SAN FRANCISCO, Jan. 30 /PRNewswire/ -- Agouron Pharmaceuticals, Inc. today
reported that, in a twelve-month followup analysis of patients in three HIV
protease inhibitor trials, antiretroviral combination therapy containing
protease inhibitors plus reverse transcriptase inhibitors (RTIs) did not show
an increase in the risk of myocardial infarction (MI) compared to therapy
containing only RTIs. Investigators will present results this week at the 7th
Conference on Retroviruses and Opportunistic Infections in San Francisco,
California.
In clinical trials for VIRACEPT(R) (nelfinavir mesylate), indinavir, and
ritonavir, incidences of MI from investigator reports were compared for
patients taking antiretroviral combination therapy containing only RTIs to the
same patients in an extension phase switching to combination therapy
containing an HIV protease inhibitor plus RTIs. The MI rate was calculated as
the number of myocardial infarctions divided by the cumulative pooled years of
treatment for all patients in each study. Prior to switching to therapy
containing VIRACEPT, indinavir, or ritonavir, the respective MI rates for
patients receiving only RTIs were 0.00 (0 MIs, 105 patient years), 2.97 (2
MIs, 674 patient years), and 2.81 (1 MI, 356 patient years). After switching
to therapy containing a protease inhibitor plus RTIs, the MI rates were 0.89
(1 MI, 1129 patient years), 2.08 (4 MI, 1922 patient years) and 2.23 (4 MI,
1794 patient years) for patients using VIRACEPT, indinavir, or ritonavir,
respectively. Patient years on therapy for each patient were calculated from
treatment start to MI onset or to stop dates for RTI therapy and to study end
for protease inhibitor therapy. MI rates on protease inhibitor containing
therapy were also consistent with other studies of MI rates that have been
conducted in the general population, such as the Framingham Heart Study, which
follow the development of cardiovascular disease over a longer period of time
in a large group of participants who have not yet developed overt symptoms of
cardiovascular disease or suffered a heart attack or stroke.
VIRACEPT in combination with other antiretroviral agents is indicated for
the treatment of HIV infection. This indication is based on analyses of
changes in HIV RNA levels and CD4 cell counts in controlled studies in which
patients received VIRACEPT in combination with nucleoside analogues or alone
for up to 48 weeks. At present, there are no results from controlled trials
evaluating the effect of therapy with VIRACEPT on clinical progression of HIV
infection, such as survival or the incidence of opportunistic infections.
VIRACEPT 1250 mg (five 250 mg tablets) BID demonstrated a safety profile
similar to that of VIRACEPT 750 mg TID, with the majority of adverse events of
mild intensity. In study 542, diarrhea of moderate or severe intensity was
the most frequently reported adverse event, occurring in 14% to 18% of
patients receiving VIRACEPT 1250 mg BID or 750 mg TID with stavudine or
lamivudine. When diarrhea occurred, it was generally managed with
nonprescription antidiarrheals.
New onset or exacerbation of diabetes mellitus and hyperglycemia, changes
in the distribution of body fat, and increased bleeding in patients with
hemophilia types A and B have been reported with protease inhibitors.
For further information about Agouron Pharmaceuticals, Inc., or about
VIRACEPT, please see Agouron's website at http://www.agouron.com, or dial toll
free 1-888-VIRACEPT (847-2237). To receive full prescribing information for
VIRACEPT via fax, dial 1-888-288-9639.
Agouron Pharmaceuticals, Inc., a wholly owned subsidiary of the
Warner-Lambert Company (NYSE: WLA), is an integrated pharmaceutical company
committed to the discovery, development, manufacturing, and marketing of
innovative therapeutic products engineered to inactivate proteins that play
key roles in cancer, AIDS, and other serious diseases. Agouron employs more
than 1200 people of whom approximately 800 are engaged in research and
development.
WIRES: Full prescribing information for VIRACEPT to follow.
VIRACEPT(R) and Agouron(R) are registered trademarks of Agouron
Pharmaceuticals, Inc.
SOURCE Agouron Pharmaceuticals, Inc.
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http://www.agouron.com
Company News On-Call:
http://www.prnewswire.com/comp/019650.html or fax,
800-758-5804, ext. 019650
CONTACT:
Joy Schmitt, Associate Director, Product
Public Relations, Agouron Pharmaceuticals, Inc., 858-622-3220
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