About 22,000 women – reflecting more than 20,000 WY of observation
– were recruited by April 2006 (Table
1).
A total of 18,365 of these women used an oral preparation. Recruitment
of DRSP/E2 users only began in late 2004 due to delayed market introduction
of the product.
Therefore, the DRSP/E2 users are still underrepresented in this interim
analysis. A very low loss to follow-up rate (approx. 2%) has been observed.
The interim analysis showed that the prevalence of certain diseases and
risk factors is higher in northern and central European countries than
in Medi-terranean countries (e.g., treated high blood pressure: 29.2%
and 8.1% for Germany and
Spain, respectively; see Table 4).
In addition, the analysis showed differences in the utilization of DRSP/E2
between these countries. It is therefore necessary to analyze the study
data stratified by country/region of origin.
The differences seen thus far between the cohorts (e.g., prevalence of
treated high blood pressure 19.2% for DRSP/E2 and 28.0% for other continuous
combined HT (Table 2)) can
be explained for the most part by the regional differences, and are not
based on substantially different baseline risk for users of individual
products.
No arterial or venous thromboembolic event had been observed in the DRSP/
E2 cohort by April 2006. However, at that time point follow-up information
was only available for 174 of the 1,622 DRSP/E2 users.
A meaningful comparison of clinical outcomes between DRSP/E2 and other
oral HRT products cannot be expected before 2007/2008.
