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Are ACE Inhibitors and Calcium Channel Blockers As Effective As Diuretics and ␤-Blockers?

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Are ACE Inhibitors and Calcium Channel Blockers As Effective As Diuretics and ␤-Blockers? J Am Board Fam Pract: first published as 10.3122/jabfm.16.2.156-a on 1 March 2003. Downloaded from STEPPED CARE:AN EVIDENCE-BASED APPROACH TO DRUG THERAPY Bruce R. Canaday, PharmD, and Keith Campagna, PharmD, Feature Editors Treatment of Uncomplicated Hypertension: Are ACE Inhibitors and Calcium Channel Blockers as Effective as Diuretics and ␤-Blockers? Joseph J. Saseen, PharmD, Eric J. MacLaughlin, PharmD, and John M. Westfall, MD, MPH Editors’ Note: This month we continue the feature - porated into clinical practice. The rest is up to the reader. STEPped Care: An Evidence-Based Approach to Drug Ther- Blending POEMs with rational thought, clinical experience, apy. These articles are designed to provide concise answers to and importantly, patient preferences can be the essence of the the drug therapy questions that family physicians encounter in art of medicine. their daily practice. The format of the feature will follow the We hope you will find these new articles useful and easy to mnemonic STEP: safety (an analysis of adverse effects that read. Your comments and suggestions are welcome. You may patients and providers care about), tolerability (pooled dropout contact the editors through the editorial office of JABFP. We rates from large clinical trials), effectiveness (how well the hope the articles provide you with useful information that can drugs work and in what patient population[s]), and price (costs be applied in everyday practice, and we look forward to your of drug, but also cost effectiveness of therapy).1 Hence, the feedback. name STEPped Care. Bruce R. Canaday, PharmD Since the informatics pioneers at McMaster University Keith Campagna, PharmD introduced evidence-based medicine,2 Slawson and col- STEPped Care Feature Editors leagues3,4 have brought it to mainstream family medicine John P. Geyman, MD, Editor education and practice. This feature is designed to further the Journal of the American Board of Family Practice mission of searching for the truth in medical practice. Authors will provide information in a structured format that allows the readers to get to the meat of a therapeutic issue in a way that References can help physicians (and patients) make informed decisions. 1. Shaughnessy AF, Slawson DC, Bennett JH. Separating the The articles will discourage the use of disease-oriented evidence wheat from the chaff: identifying fallacies in pharmaceutical http://www.jabfm.org/ promotion. J Gen Intern Med 1994;9:563–8. (DOE) to make treatment decisions. Examples of DOEs in- 2. Evidence-based medicine: a new approach to teaching the clude blood pressure lowering, decreases in hemoglobin A1c, practice of medicine. Evidence-Based Medicine Working and so on. We will include studies that are POEMs - patient- Group. JAMA 1992;268:2420–5. oriented evidence that matters (myocardial infarctions, pain, 3. Slawson DC, Shaughnessy AF, Bennett JH. Becoming a strokes, mortality, etc) - with the goal of offering our patients medical information master: feeling good about not know- ing everything. J Fam Pract 1994;38:505–13. the most practical, appropriate, and scientifically substantiated 4. Shaughnessy AF, Slawson DC, Bennett JH. Becoming an therapies. Number needed to treat to observe benefit in a single information master: a guidebook to the medical information on 28 September 2021 by guest. Protected copyright. patient will also be included as a way of defining advantages in jungle. J Fam Pract 1994;39:489–99. terms that are relatively easy to understand.5,6 5. Laupacis A, Sackett D, Roberts RS. An assessment of clin- At times this effort will be frustrating. Even as vast as the ically useful measures of the consequences of treatment. N Engl J Med 1988;318:1728–33. biomedical literature is, it does not always support what clini- 6. Wiffen PJ, Moore RA. Demonstrating effectiveness - the cians do. We will avoid making conclusions that are not concept of numbers-needed-to-treat. J Clin Pharm Ther supported by POEMs. Nevertheless, POEMs should be incor- 1996;21:23–7. It is estimated that approximately 25% of the adult Submitted, revised, 23 June 2002. American population (ie, 50 million Americans) From the Department of Clinical Pharmacy (JJS), and 1,2 Department of Family Medicine (JJS, JMW), University of have hypertension. The Sixth Report of the Joint Colorado Health Sciences Center, Denver, and the School National Committee on Detection, Evaluation, of Pharmacy (EJM), Texas Tech University Health Sciences and Treatment of High Blood Pressure (JNC VI) Center, Amarillo. Requests for reprints should be addressed to Joseph J. Saseen, PharmD, University of Colorado School has been designed to help clinicians manage this of Pharmacy, 4200 E. 9th Ave. Box C238, Denver, CO 80262. disease.1 These treatment guidelines, consistent 156 JABFP March–April 2003 Vol. 16 No. 2 J Am Board Fam Pract: first published as 10.3122/jabfm.16.2.156-a on 1 March 2003. Downloaded from with the previous JNC V report from 1993,3 rec- “antihypertensive agents,” “hypertension,” “ACE ommend diuretics and ␤-blockers as first-line inhibitors,” “calcium channel blockers,” “myocar- therapy for uncomplicated hypertension. This rec- dial infarction,” “cardiovascular diseases,” “mortal- ommendation was based on landmark placebo- ity,” and “survival.” Clinical trials were included if controlled clinical trials data that showed reduced they were human clinical trials that evaluated either morbidity and mortality with the use of these two ACE inhibitors or calcium channel blockers. Only drug classes.4–6 large-scale clinical trials that evaluated outcomes Angiotensin-converting enzyme (ACE) inhibi- (eg, cardiovascular events, stroke, mortality, etc) as tors and calcium channel blockers are recom- study endpoints were selected. Clinical trials were mended by the JNC VI as alternatives to diuretics excluded if they were not published in English and ␤-blockers unless compelling indications for language journals. their first-line use are present.1 ACE inhibitors are Numbers needed to treat (NNT) to prevent one recommended as first-line agents for patients who negative outcome were calculated for individual have type 1 diabetes mellitus with proteinuria, trials and summarized in tabular form. This article heart failure, or previous myocardial infarction will review outcome-based clinical trials that have with systolic dysfunction and long-acting dihydro- compared ACE inhibitors and calcium channel pyridine calcium channel blockers may be used as a blockers with diuretics or ␤-blockers in the man- first-line agent in those with isolated systolic hy- agement of hypertension using the STEP ap- pertension. Despite these recommendations, ACE proach: safety (an analysis of adverse effects that inhibitors and calcium channel blockers (including patients and providers care about), tolerability dihydropyridine and agents other than dihydropyr- (pooled dropout rates from large clinical trials), idine) are consistently the most frequently pre- effectiveness (how well the agent works and in what scribed antihypertensive agents in both younger patient population[s]), and price (cost of drugs, but and older patients with hypertension.7,8 also cost of effectiveness of therapy). Data from a The definitive isolated effects of ACE inhibitors recent meta-analysis were included to evaluate and calcium channel blockers on morbidity and these findings further. mortality in the treatment of uncomplicated hyper- tension are unknown because there are no placebo- controlled trials evaluating long-term benefits. Safety and Tolerability Conducting such clinical trials with these two ACE inhibitors and calcium channel blockers are http://www.jabfm.org/ newer antihypertensive agents is currently consid- considered safe and well tolerated when used to ered unethical because the benefits of treating un- treat hypertension. The most frequently encoun- complicated hypertension are well established. tered side effects with ACE inhibitors include a dry Since the publication of the JNC VI in 1997, there cough and hyperkalemia. With calcium channel are now several published clinical trials comparing blockers, constipation, edema, headache, palpita- either ACE inhibitors or calcium channel blockers tions, and slowing of the heart rate (with agents with first-line antihypertensive agents (diuretics other than dihydropyridine) can occur. on 28 September 2021 by guest. Protected copyright. and ␤-blockers).9–12 These trials have described The Veterans Affairs Cooperative Study Group long-term patient-oriented evidence that matters on Antihypertensive Agents evaluated single-drug (POEMs). It is imperative that clinicians be familiar therapy for hypertension for 1 year.13 The rates of with the major findings of these trials to select adverse effects leading to termination of treatment evidence-based antihypertensive therapy. The pur- were 4.8% and 6.5% with captopril and diltiazem, pose of this review is to determine whether new respectively, and 2.2% and 1.1% with atenolol and evidence since the publication of the JNC VI sup- hydrochlorothiazide, respectively (placebo rate was ports the first-line use of ACE inhibitors or calcium 6.4%). Although there were no statistically signif- channel blockers. icant differences in adverse effects between treat- ments, the modest sample size (n ϭ 176–188 in each group) could have resulted in a lack of power Methods to detect a difference. These findings are consistent A MEDLINE search was performed for January with the quality-of-life evaluations from the Treat- 1993 through August
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