• THE STUNNING NEW GUIDELINES FOR TREATING HYPERTENSION.

    November 18th 2017

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    ADVERSE EVENTS IN SPRINT TRIAL

    ADVERSE EVENTS IN SPRINT TRIAL

     

    The SPRINT trial was terminated prematurely due to substantial reduction in clinical outcomes as also death in participants subjected to rigorous anti hypertension therapy as opposed to standard treatment. More than 9000 participants with hypertension accompanied by cardiovascular risk or kidney disease were enrolled for the trial. The mean baseline systolic blood pressure was les than 140 mm of mercury. The lay press exploded with the information provided by American Heath agencies and the New York Times emphasised that there was a 25% reduction in clinical outcomes with sustained therapy without bothering to mention absolute changes brought about in cardiovascular outcomes by bringing down the blood pressure to 120 mm Hg. The standard treatment grips were permitted to have their blood pressure at 140 mm mercury.
    The complete data was eventually presented in the American Heart Aasociation Meeting in 2015 and simulatenously published in the New England Journal of Medicine. The paper was accompanied by two editorials and a Perspective piece. One of the editorials revealed that the manuscript was checked out by multiple reviewers, a statistician, and the editors themselves. Moreover the editors wrote that they were “proud” to have vetted the paper in a few weeks after receiving the manuscript. The rapidity of the process of vetting the research was fascinating. Normally it takes a month for the NEJM to just acknowledge a manuscript, leave aside receiving the stuff,reviewing and accepting it within a span of four weeks. The tone of the editorial was that despite adverse effects it would be worthwhile getting the blood pressure down to below 120 mm Hg. It was almost as if they were advocating going as low as below 120 mm mercury in all hypertensives.

     

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    For decades we have known that treating blood pressure significantly reduces stroke, heart failure and heart attacks. Multiple randomised trials have reported benefits of anti hypertensive therapy in the elderly. But benefits in all these trials were seen by getting the blood pressure down to the 140’s mm Hg. These benefits were substantial. In the HYVET study significant reduction was seen with treatment compared to placebo by bringing down blood pressure to the 140’s in patients over the age of 80 years. Similarly the SHEP ( Systolic Hypertension in the Elderly Program) trial demonstrated significant reduction in stroke and heart failure by lowering blood pressure in the 140’s. The JATOS trial reported that strict treatment ( bringing down blood pressure to the to 135 mm mercury approximately) versus mild treatment ( bringing blood pressure to 145 mm mercury) did not provide any clinical difference. The JATOS trial include patients of 65-80 years with blood pressure above 160 mm mercury. Another Japanese trial in patients more than 70 years failed to show improved clinical outcomes with strict anti hypertensive therapy.

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    I had urged that full disclosure of data in the SPRINT trial be published at the earliest in ( The Wire) following the New York Times story on November 5 th, 2015. The NEJM published the SPRINT trial on 26th November 2015. The SPRINT trial could not show significant reduction in myocardial infarction, stroke or acute coronary syndrome with intensive treatment. Death from cardiovascular causes was reduced from 1.4% to 0.8% only. But at the same time there were significant adverse effects necessitating visits to an Emergency of a hospital because of hypotension, syncope, electrolyte imbalance, and acute kidney failure. Obviously the paltry benefits were outweighed by serious side effects demanding a hospital visit. Remarkably the editorials barely mention the serious adverse effects seen in The Sprint trial with strict anti-hypertensive treatment. One should also bear in mind that none of the participants in the Sprint trial had diabetes.

     

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    Now with one stroke the American Hear Association has redefined hypertension in its latest guideline. We are now told that anything above 130/80 mm mercury is hypertension that merits treatment. Currently half of America’s population will be considered hypertensive requiring medication. There will be course be cursory mention of life style modification for managing people with a blood pressure of more than 130/80. But this mind boggles at the prospect of drug sales for half of the US population. The prevalence of Stage 1 hypertension would be even greater in India. I include both urban and rural populations.

     

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    We learnt the hard way that medication for ventricular arrhythmia said was not only useful but actually harmful, similarly not a single randomised trial employing an inotrope has been shown to reduce mortality in heart failure patients. Our best intentions albeit intuitively sound have a habit of boomeranging in clinical medicine. A Cochrane review on treatment of mild hypertension ( which was more than 140/90 mm mercury in the good old days) failed to show any benefit, but reported serious adverse effects were increased by almost absolute 10%. These participants invariably withdrew from the respective trial. No randomised trial in the Cochrane review showed significant reduction in mortality. Neither was there any reduction in heart attacks, stroke, or total cardiovascular events. There were 8912 participants included in 4 randomised trials in the Cochrane review.Treatment was from 4 to 5 years.

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    The cost for treating mild hypertension including doctors consultation costed more than $32 billion in 2013. The approximate cost estimated in treatment of mild hypertension during the period 2014 to 2023 will be $488 billion. A $10 billion cut in Medicare would lead to 490,000 jobs lost. Jobs lost in the event of cutting half a trillion dollars will astounding, a figure 50 times more than 490,000. The president of the American Society of Hypertension had considered the conclusions derived by Cochrane review of drug treatment in mild hypertension as “flawed.” The president Dr William White had financial connections with 15 drug companies. No major newspaper covered the controversy generated by the Cochrane review ( including the New York Times, Washington Post, Wall Street Journal, LA Times).
    The treating physician will now face tremendous pressure to prescribe drugs for these brand new hypertensives apart from advising cessation of smoking, exercise, reasonable diet, and drinking in moderation. The reader must note that the DASH diet can reduce systolic blood pressure by as much as 11.5 mm mercury, while a Mediterranean diet has been found to cut mortality by more than 55% and cardiovascular outcomes by 47%. The physician in the west will be on a slippery slope because he will be damned if he does ( the patient risking hypotension, syncope, electrolyte imbalance and even acute kidney failure) and there is always the probability of life threatening angio edema with an angiotensin converting inhibitor. The ACCORD trial also showed there was absolutely no advantage in treating diabetics to below 120 mg mercury as compared with standard treatment of below140 mm Hg. These patients of diabetes were high risk for cardiovascular events ( NEJM 2010; 362:1575).
    The latest stunning guidelines by American Heart Association advocating lowering blood pressure below 130 mm will be a boon for drug manufacturers. I won’t be surprised if a bunch of hypertension experts across the world start echoing the 130/80 mm mercury definition of hypertension. Prescribing a pill is far easier than making a person jog around or cut down weight. Moreover the mantra “ Its the economy stupid “ seems to be the driving force behind the new definition of mild hypertension despite as mentioned earlier there being little  or no advantage by treatment in randomised trials. The editors of the New England Journal of Medicine displayed unusual alacrity and haste in reviewing the SPRINT trial. The American Heart Association too has sprinted to endorse the SPRINT trial. But this sprint is surely laced with drugs, but lies beyond the jurisdiction of WADA. I would be nervous treating a 75 with hypertension year old woman to below 120 mm mercury. I also would not classify a person with a blood pressure greater than 130/80 mm mercury as an hypertensive needing drug therapy regardless of associated risk factors. This is the same American Heart Association that promulgated for decades that saturated fats are poison in spite of numerous randomised data to the contrary. At this rate I won’t be astonished if the the 130/80 threshold is pulled down further to 120/70 mm mercury in the not so distant future. Billions nay trillions of dollars are stake. Anything to boost the American economy. Also be sure that other Cardiac societies shall soon be dazzled by multiple ancillary publications and the  hypnotising eloquence of a dream team of hypertension experts from across the world. It may surprise you but more than 30% of the population in Delhi (in their thirties) has hypertension using the older definition >140/90 mm mercury.