The long-term tolerability and efficacy of OESCLIM (R): results of a 1-year study

Objectives: A 1-year, open-label, non-comparative study evaluated the long- term tolerability and acceptability of a new generation matrix patch in pos t menopausal women with estrogen deficiency. Methods: Menopausal women (224 ) from 37 centres in five European countries received OESCLIM(R) 50 mu g/d (17-beta estradiol) for 3 months, titrated if necessary to either 25 or 100 mu g/d for a further 9 months. Patients received either a continuous or di scontinuous estradiol regimen with concomitant sequential progestogen (exce pt hysterectomised patients). Skin tolerability was assessed by patient dia ries and questionnaires. Global tolerability, efficacy, laboratory paramete rs and global acceptability were also monitored. Results: Almost two-thirds of women did not experience any kind of skin reaction and only 4.3% of all applications (752/17 702) caused site reactions. Of these, the majority ca used only slight or no discomfort (63.2%). Only 0.37% of total applications required patch removal; none required therapy. A low percentage of patient s withdrew due to tolerability issues: 2.7% due to skin reactions; 7.5% due to hyperestrogenism. The mean number of hot flushes experienced by symptom atic women reduced by 91% from 4.0 at baseline to 0.4 after 2 months. Total cholesterol reduced by 3.9% and LDL cholesterol by 5.1%, with no increase in triglyceride levels. Investigators assessed treatment as effective in 96 .8% of cases; well tolerated locally in 93.1% and well tolerated generally in 89.5%. At the end of this 1 year study, 79% of patients wished to contin ue therapy. Conclusion: OESCLIM(R) is well tolerated locally and systemical ly in long-term therapy with a high proportion of patients wishing to conti nue therapy after 1 year. (C) 1999 Elsevier Science Ireland Ltd. All rights reserved.