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Posts Tagged ‘hypertension’

Reducing salt intake has no effect on heart risk

Posted by medconsumers on July 12, 2011

Reducing the salt in your diet may lower your blood pressure a bit, but it will not reduce your chances of dying from heart disease or having a heart attack or stroke. That’s the conclusion of a new review of all relevant clinical trials conducted by the Cochrane Collaboration, an independent international organization that evaluates research. Another example of conventional medical wisdom found to have no supporting evidence. (Reminds me of statin drugs—so good at reducing cholesterol, but pitiful at cutting the risk of heart attack and stroke in people without heart disease. click here)

The Cochrane reviewers identified seven studies with a combined total of 6,489 participants. Three trials had participants with normal blood pressure (Note: definition of “normal” has changed over the years); two trials had participants with high blood pressure; one had a mix of people with normal and high blood pressure; and one trial with participants with congestive heart failure. Most of the trials followed the participants for seven months to three years. Only one trial followed its participants for more than 12 years.

The trials weren’t ideal in terms of detail provided and length of follow-up, according to the Cochrane reviewers, but they were the best of all existing research on the effects of salt restriction on blood pressure. All seven trials had randomly assigned participants to either salt reduction or not. One trial, however, was an exception in that it replaced sodium with a high potassium substitute. “Potassium has effects on blood pressure and may have deleterious effects in individuals with renal [kidney] disease,” wrote the Cochrane reviewers. Most of the trials did not attempt to change other aspects of the participants’ usual diet.

Here’s what happened to the participants who were told to reduce salt intake: Salt restriction reduced systolic and diastolic blood pressure by an average of 1 mmHg (millimeter of mercury) in people with normal blood pressure and by 2 to 4 mmHg (millimeters of mercury) in those with congestive heart failure.

In short, this Cochrane review found no proof that salt restriction will help you live longer or avoid a heart attack or stroke. And guess what? This isn’t news. Here’s my interview with hypertension researcher Michael Alderman, MD, saying virtually the same thing in 1992. And again in 2003 with this interview entitled, “Prehypertension—how real is this new “disease?”  It is, of course, possible that some time in the future a well-designed, long-term clinical trial might find a health benefit to reducing salt intake. In the meantime, the  salt-reduction choice is yours to make.

Maryann Napoli, Center for Medical Consumers(c)

Posted in Heart, hypertension, Men's Health, Women's Health | Tagged: , , , , , , , | 3 Comments »

No Benefit to Reducing Blood Pressure Below 140/90

Posted by medconsumers on September 10, 2009

An Interview with Hypertension Expert, J. M. Wright, MD, PhD

By Maryann Napoli

This story is right up my alley: a prevailing medical belief is found to be baseless and perhaps even harmful. Whether they have heart disease or not, people with high blood pressure are usually put on multiple drug therapy to reduce their chances of having a heart attack or stroke. No problem there, if it weren’t for the fact that the definition of high blood pressure was expanded several times over the years, thus turning more and more of us into potential drug customers. (Expanded definitions of abnormal can be seen in other health “problems” like cholesterol, high blood sugar, low bone density—just to name a few—usually send me looking for the inevitable pharmaceutical industry involvement.) Today, a “lower the better” ideal guides the treatment of high blood pressure.

A new Cochrane review identified the seven trials that had tested this ideal and found that it didn’t hold up to scientific scrutiny. Using more drugs to reduce blood pressure lower than the standard target, 140/90 mmHg, did not prolong survival or reduce stroke, heart attack, heart failure or kidney failure. The trials had a combined total of more than 22,000 participants who were followed about 3 ½ years.

To make sense of this new information, I turned to a co-author of this Cochrane review, James M. Wright, MD, PhD, physician, researcher, pharmacologist, and professor at the University of British Columbia, Vancouver.

MN: What made you think of asking this most basic hypertension research question: Do people benefit from taking drugs to lower their blood pressure below 140/90?

JMW: We realized—more than 10 years ago—that this is one of the most important questions that needed to be answered in terms of the management of people with high blood pressure. And we knew that the way to answer it was to look at randomized, controlled trials where drug-treated people were randomly assigned to achieve either the standard blood pressure target [140/90] or something lower.

MN: How good are the trials?

JMW: The most important trial in our review is the Hypertension Optimal Treatment (HOT) trial. It had about 19,000 participants and is the largest one designed specifically to answer the question of whether getting the blood pressure lower than 140/90 actually benefits people. Yet the way this trial’s results were published in the Lancet was very biased. It appeared that the authors were not happy with the results of the randomized trial, which showed no benefit with the lower blood pressure targets.

MN: Was the HOT trial industry-funded?

JMW: Yes, the authors of the HOT trial were all big experts in hypertension. All were working closely with drug companies that make blood pressure-lowering drugs, and it was a drug company-funded trial. This randomized trial showed no benefit for lower blood pressure targets whatsoever.

MN: It was troubling to read that none of the trials in this review had looked at the potential harms of using drugs to get blood pressure lower than 140/90. That means we don’t have a full picture of the side effects of hypertension drugs, though they’ve been in use for decades.

JMW: The authors almost certainly looked for harms in these trials. You’re supposed to track serious adverse events in these trials. However, serious adverse event data were not reported from the HOT trial, and this could mean that the drug companies are withholding unfavorable findings related to their drugs.

MN: I noticed that the participants of all seven trials in your review were between the ages of 50 and 69 years. Does that means no one was over 69 in the trials?

JMW: The HOT trial had participants up to the age of 80 years.

MN: But if the researchers put the people, aged 69 to 80 years, with younger people and don’t separate the results according to age, then you really don’t have specific benefit/harms information for those of advanced age, do you?

JMW: That’s true.

MN: What about women?

JMW: I’m disappointed to tell you that we found no breakdown of the participants of the trials in this review by gender. And since we don’t have separate data for women, we don’t know whether the harms predominated in women, which is possible. I’m very aware of that. Women seem to be more prone to harms from drugs in general than men.

MN: Why?

JMW: My theory is that women, on average, weigh significantly less than men, and we [doctors] usually give the same doses to men and women. So women in general are getting a higher dose per kilogram. And that’s going to play out in terms of more harms than in men. In all the clinical trials, the same dose of the drug is given to men and to women.

MN: Last spring, I wrote about a new meta-analysis of hypertension drug trials, entitled, “Drugs for all at high risk whether blood pressure is high or not.” The findings supported the use of the so-called polypill to lower the risk of heart disease in everyone over the age of 55. Instead of the current focus on blood pressure measurement—and driving people crazy when they can’t bring their pressure down after trying multiple drugs—the authors suggest a shift in focus to reducing drug side effects with lower drug doses. What do you think?

JMW: The most important thing to look at first, before you even read that meta-analysis, is the authors’ conflict of interest.

MN: Drs. Wald and Law disclosed their conflicts at the end of their paper.

JMW: Yes, they own a patent on the idea of the polypill, which includes three antihypertensives, so their meta-analysis basically comes up with a conclusion that favors the polypill. It’s a gross conflict of interest—much worse than a doctor who is a speaker for, or receiving a grant from a drug company.

MN: But I liked some of Law’s and Wald’s conclusions, for example, most of the antihypertensive drugs are now off patent (and therefore, inexpensive) and largely interchangeable. And I’m familiar enough with your work to know that you would probably agree with their promotion of lower doses of these drugs because so many people with high blood pressure stop taking their drugs due to adverse effects.

JMW: Yes, we do agree that lower doses are almost as effective as the standard doses.

MN: What about their point that the five drug classes prescribed for high blood pressure are largely interchangeable? Do you agree with that?

JMW: Ideally, you would want to be on an anti-hypertensive drug that has been shown to reduce morbidity [non-fatal stroke, non-fatal heart attack] and mortality.

MN: That leaves you with the least expensive drug of all—thiazide diuretics.

JMW: The morbidity and mortality evidence is, by far, stronger for the thiazide diuretics than for any other drug classes.

MN: One thing bothered me about the polypill promoters. They said that halving the standard dose reduces adverse effects, claiming that the “polypill would cause symptoms in 8-15% of people (depending on the precise formulation).” What is known about adverse effects of these drugs at half dose?

JMW: We know that most adverse effects of blood pressure lowering drugs are dose-related, so lower doses are likely to have fewer adverse effects.

MN: Do you think it’s reasonable—based on the findings from your new review—for drug-treated people with blood pressures lower than 140/90 to ask their doctors to reduce the dose?

JMW: Yes, it is reasonable. Patients who have been referred to me often say, “Do I really need all these drugs?” And my reaction usually is, “We probably should start thinking of cutting back.”

MN: As recently as 2003, having a blood pressure of 120/80 was considered normal, but now it’s “prehypertension,” according to one important guidelines committee. I know that some people are put on drugs for it, but that could be just here in the U.S.

JMW: The standard of care is aggressive everywhere. [Here in British Columbia] physicians would not give any drugs to people whose blood pressure is 120/80, but the average doctor wouldn’t stop drug therapy [or lower the dose] in people whose blood pressure is this level. In the drug-treated patients I follow in the High Blood Pressure Clinic whose blood pressure is consistently low like that [120/80], I say, “you probably don’t need all these drugs, let’s try going off them gradually one at a time.”

Dr. Wright says that he has no conflict of interest pertaining to high blood pressure drugs.

More Information

Think you’re anti-hypertension drug dose is too high? Read this

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Blood Pressure Drugs for All at High Risk, Whether or Not Blood Pressure is High

Posted by medconsumers on June 1, 2009

The typical doctor visit starts with blood pressure measurement, and everyone with a high reading is told to come back again in three months. If blood pressure remains high, one drug or more is the next step, and then three-month follow-up visits continue indefinitely.

A team of British researchers wants to radically change this scenario. Blood pressure lowering drugs should be prescribed to anyone who is at high enough risk to benefit from treatment, whatever their reason for being at high risk and regardless of whether they have high blood pressure or not. What’s more, the British researchers want to change the traditional doctor-visit focus from: has your blood pressure gone down and stayed down? to: is your drug therapy causing any adverse effects?

All blood pressure drugs can dramatically reduce the risk of heart attack and stroke; and all are virtually interchangeable, say the British researchers. Therefore, any tailoring to the needs of the individual would be based on whether the drugs cause adverse effects. Fewer doctor visits would be the result, as well as fewer adverse drug reactions, many of which are currently caused by doses that are too high. Eliminated is the uncertainty many doctors have about which drugs to prescribe and who should be treated.

The proposed radical shift in thinking about blood pressure drugs appeared online last month in the British Medical Journal. Malcolm Law and colleagues based their proposal on an in-depth analysis of the data from 147 blood pressure drug trials published between 1966 and 2007. The trials had a combined total of nearly a half-million participants, aged 60 to 69 years.

Law and colleagues base their conclusions on these trials that compared people with and without heart disease given drugs or a placebo; people with normal blood pressure and high blood pressure (hypertension) with and without drug therapy.  All five classes of blood pressure drugs were represented, as well as differing doses.

Here’s what they found: Any one of the main classes of blood pressure drugs given at the standard dose will reduce the incidence of fatal and non-fatal heart attack by about 25% and stroke by about 33% and heart failure by about 33%. These reductions held up, say Law and colleagues, whether or not the people had heart disease and whether or not they had high blood pressure.

Of course, you would want to know what your risks are for each heart problem if you don’t take any drugs so you can get a clearer idea of what the risk becomes once you do. The British researchers did the math for you based on older people living in England and Wales. At age 65, the risk of having a heart attack (fatal and non-fatal) in the next ten years is about 10% in men and 5% in women. If they go on blood pressure drugs at half dose, the risk in men goes down to 5.4% and in women to 2.7%.

Adverse effects will be minimized with low-dose combination therapy. Cost is dismissed because four of the five drug classes are off patent, and the fifth (angiotensin receptor blockers) will be off patent by the end of this year. “It is difficult to defend the widespread practice of tailoring treatment. The case for individualizing blood pressure lowering disappears with low dose combination therapy based on three drugs; the greater efficacy compared with selective monotherapy or dual therapy avoids the need to choose between drugs,” wrote Law and colleagues.

Some exceptions were found to the all-drugs-are-equally-effective finding. For example, beta blockers [some brand names: Tenormin, Toprol] have an edge over other drugs when given after a recent heart attack; and calcium channel blockers are less effective than other drugs in the risk of heart failure but they had a greater stroke prevention effect than other drugs. Some drugs should be avoided in pregnancy.

Two of its co-authors, Malcolm R. Law and Nicholas J. Wald, made headlines six years ago when they proposed something similar in concept called the polypill. The polypill combines three blood pressure drugs at half the standard dose, a statin, folic acid, and aspirin. At the end of their new research paper, Law and Wald acknowledged that they had “competing interests” (i.e., conflicts of interest) because they hold patents “on the formulation of a combined pill to simultaneously reduce four cardiovascular risk factors, including blood pressure.”

Their research paper is bound to reignite a worldwide debate among doctors about the use of drugs for prevention. What’s needed now is the release of all data used in the new meta-analysis of blood pressure lowering drugs so that an additional critical analysis can be conducted by a team of researchers without competing interests.

There may be strong reasons against the idea that the benefits outweigh the risks for everyone on blood pressure drugs. For starters, the implication that adverse drug effects are banished with low doses has already been disproved in low-dose aspirin studies. No matter how low the dose in these studies, the cases of gastrointestinal bleeding are higher in the people taking low-dose aspirin than in the people taking a placebo. This is true of the Women’s Health Initiative in which the study participants were taking only 100 mg aspirin every other day.

For more information
The May 19, 2009 issue of the British Medical Journal “Use of blood pressure lowering drugs in the prevention of cardiovascular disease: meta-analysis of 147 randomized trials in the context of expectations from prospective epidemiologic studies.”

Maryann Napoli, Center for Medical Consumers© June 2009

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Posted in Drugs, Heart, hypertension | Tagged: , , | Comments Off

Drug-Coated Stent No Riskier Than Bare-Metal Stent, But…

Posted by medconsumers on June 1, 2009

Drug-coated stents, intended to keep coronary arteries from closing up again, have been under suspicion for causing harm to people years after they had an artery-opening procedure. In earlier studies, the powerful drugs used to coat the tiny wire-mesh cylinders known as stents, were linked to a slightly higher rate of death and potentially fatal blood clots. A new study of Swedish people who were implanted with either a bare-metal stent or a drug-coated stent appears to exonerate the latter.

While this is good news for people who already had a drug-coated stent implanted, it should not distract from the fact that too many Americans continue to undergo artery-opening procedures for non-emergency heart conditions that can be just as successfully treated with drugs alone.

The Swedish study was led by Stefan K. James, MD, Uppsala University Hospital, and published last month in The New England Journal of Medicine. It is based on the information reported to a nationwide registry of all people in Sweden implanted with either a bare-metal or drug-coated stent between 2003 and 2006 (nearly 48,000). Registry studies represent real-world care; whereas clinical trials are likely to deliver what is thought of as exceptionally good care, i.e., highly experienced surgeons at academic teaching hospitals operating on patients with the best prognoses.

The Swedish study found that the 1- to 5-year results from the registry patients were the same, regardless of the type of stent implanted. There was only one advantage to the drug-coated stent. The treated artery is less likely to become constricted again (restenosis). This advantage, however, was slim. Dr. James and colleagues described it this way, “The rate of restenosis at one year was low for both types of stents and was 1.5 percentage points lower with drug-coated stents than with the bare-metal stents.”
Dr. James was asked by e-mail who is an appropriate candidate for a stent, given the fact that researchers now know that a constricted artery does not indicate the location of a future heart attack. “You are correct,” he responded. “The use of the drug-coated stent should be reserved for patients at high risk for restenosis, such as diabetics.” Dr. James explained that there is also a role for drug-coated stents for people with long and very narrow constrictions, less than 3mm in diameter, in the coronary arteries.

The Swedish study illustrates the importance of following people for years after a surgical procedure to see how they fare. Earlier research from the Swedish registry, also published in The New England Journal of Medicine, indicated that people implanted with drug-coated stents had a 30% higher mortality rate. This landmark study, published in 2005, alerted doctors for the first time that the drugs used to coat the stents were causing a slightly increased risk of death and potentially fatal blood clots. It generated attention around the world and many cardiovascular surgeons changed their practice accordingly. Now surgeons start their patients on Plavix prior to surgery and continue the drug long after implantation of a drug-coated stent.

Bottom Line: Stents were first introduced to stop the high rate of restenosis that occurred after a coronary artery-opening procedure, also known as angioplasty. When it was discovered that tissue growth around the implanted stent also caused restenosis, the drug-coated stent was introduced. Some stents are coated with paclitaxel, an anti-cancer drug that has anti-inflammatory effects and others with sirolimus, an immunosuppressive drug. When the 2005 Swedish registry study indicated that the drugs used to coat the stent increased the risk of dangerous blood clots, Plavix, was introduced into the mix. Plavix (generic name: clopidogrel), heavily promoted on TV, has its own risks, primarily stomach or intestinal bleeding and ulcers of the stomach or intestines.

For decades, people have been told that large constrictions in the coronary artery signal future heart attacks which must be prevented by an immediate artery-opening procedure called angioplasty. This hypothesis was disproved 3 years ago by two landmark trials.  Many, if not most, of the one million or so Americans who undergo angioplasty each year (with or without stents) can be treated just as successfully with the same multiple-drug regimen advised for just about everyone after angioplasty.

The exception: People in the midst of a heart attack are appropriate candidates for angioplasty. Unfortunately, about one-third of all heart attack patients do not receive artery-opening treatment within the recommended 12 hours after the first symptoms of a heart attack.

More Information About the Two Landmark Trials:
Heart attack patients who did not receive the recommended treatment in time are represented in the federally-funded Occluded Artery Trial (OAT). This trial, published in 2006 in The New England Journal of Medicine, randomly assigned people who were in stable condition 3 to 28 days after a heart attack to have either an artery-opening procedure with stenting plus multiple-drug therapy or multiple-drug therapy alone. After 3 to 5 years, the people given multiple-drug therapy alone did just as well as the people who underwent an artery-opening procedure plus drugs.

The OAT found no benefit to opening a blocked artery after the heart attack patient is stabilized. The procedure “should be reserved only for certain patients such as those who are unstable or continue to have chest pain following a heart attack,” according to an OAT researcher. See 2006 press release.

In 2007, another landmark trial, known as COURAGE [Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation], produced results similar to those of OAT for people with stable heart disease. The people in this trial had angina (average 10 episodes a week) for about two years before they entered the trial; most had hypertension, over one-third had had a heart attack.  In short, they were at very high risk and were highly symptomatic for a long time prior to the start of this trial.  A five-year follow-up showed that those who were randomly assigned to have angioplasty had the same risk of heart attack and death as those who were randomly assigned to multiple drug therapy.

Maryann Napoli, Center for Medical Consumers© June 2009

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Drugs For High Blood Pressure: Which Are Best?

Posted by medconsumers on April 1, 2005

Drugs that lower high blood pressure are the cornerstone of preventive medicine. Clearly they have prevented many a heart attack or stroke, but it’s getting harder and harder for doctors to know who should get what drug… and who should not be treated at all. Every few years a committee of hypertension experts (often with strong ties to the pharmaceutical industry) lowers the threshold for the definition of normal hypertension, steadily expanding the pool of people who should be on drugs.

And every few years a study produces the bad news that a certain anti-hypertensive drug or drug combination kills more people than other drugs or drug combinations. Last December, for example, a study reported that an older, supposedly tried and true beta-blocker drug called atenolol (some brand names: Tenoretic, Apo-Atenolol) had caused more strokes and cardiac deaths than other commonly prescribed anti-hypertensives.

Many people have high blood pressure but no heart disease, and as a group they are less likely to have a large benefit from drug therapy than the people with heart disease. There are exceptions, of course, such as diabetics. And some people with high blood pressure gain nothing at all from drug therapy. A 2003 Cochrane* review of all anti-hypertensive drug trials that included women found that white women under the age of 55 years showed no benefit, nor were they harmed by the drugs.

To complicate things further, there is a wide range of anti-hypertensive drugs on the market. To keep them all straight, researchers refer to them by their drug classes, for example, ACE inhibitors, calcium channel blockers, etc. Altogether there are six drug classes and within each, multiple brand names [see below].

Last month, the British journal The Lancet published a commentary by three scientists who questioned the excessive focus on high blood pressure when there are many other risk factors—smoking, family history, diabetes, etc.—that determine who will die of heart disease. Instead, they argue for changing the focus to the prevention of blood-pressure-related diseases. “…clear evidence now shows that several blood-pressure-lowering drugs reduce the risks of major vascular events [e.g. stroke] in a broad range of non-hypertensive individuals with high-risk disorders, such as cerebrovascular disease, diabetes, or coronary heart disease.”

The Lancet commentary makes sense given the fact that studies show some anti-hypertensives (ACE inhibitors) can produce cardiovascular benefits while making only modest reductions in blood pressure. Conversely, other drugs (calcium channel blockers) are good at lowering blood pressure without doing much for the odds of having a heart attack or stroke.

How would you know whether you are taking the right drug or drug combination for your particular circumstances? Is your doctor able to keep up with all the new information—and, again, how would you know?

In 2002, a major anti-hypertensive drug trial rocked the international medical establishment with findings that challenged widely held beliefs. It found that diuretics, the oldest and cheapest anti-hypertensive drug class, are just as effective and, in some circumstances, better than the newer, expensive drugs. But just when it appeared that, at last, there is definitive anti-hypertensive drug news, the same study made it clear that many people with hypertension need another drug in addition to a diuretic.

This 2002 landmark trial, known as the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT), included over 33,000 men and women over age 55 years with mild to moderate hypertension who were at high risk for developing heart disease (e.g. 36% had diabetes). The ALLHAT had randomly assigned participants to take daily doses of a calcium channel blocker, an alpha blocker, an ACE inhibitor, or a diuretic.

Whenever a drug failed to control blood pressure, the study participants were put on a second or third additional drug selected from the other three. In other words, everyone in this study was on anti-hypertensive drugs, often two or three on a daily basis. The ALLHAT participants were broadly representative of the U.S. population in terms of race, gender, socioeconomic status, and geographical region.

Here are some of the ALLHAT findings:

  • A diuretic should be the first-choice treatment for high blood pressure;
  • the total or overall mortality—that is, the deaths from all causes—was the same for all treatments;
  • calcium-channel-blocker drugs increased the incidence of heart failure;
  • participants taking the alpha-blocker (doxazosin) were stopped prior to the intended conclusion of ALLHAT because they showed a significantly increased rate of angina, stroke, and congestive heart failure;
  • whether they were treated with a diuretic, ACE inhibitor, or an alpha blocker, the occurrences of heart-related death, and non-fatal heart attack were virtually identical.

Because most anti-hypertensive drug trials have combined the results for men and women, some researchers have pointed out that this might inflate drug therapy’s benefit to women who typically do not have heart attacks or heart-related fatalities until they are much older than men. Also, there might be gender-differences in harms associated with drugs that would show up as non-cardiac deaths.

A 2003 Cochrane review of all trials that included women concluded that in white women over 55 years, drugs reduced the rate of fatal and non-fatal cerebrovascular “events” (e.g., stroke, trans ischemic attacks), and fatal and non-fatal cardiovascular events, but they do not reduce the cardiovascular or overall mortality. Black women of any age , however, benefited on all counts (except overall mortality) from drug therapy because their cardiovascular risk is higher to begin with. Black women tend to develop hypertension earlier in life than white women. In the trials included in this Cochrane review, they also were more likely to be smokers and diabetics than white women.

Another attempt to clarify things was an all-woman study published at the end of 2004 in JAMA, the Journal of the American Medical Association. A research team led by S. Wassertheil-Smoller evaluated different drug combinations in over 30,000 older women—50 to 79 years—with hypertension but no heart disease or diabetes. They had been followed for almost six years. This is what researchers call an observational study because it looked at the different ways women with hypertension are treated in “the real world” as opposed to a clinical trial based at an academic medical center where researchers determine the treatments and assign them randomly to participants.

Here are some of the findings:

  • Of the women taking only a diuretic, this drug was equal to or superior to other drugs taken singly in preventing cardiovascular disease complications;
  • of the women taking only one drug: those on a calcium channel blocker had a higher rate of death from heart disease than those taking only a diuretic;
  • the women who took only a calcium channel blocker had a higher rate of death from heart disease compared with those who took a diuretic plus a beta-blocker;
  • and women taking a diuretic plus a calcium channel blocker had a greater rate of cardiovascular death than those on a diuretic plus a beta blocker or a diuretic plus an ACE inhibitor.

Who has hypertension?
In all the anti-hypertensive drug studies described in this article, the definitions of hypertension were roughly similar. Study participants were diagnosed as having high blood pressure when they had a systolic that is higher than 140 mm HG (millimeters of mercury) or a diastolic more than 90 mm Hg.

Bottom Line:
Diuretics are the first-choice drug for men and women. While it would seem reasonable to conclude that the calcium channel blocker should be avoided, hypertension researchers see it as a “drug of last resort”. The ALLHAT did not include low-risk people with hypertension—that is, healthy adults whose only risk for heart disease is high blood pressure. When trials show a reduction in cardiovascular deaths but not in overall deaths, this suggests that the heart-related survival benefit may be canceled by treatment-related deaths. Anti-hypertensive drug trials follow people five or six years, at most, whereas people are expected to take these drugs for life.

Many heart disease researchers believe that physicians should not focus solely on high blood pressure when deciding drug therapy. Instead, a person’s entire risk profile should be taken into consideration. And finally, this from the authors of the all-woman study: “An important question is whether it is the blood pressure lowering effect of anti-hypertensive drug therapy that is the critical element in preventing cardiovascular disease sequelae or whether particular drug classes offer benefits beyond their effects in lowering blood pressure.”

*Abstracts generated by The Cochrane Collaboration are available at www.thecochranelibrary.com , see “Pharmacotherapy for Hypertension in Women of Different Races”.

Read our 2009 article: “No benefit to reducing blood pressure below 140/90.”

Box insert

Six Anti-Hypertensive Drug Classes and Brand-Named Members

Alpha Blockers or Alpha-Adrenergic Blockers
Cardura, Minipress, Hytrin, Doxaloc, Apa-Doxazosin, Gen-Doxazosin, Med-Doxazosin

ACE (angiotensin-converting enzyme) Inhibitors
Lotensin, Benicar, Capoten, Vasotec, Monopril, Prinivil, Zestril, Univasc, Aceon, Accupril Altace, Renormax, Mavik

Angiotensin-2-Receptor Antagonists, also known as ARBs
Atacand, Teveten, Avapro, Cozaar, Micardis, Diovan

Beta Blockers (beta-adrenergic-blocking drugs)
Sectral, Atenolol, Tenormin, Kerlone, Zebeta, Ziac, Cartrol, Coreg, Normodyne, Trandate, Lopressor, Corgard, Levatol, Visken, Inderal, Blocadren

Calcium Blockers or Calcium-Channel-Blocking Drugs
Norvasc, Vascor, Cardizem, Tiazac, Plendil, DynaCirc, Cardene, Adalat CC, Procardia XL, Nimotop, Sular, Calan, Isoptin, Verelan

Thiazide Diuretics
Naturetin, Aquatag, Exna, Marazide, Diuril, Anhydron, Esidrix, HydroDiuril, Diucardin, Saluron, Enduron, Aquatensen, Renese, Metahydrin, Naqua

Maryann Napoli, Center for Medical Consumers ©
April 2005

Posted in Heart, hypertension, Men's Health, Women's Health | Tagged: , , , | Comments Off

New Info About Old Hypertension Drug

Posted by medconsumers on November 1, 2004

Can you learn anything new about a commonly prescribed drug that’s been on the market for over three decades? Can a drug be good at lowering blood pressure without reducing heart attacks, stroke or cardiovascular deaths? Can a drug that is prescribed to prevent strokes cause strokes? The answer is yes to all three questions where it concerns atenolol, according to a review published in the British journal, The Lancet (11/6/04). Ironically, atenolol has long been the first choice drug prescribed to people with hypertension.

Lately we have been hearing about old drugs that are better than newer drugs—diuretics, for example. But here’s a story of an old drug that’s worse than some of its newer competitors. In an added twist, researchers had such confidence in atenolol that it had become the standard, against which newer drugs are compared in clinical trials.

33 Years in Use
The late-breaking news about the downside of atenolol, which is sold generically and under brand names, such as Tenoretic and Apo-Atenolol, came from a new review by a Swedish team of researchers. Over the years, according to the researchers, there had been questions raised about the wisdom of using atenolol as the comparator drug in clinical trials.

The Swedish researchers led by Bo Carlberg , MD, conducted a systematic review of all studies that looked specifically at atenolol’s effect on heart-related death and complications in people with high blood pressure. They identified four trials that compared atenolol with a placebo (fake pill) or no treatment. And there were five more trials that compared atenolol with other antihypertensive drugs. Over 24,000 people, aged 60-74 years, participated in the nine trials that made up this review; they were followed for four to six years.

Here are the combined results of these trials:

  • Atenolol was no better than a placebo in reducing deaths from all causes, cardiovascular deaths, heart attacks and strokes, though the drug was better at lowering blood pressure.
  • When atenolol was compared with other antihypertensive drugs, there were no major differences in blood pressure lowering. There was, however, a significantly higher rate of deaths from all causes in the people taking atenolol, as well as a higher rate of cardiovascular mortality and stroke. The drugs against which atenolol was compared were losartan, captopril, lacidipine, and thiazide diuretics.

In an understated conclusion, Dr. Carlberg and colleagues wrote, “Our results cast doubts on atenolol as a suitable drug for hypertensive patients.”

Read this 2009 article that challenges the current practice of drug therapy for people with blood pressure higher that 120/80

Maryann Napoli, Center for Medical Consumers ©

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Prehypertension—How Real Is This New “Disease”

Posted by medconsumers on August 1, 2003

The Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood pressure announced its latest guidelines last spring. People with blood pressures that were normal or high normal, as recently as three months ago, now have a condition called prehypertension. People in this new category have blood pressures of 120 to 139 millimeters of mercury systolic (top number) or 80 to 90 diastolic (bottom number), according to the National Heart, Lung, and Blood Institute which introduced the news at a May 14th press conference.

Michael Alderman, MD, is a past president of the American Society of Hypertension. A professor of medicine and population health sciences at Albert Einstein School of Medicine, Bronx, New York, Dr. Alderman has co-authored many studies related to hypertension. He is interviewed about the new guidelines.

With the new guidelines, overnight, an estimated 50 million Americans become potential patients. Is it too cynical to think that drug industry influence is at work?

Dr. Alderman: There’s no doubt that there are elements of these new guidelines that the pharmaceutical industry will be gratified to read. As you note, the designation of prehypertension will raise the level of possibility that many among this new 50 million will be given drugs. Had the guidelines focused on global [overall] risk assessment, including people [with other risks for heart disease] then this new category would surely have made sense.

The recommended lifestyle changes, such as weight loss, exercise, and restriction of sodium and alcohol, are known to result in only small decreases in blood pressure. So everyone will eventually end up on drugs, right?

Dr. Alderman: That’s my concern. Despite these [long-standing] recommendations, Americans have been stretching at the middle. So why continue to recommend a strategy that appears to be unsuccessful? There’s an enormous amount of evidence that very intensive one-on-one intervention and counseling with a dietitian or a behaviorist can achieve modest effects, but it is 30% more expensive than taking diuretics. What’s more, lifestyle effects seem to attenuate over time. There is this notion that there’s a moral superiority to lifestyle interventions. Our goal is to save lives in the least intrusive and least expensive way possible.

What new evidence was produced to show that artery damage and an increased risk of heart disease begins at blood pressure in the 120 to 139 mm Hg /80 to 90 mm Hg range?

Dr. Alderman: For at least 20 years, there has been good evidence that the risk of cardiovascular events increases with increasing blood pressure. From a very low level there’s a continuous increase in the risk of heart disease. The question is, of course, where does the benefit from lowering blood pressure come. The Joint National Committee has arbitrarily picked a new level-instead of 140, now it’s 120. There’s no more evidence that that’s the place to go than there was before. Since I went to medical school, and I graduated in 1962, the continuous relationship of [blood] pressure to [cardiovascular] events has been known. The level at which we called people hypertensive is arbitrary, and that level has constantly been reduced since 1910. The effect of moving that level from 140 to 120 is to include 50 million Americans into something labeled prehypertension. That’s equal to the total number of people that we were calling hypertensives before. So now we have medicalized 100 million Americans instead of 50 million.

How do you determine when to be concerned about high blood pressure?

Dr. Alderman: I, and most modern-thinking doctors, believe that blood pressure is only one part of the determination of your global [overall] risk for cardiovascular disease. The concern is about risk for stroke and heart attack, and that is the sum total of many factors, including blood pressure. There are people with rather low blood pressure who are at a rather high risk for stroke and heart attack on the basis of their cholesterol, cigarette smoking, enlarged heart, kidney disease—-a whole range of things that might increase the risk for a cardiovascular event.

Those people should have their blood pressure lowered—almost whatever their blood pressure is. There are studies to prove this because lowering blood pressure does lower their risk, even if the blood pressure is 125. If your risk is, let’s say, 50 chances out of a 100 that you’ll have a heart attack, and you can lower your risk by 25%—that’s a good buy. But if your blood pressure is 125 and you have nothing else, your risk is almost entirely a result of your age—then your additional risk is very small and not likely to be meaningfully reduced by lowering blood pressure. Wise doctors and patients will recognize that simply looking at the blood pressure level is no way to decide on the need for an intervention. It’s the total risk for cardiovascular events that matters.

What about the person who, other than age, has no other risk for heart disease, but his blood pressure is high, say 180 over 110?

Dr. Alderman: Then his risk, on the basis of his blood pressure, is high enough to justify drug treatment. What I’m worried about are those people between 120 and 139 who have now been accused of having prehypertension. There’s no evidence to show that people in that range, who have no other risk factors, will benefit [from drug treatment]. If they have other risk factors, that’s a different story. But that’s not what the new guidelines say.

According to the new guidelines, if you are prehypertensive, you should lower your blood pressure with lifestyle changes. That, as we have already discussed, is not very likely to work. So what will the patient say, “I’m a failure—doomed to whatever prehypertension dooms you to,” or “Do I take one of these drugs like low-dose diuretics that cost about a penny a day and have been proven to save lives?” Well, the new guidelines are silent on that important question which millions of Americans should be asking.

You said that treatment should start with diuretics. Is it a stepped approach that is recommended, starting with diuretics and if they don’t work, you move up to beta-blockers, and so forth?

Dr. Alderman: Yes, for most people, I think that’s right. However, there are specific situations, such as kidney disease characterized by leaking protein, where other drugs are useful, for example, the angiotensin-converting enzyme inhibitors* [e.g,, Capoten, Vasotec] and the A2 receptor blockers [e.g., Atacand, Avapro]. Clinical trials say that’s the best. But for the garden variety, uncomplicated hypertension-about 70% of all people with hypertension-starting with a diuretic is right. And there’s no evidence that there is anything better, though you have to worry a little bit about diabetes and loss of potassium with diuretics. Reasonable monitoring, however, should cover that risk.

*Each of the anti-hypertensive drug classes mentioned in this interview has numerous brand names for each medication. Only two are given as examples.

You have searched the scientific evidence related to sodium restriction and consistently found no cardiovascular benefit. If so, why do the guidelines continue to tell people with high blood pressure to cut back on the salt intake?

Dr. Alderman: The National Heart, Lung and Blood Institute has been heavily invested in sodium restriction for 30 years. It’s hard to change your views. Several things are becoming clear: When you lower sodium intake in some people, it lowers blood pressure. But for most people, it doesn’t. And in a few people, it actually raises blood pressure. There’s tremendous variation, and that’s understandable because we are all so different. For example, some of us work hard, sweat, exercise; and people who sweat a lot need a lot of salt to keep even. Others have genetic differences in the way they handle salt. There are seven individual single gene conditions in which salt and blood pressure are affected. In two of them, there are salt-losing situations-if you don’t eat enough salt, your blood pressure falls and you die. In five others, you eat salt and your blood pressure goes up. Thus, we are a diverse crowd with behavioral, genetic, and environmental differences in the way salt intake affects us.

Where does that leave us?

Dr. Alderman: Scientists have generally moved the discussion beyond the effect of salt on blood pressure. Everybody agrees that if you treat 100,000 people with a low-salt diet, you would probably lower the average blood pressure a millimeter or two of diastolic and three or four systolic. And everybody agrees that that benefit would be unevenly distributed throughout the population. But the question is: Is the price paid [harm caused] by lowering the salt to attain that blood pressure going to be greater than the benefit? The reason I ask that question is this: lowering salt to reduce blood pressure has other effects. It stimulates the renin angiotensin system and increases sympathetic nerve activity, which raises the pulse rate. Both of these things adversely affect the heart. And it decreases insulin sensitivity—that’s bad for you too.

So on the one hand, your blood pressure levels falls; on the other hand, you have all these other things. The effect on human health is the sum total of all those things. That’s why [doctors should] test interventions. And that’s why we demand clinical trials to make sure we’re not hurting people more than we help them. My guess is that, in view of the genetic, behavioral, and environmental heterogeneity of the population, it is not likely that one level of sodium intake will prove to be best for all Americans.

You have suggested that doctors tell people to restrict their salt intake but never test them again.

Dr. Alderman: They virtually never do. The government says it’s a good thing to do: put people with hypertension on a low-salt diet. [Hardly any] doctors tell them to collect their urine for 24 hours, which is a reasonable way to measure salt intake. It’s hard to tell how much salt you eat because most of it comes in bread, cake, etc. Only 10-15% of your salt comes out of a saltshaker.

I’d like to end by asking you what you think of this statement from the European Heart Journal in 2000, “No randomized clinical trial has ever demonstrated any reduction of the risk of either overall or cardiovascular death by reducing systolic blood pressure from thresholds to below 149 mmHg”?

Dr. Alderman: That’s correct. Although since then, I believe that the level has dropped to 140 mmHg. But it has been shown in high-risk patients that a small reduction in blood pressure, even at lower pressure can produce a real benefit. Half the people in the HOPE [Heart Outcomes Prevention Evaluation] trial didn’t have hypertension by our 140 mm or 120 mm definitions, yet they benefited from the addition of an ACE inhibitor [e.g., Altace, Capoten] which lowered blood pressure a few mmHg. Modern thinking, as shown in the recent publication of the European treatment guidelines, incorporates hypertension into a global risk. They get away from arbitrary definitions of high blood pressure and try to make a more comprehensive, patient-centered approach to treatment.

Note: This interview with Dr. Alderman was conducted in 2003. For an update, read this 2009 interview with another research physician who found no benefit to using drugs to reduce blood pressure below 140 over 90.

Maryann Napoli, Center for Medical Consumers(c)

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Many People Stop Taking Anti-Hypertensive Drugs because the Dose is too High

Posted by medconsumers on August 1, 2003

At least half of all people stop taking their blood pressure medications because of the side effects that typically include fatigue, lethargy, dizziness, and sexual dysfunction. Jay S. Cohen, MD, knows the reason why—-the dose is set too high. He takes issue with the prevailing belief among doctors and drug manufacturers that side effects are inevitable and unavoidable. In his book Over Dose: The Case Against Drug Companies (New York: Jeremy P. Tarcher/Putnam, 2001), Dr. Cohen says that the drug companies set the dosage for all prescription drugs at a high level because it is more convenient for doctors. The source of information that most doctors turn to for dose recommendations is the Physicians’ Desk Reference, which is published by the pharmaceutical industry with oversight by the FDA.

Dr. Cohen, a research physician at the University of California, San Diego, has published numerous medical journal articles on the subject of drug dosage. He has found that most side effects never occur when people are started at a low dose that is slowly increased if needed. Nowhere is that more apparent than in the treatment of hypertension.

Every five years, the Joint National Committee on the Detection, Evaluation, and Treatment of High Blood Pressure (JNC) is convened to reassess the standard therapies for hypertension. The JNC usually gets a lot of media attention with its pronouncements, but Dr. Cohen observes that the guidelines have little effect on physician prescribing habits where it concerns dosage.

When the JNC last published guidelines, Dr. Cohen did his own survey comparing the doses recommended by the JNC with the doses recommended by the drug companies. The JNC experts recommended substantially lower initial doses for 23 out of 40 anti-hypertensive drugs. Asked about the latest JNC guidelines in a telephone interview, Dr. Cohen said that most of the guidelines are exactly the same, though a few new drugs have been added. “A lot of the [recommendations] come out again with the same standard ‘one size fits all’ dosing. Young and old, big and small, healthy and unhealthy, and people who take ten medicines and those who take one medicine,” he answered. “Whenever I’m talking about this on a radio show, veterinarians and farmers usually call in to say they always adjust medicine doses for animals.” Dr. Cohen emphasized that he is not suggesting everyone needs low doses. Only about 20-40% of all people do. “It’s usually the small, female, [and/or] elderly,” he said, “People who are sensitive to medicine–they know who they are.”

After many years of treating high blood pressure, doctors have become more amenable to lowering the dosage once they prescribe drugs in combinations of two or three, explained Dr. Cohen. To illustrate how long it takes to identify the safest and most effective dose, Dr. Cohen used diuretics as an example. “Those drugs can have major side effects that usually aren’t obvious,” he explained. “They were first marketed at doses of 50-100 mg a day, and now the standard dose is 12.5 mg. It took them decades to figure that out. 12.5 mg is fine for most people, but for those who are sensitive, there is no harm in starting lower.”

Dr. Cohen has advice for people who want to avoid high blood pressure or lower mild hypertension without drugs. “Lose weight, eat a good diet that emphasizes vegetables, fruits, whole grains, fish, poultry, and low-fat dairy products. This has been proven to lower blood pressure as much as a mild blood pressure pill.” Those who follow this type of diet, however, will still need magnesium supplementation, according to Dr. Cohen, who estimates that 80% of the population is magnesium deficient. To help people understand why, Dr. Cohen wrote a booklet called Magnesium for High Blood Pressure, which he said is available at many health food stores. “Magnesium does exactly the same thing as these expensive calcium channel blockers doctors prescribe for hypertension,” he explained. “It calms the nervous system, and relaxes the musculature, and stabilizes blood vessel function.”

For More Information:
Visit Dr. Cohen’s Web site (www.medicationsense.com) to sign up for a free electronic newsletter and learn more about his work.

Maryann Napoli, Center for Medical Consumers(c)

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