|
Frequency
| •
|
107
cases reported to FDA through June 30, 1998 |
|
-
|
46
cases on NRTI monotherapy |
|
-
|
61
cases on dual NRTI therapy |
| •
|
Majority
(36) of monotherapy cases occurred with ZDV prior to 1995 |
| •
|
Majority
(46) of dual therapy cases occurred with d4T after 1995; 36
of 46 on d4T/3TC |
•
Boxwell and Styrt1 of the FDA have conducted a search of adverse
event reports through June 30, 1998, from patients receiving NRTIs.
This search has uncovered a total of 107 cases of lactic acidosis.
The majority of these, 61 cases, were on dual NRTI therapy, while
46 cases were receiving NRTI monotherapy.
• It was discovered that the majority of monotherapy cases
reported occurred with zidovudine prior to 1995. During this time,
monotherapy with zidovudine was commonly being used. In some cases,
it was the only available antiretroviral agent available for use.
• Further investigation of the dual therapy cases found that
the majority, 46 cases, occurred with d4T after 1995. Of these 46
cases, 36 patients who developed lactic acidosis were receiving
the combination of d4T/3TC. During this time period, drug utilization
data showed a rapid rise in the popularity of these two NRTIs.
Reference:
1. Boxwell DE, Styrt BA. Lactic acidosis in patients receiving nucleoside
reverse transcriptase inhibitors (NRTIs). 39th Interscience Conference
on Antimicrobial Agents and Chemotherapy, San Francisco, CA; Sept
26-29, 1999. Abstract 1284.
|
|
