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Equivalence of Generic and Brand-Name Drugs for Cardiovascular Disease
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To the Editor: In their systematic review and meta-analysis, Dr Kesselheim and colleagues1 assessed the equivalence of generic and brand-name drugs for cardiovascular disease. Several studies that I participated in were evaluated by the authors,2-4 and I generally agree with their conclusions. However, it is important to consider the limitations of current scientific evidence.
Most studies comparing generics to brand-name drugs use normal volunteers or relatively healthy patients. Tables 1, 2, and 3 in the study by Kesselheim et al indicate that 57% of the studies involved healthy volunteers. Pharmaceutical parameters such as tablet strength, dissolution, binding excipients, and the resulting absorption determine equivalence between generics and brand drugs. Although these characteristics may be fairly consistent in homogeneous healthy young participants, they can be very different among heterogeneous older patients because physiologic parameters change with age or disease. Small changes in something as apparently minor as the rate at which . . . [Full Text of this Article]
Barry L. Carter, PharmD
barry.carter@uiowa.edu Division of Clinical and Administrative Pharmacy College of Pharmacy University of Iowa Iowa City
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