M. Franceschi

Prevalence, clinical features and avoidability of adverse drug reactions as cause of admission to a geriatric unit: a prospective study of 1756 patients.

AbstractBackground: Drug use increases with advancing age, and in older patients it is associated with an increase in adverse drug reactions (ADRs). ADRs are a primary cause of morbidity and mortality worldwide. Objectives: To evaluate the prevalence, clinical characteristics and avoidability of ADR-related hospital admissions in elderly patients. Methods: From November 2004 to December 2005, all patients aged ≥65 years consecutively admitted to the Geriatric Unit of the Casa Sollievo della Sofferenza Hospital, San Giovanni Rotondo in Italy, were evaluated for enrolment in the study. ADRs were defined according to the WHO Adverse Reaction Terminology system. Drugs were classified according to Anatomical Therapeutic Chemical classification system. The Naranjo algorithm was used to evaluate the relationship between drug use and the ADR (definite, probable, possible or doubtful) and Hallas criteria were used to evaluate the avoidability of the ADR (definitely avoidable, possibly avoidable or unavoidable). All cases of a suspected ADR were discussed by a team trained in drug safety, including three geriatricians, one clinical pharmacologist and one pharmacist. Only cases of an ADR with an agreement ≥80% were included. Results: Of the 1756 patients observed, 102 (5.8%, 42 males, 60 females, mean age 76.5 ± 7.4 years, range 65–93 years) showed certain (6.8%) or probable (91.2%) ADR-related hospitalization. Gastrointestinal disorders (48 patients, 47.1%); platelet, bleeding and clotting disorders (20 patients, 19.6%); and cardiovascular disorders (13 patients, 12.7%) were the most frequent ADRs. NSAIDs (23.5%), oral anticoagulants (20.6%), low-dose aspirin (acetylsalicylic acid) [13.7%] and digoxin (12.7%) were the drugs most frequently involved in ADRs. Of the ADRs, 45.1% were defined as definitely avoidable, 31.4% as possibly avoidable, 18.6% as unavoidable and 4.9% as unclassifiable. Of 78 patients with definitely or possibly avoidable ADRs, 17 patients (21.8%) had received an inappropriate prescription, 29 patients (37.2%) had not received a prescription for an effective gastroprotective drug concomitantly with NSAID or low-dose aspirin treatment and 32 patients (41%) were not monitored during drug treatment. Conclusion: In the elderly, almost 6% of hospitalizations are ADR related. Most of these ADRs are potentially avoidable. Strategies that reduce inappropriate prescriptions and monitoring errors, as well as improving active prevention of ADRs, are needed in elderly subjects.

Prevalence of Helicobacter pylori resistance to antibiotics in Northeast Italy: a multicentre study

Abstract Aims. To evaluate prevalence of primary Helicobacter pylori antibiotic resistances in Northeast Italy and to identify risk factors associated with this resistance. Materials and methods. A total of 248 patients undergoing upper gastrointestinal endoscopy were enrolled from 19 Endoscopy Units over a 6-month period. From each patient, 4 gastric biopsies were taken for histology and 2 were sent to the Central Referral Microbiological Laboratory for culture and determination of antibiotic activity against Helicobacter pylori by means of E-test. Strains were considered resistant when minimum inhibitory concentration was >8 μg/ml for metronidazole and > 1 μg/ml for clarithromycin. No cut-off value was predefined for amoxycillin. Results. Culture of Helicobacter pylori was successfully performed in 167 patients. Primary resistance to metronidazole, clarithromycin or amoxycillin was 14.9%, 1.8% and 0.%, respectively. Patients infected with Helicobacter pylori strains resistant to antibiotics were more frequently females than males (70.3% vs 41.4%), had a significantly lower coffee intake (66.6% vs 86.6%) and lower body mass index (23.7±2.6 vs 25.3±3.6) than patients with susceptible Helicobacter pylori strains. Age, smoking, alcohol use, family history of Helicobacter pylori infection, concomitant diseases and treatments, endoscopic diagnoses, Helicobacter pylori density and histological activity of chronic gastritis were not associated with antibiotic resistance. Multivariate analysis confirmed that female gender (odds ratio = 2.74, 95% confidence interval = 1.03–7.27) was the only significant risk factor associated with antibiotic resistance. Conclusions. In this population, primary Helicobacter pylori resistance to metronidazole was higher than resistance to clarithromycin, and female gender was significantly associated with this resistance. The low prevalence of resistance to metronidazole, clarithromycin and amoxycillin identified in this geographical area suggests that proton pump inhibitor-based triple regimens including these antibiotics may still be used as first line therapies against Helicobacter pylori infection.

Diverticular Disease in the Elderly

There are few diseases whose incidence varies as greatly worldwide as that of diverticulosis. Its prevalence is largely age-dependent: the disease is uncommon in those under the age of 40, the prevalence of which is estimated at approximately 5%; this increases to 65% in those ≧65 years of age. Of patients with diverticula, 80–85% remain asymptomatic, while, for unknown reasons, only three-fourths of the remaining 15–20% of patients develop symptomatic diverticular disease. Traditional concepts regarding the causes of colonic diverticula include alterations in colonic wall resistance, disordered colonic motility and dietary fiber deficiency. Currently, inflammation has been proposed to play a role in diverticular disease. Goals of therapy in diverticular disease should include improvement of symptoms and prevention of recurrent attacks in symptomatic, uncomplicated diverticular disease, and prevention of the complications of disease such as diverticulitis. Diverticulitis is the most usual clinical complication of diverticular disease, affecting 10–25% of patients with diverticula. Most patients admitted with acute diverticulitis respond to conservative treatment, but 15–30% require surgery. Predictive factors for severe diverticulitis are sex, obesity, immunodeficiency and old age. Surgery for acute complications of diverticular disease of the sigmoid colon carries significant rates of morbidity and mortality, the latter of which occurs predominantly in cases of severe comorbidity. Postoperative mortality and morbidity are to a large extent driven by patient-related factors.

Proton‐pump inhibitors reduce the risk of uncomplicated peptic ulcer in elderly either acute or chronic users of aspirin/non‐steroidal anti‐inflammatory drugs

Background : Although administration of gastroprotective drugs may reduce the risk of peptic ulcers associated with the chronic use of non‐steroidal anti‐inflammatory drugs or aspirin, no consensus exists as to whether this co‐therapy is effective for short‐term prevention, particularly in old age.

Incidence of secondary Helicobacter pylori resistance to antibiotics in treatment failures after 1-week proton pump inhibitor-based triple therapies: a prospective study

BACKGROUND Antibiotic-resistant Helicobacter pylori strains are becoming increasingly prevalent, although it is not clear to what extent the new resistant organisms will spread. AIM To evaluate the incidence of secondary Helicobacter pylori resistance to metronidazole, clarithromycin and/or amoxycillin after one-week proton pump inhibitor based triple therapy failure in patients who were, before therapy infected with Helicobacter pylori strains susceptible to these antibiotics. PATIENTS AND METHODS Enrolled in the study were 97 consecutive Helicobacter pylori-positive subjects infected by Helicobacter pylori strains susceptible to metronidazole, clarithromycin and amoxycillin. Activity of tested antibiotics was determined by means of the E-test. Patients were treated for seven days with a proton pump inhibitor, omeprazole 20 mg twice daily or pantoprazole 40 mg once daily, plus clarithromycin 250 mg twice daily and metronidazole 250 mg four times daily; or with a proton pump inhibitor plus amoxycillin 1 g twice daily and clarithromycin 500 mg twice daily. Two months after completion of therapy, endoscopy and gastric biopsies for histology, rapid urease test and culture were repeated. RESULTS Four patients were dropped from the study Overall Helicobacter pylori cure rates expressed as both intention-to-treat and per-protocol analyses, were, respectively 80% (40/50) and 81.6% (40/49) with proton pump inhibitor, clarithromycin and metronidazole and 76.6% (36/47) and 81.8% (36/44) with proton pump inhibitor amoxycillin and clarithromycin. No significant differences were observed between the two treatments. Subjects in whom treatment failed were significantly younger and had less active ulcer than cured patients. Of treatment failures, 70.6% (12 out of 17 subjects) de veloped a secondary resistance to metronidazole (35.33% and/or clarithromycin (64.7%). Secondary antibiotic resistance occurred in 77. 8% of treatment failures treated with proton pump inhibitor, clarithromycin and metronidazole and in 62.5% of those treated with proton pump inhibitor, amoxycillin and clarithromycin. Considering all patients treated, the overall incidence of secondary metronidazole and/or clarithromycin resistance after therapy was reported in 12.9% of subjects (12 out of 93 treated patients). CONCLUSIONS Secondary Helicobacter pylori resistances to metronidazole and/or clarithromycin occurred in large percentages in patients with treatment failure after the one-week proton pump inhibitor-based triple therapies, proton pump inhibitor, clarithromycin and metronidazole and proton pump inhibitor, amoxycillin and clarithromycin. It is likely that new antibiotics or treatment strategies will be needed in the near future to successfully treat Helicobacter pylori infection.

The Multidimensional Prognostic Index Predicts Short- and Long-Term Mortality in Hospitalized Geriatric Patients With Pneumonia

BACKGROUND Multidimensional impairment of older patients may influence the clinical outcome of acute or chronic diseases. Our purpose is to evaluate the usefulness of a multidimensional prognostic index (MPI) based on a comprehensive geriatric assessment (CGA) for predicting mortality risk in older patients with community-acquired pneumonia (CAP). METHODS This prospective study included 134 hospitalized patients aged 65 and older with a diagnosis of CAP. A standardized CGA that included information on clinical, cognitive, functional, and nutritional status as well as comorbidities, medications, and social support network was used to calculate MPI. The pneumonia severity index (PSI) was also calculated. The predictive value of the MPI for all cause mortality over a 1-year follow-up was evaluated and was compared with that of PSI. RESULTS Higher MPI values were significantly associated with higher mortality at 30 days (Grade 1 = 3%, Grade 2 = 12%, Grade 3 = 44%, p < .001), 6 months (Grade 1 = 7%, Grade 2 = 21%, Grade 3 = 50%, p < .001), and 1 year (Grade 1 = 10%, Grade 2 = 33%, Grade 3 = 53%, p < .001). A close agreement was found between the estimated mortality by MPI and the observed mortality. MPI had a significant greater discriminatory power than PSI both at 30 days (area under the receiver operating characteristic [ROC] curve = 0.83 vs 0.71, p = .019) and 6 months (0.79 vs 0.69, p = .035), but not after 1 year of follow-up (0.80 vs 0.75, p = .185). CONCLUSIONS This MPI, calculated from information collected in a standardized CGA, accurately stratifies hospitalized elderly patients with CAP into groups at varying risk of short- and long-term mortality. The predictive accuracy of the MPI was higher than the predictive value of the PSI.

Pantoprazole versus one-week Helicobacter pylori eradication therapy for the prevention of acute NSAID-related gastroduodenal damage in elderly subjects

To compare the efficacy of pantoprazole vs. a one‐week Helicobacter pylori eradication therapy for the prevention of NSAID‐related gastroduodenal damage.

The Prevalence of Diarrhea and Its Association With Drug Use in Elderly Outpatients: A Multicenter Study

OBJECTIVES: To evaluate the prevalence of diarrhea and its association with drug use in elderly outpatients.METHODS: The study was carried out by 133 general practitioners (GPs) who referred to 24 geriatric units in Italy. The demographic data, disability, gastrointestinal symptoms, and current medications were evaluated using a structured interview, including the evaluation of the activities of daily living (ADL), the instrumental activities of daily living (IADL), and the gastrointestinal symptoms rating scale (GSRS).RESULTS: The study included 5,387 elderly subjects who regularly completed the structured interview. In total, 488 patients (9.1% of the whole population, 210 men and 278 women, mean age 75.6 ± 6.2 yr, range 65–100 yr) reported diarrhea, that is, items 11 and 12 of the GSRS, during the 7-day period before the interview. The prevalence of diarrhea significantly increased with older age (P= 0.025), the severity of ADL (P < 0.0001) and IADL disability (P < 0.0001), and the number of drugs taken (P= 0.0002). A multivariate analysis demonstrated that the presence of diarrhea was significantly associated with the use of antibiotics (odds ratio [OR] 4.58, 95% confidence interval [CI] 1.95–10.73), proton pump inhibitors (OR 2.97, 95% CI 2.03–4.35), allopurinol (OR 2.19, 95% CI 1.26–3.81), psycholeptics (OR 1.82, 95% CI 1.26–2.61), selective serotonin reuptake inhibitors (OR 1.71, 95% CI 1.01–2.89), and angiotensin II receptor blockers (OR 1.46, 95% CI 1.08–1.99), also accounting for sex, age, and the use of antidiarrheal agents and drugs for functional gastrointestinal disorders.CONCLUSION: Diarrhea is a common problem in elderly outpatients. Its prevalence increases with old age, the severity of disability, and the number of drugs. Monitoring the presence of diarrhea and its complications in elderly patients who need treatments with drugs significantly associated with diarrhea may be clinically useful.

Bovine lactoferrin for Helicobacter pylori eradication: an open, randomized, multicentre study.

Background  Cure rates for eradication of Helicobacter pylori appear to be decreasing, thus more effective therapies must be identified.

Short- and long-term therapy for reflux oesophagitis in the elderly: a multi-centre, placebo-controlled study with pantoprazole.

Background: No placebo‐controlled clinical trials have yet been published on the efficacy of therapy in older subjects with oesophagitis.