Issue: April 2014
March 05, 2014
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Drug adjustment could be preferable to renal denervation in resistant hypertension

Issue: April 2014
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Patients with treatment-resistant hypertension who had their drug treatment adjusted experienced superior BP lowering effects compared with those who received renal denervation, results of a small study published in Hypertension concluded.

In the study, 65 patients were assessed for eligibility, from which 45 were excluded for several reasons, including poor drug adherence and secondary and spurious hypertension. From the final 20 patients, 10 were randomly assigned drug-adjusted treatment and 10 (with one excluded for Conn’s syndrome) renal denervation (Symplicity, Medtronic/Ardian); adjustment of antihypertensive drug treatment in the former group occurred at baseline, 1 and 3 months, according to 2007 European Society of Hypertension/European Society of Cardiology Hypertension Guidelines.

Researchers defined treatment-resistant hypertension as office systolic BP >140 mm Hg, despite patients being on maximally tolerated doses of at least three antihypertensive drugs, including a diuretic. Furthermore, researchers required that patients have ambulatory daytime systolic BP >135 mm Hg after witnessed intake of antihypertensive drugs.

The researchers stopped the study early for ethical reasons because renal denervation had an uncertain BP-lowering effect.

According to the results, the drug-adjusted group experienced an office BP change from 160 ± 14/88 ± 13 mm Hg at baseline to 132 ± 10/77 ± 8 mm Hg at 6 months (systolic P<.0005; diastolic P=.02). However, in the renal denervation group, the reduction was not statistically significant (156 ± 13/91 ± 15 mm Hg to 148 ± 7/89 ± 8 mm Hg; systolic P=.42; diastolic P=.48).

Both systolic BP (P=.002) and diastolic BP (P=.004) were significantly lower in the drug-adjusted group at 6 months, and the absolute changes in systolic BP were larger in the drug-adjusted group (P=.008).

Ambulatory BPs changed in parallel to office BPs, according to researchers.

“We feel that the power of commercial marketing has by far overtaken the ethical considerations and principles of evidence-based medicine in the context of getting renal denervation done in Germany and some other places in Europe, and the routine use of renal denervation for apparent treatment-resistant hypertension must stop at least temporarily,” they wrote.

Disclosure: The researchers report financial disclosures with Amgen, AstraZeneca, Bayer, Boston Scientific, Hemo Sapiens, Medtronic, Merck Sharp & Dome, Novartis, Pronova, Serodus, St. Jude Medical and Takeda.