Another scare about antihypertensive therapy

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<ul><li><p>Another Scare AboutAntihypertensive Therapy</p><p>Norman M. Kaplan, MD</p><p>Hypertension is the most common risk factor forcardiovascular diseases that are the most com-mon cause of disability and death in the United States(US) and all developed societies. Unfortunately, only1 of 4 hypertensive persons in the US have their bloodpressure adequately treated.</p><p>As the silent killer, hypertension will always bedifficult to control. It is hard to keep asymptomaticpeople on daily treatment for life when they recognizeno obvious benefit, but rather have adverse effects andoften spend large amounts of money for medications.</p><p>Fortunately, an increasingly large number of med-ications have become available that can lower bloodpressure effectively in almost all patients when takenonly once a day and with relatively few adverse ef-fects. When added to the appropriate changes in life-style, including weight loss, regular exercise, moder-ation of sodium, and alcohol intake, almost all patientscan be controlled.</p><p>However, to ensure such control, physicians andpatients must have confidence in their treatment reg-imen, in both its efficacy and its safety. Unfortunately,yet another unsubstantiated claim that one of the mostwidely used antihypertensive drugs, the calcium chan-nel blocker, is unsafe, has recently been widely pub-licized, making the front page of the New York Times(August 28, 2000) with the subtitle that, Some drugsfor high blood pressure fail to stop heart ailments.</p><p>The information quoted in the Times and othernewspapers, magazines, television, and the Internetwas largely taken from the press release of August 24,2000, from the home base of the lead investigators,Wake Forest University Baptist Medical Center, pro-viding some of the information from a meta-analysisof 9 published articles that were said to reveal a 26%increased risk of heart attack and heart failure withcalcium channel blockers compared with other anti-hypertensive drugs.1 When the estimated numbers ofpatients taking these drugs was multiplied by theirincreased risk, the press release and the media quotesstated that up to 85,000 unnecessary heart attacks orheart failures may occur worldwide.</p><p>Without attacking the scientific validity of thisanalysis, it should be noted that 2 additional pointsmade by the investigators in their oral presentation atthe European Society of Cardiology on August 29,2000, were totally disregarded. First, in the 3 major</p><p>trials composing .90% of all the patients, there was a22% increase in heart attacks but an 11% decrease instrokes and no difference whatever in mortality.Therefore, at least 42,500 persons would have beensaved from stroke by taking a calcium blocker. Ofinterest, a more complete analysis of all 14 publishedtrials comparing different antihypertensive drugs,which was presented at the International Society ofHypertension on August 24, 2000, reported a 12%greater incidence of heart attack, but a 14% lowerincidence of stroke with calcium blockers than withother drugs. This report, not contentious and nothyped by investigators to the press, received no mediacoverage.</p><p>As expected, the wide press and media coverage ofthe blast from Wake Forest provoked a great deal offear and anxiety among patients taking the calciumchannel blockers. If they called their physicians beforestopping their presumably dangerous medication, thephysician, with no more knowledge of the data thanwhat was in the paper or on TV, could only give eitheruninformed tacit agreement, thereby depriving pa-tients of effective treatment, or an embarrassed admis-sion of ignorance about what to do. Among patientswho abruptly stopped their medications without con-tacting their physicians, heart attacks and strokeslikely occurred, as had been noted after the 1995scare.</p><p>The people responsible for this media scare are thesame people who caused the similar agitation in 1995and 1996, with claims that calcium channel blockerscaused heart attacks,2 cancer,3 and gastrointestinalbleeding.4 The initial claim was largely based on thestraw man of serious consequences of large doses ofshort-acting calcium channel blockers in highly vul-nerable survivors of an acute myocardial infarction,noted many years before because these drugs weretried in a number of circumstances, some favorably,some unfavorably. By the time of the 1995 claim, theuse of large doses of short-acting calcium channelblockers had been recognized to be unsafe and hadnever been recommended.</p><p>Over the subsequent 5 years, multiple, properlycontrolled trials have attested to the efficacy andsafety of long-acting calcium channel blockers.57 Thethreat of cancer has been thoroughly refuted8,9 and thepossibility of gastrointenstinal bleeding recognized tobe unlikely.10</p><p>Media attention to contentious data cannot andshould not be curtailed, but there is no excuse for therepeated inflammatory tactics of Furberg and associ-ates.2 If significant dangers are exposed, drug compa-nies and regulatory agencies should be called upon for</p><p>From The University of Texas Southwestern Medical Center at Dallas,Dallas, Texas. Manuscript received and accepted October 10,2000.</p><p>Address for reprints: Norma M. Kaplan, MD, The University ofTexas Southwestern Medical Center at Dallas, 5323 Harry HinesBoulevard, Dallas, Texas 75390-8899.</p><p>7592001 by Excerpta Medica, Inc. All rights reserved. 0002-9149/01/$see front matterThe American Journal of Cardiology Vol. 87 March 15, 2001 PII S0002-9149(00)01497-1</p></li><li><p>immediate actions, as frequently performed over therecent past with either recalls or warnings about mul-tiple approved drugs.</p><p>At the least, all authoritative journals should followthe modified Ingelfinger rule: Publish important dataalmost immediately after rapid peer review, placingthose with an urgent message on the Internet; reject allpapers that have been thrashed and trashed by willfulprepublication hype. Thereby, perhaps the recurrentscares about antihypertensive therapy will be muted soas to interfere less with the already difficult manage-ment of this condition.</p><p>1. News Release. Major new study finds long-acting calcium channel blockersinferior to other antihypertensive drugs. Wake Forest University, Baptist MedicalCenter, Office of Public Relations and Marketing, Winston-Salem, North Caro-lina. August 24, 2000. (www.wfubmc.edu).2. Furberg CD, Psaty BM, Meyer JV. Dose-related increase in mortality inpatients with coronary heart disease. Circulation 1995;91:13261331.3. Pahor M, Guralnik, JM, Ferrucci L, Corti M.-C., Salive ME, Cerhan JR,</p><p>Wallace RB, Havlik RJ. Calcium-channel blockade and incidence of cancer inaged populations. Lancet 1996;348:493497.4. Pahor M, Guralnik JM, Furberg CD, Carbonin P, Havlik RJ. Risk of gastro-intestinal haemorrhage with calcium antagonists in hypertensive person over 67years old. Lancet 1996;348:10611065.5. Staessen JA, Fagard R, Thijs L, Celis H, Arabidze GG, Birkenhager WH,Bulpitt CJ, de Leevw PW, Dollery CT, et al, for the Syst-Eur Trial Investigators.Randomised double-blind comparison of placebo and active treatment for olderpatients with isolated systolic hypertension. Lancet 1997;350:757764.6. Brown MJ, Palmer CR, Castalgne A, de Leeuw P, Mancia G, Rosenthal T,Ruilope LM. Morbidity and mortality in patients randomised to double-blindtreatment with a long-acting calcium-channel blocker or diuretic in the Interna-tional Nifedipine GITS study: intervention as a goal in hypertension treatment(INSIGHT). Lancet 2000;356:366372.7. Hansson L, Hedner T, Lund-Johansen P, Kjeldsen SE, Lindholm H, SyvertsenJ, Lanke, J, de Faire U, Dahlof B, Karlberg BE, et al. Randomised trial of effectsof calcium antagonists compared with diuretics and b-blockers on cardiovascularmorbidity and mortality in hypertension: the Nordic Diltiazem (NORDIL) study.Lancet 2000;356:359365.8. Sorensen HT, Olsen JT, Mellemkjaer L, et al. Cancer risk and mortality inusers of calcium channel blockers. Cancer 2000;89:165172.9. Cohen HJ, Pieper CF, Hanlon JT, Wall WE, Burchett BM, Havlik RJ. Calciumchannel blockers and cancer. Am J Med 2000;108:210215.10. Suissa S, Bourgault C, Barkun A, Sheehy O, Ernst P. Antihypertensive drugsand the risk of gastrointestinal bleeding. Am J Med 1998;105:230235.</p><p>760 THE AMERICAN JOURNAL OF CARDIOLOGYT VOL. 87 MARCH 15, 2001</p></li></ul>