[Bronchospasm and flushing after vaccination with 23 serotype pneumococcal polysaccharide in chronic patients]. / Broncoespasmo y flushing tras la vacunación con neumococo polisacárida de 23 serotipos en pacientes crónicos.

OBJECTIVE: To describe the clinical-epidemiological characteristics of a series of suspected systemic adverse reactions registered with the 23 serotype pneumococcal polysaccharide vaccine (PNEUMOVAX23®). Calculate the cumulative incidence of the reaction and know if similar and/or compatible cases have been described in the scientific literature or in pharmacovigilance. METHODS: Observational and retrospective study realized between 01/12/2015 and 30/09/2017 in the Vaccines Unit of an autonomic reference hospital. We calculated the cumulative incidence of the adverse reaction for that vaccine. The common pharmacovigilance database (FEDRA) was consulted. RESULTS: Nine systemic adverse reactions were recorded (flushing + bronchospasm + SatO2<95%). The cumulative incidence was 1.036%. The outcome was recovered/resolved for everyone. No similar and/or compatible cases were found. CONCLUSIONS: The reactions described do not appear in the PNEUMOVAX23® data sheet. Epidemiologically, no causal relationship can be established between the symptoms and the variables studied. This study could be the basis for more detailed research that could modify the vaccine data sheet.

Obesity and glycemic control in patients with diabetes mellitus: Analysis of physician electronic health records in the US from 2009-2011.

AIMS: Examine the association between obesity and glycemic control among patients with type 1 (T1DM) or type 2 diabetes mellitus (T2DM). METHODS: Data from US physician electronic health records (Humedica®) from 2009-2011 were utilized. Patients were defined as having above-target glycemic control if they had an HbA1c ≥7% at any time during the study period. Multinomial logistic regressions were conducted separately for T1DM and T2DM patients, and examined associations between BMI categories and probability of having above-target glycemic control (≥7% and <8%, ≥8% and <9%, or ≥9%) while controlling for patient demographics, general health, comorbid conditions, and antihyperglycemic medication use. RESULTS: There were 14,028 T1DM and 248,567 T2DM patients; 47.8% of T1DM and 63.4% of T2DM were obese (BMI ≥30kg/m(2)). For T1DM, being overweight (BMI 25-<30), obese class I (30-<35), II (35-<40), or III (≥40) was associated with a significantly higher probability of having HbA1c≥8% and <9% or ≥9%, while being overweight was associated with a significantly higher probability of having HbA1c ≥7% and <8% compared to normal BMI (BMI≥18.5 and<25). For T2DM patients, being overweight, obese class I, II, or III was associated with a significantly higher probability of having HbA1c ≥7% and <8%, ≥8% and <9%, or ≥9%. CONCLUSIONS: For both T1DM and T2DM patients, there were positive and statistically significant associations between being overweight or obese and having suboptimal glycemic control. These findings quantify the associations between obesity and glycemic control, and highlight the potential importance of individual characteristics on glycemic control.

The impact of comorbid depression on adherence to therapy for multiple sclerosis.

Objective. Examine the impact of comorbid depression on adherence to disease-modifying therapy (DMT) for multiple sclerosis (MS). Methods. A retrospective database was used to identify patients with MS treated with a DMT. Patients with MS and comorbid depression were matched to patients with MS only. Adherence to DMT was proxied by the medication possession ratio (MPR) and multivariate regressions were used to examine the association between comorbid depression and adherence to DMT. Results. Patients with comorbid depression had a 10 point lower MPR (P < 0.01) and were less likely to achieve a MPR of at least 80% (odds ratio (OR) = 0.55; 95% confidence interval (CI) 0.42-0.74) than those without depression. While treatment with an antidepressant generally had no significant impact on the likelihood of achieving an MPR threshold of 80% (OR = 1.32; 95% CI 0.50-3.48), adherence to antidepressant therapy guidelines were associated with improved adherence to DMT therapy. Conclusions. MS patients with comorbid depression were approximately half as likely to be adherent to their DMT relative to patients with MS without depression. Although treatment with antidepressant therapy generally did not improve the likelihood of adherence, treatment with antidepressants for at least 6 months was associated with better adherence to DMT.

The relationship between alternative medication possession ratio thresholds and outcomes: evidence from the use of glatiramer acetate.

OBJECTIVE: To examine how changes in the medication possession ratio (MPR) affect the probability of multiple sclerosis (MS) relapses and total and MS-related charges among patients treated with glatiramer acetate (GA). METHODS: Data were obtained from i3 InVision™ Data Mart for January 1, 2006 through March 31, 2010. Patients were included if they were diagnosed with MS, initiated therapy with GA, and had continuous insurance coverage from 6 months prior through 24 months after initial use of GA (n=839). Multivariate regressions which controlled for patient characteristics examined the association between achievement of alternative MPR goals and patient relapses and charges. RESULTS: Patients who achieved an MPR of at least 0.7 had significantly lower odds of relapse than those with MPR thresholds below 0.7, with achievement of a threshold of 0.7, 0.8, or 0.9, associated with an odds ratio of relapse of 0.545 (95% CI=0.351-0.824), 0.568 (95% CI=0.371-0.870), and 0.421 (95% CI=0.260-0.679), respectively. Attaining higher MPR thresholds resulted in larger reductions in direct medical charges, excluding GA and other MS-related drugs. MPR of 0.25 was associated with $1699 lower 2-year total direct medical charges (p=0.009) while a threshold of 0.95 was associated with $2136 lower total charges (p<0.001), compared to patients not reaching these respective thresholds. MPR of 0.90 was associated with $986 lower MS-related charges than for those with MPR<0.90 (p=0.050). Results also revealed an association between patient adherence to GA and statistically significant reductions in charges for specific components of care. LIMITATIONS: Results are generalizable only to patients with medical and prescription benefit coverage without regard for functional status. CONCLUSIONS: As adherence improved the odds of relapse decreased and charge offsets generally increased. Results suggest that, despite higher costs associated with increased usage of GA, patient outcomes are improved and there are cost-offsets associated with adherent use of GA.

Association between androgen-deprivation therapy and incidence of diabetes among males with prostate cancer.

OBJECTIVES: Previous research has documented an increase in metabolic syndrome among patients who use androgen-deprivation therapy (ADT). Given that metabolic syndrome is related to diabetes, this research examined whether use of ADT was associated with an increase in the incidence of diabetes. METHODS: A retrospective, claims database was used to compare men diagnosed with prostate cancer who received ADT (N = 1231) with men diagnosed with prostate cancer who did not receive ADT (N = 7250). Unjustified comparisons among the cohorts were examined using chi-square statistics for categorical variables and t-statistics for continuous variables. A multivariate logistic regression was estimated to examine the association between receipt of ADT and the incidence of diabetes, while controlling for a wide range of factors that also potentially affect the probability of being newly diagnosed with diabetes. RESULTS: Descriptive statistics revealed that the patients who initiated ADT were significantly older (P <0.01), in poorer health (P <0.01), and more likely to have a prior diagnosis of hypertension (P = 0.04). Results from the multivariate regression indicate that for men diagnosed with prostate cancer, demographic characteristics, comorbid conditions, prior statin use, and receipt of ADT all affect the probability of incident diabetes. While controlling for other factors, the estimated relative risk of incident diabetes associated with the receipt of ADT was 1.36 (P = 0.01). CONCLUSIONS: Results from this study suggest that among prostate cancer patients, those initiating ADT are more likely to develop incident diabetes within 1 year. This finding supports previous research that established the relationship between ADT and metabolic syndrome.

Effect of immunomodulatory therapy and other factors on employment loss time in multiple sclerosis.

The factors that influence time missed from work among individuals diagnosed with multiple sclerosis were the focus of this study. Records of individuals who were employed and diagnosed with multiple sclerosis between the years 1999 and 2002 (N=284) were examined for details pertaining to their medical claims. Multivariate regressions, controlling for demographic characteristics, type of immunomodulatory medication, and overall severity of illness, were used in the examination of the total number of days missed from work for any reason and those missed due to absenteeism, short-term disability, or worker's compensation. Results indicate that lost work time is affected by severity of illness, and type of immunomodulatory therapy. Comparing individuals treated with the specific immunomodulator glatiramer acetate, interferon beta-1a (intramuscular), or interferon beta-1b, to those who did not receive multiple sclerosis medications of this type; only glatiramer acetate was associated with significantly fewer days missed from work for short term disability (18.24 fewer days, P<0.03), worker's compensation (29.50 fewer days, P<0.04) or any reason (53.70 fewer days, P< 0.003).

A comparison of total hospital costs for percutaneous coronary intervention patients receiving abciximab versus tirofiban.

The purpose of this study was to examine the total hospital costs associated with the receipt of abciximab versus tirofiban for percutaneous coronary intervention (PCI) patients. Hospital billing data for patients with a primary procedure of PCI was examined for the period of July 1998 to June 1999 from HCIA-Sach's Clinical Pathways Database. Data were analyzed for all patient discharges whose records indicated use of abciximab or tirofiban with a PCI. Results are reported for 3,967 patients. Multivariate analysis was used to control for a wide range of factors (GP IIb/IIIa selection, patient demographics, stent use, insurance type, health conditions, admission information, and hospital characteristics) that may influence the cost of hospitalization. A two-stage sample selection model was used to estimate total costs. The first stage of the analysis utilizes a probit regression to determine the factors associated with the likelihood of receiving abciximab versus tirofiban. The second stage of the analysis examines the factors associated with total hospital costs, while controlling for unobserved factors that may be correlated with the patient's likelihood of receiving abciximab. The mean unadjusted cost per hospitalization, including drug costs, was $10,762 (abciximab $10,813 and tirofiban $10,567). After controlling for high-risk indications and selection bias with the two-stage sample selection model, results indicate there was no significant difference in costs associated with the receipt of abciximab versus tirofiban. However, the results also indicate that the two-stage sample selection model may not be needed (lambda was not statistically significant) hence, the cost equation was reestimated using ordinary least-squares methodology (OLS). In the OLS analysis, receipt of abciximab versus tirofiban was associated with a significant reduction in costs ($470 reduction; P = 0.05). This study uses real-world data to examine the total hospital costs for PCI patients who receive abciximab versus tirofiban. Results of the two-stage sample selection model indicate there is no difference in total hospital costs (including drug costs) between abciximab- and tirofiban-treated patients. If the results of the OLS model are considered, a slight decrease in total hospital costs is observed in abciximab recipients. Cost-containment strategies that focus on component costs may not lead to intended overall cost savings.

Impact of abciximab versus eptifibatide on length of hospital stay for PCI patients.

The purpose of this study is to compare the profile of percutaneous coronary intervention (PCI) patients who receive abciximab versus eptifibatide, as well as to compare the effect of abciximab versus eptifibatide on hospital length of stay. Retrospective data were obtained from HCIA's Clinical Pathways Database on 5,446 coronary angioplasty patients who were administered either abciximab or eptifibatide. Estimation was conducted via a two-stage sample selection model. In the first stage, a probit regression was employed to determine which factors were associated with a higher probability of being administered abciximab versus eptifibatide. In the second stage, a negative binomial model was used to estimate the impact of a wide range of factors (selection of GPIIb/IIIa, patient demographics, insurance provider, health conditions, admission information, and hospital characteristics) on total hospital length of stay, as well as on postprocedural length of stay. After controlling for high-risk indications and other sources of selection bias, results indicate that receipt of abciximab was associated with a significantly shorter length of total hospital stay (0.83 fewer days; P < 0.001) than receipt of eptifibatide. Additionally, receipt of abciximab was found to be associated with a significantly shorter postprocedural hospital length of stay (0.48 fewer days; P = 0.002) compared to receipt of eptifibatide. Results of this study indicate that PCI patients who are administered abciximab versus eptifibatide have a significantly shorter length of hospital stay (both total and postprocedural). This finding is important since hospital length of stay reflects the occurrence of complications and has been found to be directly related to the resources consumed during in-patient management of patients. Cathet Cardiovasc Intervent 2001;53:296-303.

Impact of abciximab versus tirofiban on hospital length of stay for PCI patients.

The purpose of this retrospective study was to examine in a naturalistic setting the effect of abciximab versus tirofiban on hospital length of stay for patients undergoing percutaneous coronary intervention (PCI). Retrospective data were obtained from HCIASach's Clinical Pathways Database on 5,560 PCI patients who were administered either abciximab or tirofiban. Multivariate analysis was used to control for a wide range of factors (GPIIb/IIIa selection, patient demographics, insurance provider, health conditions, admission information, and hospital characteristics) that may influence hospital length of stay. Estimation was conducted via a two-stage sample selection model. After controlling for high-risk indications and sources of selection bias, results indicate that receipt of abciximab was associated with significantly shorter lengths of hospital stays compared to tirofiban (1.01 fewer days; p < 0.001). In a subgroup analysis of patients having an acute myocardial infarction (AMI; n = 2,593), receipt of abciximab was also found to be associated with significantly shorter hospital stays compared to tirofiban (0.60 fewer days; p < 0.001). Results of this study indicate that patients who are administered abciximab versus tirofiban have significantly shorter hospital stays. This reduction in length of stay may imply potential cost offsets for PCI patients who receive abciximab.

A comparison of abciximab use in MCO and non-MCO populations.

OBJECTIVE: To compare abciximab use in managed care organization (MCO) patients and non-MCO patients undergoing coronary angioplasty, specifically (1) the factors influencing abciximab use, (2) the impact of abciximab on hospital length of stay (LOS), and (3) differences in results in MCO and non-MCO patients. STUDY DESIGN: A retrospective observational study based on data from 87 US hospitals on 13,384 angioplasty patients. PATIENTS AND METHODS: Multivariate analysis was used to control for a wide range of factors (patient demographics, health conditions, admission information, and hospital characteristics) that may influence the likelihood of receiving abciximab and hospital length of stay (LOS). Estimation was conducted via a 2-stage sample selection model. RESULTS: Comorbidities, hospital characteristics, and geographic regions influenced abciximab use in MCO and non-MCO populations. In the non-MCO population, women and minority group members were significantly less likely than white male patients to receive abciximab. Both MCO and non-MCO angioplasty patients who were given abciximab had significantly shorter LOSs (0.66 +/- 0.27 fewer days and 0.87 +/- 0.13 fewer days, respectively) than did patients who were not given this drug. CONCLUSIONS: Access to care for MCO and non-MCO populations differed. Non-MCO women and minorities were less likely than non-MCO white men to receive abciximab, but this difference was not observed in the MCO population. After controlling for high-risk indications and selection bias, MCO and non-MCO patients who received abciximab had significantly shorter LOSs than did those who did not receive abciximab. This finding is consistent with the many clinical trials that have observed a reduction in ischemic complications associated with abciximab use.

Shorter hospital stays for angioplasty patients who receive abciximab.

The purpose of this retrospective study is to examine the effect of abciximab treatment on hospital length of stay for patients undergoing angioplasty in a naturalistic setting. Multivariate analysis was used to control for a wide range of factors (patient demographics, insurance provider, health conditions, admission and discharge information, and hospital characteristics) that may influence length of stay. Estimation was conducted on a sample of 13,384 angioplasty patients via a two-stage sample selection model. In addition, the model was re-estimated for a subgroup of 4,800 patients who underwent angioplasty and were also diagnosed with acute myocardial infarction. The study finds that patients in poorer health were more likely to receive abciximab. After adjusting for high-risk indications and selection bias, results also indicate that angioplasty patients (n = 13,384) who are given abciximab have a significantly shorter length of stay (0.89+/-0.12 fewer days) than those patients who did not receive abciximab. In a subgroup analysis of patients who had an acute myocardial infarction (n = 4,800), patients receiving abciximab were also found to have significantly shorter hospital stays (0.54+/-0.26 fewer days) than patients who did not receive abciximab. These results indicate that there are potential economic benefits for hospitals administering abciximab.

Association between abciximab and length of stay in intensive care for patients undergoing percutaneous coronary intervention. A 2-stage econometric model in a naturalistic setting.

OBJECTIVE: To examine the effect of abciximab treatment on intensive care length of stay for patients undergoing percutaneous coronary intervention (PCI). DESIGN AND SETTING: A retrospective study conducted in a naturalistic setting. METHODS: A 2-stage econometric model was used to control for the influence of possible selection bias across categories of patients and for both observable and unobservable factors correlated with each patient's treatment selection and length of stay in intensive care. Multivariate analysis was applied to control for a wide range of factors (patient demographics, insurance provider, health conditions, admission and discharge information, and hospital characteristics) that may influence intensive care length of stay. Retrospective data were obtained from HCIA's Clinical Pathways Database. PARTICIPANTS: Patients (n = 13,364) who were hospitalised in any of 87 hospitals across the US over the period from October 1, 1995 to December 1, 1996. RESULTS: After controlling for high-risk indications and selection bias, results indicated that administration of abciximab was associated with a significantly shorter length of stay in intensive care compared with not administering a GPIIb/IIIa inhibitor (0.45 fewer days; p < or = 0.0001). In a subgroup analysis of patients having an acute myocardial infarction (n = 4793), administration of abciximab was also associated with a significantly shorter intensive care stay (0.27 fewer days; p < 0.0001). CONCLUSION: Results of this study indicate that the administration of abciximab is associated with a reduction in the length of stay in intensive care. This reduction implies potential cost offsets for patients undergoing PCI who receive abciximab.

Trypanosoma cruzi: enhanced alpha-macroglobulin levels correlate with the resistance of BALB/cj mice to acute infection.

Trypanosoma cruzi proteinases are very likely involved in host-cell invasion. Physiological plasma-proteinase inhibitors from the macroglobulin (MG) family, among them alpha-2-macroglobulin (A2M), are found in tissues and in the plasma of mammals. By complexing to all classes of proteinases, MGs inhibit their action on high-molecular-weight substrates. In vitro studies have shown that A2M impairs T. cruzi proteases and, consequently, the parasite's ability to invade host cells and enhances the phagocytic and microbicidal actions of resident macrophages against T. cruzi. To test the hypothesis of a putative "protective" effect for MG, we quantified it in BALB/cj mice during the course of an experimental T. cruzi infection, comparing a posteriori the levels in mice that died with those in animals that survived, which were considered as being susceptible and resistant to the infection, respectively. The results showed that surviving mice showed an increase in plasma concentrations of MG during the first few weeks after the infection, whereas the levels in mice that died during the acute phase did not differ significantly from those in non-infected mice. These findings and the previous in vitro data indicate a role for physiological proteinase inhibitors, particularly alpha-macroglobulins, in resistance to T. cruzi infection, whereby a balance between parasite proteases and host protease inhibitors may be crucial. MG may thus participate in the complex network of reactions involved in the early acute phase of the disease and contribute by conferring to the host an ability to survive the infection.