Population Health Model Predicting the Long-Term Impact of Sotatercept on Morbidity and Mortality in Patients with Pulmonary Arterial Hypertension (PAH).

INTRODUCTION: Pulmonary arterial hypertension (PAH) is a rare, progressive disease associated with significant morbidity and mortality. The phase 3 STELLAR trial tested sotatercept plus background therapy (BGT) versus placebo plus BGT. BGT was comprised of mono-, double-, or triple-PAH targeted therapy. Building on STELLAR findings, we employed a population health model to assess the potential long-term clinical impact of sotatercept. METHODS: Based on the well-established ESC/ERS 4-strata risk assessment approach, we developed a six-state Markov-type model (low risk, intermediate-low risk, intermediate-high risk, high risk, lung/heart-lung transplant, and death) to compare the clinical outcomes of sotatercept plus BGT versus BGT alone over a lifetime horizon. State-transition probabilities were obtained from STELLAR. Risk stratum-adjusted mortality and lung/heart-lung transplant probabilities were based on COMPERA PAH registry data, and the post-transplant mortality probability was obtained from existing literature. Model outcomes were discounted at 3% annually. Sensitivity analyses were conducted to examine model robustness. RESULTS: In the base case, sotatercept plus BGT was associated with longer life expectancy from model baseline (16.5 vs 5.1 years) versus BGT alone, leading to 11.5 years gained per patient. Compared with BGT alone, sotatercept plus BGT was further associated with a gain in infused prostacyclin-free life years per patient, along with 683 PAH hospitalizations and 4 lung/heart-lung transplant avoided per 1000 patients. CONCLUSIONS: According to this model, adding sotatercept to BGT increased life expectancy by roughly threefold among patients with PAH while reducing utilization of infused prostacyclin, PAH hospitalizations, and lung/heart-lung transplants. Real-world data are needed to confirm these findings. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT04576988 (STELLAR).

Cost-Effectiveness Analysis of Molnupiravir Versus Best Supportive Care for the Treatment of Outpatient COVID-19 in Adults in the US.

BACKGROUND AND AIMS: Coronavirus disease 2019 (COVID-19) imposes a substantial and ongoing burden on the US healthcare system and society. Molnupiravir is a new oral antiviral for treating COVID-19 in outpatient settings. This study evaluated the cost-effectiveness profile of molnupiravir versus best supportive care in the treatment of adult patients with mild-to-moderate COVID-19 at risk of progression to severe disease, from a US payer's perspective. METHODS: The model was developed using a decision tree for the short-term acute phase of COVID-19 and a Markov state transition model for the long-term post-acute phase. This model compared molnupiravir with best supportive care as consistent with the MOVe-OUT trial. Costs were reported in 2021 US dollars. Transition probabilities were derived from the phase III MOVe-OUT trial and the TriNetX real-world electronic health records database. Costs were derived from the TriNetX database and utility values from a de novo, vignette-based utility study. Deterministic and probabilistic sensitivity analyses (DSA/PSA) were conducted. Primary outcomes included proportion hospitalized, proportion who died overall and by highest healthcare setting at the end of the acute phase, quality-adjusted life-years (QALYs), and incremental costs per QALY gained over a lifetime (100 years) horizon, discounted at 3% annually and assessed at a willingness-to-pay (WTP) threshold of $100,000 per QALY. RESULTS: In this model, the use of molnupiravir led to an increase in QALYs (0.210) and decrease in direct total medical costs (-$895) per patient across a lifetime horizon, compared with best supportive care in COVID-19 outpatients. Molnupiravir was the dominant intervention when compared with best supportive care. Patients treated with molnupiravir were less likely to be hospitalized (6.38% vs. 9.20%) and more likely to remain alive (99.88% vs. 98.71%) during the acute phase. Through DSA, molnupiravir treatment effect of hospitalization reduction was identified to be the most influential parameter, and through PSA, molnupiravir remained dominant in 84% of the total simulations and, overall, 100% cost effective. CONCLUSION: This analysis suggests that molnupiravir is cost effective compared with best supportive care for the treatment of adult outpatients with COVID-19. However, our study was limited by the unavailability of the most recent information on the rapidly evolving pandemic, including new viral variants, patient populations affected, and changes in standards of care. Further research should explore the impact of vaccination on the cost effectiveness of molnupiravir and other therapies, based on real-world data, to account for these changes, including the impact of vaccination and immunity.

Validating the UK prospective diabetes study outcome model 2 using data of 94,946 Israeli patients with type 2 diabetes.

AIMS: To externally validate the United Kingdom Prospective Diabetes Study (UKPDS) Outcome Model 2 (OM2) in contemporary Israeli patient populations. METHODS: De-identified patient data on demographics, time-varying risk factors, and clinical events of newly diagnosed type 2 diabetes patients were extracted from the Maccabi Healthcare Services (MHS) diabetes registry over years 2000-2013. Depending on the baseline risk, patients were categorized into low-risk and intermediate-risk groups. In addition to assessing discriminatory performance, the predicted and observed 15-year cumulative incidences of diabetes complications and death were compared among all patients and for the two risk-groups. RESULTS: The discriminatory capability of OM2 was moderate to good, C-statistic ranging 0.71-0.95. The model overpredicted the risk for MI, blindness and death (Predicted/Observed events (P/O: 1.32-2.31)), and underpredicted the risk of IHD (P/O: 0.5). In patients with a low baseline risk, overpredictions were even more pronounced. OM2 performed well in predicting renal failure and ulcer risk in patients with a low risk but predicted well the risk of death, stroke, CHF, and amputation in patients with an intermediate risk. CONCLUSION: OM2 demonstrated good to moderate discrimination capability for predicting diabetes complications and mortality risks in Israeli diabetes population. The prediction performance differed between patients with different baseline risks.

Cost Effectiveness of Vericiguat for the Treatment of Chronic Heart Failure with Reduced Ejection Fraction Following a Worsening Heart Failure Event from a US Medicare Perspective.

OBJECTIVE: Given the high economic burden of disease among adult patients with chronic heart failure with reduced ejection fraction (HFrEF) following a worsening heart failure event in the US, this study aimed to estimate the cost effectiveness of vericiguat plus prior standard-of-care therapies (PSoCT) versus PSoCT alone from a US Medicare perspective. METHODS: A four-state Markov model (alive prior to heart failure hospitalization, alive during heart failure hospitalization, alive post-heart failure hospitalization, and death) was developed to predict clinical and economic outcomes, based on the results of the VICTORIA trial, in which patients with chronic HFrEF following a worsening heart failure were randomized to placebo or vericiguat, in addition to PSoCT, which consisted of ß-blockers, renin-angiotensin-aldosterone inhibitors, mineralocorticoid receptor antagonists, and the angiotensin receptor-neprilysin inhibitor sacubitril/valsartan. Risks of heart failure hospitalization and cardiovascular mortality were based on multivariable regression models derived from VICTORIA data. Utilities were derived from VICTORIA EQ-5D data and the literature. Costs included drug acquisition, heart failure hospitalization, routine care, and terminal care. Primary outcomes included heart failure hospitalization, cardiovascular mortality, life-years, quality-adjusted life-years (QALYs), and incremental costs per QALY gained over a 30-year lifetime horizon, discounted at 3.0% annually. RESULTS: For the VICTORIA overall intent-to-treat population, compared with PSoCT, vericiguat plus PSoCT resulted in 19 fewer heart failure hospitalizations and 13 fewer cardiovascular deaths per 1000 patients, as well as 0.28 QALY gained per patient at an incremental cost of $23,322, leading to $82,448 per QALY gained. CONCLUSIONS: Based on the results of VICTORIA, patients treated with vericiguat had lower rates of heart failure hospitalization and cardiovascular death. The addition of vericiguat to PSoCT was estimated to increase QALYs and to be cost effective at a willingness-to-pay threshold of $100,000 per QALY gained.

Budget Impact Analysis of Vericiguat for the Treatment of Chronic Heart Failure with Reduced Ejection Fraction Following a Worsening Event.

INTRODUCTION: In the USA, patients with chronic heart failure (HF) with reduced ejection fraction (HFrEF) following a worsening HF event (WHFE) have significantly increased healthcare resource use and medical costs. This analysis aimed to estimate the budget impact of vericiguat as an add-on therapy to guideline-directed medical therapy (GDMT) for the treatment of chronic HFrEF following a WHFE from a US commercial payer perspective. METHODS: A model was developed to estimate the budget impact of adding vericiguat to the formulary by comparing a current scenario (GDMT) and a new scenario (vericiguat plus GDMT) to a hypothetical 10-million-member commercial payer over a 3-year time horizon. Epidemiology data was obtained from literature. Treatment utilization rates of GDMT and clinical inputs (HF hospitalization and cardiovascular [CV] morality) were based on the VICTORIA trial in which patients with chronic HFrEF following a WHFE were randomized to GDMT plus placebo or GDMT plus vericiguat. Costs (2020 US$) included drug acquisition, hospitalization, routine care, and mortality. RESULTS: Approximately 20,510 prevalent cases in year 1 and 3109 annual incident cases in subsequent years were estimated to be eligible for treatment with vericiguat. At a utilization rate of 5%, 10%, and 15% for vericiguat over years 1-3, the per member per month (PMPM) budget impact was estimated to be $0.048, $0.064, and $0.086, respectively, associated with 44, 32, and 30 fewer HF hospitalizations and 7, 12, and 18 fewer CV deaths, respectively. Reduction in HF hospitalizations and CV deaths reduced the budget impact by 14% in total over 3 years. CONCLUSION: Adding vericiguat to commercial plan formulary was associated with limited budget impact, primarily driven by drug acquisition costs but partially offset by reduced cost of HF hospitalizations and CV deaths.

Comparative Efficacy of Dual and Single Initiation of Add-On Oral Antihyperglycemic Agents in Type 2 Diabetes Uncontrolled on Metformin Alone: A Systematic Literature Review and Network Meta-Analysis.

INTRODUCTION: Current guidelines recommend adding an oral antihyperglycemic agent (AHA) to metformin in patients with type 2 diabetes mellitus (T2DM) uncontrolled on metformin. Recent randomized clinical trials (RCTs) have demonstrated that adding dual AHAs instead of a single AHA provided more effective glycemic control. However, the comparative efficacy of approved single and dual initiation strategies is unknown. Therefore, we conducted a Bayesian network meta-analysis to compare the efficacy of dual and single add-on oral AHAs in patients uncontrolled on metformin. METHODS: A systematic literature review of RCTs was conducted following Cochrane and ISPOR guidelines. MEDLINE, Embase, and CENTRAL were searched from inception to November 19, 2019. Approved oral doses of sodium-glucose co-transporter-2 (SGLT-2) inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, and glucagon-like peptide-1 (GLP-1) receptor agonists in single or dual initiation therapies were indirectly compared. Outcomes focused on efficacy and included mean change from baseline in hemoglobin A1c (HbA1c), weight, systolic blood pressure (SBP), diastolic blood pressure, and achieving HbA1c target < 7% at 24-26 weeks. Fixed and random effects models with Markov chain Monte Carlo simulations were used. RESULTS: Of 1955 unique records screened, 25 RCTs (14,264 participants) were included. In patients uncontrolled on metformin, dual AHA added to metformin had statistically significant or a trend of greater reduction in HbA1c compared to single AHAs, with ertugliflozin + sitagliptin showing the greatest improvement. Statistically significant reductions in weight and SBP were observed with ertugliflozin + sitagliptin, ertugliflozin, or canagliflozin compared to single initiation DPP-4 inhibitors. CONCLUSION: For reduction of HbA1c, weight, and SBP in patients uncontrolled on metformin, add-on dual AHAs showed greater improvement compared to single AHAs. These findings can further inform the treatment of T2DM patients uncontrolled on metformin.

Cost-effectiveness analysis of cytomegalovirus prophylaxis in allogeneic hematopoietic cell transplant recipients from a US payer perspective.

To evaluate the cost-effectiveness of letermovir versus no prophylaxis for the prevention of cytomegalovirus infection and disease in adult cytomegalovirus-seropositive allogeneic hematopoietic cell transplantation (allo-HCT) recipients. A decision model for 100 patients was developed to estimate the probabilities of cytomegalovirus infection, cytomegalovirus disease, various other complications, and death in patients receiving letermovir versus no prophylaxis. The probabilities of clinical outcomes were based on the pivotal phase 3 trial of letermovir use for cytomegalovirus prophylaxis versus placebo in adult cytomegalovirus-seropositive recipients of an allo-HCT. Costs of prophylaxis with letermovir and of each clinical outcome were derived from published sources or the trial clinical study reports. Incremental cost-effectiveness ratios (ICERs) in terms of cost per quality-adjusted life year (QALY) gained were used in the model. One-way and probabilistic sensitivity analyses were conducted to explore uncertainty around the base-case analysis. In this model, the use of letermovir prophylaxis would lead to an increase of QALYs (619) and direct medical cost ($1 733 794) compared with no prophylaxis (578 QALYs; $710 300) in cytomegalovirus-seropositive recipients of an allo-HCT. Letermovir use for cytomegalovirus prophylaxis was a cost-effective option versus no prophylaxis with base-case analysis ICER $25 046/QALY gained. One-way sensitivity analysis showed the most influential parameter was mortality rate. The probabilistic sensitivity analysis showed a 92% probability of letermovir producing an ICER below the commonly accepted willingness-to-pay threshold of $100 000/QALY gained. Based on this model, letermovir use for cytomegalovirus prophylaxis was a cost-effective option in adult cytomegalovirus-seropositive recipients of an allo-HCT.

Budget Impact of Oral Semaglutide Intensification versus Sitagliptin among US Patients with Type 2 Diabetes Mellitus Uncontrolled with Metformin.

BACKGROUND: Oral semaglutide was approved in 2019 for blood glucose control in patients with type 2 diabetes mellitus (T2DM) and was the first oral glucagon-like peptide 1 receptor agonist (GLP-1 RA). T2DM is associated with substantial healthcare expenditures in the US, so the cost of a new intervention should be weighed against clinical benefits. OBJECTIVE: This study evaluated the budget impact of a treatment pathway with oral semaglutide 14 mg daily versus oral sitagliptin 100 mg daily among patients not achieving target glycated hemoglobin (HbA1c) level despite treatment with metformin. METHODS: This study used the validated IQVIA™ CORE Diabetes Model to simulate the treatment impact of oral semaglutide 14 mg and sitagliptin 100 mg over a 5-year time horizon from a US healthcare sector (payer) perspective. Trial data (PIONEER 3) informed cohort characteristics and treatment effects, and literature sources informed event costs. Population and market share data were from the literature and data on file. The analysis evaluated the estimated budget impact of oral semaglutide 14 mg use for patients currently using sitagliptin 100 mg considering both direct medical and treatment costs to understand the impact on total cost of care, given underlying treatment performance and impact on avoidable events. RESULTS: In a hypothetical plan of 1 million lives, an estimated 1993 patients were treated with sitagliptin 100 mg in the target population. Following these patients over 5 years, the incremental direct medical and treatment costs of a patient using oral semaglutide 14 mg versus sitagliptin 100 mg was $US16,562, a 70.7% increase (year 2019 values). A hypothetical payer would spend an additional $US3,300,143 (7.1%) over 5 years for every 10% of market share that oral semaglutide 14 mg takes away from sitagliptin 100 mg. Univariate and scenario analyses with alternate inputs and assumptions demonstrated consistent results. CONCLUSIONS: Use of oral semaglutide 14 mg in patients currently receiving sitagliptin 100 mg substantially increases the budget impact for patients with T2DM whose blood glucose level is not controlled with metformin over a 5-year time horizon for US healthcare payers.

Patients with type 2 diabetes mellitus (T2DM) have many treatment options. Choices depend on factors such as cost, preference, and patient characteristics. Oral semaglutide was recently approved for the treatment of T2DM as the first oral therapy of its class. This study estimated the cost for patients treated with sitagliptin 100 mg, a commonly used T2DM treatment, versus oral semaglutide 14 mg for patients whose disease is not well controlled with metformin. Costs and effects were estimated over 5 years for each treatment strategy using predictive model equations and clinical trial data for the two treatments. These costs were considered for both a hypothetical healthcare plan of 1 million lives and the full US population. A patient treated with oral semaglutide 14 mg would expect to see 70.7% higher costs than a patient treated with sitagliptin 100 mg over 5 years. For every 10% of patients who would switch from sitagliptin 100 mg to oral semaglutide 14 mg, costs would increase by 7.1%. Changing the cost of oral semaglutide 14 mg had the greatest impact on model results. The findings from the analysis were consistent across a range of alternate model inputs. Oral semaglutide 14 mg is more costly than sitagliptin 100 mg over 5 years.

Cost-effectiveness of letermovir as cytomegalovirus prophylaxis in adult recipients of allogeneic hematopoietic stem cell transplantation in Hong Kong.

BACKGROUND: The cost-effectiveness of letermovir as cytomegalovirus (CMV) prophylaxis in adult seropositive patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT), compared with the conventional strategy of preemptive treatment, has not been evaluated in Asia. METHODS: A decision analytical model, simulating the clinical progression of CMV infection on a lifetime horizon, was developed to compare prophylactic strategy with letermovir with preemptive therapy alone as anti-CMV strategies. Prophylaxis comprised administering letermovir for 14 weeks, with clinical outcomes measured at 24 weeks, followed by preemptive therapy if CMV infection occurred. This approach was modeled on outcomes of the letermovir phase 3 clinical study. The model enumerated the cost of letermovir prophylaxis, quality-adjusted life years (QALYs), and incremental cost per QALYs gained with prophylaxis. The opposite arm involved regular monitoring and preemptive therapy for CMV reactivation. Real-world costs from the adult HSCT center at Queen Mary Hospital, Hong Kong, were adopted for analysis. Costs and clinical benefits, expressed as QALYs, were discounted at 3% per year. RESULTS: Letermovir prophylaxis compared with preemptive therapy only would lead to an increase of life-year and QALYs at increased costs. Incremental cost-effectiveness analysis showed that letermovir prophylaxis had an associated cost of HKD 193,580 for each life-year gained, and HKD 234,675 for each QALY gained. Probabilistic sensitivity analysis showed that the majority of incremental cost-effectiveness ratio fell below the cost-effectiveness threshold of HKD 382,046 (one gross domestic product per capita) per QALY gained. CONCLUSIONS: Letermovir prophylaxis would be cost-effective for preventing CMV infection in adult seropositive allogeneic HSCT recipients in Hong Kong.

Assessment of Reported Comparative Effectiveness and Safety of Atypical Antipsychotics in the Treatment of Behavioral and Psychological Symptoms of Dementia: A Network Meta-analysis.

Importance: Atypical antipsychotics offer modest effectiveness compared with placebo but with serious safety risks, including a boxed warning for the risk of death in the treatment of behavioral and psychological symptoms of dementia (BPSD). Their comparative effectiveness and safety are not fully known. Objective: To assess the relative benefits and safety of atypical antipsychotics in the treatment of BPSD shown in randomized clinical trials using network meta-analysis. Data Sources: PubMed/MEDLINE, Embase, PsychINFO, and Cochrane Library were searched from their inception until May 31, 2018. Key terms included dementia and atypical antipsychotics. Study Selection: Randomized clinical trials comparing any atypical antipsychotic with another atypical antipsychotic or with placebo were included in the analysis. Data Extraction and Synthesis: Two independent reviewers used a standardized data extraction and quality assessment form. Random-effects network meta-analyses were performed. Effect sizes were reported as standardized mean differences (SMDs) for continuous outcomes and odds ratios (ORs) for dichotomous outcomes with 95% CIs. In addition to ORs, the surface under the cumulative ranking curve (SUCRA) was ascertained, which represents the percentage of the effectiveness or safety for each treatment compared with a hypothetical treatment that would be ranked first without uncertainty. Main Outcomes and Measures: The primary effectiveness outcome assessed was the Neuropsychiatric Inventory (NPI); secondary effectiveness outcomes were the Brief Psychiatric Rating Scale (BPRS) and Cohen-Mansfield Agitation Inventory (CMAI). The primary safety outcomes were death and cerebrovascular adverse events (CVAEs). Secondary safety outcomes were extrapyramidal signs/symptoms; somnolence/sedation; falls, fracture, or injury; and urinary tract infection/incontinence. Results: Seventeen studies (5373 patients) were included. The mean (SD) age of all participants was 80.8 (3.1) years, and most were women (3748 [69.8%]). Compared with placebo, aripiprazole was associated with improvement in outcomes on the NPI (SMD, -0.17; 95% CI, -0.31 to -0.02), BPRS (SMD, -0.20; 95% CI, -0.35 to -0.05), and CMAI (SMD, -0.30; 95% CI, -0.55 to -0.05); quetiapine was associated with improvement in outcomes on the BPRS (SMD, -0.24; 95% CI, -0.46 to -0.01), and risperidone was associated with improvement in outcomes on the CMAI (SMD, -0.26; 95% CI, -0.37 to -0.15). Differences between atypical antipsychotics were not significant for effectiveness, death, or CVAE. Compared with placebo, risperidone (OR, 3.85; 95% CI, 1.55-9.55) and olanzapine (OR, 4.28; 95% CI, 1.26-14.56) were associated with increased risk of CVAEs. The SUCRA estimated relative ranking of treatments suggested that aripiprazole might be the most effective and safe atypical antipsychotic and that olanzapine provides the least benefit overall; however, these results should be interpreted with caution where point estimates (OR and SMD) show that there is no statistically significant difference. Conclusions and Relevance: This network meta-analysis supports the existence of a trade-off between the effectiveness and safety of atypical antipsychotics in the treatment of BPSD and confirms that a single most effective and safe treatment option does not exist. Clinicians should individualize the assessment of safety risks against expected benefits when prescribing these medications to patients with dementia.

Systematic assessment of decision analytic models for the cost-effectiveness of bariatric surgery for morbid obesity.

Bariatric surgery among patients with morbid obesity is very effective for providing long-term weight loss and remission of obesity-related co-morbidities. However, it is very expensive and its cost effectiveness is commonly argued. Long-term cost-effectiveness evaluations of bariatric surgery have often relied on decision models. A systematic review was performed on the methodologic approaches and their quality, evaluated the quality of reporting, and summarized findings and conclusions in published cost-effectiveness models of bariatric surgery for morbid obesity. A search from different databases with an end date of October 15, 2017 was completed. The initial search for title and abstract screening resulted in 741 articles. A total of 50 articles were included for full-text review and 23 economic evaluation studies were included in the systematic review. The reporting quality scores of most articles were rated as acceptable between 61% and 100%. Most studies (89%) were modeled for adult patients with age range between 25 and 75 years old. Sixty-one percent of studies defined their health states by the existence or absence of different obesity-related co-morbidities. Eleven percent of studies took the societal perspective. Most studies (61%) used a lifetime horizon. Thirty-nine percent of studies identified the extent of weight loss as the most sensitive and influential parameter. Seventeen (74%) did not report a formal model validation. Laparoscopic Roux-en-Y gastric bypass was reported as the most cost-effective strategy most often when it compared with no treatment or medical management. While most had acceptable quality of reporting levels, several gaps in the quality of reporting and quality of methods emerged, which led to recommendations for how to improve quality in future studies.

Cost-Effectiveness Analysis of Bariatric Surgery for Morbid Obesity.

BACKGROUND: In the USA, three types of bariatric surgeries are widely performed, including laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and laparoscopic adjustable gastric banding (LAGB). However, few economic evaluations of bariatric surgery are published. There is also scarcity of studies focusing on the LSG alone. Therefore, this study is evaluating the cost-effectiveness of bariatric surgery using LRYGB, LAGB, and LSG as treatment for morbid obesity. METHODS: A microsimulation model was developed over a lifetime horizon to simulate weight change, health consequences, and costs of bariatric surgery for morbid obesity. US health care prospective was used. A model was propagated based on a report from the first report of the American College of Surgeons. Incremental cost-effectiveness ratios (ICERs) in terms of cost per quality-adjusted life-year (QALY) gained were used in the model. Model parameters were estimated from publicly available databases and published literature. RESULTS: LRYGB was cost-effective with higher QALYs (17.07) and cost ($138,632) than LSG (16.56 QALYs; $138,925), LAGB (16.10 QALYs; $135,923), and no surgery (15.17 QALYs; $128,284). Sensitivity analysis showed initial cost of surgery and weight regain assumption were very sensitive to the variation in overall model parameters. Across patient groups, LRYGB remained the optimal bariatric technique, except that with morbid obesity 1 (BMI 35-39.9 kg/m2) patients, LSG was the optimal choice. CONCLUSION: LRYGB is the optimal bariatric technique, being the most cost-effective compared to LSG, LAGB, and no surgery options for most subgroups. However, LSG was the most cost-effective choice when initial BMI ranged between 35 and 39.9 kg/m2.

The impact of bariatric surgery on pulmonary function: a meta-analysis.

Morbid obesity may affect several body systems and cause ill effects to the cardiovascular, hepatobiliary, endocrine, and mental health systems. However, the impact on the pulmonary system and pulmonary function has been debated in the literature. A systematic review and meta-analysis for studies that have evaluated the impact of bariatric surgery on pulmonary function were pooled for this analysis. PubMed, Cochrane, and Embase databases were evaluated through September 31, 2016. They were used as the primary search engine for studies evaluating the impact pre- and post-bariatric surgery on pulmonary function. Pooled effect estimates were calculated using random-effects model. Twenty-three studies with 1013 participants were included in the final meta-analysis. Only 8 studies had intervention and control groups with different time points, but 15 studies had matched groups with different time points. Overall, pulmonary function score was significantly improved after bariatric surgery, with a pooled standardized mean difference of .59 (95% confidence interval: .46-.73). Heterogeneity test was performed by using Cochran's Q test (I2 = 46%; P heterogeneity = .10). Subgroup analysis and univariate meta-regression based on study quality, age, presurgery body mass index, postsurgery body mass index, study design, female patients only, study continent, asthmatic patients in the study, and the type of bariatric surgery confirmed no statistically significant difference among these groups (P value>.05 for all). A multivariate meta-regression model, which adjusted simultaneously for these same covariates, did not change the results (P value > .05 overall). Assessment of publication bias was done visually and by Begg's rank correlation test and indicated the absence of publication bias (asymmetric shape was observed and P = .34). This meta-analysis shows that bariatric surgery significantly improved overall pulmonary functions score for morbid obesity.

The impact of transsphenoidal surgery on neurocognitive function: A systematic review.

BACKGROUND: Cognitive impairment following transsphenoidal surgery (TSS) among patients with pituitary tumors has been intermittently reported and is not well established. We performed a systematic review to summarize the impact of TSS on cognitive function. METHODS: We conducted a systematic search of the literature using the PubMed, Cochrane, and Embase databases through October 2014. Studies were selected if they reported cognitive status after surgery and included at least 10 adult patients with pituitary tumors undergoing either endoscopic or microscopic TSS. RESULTS: After removing 69 duplicates, 758 articles were identified, of which 24 were selected for full text review after screening titles and abstracts. After reviewing full texts, nine studies with a combined total of 682 patients were included in the final analysis. Eight studies were cross-sectional and one was longitudinal. These studies used a wide variety of neurocognitive tests to assess memory, attention and executive function post-operatively. Of the eight studies, six reported impairments in verbal and non-verbal memory post-operatively, while others found no association related to memory, and some reported an improvement in episodic, verbal, or logical memory. While four studies found an impaired association between TSS and attention or executive function, another four studies did not. CONCLUSION: The current literature on cognitive impairments after TSS is limited and inconsistent. This review demonstrates that patients undergoing TSS may experience a variety of effects on executive function and memory post-operatively, but changes in verbal memory are most common.

Blood pressure and neuropsychological test performance in healthy postmenopausal women.

PURPOSE: To study the association between blood pressure and neuropsychological test performance in healthy postmenopausal women. METHODS: Data from 88 healthy postmenopausal women aged 46-73 years, who were not experiencing hot flashes, and who had participated in a prior drug trial, were analyzed to find whether baseline blood pressure was associated with impaired performance on neuropsychological testing done at 3 follow-up visits separated by 4 weeks. Factor analysis was used to reduce the dimensions of neuropsychological test performance. Mixed linear modeling was used to evaluate the association between baseline blood pressure and repeatedly measured neuropsychological test performance at follow-up in a complete case analysis (n=53). In a sensitivity analysis (n=88), multiple-imputation using the Markov Chain Monte Carlo method was used to account for missing data (blood pressure results) for some visits. RESULTS: The variables recording neuropsychological test performance were reduced to two main factors (Factor 1=selective attention; Factor 2=complex processing). In the complete case analysis, the association between a 20-mmHg increase in diastolic blood pressure and Factor 1 remained statistically significant after adjusting for potential confounders, before adjusting for systolic blood pressure (slope=0.60; 95%CI=0.04,1.16), and after adjusting for systolic blood pressure (slope=0.76; 95%CI=0.06, 1.47). The positive slopes indicated an increase in the time spent performing a given task (i.e., a decrease in neuropsychological test performance). No other significant associations were found between systolic blood pressure and either factor. The results did not materially change after applying the multiple-imputation method. CONCLUSIONS: An increase in diastolic blood pressure was associated with a decrease in neuropsychological test performance among older healthy postmenopausal women experiencing hot flashes.