It is well accepted that high blood pressure increases the risk for strokes, heart disease, and kidney failure and that lowering that pressure decreases the risk. Sometimes the treatment for high blood pressure consists solely of life style changes such as regular exercise, diet, and weight control but, more often, medications are also required. These blood pressure medications, although generally not very expensive, still come with a price tag and more importantly, introduce potentially serious side-effects. So the question who does and who does not need treatment for high blood pressure is an important medical issue that affects many people.
Recently, the American Heart Association (AHA) and the American College of Cardiology (ACC) jointly issued new recommendations concerning the diagnosis and treatment of high blood pressure. In these recommendations they redefined downward the previously accepted levels of blood pressure from 140/90 to a new, lower level of 130/80. By broadening the definition of high blood pressure, the AHH and the ACC overnight increased the number of Americans who had this disorder from 32% of the adult population to 46%. Thirty per cent of men under 45 years of age and 75% of people older than 65 have blood pressures over 130/80 and now are considered to have high blood pressure. A new epidemic has been created, not because of more disease, but by redefining what constitutes disease. Non-pharmacologic treatment consisting of diet and exercise has been recommended by the AHA and ACC as initial treatment for many of these new hypertensive patients; but when diet and exercise fail, as they usually do in all but the most motivated, many people will be placed on lifelong medications. Millions of new people will now carry the hypertensive label with the emotional baggage and higher insurance premiums that accompany that label.
One might reasonably imagine that such game-changing recommendations are based on multiple indisputable studies especially when the last recommendations that were issued by the Joint National Committee on High Blood Pressure (JNC-8), the guiding group on blood pressure, had raised the limits of acceptable blood pressure. In 2014 the JNC-8 recommended that in people older than sixty, the BP should not be lowered below 150/90 because the potential side-effects caused by more aggressive treatment outweighed the possible benefits.
The about-face in the new AHA and the ACC guidelines was based primarily on a single study published in 2015, the Systolic Blood Pressure Intervention Trial (SPRINT). This was a well-designed investigation of 9361 elderly people with hypertension who, in addition, were at unusually high risk for the development of cardiac disease. The subjects in the study were divided into two groups, one of which, the standard group, was treated to achieve a goal blood pressure of 140/90 or less. The other group, the treatment group, was more intensively treated with a target blood pressure of less than 120/80. The people in this study were followed for an average of 3.2 years and cardiovascular complications and death were recorded. The intensely treated group, those whose blood pressure goal was 120/80, had an overall 25% decrease in cardiovascular complications and death compared to those who were treated to a goal of 140/90. It seemed pretty clear based on this study that lowering blood pressure more aggressively than had previously been accepted helps people live longer and healthier. The AHA and the ACC accordingly came out with their recommendations.
When the facts of the study are more clearly analyzed, however, major chinks are found in the armor. The SPRINT trial showed an incidence of 2.19% cardiovascular complications per year in the standard treated people and an incidence of 1.65% in the aggressively treated people. This .54% decrease is the 25% (.54/2.19) benefit that was described but translates only into about 1 person helped for every 185 treated. The SPRINT trial subjects were an elderly (average age 68) group of people who were at very high risk for cardiac events. The incidence of cardiovascular complications yearly in a normal risk, hypertensive population for whom these recommendations are also directed is far lower than the 2.19% incidence seen in this trial. How a meager .54% absolute benefit for aggressively treated sick elderly people applies to the general population is impossible precisely to determine by this study but would undoubtedly be even more meager.
The study, to its credit, used inexpensive blood pressure medications to treat its hypertensives and frequently used diuretics as its first line drug. When the results of the SPRINT trial were examined, there was no decrease in heart attacks(MIs) or coronary artery disease in the aggressively treated group compared to the standard treated group. The benefit for cardiovascular complications occurred solely because of a decreased incidence in heart failure and heart failure related death. In heart failure, fluid backs up from the heart and accumulates in the lung. For people who develop congestive heart failure, the usual medical treatment includes diuretics to relieve the excess fluid. It is very possible that the improvement in results seen in the SPRINT trial was the result of the incidental use of diuretics for the treatment and prevention of heart failure and had little to do specifically with blood pressure control.
Even more problematic concerning the SPRINT trial was how blood pressure was measured. People enrolled in the study were placed in a quiet room, alone. After sitting undisturbed for at least 5 minutes, an automated blood pressure device would record multiple blood pressure readings without any clinician present. This unique way to record blood pressure bears no resemblance to the way blood pressure is measured in the real world. When compared to pressures recorded by clinicians, automatic, isolated recordings are about 10-15 mm lower. So a 130 mm systolic reading in the SPRINT trial would more accurately reflect a 140 mm reading in a doctor’s office. The method of measurement alone raises major concerns about the trial’s results and the sweeping recommendations that were disseminated based on those results. It would also suggest that a clinician measured BP of 140/90 would be an acceptable pressure since it corresponds to an automatic, isolated reading of 130/80.
The new AHA/ACC guidelines follow a pattern seen throughout medicine of broadening disease definitions with doubtful medical benefit. This pattern is seen in diabetes, with recently defined prediabetes present in most older people, and for cholesterol treatment, with new almost universal indications for statins as people age. An entire generation of Americans are sick through disease redefinition and disease creation and have been made dependent on the medical establishment for treatment. The AHA/ACC guidelines continue that trend.