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Users' Guides to the Medical Literature

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Users' Guides to the Medical Literature THE MEDICAL LITERATURE Users’ Guides to the Medical Literature XIX. Applying Clinical Trial Results B. Guidelines for Determining Whether a Drug Is Exerting (More Than) a Class Effect Finlay A. McAlister, MD, FRCPC your patients with elevated choles- Herein, we define a drug class as those Andreas Laupacis, MD, MSc, FRCPC terol levels, but are uncertain which of drugs that share a similar structure and the statins on the market is best. You mechanism of action. Most classes of George A. Wells, MSc, PhD ask a general internist, cardiologist, and drugs include multiple compounds, and David L. Sackett, FRSC, MD, FRCP endocrinologist for their opinions, and because of their similar mechanisms of for the Evidence-Based Medicine each suggests a different statin, citing action, they are generally thought to con- Working Group different reasons. You contact pharma- fer similar pharmacologic effects and ceutical representatives to provide you clinical outcomes (class effects). This 3 OST CLASSES OF DRUGS IN- with evidence that their statins are bet- assumption is a key medical heuristic clude multiple com- ter than those of their competitors. Al- and underlies clinical practice guide- pounds. The opinions of though you use the JAMA series on Us- lines in which evidence from studies clinicians, manufactur- ers’ Guides to the Medical Literature to involving 1 or more drugs within a class Mers, and purchasers may differ as to assess the validity of published stud- is extrapolated to other drugs of the same whether a particular drug is more effi- ies, faced with a variety of competing class. For example, it is recommended cacious, safer, or more cost-effective claims, you realize that you need a that b-blockers be prescribed for survi- than others in its class.1 In this article, framework for grading the strength of vors of myocardial infarction or angio- we review the types of evidence com- these studies. tensin-converting enzyme inhibitors to monly cited to support the prescrib- patients with heart failure. In this cir- ing of a particular drug rather than an- The Policymaker cumstance, clinicians are likely to be other of the same class and provide a Your colleague, a purchaser for a large interested in the drug within each class hierarchy for grading studies that com- health maintenance organization (HMO), is faced with a similar di- Author Affiliations: National Health Service Research pare a drug with another of the same and Development Centre for Evidence-Based Medi- class, expanding on our discussion in lemma when she is asked to consider re- cine, John Radcliffe Hospital, Oxford, England (Drs part A of this Users’ Guide.2 placing the statin on her HMO’s formu- McAlister and Sackett); Division of General Internal Medicine, Ottawa Hospital (Dr Laupacis), and Clinical lary with a newer one. She wonders Epidemiology Unit, Loeb Health Research Institute (Drs CLINICAL SCENARIOS whether there is enough evidence to sup- Laupacis and Wells), Ottawa, Ontario. The Clinician port the contention that the new statin Dr McAlister is currently at the Division of General Internal Medicine, University of Alberta Hospital, As a clinician, you care for many pa- is as good as, or better than, the one cur- Edmonton. rently on formulary. While the new The original list of members (with affiliations) ap- tients with elevated serum cholesterol pears in the first article of this series (JAMA. 1993; levels. A speaker at a recent continu- statin is cheaper, it has been evaluated 270:2093-2095). A list of new members appears in only in short-term trials, with choles- the 10th article of the series (JAMA. 1996;275:1435- ing medical education event reviewed 1439). The following members contributed to this ar- the benefits of cholesterol-lowering terol lowering as the solitary end point. ticle: Gordon Guyatt, MD, MSc, Virginia Moyer, MD, therapy, particularly with 3-hydroxy- MPH, and David Naylor, MD, DPhil. DRUG CLASSES Corresponding Author: Finlay A. McAlister, MD, 3-methylglutaryl coenzyme A reduc- FRCPC, Division of General Internal Medicine, 2E3.24 tase inhibitors (statins), in the pri- Although there is no uniformly accepted WMC, University of Alberta, Canada Hospital, 8440 112 St, Edmonton, Alberta, Canada T5G 2R7. mary and secondary prevention of definition of a drug class—and some Reprints: Gordon Guyatt, MD, MSc, McMaster Uni- ischemic heart disease but did not rec- argue that it cannot be defined at all— versity Health Sciences Centre, 1200 Main St W, Room 2C12, Hamilton, Ontario, Canada L8N 3Z5. ommend a particular statin. You de- drugs are generally said to belong to the Users’ Guides to the Medical Literature Section Editor: cide to consider statin therapy for all same class for 1 of 3 reasons (TABLE 1). Drummond Rennie, MD, Deputy Editor (West), JAMA. ©1999 American Medical Association. All rights reserved. JAMA, October 13, 1999—Vol 282, No. 14 1371 USERS’ GUIDES TO THE MEDICAL LITERATURE this class effect, because the overall OR effects other than the mechanism of Table 1. Definitions of Drug Classes* in 32 trials involving 7105 patients was action that defined them as being from Definition Example 0.77 (95% CI, 0.67-0.88), the CIs for each the same class. It therefore may be inac- Drugs with similar Dihydropyridine chemical CCBs have of the angiotensin-converting enzyme curate to extrapolate the clinical out- structure dihydropyridine rings inhibitors overlapped, and there was no comes shown in randomized trials of 1 Drugs with similar CCBs block the mechanism of voltage-dependent statistical heterogeneity between trials of drug in a class to another member of action calcium channels on different agents. that class that has not been subjected the surfaces of cell membranes to similar outcome-centered trials. For Drugs with similar Antihypertensives Risks of Assuming a Class Effect example, some authors have argued pharmacologic (eg, CCBs, ACE Although drugs of the same class typi- that, although all of the statins act on effects inhibitors, b-blockers, thiazides, a-blockers) cally exhibit similar pharmacological ef- the 3-hydroxy-3-methylglutaryl coen- lower blood pressure fects and clinical outcomes, this may not zyme A reductase enzyme, they may *CCB indicates calcium channel blocker; ACE, angiotensin- always be the case. Note the current con- have different nonlipid effects on the converting enzyme. troversy regarding the safety of sotalol atherothrombotic process that may hydrochloride in myocardial infarction influence their clinical efficacy.13 with the most attractive efficacy-to- survivors with congestive heart failure To reduce the risk of faulty extrapo- safety ratio; purchasers, in the most after the publication of the SWORD lation and to maximize the optimal se- cost-effective drug from a class; and Trial,8 which suggested an increase in lection of treatments within a class of manufacturers, in the most frequent mortality with sotalol, compared with drugs, it may be useful to develop and prescribing of their drugs. the decrease in mortality with other apply a hierarchy of evidence when mak- The absolute treatment effects seen b-blockers. It is useful to recall a previ- ing decisions about the comparative with a drug (defined by the absolute risk ous controversy regarding the efficacy clinical efficacy and safety of drugs reduction or number needed to treat) are of b-blockers with intrinsic sympathetic within a class. As pointed out in part A influenced by the baseline risk or con- activity (ISA) in patients with myocar- of this Users’ Guide, no matter how trol event rate of those patients in whom dialinfarction.Althoughameta-analysis9 strong the pathophysiologic rationale or it is used. Thus, the absolute risk reduc- suggested that the treatment effect was indirect evidence, the efficacy and safety tion varies considerably among differ- greater with non-ISA b-blockers, sub- of a new drug must be established in ent groups of patients. On the other hand, sequent trials10 failed to confirm this, and clinical outcome studies that test more the relative treatment effect of a drug (de- the evidence11 suggests there is little dif- than just biological plausibility. fined by the relative risk reduction ference between b-blocker subgroups. [RRR]) is often (but not always4) simi- It would seem reasonable to accept a Levels of Evidence lar, irrespective of the baseline risk of trial priori that drugs within the same class Levels of evidence are increasingly used participants.5,6 If 2 drugs are tested in exert similar effects, unless there is clear by groups that make recommenda- separate placebo-controlled trials, only evidence of important differences. tions about patient care,14-16 and we have proportional effects such as the RRR However, this assumption can lead used some of them to develop guide- resulting from each drug can be com- to 2 important errors of extrapolation lines for comparing 1 drug with other pared (and then only under the assump- with major clinical consequences. First, drugs in the same class (TABLE 2). This tion of constant RRR over different con- when agents in a class of drugs (such comparison should occur as part of a sys- trol event rates). Although the point as the thiazide diuretics) all produce tematic review of all the relevant evi- estimates of effect size vary, a class effect similar pharmacological effects (blood dence on the effects of a treatment, iden- is considered to be present when drugs pressure lowering) and similar clini- tified and assessed by thorough and clear with similar mechanisms of action gen- cal effects (stroke reduction), a sec- methods such as those used in the erate RRRs (or odds ratios [ORs]) that ond class of drugs (for example, the cal- Cochrane Collaboration [Update Soft- are similar in direction and magnitude. cium channel blockers) that produce the ware, Oxford, England; 1998]. We will For example, the Collaborative Group same pharmacological effects might be describe each level in turn, using the on ACE Inhibitor Trials7 suggested that assumed to produce the same clinical choice of statin drugs as an example to there is a class effect for angiotensin- benefits.
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