Helen Lau

Effects of Pioglitazone and rosiglitazone on blood lipid levels and glycemic control in patients with type 2 diabetes mellitus: A retrospective review of randomly selected medical records

BACKGROUND The antihyperglycemic effects of pioglitazone hydrochloride and rosiglitazone maleate are well documented. The results of clinical trials and observational studies have suggested, however, that there are individual differences in the effects of these drugs on blood lipid levels. OBJECTIVE The present study evaluated the effects of pioglitazone and rosiglitazone on blood lipid levels and glycemic control in patients with type 2 diabetes mellitus. METHODS This was a retrospective review of randomly selected medical records from 605 primary care practices in the United States in which adults with type 2 diabetes received pioglitazone or rosiglitazone between August 1, 1999, and August 31, 2000. The outcome measures were mean changes in serum concentrations of triglycerides (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and glycosylated hemoglobin (HbA1c) values. RESULTS Treatment with pioglitazone was associated with a reduction in mean TG of 55.17 mg/dL, a reduction in TC of 8.45 mg/dL, an increase in HDL-C of 2.65 mg/dL, and a reduction in LDL-C of 5.05 mg/dL. Treatment with rosiglitazone was associated with a reduction in mean TG of 13.34 mg/dL, an increase in TC of 4.81 mg/dL, a reduction in HDL-C of 0.12 mg/dL, and an increase in LDL-C of 3.56 mg/dL. With the exception of HDL-C, the differences in mean changes in lipid parameters between treatment groups were statistically significant (P < 0.001, pioglitazone vs rosiglitazone). Reductions in HbA1c were statistically equivalent between treatments (1.04% pioglitazone, 1.18% rosiglitazone). CONCLUSIONS Treatment with pioglitazone was associated with greater beneficial effects on blood lipid levels than treatment with rosiglitazone, whereas glycemic control was equivalent between the 2 treatments.

Predictors of Compliance with Antihypertensive Therapy in a High-Risk Medicaid Population

OBJECTIVE To identify predictors of compliance with antihypertensive combination therapy in a Medicaid population. METHODS Retrospective medical and pharmacy claims data for Maryland Medicaid patients receiving angiotensin converting enzyme inhibitors (ACEls)/hydrochlorothiazides (HCTZs) or ACEl/calcium channel blockers as fixed-dose combinations or separate agents during the period of January 1, 2002 to December 31, 2004, were analyzed. INCLUSION Continuously enrolled patients 18 years and older and at least one year of follow-up. Exclusion: Use of fixed-dose combination antihypertensives between January 1, 2002 and June 30, 2002 (to identify incident cohort). Compliance was defined as medication possession ratio greater than or equal to 80%. Multivariate logistic regression was used to predict compliance as a function of age, gender, race, comorbidities (Charlson Comorbidity Index [CCI]), and use of either fixed-dose combination or separate agents. RESULTS There were 568 patients, 63.73% female, 68.83% African American, median age 52 years, 35.56% on fixed-dose combinations, 72.89% started on ACEI/HCTZ, and 24.82% complied with therapy. Patients younger than 40 years (OR, 0.38; p = .01; 95% CI, 0.18-0.81) and African American (OR, 0.45; p = .0004; 95% CI, 0.29-0.70) were less likely to be compliant than patients older than 60 years and Caucasian, respectively, Patients with a CCI of 1 (OR, 2.11; p = .05; 95% CI, 1.01-4.40) and those on fixed-dose combinations (OR, 1.60; p = .02, 95% CI, 1.06-2.40) were more likely to be compliant than those with higher CCIs and on separate agents, respectively. CONCLUSION Age, race, comorbidities, and simplified antihypertensive regimens were significant predictors of compliance. Higher compliance rates may enhance cardiovascular disease management outcomes.

Impact of palivizumab on expected costs of respiratory syncytial virus infection in preterm infants: Potential for savings

In its clinical assessment of the respiratory syncytial virus (RSV)-specific monoclonal antibody palivizumab, the IMpact-RSV Study Group demonstrated a reduction in hospitalizations for RSV-related lower respiratory tract infection in infants who received prophylaxis compared with infants who did not receive prophylaxis. An assessment of the RSV-related expenses for managing both groups of infants is needed to provide insight into the value of prophylaxis. The present study was conducted to identify and compare RSV-related health care expenditures incurred by infants who did not receive prophylaxis throughout one RSV season and after. Using a decision-analytic model populated with data from the contemporary medical literature, a pharmacoeconomic study was conducted from the perspective of the payer. Probabilities for RSV-related hospitalizations of infants who did and did not receive prophylaxis were abstracted from several published studies. Components of inpatient and outpatient care were identified through examination of hospital records, reviews of the published literature, and consultation with expert clinicians. Charges related to prophylaxis and medical management of infection were abstracted from hospital billing records and published data. Appropriate charges were applied to decision-tree branches and multiplied by in-line probabilities for outcomes. Products at terminal nodes were summed to establish total expected charges for both groups of infants. Widespread clinical use of prophylactic palivizumab would result in incremental expenses < or =

Impact of adjunctive thiazolidinedione therapy on blood lipid levels and glycemic control in patients with type 2 diabetes.

3459 per infant or cost savings < or =

Multicenter retrospective assessment of thiazolidinedione monotherapy and combination therapy in patients with type 2 diabetes: Comparative subgroup analyses of glycemic control and blood lipid levels

39,107 per infant. The variability in value of prophylaxis derives from the rate of RSV-related hospitalizations in the community and the total health care expense of managing infected infants.

Pharmacotherapies for attention-deficit/hyperactivity disorder: expected-cost analysis

SUMMARY Objective: This study was undertaken to assess the effect of pioglitazone hydrochloride and rosiglitazone maleate on blood lipid levels and glycemic control when these drugs are used as adjunctive therapy in type 2 diabetes. Research design and methods: Patients with type 2 diabetes receiving metformin and/or sulfonylurea (n = 829) were evaluated in this national, multicenter, retrospective study. Medical records from 318 endocrinology practices in the USA were randomly selected and screened for study inclusion. Data related to patient demographics and laboratory data were extracted from medical records and analyzed for primary and secondary outcomes. Main outcome measures: The primary study outcome was the mean change in plasma triglyceride (TG) levels. Secondary outcome measures included mean changes in total cholesterol (TChol), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) concentrations and hemoglobin A1C levels. Results:With pioglitazone, TG levels declined by a mean of 51.5 mg/dl (P < 0.001), HDL-C levels rose by 3.3 mg/dl (P < 0.001), and no change was seen in LDL-C or TChol. Treatment with rosiglitazone was associated with no significant change in TG levels and a 1.5 mg/dl mean increase in HDL-C (P < 0.001). Furthermore, rosiglitazone therapy was associated with an 8 mg/dl mean increase in TChol (P < 0.001), and a 5.8 mg/dl mean increase in LDL-C (P < 0.001). Hemoglobin A1C levels were significantly reduced by approximately 1% within thiazolidinedione (TZD) cohorts (P < 0.001), but were not significantly different between study groups (P = 0.257). Conclusions: Results from this study suggest that pioglitazone has a more favorable effect on lipid profiles of patients with type 2 diabetes compared with rosiglitazone. In particular, differences were observed in TG and LDL-C levels. Both TZDs were equivalent at reducing hemoglobin A1C levels. These differences in lipid effects may have an impact on cardiovascular outcomes. The full clinical importance of these lipid alterations must be further assessed in prospective trials.

Cost-Effectiveness of Aliskiren in Type 2 Diabetes, Hypertension, and Albuminuria

BACKGROUND Thiazolidinediones (TZDs) have contributed to the management of patients with type 2 diabetes mellitus as unique insulin-sensitizing agents. When used as monotherapy or in combination therapy, these drugs not only reduce glycosylated hemoglobin (HbA(1c)) levels, but also effect changes in blood lipid concentrations and have the potential to ameliorate cardiovascular disease risk. Although drugs in the TZD class are perceived to be equivalent clinically, prospective and retrospective studies have demonstrated their ability to modify blood lipid levels. OBJECTIVE We evaluated and compared the effects of pioglitazone and rosiglitazone monotherapy and combination therapy on blood lipid levels and HbA(1c) in patients with type 2 diabetes. METHODS We conducted a multicenter retrospective chart review of 1115 records of patients with type 2 diabetes who received pioglitazone or rosiglitazone, alone or in combination with other antidiabetic agents, between August 1, 1999, and August 31, 2000. The review was conducted to evaluate pretreatment and posttreatment levels of triglyceride, total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and HbA(1c). RESULTS All observed demographic characteristics, comorbidities, and concomitant drug use were similar in both treatment cohorts. Of the patients who received pioglitazone, 83% also received >/=1 other antihyperglycemic agent and 59% received some form of antihyperlipidemic therapy. Among those who received rosiglitazone, 81% received concomitant antihyperglycemic medication and 60% received some form of antihyperlipidemic therapy. With pioglitazone, mean levels of serum triglyceride, total cholesterol, and LDL-C decreased and HDL-C increased in most patients, with or without concomitant antihyperglycemic medications; with rosiglitazone, with or without other antidiabetic agents, triglyceride and HDL-C levels decreased, whereas total cholesterol and LDL-C levels increased in most patients. Reductions in HbA(1c) levels and increases in body weight related to each study drug were comparable. CONCLUSIONS This comparative assessment of pioglitazone and rosiglitazone, based on observational data, reveals that use of these TZDs with other antidiabetic agents was similar in 605 primary care practices in the United States. In both monotherapy and combination treatment regimens, pioglitazone was associated with greater beneficial effects on lipids than was rosiglitazone. Additional studies are needed to determine the long-term outcomes of TZD therapy with concomitant antihyperglycemic medications.

Association between incidence of acute exacerbation and medication therapy in patients with COPD

BACKGROUND Attention-deficit/hyperactivity disorder (ADHD) is a common childhood neurobehavioral disorder characterized by inattention, hyperactivity, and impulsivity. Prevalence estimates in elementary school children generally range from 3% to 8%. ADHD is frequently treated with psychostimulant medications, which have been shown to improve both cognitive and behavioral outcomes for most children. OBJECTIVE The goal of this study was to estimate the total expected costs for the treatment and management of school-age children with ADHD using 6 commonly prescribed pharmacotherapies: methylphenidate immediate-release/extended-release (MPH IR/ER), methylphenidate immediate-release (MPH IR), Metadate CD (branded MPH IR/ER), Concerta (branded MPH ER), Ritalin (branded MPH IR), and Adderall (a combination of dextroamphetamine and amphetamine salts). METHODS A literature review and clinical assessment using a 27-question survey instrument were used to capture information on the clinical characteristics of ADHD, including common treatment regimens, clinical management of patients, pathways of care, and components of care. A meta-analysis provided response rates for 3 commonly used pharmacotherapies: Metadate CD, MPH IR, and Adderall. Information from the clinical assessment and the meta-analysis were used to populate a decision-analytic model to compute total expected cost for each comparator. RESULTS The average total annual expected cost per patient was

Assessment of time to follow-up visits in newly-treated hypertensive patients using an electronic medical record database

1,487 for Metadate CD,

Predictors of fixed-dose combination antihypertensive drug therapy in a Medicaid population.

1,631 for Concerta.