The association between sociodemographic, clinical, and potentially preventive therapies with oxaliplatin-induced peripheral neuropathy in colorectal cancer patients.

PURPOSE: The purpose of this retrospective cohort study was to evaluate whether several potentially preventive therapies reduced the rate of oxaliplatin-induced peripheral neuropathy (OIPN) in colorectal cancer patients and to assess the relationship of sociodemographic/clinical factors with OIPN diagnosis. METHODS: Data were obtained from the Surveillance, Epidemiology, and End Results database combined with Medicare claims. Eligible patients were diagnosed with colorectal cancer between 2007 and 2015, ≥ 66 years of age, and treated with oxaliplatin. Two definitions were used to denote diagnosis of OIPN based on diagnosis codes: OIPN 1 (specific definition, drug-induced polyneuropathy) and OIPN 2 (broader definition, additional codes for peripheral neuropathy). Cox regression was used to obtain hazard ratios (HR) with 95% confidence intervals (CI) for the relative rate of OIPN within 2 years of oxaliplatin initiation. RESULTS: There were 4792 subjects available for analysis. At 2 years, the unadjusted cumulative incidence of OIPN 1 was 13.1% and 27.1% for OIPN 2. For both outcomes, no therapies reduced the rate of OIPN diagnosis. The anticonvulsants gabapentin and oxcarbazepine/carbamazepine were associated with an increased rate of OIPN (both definitions) as were increasing cycles of oxaliplatin. Compared to younger patients, those 75-84 years of age experienced a 15% decreased rate of OIPN. For OIPN 2, prior peripheral neuropathy and moderate/severe liver disease were also associated with an increased hazard rate. For OIPN 1, state buy-in health insurance coverage was associated with a decreased hazard rate. CONCLUSION: Additional studies are needed to identify preventive therapeutics for OIPN in cancer patients treated with oxaliplatin.

The association of peripheral neuropathy detected by monofilament testing with risk of falls and fractures in older adults.

BACKGROUND: In persons with diabetes, annual screening for peripheral neuropathy (PN) using monofilament testing is the standard of care. However, PN detected by monofilament testing is common in older adults, even in the absence of diabetes. We aimed to assess the association of PN with risk of falls and fractures in older adults. METHODS: We included participants in the Atherosclerosis Risk in Communities (ARIC) Study who underwent monofilament testing at visit 6 (2016-2017). Incident falls and fractures were identified based on ICD-9 and ICD-10 codes from active surveillance of all hospitalizations and linkage to Medicare claims. We used Cox models to assess the association of PN with falls and fractures (combined and as separate outcomes) after adjusting for demographics and risk factors for falls. RESULTS: There were 3617 ARIC participants (mean age 79.4 [SD 4.7] years, 40.8% male, and 21.4% Black adults), of whom 1242 (34.3%) had PN based on monofilament testing. During a median follow-up of 2.5 years, 371 participants had a documented fall, and 475 participants had a documented fracture. The incidence rate (per 1000 person-years) for falls or fractures for participants with PN versus those without PN was 111.1 versus 74.3 (p < 0.001). The age-, sex-, and race-adjusted 3-year cumulative incidence of incident fall or fracture was significantly higher for participants with PN versus those without PN (26.5% vs. 18.4%, p < 0.001). After adjusting for demographics, PN remained independently associated with falls and fractures (HR 1.48, 95% CI 1.26, 1.74). Results were similar for models including traditional risk factors for falls, when falls and fractures were analyzed as separate outcomes, and after adjustment for competing risk of death. CONCLUSIONS: PN, as measured by monofilament testing, is common in older adults and associated with risk of falls and fracture. Screening with monofilament testing may be warranted to identify older adults at high risk for falls.

Preliminary Risk assessment for Acrylamide and Peripheral Neuropathy.

Acrylamide (ACM) is a high-volume industrial chemical with diverse uses in manufacturing, construction and laboratory research. ACM is a well-established neurotoxic agent causing peripheral neuropathy with impairment in the arms and legs of exposed workers, most thoroughly studied in Swedish tunnel workers exposed to ACM grouting. A quantitative risk assessment was performed to assess ACM risk to workers. Using data from a published paper investigating peripheral neuropathies in Chinese chemical workers, estimates of exposure response for vibration perception threshold and nerve conduction velocities were calculated, based on hemoglobin adducts and air concentrations as exposure metrics. The benchmark dose procedure was applied in order to calculate excess risks of impairment, defined as adverse performance exceeding the 95th percentile in unexposed populations, at various concentrations of airborne ACM exposure. Under the assumptions in this risk assessment, after three years of inhalation exposure at 0.3 mg/m3, the excess attributable impairment manifest in vibration perception and nerve conduction velocity is estimated to occur in 1-2% of workers. For 10 years at 0.3 mg/m3 ACM inhalation (equivalent to 3 years at 1.0 mg/m3) the excess prevalence of impairment would be 2-14% of workers, assuming the effect continues to accrue linearly in time. Using published data, the risks of impairment from peripheral neuropathy attributable to exclusively airborne ACM exposure can be predicted for exposure periods less than 10 years. The risks associated with dermal and airborne ACM exposures can be estimated by characterizing working process environments using ACM Hb-adduct levels and possibly monitored with urinary biomarkers.

The updated five-year overall survival and long-term oxaliplatin-related neurotoxicity assessment of the FACOS study.

PURPOSE: We previously reported the first evidence of oncological benefits from a Japanese phase II trial of oxaliplatin-based adjuvant chemotherapy in patients with stage III colon cancer (the FACOS study). We herein report the long-term survival and persistent oxaliplatin-related peripheral sensory neuropathy (PSN) for patients enrolled in this trial. METHODS: Patients were scheduled to receive the mFOLFOX6 or CAPOX regimen in the adjuvant setting. The five-year overall survival (OS) rate and persistent PSN were evaluated. RESULTS: A total of 130 patients (mFOLFOX6, n = 73; CAPOX, n = 57) were eligible. The 5-year OS rate was 91.4%. No significant difference in the OS rate was observed between regimens (mFOLFOX6, 94.4%; CAPOX, 87.4%; P = 0.25). The incidence of PSN during adjuvant treatment was 55.4% in grade 1 (G1), 30.0% in G2, and 4.6% in G3. No patients showed G3 PSN at 12 months, but G1 or G2 residual PSN after 5 years was observed in 21.8% (G1, 20%; G2, 1.8%). CONCLUSIONS: Updated results from the FACOS study support the benefits of oxaliplatin-based adjuvant chemotherapy in terms of the long-term survival among Japanese patients with stage III colon cancer. However, long-term persistent PSN occurs in about 20% of survivors, counterbalancing the favorable OS.

Outcomes and adverse events of pre- and extensively drug-resistant tuberculosis patients in Kinshasa, Democratique Republic of the Congo: A retrospective cohort study.

BACKGROUND: Extensively drug-resistant tuberculosis (XDR TB) is a very serious form of tuberculosis that is burdened with a heavy mortality toll, especially before the advent of new TB drugs. The Democratic Republic of the Congo (DRC) is among the countries most affected by this new epidemic. METHODS: A retrospective analysis was performed of the records of all patients with pre- and extensively drug-resistant tuberculosis hospitalized from January 1, 2015 to December 31, 2017 and monitored for at least 6 months to one year after the end of their treatment in Kinshasa; an individualized therapeutic regimen with bedaquiline for 20 months was built for each patient. The adverse effects were systematically monitored. RESULTS: Of the 40 laboratory-confirmed patients, 32 (80%) patients started treatment, including 29 preXRB and 3 XDR TB patients. In the eligible group, 3 patients (9.4%) had HIV-TB coinfections. The therapeutic success rate was 53.2%, and the mortality rate was 46.8% (15/32); there were no relapses, failures or losses to follow-up. All coinfected HIV-TB patients died during treatment. The cumulative patient survival rate was 62.5% at 3 months, 53.1% at 6 months and 53.1% at 20 months. The most common adverse events were vomiting, Skin rash, anemia and peripheral neuropathy. CONCLUSION: The new anti-tuberculosis drugs are a real hope for the management of Drug Resistant tuberculosis patient and other new therapeutic combinations may improve favorable outcomes.

Chemotherapy-induced peripheral neuropathy (CIPN) and its treatment: an NIH Collaboratory study of claims data.

PURPOSE: Chemotherapy-induced peripheral neuropathy (CIPN) is a disabling complication of many chemotherapies. We investigated the feasibility of using health plan claims and administrative data to identify CIPN occurrence by comparing patients who received neurotoxic and non-neurotoxic chemotherapies. METHODS: The sample included over 53,000,000 patients from two regional and one national insurer in the USA (> 400,000 exposed to chemotherapy). Peripheral neuropathy was identified using a broad definition (definition 1) and a specific definition (i.e., drug-induced polyneuropathy code) (definition 2). RESULTS: CIPN incidence as measured by definition 1 within 6 months of chemotherapy initiation was 18.1% and 6.2% for patients who received neurotoxic and non-neurotoxic chemotherapy, respectively (relative risk neurotoxic vs. non-neurotoxic (RR), 2.93 (95% CI, 2.87-2.98)). For definition 2, these incidences were 3.6% and 0.1% (RR, 25.2 (95% CI, 22.8-27.8)). The incidences of new analgesic prescriptions for neurotoxic and non-neurotoxic groups were as follows: gabapentin, 7.1%/1.7%; pregabalin, 0.69%/0.31%; and duloxetine, 0.78%/0.76%. The incidence of CIPN as defined by definitions 1 and 2 was low compared with that of published research studies, but the relative risk of CIPN among patients who received neurotoxic chemotherapies compared with those who received non-neurotoxic chemotherapies was high using definition 2. CONCLUSIONS: These data suggest that as used currently by clinicians, administrative codes likely underestimate CIPN incidence. Thus, studies using administrative data to estimate CIPN incidence are not currently feasible. However, the drug-induced polyneuropathy code is a specific indicator of CIPN in administrative data and may be useful for investigating predictors or potentially preventive therapies of CIPN.

Laboratory Evaluation of Peripheral Neuropathy.

Peripheral neuropathy is a common neurological disorder, with high prevalence especially in the aged population. The general evaluative approach is to first identify the type of peripheral neuropathy prior to investigating for a possible underlying etiology, which is an increasingly important endeavor, as many causes of peripheral neuropathy are now recognized as treatable. To this end, laboratory testing plays an important adjunctive role to a detailed history and examination. This review will discuss possible diagnostic laboratory testing pathways for different types of peripheral neuropathy, with the goal of minimizing costs and false-positive results while maximizing the likelihood of identifying a potentially reversible etiology.

Are we mis-estimating chemotherapy-induced peripheral neuropathy? Analysis of assessment methodologies from a prospective, multinational, longitudinal cohort study of patients receiving neurotoxic chemotherapy.

BACKGROUND: There are inconsistencies in the literature regarding the prevalence and assessment of chemotherapy-induced peripheral neuropathy (CIPN). This study explored CIPN natural history and its characteristics in patients receiving taxane- and platinum-based chemotherapy. PATIENTS AND METHODS: Multi-country multisite prospective longitudinal observational study. Patients were assessed before commencing and three weekly during chemotherapy for up to six cycles, and at 6,9, and 12 months using clinician-based scales (NCI-CTCAE; WHO-CIPN criterion), objective assessments (cotton wool test;10 g monofilament); patient-reported outcome measures (FACT/GOG-Ntx; EORTC-CIPN20), and Nerve Conduction Studies. RESULTS: In total, 343 patients were recruited in the cohort, providing 2399 observations. There was wide variation in CIPN prevalence rates using different assessments (14.2-53.4%). Prevalence of sensory neuropathy (and associated symptom profile) was also different in each type of chemotherapy, with paclitaxel (up to 63%) and oxaliplatin (up to 71.4%) showing the highest CIPN rates in most assessments and a more complex symptom profile. Peak prevalence was around the 6-month assessment (up to 71.4%). Motor neurotoxicity was common, particularly in the docetaxel subgroup (up to 22.1%; detected by NCI-CTCAE). There were relatively moderately-to-low correlations between scales (rs = 0.15,p < 0.05-rs = 0.48 p < 0.001), suggesting that they measure different neurotoxicity aspects from each other. Cumulative chemotherapy dose was not associated with onset and course of CIPN. CONCLUSION: The historical variation reported in CIPN incidence and prevalence is possibly confounded by disagreement between assessment modalities. Clinical practice should consider assessment of motor neuropathy for neurotoxic chemotherapy. Current scales may not be all appropriate to measure CIPN in a valid way, and a combination of scales are needed.

Risk of incident claims for chemotherapy-induced peripheral neuropathy among women with breast cancer in a Medicare population.

BACKGROUND: Chemotherapy-induced peripheral neuropathy (CIPN) is a common and disabling consequence of neurotoxic therapies, yet factors that modulate the development and clinical impact of CIPN are poorly understood. This epidemiological analysis identifies risk factors for the incidence of CIPN. METHODS: This retrospective analysis of Surveillance, Epidemiology, and End Results-Medicare data examined predictors of incident CIPN claims among 11,149 women aged 66 years or older with American Joint Commission on Cancer (AJCC) stage II to IV breast cancer (and no secondary cancer diagnosis or preexisting neuropathy) who received chemotherapy. RESULTS: Overall, new CIPN claims occurred for 8.3% of patients within 1 year of starting chemotherapy. Risk emerged approximately 3 months after the start of chemotherapy and increased throughout 1 year. Paclitaxel as part of first-line therapy increased CIPN risk 2.7-fold in comparison with nonneurotoxic agents (15.9% vs 5.0%), with lower incidence rates for carboplatin and paclitaxel (11.9%), carboplatin and docetaxel (9.3%), carboplatin alone (7.7%), and docetaxel alone (6.6%). The CIPN incidence rate was higher for women who at the time of their breast cancer diagnosis were relatively young (within this Medicare sample), were at AJCC stage II or III, were married or had an equivalent status, and had fewer comorbidities, but it did not differ by race/ethnicity or poverty level. CONCLUSIONS: These Medicare claims database findings indicate that women aged 66 years or older with breast cancer are susceptible to CIPN from taxane and/or platinum compounds, with risk emerging approximately 3 months into treatment. Prospective studies of symptom emergence and clinical response (eg, stopping chemotherapy and adjunctive treatments) are indicated to determine how best to inform patients of this risk and to manage CIPN in this population.

Vitamin B6 in Health Supplements and Neuropathy: Case Series Assessment of Spontaneously Reported Cases.

INTRODUCTION: In the literature, vitamin B6 has been linked to the development of polyneuropathy. Most often, these complaints were seen when taking high doses of vitamin B6 for a long time. Evidence as to whether a lower dosage range of vitamin B6 (< 50 mg/day) can also induce neuropathy is scarce. OBJECTIVE: We aim to comprehensively describe the cases of neuropathy associated with vitamin B6 received by the Netherlands Pharmacovigilance Centre Lareb and to assess the case series concerning the use of vitamin B6 and neuropathic complaints. METHODS: We describe the number and nature of the reported cases, including suspect product, dosage, duration of use, and vitamin B6 serum levels. In addition, we describe the causality for the individual cases (Naranjo Probability Scale) and for the entire case series (Bradford Hill criteria). RESULTS: In total, 90 reports on products containing vitamin B6 included at least one adverse drug reaction in the standardized Medical Dictionary for Regulatory Activities (MedDRA®) query (SMQ; broad) 'peripheral neuropathy'. The amount of vitamin B6 in the products varied between 1.4 and 100 mg per tablet. The serum vitamin B6 level was known in 36 cases (88-4338 nmol/l), and the mean serum vitamin B6 level was 907 nmol/l. However, no statistical correlation between dosage and vitamin B6 blood levels was found. DISCUSSION AND CONCLUSION: Causality assessment of the case series of 90 reports to Lareb shows it is plausible for the vitamin B6 supplements to have caused complaints such as neuropathies. This is especially the case with higher dosages and prolonged use, but dosages < 50 mg/day also cannot be excluded.

Incidence and disease burden of chemotherapy-induced peripheral neuropathy in a population-based cohort.

OBJECTIVE: To assess disease burden of chemotherapy-induced peripheral neuropathy (CIPN), which is a common dose-limiting side effect of neurotoxic chemotherapy. Late effects of CIPN may increase with improved cancer survival. METHODS: Olmsted County, Minnesota residents receiving neurotoxic chemotherapy were identified and CIPN was ascertained via text searches of polyneuropathy symptoms in the medical record. Clinical records were queried to collect data on baseline characteristics, risk factors, signs and symptoms of CIPN, medications, impairments and International Classification of Diseases, Ninth Revision (ICD-9) diagnostic codes for all subjects. RESULTS: A total of 509 individuals with incident exposure to an inclusive list of neurotoxic chemotherapy agents between 2006 and 2008 were identified. 268 (52.7%) of these individuals were determined to have CIPN. The median time from incident exposure to first documented symptoms was 71 days. Patients with CIPN received a neuropathy ICD-9 diagnosis in only 37 instances (13.8%). Pain symptoms and use of pain medications were observed more often in patients with CIPN. Five-year survival was greater in those with CIPN (55.2%) versus those without (36.1%). Those with CIPN surviving greater than 5 years (n=145) continued to have substantial impairments and were more likely to be prescribed opioids than those without CIPN (OR 2.0, 1.06-3.69). CONCLUSIONS: Results from our population-based study are consistent with previous reports of high incidence of CIPN in the first 2 years following incident exposure to neurotoxic chemotherapeutic agents, and its association with significant pain symptomatology and accompanied long-term opioid use. Increased survival following exposure to neurotoxic chemotherapy and its long-term disease burden necessitates further study among survivors.

Risk of adverse events associated with front-line anti-myeloma treatment in Medicare patients with multiple myeloma.

This study aims to examine the risks of adverse events associated with anti-multiple myeloma (MM) therapies in a large population-based cohort of elderly patients with MM. Patients diagnosed with advanced MM from 2005 through 2009 and receiving anti-MM therapy were identified from the Surveillance, Epidemiology, and End Results (SEER)-Medicare-linked data. We compared safety outcomes between novel agents (proteasome inhibitor (PI) and immunomodulatory drugs (IMiD)) and other therapies and between PI- or IMiD-based regimens and PI plus IMiD combination regimens. Of 2587 patients with advanced MM, 2048 (79%) received novel agents and 539 (21%) received other therapies. Patients with preexisting anemia and thrombocytopenia were significantly more likely to receive novel agents (85.9 vs. 82.4%, P = 0.038; 13.8 vs. 10.4%, P = 0.036), while those with preexisting cardiovascular disease and hypertension were significantly less likely to receive novel agents (73.4 vs. 79.8%, P = 0.003; 81.3 vs. 85.2%, P = 0.035). The hazard ratios for anemia, peripheral neuropathy, and thromboembolic events for patients receiving novel agents compared with those receiving other therapies were 1.19 (95% CI, 1.06-1.32), 1.57 (95% CI, 1.15-2.15), and 1.31 (95% CI, 1.03-1.67). The hazard ratios for anemia, neutropenia, and thromboembolic events for patients receiving PI plus IMiD combination therapies compared with those receiving PI- or IMiD-based therapies were 1.31 (95% CI, 1.12-1.54), 1.66 (95% CI, 1.27-2.18, and 1.37 (95% CI, 1.02-1.86). Novel agents significantly increased the risk of anemia, peripheral neuropathy, and thromboembolic events. PI plus IMiD combination therapies were associated with significantly higher risk for anemia, neutropenia, and thromboembolic events.

Impact of chemotherapy-induced neurotoxicities on adult cancer survivors' symptom burden and quality of life.

PURPOSE: Limited information is available on the impact of chemotherapy (CTX)-induced neurotoxicity on adult survivors' symptom experience and quality of life (QOL). Purposes were to describe occurrence of hearing loss and tinnitus and evaluate for differences in phenotypic characteristics and measures of sensation, balance, perceived stress, symptom burden, and QOL between survivors who received neurotoxic CTX and did (i.e., neurotoxicity group) and did not (i.e., no neurotoxicity group) develop neurotoxicity. Neurotoxicity was defined as the presence of chemotherapy-induced neuropathy (CIN), hearing loss, and tinnitus. Survivors in the no neurotoxicity group had none of these conditions. METHODS: Survivors (n = 609) completed questionnaires that evaluated hearing loss, tinnitus, stress, symptoms, and QOL. Objective measures of sensation and balance were evaluated. RESULTS: Of the 609 survivors evaluated, 68.6% did and 31.4% did not have CIN. Of the survivors without CIN, 42.4% reported either hearing loss and/or tinnitus and 48.1% of the survivors with CIN reported some form of ototoxicity. Compared to the no neurotoxicity group (n = 110), survivors in the neurotoxicity group (n = 85) were older, were less likely to be employed, had a higher comorbidity burden, and a higher symptom burden, higher levels of perceived stress, and poorer QOL (all p < .05). CONCLUSIONS: Findings suggest that CIN, hearing loss, and tinnitus are relatively common conditions in survivors who received neurotoxic CTX. IMPLICATIONS FOR CANCER SURVIVORS: Survivors need to be evaluated for these neurotoxicities and receive appropriate interventions. Referrals to audiologists and physical therapists are warranted to improve survivors' hearing ability, functional status, and QOL.

Multi-Institutional Assessment of Adverse Health Outcomes Among North American Testicular Cancer Survivors After Modern Cisplatin-Based Chemotherapy.

Purpose To provide new information on adverse health outcomes (AHOs) in testicular cancer survivors (TCSs) after four cycles of etoposide and cisplatin (EPX4) or three or four cycles of bleomycin, etoposide, cisplatin (BEPX3/BEPX4). Methods Nine hundred fifty-two TCSs > 1 year postchemotherapy underwent physical examination and completed a questionnaire. Multinomial logistic regression estimated AHOs odds ratios (ORs) in relation to age, cumulative cisplatin and/or bleomycin dose, time since chemotherapy, sociodemographic factors, and health behaviors. Results Median age at evaluation was 37 years; median time since chemotherapy was 4.3 years. Chemotherapy consisted largely of BEPX3 (38.2%), EPX4 (30.9%), and BEPX4 (17.9%). None, one to two, three to four, or five or more AHOs were reported by 20.4%, 42.0%, 25.1%, and 12.5% of TCSs, respectively. Median number after EPX4 or BEPX3 was two (range, zero to nine and zero to 11, respectively; P > .05) and two (range, zero to 10) after BEPX4. When comparing individual AHOs for EPX4 versus BEPX3, Raynaud phenomenon (11.6% v 21.4%; P < .01), peripheral neuropathy (29.2% v 21.4%; P = .02), and obesity (25.5% v 33.0%; P = .04) differed. Larger cumulative bleomycin doses (OR, 1.44 per 90,000 IU) were significantly associated with five or more AHOs. Increasing age was a significant risk factor for one to two, three to four, or five or more AHOs versus zero AHOs (OR, 1.22, 1.50, and 1.87 per 5 years, respectively; P < .01); vigorous physical activity was protective (OR, 0.62, 0.51, and 0.41, respectively; P < .05). Significant risk factors for three to four and five or more AHOs included current (OR, 3.05 and 3.73) or former (OR, 1.61 and 1.76) smoking ( P < .05). Self-reported health was excellent/very good in 59.9% of TCSs but decreased as AHOs increased ( P < .001). Conclusion Numbers of AHOs after EPX4 or BEPX3 appear similar, with median follow-up of 4.3 years. A healthy lifestyle was associated with reduced number of AHOs.

Clinical Phenotype of Diabetic Peripheral Neuropathy and Relation to Symptom Patterns: Cluster and Factor Analysis in Patients with Type 2 Diabetes in Korea.

OBJECTIVES: Patients with diabetic peripheral neuropathy (DPN) is the most common complication. However, patients are usually suffering from not only diverse sensory deficit but also neuropathy-related discomforts. The aim of this study is to identify distinct groups of patients with DPN with respect to its clinical impacts on symptom patterns and comorbidities. METHODS: A hierarchical cluster analysis and factor analysis were performed to identify relevant subgroups of patients with DPN (n = 1338) and symptom patterns. RESULTS: Patients with DPN were divided into three clusters: asymptomatic (cluster 1, n = 448, 33.5%), moderate symptoms with disturbed sleep (cluster 2, n = 562, 42.0%), and severe symptoms with decreased quality of life (cluster 3, n = 328, 24.5%). Patients in cluster 3, compared with clusters 1 and 2, were characterized by higher levels of HbA1c and more severe pain and physical impairments. Patients in cluster 2 had moderate pain levels but disturbed sleep patterns comparable to those in cluster 3. The frequency of symptoms on each item of MNSI by "painful" symptom pattern showed a similar distribution pattern with increasing intensities along the three clusters. CONCLUSIONS: Cluster and factor analysis endorsed the use of comprehensive and symptomatic subgrouping to individualize the evaluation of patients with DPN.

A comprehensive assessment of the physical, nutritional, and psychological health status of the elderly populace in the Fayoum Governorate (Egypt).

BACKGROUND: Elderly in Egypt is approximately 7.2% of the population. The main physical health problems affecting old age is Non-communicable diseases (NCDs). Depression is the commonest geriatric psychiatric disorder related to various life events. Malnutrition is associated with poor health, and cognitive impairment. OBJECTIVES: To determine the prevalence of chronic non-communicable diseases; malnutrition and depression with identification of related risk factors among Fayoum elderly population. METHODS: A cross-sectional descriptive community based survey was conducted among elderly population 2219 in Fayoum governorate. The sample was multistage stratified cluster random. An interview structured questionnaire including socio-demographic characteristics, history of chronic NCDs, evaluation of nutritional and psychological status by MNASF and GDSLF tools respectively. RESULTS: More than ninety percent of the studied population was suffering from more than one disease either physiological or pathological. The prevalence of malnutrition and depression was 10.9% and 74.5% respectively. Logistic regression analysis revealed that female gender, with increased age, and disease burden were common risk factor for both malnutrition and depression. CONCLUSION & RECOMMENDATION: Non-communicable disease, malnutrition and depression were prevalent in our older population. These findings indicated the need for comprehensive integrated medical, psychological and nutritional health care at the level of the primary health care units.

Longitudinal patient-oriented outcomes in neuropathy: Importance of early detection and falls.

OBJECTIVE: To evaluate longitudinal patient-oriented outcomes in peripheral neuropathy over a 14-year time period including time before and after diagnosis. METHODS: The 1996-2007 Health and Retirement Study (HRS)-Medicare Claims linked database identified incident peripheral neuropathy cases (ICD-9 codes) in patients ≥65 years. Using detailed demographic information from the HRS and Medicare claims, a propensity score method identified a matched control group without neuropathy. Patient-oriented outcomes, with an emphasis on self-reported falls, pain, and self-rated health (HRS interview), were determined before and after neuropathy diagnosis. Generalized estimating equations were used to assess differences in longitudinal outcomes between cases and controls. RESULTS: We identified 953 peripheral neuropathy cases and 953 propensity-matched controls. The mean (SD) age was 77.4 (6.7) years for cases, 76.9 (6.6) years for controls, and 42.1% had diabetes. Differences were detected in falls 3.0 years before neuropathy diagnosis (case vs control; 32% vs 25%, p = 0.008), 5.0 years for pain (36% vs 27%, p = 0.002), and 5.0 years for good to excellent self-rated health (61% vs 74%, p < 0.0001). Over time, the proportion of fallers increased more rapidly in neuropathy cases compared to controls (p = 0.002), but no differences in pain (p = 0.08) or self-rated health (p = 0.9) were observed. CONCLUSIONS: In older persons, differences in falls, pain, and self-rated health can be detected 3-5 years prior to peripheral neuropathy diagnosis, but only falls deteriorates more rapidly over time in neuropathy cases compared to controls. Interventions to improve early peripheral neuropathy detection are needed, and future clinical trials should incorporate falls as a key patient-oriented outcome.

[Capsaicin Cutaneous Patch: a Cost-consequences Study in a French University Hospital]. / Étude coût-conséquences sur la capsaïcine en patch cutané dans un CHU français.

INTRODUCTION: The capsaïcine 8% cutaneous patch (Qutenza®) was recently approved for the management of patients with peripheral neuropathic pain (PNP). Considering its limited clinical efficacy data, its improvement of medical benefit was determined to be 5 which was insufficient to support its reimbursement in addition to diagnosis related groups'tarifs. Nevertheless its commercialization was associated with a marked interest considering the unmet therapeutic needs for patients with PNP. OBJECTIVES: Our objectives were to assess the effectiveness, the safety, and the economic impact of Qutenza® in real-life conditions. METHODS: An observational cost-consequences study was launched under the aegis of the Drug Committee of our hospital. Medical charts and prescriptions of all patients who received at least one patch application were analyzed. Effectiveness and safety were assessed after 12-week and 24-week of follow-up. The economic impact was measured within the Hospital and Health Insurance perspective and with limitation to direct costs. RESULTS: From March 2012 to October 2013, 91 patients (54.3 ± 14.1 years; 52.7% of male) received at least one application. The average follow- up duration was 188.3 ± 86.4 days. The PNP etiologies were mainly post-surgery (42.9%) and post-traumatology (20.8%). A therapeutic response (decrease of ENS score of least 30%) after 12 weeks and 24 weeks was observed in 27.9% and 37.1% of patients respectively. The SF-36 mental score was significantly improved. The safety profile was good. The application of the patch resulted in incremental costs of 154 euros per hospital stay without impact on outpatient-prescription drug expenditures. CONCLUSION: This study confirms the interest of Qutenza® for heavily pretreated, refractory patients with PNP. The clinical profile of responders has to be further investigated in large observational studies.

Risk score model for the assessment of coronary artery disease in asymptomatic patients with type 2 diabetes.

No model has been developed to predict significant coronary artery disease (CAD) on coronary computed tomographic angiography (CCTA) in asymptomatic type 2 diabetes. Therefore, we sought to develop a model for the prediction of significant CAD on CCTA in these patients. We analyzed 607 asymptomatic patients with type 2 diabetes who underwent CCTA. The cardiac event was defined as a composite of cardiac death, nonfatal myocardial infarction, acute coronary syndrome, and coronary revascularization. Significant CAD (diameter stenosis ≥50%) in at least one coronary artery on CCTA was observed in 188 (31.0%). During the follow-up period (median 4.3 [interquartile range, 3.7-4.8] years), 71 patients had 83 cardiac events. Clinical risk factors for significant CAD were age, male gender, duration of diabetes, hypertension, current smoking, family history of premature CAD, previous history of stroke, ratio of total cholesterol to high-density lipoprotein cholesterol, and neuropathy. Using these variables, we formulated a risk score model, and the scores ranged from 0 to 17 (area under the curve = 0.727, 95% confidence interval = 0.714-0.739, P < 0.001). Patients were categorized into low (≤3), intermediate (4-6), or high (≥7) risk group. There were significant differences between the risk groups in the probability of significant CAD (12.6% vs 29.4% vs 57.7%, P for all < 0.001) and 5-year cardiac event-free survival rate (96.6% ±â€Š1.5% vs 88.9% ±â€Š1.8% vs 73.8% ±â€Š4.1%, log-rank P for trend < 0.001). This model predicts significant CAD on CCTA and has the potential to identify asymptomatic type 2 diabetes with high risk.