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The suggestion by Bauer et al¹ that there is no increased alendronate-related risk of upper gastrointestinal (GI) tract events "even in high-risk subgroups" must be questioned. The recent report by Graham and Malaty² focused attention on the additional risk posed by concomitant use of alendronate with cyclooxygenase 1 (COX-1) nonsteroidal anti-inflammatory agents (NSAIDs), compounds with their own gastropathy risk. In addition to demonstrating a statistically significant gastric ulcer risk for alendronate therapy, Graham and Malaty² documented quadrupled risk with concomitant NSAID ingestion. As these studies^1-2 are disparate in their conclusions, it seems reasonable to examine the methods of the study by Bauer et al.¹

The study by Bauer et al,¹ also known as the Fracture Intervention Trial (FIT), was not designed to assess the risk of concomitant NSAID usage. While statisticians might argue the validity of such subsequent analysis, other issues seem more problematic.

The definition of the NSAID group . . . [Full Text of this Article]

RELATED LETTER

Alendronate and Nonsteroidal Anti-inflammatory Drug Interaction Safety Is Not Established: A Reply
Douglas C. Bauer and for the Fracture Intervention Trial Research Group
Arch Intern Med. 2000;160(17):2686-2687.
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THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Alendronate and Nonsteroidal Anti-inflammatory Drug Interaction Safety Is Not Established: A Reply
Bauer and for the Fracture Intervention Trial Research Group
Arch Intern Med 2000;160:2686-2687.
FULL TEXT