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Giovanni Gambassi

Publications and source records attributed to Giovanni Gambassi.

At least 19 recordsLinked to original sources

Heart failure, chronic diuretic use, and increase in mortality and hospitalization: an observational study using propensity score methods.

AIMS: Non-potassium-sparing diuretics are commonly used in heart failure (HF). They activate the neurohormonal system, and are potentially harmful. Yet, the long-term effects of chronic diuretic use in HF are largely unknown. We retrospectively analysed the Digitalis Investigation Group (DIG) data to determine the effects of diuretics on HF outcomes. METHODS AND RESULTS: Propensity scores for diuretic use were calculated for each of the 7788 DIG participants using a non-parsimonious multivariable logistic regression model, and were used to match 1391 (81%) no-diuretic patients with 1391 diuretic patients. Effects of diuretics on mortality and hospitalization at 40 months of median follow-up were assessed using matched Cox regression models. All-cause mortality was 21% for no-diuretic patients and 29% for diuretic patients [hazard ratio (HR) 1.31; 95% confidence interval (CI) 1.11-1.55; P = 0.002]. HF hospitalizations occurred in 18% of no-diuretic patients and 23% of diuretic patients (HR 1.37; 95% CI 1.13-1.65; P = 0.001). CONCLUSION: Chronic diuretic use was associated with increased long-term mortality and hospitalizations in a wide spectrum of ambulatory chronic systolic and diastolic HF patients. The findings of the current study challenge the wisdom of routine chronic use of diuretics in HF patients who are asymptomatic or minimally symptomatic without fluid retention, and are on complete neurohormonal blockade. These findings, based on a non-randomized design, need to be further studied in randomized trials.

Adult↗

Fatal neuroleptic malignant syndrome in a previously long-term user of clozapine following its reintroduction in combination with paroxetine.

A 77-year-old patient with initial behavioral and psychological symptoms of dementia was treated with clozapine (50 mg/daily). Since no clinical benefit was apparent, clozapine was discontinued after six weeks and the patient started on paroxetine (20 mg/daily). After three weeks on paroxetine, he was given another trial of clozapine at a starting dosage of 25 mg/daily. While clozapine had previously been well tolerated, this time he rapidly developed fever, mental confusion, lethargy, muscle spasms and rigidity. The diagnosis of neuroleptic malignant syndrome was delayed, because there was no leukocytosis and serum creatine phosphokinase was initially not elevated. Subcutaneous apomorphine was then given but, after an initial improvement, the patient developed a multiple organ failure syndrome and died.

Aged↗

Impact of inappropriate drug use among hospitalized older adults.

OBJECTIVE: Criteria for inappropriate drug use developed by Beers have been widely used in drug utilization reviews as the basis for educational materials and to assess the quality of prescribing. However, there is inconclusive evidence that these criteria can impact on patient outcomes. The objective of this study was to evaluate the impact of inappropriate drug use on all-cause mortality, adverse drug reactions (ADRs) and length of stay among in-hospital patients. METHODS: We performed a retrospective, cohort study on 5,152 patients aged 65 years or older admitted to 81 hospitals in Italy between 1997 and 1998. Inappropriate drug use was defined by 2003 Beers criteria. Outcomes of the study were: (a) in-hospital mortality; (b) incidence of ADR occurring during hospital stay; (c) length of hospital stay 13 days or more. RESULTS: The mean age of 5,152 participants was 78.8 years (standard deviation = 8.4 years), and 2,463 (47.8%) were men. During hospital stay, 1,475 (28.6% of the study sample) patients received one or more inappropriate drugs. After adjusting for potential confounders, use of inappropriate drugs was not associated significantly with either mortality [odds ratio (OR) 1.05; 95% confidence intervals (CI): 0.75-1.48], ADR (OR 1.20; 95% CI: 0.89-1.61) or length of stay 13 days or more (OR 1.09; 95% CI: 0.95-1.25). CONCLUSIONS: This study did not show any significant effect of inappropriate drug use defined by Beers 2003 criteria on health outcomes among hospitalized older adults. Further studies conducted in different settings, using additional health outcomes and alternate measures of inappropriate drug use, are needed.

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Conventional and atypical antipsychotics and the risk of hospitalization for ventricular arrhythmias or cardiac arrest.

BACKGROUND: Conventional antipsychotic drugs have been implicated as a cause of ventricular arrhythmias and cardiac arrest, but no definitive information is available regarding atypical antipsychotics. We compared the effect of conventional and atypical antipsychotics on the risk of hospitalization for ventricular arrhythmias and cardiac arrest. METHODS: We conducted a case-control study on residents of nursing homes in 6 US states by using data from the Minimum Data Set linked to Medicare inpatient claims. Cases were residents hospitalized for ventricular arrhythmias or cardiac arrest between July 4, 1998, and December 30, 1999. For each case, we identified up to 5 controls residing in the same facility during the same period. The sample consisted of 649 cases and 2962 controls. RESULTS: Use of conventional antipsychotics was associated with a nearly 2-fold increase in risk of hospitalization for ventricular arrhythmias or cardiac arrest (adjusted odds ratio, 1.86; 95% confidence interval, 1.27-2.74). There was no increased risk associated with the use of atypical antipsychotics (odds ratio, 0.87; 95% confidence interval, 0.58-1.32). The risk of hospitalization for ventricular arrhythmias or cardiac arrest was highest among conventional users with cardiac disease (odds ratio, 3.27; 95% confidence interval, 1.95-5.47). However, cardiac disease and conventional antipsychotics did not show a synergistic effect (synergy index, 1.19). CONCLUSIONS: Conventional but not atypical antipsychotics are associated with an increased risk of hospitalization for ventricular arrhythmias and cardiac arrest. The prescription of conventional antipsychotics in patients with cardiac disease should be carefully weighed.

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Potentially inappropriate medication use among elderly home care patients in Europe.

CONTEXT: Criteria for potentially inappropriate medication use among elderly patients have been used in the past decade in large US epidemiological surveys to identify populations at risk and specifically target risk-management strategies. In contrast, in Europe little information is available about potentially inappropriate medication use and is based on small studies with uncertain generalizability. OBJECTIVE: To estimate the prevalence and associated factors of potentially inappropriate medication use among elderly home care patients in European countries. DESIGN, SETTING, AND PARTICIPANTS: Retrospective cross-sectional study of 2707 elderly patients receiving home care (mean [SD] age, 82.2 [ 7.2] years) representatively enrolled in metropolitan areas of the Czech Republic, Denmark, Finland, Iceland, Italy, the Netherlands, Norway, and the United Kingdom. Patients were prospectively assessed between September 2001 and January 2002 using the Minimum Data Set in Home Care instrument. MAIN OUTCOME MEASURES: Prevalence of potentially inappropriate medication use was documented using all expert panels criteria for community-living elderly persons (Beers and McLeod). Patient-related characteristics independently associated with inappropriate medication use were identified with a multiple logistic regression model. RESULTS: Combining all 3 sets of criteria, we found that 19.8% of patients in the total sample used at least 1 inappropriate medication; using older 1997 criteria it was 9.8% to 10.9%. Substantial differences were documented between Eastern Europe (41.1% in the Czech Republic) and Western Europe (mean 15.8%, ranging from 5.8% in Denmark to 26.5% in Italy). Potentially inappropriate medication use was associated with patient's poor economic situation (adjusted relative risk [RR], 1.96; 95% confidence interval [CI], 1.58-2.36), polypharmacy (RR, 1.91; 95% CI, 1.62- 2.22), anxiolytic drug use (RR, 1.82; 95% CI, 1.51-2.15), and depression (RR, 1.29; 95% CI, 1.06-1.55). Negatively associated factors were age 85 years and older (RR, 0.78; 95% CI, 0.65-0.92) and living alone (RR, 0.76; 95% CI, 0.64-0.89). The odds of potentially inappropriate medication use significantly increased with the number of associated factors (P<.001). CONCLUSIONS: Substantial differences in potentially inappropriate medication use exist between European countries and might be a consequence of different regulatory measures, clinical practices, or inequalities in socioeconomic background. Since financial resources and selected patient-related characteristics are associated with such prescribing, specific educational strategies and regulations should reflect these factors to improve prescribing quality in elderly individuals in Europe.

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Ruffled hair and fever in an old woman with Alzheimer's disease.

In patients with dementia, the clinical presentation of unrelated medical conditions may be concealed or atypical, and symptoms difficult to interpret, or confounded by existing cognitive deterioration or by medications. These difficulties pose an extraordinary challenge to clinicians, and may contribute to the disturbing evidence of inadequate assessment and treatment of medical conditions in patients with dementia. Here, we report the case of an 82-year old woman diagnosed with Alzheimer's disease, whose MMSE score started to deteriorate rapidly after six years of steady decline as a result of a temporal arteritis. Temporal arteritis, a diagnosis which is often made several months after the onset of symptoms even in the general population, can be difficult to identify in patients with pre-existing dementia.

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Aggressive behavior of classical Kaposi's sarcoma and coexistence with angiosarcoma.

UNLABELLED: An 82-year-old Caucasian man presented with initially asymptomatic livid red plaques on the plantar surface of the feet that become confluent and evolved into invasively growing nodules accompanied by massive edema. Histology allowed a diagnosis of the classical form of Kaposi's sarcoma; the serology test result for HIV was negative, whereas the associated human herpes virus type 8 was detected by polymerase chain reaction on the skin sample. Over the subsequent 6 months, skin lesions become vegetative and partially necrotic, and extended to the hands and eyelids. Chemotherapy with vinblastine appeared to stabilize the cutaneous disease, but the patient developed a massive gastrointestinal hemorrhage secondary to dissemination to the stomach. Twelve months after the onset of the disease, vegetative and easily bleeding lesions progressively occluded the mouth of the patient: histological features were consistent with a low-grade angiosarcoma distinct from that of Kaposi's sarcoma. The patient could not chew and swallow anymore; he was put on an artificial nutrition but died shortly thereafter. This case illustrates that, even in its classical form, Kaposi's sarcoma may be a malignant, rapidly progressing tumor. LEARNING POINTS: a) The extent and rate of spread of initial skin lesions should be considered to be early signs of aggressive dissemination, even in the absence of other variables (i.e., histological pattern, human herpes virus type 8 positive mononuclear cells) associated with progression of the disease. b) An endoscopy may be useful given the high prevalence of gastrointestinal involvement. c) When classical Kaposi's sarcoma displays aggressive behavior a second, primary malignant tumor arising from the vascular tissue should be investigated. TAKE-HOME MESSAGE: Even in its classical form, Kaposi's sarcoma may be a malignant, rapidly progressing tumor with visceral involvement; also, a second malignancy may occur in nearly one patient of four. Because localized skin lesions can regress completely with radiotherapy, watchful waiting is probably inappropriate in most cases.

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Association between pain and depression among older adults in Europe: results from the Aged in Home Care (AdHOC) project: a cross-sectional study.

OBJECTIVE: To assess the association between pain and depression in a population of older adults. METHOD: We conducted a cross-sectional study using data from the Aged in Home Care (AdHOC) database, which contains information on older adults receiving home care services in 11 European countries from 2001 to 2003. Pain was defined as any type of pain or discomfort manifested over the 7 days preceding the assessment. Depression was defined as a score >or= 3 on the Minimum Data Set Depression Rating Scale. RESULTS: Mean age of 3976 subjects entering the study was 82.3 years, and 2948 (74.1%) were women. Of the total sample, 2380 subjects presented with pain (59.9%), but its prevalence differed substantially among countries. Depression was diagnosed in 181 (11.3%) of the 1596 participants without pain and in 464 (19.5%) of the 2380 participants with pain (p < .001). After adjusting for potential confounders, pain was significantly associated with depression (odds ratio [OR] 1.76, 95% confidence interval [CI] = 1.43 to 2.17). This association seemed to be modified by sex. Compared to male participants without pain, women with pain were significantly more likely to present with depression (OR = 1.77; 95% CI = 1.29 to 2.42), while no significant difference was observed for women without pain (OR = 0.86; 95% CI = 0.61 to 1.22) and men with pain (OR = 1.24; 95% CI = 0.86 to 1.79). Among women, the association of pain and depression became progressively more pronounced as pain severity, pain frequency, and number of painful sites increased. CONCLUSION: This study documented that in a large sample of older adults living in the community, pain is associated with depression, especially among women.

Age Factors↗

Cerebrovascular events among elderly nursing home patients treated with conventional or atypical antipsychotics.

OBJECTIVE: Concern exists about a possible increased risk of cerebrovascular events (CVEs) among elderly patients receiving risperidone or olanzapine. We estimated the effect of atypical and conventional antipsychotics on the risk of CVEs among elderly nursing home patients with dementia. METHOD: We conducted a case-control study on residents of nursing homes in 6 U.S. states by using the Systematic Assessment of Geriatric drug use via Epidemiology database, which includes data from the Minimum Data Set linked to Medicare inpatient claims. Participants were diagnosed with Alzheimer's disease or other forms of dementia on the basis of clinical criteria and medical history (including medical records and neuroradiologic documentation). Cases included patients hospitalized for stroke or transient ischemic attack between June 30, 1998, and December 27, 1999. For each case, we identified up to 5 controls hospitalized for septicemia or urinary tract infection residing in the same facility during the same time period. The sample consisted of 1130 cases and 3658 controls. RESULTS: After controlling for potential confounders, the odds ratio of being hospitalized for CVEs was 0.87 (95% CI = 0.67 to 1.12) for risperidone users, 1.32 (95% CI = 0.83 to 2.11) for olanzapine users, 1.57 (95% CI = 0.65 to 3.82) for users of other atypical agents, and 1.24 (95% CI = 0.95 to 1.63) for conventional antipsychotic users compared to nonusers of antipsychotics. A history of CVEs appeared to modify the effect of atypical antipsychotics other than risperidone on the risk of new events. CONCLUSION: Overall, no increased risk of CVEs seems to be conferred by atypical or conventional antipsychotics. Preexisting cerebrovascular risk factors might interact with some atypical antipsychotics to increase the risk of events. These results should be interpreted in light of the limitations of the study and need to be confirmed.

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Community care in Europe. The Aged in Home Care project (AdHOC).

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.

Activities of Daily Living↗

NSAID-related psychiatric adverse events: who is at risk?

NSAIDs are frequently used in clinical practice and they account for approximately 5-10% of all drug prescriptions. NSAID use has been associated with a risk of adverse events, which have a relevant impact on morbidity and mortality and account for a substantial increment of healthcare costs. Less common, but clinically relevant, adverse events associated with NSAID use are the impairment of the CNS and, particularly, the appearance of psychiatric symptoms. These symptoms include changes in cognition, mood state and even precipitation or exacerbation of pre-existing psychiatric disorders. This article aims to review the medical literature on published reports of NSAID-related psychiatric adverse events, identify risk factors for these events and describe mechanisms potentially involved in their onset. We identified 27 reports with data on 453 cases of NSAID-related psychiatric adverse events. Data suggest that individuals who may be particularly susceptible to such events include patients with a history of psychiatric illness and possibly parturients. Indometacin and selective cyclo-oxygenase (COX)-2 inhibitors were the most frequently reported culprit drugs; however, whether this reflects an increased incidence with these drugs compared with other NSAIDs or factors such as usage or reporting patterns is unknown.A possible explanation for the psychiatric effect of NSAIDs resides in the modulation of central neurotransmission by prostaglandins, the synthesis of which is inhibited by NSAIDs. COX-2 is a key enzyme in this process since its activity is localised in distal dendrites and dendritic spines, which are cellular specialisations involved in synaptic signalling. Dopamine is considered the most relevant neurotransmitter involved in this phenomenon. Psychiatric symptoms are a rare but relevant complication of NSAID use. This effect is probably a consequence of impairment in neurotransmission modulated by prostaglandins when NSAIDs are used by susceptible individuals. These drugs should be used with caution in high-risk individuals with pre-existing psychiatric illness, and caution may also be advisable in the postpartum period. To date, reports of NSAID-related psychiatric adverse events have most commonly involved indometacin and selective COX-2 inhibitors. Prescribers should consider warning patients of the possibility of an acute neuropsychiatric event when traditional NSAIDs or selective COX-2 inhibitors are prescribed.

Adult↗

Inappropriate medication use among hospitalized older adults in Italy: results from the Italian Group of Pharmacoepidemiology in the Elderly.

OBJECTIVE: To determine the prevalence of inappropriate medication use among hospitalized older adults and to identify predictors of this use. METHODS: A total of 5734 patients (mean age 79 years) admitted to geriatric and internal medicine wards participating in the study in 1995 and 1997 were included in this analysis. Inappropriate medication use was defined on the basis of the criteria published by Beers in 1997. Only medications used during hospital stay were considered for the present study. RESULTS: During hospital stay, 837 (14.6%) patients received one or more medications classified as inappropriate based on Beers criteria. Ticlopidine ( n=346; 6.0% of the study sample) was the most frequently used medication among those in Beers' list, followed by digoxin ( n=174; 3.0%) and amytriptyline ( n=113; 2.0%). The multivariate analysis showed that age [75-84 years vs 65-74 years, odds ratio (OR) 0.85, 95% confidence interval (CI) 0.71-1.00; >or=85 years vs 65-74 years, OR 0.58, 95% CI 0.46-0.73], cognitive impairment (OR 0.77, 95% CI 0.64-0.94), Charlson co-morbidity index (>or=2 vs 0-1, OR 1.20, 95% CI 1.02-1.40) and overall number of medications used during hospital stay (5-8 medications vs <5 medications, OR 2.20, 95% CI 1.72-2.82; >or=9 medications vs <5 medications, OR 3.68, 95% CI 2.86-4.73) were significantly associated with use of inappropriate medications. CONCLUSIONS: Inappropriate medication use was common among hospitalized older adults. The most important determinant of risk of receiving an inappropriate medication was the number of drugs being taken. Older age and cognitive impairment were associated with a reduced likelihood of using an inappropriate medication.

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Serum cholesterol levels and in-hospital mortality in the elderly.

PURPOSE: Although total cholesterol levels among middle-aged persons correlate with long-term mortality from all causes, this association remains controversial in older persons. We explored whether total cholesterol levels were independently associated with in-hospital mortality among elderly patients. METHODS: We analyzed data from a large collaborative observational study, the Italian Group of Pharmacoepidemiology in the Elderly (GIFA), which collected data on hospitalized patients. A total of 6984 patients aged 65 years or older who had been admitted to 81 participating medical centers during four survey periods (from 1993 to 1998) were enrolled. Patients were divided into four groups based on total cholesterol levels at hospital admission: <160 mg/dL (n = 2115), 160 to 199 mg/dL (n = 2210), 200 to 239 mg/dL (n = 1719), and >or=240 mg/dL (n = 940). RESULTS: Patients (mean [+/- SD] age, 78 +/- 7 years) were hospitalized for an average of 15 +/- 10 days. The mean total cholesterol level was 186 +/- 49 mg/dL. A total of 202 patients died during hospitalization. Mortality was inversely related to cholesterol levels (<160 mg/dL: 5.2% [110/2115]; 160-199 mg/dL: 2.2% [49/2210]; 200-239 mg/dL: 1.6% [27/1719]; and >or=240 mg/dL: 1.7% [16/940]; P for linear trend <0.001). After adjustment for potential confounders (demographic characteristics, smoking, alcohol use, indicators of nutritional status, markers of frailty, and comorbid conditions), low cholesterol levels continued to be associated with in-hospital mortality. Compared with patients who had cholesterol levels <160 mg/dL, the odds ratios for in-hospital mortality were 0.49 (95% confidence interval [CI]: 0.34 to 0.70) for participants with cholesterol levels of 160 to 199 mg/dL, 0.41 (95% CI: 0.26 to 0.65) for those with cholesterol levels of 200 to 239 mg/dL, and 0.56 (95% CI: 0.32 to 0.98) for those with cholesterol levels >or=240 mg/dL. These estimates were similar after further adjustment for inflammatory markers and after excluding patients with liver disease. CONCLUSIONS: Among older hospitalized adults, low serum cholesterol levels appear to be an independent predictor of short-term mortality.

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