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Volume 5, No. 1o, November 2007
Hot Topics
Obstetrics | Gynecology | Child Health | Chronic Disease and Illness
Obstetrics
SBE prophylaxis not recommended for genitourinary or gastrointestinal tract procedures
BACKGROUND: The purpose of this statement is to update the recommendations by the American Heart Association (AHA) for the prevention of infective endocarditis that were last published in 1997.
METHODS AND RESULTS: The American College of Cardiology/AHA classification of recommendations and levels of evidence for practice guidelines were used. The paper was subsequently reviewed by outside experts not affiliated with the writing group and by the AHA Science Advisory and Coordinating Committee.
CONCLUSIONS: The major changes in the updated recommendations include the following: (1) The Committee concluded that only an extremely small number of cases of infective endocarditis might be prevented by antibiotic prophylaxis for dental procedures even if such prophylactic therapy were 100% effective. (2) Infective endocarditis prophylaxis for dental procedures should be recommended only for patients with underlying cardiac conditions associated with the highest risk of adverse outcome from infective endocarditis. (3) For patients with these underlying cardiac conditions, prophylaxis is recommended for all dental procedures that involve manipulation of gingival tissue or the periapical region of teeth or perforation of the oral mucosa. (4) Prophylaxis is not recommended based solely on an increased lifetime risk of acquisition of infective endocarditis. (5) Administration of antibiotics solely to prevent endocarditis is not recommended for patients who undergo a genitourinary or gastrointestinal tract procedure. These changes are intended to define more clearly when infective endocarditis prophylaxis is or is not recommended and to provide more uniform and consistent global recommendations.
Wilson
W et al Prevention of Infective Endocarditis. Guidelines From the American
Heart Association. A Guideline From the American Heart Association Rheumatic
Fever, Endocarditis, and Kawasaki Disease Committee, Council on Cardiovascular
Disease in the Young, and the Council on Clinical Cardiology, Council on Cardiovascular
Surgery and Anesthesia, and the Quality of Care and Outcomes Research Interdisciplinary
Working Group. Circulation. 2007
Apr 19 http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd
=ShowDetailView&TermToSearch=17446442
OB/GYN CCC Editorial comment:
Please change all your SBE prophylaxis guidelines
The 2007 SBE prophylaxis guidelines are remarkable because they use levels of evidence for practice guidelines and classifications of recommendations.
Uncomplicated vaginal or cesarean delivery is not a routine indication for antibiotic prophylaxis because the rate of bacteremia is low with these procedures. However, women with the highest risk cardiac conditions described above who are undergoing uncomplicated vaginal delivery can be given the option of antibiotic prophylaxis. If bacteremia is suspected during vaginal or cesarean delivery, antibiotic prophylaxis should be administered to these patients with the highest risk cardiac conditions.
If antibiotic prophylaxis is given, the recommended drugs noted above are all safe at the time of delivery.
Indications for prophylaxis — Prophylaxis was recommended only in those settings associated with the highest risk of developing an adverse outcome if infective endocarditis (IE) were to occur. The following cardiac conditions were considered to meet this criterion:
-Prosthetic heart valves, including bioprosthetic and homograft valves.
-A prior history of IE.
-Unrepaired cyanotic congenital heart disease, including palliative shunts and conduits.
-Completely repaired congenital heart defects with prosthetic material or device, whether placed by surgery or by catheter intervention, during the first six months after the procedure.
-Repaired congenital heart disease with residual defects at the site or adjacent to the site of the prosthetic device.
-Cardiac valvulopathy in a transplanted heart.
No longer indicated — Common valvular lesions for which antimicrobial prophylaxis is no longer recommended include bicuspid aortic valve, acquired aortic or mitral valve disease (including mitral valve prolapse with regurgitation and those who have undergone prior valve repair), and hypertrophic cardiomyopathy with latent or resting obstruction.
Procedures that may result in transient bacteremia — The 2007 AHA guidelines recommend that antimicrobial prophylaxis be given to patients with the cardiac lesions cited above when they undergo procedures likely to result in bacteremia with a microorganism that has the potential ability to cause endocarditis
The risk of IE is generally considered to be the highest for all dental procedures that involve manipulation of either gingival tissue or the periapical region of teeth or perforation of the oral mucosa.
The risk of bacteremia is significantly lower for invasive genitourinary (GU) procedures such as dilation of strictures, insertions of catheters, and prostatectomy. Invasive gastrointestinal (GI) procedures, such as lower bowel endoscopy with biopsy or endoscopic retrograde cholangiopancreatography have an even lower risk of IE since bacteremia due to organisms capable of causing endocarditis occurs in less than 5 to 10 percent of cases.
The AHA guidelines no longer considers any GI (including diagnostic colonoscopy or esophagogastroduodenoscopy ) or GU procedures high risk and therefore do not recommend routine use of IE prophylaxis even in patients with the highest risk cardiac conditions defined above.
Some patients with established infections of the GI or GU tract may have enterococcal bacteremia. For patients with the highest risk cardiac conditions who have ongoing GI or GU tract infection or who are undergoing a procedure for which antibiotic therapy to prevent wound infection or sepsis is indicated, the AHA suggests an antibiotic regimen that includes an agent active against enterococci.
Patients with infected skin, skin structure, or musculoskeletal tissue generally have polymicrobial infections. When such patients undergo a surgical procedure, only bacteremia with staphylococci or beta-hemolytic streptococci are likely to cause IE. The appropriate antibiotic regimen is discussed in the UpToDate link below.
Resources
Full text article
http://www.circ.ahajournals.org/cgi/reprint/CIRCULATIONAHA.106.183095v1
Antimicrobial prophylaxis for bacterial endocarditis , UpToDate
Other
A preventive approach to lower the cesarean delivery rate in a rural hospital
Results: The exposed group (n = 794), as compared with the nonexposed group
(n = 1,075), had a higher labor induction rate (31.4% vs 20.4%, P<.001), a
greater use of prostaglandin E2 (23.3% vs 15.7%, P <.001), and a lower cesarean
delivery rate (5.3% vs 11.8%, P <.001). Adjustment for cluster effects, patient
characteristics, and the use of epidural analgesia did not eliminate the significant
association between exposure to this preventive method of care and a lower cesarean
delivery rate. Rates of other adverse birth outcomes were either unchanged or
reduced in the exposed group.
Conclusions: A preventive approach to reducing cesarean deliveries may be possible.
This study found that practitioners who often used risk-guided, prostaglandin-assisted
labor induction had a lower cesarean delivery rate without increases in rates
of other adverse birth outcomes. Randomized controlled trials of this method
of care are warranted.
Nicholson
JM, et al A preventive approach to obstetric care in a rural hospital: association
between higher rates of preventive labor induction and lower rates of cesarean
delivery.
Ann Fam Med. 2007 Jul-Aug;5(4):310-9.
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd
=ShowDetailView&TermToSearch=17664497
1 of every 6 women studied had filled a class D or X prescription
More Counseling Needed for Women of Childbearing Age Prescribed Teratogenic Drugs
CONCLUSION: Prescriptions for potentially teratogenic medications are frequently filled by women of childbearing age without documentation of contraceptive counseling
Schwarz EB et al Documentation of contraception and pregnancy when prescribing potentially teratogenic medications for reproductive-age women.Ann Intern Med. 2007 Sep 18;147(6):370-6
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd
=ShowDetailView&TermToSearch=17876020
and
Summaries for patients. Frequency of birth control services with prescriptions for unsafe drugs during pregnancy.
Summaries for patients. Frequency of birth control services with prescriptions for unsafe drugs during pregnancy.Ann Intern Med. 2007 Sep 18;147(6):I38.
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd
=ShowDetailView&TermToSearch=17876016
Risk of uterine rupture with a prior cesarean delivery is 0.3% but ranges from 0% to 0.74%
CONCLUSION: At term, the risk of uterine rupture and adverse perinatal outcome for women with a singleton and prior cesarean delivery is low regardless of mode of delivery, occurring in 3 per 1,000 women. Maternal complications occurred in 3-8% of women within the five delivery groups. LEVEL OF EVIDENCE: II.
Spong CY, et al Risk of Uterine Rupture and Adverse Perinatal Outcome at Term After Cesarean Delivery. Obstet Gynecol. 2007 Oct;110(4):801-807
Women who quit smoking before pregnancy benefit from reduced risk of abruption
These findings suggest that women who quit smoking before pregnancy may benefit from reduced risk of abruption. The observation that the recurrence of abruption is substantially increased regardless of changes in smoking habits suggests that factors other than smoking may influence the recurrence of placental abruption.
Ananth CV, et al Influence of maternal smoking on placental abruption in successive pregnancies: a population-based prospective cohort study in Sweden. Am J Epidemiol. 2007 Aug 1;166(3):289-95.
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd
=ShowDetailView&TermToSearch=17548787
Intrapartum cardiotocography in low obstetric risk increases the risk of caesarean delivery CONCLUSION: Intrapartum admission cardiotocography in women at low obstetric risk increases the risk of caesarean and instrumental delivery. In addition, there is no evidence for neonatal benefit in terms of Apgar score at 5 min after delivery. A larger sample size would be needed in order to answer this important question.
Gourounti K, Sandall J. Admission cardiotocography versus intermittent auscultation of fetal heart rate: effects on neonatal Apgar score, on the rate of caesarean sections and on the rate of instrumental delivery--a systematic review. Int J Nurs Stud. 2007 Aug;44(6):1029-35
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd
=ShowDetailView&TermToSearch=16919279
Uterine rupture risks: induction, birthweight, gestational age, and maternal characteristics
Study suggests prudent management of women with a history of caesarean delivery after finding that the risk of uterine rupture during subsequent birth is significantly increased following a previous caesarean.
CONCLUSION: The risk of uterine rupture in subsequent deliveries is not only markedly increased among women with a previous caesarean delivery but also influenced by induction of labour, birthweight, gestational age, and maternal characteristics.
Kaczmarczyk M, et al Risk factors for uterine rupture and neonatal consequences of uterine rupture: a population-based study of successive pregnancies in Sweden. BJOG. 2007 Oct;114(10):1208-14.
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd
=ShowDetailView&TermToSearch=17877673
Gynecology
2006 consensus guidelines for the management of abnormal cervical cancer screening
A group of 146 experts representing 29 organizations and professional societies met September 18-19, 2006, in Bethesda, MD, to develop revised evidence-based, consensus guidelines for managing women with abnormal cervical cancer screening tests. Recommendations for managing atypical squamous cells of undetermined significance and low-grade squamous intraepithelial lesion (LSIL) are essentially unchanged. Changes were made for managing these conditions in adolescents for whom cytological follow-up for 2 years was approved. Recommendations for managing high-grade squamous intraepithelial lesion (HSIL) and atypical glandular cells (AGC) also underwent only minor modifications. More emphasis is placed on immediate screen-and-treat approaches for HSIL. Human papillomavirus (HPV) testing is incorporated into the management of AGC after their initial evaluation with colposcopy and endometrial sampling. The 2004 Interim Guidance for HPV testing as an adjunct to cervical cytology for screening in women 30 years of age and older was formally adopted with only very minor modifications.
Wright TC Jr et al 2006 consensus guidelines for the management of women with abnormal cervical cancer screening tests Am J Obstet Gynecol. 2007 Oct;197(4):346-55
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd
=ShowDetailView&TermToSearch=17904957
2006 consensus guidelines for the management CIN or adenocarcinoma in situ
A group of 146 experts representing 29 organizations and professional societies met Sept. 18-19, 2006, in Bethesda, MD, to develop revised evidence-based, consensus guidelines for managing women with abnormal cervical cancer screening tests. The management of low-grade cervical intraepithelial neoplasia (CIN) grade 1 has been modified significantly. Previously, management depended on whether colposcopy was satisfactory and treatment using ablative or excisional was acceptable for all women with CIN 1. In the new guidelines, cytological follow-up is the only recommended management option for women with CIN 1 who have low-grade referral cervical cytology, regardless of whether the colposcopic examination is satisfactory. Treatment is particularly discouraged in adolescents. The basic management of women in the general population with CIN 2,3 underwent only minor modifications, but options for the conservative management of adolescents with CIN 2,3 have been expanded. Moreover, management recommendations for women with biopsy-confirmed adenocarcinoma in situ are now included.
Wright TC Jr, et al 2006 consensus guidelines for the management of women with cervical intraepithelial neoplasia or adenocarcinoma in situ. Am J Obstet Gynecol. 2007 Oct;197(4):340-5
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd
=ShowDetailView&TermToSearch=17904956
Editorial: The evolution of cost-effective screening and prevention of cervical carcinoma: implications of the 2006 consensus guidelines and human papillomavirus vaccination
Cervical cancer accounts for more gynecology-related deaths worldwide than any other malady, thus making it the most important preventable disease in woman’s health today. Although likely an underestimate, Parkin et al reported that cervical cancer affected 493,243 women worldwide in 2002, which makes it the second most common female cancer and the third most common cause of female cancer death, with 273,505 deaths reported. Another way to analyze the importance of cervical cancer to society is to evaluate the years of life lost by young and middle-aged women (25-64 years old). On a global basis, cancer of the cervix is responsible for approximately 2% of the total (weighted) years of life lost. However, it is the most important cause of years of life lost in Latin America and the Caribbean. Cervical cancer also contributes the largest portion to years of life lost from cancer in the populous regions of Sub-Saharan Africa and South-Central Asia, where the actual risk of loss of life from this cause is even higher, although it is somewhat overshadowed by deaths from noncancerous causes, such as acquired immunodeficiency disease and tuberculosis.
Further study of alternative screening models is needed to develop a system that can realize the cost savings in screening that is necessary to offset the added cost of universal HPV vaccination. The current guidelines are a short step toward this end; unfortunately, their net effect will likely not realize this necessary and worthy goal. Finally, although universal vaccination of teenagers and young women is a desirable policy, ethical and cultural barriers must be conquered before HPV vaccination is adopted widely across all sectors.
Monk BJ, Herzog TJ. The evolution of cost-effective screening and prevention of cervical carcinoma: implications of the 2006 consensus guidelines and human papillomavirus vaccination. Am J Obstet Gynecol. 2007 Oct;197(4):337-9
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd
=ShowDetailView&TermToSearch=17904955
Editorial comment : Alan Waxman, Univ. of New Mexico (Retired IHS OB/GYN CCC)
Putting the 2006 Consensus Guidelines into perspective
In 2001, the American Society for Colposcopy and Cervical Pathology (ASCCP) responded to the “new” 2001 revision of the Bethesda nomenclature for abnormal Pap tests by convening a conference of experts to evaluate available scientific evidence and recommend management options. The big news in 2001 was the recommendations regarding use of HPV DNA testing as a triage for the ASCUS Pap. This has become widely implemented as “Reflex HPV” testing. In the years since 2001, numerous studies have been published on the natural history of HPV and cervical dysplasia and on the effects of treatment on subsequent pregnancy. In addition, HPV DNA testing received FDA approval for use as an adjunct to the Pap test, and data from HPV vaccine trials has become available. So it seemed a good time to review and revise the ASCCP Guidelines.
The Consensus Conference process was similar to that employed 5 years earlier. Diagnosis-specific workgroups composed of physicians, expert in cervical disease, were assigned to review the literature since 2000. Preliminary recommendations were posted on a web bulletin board for comment from interested parties worldwide. By the time the consensus conference was convened in mid-September, 2001, a set of fairly mature recommendations had been developed. At the conference, each recommendation was debated by 146 representatives of 29 professional organizations and government agencies. Each recommendation was voted up or down, revised and voted on again as needed. The resulting 2006 Guidelines were published this month in the American Journal of Obstetrics and Gynecology and are available free to the public at www.asccp.org.
The new guidelines include a number of major changes that will affect the way we care for women with abnormal Pap tests. Without question, the most radical of these is in the recommended management of adolescents with LSIL or ASC-US. This is a logical progression of American Cancer Society’s 2002 recommendation to delay the first Pap test in adolescent women until about three years after the onset of sexual activity or age 21. The 2006 ASCCP Guidelines acknowledge the high prevalence of HPV infection in women under age 21, but also the high probability of spontaneous resolution of SIL and very low incidence of invasive cancer in this age group. In addition several studies have shown that treatment of dysplasia is associated with an increase in premature births with subsequent pregnancy. As a result, the 2006 Guidelines recommend deferring colposcopy for adolescent women with LSIL or ASC-US for two years, while monitoring with cytology annually, and defaulting to colposcopy only if a follow-up Pap test progresses to HSIL or if it remains ASC-US or worse at two years. This approach should identify those few young women at risk of developing cancer and prevent cost, discomfort, anxiety, and potential perinatal morbidity for the large number with minimally abnormal Pap results.
The field of cervical cancer screening and HPV continues to produce a large body of innovative research. With the approval and widespread implementation of the HPV Vaccine we are likely to see the “new” 2006 Guidelines revised and improved upon in the future. In the meantime, they offer those of us caring for women a well thought out approach to the abnormal Pap test that’s based on today’s most current evidence.
Other Cervical Cancer Screening resources this month
Less intervention for CIN 2 may be acceptable in adolescents
CONCLUSION: CIN > or = 2 is present in 35% of our cohort. Most had CIN 2, and most experienced regression. Our observation supports continued vigilance in the evaluation of adolescents but suggests that less intervention for CIN 2 may be acceptable.
Moore
K et al Adolescent cervical dysplasia: histologic evaluation, treatment,
and outcomes.
Am J Obstet Gynecol. 2007 Aug;197(2):141.e1-6.
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd
=ShowDetailView&TermToSearch=17689626
Use of routine prophylactic topical antibiotics not recommended after LLETZ
CONCLUSIONS: An antimicrobial vaginal pessary containing tetracycline and amphotericin B did not provide any significant benefit after LLETZ, except for a subgroup of women with positive vaginal or endocervical swabs. Given that this group of women cannot be identified before the procedure since swabs are not routinely taken, the use of routine prophylactic topical antibiotics cannot be recommended for the general population
Chan KK, et al The use of vaginal antimicrobial after large loop excision of transformation zone: a prospective randomised trial. BJOG. 2007 Aug;114(8):970-6.
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd
=ShowDetailView&TermToSearch=17635487
Other
Effectiveness of two tinidazole regimens in treatment of bacterial vaginosis: RCT
CONCLUSION: Both tinidazole regimens studied provided effective treatment for bacterial vaginosis
Livengood CH 3rd, et al Effectiveness of two tinidazole regimens in treatment of bacterial vaginosis: a randomized controlled trial. Obstet Gynecol. 2007 Aug;110(2 Pt 1):302-9.
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd
=ShowDetailView&TermToSearch=17666604
Minimally invasive strategy for large cysts: Laparoscopically guided minilaparotomy CONCLUSION: Laparoscopically guided minilaparotomy, when compared with laparoscopy, is able to reduce intraperitoneal spillage in patients with presumably benign large adnexal masses, with minimal increase in patient short- and long-term discomfort. Because data regarding the importance of intraperitoneal spillage during surgery for benign and malignant pathologies, as well as rupture rates during traditional laparotomy, are scarce, traditional laparotomy still represents the standard treatment. In women desiring a minimally invasive strategy for large cysts, laparoscopically guided minilaparotomy should be considered
Panici PB, et al Laparoscopy compared with laparoscopically guided minilaparotomy for large adnexal masses: a randomized controlled trial. Obstet Gynecol. 2007 Aug;110(2 Pt 1):241-8.
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd
=ShowDetailView&TermToSearch=17666596
Tailored mesh significantly reduced the rate of recurrence of anterior vaginal wall prolapse
CONCLUSION: Anterior colporrhaphy, reinforced with, tailored mesh significantly reduced the rate of recurrence of anterior vaginal wall prolapse compared with the traditional operation, but was associated more often with stress urinary incontinence.
Hiltunen R et al Low-weight polypropylene mesh for anterior vaginal wall prolapse: a randomized controlled trial. Obstet Gynecol. 2007 Aug;110(2 Pt 2):455-62.
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd
=ShowDetailView&TermToSearch=17666627
Botulinum toxin injections for adults with overactive bladder syndrome
CONCLUSIONS: Intravesical botulinum toxin shows promise as a therapy for overactive bladder symptoms, but as yet too little controlled trial data exist on benefits and safety compared with other interventions, or with placebo. Practitioners should be aware that at present there is little more than anecdotal evidence, in the form of case reports to support the efficacy of intravesical botulinum toxin; there is not much in the way of substantial, robust safety data. Furthermore, the optimal dose of botulinum toxin for efficacy and safety has not yet been demonstrated.
Duthie J, et al Botulinum toxin injections for adults with overactive bladder syndrome. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD005493
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd
=ShowDetailView&TermToSearch=17636801
Early-stage ovarian cancer No difference in adjuvant chemotherapy and radiotherapy
RESULTS: Twenty-two prospective randomized studies were analyzed, which included 4,626 patients. No difference between adjuvant chemotherapy (AC) and radiotherapy was found. There is agreement on that patients with stage IA, grade 1 tumors have excellent survival and do not need postsurgical therapy. The International Collaborative Ovarian Neoplasm 1/Adjuvant Chemotherapy in Ovarian Neoplasm trials were the first to show an effect on survival of AC, but in patients with adequate surgical staging, there was no additional effect of AC. For patients who are staged incompletely at the time of initial surgery, completion of the staging procedure with either laparoscopy or laparotomy is a reasonable approach before a final decision is made regarding the need for AC.
CONCLUSION: Future randomized studies in EOC will include the investigation of new targeted therapies and new prognostic factors in adequately staged patients.
Tropé C; Kaern J Adjuvant chemotherapy for early-stage ovarian cancer: review of the literature. J Clin Oncol. 2007; 25(20):2909-20
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17617522
Child Health
Traumatic events and alcohol use disorders among American Indian
adolescents
Researchers analyzed interviews with 432 American Indian adolescents
and young adults between the ages of 15 and 24. The participants were enrolled
tribal members living on or near two closely related Northern Plains Indian reservations.
As part of a larger survey on mental health, interviewers asked the participants
if they had experienced any of 16 types of traumatic events and about their use
of alcohol.
The traumatic events were categorized as noninterpersonal trauma (disaster, life-threatening accidents); interpersonal trauma (combat, rape, sexual abuse, physical assault/ abuse); witnessed trauma (seeing violence perpetrated upon others or observing a serious accident or disaster that resulted in harm or death of others); hearing traumatic news about a close other (life-threatening illness, rape, suicide, of a family member or friend), and other trauma.
Over one-fourth (26 percent) of those interviewed were diagnosed with alcohol use disorders. Overall, 21 percent had experienced one severe traumatic event, 10 percent had experienced two, and 16 percent had experienced three or more. Young adults (aged 20-24) experienced more traumatic events than adolescents (aged 15-19), as did participants in both age groups who reported that their parents used alcohol while they were growing up.
The odds for alcohol use disorders increased from nearly twofold for one trauma to somewhat less than fourfold for three or more traumas compared with no trauma. These results held after adjusting for age, gender, and parental alcohol use, suggesting a dose-response effect of trauma on alcohol disorders among American Indians living on or near reservations.
Boyd-Ball AJ et al Traumatic events and alcohol use disorders among American Indian adolescents and young adults. J Trauma Stress. 2006 Dec;19(6):937-47.
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd
=ShowDetailView&TermToSearch=17195969
Viracept Use Should Be Limited in Children and Pregnant Women
Interim specifications for use of nelfinavir mesylate (Viracept, Pfizer, Inc) preclude initiation of therapy in children and pregnant women, the US Food and Drug Administration warned healthcare professionals.
These measures are based on the risk for high levels of ethyl methanesulfonate ( EMS), a process-related impurity. Although no human data exist, animal studies indicate that EMS is teratogenic, mutagenic, and carcinogenic.
For pediatric patients who are stable on nelfinavir-containing regimens and pregnant women with no other therapeutic options, the benefit-risk ratio remains favorable, and nelfinavir therapy may be continued, according to an alert sent from MedWatch, the FDA's safety information and adverse event reporting program.
Although other patients are not currently affected by these measures, a temporary interruption of drug supply in the future may require switching to alternative products.
Earlier this year, excess levels of EMS prompted a recall of nelfinavir in the European Union; subsequent testing revealed levels to be substantially lower in the US product and within final acceptable limits.
Toxicology experts generally agree that the lifetime risk associated with exposure to a carcinogen is about 3-fold greater among pediatric patients aged 2 to 16 years and is even higher for those aged younger than 2 years, the company said in a letter to doctors. These data were used to determine acceptable levels of EMS in pediatric formulations of nelfinavir.
Action is currently being taken to ensure that EMS levels meet final acceptable limits. Interim specifications agreed on by the company and the FDA limit the theoretical lifetime increased cancer risk in adults to fewer than 17 cases per 100,000 exposed; long-term specifications limit the risk to less than 1 case per 100,000 exposed. The background incidence in the HIV population is currently estimated to be 20 to 30 cases per 1000 patient-years.
Nelfinavir is a protease inhibitor indicated with other antiretroviral agents for the treatment of HIV infection.
Healthcare professionals should report nelfinavir-related adverse events to the FDA by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch , or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787 .
Statement Updated for Screening and Treatment of Teens at Risk for Suicide
Suicide is the third-leading cause of death for adolescents 15 to 19 years old. Pediatricians can take steps to help reduce the incidence of adolescent suicide by screening for depression and suicidal ideation and behavior. This report updates the previous statement of the American Academy of Pediatrics and is intended to assist the pediatrician in the identification and management of the adolescent at risk of suicide. The extent to which pediatricians provide appropriate care for suicidal adolescents depends on their knowledge, skill, comfort with the topic, and ready access to appropriate community resources. All teenagers with suicidal thoughts or behaviors should know that their pleas for assistance are heard and that pediatricians are willing to serve as advocates to help resolve the crisis.
Shain BN; American Academy of Pediatrics Committee on Adolescence. Suicide and suicide attempts in adolescents. Pediatrics. 2007 Sep;120(3):669-76
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd
=ShowDetailView&TermToSearch=17766542
Medication errors are made during care for half of the children seen at rural California emergency departments
http://www.ahrq.gov/research/sep07/0907RA3.htm
Maternal Weight Tied to Child's Body Composition at Age 9
Conclusions: Mothers with a higher pre-pregnant body mass index or a larger mid-upper arm circumference during pregnancy tend to have children with greater adiposity at age nine. The extent to which this is attributable to genetic factors, the influence of maternal lifestyle on that of her child, or maternal adiposity acting specifically during pregnancy on the child's fat mass cannot be determined in this study.
Gale CR et al Maternal Size in Pregnancy and Body Composition in Children. J Clin Endocrinol Metab. 2007 Aug 7
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17684051
Chronic Disease and Illness
Aging and prevalence of CVD risk factors in American Indians: the
Strong Heart Study
Although mortality rates from CVD in the United States continue to decrease,
rates are rising among Native American Indians and are now likely exceed those
of the general population. Also, CVD is the leading cause of death in American
Indians beginning at age 45 compared with age 65 for the U.S. general population.
As older American Indians age, more of them develop hypertension, diabetes, and
low levels of high density lipoprotein cholesterol (HDL-C), all risk factors
for developing cardiovascular disease, according to this study.
The researchers examined the development of major CVD risk factors among a rural group of 4,549 American Indians aged 45 to 74 during initial examination in 1989 to 1991 and 8 years later. Their work was part of the Strong Heart Study of 13 predominantly poor tribes of American Indians. This aging group had decreased prevalence of smoking and no consistent changes in adverse HDL-C and low-density lipoprotein-cholesterol (LDL-C) profiles. However, the group had substantial increases in the prevalence of hypertension and diabetes, two of the most important CVD risk factors.
For example, prevalence of hypertension increased from 42.2 percent at the initial examination to 61.3 percent among men 8 years later and from 36.4 percent to 60.3 percent among women. The prevalence of hypertension in this group (aged 40-59) was comparable with the 65 percent hypertension rate among an older group (60 years and older) that participated in the National Health and Nutrition Examination Survey (NHANES).
Diabetes remained markedly and disproportionately high in this age group of Native American Indians. Prevalence increased from 41.4 to 47.4 percent among men and from 48.4 to 55.8 percent among women during the study period—three times higher than the 16.4 percent of people with diabetes among a similar age group in the 1994 NHANES. Men had a nonsignificant decrease in LDL-C and men and women initially had rapid increases in the prevalence of low HDL-C, which may have been affected by factors such as diabetes or insulin resistance that were also associated with this group.
Rhoades
DA, Welty
TK et al Aging and the prevalence of cardiovascular disease risk factors
in older American Indians: the Strong Heart Study.
J Am Geriatr Soc. 2007 Jan;55(1):87-94.
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd
=ShowDetailView&TermToSearch=17233690
Both coping and communication-enhancing and supportive counseling work after cancer
Women with greater than average increases in physician-rated physical symptoms and/or women who were more expressive of positive emotions benefited more from SC than women with lower than average increases in symptom scores and/or women who were less expressive of positive emotions. These findings suggest that both interventions may be effective in treating depressive symptoms among patients with gynecological cancer. Future research should evaluate whether bolstering both psychological interventions with additional intervention sessions and topics in the disease trajectory will result in persistent long-term effects.
Manne
SL et al Coping and communication-enhancing intervention versus supportive
counseling for women diagnosed with gynecological cancers.
J Consult Clin Psychol. 2007 Aug;75(4):615-28.
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd
=ShowDetailView&TermToSearch=17663615
Opioid Analgesia During Evaluation of Acute Abdominal Pain
Clinical Question
Does providing early opioid analgesia during evaluation of acute abdominal pain improve patient comfort or outcomes?
Evidence-Based Answer
Providing early opioid analgesia to patients presenting with acute abdominal pain does not affect or delay management decisions, but it lessens pain intensity as rated by the patient.
Practice Pointers
The differential diagnosis of acute abdominal pain includes many causes that may require urgent surgical treatment or hospitalization such as appendicitis, cholecystitis, bowel obstruction, kidney stones, perforated peptic ulcer, pancreatitis, diverticulitis, pelvic abscesses, and ectopic pregnancy. Most acute abdominal pain is visceral pain, which is characterized by generalized aching, pressure, or sharp pain. Visceral pain generally responds best to intraspinal local anesthetic or nonsteroidal anti-inflammatory drugs or opioids administered via any route.1 It is common practice to withhold opioid analgesia in patients with acute abdominal pain. This practice is based on the theory that opioids might mask symptoms, causing inaccurate or delayed diagnostic and treatment decisions.
To evaluate the accuracy of this theory, the authors of this Cochrane review searched for randomized controlled trials comparing opioid analgesia with no analgesia in adults with abdominal pain. Six trials, including 699 total patients, were identified. Most of the trials compared 5 to 15 mg of morphine (Duramorph) with an equivalent amount of saline. There were no significant differences between groups in changes in the physical examination, errors in treatment decisions, inaccurate diagnoses, nausea and vomiting, or length of hospitalization. The two studies that reported patient comfort found significant improvement with opioids. There was not enough information to determine if opioid use causes a delay in the decision to operate, affects costs, or affects morbidity. There was also insufficient evidence to suggest an optimal treatment regimen.
Manterola C, Astudillo P, Losada H, Pineda V, Sanhueza A, Vial M. Analgesia in patients with acute abdominal pain. Cochrane Database Syst Rev 2007;(3):CD005660.
Cochrane Briefs http://www.aafp.org/afp/20071001/cochrane.html
Does Screening Mammography Benefit Women in Their 40s?
Conclusion: The authors conclude that although women in their 40s who undergo screening mammography have a lower risk of breast cancer-related death, screening also results in harms that may be clinically significant for some women. The authors suggest that an individualized risk assessment, taking into account patient factors such as family history and the value attached to a false-positive test result, may be appropriate to guide decisions about breast cancer screening in this age group.
Echoing the conclusions of the systematic review by Armstrong and colleagues, an accompanying American College of Physicians clinical practice guideline recommends individualized risk assessment and shared decision making for women in their 40s who are considering breast cancer screening.1 This guideline differs from recommendations of other organizations. For example, the U.S. Preventive Services Task Force (USPSTF) recommends screening mammography every one to two years for women 40 years and older.2 The USPSTF is currently updating its recommendation.
Armstrong K, et al. Screening mammography in women 40 to 49 years of age: a systematic review for the American College of Physicians. Ann Intern Med April 3, 2007;146:516-26
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd
=ShowDetailView&TermToSearch=17404354
CDC Updates Guidelines for Use of Influenza Vaccine and Antiviral Agents
This report updates the 2006 recommendations by CDC's Advisory Committee on Immunization Practices (ACIP) regarding the use of influenza vaccine and antiviral agents (CDC. Prevention and control of influenza: recommendations of the Advisory Committee on Immunization Practices [ACIP]. MMWR 2006;55[No. RR-10]). The groups of persons for whom vaccination is recommended and the antiviral medications recommended for chemoprophylaxis or treatment (oseltamivir or zanamivir) have not changed. Estimated vaccination coverage remains <50% among certain groups for whom routine annual vaccination is recommended, including young children and adults with risk factors for influenza complications, health-care personnel (HCP), and pregnant women. Strategies to improve vaccination coverage, including use of reminder/recall systems and standing orders programs, should be implemented or expanded. The 2007 recommendations include new and updated information. Principal updates and changes include 1) reemphasizing the importance of administering 2 doses of vaccine to all children aged 6 months--8 years if they have not been vaccinated previously at any time with either live, attenuated influenza vaccine (doses separated by > or =6 weeks) or trivalent inactivated influenza vaccine (doses separated by > or =4 weeks), with single annual doses in subsequent years; 2) recommending that children aged 6 months--8 years who received only 1 dose in their first year of vaccination receive 2 doses the following year, with single annual doses in subsequent years; 3) highlighting a previous recommendation that all persons, including school-aged children, who want to reduce the risk of becoming ill with influenza or of transmitting influenza to others should be vaccinated; 4) emphasizing that immunization providers should offer influenza vaccine and schedule immunization clinics throughout the influenza season; 5) recommending that health-care facilities consider the level of vaccination coverage among HCP to be one measure of a patient safety quality program and implement policies to encourage HCP vaccination (e.g., obtaining signed statements from HCP who decline influenza vaccination); and 6) using the 2007--2008 trivalent vaccine virus strains A/Solomon Islands/3/2006 (H1N1)-like (new for this season), A/Wisconsin/67/2005 (H3N2)-like, and B/Malaysia/2506/2004-like antigens.
Fiore AE et al Prevention and control of influenza. Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2007. MMWR Recomm Rep. 2007 Jul 13;56(RR-6):1-54
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd
=ShowDetailView&TermToSearch=17625497
Effectiveness of Treatments for Type 2 Diabetes
Background : About 90 percent of the 20 million persons with diabetes in the United States have type 2 disease. The prevalence of diabetes increases with age from 1.4 percent in persons younger than 45 years to 16.7 percent in persons 65 to 74 years of age. Patients with type 2 diabetes have insulin resistance, increased hepatic glucose production, reduced glucose clearance, and impaired beta cell insulin secretion. Visceral fat increases insulin resistance. In the disease course, postprandial glucose levels probably increase before fasting glucose levels increase. Several studies have shown that tight glucose control is associated with a decrease in the development and progression of microvascular complications. The Diabetes Control and Complications Trial, which evaluated patients with type 1 diabetes, found that a 2 percent reduction in A1C level was associated with a delay in the onset and progression of retinopathy and nephropathy. Similar results were found in trials evaluating patients with type 2 diabetes, but no trial has specifically evaluated patients older than 60 years.
Recommendations : Based on these trials, it is recommended that patients achieve an A1C goal of less than 7 percent. Modest weight loss can lower A1C levels by 1 percent, and moderate exercise can lower A1C levels by 0.5 percent. Treatments include medications that increase insulin secretion. Two new secretagogue medications are available: exenatide injection (Byetta); and sitagliptin (Januvia), a dipeptidyl peptidase type IV inhibitor. More established treatment options include metformin (Glucophage) and thiazolidinediones, which decrease insulin resistance; and alpha-glucosidase inhibitors, which delay absorption of carbohydrates from the gastrointestinal tract. Individually, antihyperglycemic medications reduce A1C levels by 0.5 to 2 percent. Combinations of medications with different mechanisms of action have additive effects.
If patients do not achieve A1C goals with oral medications, insulin is initiated. Other indications for insulin therapy include severe symptoms, ketoacidosis, and preconception planning. When the fasting glucose level is elevated, 10 units (or 0.1 units per kg) of nighttime basal insulin is titrated upward until fasting blood glucose is at the desired level. At lower A1C levels, postprandial blood glucose is likely to contribute more to overall glucose control. When postprandial glucose is elevated, patients should use short-acting insulins before meals and should stop using insulin secretagogues while continuing insulin sensitizers
Abrahamson MJ. A 74-year-old woman with diabetes. JAMA January 10, 2007;297:196-204.
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd
=ShowDetailView&TermToSearch=17213403
The Critical Role of Pathology in Multidisciplinary Treatment of Breast Cancer
http://www.medscape.com/viewprogram/7862?src=nlcmealert
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OB/GYN
Dr. Neil Murphy is the Obstetrics and Gynecology Chief Clinical Consultant (OB/GYN C.C.C.). Dr. Murphy is very interested in establishing a dialogue and/or networking with anyone involved in women's health or maternal child health, especially as it applies to Native or indigenous peoples around the world. Please don't hesitate to contact him by e-mail or phone at 907-729-3154.
