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PDB18 EVALUATION OF CLINICAL INERTIA IN DIABETES CARE OF NON-INSULIN-DEPENDENT TYPE 2 DIABETIC PATIENTS
A286 PDB14 HOSPITALIZATION ATTRIBUTED TO DIABETES MELLITUS AND ITS COMPLICATIONS IN THE PRIVATE HEALTH-CARE SYSTEM IN RIBEIRÃO PRETO REGION, BRAZIL Rosa R1, Bahia L2, Monteiro R3, Asano E4, Nita ME4, Donato BM5, DIAPS79 study grou P6 1 UFRGS, Porto Alegre, RS, Brazil; 2MedInsight, Rio de Janeiro, RJ, Brazil; 3USP, Ribeirão Preto, SP, Brazil; 4Bristol-Myers Squibb S/A, São Paulo, SP, Brazil; 5Bristol-Myers Squibb, Wallingford, CT, USA; 6Diabetes Mellitus Type 2 in the Brazilian Private Health Care System DIAPS79, São Paulo, SP, Brazil INTRODUCTION: Studies about the impact of hospitalizations for diabetes in the Private Health System are unknown in Brazil. OBJECTIVES: To estimate the dimension of hospitalization for diabetes mellitus (DM) and its complication in the private health-care system in Ribeirão Preto (RP) region, São Paulo. METHODS: Hospitalization data from 26 private hospitals of RP region (26 cities) were collected from a database of Social Medicine Department from São Paulo University (CPDH-Centro de Processamento de Dados). These data comprised an average of 35,964 admissions per year (2006–2007) of patients from 30 to 74 years old. Combinations of DM prevalence and hospitalization relative risk for chronic complications and general medical conditions (GMC) were added to DM first-listed hospitalizations (attributable risk methodology). The chronic complications diagnoses were divided into five groups: neurological disease, peripheral vascular disease (PVD), cardiovascular disease (CVD), renal disease, and other diabete-related complications. RESULTS: From the whole admissions, 6037 (17%) hospitalizations were attributed to DM (first-listed, chronic complications, and GMC), 3520 (58.3%) women and 2517 (41.7%) men, 1145 (19%) were from 30 to 44 years old patients, 2284 (38%) from 45 to 59, and 2607 (43%) from 60 to 74. DM as first-listed diagnosis accounted for 313 (5.2%) hospitalizations, chronic complications for 2394 (39.6%), and GMC for 3330 (55.2%). CVD (5.3%) and PVD (8.7%) represented 14% of all hospitalizations in the whole population, contrasting to 34.3% (20.9% and 13.4% respectively) in hospitalizations attributed to DM. Hospitalization rates were very similar between sex, except for cardiovascular disease (25% men vs. 18% women). Admissions due to DM represent 37% out of all hospitalizations for chronic diseases (6478). They represent 28% for neurological diseases, 42% for PVD, 41% CVD, and 20% for renal diseases. CONCLUSIONS: DM and its complications impose a relevant burden to private health-care system in Ribeirão Preto region, especially for PVD and DCV hospitalizations. PDB15 WEIGHT CHANGE FOR PATIENTS WITH TYPE 2 DIABETES: SECULAR TRENDS AND IMPACT OF DIFFERENT COMBINATIONS OF THERAPY Morgan CL1, Poole CD1, Jenkins-Jones S1, Evans LM2, Currie CJ 1 Pharmatelligence, Cardiff, UK; 2University Hospital of Wales, Cardiff, Vale of Glamorga, UK; 3 Cardiff University, Cardiff, Wales, UK OBJECTIVES: To describe the secular trend of weight gain for patients with type 2 diabetes and patterns of weight change associated with different diabetes therapy regimens using data from general clinical practice. METHODS: Data were extracted from the THIN database, where patients with type 2 diabetes were identified. The secular trend in weight for patients with type 2 diabetes was plotted for each year from 1995 to 2008 for both prevalent and for incident cases. Baseline weight at the start of the treatment period was compared to absolute and relative weight at circa 6-, 12-, and 24-month periods and compared using the Wilcoxon signed rank test for different treatment regimens. RESULTS: Mean, standardized prevalent weight increased from 84.9 to 93.6 kg for males and from 75.2 kg to 82.1 kg for females between 1995 and 2008. For incident cases, the respective figures were 89.6 kg to 96.6 kg for males and 78.4 kg to 85.7 kg for females. The total number of valid therapy periods was 105,991, accounting for over 70 different regimen combinations. There were 28 therapy combinations with a minimum of 50 observations which were selected for analysis. Between baseline and 6, 12, and 24 months, there were significant changes in weight for the majority of treatment regimens. The largest weight increase at 12 months was for patients prescribed metformin, insulin, sulfonylurea, and thiazolidinedione (median increase of 4.9 kg [95% CI 1.5 to 7.4, P < 0.001]). The largest weight decrease at 12 months patients prescribed metformin and exenatide with a median decrease of −8.1 kg (95% CI −11.0 to −5.0, P < 0.001). CONCLUSIONS: There was evidence of a secular trend of weight increase for patients with diabetes. As the impact of weight increase upon vascular outcomes is clear, consideration should be given to the affect that different treatment regimens have upon weight change. PDB16 INSULIN GLARGINE IS ASSOCIATED WITH A LOWER INCIDENCE OF DIABETIC FOOT SYNDROME AND MACROVASCULAR COMPLICATIONS COMPARED TO NPH INSULIN IN TYPE 2 DIABETICS UNDER GERMAN REAL-LIFE CONDITIONS Siegmund T1, Dippel FW2, Kostev K3, Lauterbach S4, Fuchs S5, Kotowa W5 1 Städt. Klinikum München GmbH, Munich, Germany; 2Sanofi-Aventis Deutschland GmbH, Berlin, Germany; 3IMS Health GmbH & Co. OHG, Frankfurt am Main, Germany; 4Apotheke Rotes-Kreuz-Krankenhaus, Kassel, Germany; 5IMS Health GmbH & Co. OHG, Nürnberg, Germany OBJECTIVES: The purpose of this study was to evaluate the relationship between the long-acting insulin analogue glargine (GLA) versus Neutral Protamine Hagedorn insulin (NPH) regarding the incidence of diabetic foot syndrome (DFS), myocardial infarction (MI), and ischemic stroke (IS) in type 2 diabetics (T2D) under real-life conditions in Germany. METHODS: A historic cohort study based on a representative German database (IMS® Disease Analyzer) included T2D who started a basal sup-
13th Euro Abstracts ported oral therapy (BOT) with either GLA or NPH between July 2000 and September 2007 (index date) and who provided continuously documented data between 12 months before and 24 months after initiation of BOT. Data were collected from index date until the occurrence of an event (DFS or MI/IS) or until August 2009. Duration of therapy was ≥24 months to demonstrate a potential effect of insulins considered. Therefore, the end points were measured as from the second year after index date. The identification of the end points was according to ICD-10 codes (MI: I22 and I23; IS: I63 and I64) or the original doctors texts (DFS). Kaplan–Meier curves were generated and compared by log-rank tests. Cox proportional hazard models were used to estimate the adjusted hazard ratio (HR) for the incidence of DFS and MI/IS. RESULTS: A total of 23,395 T2D fulfilled the inclusion criteria and started a BOT either with GLA (n = 9,638) or with NPH (n = 13,757). After adjustment for demographic and clinical variables, it could be demonstrated that GLA reduced the relative DFS risk by 64 % in T2D when compared to NPH (HR = 0.611; P = 0.0405). Furthermore, GLA decreased the relative MI/IS-risk by 49 % (HR = 0.671; P = 0.0562). CONCLUSIONS: When compared to NPH, GLA significantly reduces the risk of DFS in T2D under real-life conditions. Additionally, a reduction of the macrovascular events MI/IS was shown with GLA versus NPH. Prospective trials should be conducted to confirm these results. PDB17 GLYCATED HEMOGLOBIN AS A SURROGATE MARKER FOR THE APPEARANCE AND PROGRESSION OF MACRO VASCULAR COMPLICATIONS IN TYPE 2 DIABETES MELLITUS: SYSTEMATIC REVIEW AND META-ANALYSIS Weczorek A1, Marcisz A1, Rys P2, Skrzekowska-Baran I1, Plisko R1, Wladysiuk M1 1 HTA Consulting, Krakow, Poland; 2NovoNordisk, Warsaw, Poland OBJECTIVES: We performed a systematic review and meta-analysis to examine the association between HbA1c and the appearance and progression of macrovascular complications (MVC) in T2DM. METHODS: The two electronic medical databases (MEDLINE, CENTRAL) were searched to identify all papers reporting HbA1c level and macrovascular complications in T2DM. Observational and randomized, controlled trials (RCTs) with at least 1 year of follow-up were included. Estimates were made of the adjusted relative risk (or odds ratio) of complications for an increase in HbA1c of 1%. If data were insufficient to calculate RR, the odds ratio (OR) was estimated. Weighted mean differences (WMD) in HbA1c level between the case group and the control group were also calculated. RR (OR) was estimated for HbA1c increase of 1%. RESULTS: We identified 11 trials that fulfilled the inclusion criteria. Pooled data from two randomized studies showed that RR of the incidence of stroke was 3.40 (95% CI: 1,77; 6.56), myocardial infarction (two studies): 3.19, (95% CI: 1.41; 7.24) and the risk of extremity amputation or vascular surgery caused by peripheral vessels (two studies): 2.12 (95% CI: 1.08; 4.16). The results were confirmed in observational studies for stroke and myocardial infarction. No correlation was found between deaths from cardiovascular disease and HbA1c increase: RR = 1.21, (95% CI: 0.64; 2.28), but it was shown in observational studies: RR = 5.72 (95% CI: 0.76; 43.02). CONCLUSIONS: Relatively low number of studies and the number of observed macrovascular complications impede unequivocal conclusions. However, the results of our systematic review indicate a correlation between HbA1c level and appearance and progression of MVC in T2DM, especially stroke, heart infarction, and peripheral vessel disease. Thus, HbA1c might be considered a surrogate end point for MVC in T2DM, although influence of other factors (e.g., blood pressure, LDL cholesterol) should be considered.
DIABETES/ENDOCRINE DISORDERS – Cost Studies PDB18 EVALUATION OF CLINICAL INERTIA IN DIABETES CARE OF NON-INSULIN-DEPENDENT TYPE 2 DIABETIC PATIENTS Font B1, Galera J2, Lahoz R3, Gambús G2, González Clemente JM4 1 Novartis Pharma, Barcelona, Spain; 2Novartis Pharma, Barcelona, Barcelona, Spain; 3Novartis Farmacéutica S.A., Barcelona, Barcelona, Spain; 4Corporació Sanitària Parc Taulí, Sabadell, Barcelona, Spain OBJECTIVES: Clinical inertia (CI) is usually defined as the absence of drug therapy intensification in patients who fail to achieve the objectives of standard treatment. This study aims to describe the CI associated with a noninsulinized patient population with type 2 diabetes (DM2) in Spain. METHODS: Epidemiologic, retrospective, and multicenter study conducted in primary and specialist care consultations from Spain. Inclusion criteria were: adults with non-gestational DM2 and uncontrolled status (HbA1c ≥ 7%), oral hypoglycemic therapy initiated at least 2 years before, and HbA1c values available for a minimum period of three visits. Complete CI was defined as the absence of hypoglycemic treatment intensification in all uncontrolled HbA1c values. Partial CI was defined as the absence of intervention for at least one uncontrolled HbA1c value. RESULTS: 1555 patients who met all inclusion criteria have been included. Mean (SD) patients’ age was 64.7 ± 10.3 years and time from diagnosis was 9.2 ± 5.7 years. Seventy-four percent of patients presented abdominal obesity. Complete CI was estimated as 13.5%, while partial CI was observed in 31.4% of controlled patients and 71.8% of uncontrolled patients. The mean changes of treatment were 1.0 ± 1.02 in controlled patients vs. 1.8 ± 1.2 in uncontrolled patients (P < 0.0001). Significant factors statistically associated (P < 0.05) with current lack of glycemic control were: obesity, sedentary lifestyle, hypertension, hyperlipidemia, total number
13th Euro Abstracts of risk factors, and smoking status. Patients with ≥4 risk factors account for 71.7% of current glycemic control group, while this value reached 84.3% in the uncontrolled group (P < 0.0001). CONCLUSIONS: In one out of seven patients with DM2 and poor glycemic control, none action to intensify treatment has been taken during the past 2 years. Patients without current glycemic control have more than two times higher clinical inertia than the controlled ones. Intensification of treatment is twice as common in patients currently uncontrolled (85.1% vs. 44.9%). PDB19 BUDGET IMPACT ANALYSIS OF SAXAGLIPTIN FOR THE TREATMENT OF TYPE 2 DIABETES IN MEXICAN POPULATION AT PEMEX Juarez-Garcia A1, Martinez-Rivera G1, Anaya P2, Donato BM3 1 Bristol-Myers Squibb, Mexico City, Mexico; 2AstraZeneca, Edo. de Méx., Mexico; 3 Bristol-Myers Squibb, Wallingford, CT, USA OBJECTIVES: Diabetes affects approximately 8 million people in Mexico and is the first cause of death in the country. Ninety percent of all diabetes is classified as type II diabetes (T2DM). Saxagliptin, a DPP4 inhibitor, is one of a class of drugs orally administered for treatment of T2DM. Petroleos Mexicanos (PEMEX) health-care system covers approximately 43,977 patients diagnosed with T2DM. The objectives of this study are to: 1) analyze the current utilization and expenditure for oral antidiabetics (OADs) by PEMEX; and 2) evaluate the budget impact of saxagliptin for treatment of T2DM population. METHODS: An MS Excel-based budget impact model of the total population diagnosed with T2DM in PEMEX was used. OAD usage was based on the total amount purchased, by the Institution in 2009. The prices of medications were taken from the published price listing by PEMEX (2009). The following OAD medications were included in the analysis: pioglitazone, rosiglitazone, vildagliptin, and saxagliptin. Pharmaceutical expenses of OADs were considered excluding other medical costs. The time horizon was 3 years and the assumptions of the model including market dynamics were estimated by Bristol Myers Squibb. The budget impact is reported in terms of additional annual total costs. Results are presented in US dollars with an exchange rate of $13.4 MXN. RESULTS: The usage of saxagliptin in PEMEX represents savings to the institution of US$56,132 for the first year of use, with increases in savings for year two and year three US$102,910 and US$154,441 respectively. The impact of saxagliption on the budget was primarily driven by the gradual substitution of pioglitazone, rosiglitazone, and vildagliptin with saxagliptin over the 3-year of analysis. CONCLUSIONS: The budget impact of adding saxagliptin as a treatment option for T2DM patients reveals that the accumulated savings for PEMEX for the estimated timeframe is around US$ 313,485. PDB20 A PHARMACOECONOMIC MODEL FOR ADJUVANT TREATMENT IN A SMOKING CESSATION INTERVENTION IN PATIENTS WITH TYPE 2 DIABETES MELLITUS AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE Kayadibinli M1, Durguner B1, Ulus P1, Ozdemir B2 1 Pfizer Pharmaceuticals, Istanbul, Turkey; 2Omega Contract Research Organization, Ankara, Turkey OBJECTIVES: The present model was aimed to demonstrate the annual cost of the smoking-related diseases in patients with type 2 diabetes mellitus (DM) and chronic obstructive pulmonary disease (COPD), and to establish the budget that would be saved with varenicline (nicotinic receptor partial agonist) reimbursement by the government. METHODS: The model was carried out in two contexts; the costs of the smoking-related diseases and exacerbations in patients with type 2 DM and COPD were estimated in smoking conditions, and varenicline use. The model was constructed on a total of 900,000 type 2 DM patients and 106,410 COPD patients by assuming approximately 3.8 million type 2 DM patients and 2.0 million COPD patients in Turkey of which 23% and 48% were considered to be smokers, respectively. RESULTS: According to the model, the ratio of patients willing to quit smoking was estimated as 35% in type 2 DM group and 54% in COPD group. Of those, 20% (n = 63,000) type 2 DM patients and 30% (n = 17,238) COPD patients were assessed to use varenicline. The annual cost of the smoking-related diseases and exacerbations was calculated as 72.40 million USD according to the 43,341 events; the unit direct costs for myocardial infarcts, stroke, and congestive heart failure were calculated as US$2,523.55, US$1,930.70, and US$1,412.33, respectively, in type 2 DM patients, whereas it was US$1,567.55 in COPD patients. After varenicline use, the government would save US$9.47 million per year by 5608 preventable events. Moreover, the annual cost of varenicline was estimated to be US$23.46 million for 80,238 patients. Accordingly, the total cost of the smoking-related diseases and exacerbations would be US$13.99 million for the first year. CONCLUSIONS: Varenicline reimbursement decreases the annual cost of the smoking-related diseases and exacerbations in patients with type 2 DM and COPD. PDB21 COMPARISON OF COSTS OF THE INSULIN TREATMENT OF TYPE 2 DIABETES MELLITUS WITH INSULIN GLARGINE AND INSULIN DETEMIR Álvarez Guisasola F1, Mauricio Puente D2, Garcia Coscolin T3, Rubio Terres C4 1 Center of Health La Calzada, Gijón, Asturias, Spain; 2Vilanovaxs Arnau Hospital, Lleida, Spain; 3Sanofi-Aventis, Madrid, Spain; 4Health Value, Madrid, Spain OBJECTIVES: Large published data suggested that some patients initiating with the recommended once-daily detemir administration require twice-daily dosing to opti-
A287 mize blood glucose control; therefore, the clinical outcome in this selected population was tested in a randomized controlled trial. The objective of this study is to compare the costs of two treatments of type 2 diabetes mellitus (DM2): Insulin glargine (glargine) and insulin detemir (detemir) in patients with DM2 not controlled with OADs. METHODS: A costs analysis of the insulin treatment was carried out with National Health System perspective. Costs with glargine or detemir linked to DM2 patients were calculated according to the administered doses in a clinical trial of 24 weeks of duration, which included 964 insulin-naive patients, with a DM2 average duration of 10 years and average HbA1c = 8.7%. For both insulin, started dose was 0, 2 U/kg. The administration of a daily dose of glargine and two daily doses of detemir led to similar average levels of glycosylated hemoglobin (−1.46 ± 1.09 and −1.54 ± 1.11 %; P = 0.149). However, patients treated with glargine needed significantly minor insulin than those treated with detemir (43.5 vs. 76.5 U, P < 0.001). RESULTS: The application of this model would be translated in minor daily costs for glargine and concretely its use would suppose an annual cost of c814.52 opposite to the c1461.5 of detemir. In consequence, utilization of glargine instead of detemir would be associated with an annual saving of c647.13 for patient with DM2, which supposes a saving of 44.2% with glargine opposite to detemir. CONCLUSIONS: According to the present model, in the above mentioned population, insulin glargine is a treatment of the DM2 associated with minor costs than insulin detemir. PDB22 COST STUDY OF SELF-MONITORING BLOOD GLUCOSE THROUGH GLUCOMETERS IN PATIENTS WITH DIABETES MELLITUS II IN SPAIN Franch J1, Orozco D2, García A3, Coiduras A4, Buendía C5, Febrer L6, Lizan L7 1 CAP Raval Sud, Barcelona, Catalunya, Spain; 2Research Unit Alicante—San Juan, Alacant, Spain; 3Primary Care Ciudad Real, Ciudad Real, Spain; 4SAP Esquerre, Barcelona, Catalunya, Spain; 5EAP Sants, Barcelona, Catalunya, Spain; 6Bayer Healthcare, Barcelona, Spain; 7 Outcomes’10, Castellon, Spain OBJECTIVES: The objective of this study is to determine the potential differences in the economical impact for the National Health System (NHS) in Spain of using different glucometric systems for self-monitoring blood glucose (SMBG) in patients with type II diabetes mellitus (DM II). METHODS: An economic model was built based on three information sources: 1) literature review; 2) costs databases; and 3) expert opinion. Six different glucometers were analyzed according to their codification characteristics and their corresponding strips package characteristics, leading to four different system possibilities: 1) autocoded/individual strip package; 2) manually coded/ individual strip package; and 3) autocoded/ collective strip package; and 4) manually coded/collective strip package. The perspective was that of the NHS. RESULTS: With more than 2 million people suffering from DM II in Spain, we calculated the impact of glucometer miscoding relating it to cardiovascular episodes and glucose disorders occurred. Also, collective strip package implied, due to shorter time of strip stability after its opening, considerable strip waste especially in those patients with low frequency of SMBG recommendation. Results show that autocoded glucometers which have individual package for strips safe c5 million (10%) versus those manually coded and having individual strip package in diabetic patients’ management to the NHS; versus those autocoded but with collective strip package, savings rise to c15 million (24%) and versus those manually coded and with collective package the amount of saving is of c22 million (31%). The one-way sensitivity analysis performed with the most relevant variables confirmed this tendency. CONCLUSIONS: Glucometric systems not requiring patient intervention for coding and with individual strip package minimize the total cost of SMBG of type II diabetic patients in Spain. PDB23 COST ANALYSIS FOR THE TREATMENT OF DIABETES MELLITUS IN DIFFERENT HEALTH SECTORS OF HEALTH-CARE SYSTEM OF PAKISTAN Malik M, Hussain A, Khan J Hamdard University, Islamabad, Punjab, Pakistan OBJECTIVES: Despite the efforts made worldwide, data regarding the cost of care in Pakistan are scarce. This study was aimed at assessing the direct costs incurred in the treatment of diabetes and its variation among government, semi-government, and private sectors of Islamabad, Pakistan. METHODS: It was a comparative cross-sectional study in which data was collected from patients by conveniently sampling. The direct cost of treatment of diabetes was determined in terms of variables consultation fee, cost of medicine, travelling cost, fees for laboratory test for glucose monitoring, cost of home blood glucose monitoring device, and cost of strips used for home blood glucose monitoring. RESULTS: The annual mean direct cost for government, semigovernment, and private sectors were Rs. 6481.73, Rs. 9785.25 and Rs. 27790.31, respectively, while the monthly mean directs costs were Rs. 540.14, Rs. 815.43, and Rs. 2315.85, respectively. The total direct cost of treatment of diabetes per month for all health facilities was Rs. 986.61. It was found from the analysis that the mean costs for individual variables were highest in the private sector as compared to semi-government and government sector. The consultation fee charged by the private sector is much higher than the other two sectors. CONCLUSIONS: The private sector of Pakistan is incurring more cost for the treatment of diabetes mellitus. This difference in cost among health sectors is a burden on the economic status of the country. Moreover, untreated diabetes or comorbidities increase the overall treatment cost and this can affect the affordability of the patient.
13th Euro Abstracts ported oral therapy (BOT) with either GLA or NPH between July 2000 and September 2007 (index date) and who provided continuously documented data between 12 months before and 24 months after initiation of BOT. Data were collected from index date until the occurrence of an event (DFS or MI/IS) or until August 2009. Duration of therapy was ≥24 months to demonstrate a potential effect of insulins considered. Therefore, the end points were measured as from the second year after index date. The identification of the end points was according to ICD-10 codes (MI: I22 and I23; IS: I63 and I64) or the original doctors texts (DFS). Kaplan–Meier curves were generated and compared by log-rank tests. Cox proportional hazard models were used to estimate the adjusted hazard ratio (HR) for the incidence of DFS and MI/IS. RESULTS: A total of 23,395 T2D fulfilled the inclusion criteria and started a BOT either with GLA (n = 9,638) or with NPH (n = 13,757). After adjustment for demographic and clinical variables, it could be demonstrated that GLA reduced the relative DFS risk by 64 % in T2D when compared to NPH (HR = 0.611; P = 0.0405). Furthermore, GLA decreased the relative MI/IS-risk by 49 % (HR = 0.671; P = 0.0562). CONCLUSIONS: When compared to NPH, GLA significantly reduces the risk of DFS in T2D under real-life conditions. Additionally, a reduction of the macrovascular events MI/IS was shown with GLA versus NPH. Prospective trials should be conducted to confirm these results. PDB17 GLYCATED HEMOGLOBIN AS A SURROGATE MARKER FOR THE APPEARANCE AND PROGRESSION OF MACRO VASCULAR COMPLICATIONS IN TYPE 2 DIABETES MELLITUS: SYSTEMATIC REVIEW AND META-ANALYSIS Weczorek A1, Marcisz A1, Rys P2, Skrzekowska-Baran I1, Plisko R1, Wladysiuk M1 1 HTA Consulting, Krakow, Poland; 2NovoNordisk, Warsaw, Poland OBJECTIVES: We performed a systematic review and meta-analysis to examine the association between HbA1c and the appearance and progression of macrovascular complications (MVC) in T2DM. METHODS: The two electronic medical databases (MEDLINE, CENTRAL) were searched to identify all papers reporting HbA1c level and macrovascular complications in T2DM. Observational and randomized, controlled trials (RCTs) with at least 1 year of follow-up were included. Estimates were made of the adjusted relative risk (or odds ratio) of complications for an increase in HbA1c of 1%. If data were insufficient to calculate RR, the odds ratio (OR) was estimated. Weighted mean differences (WMD) in HbA1c level between the case group and the control group were also calculated. RR (OR) was estimated for HbA1c increase of 1%. RESULTS: We identified 11 trials that fulfilled the inclusion criteria. Pooled data from two randomized studies showed that RR of the incidence of stroke was 3.40 (95% CI: 1,77; 6.56), myocardial infarction (two studies): 3.19, (95% CI: 1.41; 7.24) and the risk of extremity amputation or vascular surgery caused by peripheral vessels (two studies): 2.12 (95% CI: 1.08; 4.16). The results were confirmed in observational studies for stroke and myocardial infarction. No correlation was found between deaths from cardiovascular disease and HbA1c increase: RR = 1.21, (95% CI: 0.64; 2.28), but it was shown in observational studies: RR = 5.72 (95% CI: 0.76; 43.02). CONCLUSIONS: Relatively low number of studies and the number of observed macrovascular complications impede unequivocal conclusions. However, the results of our systematic review indicate a correlation between HbA1c level and appearance and progression of MVC in T2DM, especially stroke, heart infarction, and peripheral vessel disease. Thus, HbA1c might be considered a surrogate end point for MVC in T2DM, although influence of other factors (e.g., blood pressure, LDL cholesterol) should be considered.
DIABETES/ENDOCRINE DISORDERS – Cost Studies PDB18 EVALUATION OF CLINICAL INERTIA IN DIABETES CARE OF NON-INSULIN-DEPENDENT TYPE 2 DIABETIC PATIENTS Font B1, Galera J2, Lahoz R3, Gambús G2, González Clemente JM4 1 Novartis Pharma, Barcelona, Spain; 2Novartis Pharma, Barcelona, Barcelona, Spain; 3Novartis Farmacéutica S.A., Barcelona, Barcelona, Spain; 4Corporació Sanitària Parc Taulí, Sabadell, Barcelona, Spain OBJECTIVES: Clinical inertia (CI) is usually defined as the absence of drug therapy intensification in patients who fail to achieve the objectives of standard treatment. This study aims to describe the CI associated with a noninsulinized patient population with type 2 diabetes (DM2) in Spain. METHODS: Epidemiologic, retrospective, and multicenter study conducted in primary and specialist care consultations from Spain. Inclusion criteria were: adults with non-gestational DM2 and uncontrolled status (HbA1c ≥ 7%), oral hypoglycemic therapy initiated at least 2 years before, and HbA1c values available for a minimum period of three visits. Complete CI was defined as the absence of hypoglycemic treatment intensification in all uncontrolled HbA1c values. Partial CI was defined as the absence of intervention for at least one uncontrolled HbA1c value. RESULTS: 1555 patients who met all inclusion criteria have been included. Mean (SD) patients’ age was 64.7 ± 10.3 years and time from diagnosis was 9.2 ± 5.7 years. Seventy-four percent of patients presented abdominal obesity. Complete CI was estimated as 13.5%, while partial CI was observed in 31.4% of controlled patients and 71.8% of uncontrolled patients. The mean changes of treatment were 1.0 ± 1.02 in controlled patients vs. 1.8 ± 1.2 in uncontrolled patients (P < 0.0001). Significant factors statistically associated (P < 0.05) with current lack of glycemic control were: obesity, sedentary lifestyle, hypertension, hyperlipidemia, total number
13th Euro Abstracts of risk factors, and smoking status. Patients with ≥4 risk factors account for 71.7% of current glycemic control group, while this value reached 84.3% in the uncontrolled group (P < 0.0001). CONCLUSIONS: In one out of seven patients with DM2 and poor glycemic control, none action to intensify treatment has been taken during the past 2 years. Patients without current glycemic control have more than two times higher clinical inertia than the controlled ones. Intensification of treatment is twice as common in patients currently uncontrolled (85.1% vs. 44.9%). PDB19 BUDGET IMPACT ANALYSIS OF SAXAGLIPTIN FOR THE TREATMENT OF TYPE 2 DIABETES IN MEXICAN POPULATION AT PEMEX Juarez-Garcia A1, Martinez-Rivera G1, Anaya P2, Donato BM3 1 Bristol-Myers Squibb, Mexico City, Mexico; 2AstraZeneca, Edo. de Méx., Mexico; 3 Bristol-Myers Squibb, Wallingford, CT, USA OBJECTIVES: Diabetes affects approximately 8 million people in Mexico and is the first cause of death in the country. Ninety percent of all diabetes is classified as type II diabetes (T2DM). Saxagliptin, a DPP4 inhibitor, is one of a class of drugs orally administered for treatment of T2DM. Petroleos Mexicanos (PEMEX) health-care system covers approximately 43,977 patients diagnosed with T2DM. The objectives of this study are to: 1) analyze the current utilization and expenditure for oral antidiabetics (OADs) by PEMEX; and 2) evaluate the budget impact of saxagliptin for treatment of T2DM population. METHODS: An MS Excel-based budget impact model of the total population diagnosed with T2DM in PEMEX was used. OAD usage was based on the total amount purchased, by the Institution in 2009. The prices of medications were taken from the published price listing by PEMEX (2009). The following OAD medications were included in the analysis: pioglitazone, rosiglitazone, vildagliptin, and saxagliptin. Pharmaceutical expenses of OADs were considered excluding other medical costs. The time horizon was 3 years and the assumptions of the model including market dynamics were estimated by Bristol Myers Squibb. The budget impact is reported in terms of additional annual total costs. Results are presented in US dollars with an exchange rate of $13.4 MXN. RESULTS: The usage of saxagliptin in PEMEX represents savings to the institution of US$56,132 for the first year of use, with increases in savings for year two and year three US$102,910 and US$154,441 respectively. The impact of saxagliption on the budget was primarily driven by the gradual substitution of pioglitazone, rosiglitazone, and vildagliptin with saxagliptin over the 3-year of analysis. CONCLUSIONS: The budget impact of adding saxagliptin as a treatment option for T2DM patients reveals that the accumulated savings for PEMEX for the estimated timeframe is around US$ 313,485. PDB20 A PHARMACOECONOMIC MODEL FOR ADJUVANT TREATMENT IN A SMOKING CESSATION INTERVENTION IN PATIENTS WITH TYPE 2 DIABETES MELLITUS AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE Kayadibinli M1, Durguner B1, Ulus P1, Ozdemir B2 1 Pfizer Pharmaceuticals, Istanbul, Turkey; 2Omega Contract Research Organization, Ankara, Turkey OBJECTIVES: The present model was aimed to demonstrate the annual cost of the smoking-related diseases in patients with type 2 diabetes mellitus (DM) and chronic obstructive pulmonary disease (COPD), and to establish the budget that would be saved with varenicline (nicotinic receptor partial agonist) reimbursement by the government. METHODS: The model was carried out in two contexts; the costs of the smoking-related diseases and exacerbations in patients with type 2 DM and COPD were estimated in smoking conditions, and varenicline use. The model was constructed on a total of 900,000 type 2 DM patients and 106,410 COPD patients by assuming approximately 3.8 million type 2 DM patients and 2.0 million COPD patients in Turkey of which 23% and 48% were considered to be smokers, respectively. RESULTS: According to the model, the ratio of patients willing to quit smoking was estimated as 35% in type 2 DM group and 54% in COPD group. Of those, 20% (n = 63,000) type 2 DM patients and 30% (n = 17,238) COPD patients were assessed to use varenicline. The annual cost of the smoking-related diseases and exacerbations was calculated as 72.40 million USD according to the 43,341 events; the unit direct costs for myocardial infarcts, stroke, and congestive heart failure were calculated as US$2,523.55, US$1,930.70, and US$1,412.33, respectively, in type 2 DM patients, whereas it was US$1,567.55 in COPD patients. After varenicline use, the government would save US$9.47 million per year by 5608 preventable events. Moreover, the annual cost of varenicline was estimated to be US$23.46 million for 80,238 patients. Accordingly, the total cost of the smoking-related diseases and exacerbations would be US$13.99 million for the first year. CONCLUSIONS: Varenicline reimbursement decreases the annual cost of the smoking-related diseases and exacerbations in patients with type 2 DM and COPD. PDB21 COMPARISON OF COSTS OF THE INSULIN TREATMENT OF TYPE 2 DIABETES MELLITUS WITH INSULIN GLARGINE AND INSULIN DETEMIR Álvarez Guisasola F1, Mauricio Puente D2, Garcia Coscolin T3, Rubio Terres C4 1 Center of Health La Calzada, Gijón, Asturias, Spain; 2Vilanovaxs Arnau Hospital, Lleida, Spain; 3Sanofi-Aventis, Madrid, Spain; 4Health Value, Madrid, Spain OBJECTIVES: Large published data suggested that some patients initiating with the recommended once-daily detemir administration require twice-daily dosing to opti-
A287 mize blood glucose control; therefore, the clinical outcome in this selected population was tested in a randomized controlled trial. The objective of this study is to compare the costs of two treatments of type 2 diabetes mellitus (DM2): Insulin glargine (glargine) and insulin detemir (detemir) in patients with DM2 not controlled with OADs. METHODS: A costs analysis of the insulin treatment was carried out with National Health System perspective. Costs with glargine or detemir linked to DM2 patients were calculated according to the administered doses in a clinical trial of 24 weeks of duration, which included 964 insulin-naive patients, with a DM2 average duration of 10 years and average HbA1c = 8.7%. For both insulin, started dose was 0, 2 U/kg. The administration of a daily dose of glargine and two daily doses of detemir led to similar average levels of glycosylated hemoglobin (−1.46 ± 1.09 and −1.54 ± 1.11 %; P = 0.149). However, patients treated with glargine needed significantly minor insulin than those treated with detemir (43.5 vs. 76.5 U, P < 0.001). RESULTS: The application of this model would be translated in minor daily costs for glargine and concretely its use would suppose an annual cost of c814.52 opposite to the c1461.5 of detemir. In consequence, utilization of glargine instead of detemir would be associated with an annual saving of c647.13 for patient with DM2, which supposes a saving of 44.2% with glargine opposite to detemir. CONCLUSIONS: According to the present model, in the above mentioned population, insulin glargine is a treatment of the DM2 associated with minor costs than insulin detemir. PDB22 COST STUDY OF SELF-MONITORING BLOOD GLUCOSE THROUGH GLUCOMETERS IN PATIENTS WITH DIABETES MELLITUS II IN SPAIN Franch J1, Orozco D2, García A3, Coiduras A4, Buendía C5, Febrer L6, Lizan L7 1 CAP Raval Sud, Barcelona, Catalunya, Spain; 2Research Unit Alicante—San Juan, Alacant, Spain; 3Primary Care Ciudad Real, Ciudad Real, Spain; 4SAP Esquerre, Barcelona, Catalunya, Spain; 5EAP Sants, Barcelona, Catalunya, Spain; 6Bayer Healthcare, Barcelona, Spain; 7 Outcomes’10, Castellon, Spain OBJECTIVES: The objective of this study is to determine the potential differences in the economical impact for the National Health System (NHS) in Spain of using different glucometric systems for self-monitoring blood glucose (SMBG) in patients with type II diabetes mellitus (DM II). METHODS: An economic model was built based on three information sources: 1) literature review; 2) costs databases; and 3) expert opinion. Six different glucometers were analyzed according to their codification characteristics and their corresponding strips package characteristics, leading to four different system possibilities: 1) autocoded/individual strip package; 2) manually coded/ individual strip package; and 3) autocoded/ collective strip package; and 4) manually coded/collective strip package. The perspective was that of the NHS. RESULTS: With more than 2 million people suffering from DM II in Spain, we calculated the impact of glucometer miscoding relating it to cardiovascular episodes and glucose disorders occurred. Also, collective strip package implied, due to shorter time of strip stability after its opening, considerable strip waste especially in those patients with low frequency of SMBG recommendation. Results show that autocoded glucometers which have individual package for strips safe c5 million (10%) versus those manually coded and having individual strip package in diabetic patients’ management to the NHS; versus those autocoded but with collective strip package, savings rise to c15 million (24%) and versus those manually coded and with collective package the amount of saving is of c22 million (31%). The one-way sensitivity analysis performed with the most relevant variables confirmed this tendency. CONCLUSIONS: Glucometric systems not requiring patient intervention for coding and with individual strip package minimize the total cost of SMBG of type II diabetic patients in Spain. PDB23 COST ANALYSIS FOR THE TREATMENT OF DIABETES MELLITUS IN DIFFERENT HEALTH SECTORS OF HEALTH-CARE SYSTEM OF PAKISTAN Malik M, Hussain A, Khan J Hamdard University, Islamabad, Punjab, Pakistan OBJECTIVES: Despite the efforts made worldwide, data regarding the cost of care in Pakistan are scarce. This study was aimed at assessing the direct costs incurred in the treatment of diabetes and its variation among government, semi-government, and private sectors of Islamabad, Pakistan. METHODS: It was a comparative cross-sectional study in which data was collected from patients by conveniently sampling. The direct cost of treatment of diabetes was determined in terms of variables consultation fee, cost of medicine, travelling cost, fees for laboratory test for glucose monitoring, cost of home blood glucose monitoring device, and cost of strips used for home blood glucose monitoring. RESULTS: The annual mean direct cost for government, semigovernment, and private sectors were Rs. 6481.73, Rs. 9785.25 and Rs. 27790.31, respectively, while the monthly mean directs costs were Rs. 540.14, Rs. 815.43, and Rs. 2315.85, respectively. The total direct cost of treatment of diabetes per month for all health facilities was Rs. 986.61. It was found from the analysis that the mean costs for individual variables were highest in the private sector as compared to semi-government and government sector. The consultation fee charged by the private sector is much higher than the other two sectors. CONCLUSIONS: The private sector of Pakistan is incurring more cost for the treatment of diabetes mellitus. This difference in cost among health sectors is a burden on the economic status of the country. Moreover, untreated diabetes or comorbidities increase the overall treatment cost and this can affect the affordability of the patient.