Is Promotion More Efficacious Than Science?

Cardiovascular disease, I surmise, is very concerning to both those patients who have this
disease, as well as those who manage this concerning disease. Furthermore, this disease is
likely a cause of distress as well as confusion for those professionals who seek the best
treatment options.
Hypertension is one of these cardiovascular diseases, and a prevalent one at that.
Hypertension is a frequent medical condition that affectsaround 1 billion people in the world,
and around 25 percent of those in the United States alone.
Over 90 percent of the time, the etiology for one developing hypertension is not known, nor
is the condition symptomatic often. If left untreated, hypertension can be the catalyst or such
events as stroke, heart attacks, as well as heart and kidney failure.
As a result, there are increasingly many pharmacological options available to delay if not
prevent such diseases, and these drugs work in different ways for the same cardiovascular
diseases that are acquired often.
Many health care providers are understandably unclear as to which treatment option would
be most beneficial for their cardiac patient- considering the different classes of medications
for cardiovascular disease, and taking into consideration the safety and efficacy of each,
which would likely be a difficult task.
As I understand with the medical condition of hypertension, it is very important to control
elevations in one’s blood pressure to prevent future cardiovascular events caused by
prolonged uncontrolledhypertension in such individuals. Such events include an increased
risk for strokes, heart attacks, and kidney failure, among other damage that can be caused in
the unmanaged hypertensive patient.
While hypertension is evaluated according to different stages of severity, most hypertensive
people have initially what is called primary hypertension, which is also called essential
hypertension. Any stage of hypertension one might have typically requires medicinal
intervention.
With so many classes of anti-hypertension pharmaceuticals, each with their own mechanisms
of action, how does a health care provider determine which medicine the provider will
prescribe for their patient?
Some time ago, there was evidence offered to reassure health care providers what was in fact
the most reasonable and necessary drug treatment for hypertension. This reassurance wasdue
to the results of the ALLHAT trial.
This trial lasted 4 years, and the ALLHAT trial was published in the Journal of the American
Medical Association in 2002. Also, the trial was conceptualized and implemented by the
National Institute of Health during the 1990s- with the intent to discover which class of
medication was most beneficial for hypertensive patients.
This trial was the largest study to date that addressed, among other variables, those
patientswho were hypertensive. The study thoroughly analyzed and examined which class of
medications would be the most effective for these patients. The patients in this trial were
given a selection from these different classes of medications for their hypertension treatment
that were involved in the ALLHAT trial.
In addition, the ALLHAT trial included over 40,000 subjects who were over the age of 55
and were evaluated in over 600 clinics during the course of this trial. Nearly half of the
patients in this trial had metabolic syndrome, which is a syndrome where one is obese, has
dyslipidemia, and glycemic issues as well.
While Pfizer financially contributed a small portion to support this trial, ALLHAT was
overall funded by the National Institutes of Health at a cost of around 130 million dollars.
Their objective was to determine the best medicinal treatment for the patients that were
studied in this trial according to the trial’s study plan. This study protocol had not been done
in the past, and the comparative effectiveness design strengthened this clinical trial.
Because the NIH did in fact develop and fund this study, the ALLHAT trial, as a result, was
largely if not completely void of bias and commercial interference compared with those trials
that are sponsored by the manufacturers of drugs studied in other trials often.
Because of the ideal design and methodology in which this trial was performed, most concur
the results of this trial are quite accurate and valid.
Once again, the ALLHAT trialprovided data that allowed a true comparative analysis of these
various classes of drugs for hypertension, which included calcium channel blockers, ACE
inhibitors, Alpha Blockers, Beta Blockers, and diuretics.
The researchers examined the action of these classes of medications on the subjects who
possessed various cardiovascular disease states- with a focus on the ability of each one of
these different classes of drugs on the disease of hypertension the patients in the study had
during the trial.
As the trial was completed with data collected and analyzed after a 4 year period, the
ALLHAT trial concluded that one particular class of medications involved in this study
proved to be the most advantageous for the subjectsin the trial.
Superior in what it showed as far as its safety, efficacy and cost for those who require
treatment for their cardiovascular disease state, as well as the prevention or the delay of
progression of additional cardiovascular disease states that werestudied and examined.
Amazingly, this one drug class in this study in fact is nearly as old as the subjects involved in
the trial.
ALLHAT results specifically and clearly concluded that thiazide diuretics are, overall, the
preferred choice of medicinal treatment for initial medicinal therapy with those who
arehypertensive patients, as this class of drugs overall proved to be equivalent if not superior
in many ways compared with the other classes of drugs in the study.
Diuretics offered great protection against cardiovascular disease and controlled hypertensive
patients as they needed to be, and proved that diuretics should be the first line drug of choice
in such patients. The diuretics also decreased the risk of mild congestiveheart failure and
stroke, as well, compared with the other classes of drugs in this trial.
Thiazide diuretics were in fact superior in these risk factors in this comparative effectiveness
protocol, and just as effective as the other classes of drugs it was compared to in this trial
with preventing myocardial infarctions.
Thiazide diuretics in fact have been studied in such disease states associated with
cardiovascular disease for over 40 years and have shown similar results as were shown in this
trial.
This class of medications, diuretics, have been available in the United States for well over 50
years, and presently costs about 25 dollars a year, instead of a few dollars a day for many if
not most branded medications for CV conditions that were examined in the ALLHAT trial.
So this finding, of course, concludes that diuretics not only provide equivalent if not
superior benefits for cardiovascular disease patients, but also provides cost savings as well as
illustrated in this trial.
Again, the ALLHAT trial was rare and unique in that it compared diuretics to these other
classes of medications directly, which is not done frequently with clinical trials involving
branded pharmaceuticals, as they usually do comparative studies with simply placebos most
of the time, so their efficacy comes into question as a result.
Yet, even though this trial was potentially beneficial for so many who are involved with
prescribing medications as initial therapy for their hypertensive patients, the
recommendations based on this trial to start a patient on such a diuretic was remarkably not
followed entirely if not mostly by those health care providers.
There was of course hope and expectation that diuretics would be utilized to a greater degree
based on the results of this trial, and the researchers were puzzled that this was not occurring.
So much amazement was occurring with these researchers of the ALLHAT trial results that
they eventually implemented what was called an ALLHAT dissemination plan from the years
2003 to 2006 at a cost of close to 4 million dollars.
They desired to educate health care providers about the ALLHAT results, and the
significance of the findings. However, the acknowledgement of the benefits of diuretics
continue to be unrecognized by health care providers who select other classes of drugs to
treat their hypertensive patients, as they still do today.
The other classes aside from diuretics do in fact have benefits with cardiovascular patients,
with compelling indications in particular. Yet the etiology for the prescribing habits
regarding diuretics and why this class of medications is not chosen as often as they should be
is largely unknown after several attempts to convince health care providers otherwise.
Others have speculated why this issue with diuretics in the ALLHAT trial never caught the
attention to change the prescribing habits of health care providers, overall.
For example, and of no great surprise, these results of the ALLHAT study appeared to be of
notable concern to those pharmaceutical companies who promote the other classes of
medications in the ALLHAT trial that are more expensive than a thiazide diuretic.
Reportedly, these companies who market these other classes of drugs increased their
promotional spending in order to blunt the potential effects this trial may have on the usage
of their cardiovascular medications that again belong to the classes that were involved in the
ALLHAT trial soon after the results from this trial were published.
Sampling of their branded medications to health care providers increased noticeably as well
from those pharmaceutical companies that had branded medications for cardiovascular
disease states.
Thiazide diuretics, while clearly the apex for the prevention and management of hypertension
and other cardiovascular disease states, do not engage in this promotional behavior that
appears to be more of a powerful force than evidence-based medicine, as with the case of this
diuretic and the benefits of this class of drugs that has been discussed..
Furthermore, drugs combining two medications from different classes of medications for
hypertension and other cardiovascular disease states are increasingly preferred by many
health care providers for understandable reasons presently.
The reasons included the severity of the cardiovascular disease states that may exist, along
with the risk of developing these cardiovascular conditions with their patients. It has been
said that nearly 70 percent of hypertensive patients alone require more than one medication
to adequately have their hypertension controlled.
It is not unusual, for example, for a branded pharmaceutical company to combine their
medication for hypertension with a diuretic for those patients that may have a stage of
hypertension that requires simply more than just one drug for reduction of their high blood
pressure.
On the other hand, some cardiovascular combination medications are absent of a diuretic.
Yet diuretics remain the first line choice of treatment based on the results of the ALLHAT
trial, regardless, and should be included in any combination drug chosen for the treatment of
most cardiovascular disease patients with hypertension that requires more than one drug for
control of their high blood pressure, according to others.
More convincing is that the JNC-7, a report that concludes which medication is best for the
prevention and treatment of high blood pressure as well as other cardiovascular conditions,
concurs with the results of the ALLHAT trial.
As a result,the JNC states in their report that diuretics are preferred for first-step hypertension
therapy, and acknowledge that this class of medications is presently under-utilized. The
Report is rather thorough, and is developed by the American Heart Association. The report is
also recognized and respected by health care providers who treat cardiovascular disease.
I’m comfortable as a layperson in suggesting that the cardiovascular experts should and in
fact be obligated to continue to make others aware of the results of the ALLHAT trial, and
should also convince other health care providers that diuretics should be the preferred choice
of medicinal therapy for the medical conditions illustrated and treated in the ALLHAT trial.
Often, such a diuretic is combined with another medication to reduce hypertension, such as a
beta blocker, although some believe according to clinical evidence that beta blockers may
increase the incidence of diabetes.
In particular, thiazide diuretics are most beneficial for those hypertensive patients that are
African American, the elderly, obese patients, those with heart failure, or those with chronic
kidney disease, others have concluded.
And it should be noted that this type of diuretic depletes potassium from the patient taking
this drug, so caution should be utilized regarding this issue, as well as the patient who is
prescribed a diuretic should be informed of additional possible side effects associated with a
thiazide diuretic, although they are infrequent.
Along with the cost savings that could amount to billions of dollars saved annually, diuretic
medicinal therapy would ensure both health care provider and patients that they are receiving
the proven and ideal treatment which will control their hypertension.
In addition, this medicinal therapy will delay the progression and prevent additional
cardiovascular events with this particular drug. This is most noticeable in those patients who
require medicinal treatment for their hypertension long term, as well as those who are elderly.
Unfortunately, it appears what may be one of the most authentic trials conducted has been
and continues to be largely disregarded or not recalled by those who treat hypertension.
This is likelydue to the forces of others whose objectives are of a different nature besides the
restoration of the health of others as it relates to the diseases addressed in the ALLHAT trial.
So again, it appears in this situation that promotion has been a more powerful force than what
science has provided.
www.amhrt.org
Dan Abshear