Determinants of glycaemic control in a practice setting: the role of weight loss and treatment adherence (The DELTA Study).

AIMS: Examine the association between weight loss and adherence with glycaemic goal attainment in patients with inadequately controlled T2DM. MATERIALS AND METHODS: Patients ≥ 18 years with T2DM from a US integrated health system starting a new class of diabetes medication between 11/1/10 and 4/30/11 (index date) with baseline HbA1c ≥ 7.0% were included in this cohort study. Target HbA1c and weight change were defined at 6-months as HbA1c < 7.0% and ≥ 3% loss in body weight. Patient-reported medication adherence was assessed per the Medication Adherence Reporting Scale. Structural equation modelling was used to describe simultaneous associations between adherence, weight loss and HbA1c goal attainment. RESULTS: Inclusion criteria were met by 477 patients; mean (SD) age 59.1 (11.6) years; 50.9% were female; 30.4% were treatment naïve; baseline HbA1c 8.6% (1.6); weight 102.0 kg (23.0). Most patients (67.9%) reported being adherent to the index diabetes medication. At 6 months mean weight change was -1.3 (5.1) kg (p = 0.39); 28.1% had weight loss of ≥ 3%. Mean HbA1c change was -1.2% (1.8) (p< 0.001); 42.8% attained HbA1c goal. Adherent patients (OR 1.70; p = 0.02) and diabetes therapies that lead to weight loss (metformin, GLP-1) were associated with weight loss ≥ 3% (OR 2.96; p< 0.001). Weight loss (OR 3.60; p < 0.001) and adherence (OR 1.59; p < 0.001) were associated with HbA1c goal attainment. CONCLUSIONS: Weight loss ≥ 3% and medication adherence were associated with HbA1c goal attainment in T2DM; weight loss was a stronger predictor of goal attainment than medication adherence in this study population. It is important to consider weight-effect properties, in addition to patient-centric adherence counselling, when prescribing diabetes therapy.

Consideration of international generic distribution policies on patient outcomes in the United States and Germany.

Generic substitution of narrow therapeutic index drugs can have unintended consequences. Generic switching is often driven by cost incentives, regulations and supply, but may raise concerns about equal bioavailability, therapeutic equivalence and about possible confusion for the patient. Integrated systems of care with active management of patient behaviors, including adherence, may minimize the impact of switching. This article is intended to present policy drivers and potential consequences of generic switching and the role of pharmacist education in minimizing patient risk using warfarin and the pharmaceutical distribution systems of the United States and Germany as examples.

Analysis of glycaemic control and weight change in patients initiated with human or analog insulin in an US ambulatory care setting.

BACKGROUND: Insulin is a mainstay in the treatment of type 1 diabetes and is a recommended option in patients with type 2 diabetes who fail to maintain glycaemic control on other non-insulin therapies. The purpose of this study was to describe patient characteristics and evaluate changes in glycaemic control and weight in patients treated with insulin in an ambulatory care setting. METHODS: Patients with diabetes were identified from the General Electric electronic medical record (EMR) database (1 September 2004 to 30 April 2008). Patients were > or =18 years, insulin naive, newly treated with monoinsulin therapy (index date). Baseline characteristics were identified overall and stratified by insulin type (basal, mixed, and rapid). Basal insulins were described by human versus analog and for insulin detemir and insulin glargine. Change in haemoglobin A1C (HbA1C) and weight from baseline (45 days pre- to 15 days postindex date) to 6 months (+/-90 days) were compared. Regression analyses were used to evaluate HbA1C outcomes across insulins and for the likelihood of gaining 0.9 kg (2 lbs) for detemir versus glargine controlling for baseline characteristics. RESULTS: A total of 12 136 patients were included. A majority were initiated on a basal insulin (64.7%) followed by mixed (20.8%) and rapid (14.4%). Basal users had significantly higher mean body weight and lower mean baseline HbA1C than mixed users (p < 0.001 for all), and were significantly older, had higher baseline HbA1C and higher baseline body mass index (BMI) than rapid insulin users (p < 0.001 for all). Glargine patients had a significantly higher mean baseline HbA1C (p = 0.003) than detemir patients. The adjusted reduction in HbA1C was greater for rapid insulin than for mixed or basal insulin (p < or = 0.05). The adjusted differences in HbA1C between basal human and basal analog insulins and between detemir and glargine were not statistically significant (p > 0.05). Patients using detemir were 30% less likely to gain 0.9 kg or more than glargine users (p < 0.05). CONCLUSIONS: HbA1C outcomes in the ambulatory care setting were generally not different between insulin classes. The likelihood of weight gain was less with insulin detemir than with insulin glargine. Thus, real-world weight outcomes for basal analog insulin may differ by specific product.

Six-month outcomes on A1C and cardiovascular risk factors in patients with type 2 diabetes treated with exenatide in an ambulatory care setting.

AIM: This study evaluated changes in clinical effectiveness measures of patients with type 2 diabetes initiating exenatide therapy in a real-world setting. METHODS: Eligible patients identified in the General Electric (GE) electronic medical record (EMR) research database from 1 January 2000 through 31 December 2007 were > or =18 years old with type 2 diabetes. Patients had prescription orders in the previous 395 days for metformin, a sulfonylurea, or a thiazolidinedione as monotherapy or in combination, and had at least 6 months of follow-up activity. Baseline clinical measures were documented from 45 days prior up to 15 days after exenatide initiation and follow-up measures documented at 6 months +/- 45 days. RESULTS: A total of 1709 patients were identified for study inclusion. The overall mean A1C reduction (s.e.m.) at 6 months was -0.8% (0.05) (p<0.001), weight loss was -3.2 kg (0.14) (p<0.001), blood pressure (BP) lowering was -1.9 mmHg (0.46) systolic blood pressure (SBP) (p<0.001) and -0.5 mmHg (0.27) diastolic blood pressure (DBP) (p = 0.078). Changes in low-density lipoprotein (LDL), triglycerides and HDL were -7.4 mg/dl (1.7) (p<0.001), -23.2 mg/dl (6.7) (p = 0.001) and -0.8 mg/dl (0.33) (p = 0.012) respectively. In a quartile analysis by weight loss, mean A1C reduction ranged from -1.1 to -0.65% in the highest to lowest weight loss quartiles respectively. CONCLUSIONS: In a real-world setting, exenatide initiation is associated with significant improvements in the measures of clinical effectiveness for type 2 diabetes. These reductions were comparable to those reported in randomized, controlled registration trials after 6 months of therapy.

Cytotoxicity, uptake, polyglutamate formation, and antileukemic effects of 8-deaza analogues of methotrexate and aminopterin in mice.

In contrast to methotrexate (MTX) and aminopterin (AMT), the 8-deaza analogues of these antifolates are not substrates for rabbit liver aldehyde oxidase. Since they are not converted to 7-hydroxy derivatives, they have been investigated with regard to their cytotoxicity for CCRF-CEM cells, transport into these cells, and conversion to polyglutamate forms. For this purpose 3H-labeled analogues were synthesized. The drug concentrations of the analogues required to inhibit cell growth by 50% are significantly lower than for the parent compounds particularly for a short exposure of cells to the drug. Vmax and Km for unidirectional influx do not differ greatly among the four drugs, but amounts of uptake over 1 h are markedly different and increase in the order MTX less than 8-deazaMTX less than AMT less than 8-deazaAMT. During 1 h of uptake a much greater proportion of the 8-deaza analogues is converted to polyglutamate forms than in the case of parent drugs. Only 52% of MTX is converted to polyglutamates, whereas in the case of the other three compounds the conversion is greater than or equal to 90%. However, MTX is relatively efficient in adding two glutamate residues, whereas the other drugs predominantly accumulate as forms with only one additional glutamate (+Glu1). During 1 h of efflux the drugs without additional glutamates decrease to low concentrations and there is also a major loss of +Glu1 form, but there is also an increase in longer chain forms, especially in the case of MTX. The net result is a still greater disparity in total intracellular levels of the four drugs after the period of efflux. MTX has much lower toxicity in mice in vivo than the other three compounds, 8-deazaAMT being the most toxic. At the maximum tolerated dose MTX produced a considerably greater increase in life span for mice bearing P388 than any of the other drugs, and a somewhat greater increase for mice bearing L1210. Thus the 8-deaza analogues do not offer a therapeutic advantage over MTX against leukemias in the mouse, primarily due to their much greater toxicity.

The effect of pharmacogenetic profiling with a clinical decision support tool on healthcare resource utilization and estimated costs in the elderly exposed to polypharmacy.

OBJECTIVE: To compare healthcare resource utilization (HRU) and clinical decision-making for elderly patients based on cytochrome P450 (CYP) pharmacogenetic testing and the use of a comprehensive medication management clinical decision support tool (CDST), to a cohort of similar non-tested patients. METHODS: An observational study compared a prospective cohort of patients ≥65 years subjected to pharmacogenetic testing to a propensity score (PS) matched historical cohort of untested patients in a claims database. Patients had a prescribed medication or dose change of at least one of 61 oral drugs or combinations of ≥3 drugs at enrollment. Four-month HRU outcomes examined included hospitalizations, emergency department (ED) and outpatient visits and provider acceptance of test recommendations. Costs were estimated using national data sources. RESULTS: There were 205 tested patients PS matched to 820 untested patients. Hospitalization rate was 9.8% in the tested group vs. 16.1% in the untested group (RR = 0.61, 95% CI = 0.39-0.95, p = 0.027), ED visit rate was 4.4% in the tested group vs. 15.4% in the untested group (RR = 0.29, 95% CI = 0.15-0.55, p = 0.0002) and outpatient visit rate was 71.7% in the tested group vs. 36.5% in the untested group (RR = 1.97, 95% CI = 1.74-2.23, p < 0.0001). The rate of overall HRU was 72.2% in the tested group vs. 49.0% in the untested group (RR = 1.47, 95% CI = 1.32-1.64, p < 0.0001). Potential cost savings were estimated at $218 (mean) in the tested group. The provider majority (95%) considered the test helpful and 46% followed CDST provided recommendations. CONCLUSION: Patients CYP DNA tested and treated according to the personalized prescribing system had a significant decrease in hospitalizations and emergency department visits, resulting in potential cost savings. Providers had a high satisfaction rate with the clinical utility of the system and followed recommendations when appropriate.

The Impact of Generic Substitution on Health and Economic Outcomes: A Systematic Review.

BACKGROUND: Generic drugs are considered therapeutically equivalent to their original counterparts and lower in acquisition costs. However, the overall impact of generic substitution (GS) on global clinical and economic outcomes has not been conclusively evaluated. OBJECTIVE: To test whether (1) generics and original products yield the same health outcomes, and (2) generic therapies save economic resources versus original therapies. METHODS: We performed a systematic literature review in Medline, Embase, and the Cochrane Database of Systematic Reviews to identify original studies that examine clinical or economic outcomes of GS. After standardized data extraction, reported outcomes were categorized as supporting or rejecting the hypotheses. Each reported outcome was assessed and accounted for supporting and opposing GS. One publication could provide multiple outcome comparisons. RESULTS: We included 40 studies across ten therapeutic areas. Fourteen studies examined patients on de novo therapy; 24 studies investigated maintenance drug therapy, and two studies considered both settings. Overall, 119 outcome comparisons were examined. Of 97 clinical outcome comparisons, 67% reported no significant difference between generic drugs and their off-patent counterparts. Of 22 economic comparisons, 64% suggested that GS increased costs. Consequently, hypothesis (1) was supported but hypothesis (2) was not. We found no major differences among studies that investigated clinical outcomes with de novo or maintenance therapy. CONCLUSION: The review suggests that clinical effects are similar after GS. However, economic savings are not guaranteed. More systematic research comparing clinical and economic outcomes with or without GS is needed to inform policy on the use of generic substitution.

Folate analogues as inhibitors of thymidylate synthase.

Recent demonstrations that deazafolate analogues may act as potent inhibitors of thymidylate synthase (TS) provided a firm rationale for the synthesis of N10-propargyl derivatives of 8-deazafolate and 8-deazaaminopterin (4). A complete assignment of the 1H NMR spectra of these compounds was made possible through application of 2D (COSY) techniques at 200 MHz. Data describing the inhibition of TS derived from human leukemia (K562) cells are presented. IC50 values of 2.25 and 1.26 microM were determined for 8-deaza-10-propargylfolate (3) and 8-deaza-10-propargylaminopterin, respectively. Comparison of the data for various folate analogues reveals a striking dependence of TS inhibitory potency upon the number of nitrogens in the folate pyrazine ring.

Patterns of antihypertensive use among patients in the US Department of Defense database initially prescribed an angiotensin-converting enzyme inhibitor or calcium channel blocker.

The US Department of Defense recently assembled electronic records of outpatient prescriptions dispensed through the Uniformed Services Prescription Database Project (USPDP) going back to 1990. The objectives of this portion of a larger study were: (1) to examine longitudinally the patterns of antihypertensive drug use during the first year of therapy in patients whose initial therapy was with an angiotensin-converting enzyme (ACE) inhibitor or a calcium channel blocker (CCB); (2) to determine continuous and noncontinuous users of antihypertensive drugs; and (3) to estimate the direct medication costs for each pattern of medication use. Filtering criteria for patient and prescription identification were developed, because the USPDP contains no records of confirmatory diagnoses of hypertension. Once data filters were implemented, information for 771 patients was analyzed. An ACE inhibitor was the initial therapy for 328 patients, accounting for 1935 antihypertensive medication prescription fills, and a CCB was the initial therapy for 443 patients, accounting for 2459 fills (including refills). Slightly more than half of the patients (n = 401, 52.0%) were classified as continuous users (> or = 80% medication-possession ratio [supply of medication in days divided by the number of days in the 12-month study period]). In the first year, 177 of these continuous users (44.1%) had no change in therapy in the first year, 49 (12.2%) had an increase in dose, 8 (2.0%) had a decrease in dose, 15 (3.7%) had a change to a different therapeutic class of antihypertensive medication, 14 (3.5%) were changed to a different medication in the same therapeutic class, 20 (5.0%) had a new medication added to the regimen, and 118 (29.4%) had complex regimens involving more than one change. For continuous users, the mean medication supply in days was 354.6, and the average time before a medication change was 152.1 days for those continuous users who had one change in therapy. The overall average wholesale price (AWP) and average manufacturer price (AMP) for continuous users during 1 year of therapy were $471.31 and $378.51, respectively. For those patients whose therapy was changed to an ACE inhibitor/CCB combination and who were continuous users, the average AWP was $598.47 per year ($492.05 AMP). Once the change from monotherapy to an ACE inhibitor/CCB combination occurred in continuous users, AWP costs per member per month increased by approximately $22.00 ($18.00 AMP). Over half of the patients whose initial therapy was an ACE inhibitor or CCB had at least one change in their first year of therapy. Research into the reasons for these changes and their outcomes is needed.

The challenge of integrating monoclonal antibodies into the current healthcare system.

Although there are few monoclonal antibody (MoAb) products on the market, the biotechnology industry has made considerable progress over the last decade. The industry has developed new technology to address the primary hurdles facing the development of MoAbs--including the immune response to murine-derived antibodies as well as lack of tumor specificity. As the techniques for development become more refined, more products will be approved by the Food and Drug Administration. Integrating these products into the existing healthcare system will be a challenge, given their high acquisition costs. Recent pharmacoeconomic examples outlined in this paper confirm that MoAb products will need to be supported with proven clinical and economic profiles. As long as a global clinical and economic perspective is taken and patient care benefits can be demonstrated, the place of MoAbs in the future of healthcare will be assured.

Evaluation of Pharmacy and Therapeutic (P&T) Committee member knowledge, attitudes and ability regarding the use of comparative effectiveness research (CER) in health care decision-making.

BACKGROUND: Comparative effectiveness research (CER) is a constellation of research methods designed to improve health care decision making. Educational programs that improve health care decision makers' CER knowledge and awareness may ultimately lead to more cost-effective use of health care resources. OBJECTIVES: This study was conducted to evaluate changes in CER knowledge, attitudes, and ability among Pharmacy and Therapeutics (P&T) Committee members and support staff after attending a tailored educational program. METHODS: Physicians and pharmacists from two professional societies and the Indian Health Service who participated in the P&T process were invited via email to participate in this study. Participants completed a questionnaire, designed specifically for this study, prior to and following the 4-hour live, educational program on CER to determine the impact on their related knowledge, attitudes, and ability to use CER in decision-making. Rasch analysis was used to assess validity and reliability of subsections of the questionnaire and regression analysis was used to assess programmatic impact on CER knowledge, attitude, and ability. RESULTS: One hundred and forty of the 199 participants completed both the pre- and post-CER session questionnaires (response rate = 70.4%). Most participants (>75%) correctly answered eight of the ten knowledge items after attending the educational session. More than 60% of the respondents had a positive attitude toward CER both before and after the program. Compared to baseline (pretest), participants reported significant improvements in their perceived ability to use CER after attending the session in these areas: using CER reviews, knowledge of CER methods, identifying problems with randomized controlled trials, identifying threats to validity, understanding of evidence synthesis approaches, and evaluating the quality of CER (all P values < 0.001). The questionnaire demonstrated acceptable reliability and validity evidence (limited evidence of construct under-representation and construct irrelevant variance). CONCLUSIONS: The CER educational program was effective in increasing participants' CER knowledge and self-perceived ability to evaluate relevant evidence. Improving knowledge and awareness of CER and its applicability is a critical first step in improving its use in health care decision making.

Outcomes associated with concordance of oral antidiabetic drug treatments to prescribing information in patients with type 2 diabetes mellitus and chronic kidney disease.

OBJECTIVES: This retrospective study aims to examine the association between prescribing information (PI)-concordant oral antidiabetic drug (OAD) treatment and clinical and economic outcomes in patients with type 2 diabetes mellitus and stages 3-5 chronic kidney disease (CKD). METHODS: The study used a large, national administrative claims database with laboratory findings to identify patients with a diagnosis of diabetes and indication of stages 3-5 CKD (first observed indication as the index date) between 1/1/2005 and 30/06/2009. OADs prescribed during 6 months following the index date (baseline period) were evaluated and patients were considered non-PI-concordant if any did not meet the recommendations regarding patients with renal impairment. Glycemic control and measures of healthcare costs (standardized to 2010 US dollars using the Consumer Price Index) and resource utilization were assessed during the 12 months following the baseline period. Severe hypoglycemic events were assessed after the baseline period until lost to follow-up. Regression analyses were performed after adjusting for demographic and clinical characteristics. RESULTS: Among the 3300 patients included in the study, 2454 (74.4%) were non-PI-concordant. The non-PI-concordant patients had higher risk of severe hypoglycemic events identified in all settings (HR = 1.35, 95% CI: 1.10-1.67) and events identified in inpatient hospital setting (HR = 2.51, 95% CI: 1.49-4.22), were more likely to have inpatient hospital admissions (OR = 1.27, 95% CI: 1.02-1.57), and were less likely to have glycemic control (OR = 0.56, 95% CI: 0.44-0.71). Annual diabetes-related cost was $1638 higher in the non-PI-concordant cohort (p = 0.0048). LIMITATION: The retrospective cohort design does not allow for conclusions to be drawn on the causal effect of PI-concordant use based on the associations observed. CONCLUSION: Our findings suggest PI-concordant treatment to be associated with better clinical and diabetes-associated economic outcomes. Future research is warranted to confirm the associations found in this study.

Evaluation of cardiovascular risk factors, events, and costs across four BMI categories.

OBJECTIVE: The purpose of this study was to analyze the 1-year cost of cardiovascular (CV) events by body mass index (BMI) subgroups from a US employer health plan perspective. DESIGN AND METHODS: Patients aged 20-64 years from the GE Centricity Electronic Medical Record, National Health and Nutrition Examination Survey, and MarketScan databases were used to determine prevalence of risk factors (RFs) and CV events and 1-year costs. Risk factors included hypertension (HTN), diabetes, and hyperlipidemia (HLD) and CV events included myocardial infarction, angina, heart failure, and stroke. CV event costs were determined from claims by ICD-9 code in patients with overweight/obesity. RESULTS: Of 220,136 patients identified in GE, BMI was 25-26.9 in 19.4%, 27-29.9 in 30.4%, 30-34.9 in 27.9%, and ≥35 in 22.3%. Patients with diabetes, HTN, and HLD increased with BMI from 1.8% (25-26.9) to 11.4% (≥35) in males and 1.1% to 6.8% in females. Prevalence of CV events increased from 0.1% with no RFs up to 10.2% with multiple RFs. The average 1-year cost per patient increased from $1122 to $2383 as BMI increased. CONCLUSIONS: Patients with higher BMI values had an increased prevalence of RFs and CV events, which lead to higher average 1-year costs.

Predictors of persistence with 5-aminosalicylic acid therapy for ulcerative colitis.

BACKGROUND: Individuals with ulcerative colitis (UC) are at risk for poor persistence with therapy. AIM: To identify factors predicting persistence with 5-aminosalicylic acid (5-ASA) therapy after 3 and 12 months in subjects with UC. METHODS: In this retrospective cohort study, persistence with 5-ASA therapy was determined from prescription refill data from a commercial health insurance claims database. The analysis included subjects with UC who filled a prescription for any oral 5-ASA between October 2002 and September 2004. Persistence was defined as prescription refill at 3 and/or 12 months. Multivariate logistic regression modelling identified variables independently associated with persistence at 3 and 12 months. RESULTS: In all, 3574 subjects were identified. Fifty-seven per cent (2044) were persistent at 3 months. Glucocorticoid use before the index prescription predicted improved persistence at 3 months. Psychiatric diagnosis, mail order of the index prescription, female gender and co-pay predicted decreased persistence. At 12 months, 1124 (55%) remained persistent. Rectal 5-ASA use, older age and switching to a different 5-ASA predicted improved persistence at 12 months. Hospitalization for a gastrointestinal condition, mail order of the 3-month prescription and number of co-morbid illnesses predicted lower persistence. CONCLUSION: Persistence with 5-ASA treatment in UC is complex and multifactorial, and differs by time period.

The economic consequences of noncompliance in cardiovascular disease and related conditions: a literature review.

OBJECTIVES: To review studies on the cost consequences of compliance and/or persistence in cardiovascular disease (CVD) and related conditions (hypertension, dyslipidaemia, diabetes and heart failure) published since 1995, and to evaluate the effects of noncompliance on healthcare expenditure and the cost-effectiveness of pharmaceutical interventions. METHODS: English language papers published between January 1995 and February 2007 that examined compliance/persistence with medication for CVD or related conditions, provided an economic evaluation of pharmacological interventions or cost analysis, and quantified the cost consequences of noncompliance, were identified through database searches. The cost consequences of noncompliance were compared across studies descriptively. RESULTS: Of the 23 studies identified, 10 focused on hypertension, seven on diabetes, one on dyslipidaemia, one on coronary heart disease, one on heart failure and three covered multiple diseases. In studies assessing drug costs only, increased compliance/persistence led to increased drug costs. However, increased compliance/persistence increased the effectiveness of treatment, leading to a decrease in medical events and non-drug costs. This offset the higher drug costs, leading to savings in overall treatment costs. In studies evaluating the effect of compliance/persistence on the cost-effectiveness of pharmacological interventions, increased compliance/persistence appeared to reduce cost-effectiveness ratios, but the extent of this effect was not quantified. CONCLUSIONS: Noncompliance with cardiovascular and antidiabetic medication is a significant problem. Increased compliance/persistence leads to increased drug costs, but these are offset by reduced non-drug costs, leading to overall cost savings. The effect of noncompliance on the cost-effectiveness of pharmacological interventions is inconclusive and further research is needed to resolve the issue.

The effect of fixed combination of fluticasone and salmeterol on asthma drug utilization, asthma drug cost, and episodes of asthma exacerbations.

OBJECTIVE: This study evaluated the use and drug costs of inhaled corticosteroids (ICSs), long-acting beta2-agonists (LABAs), and fluticasone propionate and salmeterol in a fixed-dose combination (FSC) and their relationship to asthma exacerbations before and after the market introduction of FSC in April 2001. METHODS: This is a retrospective analysis of employer-sponsored health insurance claims filed between January 1, 1998, and December 31, 2003 to detect impact of introduction of FSC (approved by the US Food and Drug Administration in August 2000) on utilization and cost of FSC, any ICS (excluding FSC), and any LABA (excluding FSC) along with utilization of medical services related to asthma exacerbations. Asthma medications were identified using National Drug Codes and Redbook, whereas asthma exacerbations were identified using ICD-9-CM primary diagnosis code 493.x. These medical and pharmacy claims were converted to rates per 100 asthma office visits. RESULTS: For all ICSs, the average pharmacy claims per 100 office visits increased from 383 in the year before FSC was introduced to 407 (120 [29.5%] were for FSC and 287 [70.5%] were for single-entity ICSs) in 2003. LABA prescribing increased from 72 in the year before FSC to 147 (120 from FSC, 27 single-entity LABA) in 2003 (p < 0.001). An additional $13,511 per 100 asthma office visits was spent on the FSC product (p < 0.001). After the introduction of FSC, there was no significant difference in asthma admissions (p = 0.17), whereas emergency department (ED) visits increased by 0.92 visits per 100 office visits (p = 0.03). The diagnosis and severity of asthma was inferred from the pharmacy claims and patients with chronic obstructive pulmonary disease could not be excluded. In addition, the study was not designed to assess the impact of other asthma medications on the disease and/or associated costs, and patient adherence to claimed medication could not be monitored. CONCLUSIONS: The introduction of FSC was associated with increased LABAs/FSC patient exposure and expenditure with no change in asthma hospitalizations and an increase in ED visits.