Analysis of the effectiveness and cost benefit of leukotriene modifiers in adults with asthma in the Ohio Medicaid population.

OBJECTIVE: The objectives of this research were to (1) determine the association of the use of leukotriene modifiers (LMs) with 3 clinical outcome measures that can serve as proxy measures of effectiveness: subsequent emergency room visits, hospitalizations, and steroid bursts, and (2) estimate whether LM use compared with nonuse is cost beneficial from a Medicaid payer perspective. METHODS: This was a retrospective, longitudinal study of asthma patients in the fee-for-service Ohio Medicaid program. The study population included 5,541 adult patients who were identified as having a claim containing an International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code for asthma (code 493.xx, excluding 493.2x) in 2001. Logistic regression, controlling for selection bias through the use of propensity scores, was used to determine the association of LM use on 3 outcome measures: emergency room visits, hospitalizations, and steroid bursts. An oral steroid burst was defined as a pharmacy claim for oral prednisone in the date range from 1 day before to 3 days after an office visit that has an ICD-9-CM code for asthma. A cost-benefit analysis was also performed. RESULTS: During the prestudy period, the LM users had higher total medical costs of $72.06 per patient per month (PPPM, $170.60 vs. $98.54, P <0.001). During the outcome period, there was no significant association between LM use and emergency room visits (odds ratio [OR] 1.09; 95% confidence interval [CI], 0.84-1.38), hospitalizations (OR 1.02; 95% CI, 0.66-1.59), or steroid bursts (OR 1.30; 95% CI, 0.89-1.90). Because LM use was not more effective than nonuse and is more expensive than nonuse, a situation of dominance prevails. The mean cost difference in the 3 primary outcome measures between LM users and nonusers was $1.63 PPPM ($34.93 vs. $33.30, P=0.019). CONCLUSION: In this study of adult Medicaid asthma patients, users of LMs did not have greater asthma control as measured by emergency room visits, hospitalizations, or steroid bursts. In this cohort of adult asthma patients with at least 1 asthma medication, there does not appear to be any cost offsets to the Ohio Medicaid program associated with the use of LMs. The use of LMs was associated with higher total costs for asthma care.

Acute pancreatitis associated with different combination therapies in patients infected with human immunodeficiency virus.

STUDY OBJECTIVE: To assess the risk of acute pancreatitis in patients receiving various combinations of protease inhibitors, nucleoside reverse transcriptase inhibitors (NRTIs), and nonnucleoside reverse transcriptase inhibitors (NNRTIs) for treatment of human immunodeficiency virus (HIV) infection. DESIGN: Retrospective cohort study. DATA SOURCE: Ohio Medicaid claims database, January 1997-December 2002. PATIENTS: Four thousand nine hundred seventy-two patients with HIV infection who had received at least one antiretroviral drug. MEASUREMENTS AND MAIN RESULTS: Three combination regimens were evaluated: didanosine plus other antiretroviral agents, protease inhibitors plus NRTIs or NNRTIs, and NRTI combinations (no didanosine) or NRTIs plus NNRTIs. We used Cox proportional hazard regression and Kaplan-Meier plots to examine the risk for acute pancreatitis. We identified 159 (3.2%) cases of acute pancreatitis during the study period. For patients who were newly treated for HIV, the incidence of acute pancreatitis was 1.95/100 person-years. Half of these cases developed within 500 days of the start of drug therapy. Hazard ratios (HRs) for acute pancreatitis were 39-54% higher for nonwhite patients than Caucasians and 240-290% higher for symptomatic versus nonsymptomatic patients. Hazard ratios also were significantly associated with increased age, liver injuries (HR 2.94, 6.73), and cardiovascular diseases (HR 1.68, 2.36), respectively, for both newly treated and previously diagnosed patients with HIV. The risk for patients receiving either protease inhibitors plus an NRTI or an NNRTI, or NRTI plus NNRTI combinations was not significantly different from the risk associated with didanosine combination therapy (p>0.10). CONCLUSION: The risk of acute pancreatitis was significantly associated with age, race, symptomatic HIV infection, and liver and cardiovascular diseases. However, risk did not differ significantly among patients with different antiretroviral regimens. Our results can be used by the medical community to enhance patient safety and minimize costly adverse drug reactions among patients with HIV infection.

Impact of regulatory labeling for troglitazone and rosiglitazone on hepatic enzyme monitoring compliance: findings from the state of Ohio medicaid program.

PURPOSE: Troglitazone, the first drug of the thiazolidinediones class for type II diabetes, was first marketed in March 1997 and was removed from the U.S. market 36 months later after 90 cases of liver failure were reported despite multiple warnings containing liver enzyme monitoring recommendations. Rosiglitazone has been available since June 1999 and is still on the market. The purpose of this study was to evaluate the impact of labeled hepatic enzyme monitoring for troglitazone and rosiglitazone. METHODS: Drug cohorts were assembled, using population-based fee-for-service Medicaid claims, for patients between 18 and 65 years of age who had received at least one troglitazone (n = 7226) or rosiglitazone (n = 1480) prescription between 1 April, 1997, and 21 March, 2000. The outcome of interest was the percentage of patients, based on their first treatment episode, who had baseline and post-baseline liver enzyme testing. RESULTS: Overall baseline testing was under 9% before regulatory actions, increased to 14% after the first two 'Dear Doctor' letters issued by the FDA in October and December 1997, and peaked to about 26% afterwards. Coincident with the marketing of rosiglitazone and the fourth 'Dear Doctor' letter issued in June 1999, baseline testing dropped to 18%. Baseline testing increased 2.5-fold (race-sex-age adjusted) after regulatory action. Achieving 50% post-baseline testing took approximately 6 months for both drugs. CONCLUSION: Regulatory actions had only modest effects on the incidence of liver monitoring. More effective and timely communication strategies, health provider prescribing interventions and modification of health provider behaviors to enhance compliance with recommended risk management measures need to be identified, evaluated and implemented.

Characteristics and risk factors associated with high-cost Medicaid recipients.

Characteristics and risk factors of fee-for-service Medicaid patients (age < 65 yr) with high health care costs were assessed by analyzing Ohio's Medicaid claims database. High-cost recipients were defined as those with average monthly Medicaid expenses at or above the 90th percentile. The records of 10,582 high-cost patients and 11,045 comparison patients were examined for clinical comorbidity, mortality status, enrollment, and demographic factors, using logistic and logarithmic multiple regression. Researchers found that a Medicaid recipient had the greatest odds of being in the following groups: dying (odds ratio = 4.0), disabled (2.2), urban resident (1.8), and male (1.3). They concluded that state and federal efforts to control Medicaid expenditures should focus on those high-costrecipients and examine their service utilization.

Beta-blocker underuse in secondary prevention of myocardial infarction.

OBJECTIVE: To review the clinical benefits of beta-blockers as secondary prevention following a myocardial infarction (MI) and to address the reasons that clinicians are reluctant to use beta-blockers in specific patient populations. DATA SOURCES: MEDLINE was searched for articles published from January 1966 to October 2002. Relevant studies were identified by systematic searches of the literature for all reported studies of associations between beta-blocker underuse and secondary prevention of MI. Additional studies were identified by a hand search of references of original or review articles. STUDY SELECTION AND DATA EXTRACTION: English-language human studies were selected and analyzed. DATA SYNTHESIS: Associations were observed in studies of beta-blocker use as secondary prevention of MI. A lower rate of beta-blocker treatment occurred in older patients and in patients with comorbid conditions such as diabetes, heart failure, chronic obstructive pulmonary disease, asthma, and peripheral arterial disease. In addition, underuse was attributed to the perception of high rates of adverse events associated with beta-blockers. beta-Blocker use as secondary prevention of an MI can lead to a 19-48% decrease in mortality and up to a 28% decrease in reinfarction rates. Nonetheless, beta-blockers are significantly underused in many patient populations due to concomitant disease states. Due to their normal physiologic deterioration, the elderly are at an increased risk of low cardiac output and bradycardia when given a beta-blocker; therefore, they should be started on a low dose that is then slowly titrated. In diabetic patients, beta-blockers can impair glucose control leading to hypoglycemia; therefore, post-MI diabetic patients must routinely monitor their blood glucose levels. In patients with decompensated heart failure, beta-blocker use can lead to further cardiac depression, but lower oral starting doses with slow titration can reduce this risk. beta-Blockers can induce bronchospasm in patients with chronic obstructive pulmonary disease or asthma, but cardioselective beta-blockers and appropriate use of medications such as albuterol can minimize these effects. Finally, in patients with peripheral arterial disease, with the exception of hypertensive patients with Reynaud's phenomenon, beta-blockers can be used safely. The only absolute contraindications to beta-blockers are severe bradycardia, preexisting sick sinus syndrome, second- and third-degree atrioventricular block, severe left ventricular dysfunction, active peripheral vascular disease with rest ischemia, or reactive airway disease so severe that airway support is required. CONCLUSIONS: Overall, the cardiovascular benefits of beta-blockers as secondary prevention of MI significantly outweigh the risks associated with their use.

Predictors of warfarin use among Ohio medicaid patients with new-onset nonvalvular atrial fibrillation.

BACKGROUND: Despite demonstrated efficacy in stroke prevention, warfarin is underused in patients with atrial fibrillation (AF). Reasons for warfarin nonuse are unclear. METHODS: We conducted a retrospective cohort analysis using Ohio Medicaid administrative billing data to ascertain determinants of warfarin use for patients with new-onset nonvalvular AF. The database included data from all institutions, providers, and pharmacies providing services to Ohio Medicaid enrollees. Subjects included all 11699 continuously enrolled fee-for-service recipients of Ohio Medicaid with a new diagnosis of nonvalvular AF between January 1, 1998, and December 31, 2000. We determined incipient warfarin use and presence of risk factors for stroke and hemorrhage by searching claims records for corresponding International Classification of Diseases, Ninth Revision, Clinical Modification codes and National Drug Codes. Univariate and multivariable analyses were performed to examine the association of risk factors with warfarin use. RESULTS: Only 9.7% of all patients and 11.9% of those without apparent contraindications filled prescriptions for warfarin from 7 days preceding to 30 days after the development of AF. Hypertension and congestive heart failure independently predicted increased warfarin use. Older age (>or=85 years), younger age (<55 years), prior intracranial hemorrhage, prior gastrointestinal hemorrhage, predisposition to falls, alcohol or other drug abuse, renal impairment, and conditions perceived as barriers to compliance predicted decreased warfarin use. CONCLUSIONS: Few in this cohort of Ohio Medicaid patients with incident AF filled prescriptions for warfarin within 30 days of the diagnosis. Several factors, including alcohol or other drug abuse or dependence, psychiatric disease, homelessness or inadequate housing, and lack of a caregiver, were highly prevalent and seemed to bias against warfarin prescribing.

Acetaminophen overuse in the Ohio Medicaid population.

OBJECTIVE: To examine patterns of use of acetaminophen in patients with and without risk factors for hepatotoxicity in the Ohio Medicaid population. DESIGN: Retrospective, cross-sectional analysis of claims data. SETTING: Ohio. PATIENTS: Ohio Medicaid patients (n = 22,496) who received at least 6 prescriptions for acetaminophen from November 1998 through April 1999. MAIN OUTCOME MEASURE: Overuse of acetaminophen, defined as an average daily dose (ADD) greater than or equal to 4 grams/day or an ADD of greater than or equal to 3 grams/day along with diagnosis codes suggesting underlying liver dysfunction. RESULTS: We identified 687 patients (3.05%) who received either greater than or equal to 4 grams/day or greater than or equal to 3 grams/day and had diagnosis codes suggesting underlying liver dysfunction (n = 128). CONCLUSION: Although the number is relatively small, some Ohio Medicaid patients are receiving acetaminophen doses that exceed safety recommendations. Because acetaminophen overuse is the leading cause of liver failure, health care professionals should be alert to the possibility of acetaminophen overuse.

Relationship between asthma drug therapy patterns and healthcare utilization.

BACKGROUND AND OBJECTIVE: Asthma drug therapy problems contribute significantly to preventable hospitalizations and increased healthcare use in asthmatics. Since asthma patients often require >1 medication for control of symptoms, concurrent asthma drug therapies may be important in predicting excessive healthcare utilization. The purpose of this study was to link inappropriate asthma drug therapy patterns and selected patient demographics to healthcare utilization. METHODS: This study was a retrospective, cross-sectional analysis of Ohio Medicaid medical, institutional, and prescription claims. We included ambulatory patients aged 15-65 years who had > or =2 claims for asthma (493.x) and who were continuously enrolled in the Medicaid fee-for-service program for the 12-month period from April 1998 through March 1999. We examined age, race, gender, metropolitan residence, presence of gastroesophageal reflux disease, and the usage patterns of inhaled corticosteroids, short-acting beta(2)-agonists, long-acting beta(2)-agonists, theophylline, and leukotriene receptor modifiers to identify asthma drug therapy problems based on national guidelines. The primary outcomes included the number of asthma-related hospitalizations, asthma-related emergency department visits, and oral steroid bursts. RESULTS: Among 10 959 asthma patients, only 46.8% of the study patients received >1 puff of inhaled corticosteroid per day. Forty-four percent of the patients received >3 puffs of short-acting beta(2)-agonists per day. The most common outcome was an oral steroid burst (46.5%). Patients on high doses of short-acting beta(2)-agonists had the greatest odds of receiving an oral steroid burst and were most likely to be hospitalized. African Americans were more likely to incur a hospitalization or emergency department visit. Women had greater odds of any undesirable asthma outcome. Higher use of short-acting beta(2)-agonists led to higher odds of receiving a steroid burst or being hospitalized. Leukotriene receptor modifier use was related to higher levels of all outcomes. CONCLUSIONS: A large percentage of Ohio Medicaid patients were not receiving asthma medications in compliance with the National Heart, Lung, and Blood Institute guidelines. Despite nearly a decade of national efforts, asthma drug therapy patterns still have substantial room for improvement and continue to be associated with excess healthcare utilization.