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.

 

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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.

New Actelion Drug Found Safe And Effective In Pulmonary Arterial Hypertension– But Does It Save Lives? Reply

Macitentan, a new drug for pulmonary arterial hypertension (PAH), appears to be safe and effective, but it is unclear whether it offers any significant advantages over currently available drugs.  The drug, a dual endothelin-receptor antagonist, is under development from Actelion as an enhanced version of bosentan (Tracleer). The results of a phase 3 trial, SERAPHIN (Study with an Endothelin Receptor Antagonist in Pulmonary Arterial Hypertension to Improve Clinical Outcome), have now been published in the New England Journal of Medicine.

In the trial, 742 patients with PAH were randomized to one of three groups: a daily dose of 3 mg of macitentan, a daily dose of 10 mg of macitentan, or placebo. The primary endpoint (the time to the first occurrence of a composite endpoint of death, atrial septostomy, lung transplantation, initiation of treatment with intravenous or subcutaneous prostanoids, or worsening of pulmonary arterial hypertension) was significantly reduced in the two treatment arms:

Click here to read the full post on Forbes.

Actelion

Kaiser Program Yields Big Improvements In Hypertension Control Reply

A large percentage of the 65 million people with high blood pressure in the United States do not know they have hypertension or have not succeeded in controlling their hypertension. Although many programs have been proposed, there is little evidence that any method can produce long term improvement in hypertension control.

In a paper published in JAMA, researchers at Kaiser Permanente report the outcomes achieved with a large-scale multi-pronged approach to hypertension control. The program included a comprehensive hypertension registry and the development and sharing of performance metrics. Electronic medical records were used to encourage optimal treatment, while patients were offered free medical assistant follow-up visits and simplified medication regimens, including the use of single-pill combination therapy. Physicians were encouraged to use algorithms derived from evolving evidence.

Click here to read the full post on Forbes.

 

The Guidelines Are Dead. Long Live The Guidelines. Reply

Following last month’s surprising announcement that the National Heart, Lung, and Blood Institute would no longer issue guidelines, leaders of the American Heart Association and the American College of Cardiology have now announced that are “officially assuming the joint governance, management and public distribution” of the enormously influential cardiovascular prevention guidelines, including the much-delayed and much-anticipated hypertension and cholesterol guidelines (formerly known as JNC 8 and ATP IV). The ACC and AHA will also assume responsibility for guidelines on cardiovascular risk assessment, cardiovascular lifestyle interventions and obesity.

In an editorial published in Circulation and the Journal of the American College of Cardiology, leaders of the NHLBI, AHA, and ACC provide a little more information on how the new model will work. One important announcement, that “all chairs and members of the current writing panels have been invited to continue to work together with the ACC and AHA to finalize the guidelines,” might indicate that the hypertension and cholesterol guidelines could see the light of day in the not-too-far-distant future. In June the NHLBI’s Michael Lauer expressed confidence that these guidelines would appear in less than a year, but the AHA said that no timeline had yet been established.

Click here to read the full story on Forbes.

English: sm team guidelines logo

Deja Vu All Over Again: Study Links Calcium-Channel Blockers To Breast Cancer Reply

A new observational study raises the possibility that calcium-channel blockers (CCBs) may be associated with a higher risk for breast cancer. Although previous studies examining this relationship have failed to turn up convincing evidence of a link, the authors of a paper published in JAMA Internal Medicine state that their study is the first to look at long-term use of CCBs in a contemporary population.`

Christopher Li and colleagues analyzed data from women in the Seattle area, including 880 women with invasive ductal breast cancer, 1,027 with invasive lobular breast cancer, and 1,027 controls with no cancer. They found that women taking other antihypertensive drugs, including diuretics, beta-blockers, and angiotensin II antagonists, had no increased risk for breast cancer. But women taking CCBs had significantly elevated risk for ductal breast cancer (OR 2.4, CI 1.2-4.9, p=0.04) and lobular breast cancer (OR 2.6, CI 1.3-5.3, p=0.01). The results were consistent for different types of CCBs.

In an accompanying editorial, Patricia Coogan writes that the study “provides valid evidence supporting the hypothesis that long-term CCB use increases the risk of breast cancer.”

Click here to read the full post on Forbes.

 

Hypertension And Cholesterol Guidelines Delayed Again As NHLBI Gets Out Of The Guidelines Business Reply

The National Heart, Lung, and Blood Institute (NHLBI) will no longer issue guidelines, including the much-delayed and much-anticipated hypertension (JNC 8) and cholesterol (ATP IV) guidelines. Instead, the NHLBI will perform systematic evidence reviews that other organizations, including the American Heart Association and the American College of Cardiology, will use as a resource for their own guidelines.

The exact fate and form of the delayed hypertension and cholesterol guidelines has not yet been decided, though the NHLBI’s Michael Lauer said he was confident that these guidelines would appear in less than a year. But a lot of work remains before the documents can be published. ACC President John Harold said that  “the ACC has not formally agreed to or begun the process of updating” the NHLBI documents, “but we are open to this role and look forward to working out details with NHLBI and the American Heart Association.”

Click here to read the full story on Forbes.

 

NHLBI Director Dr. Gary Gibbons

NHLBI Director Dr. Gary Gibbons

New European Hypertension Guidelines Released With Simplified Blood Pressure Target Reply

New hypertension guidelines from the European Society of Hypertension and the European Society of Cardiology were released in Milan today at the European Meeting on Hypertension & Cardiovascular Protection.

The authors of the guidelines write that “despite overwhelming evidence that hypertension is a major cardiovascular risk, studies show that many are still unaware of the condition, that target blood pressure levels are seldom achieved”. They report that hypertension affects 30-45% of people in Europe.

Perhaps the biggest single change in the new document is the adoption of a single systolic blood pressure target for almost all patients: 140 mmHg, This replaces the previous, more complicated target, which included both systolic and diastolic recommendations for different levels of risk (140/90 mmHg for moderate to low risk patients and 130/80 mmHg target for high risk patients).  One of the authors, Robert Fagard, commented: “there was not enough evidence to justify two targets.”

Click here to read the full story on Forbes.

 

 

European Medicines Agency Starts Review of Combined Use Of Drugs That Block The Renin-Angiotensin System 1

The European Medicines Agency said last week that it was initiating a review of the combined use of agents that block the renin-angiotensin system (RAS). The three classes of RAS-blocking drugs (ACE inhibitors, ARBs, and direct renin inhibitors) are used to treat hypertension and congestive heart failure.

The EMA said that the review was being performed to address concerns that combined RAS-blocking drugs could increase the risk for hyperkalemia, hypotension, and kidney failure when compared with a single agent.  A recent meta-analysis of 33 clinical studies published in the British Medical Journal concluded that “although dual blockade of the renin-angiotensin system may have seemingly beneficial effects on certain surrogate endpoints, it failed to reduce mortality and was associated with an excessive risk of adverse events… The risk to benefit ratio argues against the use of dual therapy.”

Franz Messerli, senior author of the BMJ meta-analysis, applauded the EMA action and said that “as usual the FDA is dragging its feet.”

Click here to read the full story on Forbes.

 

 

 

St. Jude Raises The Stakes In Renal Denervation With An Outcomes Study Reply

 

The already hot field of renal denervation for resistant hypertension just got a little hotter. With the announcement of a clinical trial powered to detect improvements in cardiovascular outcomes, St. Jude Medical has raised the stakes.

“To date, the renal denervation studies that have been conducted only looked at reducing blood pressure in patients with uncontrolled or resistant hypertension,” said Michael Böhm, a principal investigator for the trial, in a St. Jude press release. “What we need to know is if this minimally invasive approach for treating hypertension also correlates to a reduction in major cardiac events such as heart attack, stroke and death, which are the primary risks for patients whose blood pressure is not well controlled.”

 Click here to read the entire post on Forbes.

St Jude EngligHTN Rendal Denervation System

St Jude EngligHTN Rendal Denervation System

 

Study Warns Against Dual Blockade of Renin-Angiotensin System In Heart Failure And Hypertension 1

The enormous success of ACE inhibitors in hypertension and heart failure spurred hope that adding a second drug to block the renin-angiotensin system would yield improved outcomes. Although definitive evidence supporting dual blockade of the renin-angiotensin system has never been found, more than 200,000 patients in the US currently receive  this therapy. Now a large new meta-analysis suggests that dual blockade results in no improvement in mortality but is associated with an increase in important adverse events.

In a paper published online in BMJ, Harikrishna Makani and colleagues at Columbia University and New York University performed a meta-analysis of more than 68,000 patients who were enrolled in clinical trials comparing dual blockade of the renin-angiotensin system with monotherapy. They found no significant difference between the groups for all cause mortality or cardiovascular mortality, although dual blockade was associated with a signifcant 18% reduction in hospital admission for heart failure:

Click here to read the full article on Forbes.