Cardiovascular and renal diseases in type 2 diabetes patients: 5-year cumulative incidence of the first occurred manifestation and hospitalization cost: a cohort within the French SNDS nationwide claims database.

BACKGROUND: Myocardial infarction (MI), stroke, peripheral arterial disease (PAD), heart failure (HF) and chronic kidney disease (CKD) are common cardiovascular renal diseases (CVRD) manifestations for type 2 diabetes. The objective was to estimate the incidence of the first occurring CVRD manifestation and cumulative hospitalization costs of each CVRD manifestation for type 2 diabetes without CVRD history. METHODS: A cohort study of all type 2 diabetes free of CVRD as of January 1st 2014, was identified and followed-up for 5 years within the French SNDS nationwide claims database. The cumulative incidence of the first occurring CVRD manifestation was estimated using the cumulative incidence function, with death as a competing risk. Cumulative hospitalization costs of each CVRD manifestations were estimated from the perspective of all payers. RESULTS: From 2,079,089 type 2 diabetes without cancer or transplantation, 76.5% were free of CVRD at baseline with a mean age of 65 years, 52% of women and 7% with microvascular complications history. The cumulative incidence of a first CVRD manifestation was 15.3% after 5 years of follow-up with a constant linear increase over time for all CVRD manifestations: The most frequent was CKD representing 40.6% of first occurred CVRD manifestation, followed by HF (23.0%), then PAD (13.5%), stroke (13.2%) and MI (9.7%). HF and CKD together reached about one patient out of ten after 5 years and represented 63.6% of first CVRD manifestations. The 5-year global cost of all CVRD hospitalizations was 3.9 billion euros (B€), i.e. 2,450€ per patient of the whole cohort, with an exponential increase over time for each specific CVRD manifestation. The costliest was CKD (2.0 B€), followed by HF (1.2 B€), then PAD (0.7 B€), stroke (0.6 B€) and MI (0.3 B€). CONCLUSIONS/INTERPRETATION: While MI, stroke and PAD remain classic major risks of complications for CVRD-free type 2 diabetes, HF and CKD nowadays represent individually a higher risk and cost than each of these classic manifestations, and jointly represents a risk and a cost twice as high as these three classic manifestations all together. This should encourage the development of specific HF and CKD preventive strategies.

Penetration rates of new pharmaceutical products in Europe: A comparative study of several classes recently launched in type-2 diabetes.

BACKGROUND: Different countries have their own systems for evaluating new medicines, and they make decisions as to when and how each new medicine is adopted. PURPOSE: To compare the rate of uptake of new diabetes medicines (dipeptidyl peptidase-4 inhibitors [DPP-4Is], glucagon-like peptide-1 receptor agonists [GLP1-RAs], and sodium-glucose co-transporter-2 inhibitors [SGLT2Is]) in the five most populated European countries. METHODS: The monthly volume of sales of antidiabetic drugs was extracted for each country from the IQVIA™ MIDAS® database for the period 2007 to 2016 and the defined daily doses (DDDs) were calculated. For each new drug, market shares were expressed as a percentage of the total market of non-insulin antidiabetic agents. RESULTS: Sharp differences were observed between the countries. Overall, the highest and fastest rates of uptake were seen for Germany and Spain, compared to lower rates for the UK and Italy. This was especially marked for DPP-4Is, where the market share reached over 30% of non-insulin antidiabetic drugs in Germany and Spain, compared to around 10% in the UK and Italy. In France, there was an initial rapid uptake, which stabilized at around 20% after three years. Rates of uptake were lower for the other drugs, with the GLP1-RAs reaching a market share of 2.5-4.5% in Germany, Spain and France, compared to less than 2.5% in the UK and Italy. The SGLT2Is reached a market share of 5-8% in Spain and Germany, compared to less than 4% in the UK and Italy, and they were not launched at all in France in March 2020. CONCLUSION: The differences in the uptake of new antidiabetic drugs may reflect different methods for assessing and introducing new medicines, as well as cultural factors. The uptake of the new medicines would appear to be more cautious in the UK and Italy, perhaps due to concerns about cost-effectiveness, whereas in Germany and Spain, and possibly also France, a new medicine's potential benefits may be prioritized.

OPADIA Study: Is a Patient Questionnaire Useful for Enhancing Physician-Patient Shared Decision Making on Physical Activity Micro-objectives in Diabetes?

INTRODUCTION: Regular physical activity (PA) is recommended by all type 2 diabetes mellitus (T2DM) management guidelines. The OPADIA study aimed to determine whether using a specific patient questionnaire (Optima-PA©) could help T2DM patients increase their PA by leading to better physician-patient communication and improved levels of shared decision making concerning Specific, Measurable, Acceptable, Realistic, Timely (SMART)-PA micro-objectives. METHODS: Physicians participating in this multicentre, prospective, randomised, real-life study were allocated to a standard group (T2DM patients managed according to usual clinical practice, n = 24) or the OPTIMA-PA group (additional use of the questionnaire, n = 30). The main outcome was the percentage of inclusion visits ending with the setting up of at least one SMART-PA micro-objective. Other outcomes were the impact of the OPTIMA-PA questionnaire on patient perceptions of shared decision making (ENTRED questionnaire) and the impact of the OPTIMA-PA questionnaire and establishing SMART-PA micro-objectives as well as patient-perceived physician empathy (ENTRED questionnaire) and GP aptitude for patient-centredness (SEPCQ scores) on patient PA levels over a 3-month period (IPAQ-SF scores). RESULTS: One hundred twenty-two patients were included in the standard group and 134 in the OPTIMA-PA group. Unexpectedly, more inclusion visits ended with SMART-PA micro-objectives being set up in the standard group (p < 0.001): 81.1% (n = 99/122) versus 59.7% (n = 80/134). However, fewer patients in the OPTIMA-PA group felt that GPs made decisions alone (32% versus 60%; p < 0.0001). Positive correlations were also observed between GP patient-centredness and patient-perceived GP empathy or increased patient PA over the study period. CONCLUSION: Although the OPTIMA-PA questionnaire did not directly promote setting up of SMART-PA micro-objectives in T2DM patients, the OPADIA study demonstrated that this tool was effective at improving patient-physician relationships by increasing patient involvement in therapeutic decision making. Our study also highlighted the importance of GP aptitude for patient-centredness for improving PA in T2DM patients.

Cost of Managing Type 2 Diabetes Before and After Initiating Dipeptidyl Peptidase 4 Inhibitor Treatment: A Longitudinal Study Using a French Public Health Insurance Database.

INTRODUCTION: Diabetes is a growing epidemic that imposes a substantial economic burden on healthcare systems. This study aimed to evaluate the cost of managing type 2 diabetes (T2D) with dipeptidyl peptidase 4 inhibitors (DPP4Is) using real-world data. METHOD: This longitudinal study used data from the French EGB (Echantillon Généraliste des Bénéficiaires) database. The annual average direct healthcare cost of treating patients with T2D was calculated 3 years prior and 3 years after initiation of DPP4I therapy. Actual total ambulatory and hospital care expenditure for the 3 years after DPP4I initiation was compared to projected costs. The distribution of costs across all care modalities was assessed over the 6-year period. RESULTS: Ambulatory and hospital care expenditure data for 919 patients with T2D starting DPP4I therapy alone or in combination in 2013 were analyzed. A total of 526 patients (57.2%) were still being treated with DPP4I 3 years after DPP4I initiation. Regardless of the treatment regimen, the ambulatory and hospital care costs increased above projected costs in the first year following DPP4I initiation, and then declined during the second and third years to levels in line with or below projected values for patients using DPP4Is as an add-on therapy. The increase in total expenditure in the first year following DPP4I initiation and the subsequent decline in costs in the second and third years were both associated with general trends in consumption across all aspects of patient care. CONCLUSION: Despite an initial increase in healthcare expenditure, concomitant with reevaluation of patient care, this study showed that initiation of DPP4Is as an add-on therapy in French patients with T2D was associated with care expenditure that was in line or below predicted values within the 3 years following treatment initiation. Additional studies are required to evaluate the economic impact of the long-term treatment benefits.

Prediction of unplanned hospital admissions in older community dwellers using the 6-item Brief Geriatric Assessment: Results from REPERAGE, an observational prospective population-based cohort study.

BACKGROUND: The 6-item Brief Geriatric Assessment (BGA) provides a priori risk stratification of incident hospital health adverse events, but it has not been used yet to assess the risk of unplanned hospital admission for older patients in primary care. This study aims to examine the association between the a priori risk stratification levels of the 6-item BGA performed by general practitioners (GPs) and incident unplanned hospital admissions in older community patients. METHODS: Based on an observational prospective cohort design, 668 participants (mean age 84.7 ± 3.9 years; 64.7% female) were recruited by their GPs during an index primary care visit. The 6-item BGA was completed at baseline and provided an a priori risk stratification in three levels (low, moderate, high). Incident unplanned hospital admissions were recorded during a 6-month follow-up. RESULTS: The incidence of unplanned hospital admissions increased with the risk level of the 6-item BGA stratification, the highest prevalence (35.3%) being reported with the high-risk level (P = 0.001). The risk of unplanned hospital admission at the high-risk level was significant (crude odds ratio (OR) = 5.48, P = 0.001 and fully adjusted OR = 3.71, P = 0.032, crude hazard ratio (HR) = 4.20; P = 0.002 and fully adjusted HR = 2.81; P = 0.035). The Kaplan-Meier's distributions of incident unplanned hospital admissions differed significantly between the three risk levels (P-value = 0.002). Participants with a high-risk level were more frequently admitted to hospital than those at a low-risk level (P = 0.001). Criteria performances of all risk levels were poor, except the specificity of the high-risk level, which was 98.2%. CONCLUSIONS: The a priori 6-item BGA risk stratification was significantly associated with incident unplanned hospital admissions in primary care older patients. However, except for the specificity of the high-risk level, its criteria performances were poor, suggesting that this tool is unsuitable for screening older patients in primary care settings at risk of unplanned hospital admission.

A predictive microsimulation model to estimate the clinical relevance of reducing alcohol consumption in alcohol dependence.

BACKGROUND: Alcohol consumption is one of the most important factors for disease and disability in Europe. In clinical trials, nalmefene has resulted in a significant reduction in the number of heavy-drinking days (HDDs) per month and total alcohol consumption (TAC) among alcohol-dependent patients versus placebo. METHODS: A microsimulation model was developed to estimate alcohol-attributable diseases and injuries in patients with alcohol dependence and to explore the clinical relevance of reducing alcohol consumption. RESULTS: For all diseases and injuries considered, the number of events (inpatient episodes) increased with the number of HDDs and TAC per year. The model predicted that a reduction of 20 HDDs per year would result in 941 fewer alcohol-attributable events per 100,000 patients, while a reduction in intake of 3,000 g/year of pure alcohol (ethanol) would result in 1,325 fewer events per 100,000 patients. CONCLUSION: The potential gains of reducing consumption in alcohol-dependent patients were considerable.

Quality of life depends on the drinking pattern in alcohol-dependent patients.

AIMS: In patients with alcohol dependence, health-related quality of life (QOL) is reduced compared with that of a normal healthy population. The objective of the current analysis was to describe the evolution of health-related QOL in adults with alcohol dependence during a 24-month period after initial assessment for alcohol-related treatment in a routine practice setting, and its relation to drinking pattern which was evaluated across clusters based on the predominant pattern of alcohol use, set against the influence of baseline variables METHODS: The Medical Outcomes Study 36-Item Short-Form Survey (MOS-SF-36) was used to measure QOL at baseline and quarterly for 2 years among participants in CONTROL, a prospective observational study of patients initiating treatment for alcohol dependence. The sample consisted of 160 adults with alcohol dependence (65.6% males) with a mean (SD) age of 45.6 (12.0) years. Alcohol use data were collected using TimeLine Follow-Back. Based on the participant's reported alcohol use, three clusters were identified: 52 (32.5%) mostly abstainers, 64 (40.0%) mostly moderate drinkers and 44 (27.5%) mostly heavy drinkers. Mixed-effect linear regression analysis was used to identify factors that were potentially associated with the mental and physical summary MOS-SF-36 scores at each time point. RESULTS: The mean (SD) MOS-SF-36 mental component summary score (range 0-100, norm 50) was 35.7 (13.6) at baseline [mostly abstainers: 40.4 (14.6); mostly moderate drinkers 35.6 (12.4); mostly heavy drinkers 30.1 (12.1)]. The score improved to 43.1 (13.4) at 3 months [mostly abstainers: 47.4 (12.3); mostly moderate drinkers 44.2 (12.7); mostly heavy drinkers 35.1 (12.9)], to 47.3 (11.4) at 12 months [mostly abstainers: 51.7 (9.7); mostly moderate drinkers 44.8 (11.9); mostly heavy drinkers 44.1 (11.3)], and to 46.6 (11.1) at 24 months [mostly abstainers: 49.2 (11.6); mostly moderate drinkers 45.7 (11.9); mostly heavy drinkers 43.7 (8.8)]. Mixed-effect linear regression multivariate analyses indicated that there was a significant association between a lower 2-year follow-up MOS-SF-36 mental score and being a mostly heavy drinker (-6.97, P < 0.001) or mostly moderate drinker (-3.34 points, P = 0.018) [compared to mostly abstainers], being female (-3.73, P = 0.004), and having a Beck Inventory scale score ≥8 (-6.54, P < 0.001), at baseline. The mean (SD) MOS-SF-36 physical component summary score was 48.8 (10.6) at baseline, remained stable over the follow-up and did not differ across the three clusters. Mixed-effect linear regression univariate analyses found that the average 2-year follow-up MOS-SF-36 physical score was increased (compared with mostly abstainers) in mostly heavy drinkers (+4.44, P = 0.007); no other variables tested influenced the MOS-SF-36 physical score. CONCLUSION: Among individuals with alcohol dependence, a rapid improvement was seen in the mental dimension of QOL following treatment initiation, which was maintained during 24 months. Improvement was associated with the pattern of alcohol use, becoming close to the general population norm in patients classified as mostly abstainers, improving substantially in mostly moderate drinkers and improving only slightly in mostly heavy drinkers. The physical dimension of QOL was generally in the normal range but was not associated with drinking patterns.

The impact of memantine in combination with acetylcholinesterase inhibitors on admission of patients with Alzheimer's disease to nursing homes: cost-effectiveness analysis in France.

The costs associated with the care of Alzheimer's disease patients are very high, particularly those associated with nursing home placement. The combination of a cholinesterase inhibitor (ChEI) and memantine has been shown to significantly delay admission to nursing homes as compared to treatment with a ChEI alone. The objective of this cost-effectiveness analysis was to evaluate the economic impact of the concomitant use of memantine and ChEI compared to ChEI alone. Markov modelling was used in order to simulate transitions over time among three discrete health states (non-institutionalised, institutionalised and deceased). Transition probabilities were obtained from observational studies and French national statistics, utilities from a previous US survey and costs from French national statistics. The analysis was conducted from societal and healthcare system perspectives. Mean time to nursing home admission was 4.57 years for ChEIs alone and 5.54 years for combination therapy, corresponding to 0.98 additional years, corresponding to a gain in quality adjusted life years (QALYs) of 0.25. From a healthcare system perspective, overall costs were €98,609 for ChEIs alone and €90,268 for combination therapy, representing cost savings of €8,341. From a societal perspective, overall costs were €122,039 and €118,721, respectively, representing cost savings of €3,318. Deterministic and probabilistic (Monte Carlo simulations) sensitivity analyses indicated that combination therapy would be the dominant strategy in most scenarios. In conclusion, combination therapy with memantine and a ChEI is a cost-saving alternative compared to ChEI alone as it is associated with lower cost and increased QALYs from both a societal and a healthcare perspective.

The impact of memantine and cholinesterase inhibitor initiation for Alzheimer disease on the use of antipsychotic agents: analysis using the Régie de l'Assurance Maladie du Québec database.

OBJECTIVE: Patients with Alzheimer disease (AD) show a high incidence of behavioural and psychological symptoms of dementia, which often lead to the prescription of antipsychotics. Our study sought to assess the impact of the initiation of memantine or cholinesterase inhibitors (ChEIs) on the use of antipsychotics. METHOD: A retrospective cohort study was conducted using data from the Quebec provincial health plan database. Patients included in our study had received a diagnosis of AD and were initial users of memantine or ChEIs. The proportion of patients who used antipsychotics was estimated using prescription data dating back to 1 year before and to 1 year after the first prescription of memantine or ChEIs. The difference between the slopes corresponding to the periods pre- and postmemantine or ChEIs was analyzed using an interrupted time series design. RESULTS: The percentage of antipsychotic users increased by 118.3% before and by 68.3% after initiation of a ChEI, and increased by 68.6% before and by 7.0% after initiation of memantine. Antipsychotic trends pre- and post-ChEI initiation were not statistically different (P = 0.89), while a statistical difference was observed when comparing the antipsychotic trends pre- and postmemantine initiation (P < 0.001). CONCLUSIONS: The initiation of memantine, unlike ChEIs, has a notable stabilization effect on the prescription of antipsychotics in patients with AD.

Benzodiazepine discontinuation with prolonged-release melatonin: hints from a German longitudinal prescription database.

OBJECTIVE: Prolonged-release (PR) melatonin is approved in Europe for the treatment of insomnia in patients aged 55 years and above. The objective of the study was to describe its prescription patterns and its impact on hypnotics use in routine clinical practice. RESEARCH DESIGN AND METHODS: This is a retrospective study analyzing PR melatonin prescription data from a German longitudinal database (IMS(®) Disease Analyzer). All patients initiating PR melatonin over the 10 months after approval (April 2008 - February 2009) were included. Patients were classified according to their use of hypnotic benzodiazepines or benzodiazepine-like drugs (BZD/Z) in the 3-month period before and after PR melatonin initiation. RESULTS: Of the 512 eligible patients, 380 (74%) were aged ≥ 55 years, 344 (67%) women and 112 (22%) previous BZD/Z users. Most of the latter (79/99, 79.8%) had used BZD/Z for at least 180 days. Approximately one-third (35/112, 31%) discontinued BZD/Z after PR melatonin initiation, and the BZD/Z discontinuation rate was higher in patients receiving two or three PR melatonin prescriptions than in patients receiving only one prescription (10/24 = 42% vs 25/88 = 28%, p = 0.21). Of the 400 patients without prior BZD/Z use, 39 (10%) received BZD/Z during the follow-up. CONCLUSIONS: Based on the observed 31% discontinuation rate, PR melatonin may help to facilitate BZD/Z discontinuation in older insomniacs.

Economic evaluation of the impact of memantine on time to nursing home admission in the treatment of Alzheimer disease.

OBJECTIVE: An observational study showed that combining memantine with a cholinesterase inhibitor (ChEI) treatment significantly delayed admission to nursing homes in patients with Alzheimer disease (AD). Our study aimed to evaluate the economic impact of the concomitant use of memantine and a ChEI, compared with a ChEI alone, in a Canadian population of patients with AD. METHOD: A cost-utility analysis using a Markov model during a 7-year time horizon was performed according to a societal and Canadian health care system perspective. The Markov model includes the following states: noninstitutionalized, institutionalized, and deceased. The model includes transition probabilities for institutionalization and death, adjusted with mortality rates specific to AD. Utilities associated with institutionalization and noninstitutionalization were included. For the health care system perspective, costs of medication as well as costs of care provided in the community and in nursing homes were considered. For the societal perspective, costs of direct care and supervision provided by caregivers were added. RESULTS: From both perspectives, the concomitant use of a ChEI and memantine is a dominant strategy, compared with the use of a ChEI alone. On a per patient basis, there was a gain of 0.26 quality-adjusted life years with the treatment including memantine and cost decreases of Can$21 391 and Can$30 512, respectively, for the societal and health care system perspective. CONCLUSIONS: This economic evaluation indicates that institutionalization is the largest cost component in AD management and that the use of memantine, combined with a ChEI, to treat AD is a cost-effective alternative, compared with the use of a ChEI alone.

Framingham stroke risk function in a large population-based cohort of elderly people: the 3C study.

BACKGROUND AND PURPOSE: External validation of the Framingham stroke risk function has been rarely performed. We assessed its predictive ability in a population-based cohort of French elderly. METHODS: The sample comprised 6913 subjects from the 3C Study, aged 65 to 84 at baseline, who were followed up to 6 years. Predictive accuracy of the original Framingham stroke risk function was assessed in a 3-step procedure: comparison between the Framingham and 3C cohorts of the prevalence of selected risk factors and the associated relative risks (RR) for stroke, comparison of the predicted to the observed number of stroke events (calibration), and ability to separate high-risk from low-risk participants (discrimination). We also compared predictive performances of the original Framingham, the recalibrated Framingham, and the local stroke risk functions. RESULTS: During follow-up, 110 incident strokes occurred. For most risk factors, RRs were comparable between the 2 cohorts, except for age in women. The original Framingham stroke risk function applied to the 3C cohort overestimated the 6-year absolute risk for stroke by a factor of 3.7 for men and 4.4 for women. However, the recalibrated Framingham and 3C functions did not show any over- or underestimation of stroke risk. The 3 stroke risk functions (original, recalibrated, and 3C) provided acceptable discrimination with areas under the ROC curve ranging from 0.67 to 0.73. CONCLUSIONS: The original Framingham stroke risk function strongly overestimated the stroke risk for 3C participants. Derived Framingham stroke score sheets should not be directly used by physicians in the French elderly population.

Pain in an emergency department: an audit.

OBJECTIVE: To evaluate the quality of care in patients with pain who visit the emergency department of a university hospital and the evolution of their pain during their emergency department stay. METHODS: A cross-sectional survey was performed using two valid scales (a numerical descriptor scale or a verbal pain intensity scale), and a structured questionnaire to patients and use of patient charts to collect information on pain intensity on arrival and before discharge, characteristics of pain and of its management. RESULTS: In the 726 participating patients, median age was 37 years (range: 18-97), and 54% of the patients were men. Upon arrival, 563 patients presented with pain (78%), rated > or =7 in 35% of the 390 patients evaluated using numerical descriptor scale. Forty-four percent had taken analgesics before arrival. Their median waiting time before initial medical examination was 30 min. Pain was identified by triage nurses (70%) or by physicians (77%) and was rated by nurses (23%) and physicians (11%). Forty-seven percent also experienced pain during care and 27% received analgesics during their stay. Pain intensity remained unchanged in 70% of patients, increased in 7% and decreased in 23%. Of the 480 patients with pain on arrival evaluated before discharge, 395 (82%) patients were unrelieved before going home, rated > or =7 in 32% of the 390 patients evaluated using numerical descriptor scale. Analgesics were ordered before leaving the emergency department in 81%. CONCLUSION: Even if pain has been identified, its assessment and management remains inadequate. The quality of care may be improved by educating the personnel in developing protocols and in evaluating pain management.