Clotting factor product administration and same-day occurrence of thrombotic events, as recorded in a large healthcare database during 2008-2013.

BACKGROUND: Thrombotic events (TEs) are serious adverse events that can occur following administration of clotting factors (CFs). OBJECTIVES: To evaluate occurrence of same-day TEs for different CF products and potential risk factors. METHODS: A retrospective cohort study of individuals exposed to CF products during 2008-2013 was conducted using a large commercial insurance database. CF products were identified by procedure codes, and TEs were ascertained via diagnosis codes. Crude same-day TE rates (per 1000 persons exposed) were estimated overall and by congenital factor deficiency (CFD) status, CF products, age and gender. Multivariable logistic regression analyses were used to control for confounding. Laboratory analysis was used to compare the procoagulant activities of FIX products. RESULTS: Of 3801 individuals exposed to CFs, 117 (30.8 per 1000) had same-day TEs recorded. The crude same-day TE rate was higher for CF users without CFD, 70.2 (102 of 1452), as compared with those with CFD, 6.4 (15 of 2349) (RR, 11.0; 95% CI, 6.4-18.9). For individuals without CFD, a significantly increased same-day TE risk was identified for factor IX complex (OR, 6.92; 95% CI, 3.11-15.40), factor VIIa (OR, 9.42; 95% CI, 4.99-17.78) and other products when compared with fibrin sealant. An increased risk of a TE was found with older age (≥ 45 years), history of TEs and underlying health conditions. The laboratory identified elevated procoagulant activity in Profilnine(®) and Benefix(®) . CONCLUSIONS: The study shows an increased same-day TE risk for CF users without CFD and suggests substantial off-label CF use. The study findings also show elevated same-day TE rates for different CF products and suggest the importance of product properties and patient factors.

Febrile non-haemolytic transfusion reaction occurrence and potential risk factors among the U.S. elderly transfused in the inpatient setting, as recorded in Medicare databases during 2011-2012.

BACKGROUND AND OBJECTIVES: Febrile non-haemolytic transfusion reaction (FNHTR) is an acute transfusion complication resulting in fever, chills and/or rigours. Study's objective was to assess FNHTR occurrence and potential risk factors among inpatient U.S. elderly Medicare beneficiaries, ages 65 and older, during 2011-2012. MATERIALS AND METHODS: Our retrospective claims-based study utilized large Medicare administrative databases. FNHTR was ascertained via ICD-9-CM diagnosis code, and transfusions were identified by recorded procedure and revenue centre codes. The study ascertained FNHTR rates among the inpatient elderly overall and by age, gender, race, blood components and units transfused. Multivariate logistic regression analyses were used to assess potential risk factors. RESULTS: Among 4 336 338 inpatient transfusion stays for elderly during 2011-2012, 2517 had FNHTR diagnosis recorded, an overall rate of 58.0 per 100,000 stays. FNHTR rates (per 100,000 stays) varied by age, gender, number of units and blood components transfused. FNHTR rates were substantially higher for RBCs- and platelets-containing transfusions as compared to plasma only. Significantly higher odds of FNHTR were identified with greater number of units transfused (P < 0.01), for females vs. males (OR = 1.15, 95% CI 1.04-1.27), and with 1-year histories of transfusion (OR = 1.25, 95% CI 1.10-1.42), lymphoma (OR = 1.22, 95% CI 1.02-1.46), leukaemia (OR = 1.90, 95% CI 1.56-2.31) and other diseases. CONCLUSIONS: Our study shows increased FNHTR occurrence among elderly with greater number of units and with RBCs- and platelets-containing transfusions, suggesting need to evaluate effectiveness of prestorage leucoreduction in elderly. The study also suggests importance of prior recipient alloimmunization and underlying health conditions in the development of FNHTR.

Transfusion-associated circulatory overload (TACO) and potential risk factors among the inpatient US elderly as recorded in Medicare administrative databases during 2011.

BACKGROUND AND OBJECTIVES: Transfusion-associated circulatory overload (TACO) is a serious transfusion complication resulting in respiratory distress. The study's objective was to assess TACO occurrence and potential risk factors among elderly Medicare beneficiaries (ages 65 and older) in the inpatient setting during 2011. MATERIALS AND METHODS: This retrospective claims-based study utilized Medicare administrative databases in coordination with Centers for Medicare & Medicaid Services. Transfusions were identified by recorded procedure and revenue centre codes, while TACO was ascertained via ICD-9-CM diagnosis code. We evaluated TACO diagnosis code rates overall and by age, gender, race, number of units and blood components transfused. Multivariate logistic regression analyses were used to estimate odds ratios (ORs) and 95% confidence intervals (CIs). RESULTS: Among 2,147,038 inpatient transfusion stays for elderly in 2011, 1340 had TACO diagnosis code, overall rate of 62·4 per 100,000 stays. TACO rates increased significantly with age and units transfused (P < 0·0001). After adjustment for confounding, significantly higher odds of TACO were found for women vs. men (OR = 1·40, 95% CI 1·26-1·60), White people vs. non-White people (OR = 1·38, 95% CI 1·20-1·62) and persons with congestive heart failure (OR = 1·61, 95% CI 1·44-1·88), chronic pulmonary disease (OR = 1·19, 95% CI 1·08-1·32) and different anaemias. CONCLUSION: Our study identified largest number of potential TACO cases to date and showed a substantial increase in TACO occurrence with age and number of units transfused. The study suggested increased TACO risk in elderly with congestive heart failure, chronic pulmonary disease and anaemias. Overall, study shows importance of large administrative databases as an additional epidemiological tool.

Antihypertensive efficacy of amlodipine and losartan after two 'missed' doses in patients with mild to moderate essential hypertension.

We compared the effects of amlodipine (5-10 mg, n=94) and losartan (50-100 mg, n=94) on the lowering of blood pressure (BP) at steady state and after two missed doses, as well as on tolerability. This was a randomized, double-blind study of 12 weeks of active treatment followed by 2 days of placebo treatment. Twenty-four-hour ambulatory blood pressure monitoring and office BP measurements were performed at baseline, week 12 and after the 2-day drug holiday. After 12 weeks, amlodipine was significantly more effective than losartan in reducing both 24-h systolic blood pressure (SBP) (-18.0 versus -10.8 mmHg) and diastolic blood pressure (DBP) (-10.6 versus -8.0 mmHg). While mean SBP and DBP for both treatments increased comparably during the drug holiday, BP values remained significantly lower than baseline for both treatments. The superior BP-lowering effect of amlodipine compared with losartan was maintained during the drug holiday.

Surveillance for influenza--United States, 1994-95, 1995-96, and 1996-97 seasons.

PROBLEM/CONDITION: Influenza epidemics occur nearly every year during the winter months and are responsible for substantial morbidity and mortality in the United States, including an average of approximately 114,000 hospitalizations and 20,000 deaths per year. REPORTING PERIOD: This report summarizes U.S. influenza surveillance data from October 1994 through May 1997, from both active and passive surveillance systems. DESCRIPTION OF SYSTEM: During the period covered, CDC received weekly reports from October through May from a) state and territorial epidemiologists on estimates of local influenza activity, b) approximately 140 sentinel physicians on their total number of patient visits and the number of cases of influenza-like illness (ILI), and c) approximately 70 World Health Organization (WHO) collaborating laboratories in the United States on weekly influenza virus isolations. WHO collaborating laboratories also submitted influenza isolates to CDC for antigenic analysis. Throughout the year, vital statistics offices in 121 cities reported deaths related to pneumonia and influenza (P&I) weekly, providing a measure of the impact of influenza on mortality. RESULTS: During the 1994-95 influenza season, 25 state epidemiologists reported regional or widespread activity at the peak of the season. Cases of ILI reported by sentinel physicians exceeded baseline levels for 4 weeks, peaking at 5%. Influenza A(H3N2) was the most frequently isolated influenza virus type/subtype. The longest period of sustained excess mortality was 5 consecutive weeks, when the percentage of deaths attributed to P&I exceeded the epidemic threshold, peaking at 7.6%. During the 1995-96 season, 33 state epidemiologists reported regional or widespread activity at the peak of the season. ILI cases exceeded baseline levels for 5 weeks, peaking at 7%. Influenza A(H1N1) viruses predominated, although influenza A(H3N2) and influenza B viruses also were identified throughout the United States. P&I mortality exceeded the epidemic threshold for 6 consecutive weeks, peaking at 8.2%. The 1996-97 season was the most severe of the three seasons summarized in this report. Thirty-nine state epidemiologists reported regional or widespread activity at the peak of the season. ILI reports exceeded baseline levels for 5 consecutive weeks, peaking at 7%. The proportion of respiratory specimens positive for influenza peaked at 34%, with influenza A(H3N2) viruses predominating. Influenza B viruses were identified throughout the United States, but only one influenza A(H1N1) virus isolate was reported overall. The proportion of deaths attributed to P&I exceeded the epidemic threshold for 10 consecutive weeks, peaking at 9.1%. INTERPRETATION: Influenza A(H1N1), A(H3N2), and B viruses circulated during 1994-1997. Local surveillance data are important because of geographic and temporal differences in the circulation of influenza types/subtypes. PUBLIC HEALTH ACTIONS: CDC conducts active national surveillance annually from October through May for influenza to detect the emergence and spread of influenza virus variants and monitor the impact of influenza-related morbidity and mortality. Surveillance data are provided weekly throughout the influenza season to public health officials, WHO, and health-care providers and can be used to guide prevention and control activities, vaccine strain selection, and patient care.

Influenza and the rates of hospitalization for respiratory disease among infants and young children.

BACKGROUND: Young children may be at increased risk for serious complications from influenzavirus infection. However, in population-based studies it has been difficult to separate the effects of influenzavirus from those of respiratory syncytial virus. Respiratory syncytial virus often circulates with influenzaviruses and is the most frequent cause of hospitalization for lower respiratory tract infections in infants and young children. We studied the rates of hospitalization for acute respiratory-disease among infants and children during periods when the circulation of influenzaviruses predominated over the circulation of respiratory syncytial virus. METHODS: For each season from October to May during the period from 1992 to 1997, we used local viral surveillance data to define periods in Washington State and northern California when the circulation of influenzaviruses predominated over that of respiratory syncytial virus. We calculated the rates of hospitalization for acute respiratory disease, excess rates attributable to influenzavirus, and incidence-rate ratios for all infants and children younger than 18 years of age who were enrolled in either the Kaiser Permanente Medical Care Program of Northern California or the Group Health Cooperative of Puget Sound. RESULTS: The rates of hospitalization for acute respiratory disease among children who did not have conditions that put them at high risk for complications of influenza (e.g., asthma, cardiovascular diseases, or premature birth) and who were younger than two years of age were 231 per 100,000 person-months at Northern California Kaiser sites (from 1993 to 1997) and 193 per 100,000 person-months at Group Health Cooperative sites (from 1992 to 1997). These rates were approximately 12 times as high as the rates among children without high-risk conditions who were 5 to 17 years of age (19 per 100,000 person-months at Northern California Kaiser sites and 16 per 100,000 person-months at Group Health Cooperative sites) and approached the rates among children with chronic health conditions who were 5 to 17 years of age (386 per 100,000 person-months and 216 per 100,000 person-months, respectively). CONCLUSIONS: Infants and young children without chronic or serious medical conditions are at increased risk for hospitalization during influenza seasons. Routine influenza vaccination should be considered in these children.

Case-control study of risk factors for avian influenza A (H5N1) disease, Hong Kong, 1997.

In May 1997, a 3-year-old boy in Hong Kong died of a respiratory illness related to influenza A (H5N1) virus infection, the first known human case of disease from this virus. An additional 17 cases followed in November and December. A case-control study of 15 of these patients hospitalized for influenza A (H5N1) disease was conducted using controls matched by age, sex, and neighborhood to determine risk factors for disease. Exposure to live poultry (by visiting either a retail poultry stall or a market selling live poultry) in the week before illness began was significantly associated with H5N1 disease (64% of cases vs. 29% of controls, odds ratio, 4.5, P=.045). By contrast, travel, eating or preparing poultry products, recent exposure to persons with respiratory illness, including persons with known influenza A (H5N1) infection, were not associated with H5N1 disease.

Postlicensure effectiveness of varicella vaccine during an outbreak in a child care center.

CONTEXT: Because lyophilized varicella vaccine must be stored frozen at -15 degrees C or less (> or = 5 degrees F) and administered within 30 minutes after reconstitution, the potential exists for decreased vaccine effectiveness when the vaccine is used under field conditions. OBJECTIVES: To describe an outbreak of varicella in a child care center and to determine postlicensure effectiveness of varicella vaccine. DESIGN: Retrospective cohort study. SETTING: A child care center in DeKalb County, Georgia, in 1996. PARTICIPANTS: Of the 184 children registered in the child care center, 148 were eligible for the study based on absence of history of varicella before January 1, 1996. MAIN OUTCOME MEASURES: Data on disease status, severity and impact of disease, and risk factors for varicella and for vaccine failure were obtained from parents and their children's pediatricians. Varicella vaccine effectiveness was calculated among children aged 12 months or older (eligible for vaccination) using the cohort method. RESULTS: The outbreak started on January 17, 1996, and lasted 15 weeks. Of the 148 eligible children, 81 (55%) developed varicella. Cases among children younger than 12 months (n =7) were more severe than cases among older children. Varicella occurred in 9 (14%) of 66 vaccinated children and 72 (88%) of 82 unvaccinated children. Varicella was less severe and resulted in fewer days of absence from the child care center among vaccinated compared with unvaccinated cases. Varicella vaccine effectiveness against all forms of disease was 86% (95% confidence interval [CI], 73%-92%), and against moderate-to-severe varicella disease it was 100% (95% CI, 96%-100%). Vaccinated children with asthma or other reactive airway diseases were 7.1 times more likely to have varicella than were vaccinated children without reactive airway diseases (95% CI, 2.4-21.3). CONCLUSIONS: Varicella vaccine administered under routine conditions in physicians' offices was highly effective in preventing varicella in an outbreak characterized by intense exposure. The role of asthma and other reactive airway diseases as risk factors for varicella disease and vaccine failure deserves to be investigated further.

Poliomyelitis in Angola: current status and implications for poliovirus eradication in Southern Africa.

As part of emergency assistance to the Ministry of Health (MOH), national surveillance data for poliomyelitis and charts of cases at the national rehabilitation hospital were reviewed. Poliomyelitis patients admitted to Angola's main pediatric hospital were examined. A mean of 86 cases of poliomyelitis/year were reported in Angola during 1989-1994. Review of records from non-MOH sources uncovered another 74 cases, primarily from areas outside governmental control. Hospital chart reviews revealed that 80% of the cases were children <3 years of age, mainly unvaccinated. Molecular analyses of isolates from cases in Luanda and at the Angola-Namibia border suggest that these isolates are closely related and that > or = 2 strains of wild poliovirus type 1 are circulating currently in Angola. This investigation confirms that poliomyelitis has remained endemic in Angola since independence in 1975. It affects primarily young and unvaccinated children. Control of poliomyelitis in Angola is essential to expand the polio-free zone in southern Africa.

Tetanus surveillance--United States, 1991-1994.

PROBLEM/CONDITION: Despite the widespread availability of a safe and effective vaccine against tetanus, 201 cases of the disease were reported during 1991-1994. Of patients with known illness outcome, the case-fatality rate was 25%. REPORTING PERIOD COVERED: 1991-1994. DESCRIPTION OF SYSTEM: Physician-diagnosed cases of tetanus are reported to local and state health departments, the latter of which reports these cases on a weekly basis to CDC's National Notifiable Disease Surveillance System. Since 1965, state health departments also have submitted supplemental clinical and epidemiologic information to CDC's National Immunization Program. RESULTS: During 1991-1994, 201 cases of tetanus were reported from 40 states, for an average annual incidence of 0.02 cases per 100,000 population. Of the 188 patients for whom age was known, 101 (54%) were aged > or = 60 years and 10 (5%) were aged < 20 years. No cases of neonatal tetanus were reported. Among adults, the risk for tetanus increased with age; the risk for persons aged > or = 80 years was more than 10 times greater than the risk for persons aged 20-29 years. All deaths occurred among persons aged > or = 30 years. The case-fatality rate (overall: 25%) increased with age, from 11% in persons aged 30-49 years to 54% in persons aged > or = 80 years. Only 12% of all patients were reported to have received a primary series of tetanus toxoid before onset of illness. For 77% of patients, tetanus occurred after an acute injury was sustained. Of patients who obtained medical care for their injury, only 43% received tetanus toxoid as part of wound prophylaxis. INTERPRETATION: The epidemiology of reported tetanus in the United States during 1991-1994 was similar to that during the 1980s. Tetanus continued to be a severe disease primarily of older adults who were unvaccinated or inadequately vaccinated. Most tetanus cases occurred after an acute injury was sustained, emphasizing the need for appropriate wound management. ACTIONS TAKEN: In addition to decennial booster doses of tetanus-diphtheria toxoid during adult life, the Advisory Committee on Immunization Practices (ACIP) recommends vaccination visits for adolescents at age 11-12 years and for adults at age 50 years to enable health-care providers to review vaccination histories and administer any needed vaccine. Full implementation of the ACIP recommendations should virtually eliminate the remaining tetanus burden in the United States.

Exudative pharyngitis possibly due to Corynebacterium pseudodiphtheriticum, a new challenge in the differential diagnosis of diphtheria.

Corynebacterium pseudodiphtheriticum has rarely been reported to cause disease in humans, despite its common presence in the flora of the upper respiratory tract. We report here a case of exudative pharyngitis with pseudomembrane possibly caused by C. pseudodiphtheriticum in a 4-year-old girl. The case initially triggered clinical and laboratory suspicion of diphtheria. Because C. pseudodiphtheriticum can be easily confused with Corynebacterium diphtheriae in Gram stain, clarification of its role in the pathogenesis of exudative pharyngitis in otherwise healthy persons is of public health importance. Simple and rapid screening tests to differentiate C. pseudodiphtheriticum from C. diphtheriae should be performed to prevent unnecessary concern in the community and unnecessary outbreak control measures.

Large outbreak of pertussis among young children in Chicago, 1993: investigation of potential contributing factors and estimation of vaccine effectiveness.

BACKGROUND: An outbreak of pertussis from July, 1993, to April, 1994, in Chicago was investigated to identify potential contributing factors. METHODS: Surveillance was enhanced to identify cases. Information from a vaccination coverage survey was used to define a retrospective cohort to estimate vaccine effectiveness of three or more doses of pertussis vaccine. RESULTS: The median age of 218 reported cases was 8 months, 46% had Hispanic surnames and cases were clustered geographically. Vaccination status was known for 173 of 191 (91%) children younger than 6 years of age. Of these 173, 90 (52%) were younger than 7 months, and 35 (20%) children at least 7 months of age had received fewer than 3 doses of pertussis vaccine. Pertussis vaccine effectiveness was 76% (95% confidence interval, 29 to 92). CONCLUSIONS: The limited ability of the current pertussis vaccination schedule to protect young infants accounted for 52% of cases, primary vaccine failure accounted for 28% of cases and failure to vaccinate children on time accounted for 20% of cases in young children. Low vaccine effectiveness did not appear to be a contributing factor.

Risk factors for pertussis in young infants during an outbreak in Chicago in 1993.

Because young infants are at highest risk for severe pertussis and death and are also too young to have received the minimal protective series of three doses of diphtheria-tetanus-pertussis (DTP) vaccine, we conducted a matched case-control study to assess risk factors for pertussis among young infants during a pertussis outbreak in Chicago in 1993. We enrolled 39 cases < 7 months of age from a single teaching hospital and 96 controls, individually matched for age, from the well-child clinic at the same hospital. Demographic characteristics, immunization status, and opportunities for disease exposure were analyzed by means of conditional logistic regression. Cases and controls were similarly up to date with their DTP vaccinations (87% and 89%, respectively). Infants of adolescent mothers (matched odds ratio [OR], 6.4; 95% confidence interval [CI], 1.3-41.4) and infants of mothers who suffered > or = 7 days of cough during the child's incubation period (matched OR, 12.0; 95% CI, 1.4 to infinity) were significantly more likely to have pertussis. Young mothers and mothers with a cough lasting > or = 7 days may be an important source of pertussis infection for their young infants.

Vaccine-associated paralytic poliomyelitis in the United States: no evidence of elevated risk after simultaneous intramuscular injections of vaccine.

During the past 30 years, Romania reported rates of vaccine-associated paralytic poliomyelitis (VAPP) approximately 10-fold higher than in the United States. The elevated VAPP risk was largely caused by multiple intramuscular (im) injections with antibiotics given within 30 days of onset of paralysis. Because it is not known whether im injections contribute to the VAPP risk in the United States, we examined VAPP cases reported since 1980. We reviewed injection histories of VAPP cases reported to the Centers for Disease Control and Prevention from 1980 to 1993: with vaccines for 1980 to 1987; and for all substances for 1988 to 1993. Rates of VAPP by number of im injections with vaccines were calculated from 1988 to 1993 with estimated vaccine coverage data from the National Health Interview Survey. From 1980 to 1993 a total of 119 cases of poliomyelitis were reported to the Centers for Disease Control and Prevention. Of these, 87 (73%) were vaccine-associated and immunologically normal: 41 were oral polio vaccine (OPV) recipient cases; 40 were OPV contact cases; and 6 were community-acquired cases. A history of im injections in the 45 days before onset of paralysis was obtained from 28 (72%) of 39 recipient cases reported from 1980 to 1993 for which dates of paralysis onset could be determined and from 1 (8%) of 13 contact cases reported from 1988 to 1993. With one exception all substances administered intramuscularly were routine childhood vaccines. No clustering of im injections in the "high risk" windows, 0 to 3 and 8 to 21 days before onset of paralysis, was observed.(ABSTRACT TRUNCATED AT 250 WORDS)