Risk of mortality and recurrent cardiovascular events in patients with acute coronary syndromes on high intensity statin treatment.

Several randomized controlled trials have shown a benefit of high-dose intensive statin treatment in reducing risk of death and second cardiovascular disease (CVD) events in patients previously diagnosed with an acute coronary syndrome (ACS). Non-randomized studies in clinical settings support these findings, but large, long-term, observational studies addressing CVD and non-CVD endpoints are lacking. In this retrospective longitudinal study, we followed ACS patients in Sweden during 2001-2012 using national health registry and medical record data. A total of 49,857 patients were identified, of whom 10,092 (20.2%) received high dose statins and 21,174 (42.7%) received no statins. Royston-Parmar parametric time-to-event models were implemented to model hazard for second CVD events and death, stratified by gender and diabetes diagnosis. We found that risk of a second CVD event developed similarly in both treatment groups, but was much higher in the no statin group. Risk of CVD-related death remained relatively constant for the high-statin group, while it increased over time for the no-statin group. Interestingly, males had higher mortality rates in the no-statin group, but not in the high-statin group. All-cause mortality and non-CVD-related death followed similar trends to those observed for CVD-related death. This work provides additional real-world evidence for effect of statins in CVD-related mortality. The hazard functions presented here can provide a basis for future survival modeling and health economic evaluation.

The burden of illness in patients with hyponatraemia in Sweden: a population-based registry study.

BACKGROUND: Hyponatraemia (HN; serum sodium level < 135 mmol/l) is the most common electrolyte disturbance seen in clinical practice, and is associated with varying spectrum of symptoms. Syndrome of inappropriate antidiuretic hormone secretion (SIADH) is the most common aetiology in hospitalised patients, and can be caused by several different underlying conditions. AIMS: The objectives of this study were to retrospectively examine the baseline characteristics, clinical outcomes and hospital resource utilisation of patients with HN and/or SIADH in Sweden over a 10-year period from 2001 to 2011. Additional analysis was performed on subpopulations of patients with hip fracture, pneumonia and small cell lung cancer (SCLC) to see if trends in outcomes were consistent across a broad range of aetiologies commonly associated with the condition. METHODS: Patient information was taken from the Swedish National Patient Registry, the Swedish Cancer Registry, the Swedish Cause of Death Register and the Swedish Prescribed Drug Register. A total of 34,537 patients (4.38%) were identified with HN and/or SIADH, with the incidence and prevalence rising over the 10-year study period. RESULTS: Of the 34,537 patients identified, 841 had hip fracture, 2635 had pneumonia and 106 had SCLC. Compared with matched control patients, those with HN and/or SIADH had a longer length of hospital stay, a higher re-admission rate and a shorter time to re-admission. CONCLUSIONS: This study showed that HN and/or SIADH negatively impact patient outcomes and healthcare resources related to hospital stay irrespective of the underlying cause. The impact of HN is not confined to the initial hospitalisation, as re-admission rates are also affected.

Lipid-lowering treatment patterns in patients with new cardiovascular events - estimates from population-based register data in Sweden.

OBJECTIVES: The aim of this study was to assess treatment patterns of lipid-lowering therapy (LLT) in patients with hyperlipidaemia or prior cardiovascular (CV) events who experience new CV events. METHODS: A retrospective population-based cohort study was conducted using Swedish medical records and registers. Patients were included in the study based on a prescription of LLT or CV event history and followed up for up to 7 years for identification of new CV events and assessment of LLT treatment patterns. Patients were stratified into three cohorts based on CV risk level. All outcomes were assessed during the year following index (the date of first new CV event). Adherence was defined as medication possession ratio (MPR) > 0.80. Persistence was defined as no gaps > 60 days in supply of drug used at index. RESULTS: Of patients with major cardiovascular disease (CVD) history (n = 6881), 49% were not on LLT at index. Corresponding data for CV risk equivalent and low/unknown CV risk patients were 37% (n = 3226) and 38% (n = 2497) respectively. MPR for patients on LLT at index was similar across cohorts (0.74-0.75). The proportions of adherent (60-63%) and persistent patients (56-57%) were also similar across cohorts. Dose escalation from dose at index was seen within all cohorts and 2-3% of patients switched to a different LLT after index while 5-6% of patients augmented treatment by adding another LLT. CONCLUSIONS: Almost 50% of patients with major CVD history were not on any LLT, indicating a potential therapeutic gap. Medication adherence and persistence among patients on LLT were suboptimal.

Work productivity loss and indirect costs associated with new cardiovascular events in high-risk patients with hyperlipidemia: estimates from population-based register data in Sweden.

OBJECTIVES: To estimate productivity loss and associated indirect costs in high-risk patients treated for hyperlipidemia who experience cardiovascular (CV) events. METHODS: Retrospective population-based cohort study conducted using Swedish medical records linked to national registers. Patients were included based on prescriptions of lipid-lowering therapy between 1 January 2006 and 31 December 2011 and followed until 31 December 2012 for identification of CV events and estimation of work productivity loss (sick leave and disability pension) and indirect costs. Patients were stratified into two cohorts based on CV risk level: history of major cardiovascular disease (CVD) and coronary heart disease (CHD) risk equivalent. Propensity score matching was applied to compare patients with new events (cases) to patients without new events (controls). The incremental effect of CV events was estimated using a difference-in-differences design, comparing productivity loss among cases and controls during the year before and the year after the cases' event. RESULTS: The incremental effect on indirect costs was largest in the CHD risk equivalent cohort (n = 2946) at €3119 (P value <0.01). The corresponding figure in the major CVD history cohort (n = 4508) was €2210 (P value <0.01). There was substantial variation in productivity loss depending on the type of event. Transient ischemic attack and revascularization had no significant effect on indirect costs. Myocardial infarction (€3465), unstable angina (€2733) and, most notably, ischemic stroke (€6784) yielded substantial incremental cost estimates (P values <0.01). CONCLUSIONS: Indirect costs related to work productivity losses of CV events are substantial in Swedish high-risk patients treated for hyperlipidemia and vary considerably by type of event.

Healthcare costs associated with cardiovascular events in patients with hyperlipidemia or prior cardiovascular events: estimates from Swedish population-based register data.

OBJECTIVES: To estimate healthcare costs of new cardiovascular (CV) events (myocardial infarction, unstable angina, revascularization, ischemic stroke, transient ischemic attack, heart failure) in patients with hyperlipidemia or prior CV events. METHODS: A retrospective population-based cohort study was conducted using Swedish national registers and electronic medical records. Patients with hyperlipidemia or prior CV events were stratified into three cohorts based on CV risk level: history of major cardiovascular disease (CVD), coronary heart disease (CHD) risk-equivalent, and low/unknown risk. Propensity score matching was applied to compare patients with new events to patients without new events for estimation of incremental costs of any event and by event type. RESULTS: A CV event resulted in increased costs over 3 years of follow-up, with the majority of costs occurring in the 1st year following the event. The mean incremental cost of patients with a history of major CVD (n = 6881) was €8588 during the 1st year following the event. This was similar to that of CHD risk-equivalent patients (n = 3226; €6663) and patients at low/unknown risk (n = 2497; €8346). Ischemic stroke resulted in the highest 1st-year cost for patients with a history of major CVD and CHD risk-equivalent patients (€10,194 and €9823, respectively); transient ischemic attack in the lowest (€3917 and €4140). Incremental costs remained elevated in all cohorts during all three follow-up years, with costs being highest in the major CVD history cohort. CONCLUSIONS: Healthcare costs of CV events are substantial and vary considerably by event type. Incremental costs remain elevated for several years after an event.

Survival and clinical metastases among prostate cancer patients treated with androgen deprivation therapy in Sweden.

OBJECTIVES: To examine the incidence of metastases and clinical course of prostate cancer patients who are without confirmed metastasis when initiating androgen deprivation therapy (ADT). METHODS: Retrospective cohort study conducted using electronic medical records from Swedish outpatient urology clinics linked to national mandatory registries to capture medical and demographic data. Prostate cancer patients initiating ADT between 2000 and 2010 were followed from initiation of ADT to metastasis, death, and/or end of follow-up. RESULTS: The 5-year cumulative incidence (CI) of metastasis was 18%. Survival was 60% after 5 years; results were similar for bone metastasis-free survival. The 5-year CI of castration-resistant prostate cancer (CRPC) was 50% and the median survival from CRPC development was 2.7 years. Serum prostate-specific antigen (PSA) levels and PSA doubling time were strong predictors of bone metastasis, any metastasis, and death. CONCLUSION: This study provides understanding of the clinical course of prostate cancer patients without confirmed metastasis treated with ADT in Sweden. Greater PSA values and shorter PSA doubling time (particularly ≤ 6 months) were associated with increased risk of bone metastasis, any metastasis, and death.

Resource allocation to brain research in Switzerland.

QUESTIONS UNDER STUDY: This study represents a first attempt at estimating Swiss resource allocation to brain research including both public and private spending. METHODS: In order to estimate public spending (by governments and charities) a survey was conducted to evaluate the way brain research is funded across Europe and especially in Switzerland. Industry funding was measured using different approaches including a survey of pharmaceutical expenditures and the costs of developing new drugs. RESULTS: Private spending is at a reasonable level because a highly developed Swiss pharmaceutical industry invests significantly in this branch of science. However, public spending is at a low level compared to other European countries, although Switzerland is the only European country where the total funding per capita exceeds that of US funding. CONCLUSIONS: A detailed investigation of Swiss resource allocation to different branches of biomedical research is warranted. Brain research should be an important part of such a study. The United States and the European Union have selected brain research as one of their priority areas within health related research. The present figures indicate that this may also be justified in Switzerland.

The cost-utility of maintenance treatment with venlafaxine in patients with recurrent major depressive disorder.

AIMS: The Prevention of Recurrent Episodes of Depression with venlafaxine XR for Two Years trial has reported advantages with maintenance treatment for patients with recurrent depressive disorder. The aim of this study was to assess the cost-utility of maintenance treatment with venlafaxine in patients with recurrent major depressive disorder, based on a recent clinical trial. METHODS: A Markov simulation model was constructed to assess the cost-utility of maintenance treatment for 2 years in recurrently depressed patients in Sweden. Risk of relapse and recurrence was based on a recent randomised clinical trial assessing the efficacy and tolerability of maintenance treatment with venlafaxine over 2 years. Costs and quality of life estimations were retrieved from a naturalistic longitudinal observational study conducted in Sweden. Health effects were quantified as quality-adjusted life-years (QALYs). Sensitivity analyses were conducted on key parameters employed in the model. RESULTS: In the base-case analysis, the cost per QALY gained of venlafaxine compared with no treatment was estimated at $18,500 over 2 years. In a probabilistic sensitivity analysis, we found that maintenance treatment with venlafaxine is cost-effective with 90% probability at a willingness to pay per QALY of $67,000 or less. Our long-term analyses also indicate that even under conservative assumptions about future risks of recurrences, maintenance treatment is cost-effective. CONCLUSION: The present study indicates that maintenance treatment for 2 years with venlafaxine is cost-effective in patients with recurrent major depressive disorder.

The cost-effectiveness of infliximab in the treatment of ankylosing spondylitis in Spain. Comparison of clinical trial and clinical practice data.

OBJECTIVE: To estimate the cost-effectiveness of treating ankylosing spondylitis (AS) with infliximab (Remicade) in Spain for up to 40 years. METHODS: A previously published disease model was adapted to the Spanish setting using resource consumption from a cross-sectional burden of an illness study in 601 patients in Spain. Cost-effectiveness estimates were based on a placebo-controlled clinical trial as well as an open clinical study in Spain. In the model, patients with insufficient response to treatment at 12 weeks [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) <4 or > or =50% reduction] discontinue treatment. The results are presented in 2005 euros, from societal and health-care payer perspectives. RESULTS: In the societal perspective, infliximab treatment dominates standard treatment in both analyses. In the perspective of the health-care system, with the assumption that, over the long term, functional ability of patients on treatment would decline at half the natural rate, the cost per quality-adjusted life year (QALY) gained was estimated at EUR 22 519 (double-blind trial) and EUR 8866 (open study). Assuming that patients' function on treatment remains stable, the cost-effectiveness ratios are EUR 15 157 and EUR 5307, respectively. Under the most conservative assumption (no effect of treatment on progression), the ratios are EUR 31 721 and EUR 13 659, respectively. In addition, the results are sensitive to the time horizon and discontinuation rates. CONCLUSIONS: Our results indicate that infliximab therapy for patients with active AS should be cost-effective both in the societal perspective (dominating) and in the perspective of the health-care system (ranges from EUR 5300 to EUR 32 000 per QALY) in Spain.

Public health implications of depression

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Costs of brain disorders in Finland.

OBJECTIVE: To calculate the costs of brain disorders on the national level. METHODS: Electronic data bases, national registers and internet data. RESULTS: Any brain disorder was estimated to affect a fifth of the Finnish population. The three most common disorders were migraine, anxiety disorder and affective disorder. The total costs of brain disorders constituted 3% of the national gross product, or 45% of all the health-care costs. However, this is likely a conservative estimate, because not all chronic brain disorders and not all costs were included. Of the total costs of brain disorders, 32% were for direct health care, 23% for indirect medical care and 45% for indirect costs. Dementia was the most costly individual brain disorder followed by addiction and affective disorders. Most costly per case were brain tumours and multiple sclerosis. CONCLUSION: Brain disorders constitute a costly part of the population's health costs. Directed preventive measures are needed to counteract the population morbidity and to control the increasing cost pressure in health care.

Cost of disorders of the brain in Ireland.

The "Cost of Disorders of the Brain in Europe" (CBDE) study was conducted by the European Brain Council (EBC) to estimate prevalence and cost of the twelve leading disorders encountered in Neurology, Neurosurgery, and Psychiatry. The data for Ireland are presented here. Prevalence and costing information was obtained by structured review of published literature for each country. Where such information was lacking, figures were estimated from European data. Costs included direct medical, direct non-medical, and indirect costs. None of the costs presented here are directly from Irish data and the prevalence figures are mostly estimated from known European rates. In 2004, 1.1 million people in Ireland were affected by a disorder of the brain. Total cost of included disorders in Ireland was 3.0 billion Euro, representing 3% of gross national product, and costing each Irish citizen Euro 775 per year. Brain disorders are prevalent and pose significant economic burden in Ireland.

Funding of headache research in Europe.

Migraine costs European Society 27 billion Euro per year. Other headaches may account for a similar amount. Given this enormous impact, the question arises as to whether the funding of research efforts in this field are sufficient. A recent European study called the Resource Allocation to Brain Research in Europe (RABRE) examined funding of brain research. Identified charities and Government agencies in Europe filled out a questionnaire regarding their funding of brain diseases. Industry spending was evaluated by three different previously validated methods. In the present report, detailed results are presented for migraine and other headaches. In 2004, migraine research was funded by nearly 315 million Euro . Of this, 308 million Euro was invested by the pharmaceutical industry, whereas public funding was estimated at 7 million Euro . No funding was identified for non-migraine headache disorders. Of the public spending, 714,000 Euro came from private foundations. There was a very large difference between different European countries in the funding of headache research. When public funding was compared with the cost of different brain disorders, migraine funding was in the middle range. This was due to relatively large industry funding. Compared with societal costs, migraine received the least public funds amongst all brain disorders, i.e. 0.025%. We conclude that migraine attracts reasonable interest from the pharmaceutical industry, but Governmental and charity funding is extremely low and no funding was identified for non-migraine headache disorders. Considering the huge economic impact of these disorders, public funding of research into migraine and other headaches should be greatly increased in the future.

Estimation of the cost of MS in Europe: extrapolations from a multinational cost study.

The present study aims at estimating the total cost of MS in Europe based on actual cost data from nine countries and published epidemiological evidence. The epidemiological data are reported as 12 months prevalence estimates and cost data calculated as annual cost per patient at given levels of disease severity. Cost data are extrapolated to the rest of Europe based on a model, using economic indexes adjusting for price level differences in different sectors between countries. The aggregated annual cost estimates are presented in Euro for 2005. In 28 European countries with a population of 466 million, an estimated 380 000 individuals are affected by MS. The total annual cost of MS in Europe is estimated at 12.5 billion in year 2005, corresponding to a cost of 27 per European inhabitant. Direct costs represent slightly more than half of the total cost (6.0 billion). Informal care is estimated at 3.2 billion, and indirect costs due to morbidity at 3.2 billion. Thus, the largest component of costs is found outside the formal health care sector. Although our model appears to predict costs reasonably well, when comparing to previous national studies not included in the estimates, there are considerable uncertainties when extrapolating cost data across countries even within Europe. These weaknesses can only be overcome by collecting primary data.