Medtronic And Boston Scientific Plan To Resume Blood Pressure Trials This Year Reply

Medtronic and Boston Scientific have announced plans to start phase 2 clinical trials this year for their updated renal denervation catheters. The once promising new technology is intended to treat hypertension unresponsive to drug therapy. The failure last year of Medtronic’s Symplicity HTN-3, the first large pivotal trial to rigorously test renal denervation, sent manufacturers back to their drawing boards to redesign the devices.

Click here to read the full post on Forbes.

 

Another Study Raises Questions About Blood Pressure Guidelines Reply

Although the general benefits of lowering high blood pressure are widely accepted, there has been intense debate over specific goals for treatment and the threshold at which therapy should be initiated.  A large new meta-analsysis published in JAMA helps shed lights on this important controversy.

UK and Australian researchers analyzed the effect of lowering blood pressure in people with type 2 diabetes using data from more than 100,00 people who participated in 40 trials.

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Study Tests High Blood Pressure Control During Pregnancy Reply

High blood pressure during pregnancy is increasingly common, largely due to older age and obesity. Although there is widespread agreement that hypertension in these women should be treated when it is high enough to raise the risk of stroke, there is little agreement about whether or how to treat mild hypertension.

In a study reported in the New England Journal of Medicine, investigators from Canada reported on 986 hypertensive pregnant women who had diastolic blood pressure of 90 to 105 mm Hg (or, for women already taking a blood pressure drug, 85 to 105 mm Hg). The women were randomized to less tight blood pressure control (target diastolic blood pressure, 100 mm Hg) or tight blood pressure control (target, 85 mm Hg). Three-quarters of the women had hypertension predating their pregnancy.

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New Device to Lower Resistant High Blood Pressure Shows Early Promise 1

A novel implantable device appears to show early promise in the treatment of resistant hypertension. The “Coupler” device from privatelyheld ROX Medical is about the size of a paper clip and is delivered via a catheter to the upper thigh, where it creates a connection between the vein and the artery, which lowers blood pressure in the arteries by letting some of the blood drain off into the veins.

In a paper published in the Lancet, European investigators report the results of an open-label trial in in which 83 patients with persistent high blood pressure despite taking multiple antihypertensive drugs were randomized to implantation of the Coupler device or current treatment…

Click here to read the full post on Forbes, including comments from Franz Messerli, Sripal Bangalore, and Deepak Bhatt.

 

Success For 40-Year Effort In One Rural County To Curb Cardiovascular Disease Reply

A 40-year program in one poor rural county to combat cardiovascular disease appears to have been successful, resulting in reduced rates of hospitalization and death compared with other counties in the same state over the same time period. The new findings from the study are described in a paper published in the Journal of the American Medical Association.

Click here to read the full post on Forbes.

 

An Emerging Consensus About Novartis’s New Potential Blockbuster Reply

Last year it became clear that Novartis had a potential blockbuster with its new heart failure drug, LCZ696, which is an angiotensin receptor- neprilysin inhibitor (ARNi) consisting of the company’s own well-known angiotensin receptor blocker valsartan (Diovan) and a novel compound, the neprilysin inhibitor sacubitiril. The results of the PARADIGM trial, which was stopped early because of a large and highly significant reduction in cardiovascular mortality, electrified the cardiovascular community. But the trial also sparked a lot of controversy when skeptics raised questions suggesting that the results were not nearly as impressive as the investigators reported.

Following the initial excitement and discussion we are now starting to get a more measured and realistic view of the drug and the trial. In recent days two important secondary PARADIGM papers have been published. A paper in Circulation looks at the experience of trial participants who didn’t die. A paper in European Heart Journal performs some sophisticated statistical wizardry to estimate how LCZ696 would have performed against placebo instead of an active comparator. It will probably come as no surprise that both papers are highly positive. The Circulation paper shows that LCZ696 was effective in preventing progression of heart failure. The EHJ paper concludes that if it had been compared to placebo in a contemporary, otherwise well-treated population LCZ696 would have produced “striking reductions in cardiovascular and all-cause mortality, as well as heart failure hospitalization.”

Far more important than these papers, in my view, are the accompanying editorials. The Circulation editorialist, Henry Krum, is an influential Australian cardiologist and the EHJ editorialist, Duke University cardiologist Rob Califf, is one of the most influential and respected cardiologists in the world…

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Why Guidelines Should Be Waged Like War 1

Here’s a modest proposal: we need fewer and shorter guidelines. In fact, I’d like to propose that guidelines, like war, should be waged only when there is absolute consensus and overwhelming evidence.

Anyone interested in the subject is aware that guidelines are in a complete mess.

Click here to read the full post on Forbes.

United Nations Security Council Resolution 707

United Nations Security Council Resolution 707 (Photo credit: Wikipedia)

 

An Old Study Fuels Debate Over Blood Pressure Guidelines Reply

In the last year new guidelines relating to cardiovascular disease have been the subject of intense criticism and debate. The status of the blood pressure guidelines has been particularly contentious, since several different groups have published contradictory guidelines, while several authors of the most prominent group, the Eighth Joint National Committee, published an impassioned dissent from their own published guideline. Many hypertension experts have taken aim at the change in therapeutic target for systolic blood pressure in patients age 60 or older, from 140 mm Hg to 150 mm Hg.

In an attempt to determine the optimal blood pressure for patients age 60 or older, Sripal Bangalore and colleagues performed a post-hoc analysis of 8,354 patients who participated in the INVEST trial, who were age 60 or older, and who had a baseline systolic blood pressure greater than 150 mm Hg…

Click here to read the full post on Forbes, including comments from Sripal Bangalore and Harlan Krumholz.

 

New Studies Fuel The Debate Over Sodium Reply

Three papers and an editorial in the New England Journal of Medicine are sure to throw fresh fuel on the ongoing fiery debate over sodium recommendations. Current guidelines recommend that people should limit their intake of sodium to 1.5  to 2.4 grams per day, but these recommendations are based on projections and have never been tested in clinical trials or other large studies.

Two papers from the  ongoing Prospective Urban Rural Epidemiology (PURE) study offer fresh evidence against the low sodium recommendations.

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Probiotics May Help Reduce Blood Pressure Reply

As interest in probiotics has grown in recent years, some evidence has emerged that probiotics may favorably reduce blood pressure, but trials have been small and inconsistent. Now a meta-analysis published in Hypertension suggests that the blood-pressure lowering effects of probiotics may be genuine.

Click here to read the full post on Forbes.

 

FDA Once Again Reaches Conclusions At Odds With Its Own Staff Reply

Once again the FDA has reached a conclusion that is directly opposed by some of its own scientists.  Last month the FDA affirmed the safety of olmesartan, a popular blood pressure lowering drug (sold as Benicar and other names). But that reassuring view is not shared by the  FDA scientists who performed the study that provided the basis for the review. And now outside experts are also raising concerns about the drug.

Back in 2010 the FDA said that it was initiating a safety review of olmesartan due to troubling findings from 2 clinical trials that raised the possibility that patients with type 2 diabetes taking olmesartan might have an increased risk of cardiovascular death. Four years later the FDA announced  that it had completed that review.

Click here to read the full post on Forbes, including comments from Sanjay Kaul and Franz Messerli and Sripal Bangalore.

Large Study Uncovers New Details About the Role of Hypertension in CVD Reply

Although high blood pressure has long been recognized and studied as a cardiovascular risk factor, a large new study published in the Lancet provides a more detailed, granular view of the specific role of different forms of hypertension.

Eleni Rapsomaniki and colleagues in the U.K. analyzed data from 1.25 million people without existing cardiovascular disease age 30 and older. An important, and perhaps surprising, new finding is that high blood pressure was not a simple monolithic cardiovascular risk factor. Instead, the researchers found that different types of hypertension at different stages of life had different cardiovascular effects.

Click here to read the full post on Forbes.

 

The Walking Dead: Renal Denervation In Europe Just Can’t Be Stopped Reply

Earlier this year the only large, well-designed trial of renal denervation– the once highly-promising catheter-based technology that was widely expected to “cure” difficult cases of resistant hypertension– failed spectacularly. Many hypertension experts believe that ultimately the technique will prove to be beneficial, but after the failure of Simplicity HTN-3 it is clear that there’s a great deal of research that needs to be performed to find out just how– or if– this novel technology should be used.

In the US this does not present a problem. The FDA has not approved renal denervation so it can only be used in a research setting. But that is not the case in Europe, where the device is available due to lower standards for device approval.

Right now Europe’s largest interventional cardiology meeting, Euro PCR, is underway in Paris. Surprisingly– or perhaps not– renal denervation is still being heavily promoted in Europe. Here is the evidence: a series of tweets by @Jeddacath, an interventional cardiologist who trained at the Brigham & Women’s Hospital in Boston and who is attending the meeting.

Click here to read the full post on Forbes.

 

Walking Dead

The Uncertain Future Of A Once Highly Promising Device For Lowering Blood Pressure Reply

Following the spectacular crash and burn of the Symplicity HTN-3 trial at the American College of Cardiology two weeks ago, the future of renal denervation (RDN)– the once highly promising catheter technology that many thought would cure resistant hypertension– appears in doubt.

Although the device has not been approved in the US– and will not be approved without further clinical trials– in Europe and other places it remains on the market. So the questions about the technology’s future revolve around the future direction of research in the field and how the existing renal denervation market will be affected by the trial results.

Click here to read the full post on Forbes.

 

No Benefit Found in First Real Test of Renal Denervation Reply

SYMPLICITY HTN-3, the eagerly awaited first rigorous test of renal denervation, shows that the real effect of the novel blood-pressure-lowering technology is dramatically lower than earlier expectations, which had been fueled by data from previous uncontrolled trials. Results of SYMPLICITY HTN-3 were presented at the American College of Cardiology conference in Washington, DC, and published simultaneously in the New England Journal of Medicine.

Click here to read the full post on Forbes.

 

Lower Blood Pressure Found In Vegetarians Reply

A new study provides the strongest evidence yet that a vegetarian diet is strongly associated with lower blood pressure. Although various health benefits of a vegetarian diet have often been proposed, a rigorous examination of the effect on blood pressure has not been previously performed.

In a paper published in JAMA Internal Medicine, Japanese researchers analyzed data from 7 clinical trials, including 311 participants, and 32 observational studies, including 21,604 participants….

Click here to read the full post on Forbes.

 

 

 

 

Blood Pressure Trajectory Over 25 Years Predicts Atherosclerosis Risk Reply

Everyone knows that blood pressure is one of the most important measurements of cardiovascular risk. Less well known is that most studies of blood pressure have relied on single or isolated measurements of blood pressure. Few studies have even attempted to examine the significance of blood pressure patterns over a long period of time.

Now, in a paper published in JAMA, researchers present an analysis of data from 3442 adults who participated in the long-term CARDIA study. Study participants were 18-30 years of age at baseline and had multiple blood pressure measurements over the course of the study. After 25 years, they had a CT scan that measured their coronary artery calcium (CAC) score.

Click here to read the full post on Forbes.

 

Blood pressure check
Blood pressure check (Photo credit: Army Medicine)

 

 

More Guideline Controversy: Blood Pressure Expert Decries ‘Political Correctness’ Reply

Now add “political correctness” to the long list of criticisms directed against the recent publication of new and updated cardiovascular guidelines. One leading hypertension expert writes that the authors of the recent AHA/ACC/CDC Science Advisory on blood pressure control were chosen not for their expertise but for political expediency.

Click here to read the full post on Forbes.

Confusion
Confusion (Photo credit: quinn.anya)

Minority Report: Five Guideline Authors Reject Change In Blood Pressure Goal Reply

It didn’t seem possible but the guideline situation just got even more confusing. Last December, after  years of delay and other twists and turns, the Eighth Joint National Committee (JNC 8) hypertension guideline was published in JAMA. The previous guideline recommended that all adults have a target systolic blood pressure below 140 mm Hg. In the new guideline, the target remained the same for adults under 60 years of age but for people over the age of 60 the new guideline set a more conservative, easier-to-achieve target of 150 mm Hg or lower.

Now, however,  five of the 17 JNC 8 authors have written a commentary, published in Annals of Internal Medicine, disagreeing with this change. They say they are in agreement with the other major recommendations of JNC 8 but that they reject the new target, arguing that the evidence does not support the change, and predict that the change may well lead to harmful consequences.

Click here to read the full post on Forbes.

Confusion

 

Pivotal Medtronic Trial For ‘Breakthrough’ Blood Pressure Device Goes Down The Tubes Reply

The hypertension community woke up this morning to a large dose of reality with an announcement by Medtronic that the novel SYMPLICITY HTN-3 trial of its much-anticipated  renal denervation device had failed to meet its primary efficacy endpoint. Renal denervation has been widely touted as a breakthrough product that could dramatically lower blood pressure by as much as 30 mm Hg, allowing physicians to cure the most severe form of high blood pressure, resistant hypertension.

“SYMPLICITY HTN-3 met its primary safety endpoint related to the incidence of major adverse events one month following randomization and renal artery stenosis to six months,” said Deepak Bhatt, the co-principal investigator of the trial, in the Medtronic press release. “Importantly, however, the trial did not meet its primary efficacy endpoint.”

Click here to read the full post on Forbes.

 

Missing High Blood Pressure Guideline Turns Up In JAMA Reply

After  years of delay and many twists and turns, the hypertension guideline originally commissioned by the NIH has now finally been published in JAMA. The evidence-based document contains a major revision of hypertension treatment targets and includes new and somewhat simplified recommendations for drug treatment.

The previous US hypertension guideline was published more than a decade ago. After many delays the new guideline was ready for publication earlier this year, but then the NIH decided to get out of the guidelines business. The American Heart Association and the American College of Cardiology assumed responsibility for the development and publication of cardiovascular guidelines and last month published four new cardiovascular guidelines, with the notable exception of the hypertension guideline. As an accompanying JAMA editorial explains:  “Rather than go through an additional review process with the AHA and the ACC the authors decided to publish their guideline in JAMA on their own.”

The big headline of the new guideline is an important change in treatment targets.

Click here to read the full story on Forbes.

Original illustration by Max Husten

Original illustration by Max Husten

No Value For Renal-Artery Stenting In CORAL Reply

Previous small studies have failed to find any benefit associated with renal-artery stenting, but the trials have been small and were not powered for clinical outcomes. Now, the CORAL (Cardiovascular Outcomes in Renal Atherosclerotic Lesions) trial, presented at the American Heart Association meeting and published simultaneously in the New England Journal of Medicine, offers strong and persuasive evidence that renal-artery stenting is not beneficial.

A total of 947 patients with renal-artery stenosis and either systolic hypertension, despite taking two or more antihypertensive agents, or chronic kidney disease were randomized to medical therapy plus stenting or medical therapy alone. There were no significant differences after 43 months in the primary composite endpoint of cardiovascular and renal events (death from cardiovascular or renal causes, MI, stroke, hospitalization for congestive heart failure, progressive renal insufficiency, or the need for renal-replacement therapy):

Click here to read the full post on Forbes.

 

FDA Approves New Pulmonary Hypertension Drug From Actelion Reply

The FDA today approved macitentan (Opsumit, Actelion), a new oral endothelin-receptor antagonist that is an enhanced version of the company’s bosentan (Tracleer). The drug is indicated to delay disease progression in patients who have pulmonary arterial hypertension (WHO Group I).

Click here to read the full post on Forbes.

 

Actelion

Prevalence Of Cardiovascular Disease Likely To Increase Despite Gains In Treatment Reply

It is the best of times and the worst of times in the battle against cardiovascular disease. On the one hand, mortality rates from cardiovascular disease in the US have dropped by more than half in the last 30 years, likely due in large part to improvements in treatment for elevated blood pressure and cholesterol levels and big declines in smoking. On the other hand, it is uncertain whether these gains will continue, and many experts think that cardiovascular disease may well be on the rise once again, largely due to the aging of the population and to increases in obesity and diabetes.

In an article in Health Affairs, Ankur Pandya and colleagues (including cardiologist Thomas Gaziano of the Brigham and Women’s Hospital) forecast cardiovascular disease trends through the year 2030 using data from the National Health and Nutrition Examination Survey. They project that although the age-adjusted risk for cardiovascular disease is likely to continue to decline through 2030, because of an aging population and the increase in obesity the overall incidence of cardiovascular disease will increase.

Click here to read the full story on Forbes.

 

 

 

Realistic Expectations For New ‘Breakthrough’ Blood Pressure Technology Reply

Early trials of renal denervation, the innovative new catheter-based blood pressure lowering technology,  have resulted in extremely impressive drops in systolic blood pressure in the range of 30 mm Hg. These results have sparked a great deal of excitement in the hypertension community and stirred the interest of a multitude of medical device companies. Some experts have proclaimed renal denervation a potential “cure” for resistant hypertension, perhaps enabling a significant number of patients to eliminate all drug therapy. Other expanded uses of the technology in more moderate forms of hypertension and other diseases are under active consideration. Now, however, a new analysis of the available data suggests the troubling possibility that renal denervation may not be nearly as effective in cutting blood pressure as had been suggested in the earlier trials. Rather than reducing systolic blood pressure by 30 mm hg, the new analysis suggests that a more realistic estimate of the effect of renal denervation may be a much more modest reduction of about 11 mm Hg.

A paper published online in Heart  demonstrates that the large reductions in blood pressure seen so far in clinical trials of renal denervation may be a consequence of certain key aspects in the design of these trials. The apparent blood pressure lowering effect of renal denervation has been greatly magnified because the trials have been uncontrolled, unblinded, and have utilized office-based blood pressure measurements rather than the far more reliable and consistent ambulatory blood pressure monitoring (ABPM).

Click here to read the full story on Forbes.