Several new oral anticoagulants are currently investigated in phase III programmes, mainly with inhibition of factor Xa or thrombin as their pharmacological target. Advantages are expected with these new drugs compared with vitamin K antagonists, but one potential drawback is the lack of specific antidotes. During the clinical studies with ximelagatran, an oral direct thrombin inhibitor withdrawn due to hepatic side effects, investigators were instructed to manage bleedings with routine measures. We have retrospectively tried to assess whether this was sufficient or whether there was a need for reversal strategies. The study population consisted of patients with major bleedings in three long-term studies (104 ximelagatran, 155 warfarin). All individual patient narratives were reviewed with respect to management of the bleeding. Complementary data were retrieved from the data-based case report forms. Approximately, two of three of the patients in both groups were subject to some kind of treatment. One-third (1/3) in both groups had transfusions documented and/or received specific medication. Vitamin K was given more often to warfarin patients. Two ximelagatran patients received prothrombin complex (four-factor concentrate), but one was a patient with a severe hepatopathy suspected to be drug-induced. Overall, the case descriptions did not reveal any apparent differences in the course of events between groups. We found no indications that the lack of an antidote posed a clinical problem in patients treated with ximelagatran as compared with warfarin. The relatively short half-life of melagatran, the active metabolite of ximelagatran, may have contributed to these results.
Background
The study is part of the ongoing Prospective Population Study of Women in Gothenburg, Sweden, initiated in 1968–1969 with the aim of characterising a total population of women who were representative of middle-aged females. The aim of the present study was to investigate the prevalence of actual analgesic use (prescribed and self-medication) and the possible association with perceived mental stress among women aged 38 and 50 years, respectively, in the Population Study of Women.
Methods
Two different cohorts of population-based samples of 38- and 50-year-old women examined in 2004–2005 and 2016–2017, respectively, were eligible participants. The women were representative for their age cohort at the time of the examinations. Use of medicines and especially analgesics, as well as perceived mental stress, was registered. Changes in medicine use among 38- and 50-year-old women between 2004 and 2005 and 38- and 50-year-old women in 2016–2017 were studied. Data were analysed using logistic regression. Use of analgesics and mental stress were analysed controlling for lifestyle factors, use of other medicines and pain.
Results
The overall sample size across the time periods was 1,073 individuals. The frequency of analgesic use in 38- and 50-year-old women was about 26% in 2004–2005 and 58% in 2016–2017. 28% of women who reported high mental stress in 2004–2005 used analgesics, compared to 60% in 2016–2017. There were no associations between self-perceived mental stress and the use of analgesics.
Conclusion
The higher use of analgesics among midlife women in 2016–2017 is in line with global findings and could be due to increased availability in Sweden of over the counter medicines. The impact of mental stress on analgesic use found previously by other researchers was not confirmed. However, medicine use as a potential coping strategy is an important public health issue that needs to be further explored.
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