NEW HAVEN, Conn., Jan. 18 — Although opioids may give patients with chronic back pain temporary relief, the drugs’ long-term efficacy is uncertain, and they carry a high potential for abuse, found a systematic review of clinical studies.

So reported Bridget A. Martell, M.D., of Yale, and colleagues, in the Jan. 16 issue of the Annals of Internal Medicine. They found that the drugs were generally no better than placebo or non-opioid controls, and that a fourth of patients on opioids displayed behaviors consistent with substance abuse.

“The findings in this review suggest that clinicians should reconsider treating chronic back pain with opioids medications, and consider other treatments with similar benefit yet fewer long-term adverse effects,” they wrote.

To better grasp the prevalence, efficacy, and risk for addiction with these agents, the authors scanned the medical literature to identify studies with an adult, non-obstetric population who were taking opioids in either oral, topical, or transdermal forms for treatment of chronic back pain. The final analysis included 38 studies that met the criteria.

Eleven of the studies included data on opioid prescribing rates, and these studies revealed a wide variation, from only 3% of patients with chronic back pain to 66%.

Patients were more likely to receive opioids if they reported “greater disability, poorer function, greater distress and suffering, and higher functional disability scores than if they had higher pain severity scores,” the authors wrote.

In a meta-analysis of four studies that compared efficacy of opioids with placebo or a non-opioid control, such as an NSAID, the authors found that opioids did not appear to be superior at reducing pain, as determined by a Hedges g estimate of the effect of size for continuous measures (g, -0.199 composite standardized mean difference, 95% confidence interval, -0.49 to 0.11, P=0.136).

In addition, when they conducted a meta-analysis of studies pitting one opioid against another (e.g., oxycodone versus codeine), they found that differences in the reduction of pain from baseline were non-significant (g. -0.93 composite standardized mean difference, 95% CI, -1.89 to -0.03]; P=0.055).

And when the authors evaluated the question of substance abuse disorder prevalence, they found that studies reported a range of 3% to 43% prevalence of current abuse, and 36% to 54% lifetime prevalence. The prevalence of “aberrant medication-taking behaviors” (essentially behaviors that don’t meet criteria for full-blown addiction) were reported to occur in anywhere from 5% to 24% of patients.

“Our findings are not consistent with previous reviews on the efficacy of opioids for chronic back pain,” the authors acknowledged. “Opioids, in some instances, have been found to be efficacious for treatment for painful conditions. Our review, however, found that the evidence in favor of opioids is not always consistent, and when supportive, only supports this treatment for short periods (for example, less than four months). Long-term trials of opioid efficacy for chronic back pain are lacking, and there is other evidence that indicates that the long-term efficacy of opioids for chronic pain may be limited.”

They cautioned that the studies they included in their analyses varied widely in quality, and that many were lacking information on trial design or follow-up. They also noted that in many of the studies analyzed, there was no association between pain relief and improvement in functional status, and that most of the trials were funded by pharmaceutical companies, and could therefore be subject to various biases.

Dr. Martell was supported by a grant from the Veterans Administration. The authors did not disclose any potential conflicts of interest.

Primary source: Annals of Internal Medicine

Source reference:
Martell BA et al. “Systematic Review: Opioid Treatment for Chronic Back Pain: Prevalence, Efficacy, and Association with Addiction.” Ann Intern Med. 2007;146:116-127.

The controversy over breast cancer screening centered largely on a handful of terms and concepts that were overlooked, ignored, misunderstood, or misinterpreted, according to the authors of a commentary on the issue.

Few observers dispute that the most contentious aspect of the U.S. Preventive Services Task Force recommendations related to the age when women should begin routine mammographic screening: 50 versus 40. The key term was “routine,” which was overlooked or ignored, depending on the source, Steven H. Woolf, MD, of Virginia Commonwealth University in Richmond, wrote in one of four commentaries in the Jan. 13 issue of JAMA.

“The USPSTF did not recommend against women having mammograms,” wrote Woolf, a member of or adviser to the task force from 1987 to 2007. “This pivotal misunderstanding resulted from poor wording of the recommendation.”

Specifically, Woolf referred to the following statement: “The USPSTF recommends against routine [emphasis added] screening mammography in women aged 40 to 49 years.”

The sentence was followed by an explanatory statement emphasizing that the decision to begin mammographic screening should be individualized and take into account “the patient’s values regarding specific benefits and harms” (Ann Intern Med 2009; 51: 716-26).

“Inserting ‘routine’ in the first sentence and adding the explanatory second sentence was meant to convey a nuance that was lost on the public,” Woolf wrote. “The panel did not oppose mammography, as widely misinterpreted, but recommended against automatic (‘routine’) imaging, without informing women about potential harms.”

One’s Harm Is Another’s Benefit

Addressing the harm issue in a second commentary, Steven Woloshin, MD, and Lisa M. Schwartz, MD, of Dartmouth Medical School in Hanover, N.H., said that recognizing and understanding the trade-offs of breast cancer screening is a requisite for informed decision making. Most of the discussion about the harms of mammography has focused on false-positive results, which can lead to unnecessary biopsies and associated anxiety and morbidity.

“False-positive test results are not the most important harm of screening — overdiagnosis is,” wrote Woloshin and Schwartz. “Because it is not possible to know which women are overdiagnosed, all are treated with surgery, chemotherapy, radiation, or some combination. Overdiagnosed women are unnecessarily diagnosed, undergo treatment that can only cause harm, and must live with the ongoing fear of cancer recurrence.”

Estimates of the frequency of overdiagnosis range from two to 10 for every cancer death avoided, they added.

Women have divergent views about the benefits and harms of screening. Many women ages 40 to 49 find breast cancer screening worthwhile despite the risk of false-positive results. Others will find the harms too great to accept.

“[That] is exactly the point,” wrote Woloshin and Schwartz. “Each woman, with the help of her physician, needs to consider these harms and benefits and decide whether to undergo screening.”

Seconding a view expressed by Woolf, Woloshin and Schwartz said balanced information is essential for clinical decision making. Noting that the goal of medicine is healthier, longer lives, they wrote “sometimes more testing helps to reach the goal, but other times less testing does. Suggestions to do less may be as much in an individual’s interest as suggestions to do more.”

Anne Murphy, MD, of Johns Hopkins, offered two perspectives on the screening controversy: one from a clinician and researcher and the other from a breast cancer survivor. She implored physicians to address both sides of the issue with their patients.

“Clinicians should specifically discuss the USPSTF recommendations, recognizing that this task force has considered a great deal of medical evidence, but also should discuss that advocacy organizations including the American Cancer Society, the Susan G. Komen for the Cure, and the Avon Foundation for Women still favor the recommendation of yearly mammography screening starting at age 40,” Murphy wrote.

Breast Self-Exam Is Another Issue

Physicians also should be prepared to address women’s questions and concerns regarding another controversial aspect of the USPSTF guideline: The recommendation against the value of teaching women breast self-examination.

“Data from large randomized studies have indicated that this type of formalized breast self-examination may result in more biopsies without reducing the risk of death,” Murphy wrote. “This issue also was addressed in prior clinical practice guidelines and by advocacy organizations, and enthusiasm for teaching formalized breast self-exam has diminished.

“However, a practical issue is that many women present to clinicians and are ultimately diagnosed with breast cancer based on self-palpation of a mass.”

In addressing the benefits of screening mammography, Wendie A. Berg, MD, PhD, also of Johns Hopkins, reviewed four major areas of controversy about the USPSTF recommendations: potential harms, raising the age for routine screening to 50, clinical breast examination, and screening after age 74, which the task force said has no supporting data.

With regard to breast self-examination, Berg said “resources might be better spent on ultrasound in women with dense breasts than on clinical breast examination.” However, she emphasized that women should tell their physicians about any changes detected on self-examination.

Berg referred to “downsides” of mammography, which she said most women would not consider harmful. She cited a survey showing that almost two-thirds of women considered 500 or more false-positive results per life saved would be a reasonable trade-off.

Given that 75% of breast cancers are diagnosed in women with no obvious risk factors, the recommendation against routine screening before age 50 is “problematic,” Berg said in her commentary. She noted progress toward development of other screening modalities to augment mammography for high-risk women. Breast ultrasound and breast MRI have shown promise in selected patients, but both modalities are associated with increased recall rates and more needle biopsies.

Once started, mammographic screening should continue “as long as a woman is in reasonably good health and would pursue treatment if cancer is identified,” Berg wrote. In support of that view, she noted that women in their 80s have an average life expectancy of 8.6 years.

“Annual mammographic screening is appropriate starting at age 40 years, provided the woman is willing to accept the downsides of false positives, including being recalled for more imaging and the possibility of a needle biopsy for a finding that is not breast cancer,” Berg concluded. “The overwhelming majority of women are willing to accept these downsides as part of the process of saving lives otherwise lost to breast cancer.”

Echoing sentiments expressed in the commentaries, an editorial by JAMA editors Catherine D. Deangelis, MD, and Phil B. Fontanarosa, MD, urged physicians and patients to make decisions about screening mammography on the basis of “unbiased, rigorous, objective evaluation of the available evidence for recommendations about screening for breast cancer and other clinical interventions.”

Citing frequent reporting inaccuracies in the news media and the “politicization of biological science,” they also emphasized the need for independent review bodies, such as the USPSTF, to offer “objective appraisals, reports, and guidelines without concern about special interests, politics, or ideology or fear of repercussions for seeking the truth in providing evidence-based recommendations.”

“In issuing the 2009 recommendation statement, the USPSTF has fulfilled its mandate to provide guidance and evidence that will help physicians and patients make informed, individualized decisions about screening for breast cancer” they wrote.

Woolf, Woloshin, Schwartz, DeAngelis, and Fontanarosa reported no disclosures. Berg disclosed relationships with Naviscan and Medipattern. Murphy disclosed relationships with the American Cancer Society, Susan G. Komen for the Cure, Avon Foundation for Women, and the Lance Armstrong Foundation.

In a report on treatment of pneumonia patients in The Annals of Internal Medicine, the authors noted that controversy persists over whether pneumonia patients are best treated at home or in the hospital.

According to the authors, patients in Pneumonia Severity Index (PSI) risk classes II and III account for 30% to 50% of hospitalizations. The mortality in these groups is estimated to be less than 1%.

Experts agree that patients in higher risk classes need to be hospitalized, but whether to hospitalize class II and III patients remains somewhat controversial.

In their unblinded, randomized, controlled trial of PSI II and III patients, first author Jordi Carratala, MD, Infectious Disease Service, Hospital Universitari de Bellvitge, Barcelona, Spain, and colleagues found that outpatients did at least as well as hospitalized patients, and the outpatients were more satisfied with their overall medical care.

The study involved 224 immunocompetent adults (18 years or older) in risk class II or III (PSI scores up to 90 points). All patients received a diagnosis of community-acquired pneumonia (CAP) in the emergency department and no extenuating circumstances.

The patients were randomized to either outpatient treatment with oral levofloxacin (500 mg/d), or hospitalization at one of two hospitals in Barcelona, Spain with sequential intravenous and oral levofloxacin (500 mg/d).

All patients received detailed written information about their diagnosis and treatment plan, as well as an emergency contact number for a nurse or investigator physician.

The authors reported an overall successful outcome in 83.6% of outpatients and 80.7% of hospitalized patients, with an absolute difference of 2.9 percentage points [95% CI, -7.1 to 12.9 percentage points].

They also reported 91.2% of outpatients were satisfied with their overall care compared to 79.1% of inpatients, with an absolute difference of 12.1 percentage points [CI, 1.8 to 22.5 percentage points].

Quality of life and percentages of patients with adverse drug reactions, medical complications, subsequent hospital admissions and overall mortality were similar in both groups.

The authors concluded: “Patients in PSI risk classes II and III can be safely treated with levofloxacin as outpatients in the absence of respiratory failure, unstable comorbid conditions requiring hospitalization, complicated pleural effusions, and social problems compromising outpatient care.” Outpatient treatment for these patients, they said, should be the standard of care.

In an accompanying editorial, Lionel Mandell, MD, McMaster University, Ontario, Canada, said the randomized study was the first to use a two-step systematic approach to identifying patients with community-acquired pneumonia who can safely be treated at home.

He said the study represented the only true prospective validation of the PSI as a tool to identify patients who would have comparable outcomes of care whether treated as inpatients or outpatients. The recommendations based upon this study are consistent with the Guidelines of the Infectious Disease Society of America.

Dr. Mandell said, “If confirmed, the findings should stimulate emergency departments to systematize their approach to CAP management.”

Primary source: Annals of Internal Medicine

Source reference:
Carratala J et al. Outpatient Care compared with hospitalization for Community-Acquired Pneumonia. Ann Intern Med. 2005;142:165-172

Additional source: Annals of Internal Medicine

BUDAPEST — A new emphasis on multimodal imaging will mark the annual meeting of the European Association of Echocardiography that kicks off here this week, but the buzz centers on how these techniques can be used in valvular heart disease.

“We’re living in a multimodality world now,” James Thomas, MD, of the Cleveland Clinic and president of the American Society of Echocardiography, notes in this exclusive On the Scene preview report.

The conference now includes sessions on MRI, CT, and nuclear imaging but “the dominant flavor will still be echocardiography there,” Thomas told MedPage Today senior staff writer Crystal Phend.

One major focus will be valvular heart disease, which is seeing rapid changes in treatment and the imaging needed to support it as interventional cardiology moves into aortic and mitral valve replacement and repair.

“There’s a huge synergy between what’s happening in echocardiography and what’s happening in the interventional world,” Thomas points out. “In particular, echocardiography is now called upon to provide real-time guidance for a lot of structural valve intervention.”

Another hot area will be imaging left ventricular strain, including controversy around measurement issues and its value in monitoring the cardiac impact of cancer treatment, he added.

ROCKVILLE, Md., Oct. 16 — The FDA announced the recall of dextroamphetamine sulfate 5-mg tablets because they may contain as much as twice the labeled amount of active ingredient.

The voluntary recall applies to three lots of the product — 77946, 81141, and 81142 — shipped between January 2007 and May 2008 by ETHEX Corporation, of St. Louis, Mo.

The manufacturer found a small number of oversized tablets in lots that hadn’t yet been distributed, according to a company release.

There have been no reported adverse events associated with the product, according to the FDA, and ETHEX said it had not received any report of oversized tablets from any of its wholesalers, retailers, or consumers.

Multiple companies sell versions of the generic dextroamphetamine sulfate. The tablets in question are round and orange and have “ETHEX” and “311″ etched on one side.

Dextroamphetamine sulfate is a psychostimulant used primarily to treat Attention-Deficit Hyperactivity Disorder (ADHD) and narcolepsy.

A dextroamphetamine sulfate overdose may put patients at an increased risk of tachycardia, hypertension, tremors, decreased appetite, headache, insomnia, dizziness, blurred vision, or nausea, the FDA said.

This is the company’s second recall this year because of manufacturing defects that resulted in double-strength tablets.

In June, ETHEX recalled morphine sulfate 60-mg extended release tablets because they were double the appropriate thickness and could contain a double dose of morphine, according to the FDA.

SAN JOSE, Costa Rica, July 15 — There’s no evidence that removing the ovaries when a hysterectomy is performed has any health benefit for women, researchers here said.

But there’s also no evidence of harm, Leonardo Orozco, M.D., of the OBGYN Women’s Hospital San Jose, and colleagues reported in a Cochrane Review.

That’s because they found only one controlled trial of the widespread practice, and that study addressed only sexual and psychological health, Dr. Orozco and colleagues said.

“There could be a real benefit of harm associated with oophorectomy, but it has not been identified,” Dr. Orozco said in a statement. “Until more reliable research is available, removal of the ovaries at the time of hysterectomy should be approached with caution.”

Currently, clinicians usually avoid prophylactic oophorectomy in women at low risk for ovarian cancer if the patient is under 40 and they routinely perform it if the patient is over 55. The decision is usually individualized for women in the intervening years, the researchers noted.

Between 1988 and 1993, CDC data show, the ovaries were conserved in up to half of women undergoing hysterectomy at 40 or older and one estimate is that about 300,000 women in the U.S. have a prophylactic bilateral oophorectomy each year.

The most common reason to remove the ovaries is to reduce the risk of ovarian cancer, the researchers said. One estimate suggested that between 4% and 14% of women who develop ovarian cancer will have had hysterectomies in which the ovaries were left.

Removing the ovaries changes the hormone balance, which affects both bone and lipid metabolism in ways similar to natural menopause. And there is some evidence that removing the ovaries — especially before the age of 35 — markedly increases the risk of myocardial infarction, the researchers said.

However, of the 119 abstracts screened for the review, only two referred to a controlled clinical trial, both of them reporting aspects of the same study, Dr. Orozco and colleagues said. The remaining 117 abstracts were excluded.

The two reports concern 362 women recruited between March 1996 and December 1999 at two centers in Sweden for a study comparing hysterectomy versus hysterectomy plus bilateral salpingo-oophorectomy.

Both reports dealt with the sexual and psychological well-being of the study participants, including such things as anxiety, depressed mood, general health and vitality, sexual experience and responsiveness, and degree of sexual satisfaction.

They also included measurements of sex steroids, plasma estradiol and sex hormone-binding globulin, free androgen index, and free plasma estradiol index both preoperatively and after a year of follow-up.

Although the study had several limitations, the results suggest that removing the ovaries during an elective hysterectomy doesn’t negatively affect sexual and psychological well-being in adequately estrogenized premenopausal women, the researchers said.

However, Dr. Orozco and colleagues said, the studies said nothing about the possible benefits and harms identified for this review, including mortality (from such causes as cancer, myocardial infarction, stroke, and thromboembolism), future gynecological interventions, and adverse events.

Because of the lack of evidence, they argued, “the benefits or harms of performing a bilateral oophorectomy remain unclear.”

They added that the existing evidence “does not support” the high numbers of prophylactic oophorectomies in clinical practice.

“There is an urgent need for (randomized controlled trials) to resolve this question,” they concluded.

The study was supported internally by the Central American Branch of the Iberoamerican Cochrane Network and the International Health Central American Institute, but there was no external support. The researchers reported no conflicts.

Primary source: Cochrane Systematic Reviews

Source reference:

Orozco LJ, et al “Hysterectomy versus hysterectomy plus oophorectomy for premenopausal women” Cochrane Database of Systematic Reviews 2008; Issue 3. Art. No.: CD005638. DOI: 10.1002/14651858.CD005638.pub2.

WASHINGTON, May 10 — When the stroke is hemorrhagic, secondary prevention measures are significantly less likely to be initiated than when the event is ischemic, researchers said here.

That finding emerged from a three-year study of 188,982 stroke patients treated at 662 hospitals, conducted by members of the American Heart Association’s Get With The Guidelines Steering Committee, reported Eric E. Smith, M.D., M.P.H., of Massachusetts General Hospital, and colleagues.

The use of each of four interventions to prevent a recurrence — lipid-lowering, diabetes control, weight loss, and smoking cessation — was significantly less in hemorrhagic stroke survivors than after an ischemic stroke or TIA, the investigators reported today at the AHA’s Scientific Forum on Quality of Care and Outcomes Research in Cardiovascular Disease and Stroke.

Dr. Smith cautioned, however, that in one case — use of statin therapy — the prescribing pattern could reflect a concern about “the known association between low cholesterol levels and an increased risk for intracranial hemorrhage.”

In that case, he said, the physician’s decision to withhold statin therapy may reflect the clinician’s assessment of the patient’s risk for a cardiovascular event — or an ischemic cerebrovascular event — against the risk of a second brain bleed.

The majority of patients (166,284) suffered ischemic strokes or TIAs, but the study included 17,195 patients who survived intracranial hemorrhage and 5,503 patients who had subarachnoid hemorrhage.

Last week the American Stroke Association and the AHA published guidelines on acute management of intracranial hemorrhage, but Dr. Smith said the results of this study suggest, “guidelines for secondary prevention of cerebrovascular and cardiovascular disease following hemorrhagic stroke may be warranted.”

Among the findings:

On average patients with intracranial hemorrhage were a year younger than ischemic stroke patients (P

The group responsible for Consumer Reports on everything from vacuums to cars today released a report card for CABG outcomes at roughly 20% of the nation’s heart surgery centers.
The ratings identify the 50 top-performing centers based on risk-adjusted clinical data submitted to the Society of Thoracic Surgeons registry.
This list, which was posted online, included Massachusetts General Hospital and a group at George Washington University Hospital but most of the centers were community medical centers. The ranking will also be published in the October print edition of Consumer Reports.

Mass General and the surgeons group at George Washington were among 50 centers that received three stars — the top rating.

Only five of the 221 surgical groups that agreed to public release of their CABG outcomes data garnered a below average or one star rating on the three-star scale, according to Consumer Reports publisher Consumer Union.

The centers with significantly below average performance were: Allied Physicians affiliated with Lutheran Hospital of Indiana Baylor All Saints Medical Center at Fort Worth, Texas Desert Springs Hospital Medical Center in Las Vegas Regional Heart Center Thoracic Surgical Associates affiliated with Mercy Medical Center in Canton, Ohio United Regional Physician Group of Wichita Falls, Texas

A Perspective article in the New England Journal of Medicine called release of the ratings “a watershed event in healthcare accountability.”

In the article, timed to the release of the doctor ratings, Timothy G. Ferris, MD, MPH, and David F. Torchiana, MD, both of Massachusetts General Hospital in Boston (a three-star center), explained that the quality of data that went into the scores far exceeds anything that healthcare consumers have had access to before in any field on a national basis.

A few states, notably New York and Pennsylvania, already provide access to clinical outcomes data.

The STS Adult Cardiac Surgery Database, though, includes voluntary reporting by more than 90% of the approximately 1,100 cardiac surgery programs in the nation. The data are collected from patient charts, which the report card aggregates into a physician group-level performance score on 11 rigorously-validated measures.

Consumers get to see not only a center’s total score but also the following: 30-day survival (such as “patients have a 98% chance of surviving at least 30 days after the procedure and of being discharged from the hospital”) Complications (such as “patients have an 89% chance of avoiding all five of the major complications”) Use of appropriate medications, such as aspirin, statins, and beta-blockers (such as “patients have a 90% chance of receiving all four of the recommended medications”) Surgical technique, such as use of an internal thoracic artery for the graft (such as “patients have a 98% chance of receiving at least one optimal surgical graft”)

“This is objective data that is about as good as you can get,” David M. Shahian, MD, also of Massachusetts General Hospital, said in an interview.

As chair of the STS committee responsible for the database, he worked extensively with Consumer Union on the public release of the data his organization has been collecting since 1989.

One of the big concerns for physicians is getting misclassified in these public ratings, which the state-based experience has shown leads providers to shy away from taking on the highest-risk patients, who although they may stand to benefit most from CABG also carry higher risk of mortality that could ding a physician’s numbers.

Cardiac surgeons should instead see public reporting of their results as an incentive to excel, Shahian urged.

“We want to assure our providers that our methods of adjusting for patient severity are quite good,” he told MedPage Today in an interview.

Doctor ratings available online previously have relied on patient reviews (which are notoriously subject to selection bias for only the most positive and negative impressions), reputation, or administrative data that rarely takes into account how sick the patient population treated was, Consumer Union noted in a press release.

However, the new reporting card still falls short in some respects, Ferris and Torchiana noted.

Selective participation of programs — only about a quarter of those in the database allowed public release of outcomes — as well as lack of physician-specific ratings or long-term outcome reporting are likely to draw criticism, they wrote in the editorial.

Despite state-required reporting in some areas, centers there may still have been reluctant to release their full data.

Ferris explained that states typically provide only mortality figures, which vary little. The primary determinant of center-to-center variability — and thus ratings — is complication rates, which have not been public, he noted.

Advocates of transparency can be expected to pressure nonparticipating cardiac surgery programs, he and Torchiana added in the editorial.

Once the participants test the waters and show others how it works, others are likely to be willing to follow, Shahian said.

In the era of increasing emphasis on transparency and accountability, few surgeons or groups have suggested public reporting is the wrong thing to do, he explained.

“In the new healthcare environment we’re in, many if not most [medical professional] societies are going to have to come to grips with this very quickly,” Shahian predicted in the interview.

While Ferris agreed, he expressed skepticism that others would find the transition so easy.

CABG has the advantage of being a procedure for which oftentimes people have a choice of providers, that is fairly reproducible, and has relatively layperson-friendly performance measures, he pointed out.

“There aren’t a lot of examples of medical services that meet those criteria,” he told MedPage Today.

In the end, public reporting data is only useful if used, and many patients likely won’t turn to Consumer Reports when choosing a thoracic surgeon, he said.

Patients should use the report card when in a nonemergent situation, Shahian argued.

But “it’s only one part,” he cautioned. “We want them to still listen to the advice of their referring cardiologists and other physicians caring for them.”

The ratings can be found at wwwnsumerReportsHealth.

Ferris and Torchiana reported having no conflicts of interest to disclose.

ATLANTA, Aug. 17 — Most states met national vaccination objectives for children in kindergarten during the 2006-2007 school year, according to a study by the CDC.

Data from 49 states and the District of Columbia showed that 83% of the reporting entities had achieved the goal of at least 95% coverage for hepatitis B vaccinations, according to a report published in the Aug. 17 issue of MMWR: Morbidity and Mortality Weekly Report.

Between 70% and 80% had hit the goal for the four other types of vaccines-polio, diphtheria/tetanus/pertussis [DTP] (or derivations), measles/mumps/rubella, and varicella, said CDC investigators Carol Stanwyck, Ph.D., and Nidhi Jain, M.D.

The study included data from all states but Nevada, which did not report vaccination coverage for the 2006-2007 school year.

“These results underscore the effectiveness of school-entry requirements in increasing vaccination coverage but highlight a need for more standardized vaccination reporting among studies,” the investigators concluded.

The 95% threshold for vaccination coverage was set forth by the Healthy People 2010 federal initiative to encourage health promotion and disease prevention.

Assimilation of the data demonstrated at least 95% coverage for the following immunizations:

Hepatitis B, 83% (35 of 42 states, plus the District of Columbia)
DTP, 76% (38 of 50)
Poliovirus, 80% (40 of 50)
MMR, 70% (35 of 50)
Varicella, 74% (32 of 43)

The data also showed that 92% to 95% of reporting states had at least 90% coverage for all five immunizations.

Drs. Stanwyck and Jain pointed out variations in approaches to gathering and reporting vaccination data. All 49 states and the District of Columbia assessed vaccination rates in public schools. However, 44 states also gathered data from private schools, and six assessed vaccination rates in home-schooled children.

The authors found that 35 states based their reports on 95% or more of children enrolled in kindergarten; seven states based their reports on a randomized sample of schools and students; and the remaining states attempted to gather data on all enrolled kindergarteners, but got information on fewer than 95% of students.

In 29 states, health departments relied on data reported directly from schools; seven states’ health departments performed separate reviews of the data; and the remaining 14 states used other methods to develop their reports.

An editorial note stated that the CDC is working with states to improve and standardize methods for reporting immunization data. The CDC initiated a standardized online reporting system for the2002-2003 school year.

The agency has reviewed states’ survey methods and has developed preliminary recommendations for standardizing data collection and reporting. The recommendations will be revised as needed after the CDC receives feedback from state officials.

Additional information about assessing and reporting vaccination coverage is available online at www.cdc/vaccines/stats-surv/schoolsurv/default.htm.

Additional source: MMWR: Morbidity and Mortality Weekly Report

Source reference:

Centers for Disease Control and Prevention. “Vaccination coverage among children in kindergarten — United States, 2006-07 school year.” MMWR 2007;56:819-821.

DALLAS, Feb. 6 — Failure to control gestational diabetes with glyburide may reflect increased drug clearance, rendering typical doses of the sulfonylurea inadequate.Pregnancy doubles the clearance rate of oral glyburide, resulting in concentrations that are more than 50% lower than those seen in type 2 diabetic patients treated with the same doses, Mary F. Hebert, Pharm.D., of the University of Washington in Seattle, reported at the Society for Maternal-Fetal Medicine meeting here.”Treatment failure in some patients may be explained by inadequate dosing,” said Dr. Hebert. “Insulin secretion, insulin resistance, and overall disposition index are higher in women with gestational diabetes than in women with type 2 diabetes.”

In addition, fetal exposure to the drug may be greater than previously recognized, she added.

Gestational diabetes and type 2 diabetes are characterized by impaired beta-cell response in relation to the degree of insulin resistance. Glyburide frequently is used to treat both types of diabetes. However, the drug’s optimal dosage and impact on glucose metabolism in gestational diabetes had not been determined, said Dr. Hebert.

In an effort to better define glyburide’s pharmacokinetics in pregnancy, the investigators evaluated 40 patients with gestational diabetes in the third trimester of pregnancy and 15 patients with type 2 diabetes. Patients in both groups had been on stable doses of glyburide for at least a week.

Each patient consumed a mixed-meal glucose load, followed by serial blood sample collection over five hours. Concentrations of insulin, glucose, and C-peptide were determined for each sample. Pharmacodynamic analysis of the samples consisted of insulin sensitivity, insulin secretion rate index, and disposition index (the product of the two parameters).

The pregnant patients received a mean glyburide dose of 3.4 mg BID, and the dose averaged 3.9 mg BID in the patients with type 2 diabetes. The dose range was 1.25 to 10 mg BID in both groups.

The area under the curve, peak concentration (Cmax), and clearance (CL/F) differed significantly between the two groups. Compared with the patients with type 2 diabetes, the pregnant patients had:

AUC 72 ng*hr/mL versus 160 ng*hr/mL (P