Comparative Effectiveness of Smoking Cessation Medications among Schizophrenic Smokers

Objective: To examine which medication could lead to a higher short and long term smoking abstinence in patients with schizophrenia. Methods: A retrospective cohort study was conducted using General Electric (GE) medical records database (1995 – 2011). The cohort consisted of adult smokers with diagnosis of schizophrenia newly initiating cessation medication. Short term and long term outcomes of cessation were measured at 3 weeks and 1 year. Descriptive and chi-square analyses were used to determine the frequencies and associations of patient characteristics with the abstinence outcomes. Logistic regression models were carried out to determine the predictors of short term and long term abstinence. Results: The cohort consisted of 3,976 patients. Abstinence rate was highest for Varenicline, followed by Bupropion, NRT, and lastly combination at week 12. At one year, abstinence rate was highest for Varenicline, followed by combination, NRT, and lastly Bupropion. Age, race, household locations and receiving counseling were associated with abstinence. No significant differences were found between cessation medications. Conclusions: There were no statistically significant differences in quitting with type of cessation medication. Predictors of better abstinence identified included older age, white race, western household location. These factors should be considered when designing future interventions for schizophrenic population as this minority population may need more tailored approaches to achieve a successful cessation outcome

Patterns of Lipid Lowering Therapy, Adherence and Up-titration in Older Adults

1. Background and rationale: Cardiovascular (CV) diseases are one of the leading causes of death in adults in the United States and are associated with a significant economic burden costing $200 billion each year which includes the cost of lost productivity. Additionally the US population is aging and increasing age is a risk factor for CV events. In 2014, 14.5% of the US population was aged 65 or older. Much of the chronic disease burden results from known risk factors which need to be effectively addressed to improve health outcomes. High levels of low-density lipoprotein cholesterol (LDL-C) has been associated with the development of CV diseases. Several classes of lipid lowering therapies (LLT) are available for reduction of LDL-C levels. Of the available LLT, statins have been the main stay of therapy for several decades and have been recommended in the clinical practice guidelines as the primary pharmacologic agents for LDL-C lowering. In recent years, new classes of drugs have become available in addition to existing agents now available as generic drugs, allowing more options for patient treatment. Results from recent clinical trials have also demonstrated that lower LDL-C values reduce the risk of CV events, with unprecedented mean values of 30 mg/dl achieved in these trials. 1.1. Current guidelines for LDL-C management: The 2018 American College of Cardiology and American Heart Association (ACC/AHA) guidelines identified patient groups that benefit from statin treatment; 1) secondary atherosclerotic cardiovascular disease (ASCVD) prevention 2) primary severe hypercholesterolemia i.e. LDL-C ≥190 mg/dl; 3) diabetes and age 40-75 years or 4) primary prevention of ASCVD. There is scarcity of evidence regarding the benefits of LLT in patients aged 75 years and above. For these patients, the ACC/AHA 2018 guidelines suggest continuing a statin if the patient is already tolerating a statin, initiation of a moderate intensity statin for secondary prevention and not starting a statin for primary prevention based on patient risk, frailty and preferences. The publication of new trial results, the availability of new therapy and the increasing prevalence of older adults using LLT coupled with less evidence regarding benefit in patients >75 make it pertinent to understand the current patterns of use of LLT in older adults. 1.2. Lipid lowering therapy management: Patients on LLT may have treatment modifications due to reasons ranging from adverse events to goal achievement or even formulary changes. If a patient does not achieve goal LDL-C reduction, a physician may up-titrate i.e., increase the potency of the LLT with an intention to lower LDL-C incrementally. On the other hand, LLT may be down-titrated or switched due to various reasons including but not limited to poor tolerability, attainment of lipid goals, or introduction of a new therapy into the regimen. Failure to intensify LLT in patients who have not achieved the goal LDL-C reduction could result in suboptimal LDL-C lowering in patients. Often times, the term clinical inertia has been used to characterize the failure of providers to modify therapy based on guidelines when the patients have suboptimal responses from existing medications. Even though clinical inertia appears to be physician behavior, it may actually result from various physician, patient or system related factors. As the evidence generated since the publication of recent trials emphasizes up-titration of LLT to achieve lower LDL-C, an understanding of the factors that predict treatment up-titration in older adults is important. The focus again is older adults as they are more prone to adverse events from statins but are also at a higher risk of CV events. 1.3. The role of adherence in management of therapy: Medication adherence is an important factor which affects achievement of the maximal therapeutic effect from the LLT. Management of therapy via switching, medication up-titration or down titration may include a window of repeated exposure to the healthcare system. This could include lipid testing, physician and pharmacy visits allowing opportunities for patient education and clarification which in turn may positively impact a patient’s adherence. Studies evaluating the relationship between medication adherence and treatment up-titration for chronic conditions have inconsistent results. Although there is some evidence that treatment modification can potentially affect adherence, there were no studies specifically assessing the association of LLT up-titration with change in medication adherence. Both up-titration and medication adherence however, affect the cumulative exposure of the patient to the drug which affects disease control and management. It is therefore important to determine what effect treatment up-titration has on adherence and whether it could compromise or enhance the ability to attain treatment goals. 2. Objectives: Aim 1: To describe the real-world treatment patterns and characteristics of patients on lipid lowering therapy in a Medicare Advantage Plan. This was a descriptive aim to understand the current patterns of LLT in clinical settings. Aim 2: To identify the sociodemographic and clinical predictors of treatment up-titration in older adults on lipid lowering therapy with a subgroup analysis in patients with uncontrolled LDL-C values at baseline (LDL-C > 70 mg/dl in patients with ASCVD). Hypothesis: There is variation in the up-titration of LLT across patient sociodemographic and clinical factors. Aim 3: Measure changes in adherence to lipid lowering therapy over time after treatment up-titration. Hypothesis: Up-titration of lipid lowering therapy affects subsequent LLT adherence. 3. Main findings: The study aims 1 and 2 had 14,360 patients using LLT. Most of them (99%) were on monotherapy and using statins (99%). Non-statin use was 2.1% either as monotherapy or as a combination. A majority of the LLT users were prevalent users (92.6%), i.e. they had some LLT use in the 1-year pre-index period. Prevalent users had fewer changes, interruptions and discontinuations as compared to new users. In a subgroup analysis of patients ≥ 75 years of age as compared to patients 65-74, it was observed that older patients were more likely to be on stable therapy, i.e. have fewer changes, up- and down titrations. Switching, interruption and discontinuation of therapy was not significantly different between patients aged 65 - 74 and patients ≥ 75 years. Predictors of treatment up-titration included younger age groups, having low income subsidization for pharmacy, hypertension and pre-index down titrations. Patients with higher CMS risk score, ASCVD, prevalent users and patients with pre-index up-titration were less likely to receive treatment up-titration in the follow-up period. In the subgroup of patients with ASCVD and with LDL-C values ≥ 70 mg/dl, increasing LDL-C value was associated with increased likelihood of up-titration. Differences in the subgroup from the overall cohort included increased likelihood to up-titrate among patients with diabetes and among patients who were adherent (proportion of days covered for LLT ≥ 0.8) at baseline. In the evaluation of the relationship between treatment up-titration and adherence, it was found that patients with no changes in the pre-index period had overall higher mean (SE) adherence measured as proportion of days covered (PDC) of 0.88 (0.12) but it decreased to 0.86 (0.16) in the follow-up period. Patients with an up-titration had a pre-PDC of 0.72 (0.26) and patients with other changes such as down-titration and switching had a pre-index mean PDC of 0.62 (0.27). In the model which evaluated the change in PDC over time, there was a decrease in monthly PDC for all the three study groups (no change, up-titration, and other changes) pre-index but all the groups had a significant increase in the PDC each month after the index date. The PDC for the no change group changed from a mean decrease by 1.4% each month to an increase by 0.3% each month after the index date. Similarly the PDC change was 1.1% decrease pre-index which changed to an increase of 1% each month for the group which had an up-titration at the index date. Lastly for the group which had other changes on or prior to the index date, the change in PDC each month pre-index was a 0.9% decrease and it shifted to a mean increase of 1.9% each month post index date. 4. Summary: Older adults on lipid lowering therapy were more likely to be stable users with fewer treatment changes, but new users had greater interruptions and discontinuations requiring more care for these high risk patients. Older patients, prevalent users, and patients with a higher risk score (indicating sicker patients) were less likely to receive treatment up-titration. High risk conditions for CV events like diabetes and hypertension were associated with an increased likelihood of up-titration. This cohort of patients was being prescribed LLT in accordance with recommendations from the guidelines. Both up-titration as well as other treatment changes were associated with an improvement in adherence to LLT indicating that regular monitoring of patients by providers may act as an effective intervention to counter the decline in adherence seen with chronic medications over time.Pharmaceutical Health Outcomes and Policy, Department o

A retrospective study of drug utilization and hospital readmissions among Medicare patients with hepatic encephalopathy

Hepatic encephalopathy (HE) is a complication occurring in patients with cirrhosis and is associated with neuropsychiatric and motor abnormalities. Symptomatic HE episodes almost always require hospitalization and the frequent recurrence of episodes is associated with poor prognosis and increased medical costs. The utilization of existing therapies for management of HE and adherence to them has yet to be evaluated using real-world claims data.The aim of this study was to evaluate HE drug regimens and adherence and their association with hospital readmissions in Medicare Advantage plan patients.This was a retrospective cohort study of patients discharged from a HE-related hospitalization or emergency room visit. Based on subsequent enrollment in the plan they were categorized into cohorts of 1 month, 3, and 6 months follow-up, and medication regimen was evaluated within the first month. The drugs evaluated included lactulose, rifaximin, and neomycin. Multivariable logistic regression was conducted to evaluate the association of drug regimen and medication adherence measured as proportion of days covered with HE readmissions.There were 347 patients hospitalized for HE with 184 patients having 30-day enrollment and either a drug refill or an outpatient visit in this duration. Medications were not refilled by 67 (36.4%) patients. Various drug regimens had different adherence with mean (standard deviation) proportion of days covered ranging from 0.56 (0.29) to 0.82 (0.16) at 3 months and 0.48 (0.3) to 0.77 (0.15) at 6 months. The results of logistic regression at 3 and 6 months did not show a significant association of medication use or medication adherence with hospital readmissions.Despite availability of therapy, medication utilization was alarmingly low after discharge of patients from HE-related hospitalization. Medication adherence was also low, which may affect the rate of recurrence and costs associated with readmissions. Efforts are needed in both care coordination of these patients to ensure they are prescribed appropriate medications and to enhance adherence to them

Association between industry payments and prescribing costly medications: an observational study using open payments and medicare part D data

Abstract Background While many new medications may offer advantages over existing drugs, some newer drugs are reformulations of existing products that provide little innovation or incremental benefit while driving up drug costs. Despite the lack of benefit of these medications, prescribers may be motivated by payments made by the pharmaceutical industry. The objective of the study was to determine the association between payments made to physicians by the pharmaceutical industry and prescriptions for certain selected costly brand name drugs. Methods This was a cross-sectional, retrospective study linking the Open Payments Database and Medicare Part D Prescriber Public Use File for 2014, including 667,278 physicians who prescribed one of 6 brand-name drugs with less costly but similarly effective alternatives: lovastatin ER, almotriptan, amlodipine+olmesartan, ibuprofen+famotidine, saxagliptin+metformin and naproxen+esomeprazole. The primary outcome was the odds of a physician prescribing one of the selected drugs, and the primary predictor was the receipt of any payment from the pharmaceutical industry. Results The odds of prescribing 3 of the 6 drugs were increased among physicians who received industry payment, compared to those without payment: amlodipine+olmesartan, aOR 1.42, (95% CI 1.36–1.49); saxagliptin+metformin, aOR 1.50, (95% CI 1.42–1.59); and naproxen+esomeprazole, aOR 1.45, (95% CI 1.25–1.68). Payment from the manufacturer of the specific drug, compared to not receiving payment from the drug’s manufacturer, was associated with increased odds of prescribing 4 of the 6 drugs: amlodipine+olmesartan, aOR 2.40, (95% CI 2.29–2.52), ibuprofen+famotidine, aOR 8.06, (95% CI 5.42–12.00), saxagliptin+metformin, aOR 2.21, (95% CI 2.10–2.34) and naproxen+esomeprazole, aOR 5.96, (95% CI 5.08–7.00). Conclusions A physician-industry financial relationship was associated with increased odds of prescribing costly brand-name drugs of uncertain medical benefit. Patients, as healthcare consumers, should demand transparency from their physicians about payment from the pharmaceutical industry to increase shared decision-making. Physician and policy makers need increased awareness and reflection on how industry payment influences their prescribing practices

Evaluating perceptions of social determinants of health and Part D star performance of Medicare Advantage-contracted primary care providers serving a South Texas market

Socioeconomic factors can have a significant impact on a patient\u27s health status and could be responsible for as much as 70%-80% of a patient\u27s overall health. These factors, called the social determinants of health (SDoH), define a patient\u27s day-to-day experiences. While the influence of such factors is well recognized, who ultimately is responsible for addressing SDoH in health care remains unclear. Physicians and other clinicians are suitably placed to assess SDoH factors that can impact clinical decision making. Understanding Medicare Advantage (MA)-contracted primary care provider (PCP) SDoH perceptions has yet to be fully explored. To (a) understand MA-contracted PCP perceptions of SDoH and (b) investigate correlations between PCP perceptions and their CMS Part D star performances, as well as their hospital admissions and emergency room admissions. Survey data were collected from MA-contracted PCPs serving a South Texas market during 2019. An 8-item survey consisting of short answer, ranking, and multiple-choice questions was deployed at attendance-mandatory provider meetings from August to October. Analyses were conducted to understand the providers\u27 SDoH perceptions. PCP responses were first summarized as frequencies and percentages. Baseline descriptive characteristics of the providers were compared by Medicare star ratings using chi-square tests (for categorical variables) and t-tests (for continuous variables). Group differences in physician beliefs on how SDoH affects patients\u27 overall health (question 1), as well as provider beliefs regarding how SDoH affects patients\u27 medication adherence practices (question 2), were assessed using chi-square and t-tests. Associations of provider SDoH perceptions with hospital admissions and emergency room admissions were also assessed. A Fischer\u27s chi-square test was used to examine associations between how PCPs answered the question regarding lack of consistent transportation (question 3) and emergency room admissions. The relationships between PCP perceptions of whose job it is to address SDoH (question 7) and hospital admissions were also evaluated. The response rate for returned surveys was 89%. Analysis revealed that the top 3 barriers were financial insecurity (24.87%), low health literacy (18.65%), and social isolation (15.03%). However, about 36% of PCPs felt they should be the primary addressor of SDoH. There was a significant association between years of practice and CMS Part D star ratings ( = 0.005). A significant association between responses in belief towards patients\u27 overall health and CMS Part D star ratings was examined ( = 0.047). There was a statistically significant difference in mean hospital admissions with PCP perception of who should address SDOH ( = 0.03). Emergency room admissions was significantly associated with perceptions regarding lack of consistent transportation ( = 0.04). No differences with star ratings were observed. Previous literature recognize safety and food insecurity as key SDoH barriers. However, they were not among the top SDoH barriers in our survey. Future research should examine patient perceptions of SDoH in this population to identify ways providers can better serve their patients. Funding for this study was provided by CareAllies, a Cigna business. Statistical analysis was completed in partnership with the University of Houston. Payne, Esse, Qian, Serna, Villarreal, and Becho-Dominguez are employees of CareAllies. Mohan and Abughosh are employed by the University of Houston College of Pharmacy. Abughosh reports grants from Valeant and Regeneron/Sanofi, unrelated to this work. Vadhariya has nothing to disclose. This research was presented virtually at the AMCP Pharmacist Virtual Learning Days event, April 2020, as well as the American College of Clinical Pharmacy Virtual Poster Symposium, May 26-27, 2020

Treatment patterns in paediatric and adult patients with SLE: a retrospective claims database study in the USA

Objective To assess real-world treatment regimens and patterns in childhood-onset SLE (cSLE) and adult-onset SLE (aSLE) cohorts, including similarities in treatments, duration of use and adherence.Methods This retrospective study utilised data from Merative L.P. MarketScan Research Databases (USA). Index date was the date of first SLE diagnosis (2010–2019). Patients aged <18 years (cSLE) and ≥18 years (aSLE) at index date with confirmed SLE diagnosis and ≥12 months continuous enrolment during pre-index and post-index periods were included. The cohorts were stratified based on the presence (existing) or absence (new) of pre-index SLE. Primary outcomes (post-index period) included treatment regimens (all patients), and adherence (proportion of days covered (PDC)) and discontinuation of therapies initiated within 90 days of diagnosis (new patients). Univariate comparisons between cSLE and aSLE cohorts were performed using Wilcoxon rank-sum and χ2 (or Fisher’s exact) tests.Results cSLE cohort included 1275 patients (mean age=14.1 years) and aSLE cohort included 66 326 patients (mean age=49.7 years). Antimalarials and glucocorticoids were commonly used among new (cSLE=64.4%/62.0%; aSLE=51.8%/49.7%) and existing (cSLE=68.6%/58.9%; aSLE=63.8%/51.3%) patients in both cohorts. Median oral glucocorticoid dose (prednisone equivalent) was higher in cSLE vs aSLE (new=22.1 vs 14.0 mg/day; existing=14.4 vs 12.3 mg/day; p<0.05). Mycophenolate mofetil use was higher in patients with cSLE vs aSLE (new=26.2% vs 5.8%; existing=37.6% vs 11.0%; p<0.0001). Compared with aSLE, more patients used combination therapies in cSLE (p<0.0001). Median PDC was higher in cSLE vs aSLE for antimalarials (0.9 vs 0.8; p<0.0001) and oral glucocorticoids (0.6 vs 0.3; p<0.0001). Treatment discontinuation was lower in cSLE vs aSLE for antimalarials (25.0% vs 33.1%; p<0.0001) and oral glucocorticoids (56.6% vs 71.2%; p<0.0001).Conclusions Management of cSLE and aSLE includes the same medication classes; differences include more intensive use of therapy in cSLE, warranting the need for approved safe medications for cSLE