Another scare about antihypertensive therapy.

H is the most common risk factor for cardiovascular diseases that are the most common cause of disability and death in the United States (US) and all developed societies. Unfortunately, only 1 of 4 hypertensive persons in the US have their blood pressure adequately treated. As the “silent killer,” hypertension will always be difficult to control. It is hard to keep asymptomatic people on daily treatment for life when they recognize no obvious benefit, but rather have adverse effects and often spend large amounts of money for medications. Fortunately, an increasingly large number of medications have become available that can lower blood pressure effectively in almost all patients when taken only once a day and with relatively few adverse effects. When added to the appropriate changes in lifestyle, including weight loss, regular exercise, moderation of sodium, and alcohol intake, almost all patients can be controlled. However, to ensure such control, physicians and patients must have confidence in their treatment regimen, in both its efficacy and its safety. Unfortunately, yet another unsubstantiated claim that one of the most widely used antihypertensive drugs, the calcium channel blocker, is unsafe, has recently been widely publicized, making the front page of the New York Times (August 28, 2000) with the subtitle that, “Some drugs for high blood pressure fail to stop heart ailments.” The information quoted in the Times and other newspapers, magazines, television, and the Internet was largely taken from the press release of August 24, 2000, from the home base of the lead investigators, Wake Forest University Baptist Medical Center, providing some of the information from a meta-analysis of 9 published articles that were said to reveal a 26% increased risk of heart attack and heart failure with calcium channel blockers compared with other antihypertensive drugs.1 When the estimated numbers of patients taking these drugs was multiplied by their increased risk, the press release and the media quotes stated that “up to 85,000 unnecessary heart attacks or heart failures may occur worldwide.” Without attacking the scientific validity of this analysis, it should be noted that 2 additional points made by the investigators in their oral presentation at the European Society of Cardiology on August 29, 2000, were totally disregarded. First, in the 3 major trials composing .90% of all the patients, there was a 22% increase in heart attacks but an 11% decrease in strokes and no difference whatever in mortality. Therefore, at least 42,500 persons would have been saved from stroke by taking a calcium blocker. Of interest, a more complete analysis of all 14 published trials comparing different antihypertensive drugs, which was presented at the International Society of Hypertension on August 24, 2000, reported a 12% greater incidence of heart attack, but a 14% lower incidence of stroke with calcium blockers than with other drugs. This report, not contentious and not hyped by investigators to the press, received no media coverage. As expected, the wide press and media coverage of the blast from Wake Forest provoked a great deal of fear and anxiety among patients taking the calcium channel blockers. If they called their physicians before stopping their presumably dangerous medication, the physician, with no more knowledge of the data than what was in the paper or on TV, could only give either uninformed tacit agreement, thereby depriving patients of effective treatment, or an embarrassed admission of ignorance about what to do. Among patients who abruptly stopped their medications without contacting their physicians, heart attacks and strokes likely occurred, as had been noted after the 1995 scare. The people responsible for this media scare are the same people who caused the similar agitation in 1995 and 1996, with claims that calcium channel blockers caused heart attacks,2 cancer,3 and gastrointestinal bleeding.4 The initial claim was largely based on the straw man of serious consequences of large doses of short-acting calcium channel blockers in highly vulnerable survivors of an acute myocardial infarction, noted many years before because these drugs were tried in a number of circumstances, some favorably, some unfavorably. By the time of the 1995 claim, the use of large doses of short-acting calcium channel blockers had been recognized to be unsafe and had never been recommended. Over the subsequent 5 years, multiple, properly controlled trials have attested to the efficacy and safety of long-acting calcium channel blockers.5–7 The threat of cancer has been thoroughly refuted8,9 and the possibility of gastrointenstinal bleeding recognized to be unlikely.10 Media attention to contentious data cannot and should not be curtailed, but there is no excuse for the repeated inflammatory tactics of Furberg and associates.2 If significant dangers are exposed, drug companies and regulatory agencies should be called upon for From The University of Texas Southwestern Medical Center at Dallas, Dallas, Texas. Manuscript received and accepted October 10, 2000. Address for reprints: Norma M. Kaplan, MD, The University of Texas Southwestern Medical Center at Dallas, 5323 Harry Hines Boulevard, Dallas, Texas 75390-8899.