Vaginal bleeding/spotting with conjugated estrogens/bazedoxifene,conjugated estrogens/medroxyprogesterone acetate,and placebo

ABSTRACT

Objective: In the 1-year phase 3 Selective estrogens, Menopause, And Response to Therapy-5 trial, cumulative amenorrhea rates with conjugated estrogens/bazedoxifene (CE/BZA) were similar to placebo and higher than with conjugated estrogens/medroxyprogesterone acetate (CE/MPA). This post hoc analysis reports bleeding/spotting rates in 4-week intervals (cycles) and 3-month intervals (quarters) with these therapies and the percentage of cases attributable to spotting only.

Methods: Generally healthy postmenopausal women with menopausal symptoms recorded vaginal bleeding/spotting in daily diaries while receiving CE 0.45 mg/BZA 20 mg, CE 0.625 mg/BZA 20 mg, CE 0.45 mg/MPA 1.5 mg, or placebo.

Results: A total of 1596 women in the modified intent-to-treat population contributed data. Incidence of bleeding/spotting was significantly (p < 0.001) lower with CE 0.45 mg/BZA 20 mg (0.54?4.44%), CE 0.625 mg/BZA 20 mg (1.26?5.02%), and placebo (1.55?4.82%) compared with CE 0.45 mg/MPA 1.5 mg (8.81?25.63%) in all 4-week cycles. Each quarter, <10% of women taking CE/BZA doses or placebo had bleeding/spotting, significantly (p < 0.001) less than the 21–36% with CE 0.45 mg/MPA 1.5 mg. Odds ratio for bleeding/spotting with CE 0.45 mg/BZA 20 mg vs CE 0.45 mg/MPA 1.5 mg was 0.1 in each quarter (95% CI, Q1–Q3: 0.1–0.2; Q4: 0.1–0.3). Across all treatments, most (88–100%) bleeding/spotting cases were spotting only. Mean days of bleeding/spotting were <1 per quarter with CE/BZA doses and placebo, which was significantly (p < 0.01) less than the 3–5 days per quarter with CE/MPA.

Conclusions: Bleeding/spotting with CE/BZA treatment was similar to placebo and significantly less frequent than with CE/MPA treatment. Most cases were spotting only across all treatments.     

Experiences of children/young people and their parents, using insulin pump therapy for the management of type 1 diabetes: qualitative review

What is known and Objective: Advances in medical technology have made insulin pumps an attractive treatment option for patients with type 1 diabetes and in particular for children and young people. Previous studies have accounted the experiences and views of children/young people and their parents for the use of the injection therapy, but very few have focused on the use of insulin pumps. The objective of this review was to identify studies that explore the experiences of children/young people and their parents on the transition from injections to insulin pump therapy, in the context of their social life. Methods: A systematic literature search was conducted, and six studies meeting the inclusion and exclusion criteria were identified. Results: Views and perspectives from the studies identified mainly focused on: introduction to the pump; reasons for the transition to pump therapy; advantages and disadvantages of this treatment option; and impact on quality of life (QoL). Parents and/or children reported that they learned about pump therapy either formally from a healthcare professional or informally from a friend or the internet. Many reasons were identified for the transition, the most important being the pursuit of stable and controlled blood sugar levels and the desire for a more flexible lifestyle. Participants highlighted the advantages of insulin pumps in terms of improved diabetes control. Moreover, there was a positive impact on the QoL, as insulin pumps provided children greater flexibility in lifestyles especially with regards to meals and socialization. In contrast, psychosocial issues such as pump visibility and physical restrictions were highlighted as disadvantages. Issues such as day‐to‐day management were also discussed. What is new and Conclusion: Exploring children/young people’s perspectives on the use of pump therapy for managing their diabetes, and parental reflections in caring for those children is important as it provides evidence informing policy for the wider implementation of this technology in the management of diabetes in children. However, the review revealed that there is a scarcity of data in this area and that further research is needed.