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BreakThrough Digest Medical News

BreakThrough Digest Medical News


Renal denervation achieves significant and sustained blood pressure reduction

Posted: 26 Aug 2012 09:00 PM PDT

Renal denervation leads to significant and sustained blood pressure reduction for up to 18 months in patients with treatment resistant hypertension, according to research presented at ESC Congress 2012. The new clinical data from the Symplicity HTN-2 randomized clinical trial were presented by principal investigator Dr Murray Esler at the scientific session, associate director of the Baker IDI Heart and Diabetes Institute of Melbourne, Australia and by Prof Böhm for the ESC Press Conference.

Treatment resistant hypertension is blood pressure that remains persistently high despite at least three prescription blood pressure medications, including a diuretic. This condition puts approximately 120 million people worldwide at risk of premature death from kidney disease and cardiovascular events such as stroke, heart attack and heart failure (1). “Treatment resistant hypertension is one of the most challenging forms of hypertension to manage because it does not respond to blood pressure lowering drugs,” said Dr Esler.

Renal denervation is a minimally invasive procedure which disrupts both afferent and efferent nerves leading into and out of the kidneys. It uses radio frequency energy emitted by a catheter device inserted into the renal arteries through the groin to treat patients resistant to drug therapy.

The Symplicity HTN-2 trial is an international, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation with the catheter-based Symplicity? renal denervation system in patients with treatment resistant hypertension. Patients with treatment resistant hypertension were randomized in a one-to-one ratio to receive renal denervation plus antihypertensive medications or antihypertensive medications alone (control group) at 24 centers in 11 countries.

At baseline, the treatment (n=49 patients) and control (n=52 patients) groups had similar high blood pressures: 178/97 mmHg and 178/98 mmHg, respectively, despite both receiving an average daily regimen of five antihypertensive medications.

Patients in the control arm of the study were offered renal denervation following assessment of blood pressure, which was the trial’s primary endpoint, at 6 months post-randomization. Thirty-five patients from the control group with systolic blood pressures ? 160 mmHg received denervation at 6 months (this became the crossover group).

The researchers found that renal denervation was safe and effective in both treatment groups up to 18 months post-procedure. Forty-three patients initially randomized to renal denervation were followed for up to 18 months and had an average blood pressure reduction of -32/-12 mmHg from baseline (p<0.01). Thirty-one patients in the crossover group were also followed for up to 18 months post-procedure and had a blood pressure reduction of -28/-11mmHg from baseline (p<0.01).

“These 18 month blood pressure reductions are consistent with the 12 month follow-up for both groups (-28/-10 mmHg from baseline for the initial treatment group and -24/-10 mm Hg from baseline for the crossover group),” said Dr Esler. “Safety results were sustained at 18 months as well, with no significant decline in kidney function.”

He added: “Up to one-third of hypertensive individuals undergoing therapy are considered resistant to treatment. We are encouraged to see that renal denervation shows substantial and sustained blood pressure reduction in treatment resistant patients.”

Dr Esler concluded: “We know the renal nerves play a crucial role in blood pressure elevation and this study shows those nerves can be targeted with renal denervation without major side effects.”

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Reference
1 Egan BM, Zhao Y, Axon RN, Brzezinski WA, Ferdinand KC. Uncontrolled and apparent treatment resistant hypertension in the United States, 1988 to 2008. Circulation. 2011;124(9):1046-1058.

Notes to editors

Please note that picture and CV from the author, abstract, picture and CV from spokesperson can be found here.

About the European Society of Cardiology www.escardio.org

The European Society of Cardiology (ESC) represents more than 75,000 cardiology professionals across Europe and the Mediterranean. Its mission is to reduce the burden of cardiovascular disease in Europe.

About ESC Congress 2012

The ESC Congress is currently the world’s premier conference on the science, management and prevention of cardiovascular disease. ESC Congress 2012 takes place 25-29 August at the Messe München in Munich. The scientific programme is available here.

More information is available from the ESC Press Office at press@escardio.org.

Contact: ESC Press Office
press@escardio.org
European Society of Cardiology

In war with ‘superbugs,’ Cedars-Sinai researchers see new weapon: Immune-boosting vitamin

Posted: 26 Aug 2012 09:00 PM PDT

 

Cedars-Sinai researchers have found that a common vitamin may have the potential to provide a powerful weapon to fight certain “superbugs,” antibiotic-resistant staph infections that health experts see as a threat to public health.

The research, published in the September 2012 edition of The Journal of Clinical Investigation, found that high doses of the nicotinamide form of vitamin B3 stimulated a specific gene (CEBPE), enhancing white blood cells’ ability to combat staph infections, including methicillin-resistant Staphylococcus aureus or MRSA.

With research ongoing, including possible clinical trials in humans, the scientists caution consumers not to treat a suspected infection by taking vitamin B3. Instead, a physician should be consulted.

“It’s critical that we find novel antimicrobial approaches to treat infection and not rely so heavily on antibiotics,” said George Liu, MD, PhD, a pediatric infectious disease physician at Cedars-Sinai’s Maxine Dunitz Children’s Health Center and co-senior author of the study. “That’s why this discovery is so exciting. Our research indicates this common vitamin is potentially effective in fighting off and protecting against one of today’s most concerning public health threats.”

Staph infections commonly cause serious, sometimes life-threatening illness. Health officials fear that indiscriminate use of antibiotics has undercut their effectiveness, leading to the rapid rise and threatening spread of resistant germs.

In laboratory tests with mice and human blood, Cedars-Sinai scientists found that vitamin B3 increased by up to 1,000 fold the ability of the immune system to kill staph bacteria. Beyond its findings related to vitamin B3, the study indicates that similar targeting of the CEBPE gene with other compounds may offer a new immune-boosting strategy to fight bacterial infections.

The researchers have been investigating a rare disease called neutrophil-specific granule deficiency, a hematologic disorder afflicting only a handful of people in the world. Due to a mutation of the gene CEBPE, patients with this disease have significantly weakened immune systems, leaving them prone to severe, chronic and life-threatening infections, including staph. The CEBPE gene regulates several antimicrobial factors in the body.

“Our goal in studying a rare disorder is that it may give us broad insight into the immune mechanisms that protect healthy individuals against staph infections,” said Pierre Kyme, PhD, a researcher in the Division of Pediatric Infectious Diseases in the Maxine Dunitz Children’s Health Center and the Immunobiology Research Institute, and co-first author of the study with Nils Thoennissen, MD, who is now with the Department of Medicine at University of Muenster in Germany. “We found that if you over-express the gene in normal individuals, the body’s immune cells do a better job of fighting off infection.”

Kyme and Thoennissen turned to vitamin B3, which has been shown to increase the expression of some other genes in the CEBP family. The results: When studied in human blood, clinical doses of the vitamin appeared to virtually wipe out the staph infection in only a few hours.

Formal testing in clinical trials with patients is called for, based on these outcomes in the laboratory and in laboratory mice studies, said Phillip Koeffler, MD, professor of medicine at Cedars-Sinai and co-senior author of the study.

“There’s more research to be done, but we believe that vitamin B3, and other compounds that are able to increase the activity of this particular gene, have the potential to be effective against other antibiotic-resistant bacteria in addition to strains of staph,” he said.

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The study was funded by grants from the National Institutes of Health (R01 AI074832, R01 CA026038-30, U54 CA143930-01 and R01 AI065604-05).

Contact: Nicole White
nicole.white@cshs.org
310-423-5215
Cedars-Sinai Medical Center