RESUMEN
Lack of adherence to medication may be the explanation for unsatisfactory drug efficacy and is often misinterpreted as resistance to treatment. When encountering patients with persistent high blood pressure despite antihypertensive treatment, it is therefore important to discover whether they are actually taking their medication. This article aims to provide an updated overview of methods of revealing and monitoring medication adherence. The article is based on non-systematic literature searches in PubMed and on the senior authors' own clinical experience.
Asunto(s)
Antihipertensivos/administración & dosificación , Monitoreo de Drogas/métodos , Cumplimiento de la Medicación , Antihipertensivos/uso terapéutico , Humanos , Hipertensión/tratamiento farmacológicoRESUMEN
After three years of excessive confidence, overoptimistic expectations and performance of 15 to 20,000 renal denervation procedures in Europe, the failure of a single well-designed US trial--Symplicity HTN-3--to meet its primary efficacy endpoint has cast doubt on renal denervation as a whole. The use of a sound methodology, including randomisation and blinded endpoint assessment was enough to see the typical 25-30 mmHg systolic blood pressure decrease observed after renal denervation melt down to less than 3 mmHg, the rest being likely explained by Hawthorne and placebo effects, attenuation of white coat effect, regression to the mean and other physician and patient-related biases. The modest blood pressure benefit directly assignable to renal denervation should be balanced with unresolved safety issues, such as potentially increased risk of renal artery stenosis after the procedure (more than ten cases reported up to now, most of them in 2014), unclear long-term impact on renal function and lack of morbidity-mortality data. Accordingly, there is no doubt that renal denervation is not ready for clinical use. Still, renal denervation is supported by a strong rationale and is occasionally followed by major blood pressure responses in at-risk patients who may otherwise have remained uncontrolled. Upcoming research programmes should focus on identification of those few patients with truly resistant hypertension who may derive a substantial benefit from the technique, within the context of well-designed randomised trials and independent registries. While electrical stimulation of baroreceptors and other interventional treatments of hypertension are already "knocking at the door", the premature and uncontrolled dissemination of renal denervation should remain an example of what should not be done, and trigger radical changes in evaluation processes of new devices by national and European health authorities.
Asunto(s)
Ensayos Clínicos como Asunto , Desnervación , Hipertensión/fisiopatología , Enfermedades Renales/fisiopatología , Presión Sanguínea/fisiología , Estimulación Eléctrica , Humanos , Hipertensión/complicaciones , Hipertensión/terapia , Enfermedades Renales/complicaciones , Enfermedades Renales/cirugíaRESUMEN
BACKGROUND: Renal denervation (RDN) has been introduced as a potential new treatment for patients with treatment-resistant hypertension, defined as a blood pressure above 140/90 mm Hg despite treatment with at least three antihypertensive drugs. We present an overview of this type of treatment, describe the method and discuss its possible future uses. METHOD: The review is based on a discretionary selection of relevant articles from our archive, our own experience and a literature search in PubMed. RESULTS: The use of RDN for treatment-resistant hypertension is based on a single randomised study with a total of 104 patients, in which the intervention group experienced a fall in blood pressure of 32/12 mm Hg, while blood pressure in the control group remained unchanged. More than 16,000 patients, particularly in Germany, have been treated on this basis. In the USA, data from a larger randomised study (n = 530) that includes sham surgery are awaited before any decision is made on whether to approve the method for use. INTERPRETATION: Before RDN can become recommended treatment in Norway, more evidence is required that the method lowers blood pressure, and that this reduces morbidity and mortality.
Asunto(s)
Hipertensión/cirugía , Riñón/inervación , Simpatectomía/métodos , Presión Sanguínea , Ablación por Catéter/efectos adversos , Ablación por Catéter/métodos , Humanos , Riñón/diagnóstico por imagen , Riñón/cirugía , Radiografía , Arteria Renal/diagnóstico por imagen , Arteria Renal/inervación , Simpatectomía/efectos adversosRESUMEN
It is unknown whether the decline in blood pressure (BP) after renal denervation (RDN) is caused by denervation itself or concomitantly improved drug adherence. We aimed to investigate the BP lowering effect of RDN in true treatment-resistant hypertension by excluding patients with poor drug adherence. Patients with resistant hypertension (n=18) were referred for a thorough clinical and laboratory work-up. Treatment-resistant hypertension was defined as office systolic BP>140 mm Hg, despite maximally tolerated doses of ≥ 3 antihypertensive drugs, including a diuretic. In addition, ambulatory daytime systolic BP>135 mm Hg was required after witnessed intake of antihypertensive drugs to qualify. RDN (n=6) was performed with Symplicity Catheter System. The mean office and ambulatory BPs remained unchanged at 1, 3, and 6 months in the 6 patients, whereas there was no known change in antihypertensive medication. Two patients, however, had a fall in both office and ambulatory BPs. Our findings question whether BP falls in response to RDN in patients with true treatment-resistant hypertension. Additional research must aim to verify potential BP lowering effect and identify a priori responders to RDN before this invasive method can routinely be applied to patients with drug-resistant hypertension. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT01673516.