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Fadia T Shaya

Publications and source records attributed to Fadia T Shaya.

At least 19 recordsLinked to original sources
PubMed2006

A perspective on African American participation in clinical trials.

The relatively low participation of African Americans in phase III clinical trials has raised concerns about the appropriateness of generalizing study results to African American populations. If African American enrollment in clinical trials continues to be low, the society may continue to see disparities in the treatment of diseases as well as unanswered questions as to why the population fares less than others when diagnosed with certain diseases such as cancer and diabetes. Additionally, more clinical trials are needed to explicitly monitor the difference in outcomes across different populations. This article discusses the various reasons why African American patient recruitment and participation is sub-optimal; the critical role of clinical trials in therapies; recommendations by important authorities; and a new practice model (Collaborative Care Model) as an innovative strategy to augment participation rates of African Americans [and other minorities] in clinical trials.

Black or African American↗
PubMed2006

Effect of initial ziprasidone dose on treatment persistence in schizophrenia.

OBJECTIVE: To determine the relationship between ziprasidone initial dose and treatment persistence among patients diagnosed with schizophrenia. METHOD: Adult Medicaid recipients (N=1096) diagnosed with schizophrenia who had ziprasidone prescription claims between July 1, 2001 and September 30, 2003, were categorized by initial dose: low (20-60 mg per day, n=464), medium (61-119 mg per day, n=320) and high dose (120-160 mg per day, n=312). Treatment persistence up to 365 days was measured using refill patterns, allowing 15-day gaps between expected refill dates. Multivariate survival analysis explored the simultaneous impact of age, gender, race, previous hospitalization, and concomitant medication usage, in addition to initial dose of ziprasidone. Sensitivity analysis tested the robustness of results with different definitions for persistence and allowable gaps between refills. RESULTS: Discontinuation rates across the observation period (maximum, 12 months per individual) were lower for patients initiated with high-dose than low-dose ziprasidone (P=0.001). Other factors significantly associated with greater discontinuation of medication were monotherapy (versus combination therapy) and hospitalization within the 6 months prior to the index date of therapy. Black race was associated with greater discontinuation, although this was not consistent across sensitivity analyses. CONCLUSIONS: Patients with schizophrenia started on high doses of ziprasidone have lower discontinuation rates in a retrospective Medicaid database than patients started on low doses. These results were robust across various sensitivity analyses.

Adult↗
PubMed2006

Comparison of first refill rates among users of sertraline, paroxetine, and citalopram.

BACKGROUND: Research suggests high rates of discontinuation of selective serotonin reuptake inhibitors (SSRIs). OBJECTIVE: The aim of this study was to compare the rates of first refill for sertraline, paroxetine, and citalopram, the 3 most commonly used SSRIs that were under patent protection at the time of the study. SSRIs that were available in generic formulations in this period were not included in the analysis because prescribing patterns and compliance rates for generic products may differ from those of branded products. METHODS: This analysis was conducted using claims data from an administrative database. Claims from January 1, 1999, through June 30, 2002, were analyzed. Adults aged 18 to 64 years with a diagnosis of depression, posttraumatic stress disorder, or social anxiety disorder who had initiated one of the SSRIs of interest during this period were included in the analysis. Refill status was determined based on a refill of the SSRI prescription within 1.5 times the days' supply dispensed or 15 days after the dispensing date of the index SSRI. To adjust for the effects of confounding factors, we conducted a multivariate logistic regression on the status of the first refill. The covariates included age (continuous variable), sex, index drugs (with sertraline as the reference group), and a dummy variable for copayment >15 dollars. RESULTS: Recipients of sertraline (n=5590) or citalopram (n=4124) were more likely than recipients of paroxetine (n=5201) to refill their original prescriptions (refill rate, 54.70%, 54.49%, and 50.99%, respectively; both comparisons, P<0.001). In the logistic regression, the effects of age, sex, and copayment were not significant. CONCLUSIONS: This study found that the likelihood of refilling the first prescription varied by SSRI. In the population studied, patients were significantly more likely to refill the first prescription for sertraline or citalopram than the first prescription for paroxetine.

Adolescent↗
PubMed2006

Cost-effectiveness analysis of linezolid compared with vancomycin for the treatment of nosocomial pneumonia caused by methicillin-resistant Staphylococcus aureus.

OBJECTIVE: This study compared the cost-effectiveness of linezolid and vancomycin in the treatment of patients with nosocomial pneumonia (NP) caused by methicillin-resistant Staphylococcus aureus (MRSA). METHODS: A retrospective decision-analytic model was applied to pooled data from 2 prospective, randomized, controlled, double-blind studies, and claims data from a large health plan (3.3 million members) located in the Mid-Atlantic region. Using hospital claims for patients in the health plan with suspected NP, we then determined their daily billed (submitted) hospital charges for 4 mutually exclusive potential health outcomes of linezolid or vancomycin treatment: survival with bacteremia, survival without bacteremia, nonsurvival with bacteremia, and nonsurvival without bacteremia. To generate the expected total daily billed hospital charge for each drug-treatment group, we weighted the determined daily billed hospital charges by the probabilities of each outcome developing in each treatment arm, as derived from the clinical-trial data. Drug acquisition costs were then incorporated, and the difference in expected total costs relative to the difference in rates of survival between the linezolid and vancomycin arms was used to calculate the incremental cost-effectiveness ratio (ICER) for linezolid. RESULTS: Costs were higher for nonsurviving patients compared with surviving patients. Estimated median daily billed treatment charges were $2888 for linezolid and $2993 for vancomycin. Based on Monte Carlo simulations, the respective 95% CIs were $2671 to $3106 and $2615 to $3372. Using mean treatment durations of 11.3 and 10.7 days, respectively, we obtained expected total hospitalization charges of $32,636 for linezolid treatment (95% CI, $30,182-$35,098), compared with $32,024 for vancomycin treatment (95% CI, $27,978-$36,078). The ICER for linezolid per life saved was $3600. CONCLUSIONS: The higher acquisition cost of linezolid was almost completely offset by improved survival and a reduction in health care costs associated with improved survival. As a result, linezolid was almost cost-neutral compared with vancomycin in the treatment of NP caused by MRSA.

Acetamides↗
PubMed2006

Disparities in access to essential new prescription drugs between non-Hispanic whites, non-Hispanic blacks, and Hispanic whites.

Prior studies do not address racial and ethnic disparities in essential new drug use and whether disparities decrease through time. Using the Medical Expenditure Panel Survey (1996-2001), racial and ethnic disparities were examined separately by comparing non-Hispanic whites to non-Hispanic blacks and Hispanic whites, respectively. New drugs were defined as approved within the past 5 years, and an expert panel identified essential drugs. Negative binomial models adjusted for socioeconomic and health characteristics. The mean annual number of times essential new drugs were obtained among non-Hispanic whites, non-Hispanic blacks, and Hispanic whites were 1.02, 0.94, and 0.70, respectively. After adjusting for confounders, ethnic disparities generally were not significant, but racial disparities became significant. This study did not identify declining disparities during early years of drugs' life cycles. Disparities exist in new, essential drug acquisition between non-Hispanic whites and non-Hispanic blacks. Socioeconomic and health characteristics explain many of the observed disparities.

Adolescent↗
PubMed2006

Addressing cardiovascular disparities through community interventions.

OBJECTIVES: To identify the components and impact of intervention programs aimed at reducing cardiovascular disparities. METHODS: A MEDLINE literature search with key words "cardiovascular" and "African American" was conducted, and all documented interventions targeted at reducing racial disparities were selected for review. We identified the type of intervention, the populations targeted, the length of intervention, and its impact. Articles that documented scientific evidence and some case reports were reviewed. RESULTS: Existing studies widely document cardiovascular disparities as they pertain to structure, process, and outcomes. Other factors affecting disparities pertain to patient, physician, system, or treatment factors. Documented programs tend to focus on lifestyle risk factors and attitudes toward those risk factors. The timelines in the studies are relatively short and do not allow for recording clinical endpoints. Most of the studies do not hinge on comprehensive community support, and they lack a sustainability component. CONCLUSIONS: The impact of programs has been short lived, which points to the need for sustainability programs possibly through community partnerships.

Black or African American↗
PubMed2006

Drug therapy persistence and stroke recurrence.

OBJECTIVE: To assess the effect of persistence of use of warfarin sodium, aspirin, or clopidogrel bisulfate on stroke recurrence in a Medicaid high-risk, largely female, African American population. STUDY DESIGN: Prospective non-concurrent cohort, longitudinal data analysis of medical and pharmacy claims of stroke patients from Medicaid managed care organizations between January 1, 2001, and December 31, 2003. METHODS: Cox proportional hazards models were used to predict the likelihood of avoiding a recurrence as a function of persistence of use of the initial medication (warfarin, aspirin, or clopidogrel) after stroke, adjusting for age, race, sex, hypertension and other comorbidities, and the pharmacotherapies prescribed. We used propensity scores to adjust for confounding by indication. RESULTS: Among 925 stroke patients (64.6% female, 75.1% > or =50 years, and 57.8% African American), hypertension and heart disease were the most prevalent comorbidities (66.1% and 65.1%, respectively); most initial strokes were nonhemorrhagic. Persistence of use of warfarin, aspirin, or clopidogrel after stroke increased the likelihood of avoiding a recurrence (hazard ratio [HR], 1.57; 95% confidence interval [CI], 1.22-2.01). Having a hemorrhagic stroke initially (HR, 0.37; 95% CI, 0.18-0.74) or having heart disease (HR, 0.82; 95% CI, 0.67-1.01), hypertension (HR, 0.63; 95% CI, 0.51-0.79), or diabetes mellitus (HR, 0.74; 95% CI, 0.60-0.91) after an initial stroke significantly decreased the likelihood of avoiding a recurrence. Patient's age, race, sex, and urban residence did not significantly predict the likelihood of avoiding a recurrence. CONCLUSIONS: Persistence of use of the initial stroke preventive medication after stroke is effective in avoiding a recurrence. Hemorrhagic stroke, heart disease, hypertension, and diabetes increase the likelihood of a recurrence.

Adult↗
PubMed2005

Selective cyclooxygenase-2 inhibition and cardiovascular effects: an observational study of a Medicaid population.

BACKGROUND: The differential effects of selective cyclooxygenase-2 (COX-2) inhibitors compared with nonspecific nonsteroidal anti-inflammatory agents (NSAIDs) on platelet aggregation and prostacyclin/thromboxane balance have led to concerns that COX-2 inhibitors may increase the risk for cardiovascular thrombotic events. Empirical studies have generally been limited to analyses of secondary end points with low event rates in clinical trials and single event rates in observational studies, all of which have come to conflicting conclusions. This observational cohort study examines the cardiovascular risk of COX-2 inhibitors compared with nonspecific NSAIDs in Maryland Medicaid enrollees, a high-risk population. METHODS: Medical and prescription claims were analyzed for noninstitutionalized Medicaid enrollees who received at least a 60-day supply of a COX-2 inhibitor or other prescription NSAID between June 2000 and June 2002 and who did not use these drugs for at least 6 months prior. Naproxen users were excluded. We developed a logistic model of propensity for treatment with COX-2 inhibitors and stratified patients by quintiles of their propensity score. The model adjusted for demographics, indications for COX-2 inhibitors, and cardiovascular risk factors. RESULTS: The study population comprised 1005 patients using COX-2 inhibitors and 5245 patients using a nonnaproxen NSAID. Of the 6250 patients, 70% were female, 50% were African American, and 30% were older than 50 years. Overall, 12% of the patients had at least 1 cardiovascular thrombotic event after treatment within the follow-up period. The propensity-adjusted odds ratio showed no significant effect of COX-2 inhibitor use on this percentage of patients (odds ratio, 1.09; 95% confidence interval, 0.90-1.33). CONCLUSION: We did not find that COX-2 inhibitors increased cardiovascular risk over nonnaproxen NSAIDs in a high-risk Medicaid population.

Adolescent↗
PubMed2005

Compliance with medicine.

Compliance with medication regimens is critical in assessing the effectiveness of treatments. As new drugs are approved for marketing and prescribed to diverse patient populations, the FDA now recommends further observational studies to continuously monitor unforeseen side effects or efficacy. More research is needed to develop valid and reliable tools to assess adherence of patients to treatment recommendations and adherence of patients to treatment guidelines, when applicable. Information on adherence is a relevant to physicians and their patients as it is to insurers and payers, who need to implement cost-effective disease management programs. This review also has highlighted examples in the adherence literature specific to glaucoma medications and based on longitudinal survival analyses of claims data. Such results may be best complemented by primary, survey-based data collected from patients in observational studies.

Clinical Trials as Topic↗
PubMed2005

Persistence, switching, and discontinuation rates among patients receiving sertraline, paroxetine, and citalopram.

STUDY OBJECTIVE: To compare persistence, switching, and discontinuation rates among patients taking brand-name selective serotonin reuptake inhibitors (SSRIs). DESIGN: Retrospective cohort study. Data Source. Protocare Sciences managed care database. PATIENTS: A total of 14,933 patients with depression, posttraumatic stress disorder, or social anxiety disorder whose prescriptions for brand-name SSRIs were filled from January 1, 1999-June 30, 2002. MEASUREMENTS AND MAIN RESULTS: A total of 5598 patients received sertraline, 4131 citalopram, and 5204 paroxetine. Adherence status was categorized as persistence, switching (from one SSRI to another SSRI), and discontinuation. Persistence was determined based on the number of days' supply of the prescribed drug, with a minimum of 15 days to refill. Survival analyses using life-table survival curves and Cox proportional hazard models were conducted. Age, sex, and copayment were covariates in the Cox proportional models. Sensitivity analysis with a longer time to refill was performed to determine whether the results were sensitive to the algorithm for determining adherence. Compared with patients receiving sertraline and citalopram, those receiving paroxetine had lower rates of persistence (23.79% vs 25.96% for sertraline [p = 0.0093] and 26.56% for citalopram [p = 0.0022]) and higher rates of switching (3.55% vs 3.32% for sertraline [p = 0.5076] and 2.78% for citalopram [p = 0.0359]) and discontinuation (72.66% vs 70.72% for sertraline [p = 0.0258] and 70.66% for citalopram [p = 0.0334]). Survival curves showed that persistence rates with sertraline and citalopram were significantly greater than with paroxetine (p<0.05, log-rank and Wilcoxon tests). Age was an independent predictor of persistence; male sex and copayment were not. The comparisons across SSRIs were robust in the sensitivity analysis that varied the time to refill allowed. CONCLUSION: Differences in the persistence rates were noted among patients receiving three brand-name SSRIs, with patients receiving paroxetine having lower persistence than those receiving sertraline and citalopram. Observed differences in persistence across SSRIs were not sensitive to model specifications. Prescription of SSRIs that demonstrate better adherence would benefit both the patient and the health care system.

Adolescent↗
PubMed2005

Medicaid managed care: disparities in the use of thiazolidinediones compared with metformin.

OBJECTIVE: To identify patient characteristics that are associated with the incidence of thiadolidinediones (TZDs) or metformin prescnbing in Medicaid managed care plans. RESEARCH DESIGN AND METHODS: We utilized a retrospective cohort study design. Two-and-one-half years of prescription claims of Medicaid managed care organizations (MCOs) patients who were new utilizers of metformin or TZDs were analyzed using univariate, bivariate and multivariate models. Multivariate logistic regression models were built to assess the combined effect of all variables on the likelihood of incident use of TZDs or metformin. RESULTS: Claims for 3,041 patients were analyzed for the period between January 15, 2000 and June 15, 2002. African Americans and urban residents were less likely to be started on TZDs (OR = 0.678, 95% C1 = 0.830-1.206; OR = 0.579, 95% CI = 0.479-0.699, respectively). Advanced age, preexisting comorbidities and diabetes complications, and prior use of other oral diabetes drugs or insulin were predictors of increased likelihood of TZD initiation. CONCLUSIONS: Race, age, residential setting, preexisting comorbidities and diabetes complications, other oral diabetes drug use, and insulin use are statistically significant predictors of initial prescribing of TZD or metformin in a Medicaid MCO population. Findings can potentially inform the management of diabetes in managed care so as to improve outcomes.

Cohort Studies↗
PubMed2005

Assessing potential risks and evaluating expected benefits.

The recent withdrawal of rofecoxib from the market will have profound and long-term effects on the methods by which society views, assesses, and monitors risk. As is the case with many drugs, the rofecoxib experience was complex from both the scientific and regulatory standpoints. A drug is marketed in the United States only if its expected benefits outweigh its risks; a recent trend has also included several cost-effectiveness considerations in launch decisions, possibly spurring further debates on ethical implications. However, a great portion of the evidence about actual outcomes of therapies is revealed in the postmarketing phase of development. It is unclear how this understanding of treatment benefit and harm should actually relate to a specific clinical decision.

Clinical Trials as Topic↗
PubMed2005

Persistence with overactive bladder pharmacotherapy in a Medicaid population.

STATEMENT OF PROBLEM AND RATIONALE: The management of chronic conditions, such as overactive bladder (OAB), is often limited by lack of patient adherence to medication. This article compares persistence rates among Medicaid patients who were prescribed 1 of 3 drugs for treatment of OAB: 2 long-acting agents with once-daily dosing, tolterodine tartrate extended-release capsules (tolterodine ER) and oxybutynin chloride extended release (oxybutynin ER), and oxybutynin immediate release (oxybutynin IR), requiring 3 tablets daily. METHODOLOGY: The study population was comprised of continuously enrolled Medicaid managed care patients filling prescriptions for tolterodine ER, oxybutynin ER, or oxybutynin IR between January 1, 2000, and December 31, 2003. Patients taking any OAB drug in the first 6 months of their observed period of enrollment were excluded to capture new users only. Using survival analyses adjusted for age, sex, and race, the rates of persistence by drug were analyzed. Possession time, the degree to which patients keep medication available even though they may not be taking it daily as prescribed, was also measured. RESULTS: Of 1637 patients (75% women, 45% African American, 26% younger than 18 years of age), 182 were started on tolterodine ER, 215 on oxybutynin ER, and 1240 on oxybutynin IR. Only 32% of those taking oxybutynin IR and 44% of those taking either long-acting agent remained adherent past 30 days. Of those remaining after 30 days, the risk of nonadherence was higher for oxybutynin ER than for tolterodine ER (hazard ratio = 1.47; 95% confidence interval, 1.01-2.14). CONCLUSION: Persistence rates are better for patients taking drugs with once-daily dosing, but there is a need for a better understanding of non-persistent patients.

Adolescent↗
PubMed2004

Health care cost of analgesic use in hypertensive patients.

BACKGROUND: Hypertension is one of the most frequently diagnosed chronic medical conditions in the United States and imposes a substantial financial and social burden on Americans. OBJECTIVE: The aim of this study was to compare the cost of health care resources for hypertensive patients taking analgesics stratified by having controlled versus uncontrolled hypertension. METHODS: This was a retrospective, database analysis of data for managed-care patients in Maryland and Washington, DC, recorded from February 1, 1999, to July 31, 2001. Hypertensive patients who were taking analgesics were stratified by their hypertension control status using a claims-based algorithm. Annualized costs and differences in annualized costs calculated for the periods before and after the initiation of analgesics were compared by patient hypertension control status. RESULTS: Of the 9805 patients in the study (mean [SD] age, 49.8 [12.04] years), 2523 (25.73%) were categorized as having uncontrolled hypertension. The mean total annualized costs differed significantly between the controlled and uncontrolled hypertension groups by 2568 dollars (P < 0.001). The annualized costs for emergency-department visits and hospitalizations for uncontrolled hypertensive patients exceeded those for controlled hypertensive patients by 9.3% and 28.0%, respectively. The differences between the postindex- and preindex-period costs for health care resources were 1972 dollars with controlled hypertension and 2961 dollars with uncontrolled hypertension (P < 0.001). The results of linear regression, after adjustments were made for preindex costs and other covariates, indicated that patients with uncontrolled hypertension had significantly increased billed annualized costs (P < 0.001). CONCLUSIONS: These data suggest that the costs of health care resources were significantly higher for analgesic users with uncontrolled hypertension than for analgesic users with controlled hypertension. A considerable proportion of the cost differential was directly attributable to hypertension-related treatment care.

Adult↗
PubMed2004

Disparities in prevalence rates for lung, colorectal, breast, and prostate cancers in Medicaid.

BACKGROUND: Given previous reports of variations in prevalence of cancer in low-income individuals, we sought to determine if disparities in cancer prevalence existed in a similarly-insured Medicaid population. METHODS: Using Maryland Medicaid administrative claims data, prevalence rates of lung, colorectal, breast, and prostate cancers were calculated for Maryland Medicaid recipients who were continuously eligible during the period from January 1, 2000 to December 31, 2000. Chi-squared tests were used to test the differences across subgroups. Cancer prevalence data were age-adjusted using Maryland Medicaid enrollees as the standard population. RESULTS: The care prevalence rates for lung, colorectal, breast, and prostate cancers were 75/10,000, 63/10,000, 92/10,000, and 45/10,000, respectively. These rates were 1.2 to 5.2 times those reported at the national level. Generally, higher cancer prevalence rates in certain racial groups in Maryland Medicaid were consistent with previous studies. Regional differences in cancer prevalence existed for each cancer studied. CONCLUSIONS: Limiting our study sample to a population of uniformly low socioeconomic individuals did not eliminate the disparity in prevalence rates between blacks and whites. Different patterns of racial disparity across regions reported by previous researchers might be due to small area variation in addition to socioeconomic status.

Adult↗
PubMed2004

Formulary decision-making considerations: COX-2 inhibitors.

When deciding the formulary status of a drug, Pharmacy & Therapeutics Committees must consider clinical efficacy, safety, financial implications, MCO population demographics, and other formulary options currently available. Differences in safety and effectiveness among drug classes and among drugs in the same class commonly take precedence over all other considerations, including economic ones. Particularly in light of recent events, the case of the cyclooxygenase-2 inhibitors for the treatment of arthritis yields interesting perspectives into formulary decision making.

Cyclooxygenase Inhibitors↗
PubMed2002

Discontinuation rates of topical glaucoma medications in a managed care population.

BACKGROUND: Rates of medication discontinuation reflect factors including effectiveness, tolerability, cost, and dosing frequency. Discontinuation data can be useful to physicians and health plan managers as they compare various glaucoma medications. OBJECTIVE: To compare rates of discontinuation of therapy in patients initially prescribed monotherapy with a topical glaucoma medication. METHODS: Members of a managed care plan who filled at least 1 prescription for latanoprost, timolol, or brimonidine during a 30-month period were eligible to participate in this study. Prescription refill records for all glaucoma agents used in the plan were extracted for the study period. Rates of discontinuation of initial glaucoma therapy were compared using Cox regression methods; Kaplan-Meier survival curves were generated. RESULTS: A total of 72,744 prescriptions were eligible, of which 48491 were for study drugs. Latanoprost was the most frequently dispensed therapy (accounting for 49.7% of study drugs), followed by timolol (30.6%), and brimonidine (19.6%). After inclusion and exclusion criteria were applied, 2283 patients were included in analyses. Latanoprost-treated patients were significantly less likely to discontinue medication than were those treated with timolol or brimonidine. Kaplan-Meier survival curves confirmed that latanoprost-treated patients exhibited the greatest persistency with therapy. CONCLUSION: In this managed care setting, rates of discontinuation in patients initially treated with latanoprost were lower than those of patients receiving comparator drugs.

Administration, Topical↗