg or enalapril 10mg) and had been given add-on amlodipine 5 mg. Patients uncontrolled with monotherapy/amlodipine 5mg were uptitrated to 10 mg. RESULTS: After 52 weeks, supine SBP/diastolic BP (DBP) decreased from baseline by 26±13/14±9 mm Hg in the indapamide SR/amlodipine group (n = 135) and by 21±14/11±9 mm Hg in the enalapril/amlodipine group (n = 156) (P = 0.006 for ΔSBP). In the amlodipine 10mg subgroup, SBP/DBP decreased from baseline by 26±13/13±9 mm Hg in the indapamide SR/amlodipine group (n = 62) and by 20±13/12±8 mm Hg in the enalapril/amlodipine group (n = 77) (P = 0.02 for ΔSBP). Treatment with indapamide SR/amlodipine was well tolerated. Few patients experienced edema, with no between-group differences. As expected with diuretics, slight changes in kalemia and in uricemia were observed in the indapamide SR/amlodipine group. Changes in fasting glucose, lipids, natremia, and creatinine clearance were similar between groups. CONCLUSIONS: Indapamide SR/amlodipine results in superior SBP reduction with a safety profile in line with that of its components and tolerability equivalent to that of an angiotensin-converting enzyme inhibitor/amlodipine strategy.

Home blood pressure measurement in elderly patients with cognitive impairment: comparison of agreement between relative-measured blood pressure and automated blood pressure measurement.

OBJECTIVES: Home blood pressure measurement (HBPM) is recommended by guidelines for hypertension management. However, this method might be difficult to use in elderly individuals with cognitive disorders. Our aim was to assess the agreement and the feasibility of HBPM by a relative as compared with 24-h ambulatory blood pressure monitoring (ABPM) in elderly patients with dementia. METHODS: Sixty outpatients with dementia aged 75 years and older with office hypertension (≥140/90 mmHg) were subjected successively to HBPM by a trained relative and 24-h ABPM. The order of the two methods was randomized. Current guidelines' thresholds for the diagnosis of hypertension were used. RESULTS: The mean (SD) age of the patients was 80.8 (6.1) years (55% women) and the mean (SD) mini-mental state examination score was 20.1 (6.9). The feasibility of relative-HBPM was very high, with a 97% success rate (defined by ≥12/18 measurements reported). The blood pressure measurements were highly correlated between the two methods (r=0.75 and 0.64 for systolic blood pressure and diastolic blood pressure, respectively; P<0.001 for both). The agreement between the methods for the diagnosis of sustained hypertension and white-coat hypertension was excellent (overall agreement, 92%; κ coefficient, 0.81; 95% CI, 0.61-0.93). Similar results were found for daytime-ABPM. CONCLUSION: In cognitively impaired elderly patients, HBPM by a relative using an automated device was a good alternative to 24-h ABPM.