The contribution of weight change to the economic burden of T2DM is unclear. This study investigated associations between weight change and HCRU in patients with T2DM initiating new antidiabetic drug class. Patients with T2DM initiating new antidiabetic drug classes (first-line, switch or add-on) between 01/01/05-01/01/12 were identified in UK Clinical Practice Research Datalink primary care (PC) records linked with Hospital-Episode-Statistics. Baseline characteristics were assessed before drug class initiation and weight change (index date) was observed 6 months after. HCRU was followed up to one year after index and included diabetes-related PC contacts and prescriptions, and all-cause hospitalisation days. Weight change was categorized as: <3.0% change (weight-neutral), 3.0%-5.4% gain (gain+), ≥5.5% gain (gain++), 3.0%-5.4% loss (loss+), ≥5.5% loss (loss++). Comparisons between weight groups were conducted using negative binomial regression. Of 9031 patients with mean age 59.2 years and 57.4% men; 54.3% were weight-neutral, 12.0% gain+, 10.2% gain++, 12.8% loss+, 10.7% loss++. Mean baseline BMI ranged from 30.1 kg/m2 (gain++) to 33.8 kg/m2 (loss++). Follow-up crude mean PC contacts for all patients was 4.6 per person-year (PPY), mean prescriptions 15.3 PPY, mean hospitalisation days 1.5 PPY. For the weight-neutral group, crude mean PC contacts, prescriptions and hospitalisation days were 4.6, 14.9 and 1.2 PPY, respectively. In initial adjusted comparisons to weight-neutral patients, gain++ had more PC contacts, gain+ and gain++ had more prescriptions whereas loss+ patients had fewer. Gain+ and loss++ patients had more hospitalisation days than weight-neutral patients. T2DM patients gaining weight after initiating new antidiabetic treatment may have increased health care resource use compared to weight-neutral patients. Higher weight loss, possibly due to underlying health problems, may also be associated with increased resource use. Causal interpretations of these results require detailed information on social and medical factors driving resource use in diabetic patients that were unavailable.

Patients with T2DM have an increased risk of comorbidities associated with weight gain. Depending on patients’ weight, treatment guidelines give preference to treatments that have favourable weight profiles, with weight gain being an important adverse event to avoid. This study aims to characterize baseline characteristics, weight and glycaemic change in patients prescribed new antidiabetic treatment. Patients with T2DM diagnosis and receiving first new antidiabetic treatment class (index) between 01/01/05-01/01/12 were identified in UK CPRD primary care records. Index class could be first-line, switch or add-on. Demographics, baseline weight and glycosylated haemoglobin (HbA1c), and change at 6 months were described by index class. Of 23,987 included (of whom 133 were lost to follow-up) 64.7% initiated metformin (MET), 15.5% sulfonylureas (SU), (14.0%) thiazolidinediones (TZD), 2.1% dipeptidyl-peptidase-4-inhibitors (DPP4), 1.9% insulin, 0.7% glucagon-like-peptide-1-agonists (GLP-1), 0.6% ‘other’, 0.5% acarbose. About 57% were men; baseline mean age for different index classes ranged between 56.5 (insulin) and 63.1 years (acarbose). Mean baseline weight ranged between 88.0 (SU) and 112.4 kg (GLP-1) and mean baseline HbA1c between 72.6 mmol/mol (8.8%) (acarbose) and 84.7 mmol/mol (9.9%) (insulin). Among 14,438 patients with six-month follow-up data an increase in weight was found for subjects initiating SU (2.1%;95%CI: 1.9;2.4,n=2,223), TZD (1.9%;95%CI: 1.7;2.1,n=2,034) and insulin (1.8% ;95%CI: 1.0;2.6,n=285). A reduction in weight was observed for patients on GLP-1 (-3.4%;95%CI: -4.3;-2.5,n=119), DPP4 (-0.9%;95%CI: -1.4;-0.4,n=347) and MET (-0.8%;95%CI: -0.9;-0.7,n=9,278). A mean reduction in HbA1c over the six month period was seen for all antidiabetic classes but was not statistical significant for GLP-1 and ‘other’. These results indicate that initiation of antidiabetic agents such as SU, TZD and insulin frequently are associated with weight gain. This underscores the need to choose agents with favourable weight profiles for overweight or obese patients, as recommended by UK T2DM treatment guidelines.

Objective The aim of this study was to examine the number of hot flush symptom-free days in symptomatic postmenopausal women treated with bazedoxifene/conjugated estrogens (BZA/CE).Methods In this 12-week, randomized, double-blind, placebo-controlled, phase-3 study, 322 postmenopausal women aged 40-65 years with an intact uterus who had >= seven moderate-to-severe daily hot flushes (or >= 50 per week) were randomized to BZA 20 mg/CE 0.45 or 0.625 mg or placebo. Subjects recorded the incidence and severity of hot flushes on daily diary cards. In this secondary analysis, the number of days per week without hot flushes from baseline to week 12 was determined. The percentage of women who experienced no hot flushes at week 12 was also evaluated.Results From baseline to week 12, the number of days per week without moderate-to-severe hot flushes or without any hot flushes steadily increased for women treated with BZA 20 mg/CE 0.45 or 0.625 mg versus placebo. In addition, the rate of increase in days per week without any hot flushes was significantly greater with either BZA/CE dose than with placebo (p < 0.0001). Compared with placebo, the percentage of women who experienced no moderate-to-severe hot flushes or no severe hot flushes at week 12 was greater with BZA 20 mg/CE 0.45 mg (p < 0.01 and p < 0.05, respectively) and BZA 20 mg/CE 0.625 mg (p < 0.001 for both).Conclusions BZA/CE increased the number of hot flush symptom-free days and the proportion of women without hot flushes over 12 weeks of therapy.

To examine in a retrospective study the incremental health care costs of breast pain and endometrial bleeding among postmenopausal women prescribed progestin containing Hormone Therapy (HT). Women age 45 to 65 who were prescribed HT (01/01/2006-09/30/2008) were selected from a large US claims database. The date of the first identified HT prescription was assigned as the index date. Patients were required to have at least 1 quarter of continuous medical and pharmacy benefits before and after the index date. Patients evidencing breast pain and/or endometrial bleeding during the follow-up period were assigned to the ‘selected AEs’ cohort, and the remaining patients were assigned to the ‘no selected AEs’ cohort. Patients were followed for at most 8 full quarters. A two-part model using logistic regression and a mixed model with repeated measurements were used in the multivariate analysis. Patients' age, medication, procedures, and health care costs during the pre-index period were adjusted in the model. Adjusted total health care costs for each quarter, 1st and 2nd years of the follow-up period, and average annual costs were provided. A total of 5,325 patients were included in the ‘selected AEs’ cohort and 49,942 in the ‘no selected AEs’ cohort. After adjusting for baseline differences, the adjusted quarterly costs ranged from $1944 to $2185 for the ‘selected AEs’ cohort and from $1699 to $1971 for the ‘no selected AEs’ cohort. The quarterly health care cost differences between the two cohorts were from $250 (p<0.0001) at first quarter to $214 (p<0.0001) at 8th quarter. The adjusted annual health care costs were higher for patients with the selected AEs ($8195 vs. $7238; p<0.0001). This study shows that the incremental total health care costs associated with endometrial bleeding and breast pain are on average $239 quarterly and $957 annually, in a US managed care setting.

ABSTRACT Postmenopausal women with vasomotor and vaginal symptoms are commonly treated with estrogens or combined estrogen/progestin therapy (hormone therapy). However, hormone therapy is associated with some safety and tolerability concerns and its benefit/risk profile may vary for women based on their time since menopause. The tissue selective estrogen complex (TSEC) pairs a selective estrogen receptor modulator with one or more estrogens, with the goal of relieving menopausal symptoms and preserving bone mineral density without stimulating the breast or endometrium. Bazedoxifene/conjugated estrogens (BZA/CE) is the first TSEC in clinical development. BZA 20 mg/CE 0.45 and 0.625 mg have been shown in phase-3 clinical trials to significantly improve hot flushes and vulvar/vaginal atrophy measures in symptomatic postmenopausal women and to prevent bone loss in postmenopausal women at risk for osteoporosis while ensuring endometrial safety. These doses of BZA/CE have also demonstrated significant improvements in quality-of-life scores, sleep parameters, and treatment satisfaction compared with placebo. BZA 20 mg/CE 0.45 and 0.625 mg showed high cumulative rates of amenorrhea and low rates of breast pain, similar to those with placebo. The favorable treatment effects seen with BZA/CE were generally consistent in women < 5 or ≥ 5 years since menopause. Based on its demonstrated efficacy and safety in women both closer to or further from menopause, BZA/CE may be an appropriate alternative to hormone therapy for the treatment of menopausal symptoms and the prevention of osteoporosis.

Objective To assess effects of desvenlafaxine (administered as desvenlafaxine succinate) on secondary outcomes of mood, climacteric symptoms, and treatment satisfaction in postmenopausal women with moderate to severe menopausal vasomotor symptoms (VMS).Methods A 12-week, multicenter, double-blind, placebo-controlled trial was conducted in postmenopausal women with >= 50 moderate to severe hot flushes per week. Participants were randomly assigned to desvenlafaxine 100 mg/day, desvenlafaxine 150 mg/day, or placebo. Secondary outcome efficacy variables included Profile of Mood States (POMS), Greene Climacteric Scale (GCS), and Menopausal Symptoms Treatment Satisfaction Questionnaire (MS-TSQ) scores. Change from baseline in POMS total mood disturbance (TMD) score and subdomain scores were evaluated using analysis of covariance, adjusting for treatment and study site as factors and baseline score. GCS total and subdomain scores were analyzed similarly. Treatment satisfaction was analyzed using the row mean score test.Results A total of 458 women were enrolled. At week 12, desvenlafaxine 100 mg/day significantly improved POMS TMD scores (p < 0.001) and four of six POMS subdomains compared with placebo (all p <= 0.005). Women taking desvenlafaxine 100 mg/day experienced significantly greater improvement in GCS total scores (p < 0.001) and five of six subdomains (all p <= 0.029) compared with placebo. Treatment with desvenlafaxine 100 mg/day resulted in significantly greater treatment satisfaction overall and in six of seven additional MS-TSQ items (all p <= 0.042). Desvenlafaxine 150-mg/day results were similar.Conclusions Desvenlafaxine treatment improved mood and climacteric symptoms in postmenopausal women with moderate to severe VMS compared with placebo, and more women were satisfied with desvenlafaxine treatment than with placebo.

Compare clinical and economic outcomes between post-menopausal women treated with combined estrogen and progestogen hormone therapy (HT) within 1 and 1-2 years after diagnosis. A retrospective analysis of women age 45 or older from a large U.S. health plan (April 2002-September 2010) was conducted. The first HT prescription during the identification period (April 2005-September 2008) was identified as the index date. Patients were selected if they initiated HT treatment within 2 years of menopause diagnosis, and had 3 years of continuous health plan enrollment before (pre-period) and 2 years after the index date (post-period). Patients with evidence of post-period pregnancy or pre-period other HT treatment were excluded. Two cohorts were created based on HT initiation date (Cohort A: HT initiated within 1 year of diagnosis; Cohort B: 1-2 years after diagnosis). Propensity score matching (PSM) was used to adjust for baseline differences in age, region, procedure used, comorbidities, and healthcare utilizations during the pre-period. Among 4268 eligible patients, 69.3% (N=2956) were included in Cohort A and 30.7% (N=1871) in Cohort B. After PSM, 1310 patients from each group were matched. Patients prescribed HT within 1 year of menopause diagnosis (Group A) were less likely to have Dual-Energy X-RAY Absorptiometry (DEXA) scans and osteopenia than patients treated between 1-2 years after menopause diagnosis. In addition, patients with earlier treatment showed a higher medication possession ratio (MPR) (0.49 vs. 0.46, p=0.272). Healthcare costs and utilizations remained similar, except patients with early HT treatment had significantly lower emergency room visit rates (22.9% vs. 26.5%, p=0.033) than patients with late HT treatment. Patients initiating HT within 1 year of menopause diagnosis had fewer comorbidities, directionally higher MPR but not significant, and lower emergency room visit rates than women initiating HT between 1-2 years. Other clinical and economic outcomes were similar.

registered in the Menopause Clinic database in Aretaieio Hospital since 1998. For each patient, the first perior postmenopausal visit was taken into consideration. Climacteric symptoms were divided in “psychological”, “psychosomatic”, “vasomotor” and “sexual” and were evaluated by the Greene Climacteric Scale in four levels. Results: The mean age of participants was 50.5±4.5. In the multivariate linear regression analysis, menopausal age was predictor of the occurrence of psychological (β=−0.115, p=0.035), vasomotor (β=−0.200, p=0.000) and combined (β=−0.158, p=0.000) symptoms. E2 was predictor of the occurrence of psychological (β=−0.084, p=0.004), vasomotor (β=−0.230, p=0.000), sexual (β=−0.141, p=0.000) and combined (β=−0.202, p=0.000) symptoms. Conclusions: In the multivariate analysis only menopausal age and sex hormones were predictors of the occurence of climacteric symptoms.

OBJECTIVE:To identify Alzheimer's disease (AD) severity measures for use in cost-effectiveness models that effectively capture the impact of AD on costs. METHODS:A review of the literature and data abstraction from papers that present 1) mean AD costs (direct, indirect, or total) by disease severity, defined using measure of cognition, functional status, and behavior; and/or 2) the results of regression analyses that estimate the strength of the association between AD costs and disease severity. RESULTS:All papers reviewed showed that mean total costs increase with disease severity regardless of severity-measurement method. The relative difference in mean total costs between patients with severe disease compared to those with moderate disease, or moderate disease compared to mild disease, was fairly consistent across studies, suggesting that any of the disease-severity measures may be used to broadly categorize patients by cost. However, when regression analysis included multiple disease-severity measures, independent associations with costs were noted for the different measures. Cognitive and functional status measures were consistently associated with direct costs, whereas functional status and behavioral measures were consistently associated with indirect costs and caregiver hours. CONCLUSIONS:Either multidimensional disease-severity measures, or a single disease-severity measure, that capture the impact of cognition, functional status, and behavior on costs are needed for cost-effectiveness models.