Methods for estimating glomerular filtration rate.
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Biomedical subjects
Publications and source records attributed to Claudio Pedone.
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BACKGROUND AND AIMS: Donepezil is effective in slowing the progression of Alzheimer's disease (AD). No data are available on the patterns of donepezil use among nursing home residents. We estimate the prevalence of the use of donepezil and the frequency of its initiation, and describe the demographic and clinical characteristics of residents taking this drug. METHODS: We used data from the Minimum Data Set (N=174659). We compared users and non-users of donepezil with respect to demographic, clinical and functional variables. We estimated the 6-month incidence of donepezil use. All analyses were stratified by the admission status of the residents (newly admitted/long-stay). RESULTS: Among those meeting the manufacturer's indication for donepezil (mild to moderate AD), the prevalence of use was 30% among newly admitted, and 19% among long-stay residents. About 3% of residents not meeting the manufacturer's indication for donepezil were taking it. The proportion of people with AD still taking donepezil after six months was 44.8% among newly admitted, and 59.5% among long-stay residents. Donepezil use was associated with cognitive impairment, behavioral problems and the use of psychotropic drugs including anti-psychotics and anti-depressants. In people without a diagnosis of AD, there seems to be an association between behavioral problems and use of donepezil. CONCLUSIONS: Donepezil is frequently used in the nursing home setting for the management of AD. Off-label use of donepezil is also relatively frequent. This may reflect an empirical perception of effectiveness on outcomes different from cognitive impairment, such as behavioral problems, although evidence is lacking.
BACKGROUND AND AIMS: Community care for older people is increasing dramatically in most European countries as the preferred option to hospital and long-term care. While there has been a rapid expansion in Evidence-Based Medicine, apart from studies of specific interventions such as home visiting and hospital at home (specialist visits or hospital services provided to people in their own homes in the community), there is little evidence of characteristics of the recipients of community care services or the organisation of services that produce the best outcomes for them and their informal carers. The AdHOC Study was designed to compare outcomes of different models of community care using a structured comparison of services and a comprehensive standardised assessment instrument across 11 European countries. This paper describes the study and baseline data. METHODS: 4,500 people 65 years and older already receiving home care services within the urban areas selected in each country were randomly sampled. They were assessed with the MDS-HC (Minimum Data Set-Home Care) instrument, containing over 300 items, including socio-demographic, physical and cognitive characteristics of patients as well as medical diagnoses and medications received. These data were linked to information on the setting, services structures and services utilization, including use of hospital and long-term care. After baseline assessment, patients were re-evaluated at 6 months with an abbreviated version of the instrument, and then at the end of one year. Data collection was performed by specially-trained personnel. In this paper, socio-demographics, physical and cognitive function and provision of hours of formal care are compared between countries at baseline. RESULTS: The final study sample comprised 3,785 patients; mean age was 82+/-7.2 years, 74.2% were females. Marital and living status reflected close family relationships in southern Europe relative to Nordic countries, where 5 times as many patients live alone. Recipients of community care in France and Italy are characterised by very high physical and cognitive impairment compared with those in northern Europe, who have comparatively little impairment in Activities of Daily Living and cognitive function. The provision of formal care to people with similar dependency varies extremely widely with very little formal care in Italy and more than double the average across all levels of dependency in the UK. CONCLUSIONS: The AdHOC study, by virtue of the use of a common comprehensive standardised assessment instrument, is a unique tool in examining older recipients of community care services in European countries and their widely varied organisation. The extreme differences seen in dependency and hours of care illustrate the probable contribution the study will make to developing an evidence based on the structure, quantity and targeting of community care, which will have major policy implications.
BACKGROUND: There is a lack of information on the effects of angiotensin-converting enzyme (ACE) inhibitors in very old people with heart failure (HF). The objective of this study is to estimate the prevalence of prescriptions of ACE inhibitors in elderly people with HF discharged from acute care hospitals, and to evaluate the effect of these drugs on 1-year mortality rates. METHODS: We used data from the Gruppo Italiano di Farmacovigilanza nell'Anziano (GIFA). In 1998, we undertook a 1-year longitudinal study on elderly people (aged 65+ years) discharged with a diagnosis of HF. We compared the demographic and clinical characteristics associated with a prescription at discharge of ACE inhibitors, and used a Cox proportional hazard regression model to calculate the relative hazard of dying associated with the use of ACE inhibitors. RESULTS: We enrolled 818 patients in the study with a mean age of 79 years (range: 65-101 years). One fourth of the participants were aged 85 years or older. ACE inhibitors were prescribed to 550 patients (67.2%) at discharge. Older age and physical disability were negatively correlated with the use of ACE inhibitors. People using ACE inhibitors had a 40% reduction of mortality (HR [hazard ratio]: 0.60; 95% CI [confidence intervals]: 0.42-0.88). The reduction in mortality was much stronger among disabled people (HR: 0.35; 95% CI: 0.19-0.64). CONCLUSION: ACE inhibitors are still underprescribed among elderly people with HF discharged from acute care hospitals. Even in this frail, elderly population, we found a beneficial effect of ACE inhibitors. There is room to further improve the quality of care for elderly people with HF.
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PURPOSE: Cognitive impairment is a common, potentially reversible condition among older patients with heart failure. Because cerebral metabolic abnormalities have been associated with reduced survival in younger patients with advanced heart failure, we assessed the effect of cognitive impairment on the survival of older patients with heart failure. METHODS: The association between cognitive dysfunction and in-hospital mortality was assessed in 1113 patients (mean [+/- SD] age, 78 +/- 9 years) who had been admitted for heart failure to 81 hospitals throughout Italy. One-year mortality was assessed in 968 patients with heart failure (age, 76 +/- 10 years) participating in the same study. Cognitive impairment was defined as a Hodkinson Abbreviated Mental Test score <7. RESULTS: In-hospital death occurred in 65 (18%) of the 357 participants with cognitive impairment and in 26 (3%) of the 756 patients with normal cognition (P <0.0001). Out-of-hospital mortality was 27% (51/191) among patients with cognitive impairment and 15% (115/777) among other participants (P <0.0001). In multivariate Cox regression models, decreasing levels of cognitive functioning were associated with increasing in-hospital mortality; cognitive impairment was associated with an almost fivefold increase in mortality (relative risk = 4.9; 95% confidence interval: 2.9 to 8.3) after adjusting for several potential confounders. CONCLUSION: Cognitive impairment is an independent prognostic marker in older patients with heart failure. Assessment of cognitive functioning, even by simple screening tests, should be part of the routine assessment of elderly patients with heart failure.
BACKGROUND: Clinical practice guidelines (CPG) are thought to be an effective tool in improving efficiency and outcomes of clinical practice. Physicians' adherence to guidelines is reported to be poor. We evaluated the relationship between generalizability of guidelines on hypertension and physicians' adherence to guidelines' recommendations for pharmacological treatment. METHODS: We used the Sixth Joint National Committee's (JNC VI) guidelines on hypertension to evaluate our hypothesis. We evaluated the evidence from controlled clinical trials on which the JNC VI bases its recommendation, and compared the population enrolled in those trials with the American hypertensive population. Data on this population came from the National Health and Nutritional Examination Survey III. RESULTS: Twenty-three percent of the NHANES population had a diagnosis of hypertension, 11% had hypertension requiring drug treatment according to the JNC VI. Only half of the population requiring treatment would have been enrolled in at least two trials. Rate of adherence to CPG was 69%. We found a weak association between generalizability and physicians' adherence to guidelines. Baseline risk was the major determinant of the decision to treat. CONCLUSION: JNC VI guidelines may not be generalizable to their target population. We found a relatively poor adherence rate to these guidelines. Failing of completely taking into account the clinical characteristics of the patients may be partly responsible for this lack of adherence.
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OBJECTIVE: The objective of this study was to assess whether calcium antagonists, which have been proven to dilate the afferent glomerular arteriole, might prevent increases in serum creatinine levels among older subjects who started treatment with angiotensin-converting enzyme (ACE) inhibitors. METHODS: We explored the association between use of calcium antagonists and incident increases in serum creatinine in 780 elderly patients with baseline creatinine levels <1.2 mg/dL (106.19 micromol/L), who were enrolled in a multicenter pharmacoepidemiology study, and who started using ACE inhibitors during their hospital stay. Among these participants, 279 also started using calcium antagonists. Demographic variables, comorbid conditions, medications, and objective tests, which were associated with increasing serum creatinine levels in separate regression models, were examined as potential confounders in a summary model. RESULTS: Among patients receiving ACE inhibitors, serum creatinine levels increased in 22% of participants who were dispensed calcium antagonists, and in 31% of other patients (P=0.005). In the summary regression model, use of calcium antagonists was associated with a decreased risk of worsening renal function (RR 0.56, 95% CI 0.37-0.84). The adjusted risk of increasing serum creatinine was lower (RR 0.25, 95% CI 0.05-0.95) in participants receiving higher calcium antagonists dosages than in those taking lower dosages. This protective effect of calcium antagonists was not detected in patients not dispensed ACE inhibitors. CONCLUSION: ACE inhibitors are underused in older subjects, mainly because of the higher incidence of renal damage among geriatric populations. Our results indicate that among elderly patients receiving ACE inhibitors, the use of calcium antagonists is associated with a reduced risk of worsening renal function. Thus, these results warrant trials aiming at establishing whether combined treatment with calcium antagonists might allow the use of ACE inhibitors in clinical practice to be expanded to the elderly population.
BACKGROUND AND AIMS: Blood pressure is known to be influenced by the season, particularly in the elderly. The association between cold weather and unrecognized hypertension has not been previously studied. The present study aimed at assessing whether recognition of hypertension in the elderly follows a seasonal pattern. METHODS: All patients over 64 with either first-listed or secondary diagnosis of hypertension at discharge (N = 4487) out of 24585 consecutively admitted to 69 wards of Geriatrics or Internal Medicine during ten bi-monthly observation periods (May-June and September-October) were enrolled. The main outcome of the study was the prevalence of unrecognized hypertension, defined as no mention of hypertension and/or antihypertensive drugs in clinical histories collected on admission, and a first-listed or secondary discharge diagnosis of hypertension. RESULTS: We found a total of 928 patients with unrecognized hypertension. Being admitted in the September-October period was independently associated with the outcome unrecognized hypertension (OR 1.25, 95% CI 1.08-1.46), as were smoking addiction (OR 1.57, 95% CI 1.23-2.0) and allocation to a medical ward (OR 1.21, 95% CI 1.04-1.41). Negative correlates of the outcome were multiple pathologies (OR 0.85, 95% CI 0.73-0.99), discharge diagnosis of coronary artery disease (OR 0.77, 95% CI 0.64-0.92) or diabetes mellitus (OR 0.81, 95% CI 0.67-0.97). CONCLUSIONS: Hypertension in the elderly may at least partly follow a seasonal pattern, and this finding may be relevant for screening and therapeutic decisions.
BACKGROUND: Use of atypical antipsychotics for "off-label" indications, such as behavioral and psychological symptoms of dementia, depression, and bipolar disorder, have been frequently reported, although not systematically studied. We describe the pattern of atypical antipsychotic use among nursing home residents and identify demographic and clinical correlates. METHOD: We conducted a cross-sectional study on 139,714 nursing home residents living in 1732 nursing homes in 5 U.S. states from Jan. 1, 1999, to Jan. 31, 2000. Data were obtained from the computerized Minimum Data Set (MDS) assessment records. RESULTS: Behavior problems associated with cognitive impairment were manifest in 86,514 residents, and, of these, 18.2% received an antipsychotic. Approximately 11% received an atypical antipsychotic, while 6.8% received a conventional agent. Clinical correlates of atypical antipsychotic use were Parkinson's disease (adjusted odds ratio [OR] = 1.57, 95% confidence interval [CI] = 1.34 to 1.84), depression (OR = 1.35, 95% CI = 1.24 to 1.46), antidepressant use (OR = 1.38, 95% CI = 1.27 to 1.49), Alzheimer's disease (OR = 1.21, 95% CI = 1.12 to 1.32), non-Alzheimer dementia (OR = 1.15, 95% CI = 1.07 to 1.24), and cholinesterase inhibitor use (OR = 1.74, 95% CI = 1.52 to 1.98). Severe functional impairment was inversely related to atypical antipsychotic use (OR = 0.76, 95% CI = 0.65 to 0.89). CONCLUSION: Atypical antipsychotics are now used more than conventional antipsychotic agents in U.S. nursing homes. Indications and dosages seem appropriate relative to labeling. Clinical and demographic differences between atypical and conventional antipsychotic users tend to be relatively small, suggesting that other factors may explain the choice of prescribing physicians. The impact of facility factors, economic forces, and physician characteristics needs to be investigated.
BACKGROUND: Optimal glycemic control prevents the onset of diabetes complications. Identifying diabetic patients at risk of poor glycemic control could help promoting dedicated interventions. The purpose of this study was to identify predictors of poor short-term and long-term glycemic control in older diabetic in-patients. METHODS: A total of 1354 older diabetic in-patients consecutively enrolled in a multicenter study formed the training population (retrospective arm); 264 patients consecutively admitted to a ward of general medicine formed the testing population (prospective arm). Glycated hemoglobin (HbA1c) was measured on admission and one year after the discharge in the testing population. Independent correlates of a discharge glycemia > or = 140 mg/dl in the training population were assessed by logistic regression analysis and a clinical prediction rule was developed. The ability of the prediction rule and that of admission HbA1c to predict discharge glycemia > or = 140 mg/dl and HbA1c > 7% one year after discharge was assessed in the testing population. RESULTS: Selected admission variables (diastolic arterial pressure < 80 mmHg, glycemia = 143-218 mg/dl, glycemia > 218 mg/dl, history of insulinic or combined hypoglycemic therapy, Charlson's index > 2) were combined to obtain a score predicting a discharge fasting glycemia > or = 140 mg/dl in the training population. A modified score was obtained by adding 1 if admission HbA1c exceeded 7.8%. The modified score was the best predictor of both discharge glycemia > or = 140 mg/dl (sensitivity = 79%, specificity = 63%) and 1 year HbA1c > 7% (sensitivity = 72%, specificity = 71%) in the testing population. CONCLUSION: A simple clinical prediction rule might help identify older diabetic in-patients at risk of both short and long term poor glycemic control.
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BACKGROUND AND AIMS: The aim of this study was to analyze trends in the use of ACE-inhibitors in patients aged 65 and older with congestive heart failure (CHF) in the period from 1988 to 1998. METHODS: We studied 2985 patients (mean age 79.7 +/- 7 years), hospitalized for CHF in 12 different bimonthly periods. Home therapy prior to hospitalization was assessed retrospectively, and data on in-hospital therapy and discharge prescriptions were collected prospectively. RESULTS: Diuretics and digitalis were the most commonly used and prescribed drugs. The use of ACE-inhibitors between 1988 and 1998 increased from 13.4 to 46.7% prior to hospitalization, and from 25.8 to 59.2% as a discharge prescription. The most important factors associated with a prescription of ACE-inhibitors at discharge were previous use (OR 4.35, 95% CI=3.65-5.19), hypertension (OR 1.76, 95% CI=1.47-2.11), valvular heart diseases (OR 2.06, 95% CI=1.51-2.81) and diabetes (OR 1.58, 95% CI=1.29-1.93). Physical impairment was associated with a decreased use of ACE-inhibitors at discharge (OR 0.55, 95% CI=0.45-0.67). CONCLUSIONS: The use of ACE-inhibitors for the treatment of CHF progressively increased both at home and in hospital wards of general medicine and geriatrics in the 10-year period studied. Nevertheless, digitalis and diuretics continue to be the most commonly prescribed drugs. A widespread educational effort is needed to increase physicians' awareness of the rationale for prescribing ACE-inhibitors for CHF patients.
OBJECTIVES: To determine the prevalence of adverse drug reaction (ADR)-related hospital admissions in an older population, to describe the most common clinical manifestations and drugs most frequently responsible for ADR-related hospital admissions, and to identify independent factors predictive of these ADRs. DESIGN: Multicenter pharmacoepidemiology survey conducted between 1988 and 1997. SETTING: Eighty-one academic hospitals throughout Italy. PARTICIPANTS: Twenty-eight thousand four hundred eleven patients consecutively admitted to participating centers during the survey periods. MEASUREMENTS: For each suspected ADR at admission, a physician, who coded description, severity, and potentially responsible drugs, completed a questionnaire. RESULTS: Mean age +/- standard deviation of the patients was 70 +/- 16. One thousand seven hundred four ADRs were identified upon hospital admission. In 964 cases (3.4% of all admissions), ADRs were considered to be the cause of these hospital admissions. Of these, 187 ADRs were coded as severe. Gastrointestinal complaints (19%) represented the most common events, followed by metabolic and hemorrhagic complications (9%). The drugs most frequently responsible for these ADRs were diuretics, calcium channel blockers, nonsteroidal antiinflammatory drugs, and digoxin. Female sex (odds ratio (OR) = 1.30, 95% confidence interval (CI) = 1.10-1.54), alcohol use (OR = 1.39, 95% CI = 1.20-1.60), and number of drugs (OR = 1.24, 95% CI = 1.20-1.27 for each drug increase) were independent predictors of ADR-related hospital admissions. For severe ADRs, age (OR = 1.50, 95% CI = 1.01-2.23 for age 65-79 and OR = 1.53, 95% CI = 1.00-2.33 for age > or =80, respectively), comorbidity (OR = 1.12, 95% CI = 1.05-1.20 for each point in the Charlson Comorbidity Index), and number of drugs (OR = 1.18, 95% CI = 1.11-1.25 for each drug increase) were the only predisposing factors. CONCLUSIONS: The most important determinant of risk for ADR-related hospital admissions in older patients is number of drugs being taken. When considering only severe ADRs, risk is also related to age and frailty.
BACKGROUND: Some antipsychotic agents have been indicated as a possible risk factor for venous thromboembolism (VTE) in adult patients with psychiatric disorders. The aim of this study was to estimate the effect of atypical and conventional antipsychotic agents on the risk of hospitalization for VTE among elderly patients. METHODS: We conducted a retrospective cohort study on nursing home residents in 5 states. We used data from the Minimum Data Set to identify 19 940 new users of antipsychotic agents and 112 078 nonusers. Hospitalization with VTE as primary discharge diagnosis was determined during a 6-month follow-up period using Medicare inpatient claims. Cox proportional hazards models provided estimates of effect adjusted for confounders. RESULTS: The rate of hospitalization for VTE was 0.91 per 100 person-years. Venous thrombosis accounted for 77.6% of events and 22.4% were pulmonary embolisms. Relative to nonusers, the rate of hospitalization for VTE was increased for users of atypical antipsychotic agents, including risperidone (adjusted hazard ratio [HR], 1.98; 95% confidence interval [CI], 1.40-2.78), olanzapine (adjusted HR, 1.87; 95% CI, 1.06-3.27), and clozapine and quetiapine fumarate (adjusted HR, 2.68; 95% CI, 1.15-6.28). No increased rate was associated with phenothiazines (adjusted HR, 1.03; 95% CI, 0.60-1.77) or other conventional agents (adjusted HR, 0.98; 95% CI, 0.52-1.87). CONCLUSIONS: Atypical antipsychotic agents appear to increase the risk of VTE. However, these events are rare, and in clinical practice the absolute risk should be weighed against the effectiveness of these medications in the elderly population.
PURPOSE: To assess the effect of moderate alcohol consumption on Adverse Drug Reactions (ADRs) among older adults admitted to acute care hospitals and to examine the consistency of this effect across gender and age groups. METHODS: We used the GIFA (Italian Group of Pharmacoepidemiology in the Elderly) database, which includes information on patients admitted to 81 medical centers in Italy. For this study we examined exclusively the ADRs detected at hospital admission that were classified as definite or probable based on the Naranjo algorithm. RESULTS: Among 22,778 participants, 894 were found to have one or more ADRs (3.9%). Gastrointestinal complications (n = 210; 0.9% of the population) were the most frequent ADRs, followed by metabolic/endocrine (n = 156; 0.7%), dermatological/allergic (n = 102; 0.4%) and arrhythmic (n = 78; 0.3%) complications. Diuretics were the most frequent culprit drugs, followed by NSAIDs and digoxin. An ADR was recorded in 383/10,427 (3.7%) non-drinkers and in 511/12,351 (4.1%) moderate drinkers. After adjusting for potential confounders, moderate alcohol consumption was associated with a 24% increased risk of ADRs (OR 1.24; 95%CI: 1.08-1.43). This effect seemed more evident among women (OR 1.30; 95%CI: 1.09-1.55), than men (OR 1.14; 95%CI: 0.90-1.43), while it was similar across different age groups (< 65 years OR 1.28; 95%CI: 0.99-1.66; 65-79 years OR 1.22; 95%CI: 0.98-1.52; > or = 80 years OR 1.20; 95%CI: 0.93-1.56). Considering the most common ADRs, moderate alcohol users presented a significantly higher risk of drug-related headache (OR 3.89; 95%CI: 1.43-10.61) and metabolic/endocrine complications (OR 1.67; 95%CI: 1.19-2.33). CONCLUSIONS: Moderate alcohol intake is associated with an increased risk of ADRs; this effect seems more evident among women than men, and it does not differ across age groups.
To identify and to measure the association between socio-demographic factors and the prevalence of adverse drug reaction at hospital admission in an elderly population, we carried out a cross-sectional study on a sample of 19,070 patients of the Gruppo Italiano di Farmacoepidemiologia nell'Anziano data base (Italy). The following socio-demographic variables were considered as independent variables: gender, age, education, living arrangement, widowhood/widowerhood, and alcohol and tobacco habit. We estimated the association of these variables with diagnosis of any adverse drug reaction at hospital admission. We used a logistic regression model to obtain estimates of this association, taking into account hepatic and renal diseases, number of diseases, number of drugs used, albumin index (indicator of nutritional condition) and cognitive function. Out of the 19,070 patients included in our study, 878 (4.3%) were diagnosed with an adverse drug reaction at admission. The multivariate analysis shows that none of the socio-demographic variables and health habits considered are associated with adverse drug reactions at admission. A worse nutritional condition of the subject (OR = 1.39; 95% CI: 1.17-1.64), the number of drugs consumed in the month previous to the admission (OR = 1.74; 95% CI: 1.47-2.08) and the presence of renal disease (OR = 1.76; 95% CI: 1.41-2.55) are associated with ADR at hospital admission. Our results suggest that special attention should be paid to avoid adverse drug reactions in elderly people with nutritional problems, renal failure or those who are using two drugs or more. Additional precautions should be taken with people with cognitive impairment, because of their reduced capacity to report their symptoms.