Remote patient monitoring for chronic heart failure in France: When an innovative funding program (ETAPES) meets an innovative solution (Satelia® Cardio).

Introduction: Remote patient monitoring (RPM) is a telehealth activity to collect and analyze patient health or medical data. Its use has expanded in the past decade and has improved medical outcomes and care management of non-communicable chronic diseases. However, implementation of RPM into routine clinical activities has been limited. The objective of this study was to describe the French funding program for RPM (known as ETAPES) and one of the RPM solution providers (Satelia®) dedicated to chronic heart failure (CHF). Methods: A descriptive assessment of both the ETAPES funding program and Satelia® RPM solution was conducted. Data were collected from official legal documents and information that was publicly available online from the French Ministry of Health. Results and Discussion: ETAPES was formally created in 2016 based on previous legislation pertaining to the national health insurance funding strategy. However, it only started to operate in 2018. Patients with CHF were only eligible if they were at medium or high risk of re-hospitalization with a New York Heart Association (NYHA) score superior or equal to two and a BNP>100 pg/ml or NT pro BNP>1000 pg/ml. Medical monitoring was supported through the therapeutic education of a patient on the RPM model of care with a minimum of three training sessions during the first six months. The use of Satelia® Cardio is noteworthy since it relies only on symptomatic monitoring through which the patient manually reports their information by answering a simple questionnaire on a regular basis and does not rely on any connected devices. Conclusion: Innovative funding programs and solutions for RPM need real-world evaluation in the future.

Effects of candesartan cilexetil on carotid remodeling in hypertensive diabetic patients: the MITEC study.

In hypertension and diabetes, early structural changes of the arterial wall precede or support atherosclerosis. There is evidence that some antihypertensive drugs exert an antiathero-sclerotic effect. Over 36 months, we investigated the effect of candesartan cilexetil (CC) on the common carotid intima-media thickness (IMT) vs amlodipine besylate (AML) in patients with type 2 diabetes and mild to moderate essential hypertension. After a 4-week wash-out period, 209 patients were randomized to either CC 8 mg or AML 5 mg once daily for a minimum of 1 month, after which, if BP was not normalized, the dosage was doubled, followed by the addition of hydrochlorothiazide 12.5 mg if necessary. No significant differences were observed between the two groups for change in IMT at M12 (-0.001 vs -0.027 mm/year for CC and AML respectively, p = 0.425), at M24 (-0.033 vs -0.019 mm per year respectively, p = 0.442), and at the last visit (-0.016 vs -0.039 mm per year respectively, p = 0.549). Within the group, comparisons did not show a significant difference in changes in IMT from baseline to the three visits. At the last visit, IMT regression was observed in 52.2% of patients receiving CC and in 51.3% of those receiving AML (p = 0.908). The augmentation in carotid lumen diameter from baseline was statistically greater in the AML group at the last visit (p = 0.034). BP variations during the study were similar in the two groups. The results of this study show that CC and AML treatments may alter identically the natural progression of carotid IMT in hypertensive type 2 diabetic patients.

[Efficacy of candesartan cilexetil in hypertensive patients with or without diabetes]. / Efficacité du candesartan cilexetil chez les hypertendus diabétiques ou non diabétiques.

OBJECTIVE: To assess the effect of an ARB, candesartan cilexetil (CC), on blood pressure (BP) from 5 double-blind, randomised, studies in hypertensive patients. METHODS: Similar design was used in the 5 selected studies. Following 2-4 weeks run-in period with placebo, patients were randomised to receive the double-blind treatment. BP were assessed at inclusion, after 4-6 weeks and at the end (8-12 weeks). Depending on the BP response, dosage of CC 8 mg was doubled at the follow-up visit if BP >or=140/90 mmHg. RESULTS: 702 patients were randomised in CC group of whom 22% (153) were diabetic. Mean BP was 160 +/- 13/94 +/- 10/65 +/- 14 mmHg for SBP/DBP/PP at inclusion and were significantly reduced to 141 +/- 15/83 +/- 10/58 +/- 13 mmHg (p<0.001) after 8-12 weeks. The results according to the diabetes status are presented in the table below: [table: see text] CONCLUSION: Results of this meta analysis analysis performed on individual data show that CC reduces significantly BP in hypertensive population with a significant decrease in the diabetic patients.

A placebo-controlled comparison of the efficacy and tolerability of candesartan cilexetil, 8 mg, and losartan, 50 mg, as monotherapy in patients with essential hypertension, using 36-h ambulatory blood pressure monitoring.

This double-blind, randomised, controlled study compared the efficacy of candesartan cilexetil 8 mg (n = 87) and losartan 50 mg (n = 89), once daily for 6 weeks, relative to placebo (n = 80) in patients with mild-to-moderate essential hypertension (diastolic blood pressure (DBP): 95-115 mmHg). Ambulatory BP measurements were done every 15 min over 36 h. At the end of the 6-week treatment, the mean change in DBP between the baseline and the 0-24-h period after the last dose of study medication was greater in patients receiving candesartan cilexetil 8 mg (-7.3 mmHg +/- 6.9 mmHg) compared with losartan 50 mg (-5.1 mmHg +/- 4.9 mmHg) (p < 0.05) or placebo (0.3 mmHg +/- 6.5 mmHg) (p < 0.001). The mean change in systolic BP (SBP) during this time was greater in patients receiving candesartan cilexetil 8 mg (-10.8 mmHg +/- 11.3 mmHg), or losartan 50 mg (-8.8 mmHg +/- 8.9 mmHg) than placebo (1.2 mmHg +/- 9.9 mmHg) (p < 0.001). Candesartan cilexetil 8 mg was associated with a greater reduction in DBP and SBP, relative to placebo, when compared with losartan 50 mg, during both daytime and night-time, and between 12 and 24 h after dosing (p < 0.001). Both active treatments were well tolerated. In patients with mild-to-moderate essential hypertension, candesartan cilexetil 8 mg therefore had greater, more consistent antihypertensive efficacy throughout the day and the night, and long-lasting efficacy after the last dose, compared with losartan 50 mg. This greater efficacy is maintained with an excellent tolerability associated with members of the angiotensin Il type 1-receptor blocker class.

Efficacy and tolerability of candesartan cilexetil vs. amlodipine as assessed by home blood pressure in hypertensive patients.

This randomised, double-blind study compared the anti-hypertensive efficacy and tolerability of Candesartan cilexetil (CC 8-16 mg) and Amlodipine (AML 5-10 mg) on home blood pressure (HBP) measurements in mild-to-moderate hypertensive patients. After a 2-week wash-out, patients aged 18-74 years, with a sitting diastolic blood pressure (sDBP)=95-115 mmHg, untreated or intolerant to therapy or uncontrolled were randomised to CC 8 mg or AML 5 mg O.D. for 12 weeks (W12). Patients not normalised or not responders at W12 had their dose doubled for the remaining 6 weeks. HBP was measured before each visit, during 5 days (three measurements in the morning, 24 h after last dose and before drug intake and three measurements before bedtime). The primary criterion was the comparison of mean morning sDBP at baseline and post-treatment. A total of 638 patients were enrolled, 540 of whom were randomised to CC or AML. The intent-to-treat and safety analyses were performed in 532 patients while 321 constituted the per protocol population. Baseline characteristics and BP values of the two groups were similar. Morning sDBP did not differ between groups at W12, but AML patients had significantly more adverse events (AEs) than those treated by CC (28 vs. 20%, p=0.03); 6% of AML patients vs. 1% of CC patients were withdrawn due to AEs (p=0.009). CC demonstrates a better tolerability over AML and an equivalent anti-hypertensive efficacy in terms of morning home DBP after 12 weeks of treatment.

[Quality of blood pressure measurement in the management of arterial hypertension. Pilot study]. / Qualité de la mesure de la PA dans la prise en charge de l'hypertension artérielle. Etude pilote.

UNLABELLED: In clinical practice, diagnosis and follow-up of hypertension is based on blood pressure (BP) as measured by auscultatory method. BP is usually measured using a stethoscope to auscultate the Korotkoff sounds and mercury or an aneroid sphygmomanometer. However due to the lack of regulatory rules, the devices are rarely checked making the quality of the measures doubtful. OBJECTIVE: To compare BP measured following the WHO recommendations, using 2 different devices: the mercury or aneroid sphygmomanometer used by the physician and a SECURUS manometer that has been calibrated just before the implementation of the study. METHOD: The study was performed with 1694 French general practitioners. Every physician included 2 ambulatory patients: a newly diagnosed non-treated hypertensive patient and a treated hypertensive patient. The physician was asked to include the first patient of each category attending his office. BP was measured sequentially with the 2 devices in a random order. Collected data were socio-demographic parameters, cardiovascular risk factors, hypertension related diseases, drug treatment for hypertension and BP levels. RESULTS: Mean BPs differ by less than 1 mmHg between the 2 devices. However 10% of the treated hypertensive patients are not classified as having normalised BP values (BP < 140/90 mmHg) or high BP values, in the same way by the 2 devices. Mean absolute difference between the 2 devices is > 5 mmHg in 22% and 13% of the physicians for SBP and DBP respectively. CONCLUSION: This pilot study emphasises the need of BP measurements of good quality in clinical practice, because of the possible impact on the care of the patients and the related costs. Regulatory rules on the control of the devices might improve the quality of BP measurements.