FDA Approves COZAAR as the First and Only Hypertension Medicine to Help Prevent Stroke in Patients with Hypertension and Left Ventricular Hypertrophy

Business Wire, March 25, 2003

             Table 1 Incidence of Primary Endpoint Events
---------------------------------------------------- -----------------
                  COZAAR         Atenolol     Risk      95%   p-Value
------------------------------ -------------- Reduc-
                  N (%)   Rate *N (%)   Rate*  tion      CI
----------------- ------ ----- ------- ------ ------ --------- -------
Primary Composite 508(11) 23.8 588(13)  27.9    13%  2% to 23% 0.021
 Endpoint
----------------- ------ ----- ------- ------ ------ --------- ------
Components of
 Primary
  Composite
   Endpoint
    (as a first
     event)
----------------------------------------------------------------------
 Stroke
  (nonfatal  )    209 (5)      286 (6)
----------------- ------ ----- ------- ------ ------ --------- -------
 Myocardial
  infarction      174 (4)      168 (4)
   (nonfatal  )
----------------- ------ ----- ------- ------ ------ --------- -------
 Cardiovascular
  mortality       125 (3)      134 (3)
----------------- ------ ----- ------- ------ ------ --------- -------
Secondary
 Endpoints (any
  time in study)
----------------- ------ ----- ------- ------ ------ --------- -------
Stroke (fatal/
 nonfatal)        232 (5) 10.8 309 (7)  14.5   25%   11% to 37%  0.001
----------------- ------ ----- ------- ------ ----- ---------- -------
Myocardial
 infarction
  (fatal/
   nonfatal)      198 (4)  9.2 188 (4)   8.7   -7%  -13% to 12%  0.491
----------------- ------ ----- ------- ------ ----- ---------- -------
Cardiovascular
 mortality        204 (4)  9.2 234 (5)  10.6   11%  -7% to 27%   0.206
----------------- ------ ----- ------- ------ ----- ---------- -------
 Due to CHD       125 (3)  5.6 124 (3)   5.6   -3%  -32% to 20%  0.839
----------------- ------ ----- ------- ------ ----- ---------- -------
 Due to Stroke     40 (1)  1.8  62 (1)   2.8   35%   4% to 67%   0.032
----------------- ------ ----- ------- ------ ----- ---------- -------
 Otherss.          39 (1)  1.8  48 (1)   2.2   16%  -28% to 45%  0.411
----------------- ------ ----- ------- ------ ----- ---------- -------
* Rate per 1000 patient years of follow up
----------------------------------------------------------------------
  Adjusted for baseline Framingham risk score and level of
  electrocardiographic left ventricular hypertrophy
----------------------------------------------------------------------
  First report of an event, in some cases the patient died
  subsequently to the event reported
----------------------------------------------------------------------
ss.Death due to heart failure, non-coronary vascular disease,
 pulmonary embolism, or a cardiovascular cause other than stroke or
 coronary heart disease
----------------------------------------------------------------------

Although the LIFE study favored COZAAR over atenolol with respect to the primary endpoint (p=0.021), this result is from a single study and, therefore, is less compelling than the difference between COZAAR and placebo. Although not measured directly, the difference between COZAAR and placebo is compelling because there is evidence that atenolol is itself effective (vs. placebo) in reducing cardiovascular events, including stroke, in hypertensive patients.