Interpreting Premenstrual Symptoms Impact Survey scores using outcomes in health-related quality of life and sexual drive impact.

OBJECTIVE: To link the Premenstrual Symptoms Impact Survey (PMSIS) scores to health-related quality of life (HRQOL) and sexual drive impact associated with premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD). STUDY DESIGN: Secondary data analysis was performed using the online survey study for PMSIS development. Women were sorted into 10 mutually exclusive score levels (N = 949). Their responses to the SF-12v2 Health Survey and the sexual drive question were dichotomized to indicate the presence of limitations/impairment. Chi-square analysis was conducted to compare the differences in percentages of women with limitations across 3 representative PMSIS score levels containing (1) women with no indication of PMS, (2) women at risk for PMS but not PMDD, and (3) women at risk for PMDD. RESULTS: The higher the PMSIS score level (more severe impact), the greater the percentage of women reported functional limitations. Women either at risk for PMS or PMDD were significantly more likely to report limitations than women with no indication of PMS in all HRQOL areas except for 2 Physical Functioning items and 1 Mental Health item and the General Health item. Significantly more women with PMS (67.5%) and with PMDD (73.3%) reported sexual drive impact than in women with no PMS (45.7%). CONCLUSION: The associations between PMSIS score levels and the premenstrual symptoms' impact on HRQOL and sexual functioning assist the interpretation of PMSIS scores and use of the tool in reproductive-age women.

An economic evaluation of colesevelam when added to metformin-, insulin- or sulfonylurea-based therapies in patients with uncontrolled type 2 diabetes mellitus.

BACKGROUND: Several early studies demonstrated that bile acid sequestrants were useful for lowering lipid levels in patients with hypercholesterolaemia and may also be useful for lowering glucose levels in patients with type 2 diabetes mellitus (T2DM) uncontrolled on existing treatment (metformin-, insulin- or sulfonylurea-based therapies). OBJECTIVE: This study modelled efficacy and safety data from the three clinical trials to evaluate the cost effectiveness to US Managed Care Organizations of add-on treatment with colesevelam for reducing diabetes-related complications. METHODS: Three randomized controlled trials in patients with T2DM and one in hyperlipidaemia established that colesevelam lowered both glycaemic and lipid parameters in adult patients participating in the studies. The validated 'diabetic risk equation' (DRE) and the 'LIPID cardiovascular risk equation' (LCRE) were used to translate the observed clinical benefits (surrogate markers related to T2DM [glycosylated haemoglobin {HbA(1c)} and fasting plasma glucose] and cardiovascular disease [low-density lipoprotein cholesterol {LDL-C}]). Performing an appropriate economic evaluation required the use of both the DRE and the LCRE. These equations parameterize the clinical efficacy measures as continuous, facilitating their application to clinical trial results as well as the replication of other well established epidemiological data. Tobit regressions were applied to a large commercially available managed care administrative claims database (2000-6), Integrated Health Care Services (IHCS), to evaluate the incremental costs associated with each type of diabetic complication. Costs were inflated to 2010 values using the Healthcare Consumer Price Index, while second- and third-year cost savings were discounted at 5% to the current year. Bootstrap sampling with 5000 samples of 100 patients per cohort was conducted, varying the number of events avoided as well as their associated cost. RESULTS: With established metformin-, insulin- or sulfonylurea-based therapies, the addition of colesevelam significantly reduced HbA(1c) by approximately 0.5% (p < 0.001) in all three studies. In addition, colesevelam reduced placebo-adjusted LDL-C by 12.8-16.7% (p < 0.001). Using the DRE and LCRE equations, the total savings from reductions in diabetes-related and cardiovascular events were $US3543, $US4074 and $US3855 for colesevelam added to metformin-, insulin- and sulfonylurea-based regimens in patients with normal lipid levels. After subtracting the cost of colesevelam, first-year savings were $US1326, $US1852 and $US1629 in the metformin, insulin and sulfonylurea studies, respectively, for patients with raised lipid levels. CONCLUSIONS: In adult patients with T2DM, the addition of colesevelam to metformin-, insulin- or sulfonylurea-based therapies significantly improves glycaemic control while also reducing LDL-C, and these improvements could translate into substantial cost reductions due to reductions in the rates of diabetes-related and cardiovascular complications.