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An Evaluation of Effectiveness in Clinical Practice

Eve R. Colson, MD; Ralph I. Horwitz, MD; Frank J. Bia, MD; Catherine M. Viscoli, MPhD

Arch Intern Med. 1991;151(4):709-713.

Abstract
To learn about the patterns of use and the effectiveness of zidovudine therapy in clinical practice, we conducted an observational cohort study of 86 patients with human immunodeficiency virus type 1 infection. All patients were followed up for at least 6 months after starting zidovudine (AZT) therapy. Of the 86 patients, 78 (91%) initially received full-dosage zidovudine (1200 mg/d), and eight received a reduced dosage (600 mg/d). During follow-up, the number able to maintain full-dosage zidovudine therapy decreased to 54 (63%) at 3 months and 40 (47%) at 6 months. Thirty-five patients required dosage reductions that lasted at least 7 days and were not preceded by an adverse outcome (death or opportunistic infection). Overall, adverse outcomes occurred for nine (26%) of those with dosage reductions compared with 22 (43%) of 51 patients with no previous dosage change. Even after adjusting for baseline cytopenias and the time of the dosage reductions, adverse outcomes did not occur significantly more often in patients who received reductions in their zidovudine dosage. Our results indicate that full-dosage zidovudine therapy cannot be maintained for most patients infected with human immunodeficiency virus, but that clinicians need not be pessimistic about treatment outcomes when dosage reductions are needed.

(Arch Intern Med. 1991;151:709-713)

Author Affiliations
From the Department of Internal Medicine, Yale University School of Medicine, New Haven, Conn.

Footnotes
Accepted for publication October 12, 1990.

Reprint requests to Yale University School of Medicine, Room IE-61 SHM, PO Box 3333, New Haven, CT 06510 (Dr Horwitz).

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ABSTRACT