Effect of statin use on liver enzymes and lipid profile in patients with Non-Alcoholic Fatty Liver Disease (NAFLD).

BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) is an independent risk factor for cardiovascular disease (CVD). Statins are recommended for treatment of dyslipidemia to reduce the overall cardiovascular risk in patients with NAFLD. However, statin treatment was underutilized and the effect of statins on liver enzymes remained unclear in this patient population. OBJECTIVES: This study aimed to provide real-world evidence of the safety and effect of statin use in patients with NAFLD. METHODS: We conducted a cross-sectional survey study of adults with NAFLD using pooled data from the US NHANES database 2009-2018. NAFLD was defined by Fatty Liver Index (FLI) ≥ 60 and United States Fatty Liver Index (USFLI) ≥ 30. Multivariate regression analyses adjusted for baseline clinical and demographic characteristics were performed to compare the liver enzymes and lipid profile between statin and non-statin users. RESULTS: The study included 2,533 adults with NAFLD, representing 22.6 million individuals in the US, with 27% receiving statin treatment between 2009 and 2018. The mean differences of liver enzymes for AST, ALT, ALP, and GGT between statin and non-statin users were -0.86 (p=0.539), -3.49 (p=0.042), -0.25 (p=0.913), and 0.57 (p=0.901), respectively. In individuals with NAFLD and dyslipidemia, total cholesterol and LDL levels were significantly lower in statin users compared to non-statin users (mean difference, -28.9; p<0.001 and -27.7; p<0.001). CONCLUSION: The use of statins was not associated with elevated liver enzymes in patients with NAFLD. Significantly lower levels of ALT, total cholesterol, and LDL were observed in statin users compared to non-statin users.

Is preoperative physical function testing predictive of length of stay in patients with colorectal cancer? A retrospective study.

Surgery is the primary treatment for colorectal cancer. A prolonged Length of Stay (pLOS) can increase risk of complications and physical inactivity, leading to a decline in physical function. While promising results were seen from preoperative exercise training and post-operative functional recovery, the predictive potential of preoperative physical function has not yet been investigated. The objective of this study is to determine if preoperative physical function can predict pLOS in patients with colorectal cancer. A total of 459 patients from 7 cohorts were analyzed. Logistic regression was used to determine risk of pLOS (>3 days), and ROC curve was plotted to establish sensitivity/specificity. Selected variables included age, sex, BMI, comorbidity, ASA status, tumor site, surgical approach, handgrip strength, Timed-Up and Go, 30-s Sit-to-Stand, 30-s Arm Curl Test, 6-Minute-Walking Test (6MWT), CHAMPS Physical Activity Questionnaire for Older Adult and the 36-Item Short Form Survey. The results showed that patients with rectal tumor are 2.7x more at risk to be in the pLOS group compared to those with colon tumor (O.R. 2.7; C.I. 1.3-5.7, p=0.01). For every increment of 20 m in 6MWT, there is a decreased risk of 9% of being in pLOS group (C.I. 1.03-1.17, p=0.00). A cut-off of 431 m can predict 70% of patients in pLOS group (AUC 0.71 C.I 0.63-0.78, p=0.00). Tumor site (rectal) and 6MWT were significant predictors of pLOS. Using the 6MWT as a screening tool for pLOS with cut-off of 431 m should be implemented in the preoperative surgical pathway.

Impact of biologics on health-related quality of life in patients with Ankylosing spondylitis: A systematic review and meta-analysis of randomized controlled trials.

OBJECTIVE: To examine the impact of novel biologic disease-modifying antirheumatic drugs (bDMARDs) with tumor necrosis factor (TNF) inhibitors or Interleukin-17A (IL-17A) antibody agents on health-related quality of life (HRQoL) outcomes in patients with radiographic axial spondyloarthritis (r-axSpA). METHODS: A literature search on PubMed, Embase, and Clinicaltrials.gov databases was performed through February 2022 to identify randomized controlled trials (RCTs) reporting HRQoL outcomes of bDMARDs for treatment of r-axSpA. Approved bDMARD therapy for r-axSpA included five TNF-inhibitors (infliximab, etanercept, adalimumab, golimumab, and certolizumab pegol) and two IL-17A antibody agents (secukinumab, and ixekizumab). Heterogeneity (I2) was used to determine the variability between studies. RESULTS: Sixteen RCTs, involving 3481 participants, were included. The placebo-controlled and treatment blinded durations ranged from 12 to 24 weeks. Compared with the placebo, bDMARD therapy was associated with significant improvement in HRQoL measures with the 36-item Short Form Survey (SF-36), European Quality of Life-5 Dimensions (EQ-5D), and Ankylosing Spondylitis Quality of Life (ASQoL). The pooled mean differences of changes from baseline for the SF-36 Physical Component Score (PCS), SF-36 Mental Component Score (MCS), EQ-5D, and ASQoL were 4.39 [95% Confidence Interval (CI): 3.24 to 5.54, P < 0.001]; 2.37 (95%-CI: 1.25 to 3.49, P = 0.003); 0.11 (95%-CI: 0.07 to 0.14, P < 0.001); and -2.45 (95%-CI: -3.21 to -1.70, P < 0.001), respectively. Heterogeneity was high (I2 = 79%) among studies reporting SF-36 PCS, and moderate (I2 = 61%, 34%, and 49%) among studies reporting SF-36 MCS, EQ-5D, and ASQoL, respectively. CONCLUSIONS: Biologic therapy was associated with a significant improvement in quality of life in patients with r-axSpA. The results were consistent among all three measures of HRQoL outcomes.

Impact of elevated BMI and types of comorbid conditions on health-related quality of life in a nationally representative US sample.

OBJECTIVE: Elevated BMI is associated with multiple chronic conditions including diabetes and CVD. Patients with overweight or obesity may also suffer from comorbidities not directly related to the pathophysiology of elevated BMI. The current study sought to determine the impact of BMI and different types of chronic conditions on health-related quality of life (HRQoL) outcomes. DESIGN: Six weight categories by BMI were identified: underweight, normal weight, overweight, Class-I obesity, Class-II obesity and Class-III obesity. Twenty chronic conditions were considered and categorised as elevated BMI-related (concordant) or -unrelated (discordant) conditions. HRQoL outcomes were measured using Short Form-6 Dimensions (SF-6D). Multivariable regression models were performed to examine the impact of type, number of comorbid conditions and BMI categories on SF-6D scores. SETTING: Medical Expenditure Panel Survey (2013-2015). PARTICIPANTS: Nationally representative sample of US population; 18 years or older (n 58 960). RESULTS: Of the sample, 1·7 %, 32·9 %, 34·0 % and 31·4 % were classified as underweight, normal weight, overweight and obese, respectively. The SF-6D scores were significantly decreased across all obesity classes, with the largest reduction in Class-III obesity (0·033; P < 0·001). Additionally, individuals with obesity having one or more concordant or discordant comorbidities further reduced SF-6D scores between 0·031 and 0·148 (P-values < 0·001) or between 0·080 and 0·212 (P-values < 0·001), respectively. CONCLUSIONS: Individuals with obesity had a significant reduction in HRQoL outcomes compared to those with normal BMI. Importantly, discordant comorbidity resulted in greater reduction in HRQoL outcomes compared to concordant comorbidity in subjects with elevated BMI.

Association between processes of diabetes care and health care utilization in patients with diabetes: Evidence from a nationally representative US sample.

BACKGROUND: This study examined the association between quality of processes of diabetes care in terms of adherence to American Diabetes Association (ADA)-recommended guidelines and health care utilization in patients with diabetes. METHODS: Adults with diabetes were identified from the pool of five panels of the Medical Expenditure Panel Survey, a nationally representative US sample, between 2012 and 2017. The Diabetes Care Survey was used to determine adherence to the ADA-recommended guidelines for processes of diabetes care if all of the following were performed annually: glycosylated hemoglobin check, foot examination, dilated eye examination, lipid panel, influenza immunization, blood pressure check, and dental examination. Health care utilization in terms of inpatient hospitalization, and emergency department (ED) and outpatient visits were estimated using two-part hurdle models. RESULTS: An estimated 26.3 million adults with diabetes were derived from the pooled 5-panel data, of which 7.8% met the ADA-recommended guidelines for processes of diabetes care, and adherence rates of individual recommendations were generally below 50%. Overall, adults who adhered to the ADA-recommendations were older, non-Hispanic white, and married nonsmokers with private insurance and higher income. Mean inpatient hospital stays, ED, and outpatient visits between ADA-adherent vs nonadherent patients were 0.98 vs 1.62 (P < .001), 0.36 vs 0.39 (P = .074), and 17.9 vs 12.8 (P < .001), respectively. CONCLUSIONS: Socioeconomic disadvantage and minority status were linked with nonadherence to the ADA-recommended processes of diabetes care. Adherence to the ADA recommendation was associated with significant reduction in inpatient hospitalization and a trend toward less ED visits. Our findings may apply to the United States and are likely to be different in other parts of the world.

Cost-Effectiveness of Treatment Strategies with Biologics in Accordance with Treatment Guidelines for Ankylosing Spondylitis: A Patient-Level Model.

BACKGROUND: Ankylosing spondylitis (AS) is a form of rheumatic disease caused by chronic inflammation of the axial skeleton. Patients with AS experience significant functional limitations and reduced quality of life. Consequently, AS imposes a substantial economic burden on society due to productivity loss and work disability. Biologics, including tumor necrosis factor (TNF) inhibitors and human anti-interleukin-17A monoclonal antibody (IL-17A) agents, are effective treatment strategies in relieving symptoms and slowing down disease progression. Currently, 5 TNF inhibitors and 2 IL-17A antibody agents are approved by the FDA for the management of AS. Of these agents, there is no clear preferred agent in initial biologic therapy, although an IL-17A antibody agent or alternative TNF inhibitor agent is recommended after failure of the initial TNF inhibitor therapy. OBJECTIVE: To assess cost-effectiveness of treatment strategies with biologics, TNF inhibitor or IL-17A, in accordance with the treatment guidelines for patients with AS. METHODS: An economic patient-level simulation combining decision-tree and Markov models was constructed from the U.S. health care payer's perspective over a 10-year time horizon. The current model examined 5 treatment strategies: (1) conventional care treatment with nonsteroidal anti-inflammatory drugs, (2) 1 TNF inhibitor, (3) an IL-17A antibody agent, (4) sequential therapy with 2 TNF inhibitors, and (5) sequential therapy with a TNF inhibitor followed by an IL-17A antibody agent. Initially, treatment responses were determined after 12-week treatments. Patients who responded to treatment entered a "responders" Markov model. Patients entered a "nonresponders" Markov model if they inadequately responded to treatment. In sequential treatment strategies, patients who inadequately responded to treatment with the first TNF inhibitor received a second TNF inhibitor or an IL-17A antibody agent. Health utility was estimated based on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Functional Index (BASFI) scores. The models accounted for real-world adherence to TNF inhibitor treatment. Scenario and probabilistic sensitivity analyses were performed to test the robustness and uncertainty of the model results. RESULTS: Over a 10-year time horizon and 100,000 simulated patients for each treatment strategy, base-case results produced average total discounted per-patient costs of $19,765, $130,302, $159,934, $190,553, and $179,118 and quality-adjusted life-years (QALYs) of 4.675, 5.410, 5.499, 5.919, and 5.893 for conventional care, treatment strategies with 1 TNF inhibitor, an IL-17A, 2 TNF inhibitors, and a TNF inhibitor followed by an IL-17A, respectively. The optimal treatments at willingness-to-pay (WTP) thresholds ≤ $130,813 per QALY, between $130,813 per QALY and $442,728 per QALY, and > $442,728 per QALY were conventional care and sequential treatment strategies with 1 TNF inhibitor, followed by an IL-17A agent and 2 TNF inhibitors, respectively. CONCLUSIONS: Study findings suggested that all treatment strategies with biologics, TNF inhibitors or IL-17A antibody agents, in the treatment guidelines for AS were not cost-effective at the common WTP of $100,000 per QALY. However, the sequential treatment with 1 TNF inhibitor followed by an IL-17A antibody agent was considered cost-effective at a higher WTP of $150,000 per QALY. DISCLOSURES: No outside funding supported this study. The authors have nothing to disclose. Primary findings of this study were presented in part at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) in Baltimore, MD, May 2018.

The Authors Respond.

DISCLOSURES: Funding for the original study referred to in this letter was received through the PhRMA Foundation Value Assessment Challenge Award. The authors have no conflicts of interest to declare.

Patient-Level Modeling Approach Using Discrete-Event Simulation: A Cost-Effectiveness Study of Current Treatment Guidelines for Women with Postmenopausal Osteoporosis.

Decision tree and Markov models have been the most commonly used modeling methods in health economic evaluations. Both methods are known for their limitations. Discrete-event simulation (DES), an event-driven model in continuous time at the patient level, is a relatively new method in health economic evaluations that addresses some limitations of the common modeling techniques. Specifically, with the advent of personalized medicine, conventional methods for value assessment that are based on population-level measures might not be appropriate. The best treatment would depend on patient characteristics and clinical profiles. Value assessment of health interventions can vary substantially and may lead to different health decision making due to patient heterogeneity. As such, modeling at the patient level is an appropriate approach for value assessment of health interventions. The DES model has several advantages, such as flexibility, ability to reflect patient heterogeneity, increased precision, and better characterization of modeling uncertainty, that may be preferred to decision tree and Markov models. In addition, with increasing health care spending and drug prices, it is important to quantify value of available treatment options for women with postmenopausal osteoporosis (PMO). The purpose of this Viewpoints article was to describe and demonstrate an application of a DES model to evaluate the cost-effectiveness of the current treatment guidelines for women with PMO. In particular, the DES model indicated that the optimal treatment at the common willingness-to-pay thresholds between $100,000 per quality-adjusted life-year (QALY) and $150,000 per QALY was denosumab. Analysis of patient heterogeneity in terms of low, medium, high, and very high risk of fractures resulted in a similar conclusion. DISCLOSURES: Funding for this study was received through the PhRMA Foundation Value Assessment Challenge Award. The author has no conflicts of interest to declare.

Effect of Treatment Preference in Randomized Controlled Trials: Systematic Review of the Literature and Meta-Analysis.

BACKGROUND: A significant limitation of the traditional randomized controlled trials is that strong preferences for (or against) one treatment may influence outcomes and/or willingness to receive treatment. Several trial designs incorporating patient preference have been introduced to examine the effect of treatment preference separately from the effects of individual interventions. In the current study, we summarized results from studies using doubly randomized preference trial (DRPT) or fully randomized preference trial (FRPT) designs and examined the effect of treatment preference on clinical outcomes. METHODS: The current systematic review and meta-analysis was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Studies using DRPT or FRPT design were identified using electronic databases, including PubMed, Cochrane Library, EMBASE, and Google Scholar between January 1989 and November 2018. All studies included in this meta-analysis were examined to determine the extent to which giving patients their preferred treatment option influenced clinical outcomes. The following data were extracted from included studies: study characteristics, sample size, study duration, follow-up, patient characteristics, and clinical outcomes. We further appraised risk of bias for the included studies using the Cochrane Collaboration's risk of bias tool. RESULTS: The search identified 374 potentially relevant articles, of which 27 clinical trials utilized a DRPT or FRPT design and were included in the final analysis. Overall, patients who were allocated to their preferred treatment intervention were more likely to achieve better clinical outcomes [effect size (ES) = 0.18, 95% confidence interval (CI) 0.10-0.26]. Subgroup analysis also found that mental health as well as pain and functional disorders moderated the preference effect (ES = 0.23, 95% CI 0.11-0.36, and ES = 0.09, 95% CI 0.03-0.15, respectively). CONCLUSIONS: Matching patients to preferred interventions has previously been shown to promote outcomes such as satisfaction and treatment adherence. Our analysis of current evidence showed that allowing patients to choose their preferred treatment resulted in better clinical outcomes in mental health and pain than giving them a treatment that is not preferred. These results underline the importance of incorporating patient preference when making treatment decisions.

Cost-effectiveness Analysis of Sequential Treatment of Abaloparatide Followed by Alendronate Versus Teriparatide Followed by Alendronate in Postmenopausal Women With Osteoporosis in the United States.

BACKGROUND: The US Food and Drug Administration has recently approved abaloparatide (ABL) for treatment of women with postmenopausal osteoporosis (PMO) at high risk of fracture. With increasing health care spending and drug prices, it is important to quantify the value of newly available treatment options for PMO. OBJECTIVE: To determine cost-effectiveness of ABL compared with teriparatide (TPTD) for treatment of women with PMO in the United States. METHODS: A discrete-event simulation (DES) model was developed to assess cost-effectiveness of ABL from the US health care perspective. The model included three 18-month treatment strategies with either placebo (PBO), TPTD, or ABL, all followed by additional 5-year treatment with alendronate (ALN). High-risk patients were defined as women with PMO ⩾65 years old with a prior vertebral fracture. Baseline clinical event rates, risk reductions, and patient characteristics were based on the Abaloparatide Comparator Trial in Vertebral Endpoints (ACTIVE) trial. RESULTS: Over a 10-year period, the DES model yielded average total discounted per-patient costs of $10 212, $46 783, and $26 837 and quality-adjusted life-years (QALYs) of 6.742, 6.781, and 6.792 for PBO/ALN, TPTD/ALN, and ABL/ALN, respectively. Compared with TPTD/ALN, ABL/ALN accrued higher QALYs at lower cost and produced an incremental cost-effectiveness ratio (ICER) of $333 266/QALY relative to PBO/ALN. In high-risk women, ABL/ALN also had more QALYs and less cost over TPTD/ALN and yielded an ICER of $188 891/QALY relative to PBO/ALN. Conclusion and Relevance: ABL is a dominant treatment strategy over TPTD. In women with PMO at high risk of fracture, ABL is an alternative cost-effective treatment.

Association between different types of comorbidity and disease burden in patients with diabetes.

BACKGROUND: This study examined the association between different types of comorbidities and the quality of diabetes care, health-related quality of life (HRQoL), and total health care expenditure. METHODS: Adult patients with diabetes were identified from the 2011 to 2013 Medical Expenditure Panel Survey, a nationally representative survey of the civilian non-institutionalized US population. Twenty different chronic conditions were captured and categorized as: (i) diabetes only; (ii) diabetes plus concordant (diabetes-related) comorbidity only; and (iii) diabetes plus one or more discordant (non-diabetes-related) comorbidities. Disease burden outcomes included the process of diabetes care (eye and foot examinations, HbA1c and cholesterol tests, influenza vaccination), HRQoL, and total health care expenditure. Multivariable models were used to examine associations between the type of comorbidity and outcomes. RESULTS: A sample of 8292 patients with diabetes was identified, of which 11.4% had diabetes only, 40.5% had concordant comorbidity only, and 48.1% reported one or more discordant comorbidities. Patients with diabetes and either type of comorbidity received better quality of diabetes care than those without a comorbidity. However, patients with discordant comorbidity showed significantly lower HRQoL measures and higher health care expenditure than those with concordant comorbidity. Adjusted total mean annual expenditure was US$4891, $6326, and $9210 for those with diabetes only and those with diabetes with one concordant or one discordant comorbidity, respectively. CONCLUSIONS: Higher disease burden in patients with diabetes was associated with discordant rather than concordant comorbidity. Future interventional studies evaluating patient-centered care models addressing different types of comorbidity are necessary to better manage these complex patients.

The Effectiveness of Continuous Glucose Monitoring in Patients with Type 2 Diabetes: A Systematic Review of Literature and Meta-analysis.

BACKGROUND: Continuous glucose monitoring (CGM) provides glucose trend information that can be used to guide treatment and motivate patients with diabetes. Currently, the evidence on effectiveness of CGM in patients with type 2 diabetes is debatable. We aim to provide a systematic review and meta-analysis to synthesize current evidence of effectiveness of CGM in adults with type 2 diabetes. MATERIALS AND METHODS: Cochrane, Embase, PubMed, and Web of Science were searched to include all studies that reported effectiveness of CGM in terms of HbA1c in adults aged 18 and older, with type 2 diabetes, on any treatment for diabetes. Heterogeneity (I2) was used to determine the variability between studies. All data were analyzed using Review Manager 5.3 software. RESULTS: Seven randomized controlled trials and three cohort studies, involving 1384 patients for real-time CGM (RT-CGM) and professional CGM (P-CGM) and 4902 patients for flash glucose monitoring (FGM), were included. RT-CGM and P-CGM were associated with a modest but statistically significant reduction in HbA1c of 0.20% (95% confidence interval [CI] -0.31 to -0.09) compared with control. Patients who received FGM had a nonsignificant reduction of 0.02% (95% CI -0.07 to 0.04) compared with control. The meta-analysis indicated a low heterogeneity between studies. CONCLUSION: Our analysis of current evidence suggests that RT-CGM and P-CGM are effective in improving HbA1c in adults with type 2 diabetes. Due to insufficient evidence, it is premature to form conclusions on the effectiveness of FGM. Future multicenter trials accessing the effectiveness of CGM as well as safety and cost-effectiveness may be necessary.

Effects of treatment, choice, and preference on health-related quality-of-life outcomes in patients with posttraumatic stress disorder (PTSD).

PURPOSE: Health outcomes may depend on which treatment is received, whether choice of treatment is given, and whether a received treatment is the preferred therapy. We examined the effects of these key factors on the EuroQol-5D (EQ-5D-3L) in patients with PTSD. METHODS: Two hundred patients aged 18-65 years with PTSD diagnosis enrolled in a doubly randomized preference trial (DRPT) examining treatment, choice of treatment, and treatment-preference effects of prolonged exposure therapy (PE) and pharmacotherapy with sertraline (SER) (clinicaltrials.gov Identifier: NCT00127673). We performed difference-in-difference analysis to estimate the treatment effects of prolonged exposure therapy (PE) as compared to pharmacotherapy with sertraline (SER), receipt of choice versus no-choice of treatment, and receipt of preferred versus non-preferred treatment on health-related quality-of-life (HRQOL) outcome using the EQ-5D-3L completed at baseline and 10-week post-treatment. RESULTS: The treatment effects of PE on the EQ-5D scores in overall patients and subgroup of patients who preferred PE were 0.150 (p = 0.025) and 0.223 (p < 0.001), respectively. The effects of treatment choice were 0.088 (p = 0.050) and 0.156 (p = 0.043) in overall patients and subgroup of patients received SER, respectively. The effects of treatment preference were 0.101 (p = 0.038) and 0.249 (p = 0.004) in overall patients and subgroup of patients SER, respectively. CONCLUSIONS: Overall, PE is associated with better improved HRQOL, especially in patients who prefer it. Independently, allowing patients to choose their preferred treatment resulted in better HRQOL than either assigning them a treatment or giving them a treatment that is not preferred.

Effectiveness of bariatric surgical procedures: A systematic review and network meta-analysis of randomized controlled trials.

BACKGROUND: Bariatric surgery has proved to be an effective strategy in treating obesity. However, randomized controlled trials (RCTs) of 3 most common bariatric surgery procedures, Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy (SG), and laparoscopic adjustable gastric band (LAGB), reported inconsistent results. We performed a systematic review and network meta-analysis to synthesize evidence of effectiveness of the 3 common bariatric procedures from relevant RCTs. METHODS: The present study was a systematic review and network meta-analysis of RCTs. All RCTs must meet the following criteria to be included in the analysis: patients with body mass index (BMI) ≥30 kg/m, reported at least 1 outcome of interest, compared at least 2 of the 3 bariatric procedures, and had follow-ups of at least 1 year. Primary outcome was weight loss, expressed as differences in mean BMI reduction and percentage excess weight loss (%EWL) following 1 year after the surgery. Network meta-analysis was based on Bayesian framework with Markov Chain Monte Carlo simulation approach. RESULTS: Eleven RCTs that met the criteria were included in the review. Of 9 trials (n = 765), the differences in mean BMI reduction were -0.76 (95% CI: -3.1 to 1.6) for RYGB versus SG, -5.8 (95% CI: -9.2 to -2.4) for RYGB versus LAGB, and -5.0 (95% CI: -9.0 to -1.0) for SG versus LAGB. Eight RCTs (n = 656) reported percentage excess weight-loss (%EWL), the mean differences between RYGB and SG, RYGB and LAGB, and SG and LAGB were 3.8% (95% CI: -8.5% to 13.8%), -22.2% (95% CI: -34.7% to -6.5%), and -26.0% (95% CI: -40.6% to -6.4%), respectively. The meta-analysis indicated low heterogeneity between studies, and the node splitting analysis showed that the studies were consistent between direct and indirect comparisons (P > .05). CONCLUSION: The RYGB and SG yielded similar in weight-loss effect and both were superior to LAGB. Other factors such as complications and patient preference should be considered during surgical consultations.

Rechallenging Statin Therapy in Veterans With Statin-Induced Myopathy Post Vitamin D Replenishment.

BACKGROUND: Statins are the primary class of medications used to lower cholesterol and reduce risks for coronary heart disease. However, statin muscular adverse effects are one of the main reasons for statin nonadherence and a barrier to cardiovascular risk reduction. OBJECTIVES: The primary objective of our study was to examine the effect of replenishing vitamin D on statin-induced myopathy in veteran patients who failed to maintain statin therapy in a pharmacist-run ambulatory care setting. Secondary objectives were to examine changes in patients' vitamin D levels, fasting lipid profiles, and achievement of lipid goals after reinitiation of statin therapy. METHODS: This was a retrospective cohort study of veteran patients conducted at a pharmacist-managed cholesterol-optimization clinic. Patients with low-serum vitamin D, history of statin-induced myopathy, and who received vitamin D replenishment prior to rechallenging statin therapy between December 1, 2008, and April 1, 2015, were identified. The primary outcome was the percentage of patients who maintained their statin therapy at 12 months after statin reinitiation. RESULTS: Twenty-seven patients met the study criteria. All patients were able to maintain their statin therapy without myalgia after vitamin D supplementation. Eleven patients (40.7%) tolerated their previously failed statins. The most frequently restarted statins were atorvastatin, pravastatin, and rosuvastatin. A 22% to 30% increase in the number of patients who achieved cholesterol goals based on the national lipid guidelines was observed at 12-month follow-up. CONCLUSION: Replenishing low vitamin D in patients with statin-induced myopathy appears to be an effective strategy in improving medication adherence and subsequently preventing cardiovascular and mortality events.

A Systematic Review of Health Economic Evaluation Studies Using the Patient's Perspective.

BACKGROUND: Patient-centered care has become increasingly important and relevant for informed health care decision making. OBJECTIVE: Our study aimed to perform a systematic review of health economic evaluation studies from the patient's perspective. METHODS: PubMed, EMBASE, and Cochrane Central databases were searched through May 2014 for cost-effectiveness, cost-utility, and cost-benefit studies using the patient's perspective in their analysis. The reporting quality of the studies was evaluated on the basis of Consolidated Health Economic Evaluation Reporting Standards. RESULTS: We identified 30 health economic evaluations using the patient's perspective, of which 7 were conducted in the United States, 9 in Europe, and 14 in Asian or other countries. Seventeen of 23 health conditions evaluated were chronic in nature. Among 12 studies that justified the use of the patient's perspective, patient's financial burden associated with medical treatment was the most commonly cited rationale. A total of 29, 17, and 15 studies examined direct medical, direct nonmedical, and indirect costs, respectively. Seventeen studies also included societal, governmental or payer's, and/or provider's perspective(s) in their analyses. Based on Consolidated Health Economic Evaluation Reporting Standards, more than 20% of the reporting items in these studies were either partially satisfied or not satisfied. CONCLUSIONS: There is a paucity of health economic evaluations conducted from the patient's perspective in the literature. For those studies using the patient's perspective, the true patient costs were not fully explored and study reporting quality was not optimal. With the increasing focus on patient-centered outcomes in health policy research, more frequent use of the patient's perspective in economic studies should be advocated.

Cost-effectiveness analysis of trastuzumab emtansine (T-DM1) in human epidermal growth factor receptor 2 (HER2): positive advanced breast cancer.

PURPOSE: The EMILIA trial demonstrated that trastuzumab emtansine (T-DM1) significantly increased the median profession-free and overall survival relative to combination therapy with lapatinib plus capecitabine (LC) in patients with HER2-positive advanced breast cancer (ABC) previously treated with trastuzumab and a taxane. We performed an economic analysis of T-DM1 as a second-line therapy compared to LC and monotherapy with capecitabine (C) from both perspectives of the US payer and society. METHODS: We developed four possible Markov models for ABC to compare the projected life-time costs and outcomes of T-DM1, LC, and C. Model transition probabilities were estimated from the EMILIA and EGF100151 clinical trials. Direct costs of the therapies, major adverse events, laboratory tests, and disease progression, indirect costs (productivity losses due to morbidity and mortality), and health utilities were obtained from published sources. The models used 3 % discount rate and reported in 2015 US dollars. Probabilistic sensitivity analysis and model averaging were used to account for model parametric and structural uncertainty. RESULTS: When incorporating both model parametric and structural uncertainty, the resulting incremental cost-effectiveness ratios (ICER) comparing T-DM1 to LC and T-DM1 to C were $183,828 per quality-adjusted life year (QALY) and $126,001/QALY from the societal perspective, respectively. From the payer's perspective, the ICERs were $220,385/QALY (T-DM1 vs. LC) and $168,355/QALY (T-DM1 vs. C). CONCLUSIONS: From both perspectives of the US payer and society, T-DM1 is not cost-effective when comparing to the LC combination therapy at a willingness-to-pay threshold of $150,000/QALY. T-DM1 might have a better chance to be cost-effective compared to capecitabine monotherapy from the US societal perspective.