Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0728731 (prematurity)
 7,134 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Objective. To determine the safety and efficacy of prophylaxis with palivizumab in reducing the incidence of hospitalization because of respiratory syncytial virus (RSV) infection in high-risk infants. Methods. A randomized, double-blind, placebo-controlled trial was conducted at 139 centers in the United States, the United Kingdom, and Canada. During the 1996 to 1997 RSV season, 1502 children with prematurity (</=35 weeks) or bronchopulmonary dysplasia (BPD) were randomized to receive 5 injections of either palivizumab (15 mg/kg) or an equivalent volume of placebo by intramuscular injection every 30 days. The primary endpoint was hospitalization with confirmed RSV infection. Children were followed for 150 days (30 days from the last injection). Those with hospitalization as a result of RSV infection were evaluated for total number of days in the hospital, total days with increased supplemental oxygen, total days with moderate or severe lower respiratory tract illness, and incidence and total days of intensive care and mechanical ventilation. The incidence of hospitalization for respiratory illness not caused by RSV and the incidence of otitis media were also evaluated. The placebo and palivizumab groups were balanced at entry for demographics and RSV risk factors. Ninety-nine percent of children in both groups completed the protocol and ~93% received all five scheduled injections. Results. Palivizumab prophylaxis resulted in a 55% reduction in hospitalization as a result of RSV (10.6% placebo vs 4.8% palivizumab). Children with prematurity but without BPD had a 78% reduction in RSV hospitalization (8.1% vs 1.8%); children with BPD had a 39% reduction (12.8% vs 7.9%). When gender, entry age, entry weight, BPD, and gestational age were included in a logistic regression model, the effect of prophylaxis with palivizumab remained statistically significant. The palivizumab group had proportionally fewer total RSV hospital days, fewer RSV hospital days with increased oxygen, fewer RSV hospital days with a moderate/severe lower respiratory tract illness, and a lower incidence of intensive care unit admission. Palivizumab was safe and well tolerated. No significant differences were observed in reported adverse events between the two groups. Few children discontinued injections for related adverse events (0.3%). Reactions at the site of injection were uncommon (1.8% placebo vs 2.7% palivizumab); the most frequent reaction was mild and transient erythema. Mild or moderate elevations of aspartate aminotransferase occurred in 1.6% of placebo recipients and 3.6% of palivizumab recipients; for alanine aminotransferase these percentages were 2.0% and 2.3%, respectively. Hepatic and renal adverse events related to the study drug were similar in the two groups. Conclusions. Monthly intramuscular administration of palivizumab is safe and effective for prevention of serious RSV illness in premature children and those with BPD.
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PMID:Palivizumab, a Humanized Respiratory Syncytial Virus Monoclonal Antibody, Reduces Hospitalization From Respiratory Syncytial Virus Infection in High-risk Infants. 972 60

Respiratory syncytial virus (RSV) is a recognised cause of lower respiratory tract infection in infants and young children. It causes severe respiratory disease in preterm infants with or without chronic lung disease. This study, conducted at Waterford Regional Hospital, evaluates the incidence of RSV infection in hospitalised children, its seasonal variation, and effectiveness of its prevention. Thirty eight percent of admitted children with bronchiolitis were RSV positive in the year 1999 November to March is the peak season for this infection. A highly selected group of 7 preterm children with or without chronic lung disease received Palivizumab prophylaxis. Not one of them acquired RSV infection. The high cost of Palivizumab was the main factor for its restricted use. Palivizumab was found to be effective in preventing RSV infection in our study. Since we had a small number of patients, further studies are needed for its economic and judicious use. Respiratory syncytial virus (RSV) is virulent easily transmissible and the most common cause of lower respiratory tract disease in children of less than 2 years of age. Up to 98% of children attending day care will be infected in single RSV season. Between 0.5% and 3.2% of children with RSV infection require Hospitalisation. Approximately 90,000 hospital admissions and 4500 deaths per year were reported in United States. In Ireland 2807 patients were admitted with Bronchiolitis in 1998. Major risk factors for hospitalisation due to RSV are Prematurity, chronic lung disease, congenital heart disease, compromised immunity and age younger then 6 weeks in otherwise healthy children. No effective treatment of RSV positive bronchiolitis beside supportive care in the form of adequate nutrition and oxygen therapy is available. Antiviral therapies such as Ribavirin has not been proved to be effective in RSV infection. Bronchodilators show variable results. Corticosteroids were not found effective. There is no effective vaccine available as yet. There is no proven method for active immunity. Various immunoglobulins are available for acquiring passive immunity against RSV infection. PREVENT study group in Jan. 1997 showed intravenous immunoglobulin (RSV- IGIV) use in reducing 41% to 63% hospitalisation in RSV patients. But RSV-IGIV was not licensed outside the United States because of risk of transmission of blood borne products, difficulty in administration ie. intravenous access, large fluid volume (15 ml/kg), high protein load (750 mg/kg), shortage of supply and need to postpone live vaccine (eg. MMR, varicella). monoclonal antibody Palivizumab was developed for prophylaxis against RSV infection. Clinical safety and efficacy of Palivizumab were demonstrated in IMpact trial published in Sept. 1998. Reduction in hospitalisation up to 55% was noted in this study. It was a pivotal randomised, double blind, placebo controlled phase 3 study conducted in 139 centres throughout Canada, United States and United Kingdom. We looked at our experience in patients admitted with bronchiolitis in Waterford Regional Hospital. We described the outcome of carefully selected Seven children of high risk group for Palivizumab prophylaxis. Its clinical Implications and cost effectiveness was evaluated in this study.
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PMID:Prophylaxis in RSV infection (Palivizumab)--is it worthwhile? 1120 17

(1) RSV infection, the main cause of bronchiolitis, can necessitate hospitalisation, especially of infants at risk, i.e. those with a history of prematurity or bronchodysplasia. No drug prevention has been available. (2) Palivizumab, a monoclonal antibody directed against respiratory syncytial virus (RSV), is now marketed for preventing respiratory tract infection by RSV in certain infants. (3) The evaluation dossier barely answers the questions raised by the use of this drug. (4) The results of six trials suggest that the optimal dose is 15 mg/kg palivizumab by monthly injection throughout the seasonal epidemic period. (5) A double-blind trial in 1 502 infants either aged less than 6 months and born prematurely (35 weeks of gestation or earlier), or aged under 2 years with a history of bronchopulmonary dysplasia, has shown that, relative to a placebo, palivizumab reduces the hospitalisation rates by 5% in absolute values. It does not influence mortality or the need for mechanical ventilation. (6) Given the lack of relevant trials, we do not know if palivizumab is effective in infants with immunodeficiency or congenital heart diseases. We do not know, either, whether the definition of groups at risk used in the only relevant trial is appropriate. (7) No serious adverse effects attributable to palivizumab were reported in clinical trials. (8) Treatment with palivizumab is costly.
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PMID:Palivizumab in prevention of bronchiolitis: new preparation. Moderate efficacy in some infants. 1147 94

Epidemiological data, especially population-based data, on respiratory syncytial virus (RSV)-related hospitalizations in Germany have been lacking to date. Since Palivizumab (Synagis, Abbott, USA) is already available and new vaccines for active immunization are under development, these data are urgently needed. From July 1996 to June 1999, nasopharyngeal aspirates of children hospitalized in Kiel with an acute respiratory tract infection were tested by multiplex reverse transcriptase polymerase chain reaction. Of 1,241 patients, 150 (12.1%) were RSV positive. RSV was the predominant pathogen detected through the end of the second year. In 37 (25%) children an underlying condition was present. For the city of Kiel and close surroundings, the cumulative incidence of RSV-positive hospitalizations in infants was 1,214/10(5) (725/10(5) in children less than 2 years). For those children less than 2 years old born with a gestational age of less than 32 weeks or 32-37 weeks, the cumulative incidence was 2,025/10(5) and 1,202/10(5), respectively (dose-effect response). For the group less than 32 weeks of age, bronchopulmonary dysplasia (BPD) as an underlying condition carried a relative risk of 17.8. The RSV season began between the end of September and January and ended between March and July. The population-based incidence of RSV-positive hospitalizations in Kiel is close to that reported from the UK and Scandinavia. Throughout Germany, approximately 10.000 RSV-related hospitalizations in infants can be expected annually. Prematurity is an effect modifier and BPD a strong risk factor for RSV-positive hospitalization in population-based studies. There is considerable variation in the start and end of the yearly epidemic.
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PMID:Incidence of respiratory syncytial virus-positive hospitalizations in Germany. 1156

Respiratory syncytial virus remains a significant cause of severe lower respiratory tract disease in children. The risk of serious RSV illness is highest among children with prematurity, chronic lung disease and congenital heart disease. No effective vaccine and anti-viral agents have been obtained even now. Therefore, conservative therapy including respiratory aid has been a principal therapy for serious RSV disease. Recently, monthly intramuscular administration of humanized anti-RSV monoclonal antibody(palivizumab) was introduced in clinical fields in USA and Europe. Palivizumab prophylaxis has appeared to be safe and effective for prevention of serious RSV illness in premature children and those with bronchopulmonary dysplasia.
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PMID:[Humanized respiratory syncytial virus monoclonal antibody]. 1190 63

We evaluated the incidence of readmission with respiratory syncytial virus (RSV) infection among the graduates of a regional Neonatal Intensive Care Unit (NICU), and characterized those who were rehospitalized. These data were used as a predictive tool to estimate the number of babies likely to suffer readmission with RSV for the year 2000 cohort. Using the published efficacies of palivizumab, the costs and benefits of protecting this cohort were assessed. Retrospective analysis of 2,507 NICU inpatient records from January 1, 1994-December 31, 1999 from the Royal Maternity Hospital, Belfast, were compared with data on positive RSV samples from 1,790 patients between January 1, 1995-December 31, 1999 from the Northern Ireland Regional Virus Laboratory. The analysis yielded 136 (7.6%) ex-NICU patients among the positive RSV samples over this 5-year period. Characteristic seasonal peaks of RSV infection with interseasonal variability were observed. Of those readmitted, 86.9% were hospitalized with RSV before their first birthday. A calculated readmission rate of 5.4% for all NICU graduates, and 6.4% for those <or=35 weeks, was found, leading to an expectation of 36 readmissions from the 668 NICU graduates in the year 2000 over the next 1-2 years, 20 of whom would be <or=35 weeks and 12 would be <or=32 weeks. A cost of pound 1.3 million would be required to protect the <or=35-week year 2000 cohort and prevent 11 readmissions. This equals pound 120,000 per admission prevented, or 28.2 patients treated to prevent 1 readmission. A readmission rate of 6.4% may differ from other studies, as it represents analysis of a greater number of RSV seasons. Using economic arguments alone, the cost of routine administration of Palivizumab to ex-NICU <or=35-week infants is prohibitive. A selective practice of immunizing those with chronic lung disease with a background of extreme prematurity over the November to March RSV season may be more cost-effective.
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PMID:Readmission with respiratory syncytial virus (RSV) infection among graduates from a neonatal intensive care unit. 1220 67

Infection with respiratory syncytial virus is frequent but most often benign. The serious forms of the illness, which make necessary hospitalisation or care in an intensive Care Unit, appear in infants of less than 6 weeks and especially in those with underlying pathologies, prematurity, congenital cardiopathies or chronic respiratory illnesses. Palivizumab (SYNAGIS) is mouse humanized monoclonal antibody which is used for prevention by monthly injections before and during the epidemic period. In a pivotal study performed on 1502 infants aged less than 6 months and former prematures of less than 36 weeks gestational age (GA) or aged less than 2 years and preventing a bronchopulmonary dysplasia, 1002 infants received 5 monthly injections, compared with 500 infants treated with placebo. There was a significant reduction of 55% risk of hospitalisation with VRS infections in the treated group, but no significant reduction in the number of stays in intensive care or deaths. The recommendation in France now is to use SYNAGIS in children aged less than 6 months, born with or GA of less then 32 weeks or aged less than 2 years and presenting a bronchopulmonary dysplasia. Questions remain on the cost-benefit ratio of this treatment and the favourable effects of this treatment in children who carry other chronic pulmonary or cardiac pathologies.
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PMID:[Prevention of respiratory syncytial virus infection by SYNAGIS (palivizumab)]. 1257 22

Palivizumab (Synagi) is a humanized monoclonal antibody that provides immunoprophylaxis against serious lower respiratory tract infections (LRTIs) caused by respiratory syncytial virus (RSV). RSV is the leading cause of hospitalization for LRTIs in infants, causing winter- or wet-season epidemics. In two double-blind, placebo-controlled trials, intramuscular palivizumab 15 mg/kg every 30 days for 5 months significantly reduced RSV-related hospitalizations by 55% in 1502 infants with prematurity and/or bronchopulmonary dysplasia/chronic lung disease (BPD/CLD) and by 45% in 1287 infants with hemodynamically significant congenital heart disease (HSCHD). Reductions were statistically significant versus placebo in infants with BPD/CLD, with all degrees of prematurity, and with acyanotic/other heart disease. Palivizumab was generally well tolerated, with < or =1.9% of recipients discontinuing treatment for tolerability reasons. In placebo-controlled trials, the most common potentially drug-related adverse events were fever, nervousness, injection-site reactions, and diarrhea. Drug-related events occurred in 7.2-11% of palivizumab recipients in controlled trials (vs 6.9-10% with placebo) and 0-7.9% in open-label trials. Very few serious potentially drug-related adverse events occurred in clinical trials; four occurred in 2 of 285 patients in one open-label trial. No significant anti-palivizumab antibodies developed during palivizumab use. Palivizumab trough serum concentrations were below the recommended 40 microg/mL in about 33% and up to 14% of children prior to their second and third palivizumab injections. In pharmacoeconomic studies, the cost of palivizumab per hospitalization averted was generally lowest in the highest-risk infants. Drug cost was generally the most influential factor in sensitivity analyses. In conclusion, prophylaxis with palivizumab significantly reduces the incidence of RSV-related hospitalization relative to placebo and is generally well tolerated in high-risk infants aged <2 years, including those with prematurity and BPD/CLD or HSCHD, which are risk factors for early or serious RSV infection. Palivizumab is approved for use in these patients. Other high-risk infants in whom palivizumab has not been formally assessed, such as those with immunodeficiency, cystic fibrosis, or location-specific risk factors (including extended hospital stays) might potentially benefit from palivizumab. The use of palivizumab in these other high-risk populations is likely to be determined as much by pharmacoeconomic considerations as by efficacy outcomes.
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PMID:Palivizumab: a review of its use as prophylaxis for serious respiratory syncytial virus infection. 1517 Mar 64

Palivizumab is a monocloncal antibody used for prevention of respiratory syncytial virus infection. This study reviews the literature regarding evidence of efficacy, safety and cost-effectiveness. The only randomised controlled trial into efficacy of palivizumab in preterm infants demonstrates clinical benefit and suggests a favourable safety profile. Further studies, however, do not provide evidence that costs saved by the reduction in hospitalisation would outweigh actual costs of the immunization for the recommended indications. There is considerable controversy over which groups of patients to include in immunization programs and analyses of cost-effectiveness are complicated by the fact that incidence of RSV infection, rates of hospitalisation and ventilation, health care costs and economic resources are variable among different health care systems and settings. Studies of cost-analysis, despite their implicit weaknesses, do not currently support the widespread use of palivizumab. In the absence of high quality cost-benefit analysis, we currently only recommend the use of palivizumab in infants at high risk of severe bronchiolitis, such as those with active chronic lung disease of prematurity. To illustrate current practice we also present data from an audit of the use of palivizumab in a regional centre in the North-East of England.
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PMID:Passive immunisation of preterm infants with palivizumab against RSV infection. 1623 60

Morbidity and mortality due to vaccine-preventable diseases are high among persons with underlying medical conditions. Thus, inactivated influenza and pneumococcal polysaccharide vaccines are recommended for individuals with cardiac disease, diabetes mellitus, chronic obstructive pulmonary disease, immunosuppression, and other chronic illnesses. Inactivated influenza vaccine is recommended for pregnant women and for persons with asthma and neuromuscular disease. Palivizumab, a respiratory syncytial virus immunoglobulin preparation, is recommended for certain infants with prematurity and chronic lung disease. Health care workers are at high risk for acquiring and transmitting hepatitis B, pertussis, measles, varicella, and influenza; hence, vaccination against these diseases is recommended. A signed declination is recommended for health care workers who refuse influenza vaccination.
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PMID:Vaccines for persons at high risk, 2007. 1727 Jan 9


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