Oncologist perspectives on chemotherapy-induced nausea and vomiting (CINV) management and outcomes: A quantitative market research-based survey.

BACKGROUND: Chemotherapy-induced nausea and vomiting (CINV) is a distressing side effect that can negatively impact patients' quality of life and could discourage completion of chemotherapy, thereby affecting overall treatment outcomes. Although adherence to antiemetic guidelines can reduce CINV incidence in patients receiving highly or moderately emetogenic chemotherapy, CINV control remains inadequate. AIMS: The objectives of this survey were to determine oncologists' practice patterns in CINV management, identify factors that contribute to antiemetic treatment failure, and determine the outcomes of uncontrolled CINV on health care resource utilisation and on patients' attitude towards chemotherapy. METHODS AND RESULTS: Quantitative market research was performed using an online questionnaire. Responses from 300 European oncologists who prescribe antiemetics and see ≥50 patients/month were analysed. Results showed that the main reasons reported by oncologists for antiemetic treatment failure were underestimating the emetogenic potential of chemotherapy, utilising weaker antiemetic regimens than required, and patient non-adherence because of administration mistakes or missed/delayed doses. Educational initiatives for the oncology multidisciplinary team may help improve guideline-consistent prescribing. Also, the availability of simpler, more convenient antiemetic therapies may improve guideline adherence and patient compliance during home administration. CONCLUSION: Achieving effective CINV control is a crucial goal to improve patients' quality of life, which should optimise chemotherapy outcomes, and would ultimately reduce health care costs.

NEPA, a new fixed combination of netupitant and palonosetron, is a cost-effective intervention for the prevention of chemotherapy-induced nausea and vomiting in the UK.

BACKGROUND: The objective was to evaluate the cost-effectiveness of NEPA, an oral fixed combination netupitant (NETU, 300 mg) and palonosetron (PA, 0.5 mg) compared with aprepitant and palonosetron (APPA) or palonosetron (PA) alone, to prevent chemotherapy-induced nausea and vomiting (CINV) in patients undergoing treatment with highly or moderately emetogenic chemotherapy (HEC or MEC) in the UK. SCOPE: A systematic literature review and meta-analysis were undertaken to compare NEPA with currently recommended anti-emetics. Relative effectiveness was estimated over the acute (day 1) and overall treatment (days 1-5) phases, taking complete response (CR, no emesis and no rescue medication) and complete protection (CP, CR and no more than mild nausea [VAS scale <25 mm]) as primary efficacy outcomes. A three-health-state Markov cohort model, including CP, CR and incomplete response (no CR) for HEC and MEC, was constructed. A five-day time horizon and UK NHS perspective were adopted. Transition probabilities were obtained by combining the response rates of CR and CP from NEPA trials and odds ratios from the meta-analysis. Utilities of 0.90, 0.70 and 0.24 were defined for CP, CR and incomplete response, respectively. Costs included medications and management of CINV-related events and were obtained from the British National Formulary and NHS Reference Costs. The expected budgetary impact of NEPA was also evaluated. FINDINGS: In HEC patients, the NEPA strategy was more effective than APPA (quality-adjusted life days [QALDs] of 4.263 versus 4.053; incremental emesis-free and CINV-free days of +0.354 and +0.237, respectively) and was less costly (£80 versus £124), resulting in NEPA being the dominant strategy. In MEC patients, NEPA was cost effective, cumulating in an estimated 0.182 extra QALDs at an incremental cost of £6.65 compared with PA. CONCLUSION: Despite study limitations (study setting, time horizon, utility measure), the results suggest NEPA is cost effective for preventing CINV associated with HEC and MEC in the UK.

[A cross-sectional survey to evaluate the cardiovascular risk profile in subjects referred to the Verona-ASL 20 general practitioners]. / Indagine trasversale per la valutazione del profilo di rischio cardiovascolare nella popolazione di soggetti assistibili afferenti ai medici di medicina generale nell'area della ASL 20 di Verona.

BACKGROUND: Most of the studies on the identification of cardiovascular risk factors have been conducted either in northern Europe or in the United States. However, genetic as well as dietary factors may vary across different countries and geographical areas and there are few data about the cardiovascular risk profile in our country. METHODS: A sample of 3144 subjects (1463 males, 1681 females aged 35-74 years) were randomly selected among the population qualifying for healthcare assistance, registered with 170 general practitioners. Demographic data, clinical information, lab tests and current pharmacological treatments were collected using an electronic case report form. RESULTS: The prevalences of cardiovascular risk factors in the population were: smoking habit 22.7%, obesity 12.8%, hypertension 39.2%, hypercholesterolemia 25.5%, hyperglycemia and diabetes 5.5%. Thirty-five point four percent of the subjects presented a low absolute 10-year cardiovascular risk level (< 5%), 31.1% an intermediate risk (5-9%), 24.9% a moderate risk (10-19%), and 8.6% a high risk (> or = 20%) of developing cardiovascular diseases. CONCLUSIONS: In the area of Verona approximately 20,000 out of 231,592 subjects, aged 35-74 years, may present an absolute 10-year cardiovascular risk level > or = 20%. These results represent the epidemiological basis for planning and implementing preventive interventions toward cardiovascular diseases.

An assessment of chemotherapy-induced nausea and vomiting direct costs in three EU countries.

BACKGROUND: chemotherapy-induced nausea and vomiting (CINV) has been commonly reported as one of the most distressing adverse effects among treated patients with cancer. Inadequately treated, CINV can lead to increased resource utilization and severely impair patients' daily functioning and quality of life. Direct costs include acquisition cost of antiemetic drugs and rescue medication, administration devices, add-on treatments, such as hydration, and additional patient care, that is, nursing and physician time, unscheduled office visits, emergency room admissions, and, in some cases, extended hospitalization or readmission. There are many reports on the cost-effectiveness of antiemetic drugs, but information on the total cost per patient associated with CINV is limited. The costs associated with severe CINV episodes are considered responsible for the most significant part of the expenditures. SCOPE: The aim of this study was to investigate the management of CINV episodes in three European health-care environments and to estimate direct costs associated with severe CINV episodes. METHODS: An online survey addressed to Italian, German, and French oncologists and oncology nurses was performed. The survey included 41 questions about the management and the resource utilization for patients experiencing any CINV episode during the 6-month period preceding the survey. Furthermore, the cost associated with severe CINV episode management was estimated by adopting the National Health Service's perspective. FINDINGS: A large proportion of patients receiving chemotherapy experienced a CINV episode (34.4% in Italy, 50.2% in France, and 40.4% in Germany); among those, 8.8% in Italy, 11.6% in France, and 19.2% in Germany experienced a severe CINV episode. Compared with Italy, Germany and France presented a greater hospitalization rate following an unplanned visit to the oncology ward or an emergency room access due to CINV. In Italy, the mean cost per patient with a severe CINV episode resulted in approximately €389, about half of the mean cost in France (€750) and a third of the mean cost in Germany (€1,017). CONCLUSIONS: Severe CINV episodes requiring hospitalization, day hospital, or hospitalization extension involve a significant cost for the National Health Services; additional studies should be conducted in order to evaluate potential ways to offset these expenses.

Assessment of antihypertensive drug use in primary care in Ravenna, Italy, based on data collected in the PANDORA project.

BACKGROUND: In the clinical-practice setting, only a small percentage of patients treated with antihypertensive drugs become normotensive. Furthermore, the diversity of drug classes used makes comparison of treatments difficult. OBJECTIVE: The goal of this study was to characterize the types and efficacy of antihypertensive treatments used in primary care in the area of Ravenna, Italy. The study was conducted in the context of the PANDORA Project, an open-ended global outcome study. METHODS: Data were gathered from general practitioners (GPs) and were stored by the GPs or through links with national health service databases. The population of interest was patients with essential hypertension taking antihypertensive medication, each of whom was observed for 365 days. Blood pressure was measured in the morning or afternoon using an automated device, in accordance with normal clinical practice. At each office visit, the GP reviewed and made any necessary adjustments to the patient's antihypertensive treatment. Antihypertensive drug use was assessed by calculating the mean daily dose (MDD) of the prescribed drug and the duration of treatment (DT). A DT > or = 273 days constituted continuous therapy, and a DT <273 days constituted discontinuous therapy. Adverse events were not collected. RESULTS: Twenty-one GPs took part in the study. The study population included 969 patients (443 men, 526 women), all of them white, whose ages ranged from 23 to 88 years. At enrollment, 327 patients were normotensive (blood pressure <140/90 mm Hg) and 642 were hypertensive despite drug treatment. More than 25 treatment regimens were identified. Over the course of follow-up, 49 patients had discontinuous therapy and 920 had continuous therapy. Among those who had continuous therapy, 117 (12.7%) took an MDD of <0.5 tablet/d; 297 (32.3%) took > or = 0.5 and <1 tablet/d; 364 (39.6%) took > or = 1 and <2 tablets/d; and 142 (15.4%) took > or = 2 tablets/d. At the end of the observation period, the proportion of normotensive patients had increased by 5.7% (P < 0.001). CONCLUSION: Based on the findings of this study, improper use of antihypertensive drug therapy appears to be one of the reasons for the relatively small proportion of patients who attain blood pressure control with treatment.

Cardiovascular risk in hypertensive patients: results of the Pandora project.

BACKGROUND: The aim of the Pandora project is to collect epidemiological information, check diagnostic and therapeutic pathways, and assess outcomes in a large hypertensive population. This report presents the results on patients enrolled in the study between 1997-1999. METHODS: Twenty-one general practitioners working in the Ravenna Local Health Service took part in the study. They were supplied with IBM compatible PCs and were trained to enter the patient's data (age, gender, familiarity for cardiovascular diseases, smoking, hospitalisations for cardiovascular disorders, diabetes, blood pressure, total cholesterolemia, creatininemia, antihypertensive therapy) on So.Ge.Pa. software. Cardiovascular risk factors were assessed according to the WHO - ISH joint committee recommendations. RESULTS: 2,608 treated hypertensive patients were enrolled, 65% of whom showed inadequate blood pressure control. The prevalence of inadequate BP control was higher in patients on multiple-drug antihypertensive therapy compared with those on monotherapy (71.9% vs. 47.9%), in older than in younger patients (70.7% vs. 56.1%) and in patients with three cardiovascular risk factors, or diabetes, or affected target organs, compared to those with two or less risk factors (72.4% vs. 63.3%), (p < 0.001 for all). 63.6% of patients were at risk for age, 36.6% for family history of cardiovascular diseases and 31.7% for severe hypercholesterolemia. CONCLUSIONS: BP control was inadequate in a large percentage of patients, but it was particularly unsatisfactory in the elderly and in patients with high cardiovascular risk. A cluster of cardiovascular risk factors was found in both adequately and inadequately controlled hypertensive patients.

Depression: cost-of-illness studies in the international literature, a review.

BACKGROUND: Depression is one of the most ancient and common diseases of the human race and its burden on society is really impressive. This stems both from the epidemiological spread (lifetime prevalence rate, up to 30 years of age, was estimated as greater than 14.4% by Angst et al.) and from the economic burden on healthcare systems and society, but also as it pertains to patient well-being. AIMS OF THE STUDY: The scope of this review was to examine studies published in the international literature to describe and compare the social costs of depression in various countries. METHODS: A bibliographic search was performed on international medical literature databases (Medline, Embase), where all studies published after 1970 were selected. Studies were carefully evaluated and only those that provided cost data were included in the comparative analysis; this latter phase was conducted using a newly developed evaluation chart. RESULTS: 10 abstracts were firstly selected; 46 of them underwent a subsequent full paper reading, thus providing seven papers, which were the subject of the in-depth comparative analysis: three studies investigated the cost of depression in the USA, three studies in the UK and one study was related to Italy. All the studies examined highlight the relevant economic burden of depression; in 1990, including both direct and indirect costs, it accounted for US$ 43.7 billion in the US (US$ 65 billion, at 1998 prices) according to Greenberg and colleagues, whilst direct costs accounted for £417 million in the UK (or US$ 962.5 million, at 1998 prices), according to Kind and Sorensen. Within direct costs, the major cost driver was indeed hospitalization, which represented something in between 43 and 75% of the average per patient cost; conversely, drug cost accounted for only 2% to 11% in five out of seven studies. DISCUSSION: Indeed, our review suggests that at the direct cost level, in both the United States and the United Kingdom, the burden of depression is remarkable, and this is confirmed by a recent report issued by the Pharmaceutical Research and Manufacturers Association (PhRMA) where prevalence and cost of disease were compared for several major chronic diseases, including Alzheimer, asthma, cancer, depression, osteoporosis, hypertension, schizophrenia and others: in this comparison, depression is one of the most significant diseases, ranked third by prevalence and sixth in terms of economic burden. Moreover, in terms of the average cost per patient, depression imposes a societal burden that is larger than other chronic conditions such as hypertension, rheumatoid arthritis, asthma and osteoporosis. The application of economic methods to the epidemiological and clinical field is a relatively recent development, as evidenced by the finding that, out of the seven studies examined, three refer to the US environment, three to the UK and one to Italy, while nothing was available about the cost of depression for large countries such as France, Germany, Spain, Japan and others. IMPLICATION FOR HEALTH CARE PROVISION AND USE: The high incidence of hospitalization, and the finding that drug cost represents only a minor component of the total direct cost of the disease, suggests that room is still available for disease management strategies that, while effectively managing the patient's clinical profile, could also improve health economic efficiency. IMPLICATION FOR HEALTH POLICIES: Disease management strategies, with particular emphasis on education, should be targeted not only at patients and medical professionals but also at health decision makers in order "to encourage effective prevention and treatment of depressive illness". IMPLICATIONS FOR FURTHER RESEARCH: Cost of illness studies are a very useful tool allowing cost data comparisons across countries and diseases: for this reason, we suggest that further research is needed especially in some western European countries to assess the true economic burden of depression on societies.

Underuse of lipid-lowering drugs and factors associated with poor adherence: a real practice analysis in Italy.

BACKGROUND: Many studies have indicated the adequate use of lipid-lowering drugs (LLDs) as a factor in reducing the risk of cardiovascular disease. However, in clinical practice, a very high percentage of patients are not adequately treated. OBJECTIVE: To analyze the management of hypercholesterolemia in a non-experimental setting and to estimate the factors associated with poor adherence to treatment. METHODS: A longitudinal study was performed using clinical and demographic data recorded in the General Practitioners' database. The sample included all patients, aged 30 years or over, with total blood cholesterol measured between 1 January and 31 December 2000. Utilization of LLDs was defined as the standardized daily dose of the drugs purchased during the 12 months preceding the cholesterol measurement. RESULTS: The study included 4764 patients (mean age 59.4+/-14.1 years, 40.7% males). Of the subjects with a total cholesterol higher than a 6.5 mmol/l, approximately 17% were treated with LLDs. About 39% of the patients with previous atherosclerotic diseases were taking statins. Analysis of patients taking LLDs showed that 40.6% of subjects took less than half of the defined daily dose. Factors associated with poor adherence to treatment were: absence of previous atherosclerotic diseases, absence of concomitant diseases, and smoking. A total cholesterol of less than 5 mmol/l was achieved in 19.9% of patients. CONCLUSIONS: Analyzing the data contained in the general medicine database made it possible to evaluate the use of LLDs in clinical practice and to establish the need to pay greater attention to achieving the objective set by the treatment.

Different aspects of adherence to antihypertensive treatments.

This review collects together data concerning the measurement of patient behavior towards antihypertensives, considering all its aspects - adherence, persistence and switching. The wide heterogeneity of terms, outcome definitions and methods of assessment (the multiplicity of approaches did not allow a full meta-analysis, but a qualitative description of the results) are demonstrated. The percentages of adherence/compliance from the studies discussed in this review range from 15 to 99% across different study designs, populations and methods. Large, observational studies are suggested as a reliable method to measure patient behavior. An emerging issue is the relevance of patient motivation and education, which could provide a higher level of compliance to treatment, thus allowing achievement of better clinical outcomes and improved use of resources for the healthcare system.

The pandora project: cost of hypertension from a general practitioner database.

AIM: The Pandora Project is a longitudinal database--implemented by general practitioners since June 1997 in the Ravenna area (Italy)--providing information on patients with hypertension. Data from 1,651 patients were followed up for I year in order to investigate the cost of hypertension. Only direct medical costs were considered in the perspective of the National Healthcare System. FINDINGS: At enrollment, 552 patients were classified as normotensive, 1,099 as hypertensive. After 1 year, among normotensive group, 352 patients remained normotensive and 200 became hypertensive; among hypertensive group, 323 patients became normotensive and 776 remained hypertensive. The average total cost per patient at follow-up was 779.59 Euros. About 46% of total cost was due to anti-hypertensive therapy, irrespective of the evolution of blood pressure levels registered, whilst other direct costs represented 54% of total patient cost in all cohorts. It is possible that co-morbidities play a significant role in this situation. Patient aged 80-89 years generate higher costs. Even if further investigation is needed on the burden of comorbidity on a per-patient cost of hypertension, this work provides evidence that the average total cost per patient is likely to increase with age and co-morbidities. Key words: cost-of-illness, costs, economics, hypertension.