12/07/2015

Update on the trial of SPRINT: preliminary results pan out

Update on the trial of SPRINT: preliminary results pan outUpdate on the trial of SPRINT: preliminary results pan out - In a previous blog, she presented the preliminary results of SPRINT, a clinical trial that examined whether a target systolic blood pressure of 120 mm Hg or less would be better than a target of 140 mm Hg in patients with hypertension (high blood pressure).

The National Heart, Lung and Blood Institute of the National Institutes of Health issued a press release with exciting results. Now, all the work was published in the New England Journal of Medicine, and the results seem so practical that changes the first appeared, demonstrating a stricter target blood pressure can reduce the likelihood of death. In the world of medicine, which is really great news.

The SPRINT researchers randomly assigned 9361 patients with increased cardiovascular risk (but not diabetes) with a systolic blood pressure of 130 mm Hg or higher than any standard or intensive therapy treatments. Standard treatment meant a lower target to 140 mm Hg for systolic blood pressure (the top number) and the intensive treatment meant a target of less than 120 mm Hg. 

On average, patients in the trial were followed for 3 , 26, by which time the trial was stopped earlier than expected because the researchers examined the results were too compelling to allow the study to continue. There was a 25% reduction in the rate of cardiovascular events, including events such as myocardial infarction, heart failure and stroke. There was a 27% reduction in risk of death.

It is important to note that very few medical interventions effectively reduce the risk of death. Among the doctors who performed clinical trials, this would be considered a home run. 

To achieve the highest degree of reduction in blood pressure, an average of three drugs are needed instead of two. Not surprisingly (for all physicians), which resulted in more side effects such as low blood pressure, fainting, kidney failure and electrolyte abnormalities in blood tests.

In practical terms, this means that to achieve the impressive results seen in this study, patients will have to take more drugs and should be carefully monitored by their doctors. Otherwise, the benefits shown in this research context can not be fully reproducible in practice in the real world, and the risk of serious side effects may be even higher.

Moreover, the results do not apply to everyone at increased cardiovascular risk have high blood pressure. For example, patients with diabetes, heart failure, previous stroke, or under 50 and not included in the study.

People with high blood pressure (systolic 180 mm Hg or more) were also excluded. There were many 75 years or more patients in the trial, which is great because many studies exclude older people, but none of these elderly volunteers studies living in nursing homes or assisted living facilities.

What patients with high blood pressure should do? Make an appointment to see your primary care physician to determine if you need a more aggressive management of blood pressure senses. No urgency to do this, since the adverse effects of high blood pressure in the range studied in this test usually take time to manifest.  

But I do not pretend to wait until your annual health check, or - the beneficial results seen in the SPRINT trial began to be evident in about a year. And it may take a few visits to get a drug plan to reduce blood pressure without causing too many side effects.

The good news is that there are many generic drugs for high blood pressure, so with a bit of trial and error, many patients can achieve the degree of control of blood pressure observed in this study.

The reality, however, is that the United States and around the world, many patients have uncontrolled blood pressure, even above the recommended targets. Therefore, the challenge remains is how we ensure that similar to the proof of this important advance in our understanding of the treatment of patients with hypertension.  

According to current estimates, in a study recently published in the Journal of the American College of Cardiology suggest that Article in the United States, the results of Sprint directly apply to about 8% of adults and treatment about half do not receive for high blood pressure, which corresponds to more than 8 million people!

The identification of these persons, some of which may even have a blood pressure of 130, will not be easy because they can not get regular medical care.


Therefore, the SPRINT study also implies that even if you do not have a diagnosis of high blood pressure, you should know what their blood pressure is and talk to your doctor about how to assess the risks and benefits of treatment to meet you what is the goal of optimal blood pressure for you. 
By: Deepak Bhatt, MD, MPH  

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