The impact of renal denervation procedure on use of antihypertensive drugs in the real-life setting

Purpose. Randomised controlled trials have shown that renal denervation lowers office and ambulatory blood pressure. The aim of the present study was to evaluate whether patients undergoing renal denervation procedure in a real-life setting have a reduction in antihypertensive drug prescription over the subsequent years. Material and methods. Using the healthcare utilisation database of the Lombardy Region (Italy), the 136 patients who, during the period 2011–2016, were prescribed four or more antihypertensive drugs and underwent renal denervation were included in the study cohort. The number and type of antihypertensive drugs were assessed over the year before and during the three-year period after renal denervation. Results. The median age of the patients was 67 years and 68% of them were men. Based on a multisource comorbidity score, about 40% of patients showed a poor or very poor clinical status. Before renal denervation, the majority of the patients were prescribed four or five antihypertensive drugs. The number of drugs decreased after the denervation and reached 55% after three years. Over the same period, patients prescribed six drugs decreased from 18% to 2%. All antihypertensive drugs were less prescribed throughout the post denervation period. Compared to the year before the denervation, after three years prescription of diuretics was reduced by 15%, calcium channel blockers by 21%, ACE-inhibitors by 32%, angiotensin receptor blockers by 22%, beta-blockers by 20%, and alfa-blockers by 30%. Use of antihypertensive drugs exhibited a reduction also in an age, sex, and clinically matched control group with no renal denervation to an extent, however, much lower than in denervated patients (p-value = 0.013). Conclusion. In the real-life setting, patients who underwent renal denervation had a clearcut reduction in antihypertensive drug prescription over the following years.Plain Language SummaryPatients exhibited a reduction in the prescription of antihypertensive drugs during the three years that followed the denervation procedureThe decrease in the number of antihypertensive drugs was marked, started after a relatively short time (six months), and involved all drugs prescribed before the denervationThe number of hospitalisations for a cardiovascular event was similar before and after renal denervationAlbeit blood pressure values were not recorded in our database, all these findings taken together suggest the renal denervation procedure has a favourable influence on blood pressure control and is not associated with an increase in the risk of major cardiovascular complications Patients exhibited a reduction in the prescription of antihypertensive drugs during the three years that followed the denervation procedure The decrease in the number of antihypertensive drugs was marked, started after a relatively short time (six months), and involved all drugs prescribed before the denervation The number of hospitalisations for a cardiovascular event was similar before and after renal denervation Albeit blood pressure values were not recorded in our database, all these findings taken together suggest the renal denervation procedure has a favourable influence on blood pressure control and is not associated with an increase in the risk of major cardiovascular complications</p

Office-based systolic and diastolic blood pressure based upon treatment strategy among 423 frequency-matched INVEST patients who did not have ambulatory blood pressure monitoring.

<p>The minimum <i>P</i> values were 0.12 and 0.09, respectively.</p

Consort diagram showing selection of INVEST patients for the ambulatory monitoring substudy analysis.

<p>The subgroup consisted of 141 patients undergoing 24-hour ambulatory monitoring at baseline and after 1 year of treatment. Patients were excluded if their blood pressure and heart rate recordings did not meet the criteria for inclusion (adequate technical quality ≥85% of the 24-hour recording period, <3 consecutive hours without valid measurements, and <4 non-consecutive hours without valid measurements).</p

Baseline Clinical Characteristics of Ambulatory Monitoring Patients According to Treatment Strategy, and Compared to Remaining, Non-Ambulatory Monitoring INVEST Patients.

<p>Data are presented as mean (SD) or number (percent).</p><p>BMI, body mass index; CABG, coronary artery bypass graft; INVEST, INternational VErapamil SR-Trandolapril STudy; LVH, left ventricular hypertrophy; PCI, percutaneous coronary intervention; SD, standard deviation; TIA, transient ischemic attack.</p><p>^aComparing ambulatory monitoring study patients randomized to verapamil SR- vs. atenolol-based treatment strategies, <i>P</i> value uniformly nonsignificant.</p><p>^bComparing all ambulatory monitoring INVEST study patients with remaining, non-ambulatory monitoring patients.</p><p>^cPatients taking beta-blockers within 2 weeks of randomization or taking beta-blockers for an MI that occurred in the previous 12 months were excluded from INVEST to avoid withdrawal phenomena in patients randomized to the verapamil-based treatment strategy [<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0122726#pone.0122726.ref031" target="_blank">31</a>].</p><p>Baseline Clinical Characteristics of Ambulatory Monitoring Patients According to Treatment Strategy, and Compared to Remaining, Non-Ambulatory Monitoring INVEST Patients.</p

Study variables assessed at high altitude in baseline condition, after 15 minutes of slow breathing exercise and after 5 and 30 minutes of recovery.

<p>Data are separately shown for Study A and B.</p>*<p>-p<0.05, **-p<0.01, ***, p<0.001 vs. baseline; † - p<0.05, †† - p<0.01, †††, p<0.001 vs. slow breathing.</p><p>Sp_O2, blood oxygen saturation; p_tO2– transcutaneous oxygen partial pressure; pt_CO2– transcutaneous CO₂ partial pressure; Et_CO2– end tidal CO₂ pressure in the exhaled air; SBP – systolic blood pressure; DBP – diastolic blood pressure; PP – pulse pressure; HR – heart rate; sPAP – systolic pulmonary artery pressure; RF – respiratory frequency; Vt – tidal volume; VE – minute ventilation; VA – alveolar volume; Dl_CO - pulmonary CO diffusion; TFC – thoracic fluid content.</p

Schematic representation of the sequence of data collection in studies A and B.

<p>Sp_O2, blood oxygen saturation; Pt_O2, transcutaneous oxygen partial pressure; Pt_CO2, transcutaneous CO₂ partial pressure; HR, heart rate; BP, blood pressure; RF, respiratory frequency; PAP, pulmonary artery pressure; Vt, tidal volume; VE, minute ventilation; Dl_CO, pulmonary CO diffusion; VA = alveolar volume; TFC, thoracic fluid content; Pet_CO2, end tidal CO₂ pressure in the exhaled air.</p

Office-based and 24-hour ambulatory monitoring systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate (HR) at baseline and following 1 year of treatment.

<p>The baseline data contain both verapamil SR- and atenolol-based strategies combined, while the data following 1 year of treatment is individualized to treatment strategy. For comparison, baseline office-based data for the remaining INVEST patients, who did not have ambulatory blood pressure monitoring, are shown to the left. Horizontal line through each box represents median; bottom and top of box represent first and third quartiles; the whiskers represent minimum and maximum of all data.</p

Datasheet1_Joint statement for assessing and managing high blood pressure in children and adolescents: Chapter 1. how to correctly measure blood pressure in children and adolescents.pdf

The joint statement is a synergistic action between HyperChildNET and the European Academy of Pediatrics about the diagnosis and management of hypertension in youth, based on the European Society of Hypertension Guidelines published in 2016 with the aim to improve its implementation. The first and most important requirement for the diagnosis and management of hypertension is an accurate measurement of office blood pressure that is currently recommended for screening, diagnosis, and management of high blood pressure in children and adolescents. Blood pressure levels should be screened in all children starting from the age of 3 years. In those children with risk factors for high blood pressure, it should be measured at each medical visit and may start before the age of 3 years. Twenty-four-hour ambulatory blood pressure monitoring is increasingly recognized as an important source of information as it can detect alterations in circadian and short-term blood pressure variations and identify specific phenotypes such as nocturnal hypertension or non-dipping pattern, morning blood pressure surge, white coat and masked hypertension with prognostic significance. At present, home BP measurements are generally regarded as useful and complementary to office and 24-h ambulatory blood pressure for the evaluation of the effectiveness and safety of antihypertensive treatment and furthermore remains more accessible in primary care than 24-h ambulatory blood pressure. A grading system of the clinical evidence is included.</p

Datasheet2_Joint statement for assessing and managing high blood pressure in children and adolescents: Chapter 1. how to correctly measure blood pressure in children and adolescents.pdf

The joint statement is a synergistic action between HyperChildNET and the European Academy of Pediatrics about the diagnosis and management of hypertension in youth, based on the European Society of Hypertension Guidelines published in 2016 with the aim to improve its implementation. The first and most important requirement for the diagnosis and management of hypertension is an accurate measurement of office blood pressure that is currently recommended for screening, diagnosis, and management of high blood pressure in children and adolescents. Blood pressure levels should be screened in all children starting from the age of 3 years. In those children with risk factors for high blood pressure, it should be measured at each medical visit and may start before the age of 3 years. Twenty-four-hour ambulatory blood pressure monitoring is increasingly recognized as an important source of information as it can detect alterations in circadian and short-term blood pressure variations and identify specific phenotypes such as nocturnal hypertension or non-dipping pattern, morning blood pressure surge, white coat and masked hypertension with prognostic significance. At present, home BP measurements are generally regarded as useful and complementary to office and 24-h ambulatory blood pressure for the evaluation of the effectiveness and safety of antihypertensive treatment and furthermore remains more accessible in primary care than 24-h ambulatory blood pressure. A grading system of the clinical evidence is included.</p

Effects of endpoint adjudication on the results of ADVANCE blood pressure lowering arm.

<p>Effects of blood pressure lowering treatment on the risks of clinical outcomes were examined based on diagnoses reported by the site investigators (SI) and those assigned by the endpoint adjudication committee (EPAC). Centers of the boxes are placed at the estimates of effect; areas of the boxes are proportional to the reciprocal of the variance of the estimates. Horizontal lines represent 95% confidence intervals (CI).</p