BackgroundAmong schizophrenia patients relapsed on an oral antipsychotic (AP), this study compared the impact of switching to atypical AP long-acting injectable therapy (LAT) versus continuing oral APs on hospitalization and emergency room (ER) visit recurrence.MethodsElectronic records from the Premier Hospital Database (2006-2010) were analyzed. Adult patients receiving oral APs during a schizophrenia-related hospitalization were identified and, upon relapse (i.e., rehospitalization for schizophrenia), were stratified into (a) patients switching to atypical LAT and (b) patients continuing with oral APs. Atypical LAT relapse patients were matched 1:3 with oral AP relapse patients, using a propensity score model. Andersen-Gill Cox proportional hazards models assessed the impact of atypical LAT versus oral AP on time to multiple recurrences of all-cause hospitalizations and ER visits. No adjustment was made for multiplicity.ResultsAtypical LAT (N = 1032) and oral AP (N = 2796) patients were matched and well-balanced with respect to demographic (mean age: 42.1 vs 42.4 years, p = .5622; gender: 43.6% vs 44.6% female, p = .5345), clinical, and hospital characteristics. Over a mean 30-month follow-up period, atypical LATs were associated with significantly lower mean number of rehospitalizations (1.25 vs 1.61, p < .0001) and ER visits (2.33 vs 2.67, p = .0158) compared with oral APs, as well as fewer days in hospital (mean days: 13.46 vs. 15.69, p = .0081). Rehospitalization (HR 0.81, 95% CI 0.76–0.87, p < .0001) and ER visit (HR 0.88, 95% CI 0.87–0.93, p < .0001) rates were significantly lower for patients receiving atypical LAT versus oral APs.ConclusionsThis hospital database analysis found that in relapsed schizophrenia patients, atypical LATs were associated with lower rehospitalization and ER visit rates than oral APs.
This study was funded by Novartis Pharmaceuticals. Novartis employees were involved in all aspects of this study. Vegesna and Sasane are employed by and own stock in Novartis. Nazareth and Ko were employees of Novartis at the time of this study. Frois, Demean, Carpenter, and Wu are or have been employed by Analysis Group, which received a grant from Novartis for this research. Navarro received consulting fees from Novartis for his involvement in this research. Study concept and design were contributed by Sasane, Frois, Nazareth, and Wu. Navarro, Demean, and Frois took the lead in data collection, assisted by Carpenter, Ko, and Nazareth. Data interpretation was provided by Frois, Carpenter, Nazareth, and Ko, along with Sasane, Demean, Wu, and Navarro. The manuscript was written by Frois, Demean, Nazareth, and Ko, along with Sasane, Carpenter, Wu, and Navarro, and revised by Frois, Ko, and Vegesna, along with Sasane, Nazareth, Wu, and Navarro.
ObjectiveTo compare the efficacy and safety of a concentrated formulation of insulin glargine (Gla-300) with other basal insulin therapies in patients with type 2 diabetes mellitus (T2DM).DesignThis was a network meta-analysis (NMA) of randomised clinical trials of basal insulin therapy in T2DM identified via a systematic literature review of Cochrane library databases, MEDLINE and MEDLINE In-Process, EMBASE and PsycINFO.Outcome measuresChanges in HbA1c (%) and body weight, and rates of nocturnal and documented symptomatic hypoglycaemia were assessed.Results41 studies were included; 25 studies comprised the main analysis population: patients on basal insulin-supported oral therapy (BOT). Change in glycated haemoglobin (HbA1c) was comparable between Gla-300 and detemir (difference: −0.08; 95% credible interval (CrI): −0.40 to 0.24), neutral protamine Hagedorn (NPH; 0.01; −0.28 to 0.32), degludec (−0.12; −0.42 to 0.20) and premixed insulin (0.26; −0.04 to 0.58). Change in body weight was comparable between Gla-300 and detemir (0.69; −0.31 to 1.71), NPH (−0.76; −1.75 to 0.21) and degludec (−0.63; −1.63 to 0.35), but significantly lower compared with premixed insulin (−1.83; −2.85 to −0.75). Gla-300 was associated with a significantly lower nocturnal hypoglycaemia rate versus NPH (risk ratio: 0.18; 95% CrI: 0.05 to 0.55) and premixed insulin (0.36; 0.14 to 0.94); no significant differences were noted in Gla-300 versus detemir (0.52; 0.19 to 1.36) and degludec (0.66; 0.28 to 1.50). Differences in documented symptomatic hypoglycaemia rates of Gla-300 versus detemir (0.63; 0.19to 2.00), NPH (0.66; 0.27 to 1.49) and degludec (0.55; 0.23 to 1.34) were not significant. Extensive sensitivity analyses supported the robustness of these findings.ConclusionsNMA comparisons are useful in the absence of direct randomised controlled data. This NMA suggests that Gla-300 is also associated with a significantly lower risk of nocturnal hypoglycaemia compared with NPH and premixed insulin, with glycaemic control comparable to available basal insulin comparators.
Metastatic and recurrent, locally-advanced HNC patients frequently receive cancer-related treatments and incur substantial economic burden.
analysis RESULTS: From the obesity cohort 138 subjects had a mean age (46.4 ± 16.5) years, about 90 (65.2%) cases, had UCG, (95% CI: 8.3 e 8.9). However, from 107 normal weight cases, with age (58.7 ± 15.6) years, only 45 (42.1%) patients had UCG, (95% CI: 7.6 e 8.4). T-test explored a statistically significant difference of HbA1c% means among the obesity cohort and normal body weight group [(8.6 ± 1.8) vs. (8 ± 2) respectively, (P-value¼ 0.027)]. Pearson correlation indicated a positive association between BMI and HbA1c% (r¼ 0.144, P-value¼ 0.024) and linear regression confirmed BMI as a predictor of HbA1c (r2¼ 0.021, p-value¼ 0.024). The relative risk of UCG in diabetic obese patients was (RR: 1.55, 95% CI: 1.2 e 2). The excess relative risk was 55%. The absolute risk was 23.2%, and the number needed to harm was 5. CONCLUSIONS: Obese outpatients with type 2 diabetes have a higher HbA1c mean value and higher risk of UCG than subjects with normal body weight. Obese patients need extra diabetic care.
BACKGROUND: The U.S. health care system's transition to a value-based reimbursement model holds important implications for medical innovation, care delivery, and value-based assessments of therapeutic interventions. This transition has been especially noteworthy in oncology, with substantial ongoing changes to payer reimbursement and the provider landscape, as well as the introduction of value frameworks to guide drug treatment decision making. The implications of these changes for provider assessments of drug value and evidence needs remain unclear.OBJECTIVES: To understand provider perspectives on drug value assessment and the utility of existing oncology value frameworks by identifying (a) key value-based trends in the evolving oncology landscape, (b) provider definitions of drug value, (c) the role of existing value frameworks in provider decision making, and (d) future provider evidence needs for making value-based treatment decisions. METHODS:We conducted a literature review to identify existing oncology value frameworks and definitions of drug treatment value in oncology. Using a structured discussion guide informed by this literature review, we conducted 12 telephone-based in-depth interviews in November and December 2017 with U.S. oncology providers involved in organizational drug treatment and formulary decision making within their practices. Responses to interview questions were analyzed and reported as averages and percentages across participants. RESULTS: Of 293 publications identified by keyword searches, 35 relevant articles were identified. Among these, the literature review identified no common definition for providers to assess drug value. Interview research participants described large ongoing changes in the oncology provider landscape, with economic pressures from payers as the foremost leading factor. Although 5 value frameworks were found in the literature, interviews found that in practice few providers consider these value frameworks to be key influences when evaluating treatment or formulary decisions. Furthermore, while 83% of participants' organizations employed some form of internal clinical pathways, only the minority (25%) with pathways integrated in their electronic medical record (EMR) systems saw these pathways as significantly affecting clinicians' drug treatment decision making. To aid the ongoing shift from volume-based to value-based care, we found that, rather than value frameworks, providers are looking for patient-level tools to make more appropriate drug decisions. CONCLUSIONS: Payer reimbursement pressures are leading to radical changes in the oncology provider landscape, and there is a need for improved guidance for providers in assessing drug value. In particular, this study identifies the need for a timely and multifaceted summary of information required to assess the value of alternative treatment options for a given patient. Manufacturers also need to make significant strides to help generate and improve the dissemination of evidence to support the value of their the...
Objectives: To develop an economic model that estimates the cost burden of psychiatric relapse and recidivism among patients with schizophrenia after release from jail/prison from a US state government perspective. MethOds: A Markov state-transition model was developed to estimate the numbers of schizophrenia patients newly-released from jail/prison who would experience psychiatric relapse and/or arrest and re-incarceration over a period of three years, along with corresponding costs. The model includes three health states: 1) in community, on therapy, 2) in community, off therapy, and 3) incarcerated. A patient's probability of psychiatric hospitalization increases with treatment discontinuation, and the probability of arrest increases with the risk of a psychiatric hospitalization. Data from the US Census and Bureau of Justice Statistics were used to estimate the model population. Published literature was used to estimate the risks of psychiatric relapse, arrest, and direct cost inputs associated with hospitalization, arrest, trial, and incarceration. Felony and misdemeanor incarceration rate and sentence length data from the State of Florida were applied as a base case scenario. The rate of antipsychotic treatment following release from jail/prison and annual risk of medication discontinuation were varied in sensitivity analyses. Results: Among 34,500 persons released from Florida state prison annually, 5,307 were estimated to have schizophrenia. The estimated three-year cumulative direct costs to the state government
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