Intensive care unit-related fluconazole use in Spain and Germany: patient characteristics and outcomes of a prospective multicenter longitudinal observational study.

BACKGROUND: Candida spp. are a frequent cause of nosocomial bloodstream infections worldwide. OBJECTIVE: To evaluate the use patterns and outcomes associated with intravenous (IV) fluconazole therapy in intensive care units in Spain and Germany. PATIENTS AND METHODS: The research reported here was a prospective multicenter longitudinal observational study in adult intensive care unit patients receiving IV fluconazole. Demographic, microbiologic, therapy success, length of hospital stay, adverse event, and all-cause mortality data were collected at 14 sites in Spain and five in Germany, from February 2004 to November 2005. RESULTS: Patients (n = 303) received prophylaxis (n = 29), empiric therapy (n = 140), preemptive therapy (n = 85), or definitive therapy (n = 49). A total of 298 patients (98.4%) were treated with IV fluconazole as first-line therapy. The treating physicians judged therapy successful in 66% of prophylactic, 55% of empiric, 45% of preemptive, and 43% of definitive group patients. In the subgroup of 152 patients with proven and specified Candida infection only, 32% suffered from Candida specified as potentially resistant to IV fluconazole. The overall mortality rate was 42%. CONCLUSION: Our study informs treatment decision makers that approximately 32% of the patients with microbiological results available suffered from Candida specified as potentially resistant to IV fluconazole, highlighting the importance of appropriate therapy.

Lower risk of hypoglycemia with sitagliptin compared to glipizide when either is added to metformin therapy: a pre-specified analysis adjusting for the most recently measured HbA(1c) value.

BACKGROUND: In a previously-published study, adding sitagliptin or glipizide to ongoing metformin therapy provided similar HbA(1c) improvement (both groups, -0.7%) after 52 weeks in patients with type 2 diabetes (T2DM). Significantly fewer patients experienced symptomatic hypoglycemia with sitagliptin (5% of 588 patients) compared to glipizide (32% of 584 patients). Glycemic efficacy and patient characteristics may influence hypoglycemic events. The present analysis evaluated the risk of hypoglycemia with sitagliptin or glipizide after adjusting for the most recently measured HbA(1c) value. METHODS: Data for this analysis were from the aforementioned 52-week, randomized, double-blind, active-controlled study. The primary endpoint was confirmed hypoglycemia (i.e., symptomatic hypoglycemia confirmed with a concurrent fingerstick glucose ≤70 mg/dL [3.9 mmol/L]); the secondary endpoint was severe hypoglycemia (requiring medical or non-medical assistance or symptoms of neuroglycopenia). Complementary log-log regression random effects models with terms for treatment, most recently measured HbA(1c) value, time (i.e., days since randomization), gender, and age (< or ≥65 years) were used to assess adjusted subject-specific treatment effects. RESULTS: Over the full range of HbA(1c) levels and follow-up time, the risk of confirmed hypoglycemic events was lower with sitagliptin compared with glipizide (31 vs. 448 events; adjusted hazard ratio [HR] = 0.05 [95% CI: 0.03, 0.09], p < 0.001). The risk was also lower with sitagliptin in the younger (HR = 0.06 [95% CI: 0.03, 0.12], p < 0.001) and older (HR = 0.02 [0.01, 0.08], p < 0.001) age groups compared with glipizide. For severe hypoglycemia events (2 vs. 22), the risk was lower with sitagliptin (HR = 0.08 [95% CI: 0.01, 0.47]; p = 0.005). LIMITATIONS: The actual time between the HbA(1c) measurement and the hypoglycemic event was variable and not controlled for in the analysis. CONCLUSION: In pre-specified analyses adjusting for the most recently measured HbA(1c) value, there was a substantial reduction in risk for confirmed hypoglycemia with sitagliptin compared to glipizide when added to ongoing metformin therapy in patients with T2DM. The risk of confirmed hypoglycemia was very low in younger and older patients treated with sitagliptin.

Cost of clinical events in health economic evaluations in Germany: a systematic review.

Guidance from the Institute for Quality and Efficiency in Health Care (IQWiG) on cost estimation in cost-benefit assessments in Germany acknowledges the need for standardization of costing methodology. The objective of this review was to assess current methods for deriving clinical event costs in German economic evaluations. A systematic literature search of 24 databases (including MEDLINE, BIOSIS, the Cochrane Library and Embase) identified articles, published between January 2005 and October 2009, which reported cost-effectiveness or cost-utility analyses. Studies assessed German patients and evaluated at least one of 11 predefined clinical events relevant to patients with diabetes mellitus. A total of 21 articles, describing 199 clinical cost events, met the inclusion criteria. Year of costing and time horizon were available for 194 (97%) and 163 (82%) cost events, respectively. Cost components were rarely specified (32 [16%]). Costs were generally based on a single literature source (140 [70%]); where multiple sources were cited (32 [16%]), data synthesis methodology was not reported. Cost ranges for common events, assessed using a Markov model with a cycle length of 12 months, were: acute myocardial infarction (nine studies), first year, 4,618-17,556 €; follow-up years, 1,006-3,647 €; and stroke (10 studies), first year; 10,149-24,936 €; follow-up years, 676-7,337 €. These results demonstrate that costs for individual clinical events vary substantially in German health economic evaluations, and that there is a lack of transparency and consistency in the methods used to derive them. The validity and comparability of economic evaluations would be improved by guidance on standardizing costing methodology for individual clinical events.

Caspofungin for treatment of invasive aspergillosis in Germany: results of a pre-planned subanalysis of an international registry.

BACKGROUND: This study is a pre-planned country-specific subanalysis of results in Germany from a multinational multicenter registry to prospectively assess real-world experience with caspofungin administered for treatment of proven or probable invasive aspergillosis (IA). METHODS: Data from patients treated with caspofungin for a single episode of IA were collected. Effectiveness was determined by the local investigator as favorable (complete or partial response) or unfavorable (stable disease, failure or death) at the end of caspofungin therapy. Descriptive statistics with binomial exact confidence intervals were employed. RESULTS: Forty-two consecutive patients were identified in three German centers. Three patients (7%) had proven IA and 39/42 (93%) had probable IA (modified European Organization for Research and Treatment of Cancer/Mycosis Study Group (EORTC/MSG) criteria). Forty-one patients had pulmonary IA and one had tracheal IA. Caspofungin monotherapy was received by 36/42 patients (86%); of these, 26/36 (72%) received salvage therapy. A favorable response was observed in 29/42 patients (69%; 95% CI 53 to 82%); of these, 21/29 (72%) had a complete and 8/29 (28%) a partial response. Favorable response rate was 69% in patients with monotherapy (95% CI 52% to 84%; 25/36 patients), and 67% in patients receiving combination therapy (95% CI 22% to 96%; 4/6 patients). Favorable response rate in patients with first line therapy was 64% (95% CI 31% to 89%; 7/11 patients), and 73% in patients with second line therapy (95% CI 54% to 88%; 20/30 patients). No adverse events were reported. In total, 35/42 patients (83%; 95% CI 69 to 93%) survived seven days after completion of caspofungin therapy. CONCLUSIONS: These real-life findings in Germany are consistent with the international findings from this registry and with findings from randomized studies.

Cost-effectiveness of extended-release niacin/laropiprant added to a stable simvastatin dose in secondary prevention patients not at cholesterol goal in Germany.

Coronary heart disease (CHD) remains the leading cause of death in Germany despite statin use to reduce low-density lipoprotein cholesterol (LDL-C) levels; improving lipids beyond LDL-C may further reduce cardiovascular risk. A fixed-dose combination of extended-release niacin (ERN) with laropiprant (LRPT) provides comprehensive lipid management. We adapted a decision-analytic model to evaluate the economic value (incremental cost-effectiveness ratio [ICER] in terms of costs per life-years gained [LYG]) of ERN/LRPT 2 g over a lifetime in secondary prevention patients in a German setting. Two scenarios were modelled: (1) ERN/LRPT 2 g added to simvastatin 40 mg in patients not at LDL-C goal with simvastatin 40 mg; (2) adding ERN/LRPT 2 g compared with titration to simvastatin 40 mg in patients not at LDL-C goal with simvastatin 20 mg. In both scenarios, adding ERN/LRPT was cost-effective relative to simvastatin monotherapy at a commonly accepted threshold of €30,000 per LYG; ICERs for ERN/LRPT were €13,331 per LYG in scenario 1 and €17,684 per LYG in scenario 2. Subgroup analyses showed that ERN/LRPT was cost-effective in patients with or without diabetes, patients aged ≤ 65 or >65 years and patients with low baseline high-density lipoprotein cholesterol levels; ICERs ranged from €10,342 to €15,579 in scenario 1, and from €14,081 to €20,462 in scenario 2. In conclusion, comprehensive lipid management with ERN/LRPT 2 g is cost-effective in secondary prevention patients in Germany who have not achieved LDL-C goal with simvastatin monotherapy.

Risk factor levels, risk factor combinations, and residual coronary risk: population-based estimates for secondary prevention patients using statins.

BACKGROUND: Population-based risk factor combinations and residual risks for coronary heart disease (CHD) patients on statins were assessed in order to bridge the gap between knowledge on relative effects from clinical trials and absolute risk from real-world practice. DESIGN: Population-based, retrospective 1-year cross-sectional primary care study in CHD patients (ICD-10 I20-I25) on ongoing statin monotherapy in Germany in 2007 (MediPlus database, IMS Health). METHODS: Prevalence charts for 384 risk factor combinations were constructed. Population-averaged residual risks were estimated using the Framingham secondary prevention algorithm and generalized estimating equations accounting for repeated measurements within patients. RESULTS: 13,256 CHD patients in 332 practices were eligible for the study (7791 men, 5465 women, 32.6% with diabetes mellitus, 82.5% on simvastatin at a mean effective dose of 26.7 mg/d). The overall residual 10-year coronary risk was projected at 35.1% (robust 95% CI 34.8-35.4). In 83.6% of patients this risk was ≥20% and in 36.5% of patients the risk was ≥40%. An increase in tablet strength to 40 mg (fluvastatin 80 mg) and in exposure to 40 mg/d (fluvastatin 80 mg/d) would be expected to reduce the predicted residual 10-year coronary risk to 34.1% and 33.8%, respectively. CONCLUSION: Even when receiving high-dose statin monotherapy, the typical CHD patient in Germany is projected to be exposed to a residual coronary risk that is substantially above the generally recognized intervention threshold of 20% over 10 years. The question of how to further reduce residual coronary risk without compromising patient safety in patients on optimal statin therapy remains an important clinical challenge.

Fear of hypoglycaemia: defining a minimum clinically important difference in patients with type 2 diabetes.

BACKGROUND: To explore the concept of the Minimum Clinically Important Difference (MID) of the Worry Scale of the Hypoglycaemia Fear Survey (HFS-II) and to quantify the clinical importance of different types of patient-reported hypoglycaemia. METHODS: An observational study was conducted in Germany with 392 patients with type 2 diabetes mellitus treated with combinations of oral anti-hyperglycaemic agents. Patients completed the HFS-II, the Treatment Satisfaction Questionnaire for Medication (TSQM), and reported on severity of hypoglycaemia. Distribution- and anchor-based methods were used to determine MID. In turn, MID was used to determine if hypoglycaemia with or without need for assistance was clinically meaningful compared to having had no hypoglycaemia. RESULTS: 112 patients (28.6%) reported hypoglycaemic episodes, with 15 patients (3.8%) reporting episodes that required assistance from others. Distribution- and anchor-based methods resulted in MID between 2.0 and 5.8 and 3.6 and 3.9 for the HFS-II, respectively. Patients who reported hypoglycaemia with (21.6) and without (12.1) need for assistance scored higher on the HFS-II (range 0 to 72) than patients who did not report hypoglycaemia (6.0). CONCLUSION: We provide MID for HFS-II. Our findings indicate that the differences between having reported no hypoglycaemia, hypoglycaemia without need for assistance, and hypoglycaemia with need for assistance appear to be clinically important in patients with type 2 diabetes mellitus treated with oral anti-hyperglycaemic agents.

Blood pressure control in the year following coronary events.

BACKGROUND: Blood pressure control is often insufficient in secondary prevention. The objective of the present study was to determine predictors for long-term elevated blood pressure (BP) in patients after coronary events. METHODS: Patients were included at admission to inpatient cardiac rehabilitation. A total of 18 cardiac rehabilitation centers in Germany participated. Indications for admission were myocardial infarction (MI), coronary artery bypass grafting (CABG), or percutaneous transluminal coronary angioplasty (PTCA). The duration of follow-up was 12 months. Risk factors, medication, and clinical events were assessed from patients and their physicians. RESULTS: A consecutive sample of 1907 men (mean age 60+/-10 years) and 534 women (mean age 65+/-10 years) was admitted; the 12-month follow-up rate was 85%. Of all patients, 38% had a BP > or =140 and/or > or =90 mmHg at admission to the rehabilitation center compared to 48% at the 12-month follow-up. Patients with diabetes were less likely to achieve BP <140/90 mmHg compared to patients without diabetes (43% vs. 56%; P<0.001). In multivariable analyses, significant predictors for elevated BP after 12 months were baseline BP > or =140/90 mmHg (RR 2.5; 95% CI 1.7, 3.7), diabetes (RR 2.2; 95% CI 1.4, 3.5), and indication for admission (MI vs. CABG RR 0.6; 95% CI 0.4, 1.0, and PTCA vs. CABG RR 0.5; 95% CI 0.2, 1.0). CONCLUSIONS: Long-term blood pressure control is not satisfactory in about half of the patients following coronary events. Particularly, patients with diabetes appear to be at risk for elevated blood pressure.

Health outcomes and cost-effectiveness of aprepitant in outpatients receiving antiemetic prophylaxis for highly emetogenic chemotherapy in Germany.

BACKGROUND: Chemotherapy-induced nausea and vomiting (CINV) remains a major adverse effect of cancer therapy. We aimed to determine outcomes associated with use of aprepitant in outpatients undergoing highly emetogenic chemotherapy in Germany from a patient's and payer's perspective. METHODS: A decision-analytic model compared an aprepitant regimen (aprepitant/ondansetron/dexamethasone) to a control regimen (ondansetron/dexamethasone) over a five days period. Clinical results and resource utilisation observed in aprepitant phase III clinical trials were assigned German unit cost data. RESULTS: Complete response over one chemotherapy cycle was observed in 68% of patients in the aprepitant group (N=514) compared to 48% of patients in the control group (N=518). Patients were estimated to have gained an equivalent of 15 additional hours of perfect health per cycle (0.63 quality-adjusted life days) with aprepitant-based regimen compared to control regimen. Cost per quality-adjusted life year gained with aprepitant was estimated at euro28,891. CONCLUSIONS: Aprepitant substantially improved CINV-related health outcomes in patients undergoing highly emetogenic chemotherapy. Incremental benefits materialised in a cost-effective fashion.

Prospective study of amphotericin B formulations in immunocompromised patients in 4 European countries.

BACKGROUND: Amphotericin B is a widely used broad-spectrum antifungal agent, despite being associated with significant adverse events, including nephrotoxicity. METHODS: The present prospective study collected data on outcomes for 418 adult patients treated consecutively with polyenes in hematology and oncology wards in 20 hospitals in Europe. RESULTS: Patients initially received amphotericin B deoxycholate (62% of patients), liposomal amphotericin B (27%), or other lipid formulations of amphotericin B (11%). Of the patients initially treated with amphotericin B deoxycholate, 36% had therapy switched to lipid formulations of amphotericin B, primarily because of increased serum creatinine levels (in 45.7% of patients) or other amphotericin B-attributable adverse events (in 41.3% of patients). Nephrotoxicity, which was defined as a > or = 50% increase in the serum creatinine level, developed in 57% of patients with normal kidney function at baseline. Predictors of nephrotoxicity included formulation type and duration of treatment. Compared with patients without nephrotoxicity, patients with nephrotoxicity had a higher mortality rate (24%), and their mean length of stay in the hospital was prolonged by 8.6 days. Slight increases in the serum creatinine level (i.e., > or = 50%) were associated with a significantly longer stay in the hospital. Severe nephrotoxicity (i.e., a > or = 200% increase in the serum creatinine level) was a significant predictor of death, as were severe underlying medical conditions and documented fungal infection. CONCLUSION: This prospective study confirmed that, in European hospitals, amphotericin B formulations have a major influence on the length of stay in the hospital and nephrotoxicity-associated mortality.

Lifetime cost of ischemic stroke in Germany: results and national projections from a population-based stroke registry: the Erlangen Stroke Project.

BACKGROUND AND PURPOSE: The number of stroke patients and the healthcare costs of strokes are expected to rise. The objective of this study was to determine the direct costs of first ischemic stroke and to estimate the expected increase in costs in Germany. METHODS: An incidence-based, bottom-up, direct-cost-of-ischemic-stroke study from the third-party payer's perspective was performed, incorporating 10-year survival data and 5-year resource use data from the Erlangen Stroke Registry. Discounted lifetime year 2004 costs per case were obtained and applied to the expected age and sex evolution of the German resident population in the period 2006 to 2025. RESULTS: The overall cost per first-year survivor of first-ever ischemic stroke was estimated to be 18,517 euros (EUR). Rehabilitation accounted for 37% of this cost, whereas in subsequent years outpatient care was the major cost driver. Discounted lifetime cost per case was 43,129 EUR overall and was higher in men (45,549 EUR) than in women (41,304 EUR). National projections for the period 2006 to 2025 showed 1.5 million and 1.9 million new cases of ischemic stroke in men and women, respectively, at a present value of 51.5 and 57.1 billion EUR, respectively. CONCLUSIONS: The number of stroke patients and the healthcare costs of strokes in Germany will rise continuously until the year 2025. Therefore, stroke prevention and reduction of stroke-related disability should be made priorities in health planning policies.

Regional variation in medication following coronary events in Germany.

BACKGROUND: Mortality rates from ischaemic heart disease have consistently been higher in East compared to West Germany both prior to and since reunification. Coronary care is inversely related to mortality from ischaemic heart disease. The objective of the present study was, therefore, to compare cardiovascular medication in East and West German patients following cardiac rehabilitation. METHODS: East German (n = 530) and West German (n = 1638) patients were included at admission to one of 18 rehabilitation centres. Inclusion criteria were myocardial infarction, coronary artery bypass grafting and percutaneous transluminal coronary angioplasty. The follow-up period was 12 months. RESULTS: At admission, East and West German patients differed with regard to sociodemographic variables, risk factors and medical conditions. At 12 months, a higher percentage of West compared to East German patients were prescribed beta-blockers (71% vs. 65%, P = 0.04) and lipid-lowering agents (64% vs. 55%, P = 0.002). Angiotensin converting enzyme (ACE) inhibitors, on the other hand, were prescribed more frequently in the East compared to the West (60% vs. 48%, P < 0.001). In multivariable analyses, region of residence remained a significant predictor for the prescription of lipid-lowering agents (East vs. West: OR 0.61, 95% CI 0.46-0.81) and ACE inhibitors (East vs. West: OR 1.78, 95% CI 1.33-2.39). CONCLUSION: There is a considerable variation in the prescription of cardiovascular medication in secondary prevention within Germany. Some, but not all, of this variation can be explained by differences in patient characteristics.

Accessing a new medication in Germany: a novel approach to assess a health insurance-related barrier.

PURPOSE: Knowledge of the existence, position, and magnitude of barriers to equitable healthcare is an important consideration in shaping healthcare policies. METHODS: The authors developed a novel three-dimensional person-time-related hurdle model and followed a cohort of 7358 statutorily (SHI) and 457 privately health insured (PHI) patients with migraine headaches at 377 primary-care practices (MediPlus, IMS Health) in the second to fourth year of the HealthCare Structural Reform Act in Germany. RESULTS: For SHI compared with PHI migraine patients, there was a hurdle to receiving sumatriptan at all (2.4-fold lower hazard, 95% confidence interval, 1.8-3.2). Among patients who received sumatriptan, frequency and intensity of use differed only minimally between SHI and PHI patients. CONCLUSIONS: These findings have implications for healthcare researchers and healthcare policies. The framework extends traditional hurdle models and can serve as a model for quantifying barriers to receipt of services under different funding policies.

Real-world effectiveness of lipid-lowering therapy in male and female outpatients with coronary heart disease: relation to pre-treatment low-density lipoprotein-cholesterol, pre-treatment coronary heart disease risk, and other factors.

BACKGROUND: Determinants of the real-world effectiveness of lipid-lowering therapy have been rarely assessed in an unselected observational coronary heart disease (CHD) community cohort over time. DESIGN: Randomly drawn patients (n=605) from randomly drawn practices (n=62) were retrospectively followed for a median of 3.6 years (1998-2002) on lipid-lowering therapy (98% statins). METHODS: Coronary heart disease population-averaged estimates and variances accounting for repeated measurements within patients were obtained using generalized estimating equations. RESULTS: Post-treatment low-density lipoprotein-cholesterol (LDL-C) was 124 mg/dl in men and 141 mg/dl in women and was independently associated (all P<0.05) with pre-treatment LDL-C (+3.7 mg/dl per 10 mg/dl increment), female sex (+14.0 mg/dl), coronary bypass (-9.5 mg/dl), drug-treated diabetes mellitus (-6.8 mg/dl), and era 2002/2001 versus 1999/2000 (-6.4 mg/dl) in age-adjusted multivariate analyses. Holding pre-treatment LDL-C constant post-treatment LDL-C was associated with pre-treatment Framingham CHD risk in men (-13.9 mg/dl per doubling of risk), whereas LDL-C control in women resembled that in low-risk men. The likelihood of attaining LDL-C <100 mg/dl was 0.28 in men and 0.17 in women and was likewise associated with the above factors. CONCLUSION: Low-density lipoprotein-cholesterol control remained low despite lipid-lowering therapy across a wide range of pre-treatment LDL-C and pre-treatment CHD risk. Low-density lipoprotein-cholesterol control in women was inferior to that in men, a finding that warrants attention and clarification.

Quantifying delay in access to new medical treatment: an application of risk advancement period methodology.

BACKGROUND: We present a novel application of the concept of risk or rate advancement to compute the extent of delay in adoption of an effective new drug in 2 German health insurance systems. METHODS: We identified individuals with migraines, age 18 to 65 years, in 371 primary care practices in Germany in 1994 (MediPlus, IMS Health database). These included 8173 persons covered under the statutory health insurance system and 503 persons covered by private health insurance. We derived risk and population risk advancement periods for sumatriptan compared with nonserotoninergic acute migraine therapy using multiplicative risk regression and generalized estimating equations, adjusted for patient, physician, and practice cofactors. RESULTS: For patients at the mean age of the cohort, 43 years of age, sumatriptan was prescribed 1.2 (95% confidence interval [CI] = 0.3-2.0) years later among those in the statutory health insurance system compared with those who had private insurance. The lag increased by 0.6 (-0.1 to 1.3) years for every 10 years of patient age. In the age-mix of our sample, access to the health benefits of sumatriptan therapy lagged nearly 1.5 years behind in the statutory health insurance system and for Germany as a whole. CONCLUSIONS: Migraine patients' access to sumatriptan therapy lagged substantially in the statutory health insurance system and in the country as a whole. Risk advancement periods provide a useful methodology for communicating major healthcare issues in a meaningful way to society and policymakers.

The disparity in access to new medication by type of health insurance: lessons from Germany.

BACKGROUND: Drug provision within the German statutory health insurance system has undergone several reforms, including the introduction of drug macrobudgets in 1993. OBJECTIVE: The objective of this study was to investigate the extent to which statutorily (SHI) and fully privately (PHI) health-insured patients were provided with new medication recommended by professional bodies in an equitable fashion using the example of migraine patients. RESEARCH DESIGN: We conducted a retrospective cohort study. SETTING: A total of 367 primary-care practices (MediPlus, IMS Health) in Germany in the second year of the HealthCare Structural Reform Act were studied. SUBJECTS: Subjected consisted of 7703 SHI and 470 PHI migraineurs (International Classification of Diseases, 10th edition G43) aged 18 to 65 years at their first migraine prescription visit in 1994. OUTCOME MEASURE: We compared prescription of oral or subcutaneous serotonin 5HT1B/1D receptor agonist sumatriptan with nonserotoninergic migraine therapy. RESULTS: In multiplicative risk regression with variance estimation accounting for clustering of patients within practices, PHI patients were 2.3 times (95% confidence interval [CI], 1.6-3.3) more likely to receive sumatriptan than their SHI counterparts at the mean age of the cohorts (43 years) adjusted for incident versus prevalent migraine treatment, the gender of the patient, the age, gender, and primary care specialist group of the physician, and the type and the community size class of the practice. This disparity widened by 38% (95% CI, 1-88%) every 10 years of patient age. CONCLUSION: Even though virtually everyone in Germany has health insurance and drug coverage, use of new and recommended migraine medicines was less common among those with SHI compared with their privately insured counterparts. Systematic studies of access to health care recommended by professional bodies will be critically important to ensure delivery of high-quality health care for all patients.

Cost-effectiveness of ezetimibe coadministration in statin-treated patients not at cholesterol goal: application to Germany, Spain and Norway.

BACKGROUND: Despite the growing use of statins, many hypercholesterolaemic patients fail to reach their lipid goal and remain at elevated risk of coronary heart disease (CHD). Alternative treatment strategies, such as ezetimibe coadministration and statin titration, can help patients achieve greater lipid control, and thereby lower their CHD risk. But is it cost effective to more aggressively lower cholesterol levels across a broad range of current statin users? METHODS: Using a decision-analytic model based on epidemiological and clinical trials data, we project the lifetime benefit and cost of alternative lipid-lowering treatment strategies for CHD and non-CHD diabetic patients in Germany, Spain and Norway. RESULTS: It is projected that from 40% to 76% of these patients who have failed to reach their lipid goal with their current statin treatment will be able to reach their goal with ezetimibe coadministration; this represents a gain of up to an additional absolute 14% who will be able to reach their goal compared with a 'titrate to goal' strategy where patients are titrated in order to reach their lipid goal (up to the maximum approved dose). For CHD patients, the estimated incremental cost-effectiveness ratio for ezetimibe coadministration is under Euro 18 000 per life-year gained (Euro/LYG) and 26 000 Euro/LYG compared with strategies based on the observed titration rates and the aggressive 'titrate to goal' strategy, respectively; for non-CHD diabetic patients, these ratios are under 26 000 Euro/LYG and 48 000 Euro/LYG for ezetimibe coadministration compared with the two titration strategies. CONCLUSION: Compared with statin titration, ezetimibe coadministration is projected to be cost effective in the populations and countries studied.

[Return to work after cardiologic rehabilitation]. / Berufliche Wiedereingliederung nach kardiologischer Rehabilitation.

OBJECTIVES: The objectives of the present study were to determine prospectively return to work and its predictors in patients after cardiac rehabilitation. METHODS: Patients were enrolled at admission to inpatient cardiac rehabilitation centres (n = 18). Primary indications for admission were myocardial infarction, coronary artery bypass grafting or percutaneous transluminal coronary angioplasty. RESULTS: We included 2441 consecutive patients (1907 men, mean age: 60 +/- 10 years; 534 women, mean age: 65 +/- 10 years). A total of 43% of all patients had been actively employed before the event. Of these patients, 65% had returned to work six months and 67% 12 months after cardiac rehabilitation. Successful return to work after 12 months was significantly predicted by younger age, non-manual work, self-employment, a higher physical and mental quality of life, and a better exercise ECG result. CONCLUSION: Return to work is predicted by sociodemographic factors, quality of life, and the exercise ECG at the rehabilitation centre. The determination of early predictors for return to work may aid to identify patients particularly at risk for failure to return to work.