Putting ALLHAT into Perspective: DO DRUG COMPANIES CREATE PROBLEMS OR FIND SOLUTIONS?

9 Jun
2010

DO DRUG COMPANIES CREATE PROBLEMSWhich came first, the chicken or the egg? If diuretics had been a panacea for curing hypertension, it is unlikely that drug companies would have taken on the financial risk of developing alternative classes of antihypertensive drugs. As previously discussed, diuretics alone are often inadequate for controlling hypertension and are contraindicated for, or are not well tolerated by, some patients with certain conditions. Developing alternative classes of drugs to attack hypertension by different biochemical means was, and remains, a reasonable solution to a complex problem.

In covering the ALLHAT outcomes, the media made generalizations based on reported price differentials among the specific study drugs and concluded that diuretics as a class of drugs were considerably less expensive than the other classes. In reality, the price differential is not very great. There are less expensive ACE-inhibitors and calcium-channel blockers than those chosen for the study.
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People interpret data in various ways. Since the publication of the ALLHAT outcomes, some journalists have used national prescription-utilization data to show a decrease in diuretic prescriptions as a percentage of total prescriptions for hypertension. They characterize this as a negative trend, and they blame drug companies. Examining the same national prescription data for the same two-decade time period, we can see that the number of diuretic prescriptions increased by 10 million (from 109 million to 119 million). Actually, both of these observations would be expected, given that most patients require more than one drug class for optimal blood pressure control.

Much of the research on new drugs is done under the auspices, and at the expense of, drug companies. This research consists of clinical trials that compare each new drug with a placebo to test the effectiveness of the drug, to ensure its safety, and to secure approval of the Food and Drug Administration (FDA). Industry and health policy leaders agree that it is unreasonable to expect pharmaceutical companies to conduct large-scale, high-cost drug comparison trials such as ALL-HAT. This is not to say that the government should bear the entire burden; in fact, several pharmaceutical manufacturers made substantial financial contributions toward the NIH’s $125 million budget for ALLHAT. It has been reported that Pfizer contributed a total of $50 million and that AstaZeneca and Bristol-Myers Squibb joined Pfizer in contributing drugs for the study.

WHICH QUESTIONS REMAIN UNANSWERED?

As with all research, regardless of the scope or size, ALLHAT doesn’t just answer questions; it raises more questions. For example, patients receiving chlorthalidone had fewer strokes than patients receiving one of the two other drugs, but what are the implications for diuretics as a class of drugs? Would a different diuretic drug perform as well or better? Similarly, there are ACE-inhibitors that provide better blood pressure control over the duration of each dose than lisinopril, the study drug. Would an ACE-inhibitor with better 24-hour control have shown better results? canadian pharmacy viagra

Answers to these and other questions are beginning to appear in the literature. In another recent study, researchers compared a different ACE-inhibitor with hydrochlorthiazide, a diuretic commonly prescribed by American physicians. They concluded that antihypertension treatment consisting of ACE-inhibitors in older patients, particularly in men, seemed to produce better primary and secondary outcomes than diuretic treatment, despite similar reductions in blood pressure. These findings appear to contradict those of the ALLHAT reports.

SUMMARY

Although diet and other lifestyle modifications remain the frontline methods of attack on hypertension, the ALLHAT study reinforces current medical practice and national guidelines that recommend diuretics as a first-line drug in hypertension therapy. In all likelihood, national guidelines will continue to recommend, and physicians will continue to prescribe, diuretics (alone or in combination with another antihypertensive agent) as initial therapy because of their proven benefits; however, treatment must always be tailored to each patient’s unique physiology, metabolism, and temperament. Not everyone with hypertension responds effectively to diuretics; indeed, earlier and subsequent studies have shown that most patients need a combination of drugs to maintain an acceptable blood pressure.

The message to the public should be as follows:

  • If you are told that you have hypertension, ask your doctor about starting out with a diuretic. Especially in the initial stages of the condition, this drug may be effective in lowering your blood pressure to a safe level without significant side effects.
  • Because hypertension is complex, your physician should monitor your condition closely. At any time during the course of the disease, it may become necessary to switch to another medication or to add a drug to your treatment to maintain control of your blood pressure.
  • If you are already taking one or more medications to control blood pressure, keep taking them as prescribed, and ask your doctor about the potential benefits of changing medications.
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We in the medical community and the health care industry hail ALLHAT for its significant contribution to the literature and to our understanding of the effectiveness of specific drugs in treating hypertension and in reducing the risks for primary and secondary adverse outcomes, but we caution against over-interpreting the findings and generalizing about treatments that must remain individualized.

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