Fat redistribution in indinavir-treated patients with HIV infection: A review of postmarketing cases.
BACKGROUND
Fat redistribution (FR) occurring alone or in association with hyperlipidemia has been associated with protease inhibitors (PI) and nucleoside reverse transcriptase inhibitors (NRTIs); however, the relationship between FR features, relationship of FR to hyperlipidemia, and pathogenesis of FR is unknown.


OBJECTIVE
To characterize the spectrum of FR, assess relationships among FR features, determine trends in occurrence of FR, and determine relationship of FR to hyperlipidemia.


METHODS
Review of postmarketing indinavir reports of FR in Merck & Co. Inc.'s database.


METHODS
282 reports of FR among HIV-positive patients taking indinavir submitted through the passive postmarketing system to Merck through February 23, 1998.


RESULTS
282 FR reports were compared across 3 groups: fat accumulation (FA) only, FA with peripheral wasting (FA with PW), and peripheral wasting only (PWO). Of 282 reports, 56% (159 of 282) had FA only, 22% (63 of 282) had FA with PW, and 21% (60 of 282) had PWO. The proportions of reports of PWO was higher in men, whereas the proportion of reports of FA was higher in women. Blood lipids were provided in 93 of 282 reports; were elevated in 69 of 93, and were normal in 24 of 93 reports. Proportions of hyperlipidemia and hypertriglyceridemia reports were significantly higher in the PWO group versus FA only group (p =.024 and.003, respectively) and versus FA with/without PW groups (p =.038 and.005, respectively). Weight gain was more frequently reported in those with FA (100%) or FA with PW (68%), whereas weight loss was usually reported in those with PWO (83%). In all, 98% of patients reporting FR on indinavir for whom a concomitant drug history was available were also taking lamivudine, stavudine, or both. A higher proportion of patients reporting PWO (34 of 60; 56.7%) versus FA (42 of 159; 26.4%) only took both lamivudine and stavudine.


CONCLUSIONS
Differences observed from analysis of cases in clinical features, gender, weight change, concomitant medications, and presence of hyperlipidemia among the three groups of FR cases reported to Merck suggests that PWO may be a distinct entity from other features of FR. The data suggest that certain antiretroviral combinations predispose HIV persons to development of FR.
Benson
J O
JO
Merck & Company, Inc., West Point, Pennsylvania, USA. joan_benson@merck.com
McGhee
K
K
Coplan
P
P
Grunfeld
C
C
Robertson
M
M
Brodovicz
K G
KG
Slater
E
E
D000273:Adipose Tissue / Q000503:physiopathology*; D000328:Adult; D000368:Aged; D001823:Body Composition; D016208:Databases, Factual; D004345:Drug Industry / Q000191:economics; D016903:Drug Monitoring; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D017320:HIV Protease Inhibitors / Q000009:adverse effects*; D006801:Humans; D019469:Indinavir / Q000009:adverse effects*; D008060:Lipodystrophy / Q000139:chemically induced*; D008297:Male; D008875:Middle Aged
D017320:HIV Protease Inhibitors; D019469:Indinavir