November 1st, 2010
Mind the Gap: Real-World ACE Inhibitor Cough Much More Common Than Listed on Labels
The real-world incidence of ACE inhibitor-associated cough is much higher than the reported rate on drug labels and printed in the Physicians’ Desk Reference, according to a study published in the American Journal of Medicine. Sripal Bangalore and colleagues analyzed data from 125 published studies with ACE inhibitors including almost 200,000 patients. They found that the pooled weighted incidence of cough for enalapril was 11.48%, compared with the 1.3% rate reported on the drug’s label. The pooled weighted withdrawal rate due to cough was 2.57% in the trials compared with 0.1% on the label. They also found that although the reported cough rates of different ACE inhibitors vary widely on the labels, in trials the incidence of cough is similar across all the ACE inhibitors.
The authors conclude: “Action must be taken to ensure that the drug labeling is regularly updated both for safety and for medication-specific adverse effects.”