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The Class Effect Is Relevant to Geriatrics

In ‘‘The Class Effect: Is It Relevant to Geriatrics?’’ Drs. Beers and Stefanacci grapple with the fundamental concerns of organizing drug choices and venture into the dilemma faced by the United States Pharmacopeia (USP) and the Centers for Medicare and Medicaid Services (CMS) as the formulary rules associated with the Medicare Modernization Act have unfurled. The question is timely and perplexing and raises a myriad of collateral issues that clinicians face. Class is defined in Webster’s dictionary as a number or group of things regarded as forming a group by reasons of common attributes, characteristics, qualities or traits; and any division of things according to rank or grade. Class assignment even by like attributes, characteristics, and qualities is inherently flawed because any such grouping is approached subjectively depending on the perspective of the classifier. To suggest that a drug grouping has a class effect is to suggest that, whatever grouping assignment is used, the drugs within the grouping are the same. Interclass comparison of medications is only as good as the framework of class organization and the known characteristics or attributes of the class constituents. The question of class effect posed from the patient, prescriber, payor, health system, pharmaceutical industry, or government perspectives would produce dramatically different results. The granularity and number of choices within each grouping would vary substantially as a function of efficacy, safety, dosage form, route of administration, storage conditions, taste, swallowing ease, color, administration time, and cost of medication. For example, a class of drugs for hypertension in older people could include drugs of equal efficacy and safety but comprise medications from varied pharmacological classes. A classification of this nature would promote optimum, safe, therapeutic outcomes. Rather than choosing between lisinopril and ramipril in a pharmacological class of angiotensin-converting enzyme inhibitors (ACEIs), clinicians might select an ACEI versus a betablocker or diuretic in a class of drugs for hypertension. Managed care organizations and large integrated delivery systems have relied on pharmacological class effect in the development of formularies for years. Trends in the industry are to adopt evidence-based approaches to formulary management. Assumption of class effect has served as the basis for many tiered formulary systems and selection of preferred drugs within a pharmacological drug class, but whether class effects exist remains largely undetermined for most drugs. Sound scientific evidence must be available to conclude that a grouping of drugs has a class effect (Table 1). Many have classified the quality of scientific evidence needed to determine equal efficacy or safety. Well-conducted metaanalyses or randomized, controlled clinical trials are considered the best scientific evidence. When head-to-head randomized, controlled trials produce unequivocal evidence of comparative efficacy and safety (no statistically significant difference between treatments), then class equivalency can concluded. In actuality, it is rare that sufficiently sound approaches to drug comparisons within classes have been conducted to draw conclusions about comparative efficacy or safety. A recent examination of the pharmacological class of drugs known as angiotensin receptor blockers (ARBs) performed by the Center for Evidence-Based Policy in Oregon revealed that there are no head-to-head trials comparing ARBs in hypertension, high cardiovascular risk, recent myocardial infarction, heart failure, or nephropathy. As is summarized in Table 2, to draw any conclusions about comparative efficacy or safety of ARBs, readers must filter through a series of heterogeneous trials with various controls and methodologies to determine how each ARB compares with placebo and then extrapolate how each would compare with other ARBs. Although the Food and Drug Administration (FDA) requires two placebo-controlled trials for approval of new drugs, trials comparing new chemical entities to existing medications are not required and thus uncommonly conducted before FDA approval. If existing medications are included in clinical trials, they often serve as active controls, and trials are not powered to allow readers to draw conclusions about the comparative efficacy or safety of therapies. The risk for pharmaceutical manufacturers is too great, given the potential that the existing drugs may outperform the new chemical entity and hinder drug sales after FDA approval.