Safety In Older Patients Research Articles

Low-dose methotrexate use and safety for older patients with bullous pemphigoid and impaired renal function: A cohort study

Low-dose methotrexate use and safety for older patients with bullous pemphigoid and impaired renal function: A cohort study

Adverse Drug Reactions Involving Protein Kinase Inhibitors: A French Pharmacovigilance Database Study Comparing Safety in Younger and Older Patients (≥ 75years) with Cancer.

Despite the increasing incidence of cancers in elderly people, this population remains under-represented in clinical trials. As a result, data describing the safety and efficacy of protein kinase inhibitors (PKIs) specifically in older patients with cancer are lacking. Advanced age may have a significant impact on drug pharmacology, but data on PKI safety in older patients remain poorly described in "real life". We performed an observational study describing adverse drug reactions (ADRs) related to PKIs and compared the results for younger and older (aged ≥ 75years) patients. We extracted all notifications considered to be related to PKIs from our regional pharmacovigilance database between March 2003 and November 2015. Information about patients, drug exposure, and ADRs were captured. After a descriptive analysis of ADRs, we compared their characteristics between older and younger patients. In total, 214 patients experienced 320 ADRs related to PKIs. Slightly over half the patients were male (57%). The mean age was 64.1years (range 15-90), and 52 (24.3%) patients were aged ≥ 75years. Cutaneous reactions were the most frequently reported ADRs (22.9%), followed by gastrointestinal (16.8%) and respiratory (12.1%) ADRs. The most often involved PKIs were imatinib [54 patients (25.2%)], dasatinib [25 (11.7%)], sunitinib [25 (11.7%)], erlotinib [25 (11.7%)], and sorafenib [24 (11.2%)], followed by vemurafenib [17 (7.9%)] and everolimus and nilotinib, with 11 patients (5.1%) each. These drugs were administered mostly for three therapeutic indications: chronic myeloid leukemia [56 patients (26.2%)], malignant urinary tract cancer [31 (14.5%)], and bronchial cancer [27 (12.6%)]. Comparison of PKI-related ADRs between older and younger patients showed no significant difference, except for the mean number of coadministered drugs (5.3 vs. 4.2; p = 0.03) and the proportion of vascular ADRs (17.3 vs. 4.3%; p = 0.005), mainly arterial hypertension, which were both significantly more frequent in the older group. Our work showed that PKI-related ADRs in older patients were similar to those in younger adults, except for vascular ADRs, which were significantly more frequent in the older population. Our results require confirmation by larger studies but could lead physicians to be more vigilant about cardiovascular comorbidities during initiation of PKIs in elderly people.

Microvascular Decompression for Treatment of Trigeminal Neuralgia: Factors That Predict Complete Pain Relief and Study of Efficacy and Safety in Older Patients.

Microvascular decompression (MVD) is an effective method for directly treating the etiology of trigeminal neuralgia (TGN). This study aims to investigate the factors that predict complete pain relief after MVD for treatment of TGN, and to study efficacy and safety in older patients. This study was conducted in patients with TGN that were treated by MVD at Siriraj Hospital between 2004 and 2015. Cases with secondary TGN were excluded. Data was gathered from medical records, preoperative magnetic resonance imaging, intraoperative findings, and by telephone in patients lost to follow-up. Of 110 included patients, 68 and 42 patients were younger and older than 60 years, respectively. Median age was 53.6 years old. Typical type of TGN, paroxysmal pain, large offending vessel on preoperative magnetic resonance imaging, and multiple locations of trigeminal nerve compression were associated with early postoperative pain-free status. No variables were associated with long-term outcome. Multivariate analysis using binary logistic regression revealed typical type of TGN to be the only factor associated with early postoperative pain-free status. No significant difference was observed between the <60 and ≥60 age groups for surgical outcome and rate of complications. Presence of typical type TGN was the only factor found to independently predict a pain-free outcome in the early postoperative period. No factors were associated long-term pain-free outcome. MVD is an effective and safe operative procedure, and it should be regarded as a safe and viable alternative for treating intractable TGN in older patients.

Comparison of Drug Use Between Clinical Practice and Regulatory Approval: Results in Older Japanese Patients With Rheumatoid Arthritis, Diabetes, High Blood Pressure, or Depression.

In this study, differences in older patients between drug use as reported in clinical practice and in clinical trials for regulatory approval were examined. Electronic medical record (EMR) data such as patient background (age, sex), concomitant drugs, data on laboratory tests, and prescribed doses of drugs from outpatients with rheumatoid arthritis, diabetes, high blood pressure, or depression at Chiba University Hospital were obtained for the period from January 2003 to December 2012. These data were compared with data from relevant clinical trials for regulatory approval in order to examine differences in drug use. There were 5134 eligible patients. The prescribed doses of drugs were lower than the standard approved doses for depression and rheumatoid arthritis but were generally within the approved dose range for type 2 diabetes mellitus and hypertension. When comparing the characteristics of older patients taking tacrolimus, 5.6% to 17.0% of those would not be able to participate in clinical trials because of liver or renal abnormality, and the incidence rates of some adverse drug events (ADEs) differed significantly between clinical practice and clinical trials. Appropriate doses of drugs for older patients may differ from approved doses in certain diseases. Complex situations such as a lot of polypharmacy, comorbidity, and functional impairment in older patients in clinical practice make it difficult to evaluate safety based on data from clinical trials. In the future, utilization of a database created from the EMR of older patients should be considered for assessment of drug safety in older patients in clinical practice.

The efficacy and safety of intravenous lidocaine for analgesia in the older adult: a literature review

Opioids remain the mainstay of analgesia for the treatment of moderate to severe acute pain. Even in the young, the use of opioids can be associated with an increased incidence of post-operative complications such as respiratory depression, vomiting, pruritus, excessive sedation, slowing of gastrointestinal function, and urinary retention. The need to manage acute pain in the older patient is becoming more common as the population ages, and increasingly older patients are undergoing more major surgery. Medical conditions are more common in older people and can result in the requirement of systemic analgesia for fractures, malignancy, nociceptive or neuropathic pain and peripheral vascular disease. Effective pain control can be difficult in older patients as there is a higher incidence of coexistent diseases, polypharmacy and age-related changes in physiology, pharmacodynamics and pharmacokinetics. Consequently, due to the fear of respiratory depression in older people, this leads to inadequate doses of opioid being given for the treatment of their pain. Lidocaine has analgesic, anti-hyperalgesic and anti-inflammatory properties and is metabolized by the liver which is limited by perfusion, and heart failure or drugs can alter this, affecting its clearance. Therefore, there are concerns regarding safety in older patients as plasma concentrations have both intersubject and intrasubject variability. The aim of this literature review is to assess the efficacy and safety of intravenous lidocaine as an adjuvant in pain management for the older patient. In total, 12 studies fulfilled the criteria. Lidocaine infusions were found to reduce pain scores and be opioid sparing in abdominal and urological surgery, in patients with opioid-refractory malignancy pain, neuropathic pain and critical limb ischaemia. Patients with malignancy were more likely to develop adverse effects, but no patients required treatment for lidocaine toxicity.

Functional outcomes following ileal pouch-anal anastomosis (IPAA) in older patients: a systematic review.

AimIleal pouch-anal anastomosis (IPAA) is performed in ulcerative colitis or familial adenomatous polyposis with a view to restoration of GI continuity and prevention of permanent faecal diversion. Debate exists as to its safety in older patients. This review aims to assess functional outcomes and safety of restorative proctocolectomy (RPC) in older compared to younger patients.MethodsLiterature search was performed for age-stratified studies which assessed functional outcomes of IPAA. Twelve papers were included overall. Patients were categorized into ‘older’ and ‘younger’ groups. Analysis was split into three separate parts: 1. Age cut-off of 50 ± 5 years (with sensitivity analysis); 2. Age cut-off of 65 ± years; 3. Long-term outcomes (>10 years).ResultsWith an age cut-off of 50 years (4327 versus 513 patients), complication rates were comparable with the exception of an increased rate of small-bowel obstruction in the younger patients (p = 0.034). At 1 year, 24-h stool frequency was significantly higher in the older patient group (p < 0.0001). Daytime (p < 0.0001) and night-time (p < 0.0001) incontinence rates were also significantly higher in older patients.Overall, function deteriorated with time across all ages; however, after 10 years, there was no significant difference in incontinence rates between age groups.Dehydration and electrolyte loss was a significant problem in patients over 65 (p < 0.0001).Despite differences in postoperative function, quality of life was comparable between groups; however, only a few studies reported quality of life data.ConclusionIPAA is safe in older patients, although treating clinicians should bear in mind the increased risk of dehydration. Postoperative function is worse in older patients, but seems to level out with time and does not appear to significantly impact on overall quality of life and patient satisfaction. Assessment for suitability for RPC should not be based on chronological age in isolation. It is imperative that the correct support is given to older patients with worsened postoperative function in order to maintain patient satisfaction and adequate quality of life.

OTCs and older patients: A plethora of opportunities

OTCs and older patients: A plethora of opportunities

What do patients wear on their feet? A service evaluation of footwear in elderly patients

Background/Aims: Appropriate footwear is regarded as an important component of falls prevention in older people. Scant data exists regarding the types of footwear older patients wear in hospital, which may hinder the development of future interventions in this high-risk fall group. To address this, we conducted a service evaluation to examine and describe the style and quality of footwear worn by older patients in hospital. Methods: The footwear of older patients admitted to an acute NHS trust in England was assessed using the Footwear Assessment Tool. Patients were interviewed about their footwear choices. Results: A total of 730 pairs of footwear from 675 patients were assessed. The most common types of footwear worn were slippers (46%) and gripper socks (37%). Much of the footwear had a good fit, but over 50% lacked adequate structure, stability and support, more than 60% had no cushioning and 60% had no fixation. Approximately 60% of footwear was more than 12 months old, with signs of moderate to excess wear. Patients valued comfort and the familiarity of their own footwear. Conclusions: This service evaluation provides new information on footwear worn by older inpatients in hospital. Many patients are wearing footwear with insufficient structure to promote optimal stability or gait. Providing safe footwear that is suitable for use in hospital is potentially a low-technology and resource-efficient way to promote safety in older patients.

7 * WHAT DO PATIENTS WEAR ON THEIR FEET? A SERVICE EVALUATION OF FOOTWEAR IN ELDERLY PATIENTS (STEP)

Background/Aims: Appropriate footwear is regarded as an important component of falls prevention in older people. Scant data exists regarding the types of footwear older patients wear in hospital, which may hinder the development of future interventions in this high-risk fall group. To address this, we conducted a service evaluation to examine and describe the style and quality of footwear worn by older patients in hospital. Methods: The footwear of older patients admitted to an acute NHS trust in England was assessed using the Footwear Assessment Tool. Patients were interviewed about their footwear choices. Results: A total of 730 pairs of footwear from 675 patients were assessed. The most common types of footwear worn were slippers (46%) and gripper socks (37%). Much of the footwear had a good fit, but over 50% lacked adequate structure, stability and support, more than 60% had no cushioning and 60% had no fixation. Approximately 60% of footwear was more than 12 months old, with signs of moderate to excess wear. Patients valued comfort and the familiarity of their own footwear. Conclusions: This service evaluation provides new information on footwear worn by older inpatients in hospital. Many patients are wearing footwear with insufficient structure to promote optimal stability or gait. Providing safe footwear that is suitable for use in hospital is potentially a low-technology and resource-efficient way to promote safety in older patients.

Solumatrix diclofenac safety in older patients with osteoarthritis pain

Solumatrix diclofenac safety in older patients with osteoarthritis pain

No better solution for antipsychotic treatment with regard to long-term safety and effectiveness

Using various end points, the comparative effectiveness and safety of antipsychotics in patients with schizophrenia and other psychiatric indications have been demonstrated by a number of experimental and observational studies.1...

Letter: sorafenib hepatotoxicity may be enhanced during treatment of advanced hepatocellular carcinoma in HIV‐infected patients

escaping a colectomy. The question, raised by Dr Barreiro-de Acosta and Dr Gisbert, whether infliximab is useful and safe for all patients is clinically very relevant. Advanced age has been associated with increased risk of severe infections and mortality after anti-tumour necrosis factor therapy in inflammatory bowel disease. Our data do not provide a definite answer on safety in older patients, as the study was not designed for such an analysis and the number of patients >65 years of age was small (n = 6). Although the overall mortality within 3 months was low (1.4%), it must be pointed out that two of three deaths occurred in this age group. However, it must be emphasised that we did not assess the contribution of severity of bowel disease and concomitant therapy such as corticosteroids to the lethal outcome in these patients. Increased age and comorbidity are also associated with a higher risk for post-operative complications after a colectomy. 7 Altogether, this underscores the need for specific therapeutic guidelines for elderly patients with a severe attack of UC.

Letter: infliximab in severe ulcerative colitis – is it useful for all patients? Authors’ reply

We would like to thank Dr Barreiro-de Acosta and Dr Gisbert for their positive comments1 regarding our study on infliximab as rescue therapy in a steroid-refractory, severe attack of ulcerative colitis (UC).2 Whether patients receiving infliximab can avoid a colectomy, not only in the short- but also in the long-term, is an important issue, and our data are promising in this respect. The probability of colectomy-free survival at 12 months was 0.64 (95% CI 0.57–0.70) and at 5 years, 0.53 (95% CI 0.44–0.61). Furthermore, a steroid-free, clinical remission was achieved at 12 months in the majority of patients escaping a colectomy. The question, raised by Dr Barreiro-de Acosta and Dr Gisbert, whether infliximab is useful and safe for all patients is clinically very relevant. Advanced age has been associated with increased risk of severe infections and mortality after anti-tumour necrosis factor therapy in inflammatory bowel disease.3-5 Our data do not provide a definite answer on safety in older patients, as the study was not designed for such an analysis and the number of patients >65 years of age was small (n = 6). Although the overall mortality within 3 months was low (1.4%), it must be pointed out that two of three deaths occurred in this age group. However, it must be emphasised that we did not assess the contribution of severity of bowel disease and concomitant therapy such as corticosteroids to the lethal outcome in these patients. Increased age and comorbidity are also associated with a higher risk for post-operative complications after a colectomy.6, 7 Altogether, this underscores the need for specific therapeutic guidelines for elderly patients with a severe attack of UC. The authors’ declarations of personal and financial interests are unchanged from those in the original article.2

Beers revised: Drugs not to use in older adults

Older adults are generally characterized as patients who may be at an increased risk for adverse drug events because of altered pharmacokinetics, increased exposure to multiple concomitant medications, and comorbid conditions. In 1991, Mark Beers, MD, and colleagues published criteria listing "potentially inappropriate medications" for older patients. Updates to these criteria were subsequently published in 1997, 2003, and earlier this year in the Journal of the American Geriatrics Society . The revised 2012 version heralds a new partnership between an interdisciplinary panel of experts and the American Geriatrics Society.

Feasibility of outpatient consolidation chemotherapy in older versus younger patients with acute myeloid leukemia

Intensive consolidation chemotherapy for acute myeloid leukemia (AML) patients in complete remission is being increasingly administered on an outpatient basis. Although this approach has been found to be safe and feasible in younger patients, its safety in older patients remains unknown. We therefore undertook an evaluation of outpatient-based consolidation chemotherapy in older AML patients, and compared results to younger patients treated at the same institution over the same time period. The overall rate of readmission was ~50%, mostly for infections, with mean admission duration of 2 weeks. The overall mortality rate was 2.2%. Readmission rates and duration of readmission were somewhat higher in older patients, but infection rate, intensive care (ICU) admissions, and mortality rates were comparable to those in the younger patient cohort. However, we also observed that rates of febrile neutropenia, bacteremia, ICU admission, and death were significantly higher during the second consolidation, as compared with the first, in both younger and older patients. We conclude that outpatient-based consolidation therapy can be safely undertaken in a substantial proportion of fit older patients with AML.

Long-term darifenacin treatment for overactive bladder in patients aged 65 years and older: analysis of results from a 2-year, open-label extension study

ABSTRACTObjectives: This analysis evaluated the long-term safety, tolerability and efficacy of darifenacin, a muscarinic M3 selective receptor antagonist, in the treatment of overactive bladder (OAB) in patients ≥ 65 years of age.Methods: Patients who completed one of two 12-week, placebo-controlled, double-blind, feeder studies received once-daily (o.d.) treatment with darifenacin 7.5 mg for the first 2 weeks of the 2-year, open-label extension study. The dose could be subsequently adjusted (7.5 or 15 mg o.d.) according to need. Safety and tolerability were assessed, and efficacy variables/endpoints were evaluated from patient diary data.Results: 214 patients (65–89 years) entered and 137 (64.0%) completed the 2-year extension study, amounting to 308 patient-years’ drug exposure. Darifenacin was well tolerated with no new safety concerns. The most common adverse events (AEs) were dry mouth and constipation, which infrequently resulted in discontinuation (2.3% and 4.2%, respectively). Darifenacin produced significant improvements in OAB symptoms that were maintained over the 2-year period (median reduction from feeder-study baseline to 2 years: –11.0 [–83.7%] for incontinence episodes/week and –1.2 [–12.4%] for micturitions/day, both p < 0.05), with 44.4% patients achieving ≥ 90% reduction in incontinence episodes at 2 years.Conclusions: Darifenacin demonstrated good tolerability and safety in older patients with OAB. The improvement in OAB symptoms was sustained throughout the 2-year extension, resulting in high treatment persistence rates. Results were comparable with those in the overall OAB population from this study, indicating that darifenacin treatment is effective and well tolerated irrespective of age.

How Can We Ground the “Frequent Fliers”?

How Can We Ground the “Frequent Fliers”?

Age and the Risk of Warfarin‐Associated Hemorrhage: The Anticoagulation and Risk Factors In Atrial Fibrillation Study

To assess whether older age is independently associated with hemorrhage risk in patients with atrial fibrillation, whether or not they are taking warfarin therapy. Cohort study. Integrated healthcare delivery system. Thirteen thousand five hundred fifty-nine adults with nonvalvular atrial fibrillation. Patient data were collected from automated clinical and administrative databases using previously validated search algorithms. Medical charts were reviewed from patients hospitalized were for major hemorrhage (intracranial, fatal, requiring >or=2 units of transfused blood, or involving a critical anatomic site). Age was categorized into four categories (<60, 60-69, 70-79, and >or=80), and multivariable Poisson regression was used to assess whether major hemorrhage rates increased with age, stratified by warfarin use and adjusted for other clinical risk factors for hemorrhage. A total of 170 major hemorrhages were identified during 15,300 person-years of warfarin therapy and 162 major hemorrhages during 15,530 person-years off warfarin therapy. Hemorrhage rates rose with older age, with an average increase in hemorrhage rate of 1.2 (95% confidence interval (CI) 1.0-1.4) per older age category in patients taking warfarin and 1.5 (95% CI=1.3-1.8) in those not taking warfarin. Intracranial hemorrhage rates were significantly higher in those aged 80 and older (adjusted rate ratio=1.8, 95% CI=1.1-3.1 for those taking warfarin, adjusted rate ratio=4.7, 95% CI=2.4-9.2 for those not taking warfarin) than in those younger than 80. Older age increases the risk of major hemorrhage, particularly intracranial hemorrhage, in patients with atrial fibrillation, whether or not they are taking warfarin. Hemorrhage rates were generally comparable with those reported in previous randomized trials, indicating that carefully monitored warfarin therapy can be used with reasonable safety in older patients.

Nurses face a ‘juggling act’ over safety of older patients

Nurses face a ‘juggling act’ over safety of older patients

Internal Low Energy Atrial Cardioversion: Efficacy and Safety in Older Patients with Chronic Persistent Atrial Fibrillation

Low-energy internal atrial cardioversion is a relatively new technique based on delivery of intracardiac shocks through transvenous catheters placed into the atria or the vessels. The aim of this study was to assess in older and younger patients with chronic persistent atrial fibrillation (AF) the efficacy and safety of transvenous low-energy internal atrial cardioversion performed without routine administration of sedatives or anesthetics. A prospective longitudinal study. A cardiological university hospital. 82 patients, divided into older (> or = 60 years) (n = 49) and younger (n = 33) subjects. Atrial defibrillation threshold for internal cardioversion, measured as leading edge voltage (V) and delivered energy (J) of effective shocks, percentage of patients maintaining sinus rhythm at short-term (within 3 days) and at long-term follow-up. Patients with chronic persistent AF, treated with oral anticoagulants for at least 3 to 4 weeks, were admitted to hospital. Following a clinical work-up, patients were subjected to low-energy internal atrial cardioversion with shock delivery according to a step-up protocol. Internal cardioversion was effective in restoring sinus rhythm in 90% (44/49) of the older patients and in 94% (31/33) of the younger patients. Shocks were effective at a mean energy between 6 and 8 joules (range 0.9-23) and administration of sedatives or anesthetics was required during the procedure in 22% (11/49) of older and in 48% (16/33) of younger patients (P = .026 at chi-square). No major complications occurred during the procedure. Pharmacological prophylaxis of AF recurrences was instituted immediately following the procedure. During inhospital stay and during the follow-up (mean 12 +/- 9 months for older patients and 15 +/- 10 months for younger patients), AF recurred in 39% (17/44) of older patients and in 16% (5/31) of younger subjects (P = .064 at chi-square). Internal low energy cardioversion is a very effective procedure for restoring sinus rhythm in patients with AF; it can be performed in older patients, and administration of sedatives or anesthetics can be avoided or minimized in a substantial proportion of subjects. Recurrences of AF in the long term tend to be higher in older subjects and intensive prophylaxis with antiarrhythmic drugs is required.