Rotavirus live, oral, pentavalent vaccine.


BACKGROUND:On February 3, 2006, the US Food and Drug Administration (FDA) approved a live, oral, pentavalent (G1-G4, P1[8]) human-bovine reassortant rotavirus vaccine for the prevention of rotavirus gastroenteritis (RVGE) in infants in the United States. The Advisory Committee of Immunization Practices of the Centers for Disease Control and Prevention (CDC) and the American Academy of Pediatrics (AAP) recommended routine immunization of infants using 3 doses of the oral pentavalent rotavirus vaccine (PRV) at 8, 12, and 24 months of age, with the first dose administered between 6 and 12 weeks of age and subsequent doses administered at 4- to 10-week intervals. OBJECTIVE:This article reviews the composition, clinical efficacy, adverse events, and cost-effectiveness associated with its use. METHODS:Relevant literature was identified through searches of MEDLINE (1990-June 2007) and International Pharmaceutical Abstracts (1990-July 2007). Search terms included, but were not limited to, RotaTeq, PRV, intussusception, rotavirus infection, and cost-effectiveness. Further publications were selected from the reference lists of identified articles. Guidelines for use were identified from the Web sites of the CDC and the AAP. RESULTS:Two published Phase III clinical trials involving the PRV were identified. The Rotavirus Efficacy and Safety Trial (REST) and the Concomitant Use Study, a subanalysis of REST, found that PRV was efficacious and well tolerated. The vaccine was associated with preventing RVGE of any severity in 74% of patients and severe RVGE in 98%. The combined prevalence of hospitalizations and emergency department (ED) visits was reduced by 94.5% (95% CI, 91.2%-96.6%), including a decrease in hospitalizations of 95.8% (95% CI, 90.5%-98.2%) and a decrease in ED visits 93.7% (95% CI, 88.8%-96.5%), with vaccine administration compared with placebo. There were also reductions in physician's office visits of 86% (95% CI, 73.9%-92.5%) and the number of workdays lost for parents (65 vs 487). There were no confirmed cases of intussusception due to the vaccine. The prevalences of fever, diarrhea, and vomiting were not significantly different between the vaccine and placebo groups. Overall, the vaccine was well tolerated. The second study, a multicenter, randomized, placebo-controlled trial, found that PRV was efficacious, well tolerated, and immunogenic at the end of the vaccine's shelf-life. The vaccine was associated with preventing RVGE of any severity in 72.5% of cases and severe RVGE in 100% of cases. No cases of intussusception were reported. The Concomitant Use Study found that PRV could be administered concomitantly with other routine vaccinations during the first 24 weeks of life. Recently, the FDA's Vaccine Adverse Event Reporting System (VAERS) received 28 reports of cases that occurred after the first, second, and third doses. Approximately 50% of cases occurred 1 to 21 days after vaccination. Sixteen of the infants required hospitalization, while the remaining 12 required contrast or air enema intervention to reduce the intussusception. CONCLUSIONS:Based on the results from published studies, PRV appears effective in decreasing the prevalence of RVGE in the United States. Despite evidence from the large trial and no reported cases of intussusception, this event has been reported to VAERS. Continued postmarketing surveillance by the manufacturer, together with the VAERS and the CDC, will confirm whether use of the vaccine increases the risk for intussusception.


Clin Ther


Clinical therapeutics


Tom-Revzon C




Has Abstract


2007-12-01 00:00:00














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    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Temple J,Mogabgab WJ

    更新日期:1982-01-01 00:00:00

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    abstract:BACKGROUND:NSAIDs are associated with risks of gastrointestinal (GI) and cardiovascular (CV) toxicities. It has been reported that the risks of GI and CV events are dose related, resulting in guidance explicitly emphasizing the use of NSAIDs at the lowest effective dose for the shortest duration. To understand the pote...

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  • Safety and Efficacy of Glycoprotein IIb/IIIa Inhibitors in Patients With Acute Myocardial Infarction in the Presence of Intracoronary Thrombus: An Analysis From the Grand Drug-eluting Stent Registry.

    abstract:PURPOSE:To evaluate the safety and efficacy of glycoprotein IIb/IIIa inhibitors (GPIs) in patients with acute myocardial infarction (AMI) in the presence of intracoronary thrombus undergoing percutaneous coronary interventions. METHODS:This study, performed from January 1, 2004, to November 31, 2014, at 55 centers in ...

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    pub_type: 信件,多中心研究


    authors: Zheng C,Kang J,Yang HM,Han JK,Park KW,Kang HJ,Koo BK,Kim HS

    更新日期:2020-05-01 00:00:00

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    abstract:PURPOSE:Chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) are common functional gastrointestinal disorders. The prevalence of constipation-related issues tends to increase with age. This analysis pooled data from Phase III trials in CIC and IBS-C to assess the safety and effic...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Menees SB,Franklin H,Chey WD

    更新日期:2020-07-01 00:00:00

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    abstract:BACKGROUND:Preclinical studies have reported that the relative bioavailability of dalcetrapib, a modulator of cholesteryl ester transfer protein (CETP) inhibitor activity, was ∼60% higher when administered in the fed state compared with the fasting state. OBJECTIVE:This article reports on 3 studies conducted to assess...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,随机对照试验


    authors: Derks M,Kawamura H,Abt M,Meneses-Lorente G,Phelan M,Ishikawa T

    更新日期:2011-06-01 00:00:00

  • Efficacy of GLP-1 receptor agonists and DPP-4 inhibitors: meta-analysis and systematic review.

    abstract:BACKGROUND:Considerable clinical data on the treatment of type 2 diabetes with incretin-based therapies (glucagon-like peptide 1 receptor agonists [GLP-1RAs] and dipeptidyl-peptidase IV [DPP-4] inhibitors) are available. OBJECTIVE:This meta-analysis was performed to support the understanding of the overall evidence by...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,meta分析,评审


    authors: Aroda VR,Henry RR,Han J,Huang W,DeYoung MB,Darsow T,Hoogwerf BJ

    更新日期:2012-06-01 00:00:00

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    abstract::The Omnibus Budget Reconciliation Act of 1990 (OBRA-90) may be the most significant piece of legislation affecting the practice of pharmacy since the Durham-Humphrey amendments to the Food, Drug and Cosmetic Act. As part of the OBRA-90 legislation, the Health Care Financing Administration (HCFA) was required to publis...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Nightengale B,Reeder CE

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    pub_type: 临床试验,杂志文章,随机对照试验


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    更新日期:1994-11-01 00:00:00

  • Comparison of fixed-dose combinations of telmisartan/hydrochlorothiazide 40/12.5 mg and 80/12.5 mg and a fixed-dose combination of losartan/hydrochlorothiazide 50/12.5 mg in mild to moderate essential hypertension: pooled analysis of two multicenter, pros

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    journal_title:Clinical therapeutics

    pub_type: 杂志文章,meta分析


    authors: Lacourcière Y,Neutel JM,Schumacher H

    更新日期:2005-11-01 00:00:00

  • Real-time Assessment of the Development and Function of the Placenta Across Gestation to Support Therapeutics in Pregnancy.

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    journal_title:Clinical therapeutics

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    更新日期:2020-11-24 00:00:00

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    authors: Zou JJ,Ji HJ,Wu DW,Yao J,Hu Q,Xiao DW,Wang GJ

    更新日期:2008-09-01 00:00:00

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    journal_title:Clinical therapeutics

    pub_type: 临床试验,杂志文章,多中心研究,随机对照试验


    authors: Goldstein JL,Huang B,Amer F,Christopoulos NG

    更新日期:2004-10-01 00:00:00

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    pub_type: 临床试验,杂志文章,多中心研究,随机对照试验


    authors: McCluskey D,Touger MS,Melis R,Schleusener DS,McCluskey D

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  • Evaluation of the pharmacokinetics, food effect, pharmacodynamics, and tolerability of DA-1229, a dipeptidyl peptidase IV inhibitor, in healthy volunteers: first-in-human study.

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    authors: Kim TE,Lim KS,Park MK,Yoon SH,Cho JY,Shin SG,Jang IJ,Yu KS

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  • Antibiotic prescribing in ambulatory care settings for adults with colds, upper respiratory tract infections, and bronchitis.

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    journal_title:Clinical therapeutics

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    authors: Chaivichacharn P,Avihingsanon A,Manosuthi W,Ubolyam S,Tongkobpetch S,Shotelersuk V,Punyawudho B

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  • An evaluation of patients' preferences for osteoporosis medications and their attributes: the PREFER-International study.

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    journal_title:Clinical therapeutics

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    authors: Gervaix A,Ansaldi F,Brito-Avô A,Azzari C,Knuf M,Martinón-Torres F,Tuerlinckx D,Tin Htar MT,Syrogiannopoulos GA

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    journal_title:Clinical therapeutics

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    更新日期:2013-08-01 00:00:00

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    journal_title:Clinical therapeutics

    pub_type: 杂志文章,随机对照试验


    authors: Datto C,Berggren L,Patel JB,Eriksson H

    更新日期:2009-03-01 00:00:00

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    abstract::Health care provision in the United States is driven by the fact that most health insurance is commercial and private. This leads to the tendency to view patients as units that will produce a future cash yield. The quality of life (QOL) movement in the United States is in some ways a response to this view and has a ro...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,评审


    authors: Leppik IE

    更新日期:1998-01-01 00:00:00

  • Relationship between compliance and persistence with osteoporosis medications and fracture risk in primary health care in France: a retrospective case-control analysis.

    abstract:BACKGROUND:Nonadherence to treatment is an important determinant of long-term outcomes in women with osteoporosis. OBJECTIVES:This study was conducted to investigate the association between adherence and osteoporotic fracture risk and to identify optimal thresholds for good compliance and persistence. A secondary obje...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Cotté FE,Mercier F,De Pouvourville G

    更新日期:2008-12-01 00:00:00

  • Paroxetine and congenital malformations: meta-Analysis and consideration of potential confounding factors.

    abstract:BACKGROUND:Antidepressants have been commonly used by women of childbearing age. Recent studies suggest that paroxetine, a selective serotonin reuptake inhibitor (SSRI), might specifically increase teratogenic risk. OBJECTIVES:The purpose of this study was to quantify first-trimester exposure to paroxetine and birth d...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,meta分析,评审


    authors: Bar-Oz B,Einarson T,Einarson A,Boskovic R,O'Brien L,Malm H,Bérard A,Koren G

    更新日期:2007-05-01 00:00:00

  • Impact of ezetimibe coadministered with statins on cardiovascular events following acute coronary syndrome: a 3-year population-based retrospective cohort study in Taiwan.

    abstract:BACKGROUND:Conflicting results using the combination of ezetimibe and statins to reduce the risk of cardiovascular events in patients with acute coronary syndrome (ACS) have been reported. OBJECTIVE:The aim of this work was to assess the effectiveness of ezetimibe coadministered with statins in reducing cardiovascular...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Lin CF,Gau CS,Wu FL,Hsiao FY,Bai CH,Shen LJ

    更新日期:2011-09-01 00:00:00

  • Endoscopic comparison of three aspirin preparations and placebo.

    abstract::Eighty of 84 volunteers aged 22 to 70 years successfully completed a 3-month, single-blind endoscopic study in which they received single-dose placebo or 325 mg/day of enteric-coated aspirin (ECA), buffered aspirin (BA), or plain aspirin (ASA). Upper endoscopy was performed at the beginning of the study and after 4, 8...

    journal_title:Clinical therapeutics

    pub_type: 临床试验,杂志文章,随机对照试验


    authors: Petroski D

    更新日期:1993-03-01 00:00:00

  • Acid-neutralizing capacity and sodium content of antacid products from Belgium.

    abstract::The acid-neutralizing capacity and sodium content of nine antacid products available in Belgium were evaluated and compared with typical values for Mylanta-II. Liquid and tablets of Mylanta-II have a higher acid-neutralizing capacity per unit dose than do all the other Belgian antacids tested. On a unit dose basis, th...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Gombatz VW

    更新日期:1984-01-01 00:00:00

  • Antidepressant pharmacotherapy: economic outcomes in a health maintenance organization.

    abstract::Recent pharmacotherapeutic advances in the treatment of depression have included the development of selective serotonin re-uptake inhibitors (SSRIs). The present study was designed to contrast direct health service expenditures for the treatment of depression among patients enrolled in a health maintenance organizatio...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Sclar DA,Robison LM,Skaer TL,Legg RF,Nemec NL,Galin RS,Hughes TE,Buesching DP

    更新日期:1994-07-01 00:00:00

  • Safety and efficacy of feprazone for long-term treatment of rheumatoid arthritis and osteoarthritis.

    abstract::Long-term safety and efficacy of feprazone (4-prenyl-1,2-diphenyl-3,5-pyrazolidinedione), an antirheumatic drug that is well tolerated in the gastrointestinal tract, were assessed in a noncontrolled multicenter trial. Administered at a daily dosage of 600 mg for a mean duration of 114.1 days, feprazone was well tolera...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Bianchi G,Cerri B,Grasso S,Carazzi R,Dotti F,Ongari R,Cerrato O,Viara M

    更新日期:1981-01-01 00:00:00

  • Cefpodoxime for antimicrobial prophylaxis in neutropenia: a retrospective case series.

    abstract:BACKGROUND:Antimicrobial prophylaxis in select neutropenic patients has reduced fever, infection rates, hospital length of stay, and hospitalization rates. Guidelines from the Infectious Diseases Society of America recommend the consideration of prophylaxis with a fluoroquinolone in patients at high risk for infection ...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Wojenski DJ,Barreto JN,Wolf RC,Tosh PK

    更新日期:2014-06-01 00:00:00