BETHESDA, Md., July 13 — More low-birth-weight infants are being born but older kids are heavier than ever, according to the federal government’s latest snapshot of child health.

In its 10th annual report, the Federal Interagency Forum on Child and Family Statistics showed little change in the overall well-being of American children from last year’s numbers, but it revealed a few encouraging as well as a few distressing trends.

The report, titled America’s Children: Key National Indicators of Well-Being, 2007, is a compilation of statistics on children’s health, family life, housing, education, and behavior, gathered from cabinet-level departments plus the Environmental Protection Agency, National Science Foundation, and the Office of Management and Budget.

“When we review the health aspects of the report, we see some continuing problems, we see progress, and we see differences by race, by ethnicity and by poverty level or income level,” commented Edward Sondik, Ph.D., director of the National Center for Health Statistics, in a press briefing.

Among the positives, he said are improved immunization rates among toddlers over the past decade, with 81% of children ages 19 to 35 months having received the recommended series of vaccinations, up from 70% in 1994.

“This indicator is particularly significant, because we do not see differences here by race or ethnicity,” he said.

In addition, the birth rate for teens 15 to 17 has continued to decline, to a record low of 21 per 1,000, down from 39 per 1,000 in 1991. The birth rate for non-Hispanic black girls declined by 60% from 1991 to 2005, reversing a trend toward higher teen births in this population from 1986 to 1991. Among non-Hispanic white girls, the birth rate declined by half over the same period.

Second-hand smoke, as measured by detectable levels of the nicotine metabolite cotinine in the blood of children, also declined significantly, from 88% in 1988 to 1094, to 59% in 2001 to 2004.

“But still, more than half of children ages four to 11 have detectable levels,” Dr. Sondik said.

Asthma rates, included as a health indicator for the first time in the annual reports, occurred in 2005 in about 9% of children from birth to age 17, with about 5% of all children having or more asthma attacks during the previous year. As seen in other studies, asthma prevalence was higher among African Americans, at 13%, and although Hispanics in general had about a 9% asthma prevalence, the prevalence among children of Puerto Rican origin was 20%, compared with only about 5% for Mexican Americans.

“It must be related to some kinds of differences in the environments to which they were exposed as younger children, or genetic susceptibility differences among these subparts of the population,” commented Duane Alexander, M.D., director of the National Institute of Child Health and Human Development.

Among the negative trends was the increase in the percentage of infants with a low birth weight, which has grown steadily from 6.7% in 1984, to 9.2% in 2003.

“We’ve got all this technology to help kids with low birth weight survive, but what we haven’t been as successful with is prenatal care, particularly for low income populations, and that’s what determines a lot of the low birth weights that we see,” said community health specialist Shari Nethersole, M.D., of Children’s Hospital Boston and Harvard Medical School, who was not involved with the report.

Over roughly the same period, the proportion of children ages six to 17 who were overweight increased from 6% in 1976 to 1980 to 11% in 1988 to 1994 and continued to rise to 18 in 2003 to 2004. Dr. Sondik cited the prospect, if the trend continues, of higher rates of obesity, type 2 diabetes, and other health problems.

Among the other notable elements of the report (all changes are significant unless otherwise noted):

5% of children ages four to 17 were reported by a parent to have definite or severe emotional or behavioral difficulties. Eighty-one percent of the parents consulted a health care provider or school staff member about their child’s difficulties, 40% reported that their child was prescribed medication for the problem, and 47% reported that the child had received non-drug therapy.
60% of children in 2005 were living in counties where one or more air pollutants was above allowable levels, up from 46% in 2004.
10% of children lived in communities with substandard drinking water, up from 8% in 2004.
Blood lead levels in children ages one to five were unchanged, at a median of 1.6 g/dL.
More children are living in households where the cost of shelter is burdensome, conditions are crowded, or the housing is physically inadequate. The rate was 40% in 2005, compared with 37% in 2003.
The rate of adolescents ages 12 to 17 involved in serious crimes increased from 14/1,000 in 2004, to 17/1,000 in 2005.

The report is available for download at childstats or by clicking the complimentary link at the top right of your screen.

Primary source:

Additional source: America’s Children: Key National Indicators of Well-Being, 2007

Source reference:

America’s Children

The 30-year-old woman arrived at the Henry Ford Hospital emergency room in Detroit out of breath and coughing blood.

It didn’t take long for doctors to figure out why: The woman admitted to having been at a party at a hotel five days prior at which she — and others — received injections of liquid silicone to “enhance” the buttocks and various body parts.

The silicone was not the medical silicone that is sometimes used for implants, but the type easily procured at hardware stores like Home Depot. The fat solvent used to make the silicone had quickly traveled to her lungs and gotten stuck in the airways, resulting in “silicone embolism syndrome,” or clots, in this case, in the smaller vessels in her lungs.

The syndrome, admittedly rare, was first seen in transsexual men wanting to augment their breasts in the 1970s.

“There are two types of side effects [that can result from silicone injections],” said Dr. Angel Coz, the pulmonary and critical care specialist who treated the woman. “Lungs is one of them. The other goes to the brain. The mortality in lungs is close to 20 percent but in the brain it’s close to 100 percent.”

This woman, who was attempting to augment her buttocks, was one of the lucky ones. She survived after receiving steroids, said Coz, who is slated to present information on the case Monday at the American College of Chest Physicians’ annual meeting in Honolulu.

Others have died.

“We’ve been hearing about this,” said Dr. Malcolm Z. Roth, president of the American Society of Plastic Surgeons. “There are ‘pumping parties,’ involving high-volume injections to fill up the face, lips, cheekbones, chin or breast. Often it’s buttock enhancement and often it’s not sterile.”

And these illicit procedures may be on the rise, thanks to a slow economy and pocketbooks that aren’t full enough to afford licensed plastic surgeons, said Roth, who is also chief of plastic surgery at the Albany Medical Center in New York.

“It’s really a white-coat deception,” Roth said. “Sometimes the person doing the injections claims to be a physician from another country and in some cases the patient knows very well it’s not a physician but, feeling they can’t afford to go to a legitimate board-certified plastic surgeon, they find a short cut.”

Two other, similar cases of patients developing complications after silicone injections are also being presented at the meeting this week.

One involved a 22-year-old woman who showed up at the UCLA Medical Center emergency room, also with shortness of breath. This quickly progressed to right ventricular failure of the heart and the patient died despite the physicians’ best efforts.

Most likely, the silicone and solvent had damaged the lungs, leading to collapse of the heart.

This patient had had injections in her buttocks from “a doctor in Mexico” earlier that day, a friend told doctors.

The researchers presenting the case said this is the first documented case of right ventricular failure from silicone injections.

The third case was a 23-year-old woman with the familiar symptoms, shortness of breath and cough, who had had several silicone injections in her buttocks.

She was diagnosed with silicone embolism syndrome but, after receiving oxygen and steroids and spending five days in the hospital, recovered and went home.

According to Roth, patients should “run away from these procedures.”

“You don’t do medical procedures in a hotel room or garage. This procedure is illegal,” he said. “Patients need to do their homework and check the credentials of the professional they’re considering for their cosmetic procedure.”

“This is something that is not done by doctors,” added Coz. “It’s completely out of the realm of what any physician would do.”

More information

Find out about legitimate plastic surgery procedures at the American Society of Plastic Surgeons.

BETHESDA, Md., June 30 — Inherited variations in a gene that codes for skin pigmentation can dramatically increase the risk of acquiring mutations in another gene that’s linked to one form of melanoma, researchers here say.

The finding means that even people with dark skin may be at increased risk, if they inherit a mutated form of the melanocortin-1 receptor (MC1R) gene, said Maria Teresa Landi, M.D., Ph.D., of the National Cancer Institute here.

The new understanding “could lead to more targeted therapy and targeted prevention,” Dr. Landi said in an interview.

Researchers have known for some time that there are links between inherited variation in the gene—which is involved in such things as skin pigment and hair color—and melanoma, especially in areas of skin highly exposed to sunlight.

At the same time, melanoma that occurs on parts of the body that are only intermittently exposed to sun—so-called non-chronic sun damage (non-CSD) melanoma—is highly likely to have mutations in a known oncogene, BRAF, Dr. Landi and colleagues noted in a report in the online edition of the journal Science.

But exactly why those tumors should be highly associated with BRAF mutations, while they’re less frequent in chronic sun damage cancers, was not known, Dr. Landi said. “We have now discovered that MC1R dramatically predisposes individuals with no excessive sun exposure and variable pigmentation to developing (non-CSD) melanoma,” by increasing the risk of BRAF mutations.

“This is not (melanoma caused by) chronic, chronic, chronic sun exposure,” Dr. Landi said. “It’s typical of the indoor worker who goes on vacation and spends a lot of time in the sun suddenly.”

Analysis of two cohorts of patients with non-chronic sun damage melanoma—one in Italy and one in the U.S.—showed that having variant forms of the MC1R gene sharply increased the risk of having mutations in BRAF, although, Dr. Landi and colleagues said, “the mechanism mediating this susceptibility is currently unknown.”

There’s no immediate implication for clinical practice, Dr. Landi said: “At the moment, we only know this link.” But, she noted, clinical trials of drugs that target the BRAF pathways are already under way and understanding the link between MC1R and BRAF may lead to better drug development.

In the two cohorts, having one or more variant alleles of MC1R was associated with an increased risk of BRAF mutations. Compared to patients with non-chronic sun damage melanoma and wild-type MC1R:

Italian patients with any variant had more than 13 times the risk of BRAF mutations. The odds ratio was 13.2, with a 95% confidence interval from 2.1 to 81.4.
American patients with any variant had six times the risk. The odds ratio was 6.0, with a 95% confidence interval from 1.2-30.6.

When the researchers compared the Italian cohort (of 85 patients) with 171 healthy controls, they found that the overall melanoma risk was 3.3-fold higher in individuals with any MC1R variant compared to individuals with no variant and that the risk increased with the number of variations.

Stratifying the tumors based on the presence or absence of BRAF mutations showed that the increased risk of non-chronic sun damage melanoma was entirely confined to cancers with BRAF mutations, Dr. Landi and colleagues reported.

For people with one MC1R variant allele, the odds ratio was 7.2 (with a 95% confidence interval from 2.1 to 24.9) and climbed to 17.0 (with a 95% confidence interval from 4.2 to 68.6) for those with multiple variant alleles, compared with wild-type MC1R. The finding was highly significant with P<0.0001 for the trend.

Primary source: Scienceexpress

Source reference:

Maria Teresa Landi et al. “MC1R Germline Variants Confer Risk for BRAF-Mutant Melanoma.” Science 2006; DOI: 10.1126/science.1127515

Certain lots of epoetin alfa (Epogen and Procrit) — used to treat anemia related to HIV therapy, chronic renal failure, and chemotherapy — were voluntarily recalled due to the presence of thin, barely-visible glass flakes in the solution which could cause adverse events.

According to a statement from the drug’s manufacturer, Amgen, the glass debris may have formed while the solution sat in glass vials.

The recall was done as a precaution, according to an FDA Safety Alert.

The risk of adverse events is greater in patients who receive intravenous injections compared with subcutaneous injections, Amgen said in a separate statement to healthcare professionals.

Potentially serious problems resulting from use of an injectable product containing particulates include embolic, thrombotic, and other vascular events (e.g., phlebitis) when delivered intravenously — and foreign body granuloma, injection site reaction, and increased immunogenicity when delivered via subcutaneous injections, according to the FDA.

So far, there have been no reported adverse events, Amgen said.

The company advised healthcare professionals should inspect vials of the products for visible particulate matter or drug discoloration before administration.

The affected products include specific lot numbers of: Epogen 1 mL single-dose 2000, 3000, 4000, and 10,000 units/mL Epogen 2 mL multidose 10,000 units/mL Epogen 1 mL multidose 20,000 units/mL Procrit six single-dose vial cartons and 25 single dose vial trays of 2000 units/mL, 3000 units/mL, 4000 units/mL, and 10,000 units/mL Procrit 2 mL four multidose vial cartons of 10,000 units/mL Procrit 1 mL four multidose vial cartons of 20,000 units/mL Procrit four single-dose vial cartons of 40,000 units/mL

Amgen, based in Thousand Oaks, Calif., conducted the recall in cooperation with the FDA.

More than half of the multiple sclerosis patients in a closely watched study had narrowing of some neck veins leading from the brain, researchers said.

On the other hand, so did 22.4% of healthy controls in the first large study to test a new theory about the disease: that it’s caused by such abnormally narrow veins, a condition dubbed “chronic cerebrospinal venous insufficiency.”

Nevertheless, Robert Zivadinov, MD, PhD, of the University of Buffalo, said in a university news release that he is “cautiously optimistic and excited” about the results, which were originally scheduled to be presented at the annual meeting of the American Academy of Neurology in April.

“The data encourage us to continue on the same course,” he said in the statement. “They show that narrowing of the extracranial veins, at the very least, is an important association in multiple sclerosis.”

Zivadinov was traveling and not immediately available for further comment.

The study drew intense interest when it began enrolling patients last year, because the theory that abnormal veins play a role in multiple sclerosis — as yet unproved — is the first major shift in thinking about the disease in decades. (See Radical MS Theory Stirs Interest)

But experts cautioned that the press release doesn’t contain enough details to allow scientists to judge the validity of the results, which in any case are partial and preliminary.

“From the press release, it’s very difficult to analyze this in any way,” said John Richert, MD, executive vice president for research and clinical programs at the National Multiple Sclerosis Society.

“It makes you want to see more,” he told MedPage Today.

The release, which has not been subject to the usual scientific peer review, contained data on 441 volunteers, including 280 with multiple sclerosis, most of them adults.

However, that’s a small fraction of the more than 1,700 volunteers, including 1,000 adults and 50 children with the disease, who are expected to be enrolled.

It also was limited to data on ultrasound scans of the volunteers. The results of magnetic resonance imaging, to test other aspects of the theory, were not given.

Blocked veins in the volunteers were studied according to five criteria, other experts noted, but what they were wasn’t reported, so that it was impossible to tell if they differed from earlier studies.

The release also said the researchers saw a correlation between venous insufficiency and the progression of the disease, “but even that statement is difficult to interpret exactly,” Richert said.

The Buffalo study is a follow-up to research conducted by Paolo Zamboni, MD, of the University of Ferrara in Italy, which showed chronic cerebrospinal venous insufficiency to be strongly associated with multiple sclerosis.

Zamboni also conducted a small surgical intervention trial that appeared to show a benefit to patients from opening up the veins.

Not all experts were skeptical of the reports.

The Buffalo report was a surprise mainly because its results were “less impressive” than Zamboni’s findings, according to Salvatore Sclafani, MD, of SUNY Downstate College of Medicine in Brooklyn.

Sclafani said in an e-mail that the difference may be a function of a “steep learning curve” in reading and interpreting the results of the ultrasound scans of volunteers’ veins. “My own personal experience with the ultrasound examinations is that they are quite difficult to perform,” he said

“I have now studied many patients with MS and all have had abnormalities of the veins,” said Sclafani, who has recently begun studying the issue.

The Buffalo results vary slightly, depending on how some “borderline” volunteers are counted, the release said.

If the 10.2% of volunteers whose results were classed as borderline were included in the normal category, the incidence of venous insufficiency was 56.4% in the multiple sclerosis patients and 22.4% in the controls.

On the other hand, if the borderline results were excluded, the proportion of affected patients rose to 62.5%, compared with 25.9% percent of healthy controls.

But the finding that a proportion of healthy controls had venous insufficiency needs further investigation, Zivadinov said in the release.

This article was developed in collaboration with ABC News.

DENVER, Sept. 17 — Massage therapy afforded patients with advanced cancer immediate relief of pain and improvement in mood, a randomized trial found.

But relief was short-lived, Jean S. Kutner, M.D., of the University of Colorado, and colleagues reported in the Sept. 16 issue of the Annals of Internal Medicine.

The single-blind study that compared massage therapy with simple-touch therapy included 380 adults with advanced cancer (stages III or IV), 90% in hospice care, with moderate-to-severe pain. The patients were enrolled from November 2003 through October 2006.

Massage therapy, provided by licensed therapists, consisted of six 30-minute sessions over two weeks with at least 24 hours between treatment sessions.

The intervention included gentle, smooth, gliding strokes (effleurage), squeezing, rolling, and kneading of muscles (petrissage), and trigger-point release using finger pressure at painful areas to break cycles of spasm and pain.

Simple-touch therapy, given to the control group, consisted of placement of both hands on the patient for three minutes at each of a variety of locations. Pressure was light and consistent, with no side-to-side hand movement. Providers had no past body or energy work experience. Sessions lasted for 30 minutes over two weeks.

Primary outcomes were immediate change in pain (as measured by the Memorial Pain Assessment Card) and sustained change, measured using the Brief Pain Inventory (BPI).

Secondary outcomes were immediate change in mood, 60-second heart and respiratory rates and sustained change in quality of life, symptom distress, and analgesic medication use.

The researchers recorded the name, dose, and frequency of medications taken during the preceding 24 hours every week to document analgesic medication use. To permit comparisons, medication doses were converted to parenteral morphine equivalents (mg/d).

The immediate outcome analysis included 298 patients; 348 participated in the immediate and sustained outcome analysis.

For a variety of reasons, such as death or withdrawal from the study, 82 persons did not receive any allocated study treatments (37 massage patients, 45 controls participants).

Both groups demonstrated immediate improvement in pain. The massage group saw a decline of 1.87 points (95% CI -2.07 to -1.67 points) and controls had a drop of 0.97 points (95% CI -1.18 to -0.76 points).

Mood also improved in both groups, with those in the massage group gaining 1.58 points (95% CI 1.40 to 1.76 points) and controls 0.97 point (95% CI 0.78 to 1.16 points).

Massage was clinically superior for both immediate pain relief and improving mood (mean difference, 0.90 and 0.61 points, respectively; P< 0.001).

However both groups demonstrated statistically, but not clinically, significant improvement in pain relief over three weeks, the researchers reported.

Mean differences over time for sustained pain relief were:

mean pain, 0.07 point(95% CI -0.23 to 0.37 points
worst pain, -0.14 point (95% CI -0.59 to 0.31 points)
quality of life, 0.08 point (95% CI -0.37 to 0.53 points)
symptom distress, -0.002 point (95% CI -0.12 to 0.12 points)
or analgesic medication use, -0.10 mg/d (95% CI -0.25 to 0.05 mg/d)

There were no statistically significant differences in adverse events or deaths.

Study limitations noted by the researchers included the fact that the immediate outcome measures were obtained by unblinded study therapists, possibly leading to reporting bias and an overestimation of a beneficial effect. Also, patients self-reported most measures.

The generalizability to all patients with advanced cancer is uncertain. The study patients were English-speaking adults with an estimated life expectancy of three weeks or longer who could participate.

Furthermore, the researchers noted, the differential beneficial effect of massage therapy over simple touch was not conclusive without a usual-care control group.

However, their findings, they said, support offering massage for immediate symptom relief.

They also noted that, considering the potential therapeutic benefits of attention and simple touch, the hands-on therapy could be provided by family members or hospice volunteers, as an adjunct to usual care.

The study was supported by the National Institutes of Health and National Center for Complementary and Alternative Medicine, the Mendel/Asarch Lung Cancer Family Foundation Grants Program, the Paul Beeson Physician Faculty Scholars in Aging Research Award, and the Robert Wood Johnson Generalist Physician Faculty Scholars Program (Dr. Kutner).

No financial conflicts of interest were reported.

Primary source: Annals of Internal Medicine

Source reference:

Kutner JS, et al “Massage Therapy versus Simple Touch to Improve Pain and Mood in Patients with Advanced Cancer: A Randomized Trial” Ann Intern Med 2008; 149: 369-379.

BIRMINGHAM, Ala., Jan. 7 — If a woman who has had a Caesarean delivery has another such elective procedure before 39 weeks of gestation, the risk of an adverse neonatal outcome increases by 50% or more, a large cohort study suggested.

A repeat elective Caesarean at 38 weeks was associated with an odds ratio of 1.5 for adverse outcomes, increasing to 2.1 for Caesarean delivery at 37 weeks, Alan Tita, M.D., of the University of Alabama at Birmingham, and colleagues reported in the Jan. 8 issue of the New England Journal of Medicine.

Adverse respiratory outcomes, need for mechanical ventilation, newborn sepsis, hypoglycemia, admission to the neonatal ICU, and hospitalization for five days or longer all occurred more often in babies delivered by Caesarean before 39 weeks of gestation.

“These early deliveries are associated with a preventable increase in neonatal morbidity and admissions to the neonatal ICU, which carry a high economic cost,” the authors concluded. “These findings support recommendations to delay elective delivery until 39 weeks of gestation and should be helpful in counseling.”

Because of an increased risk of respiratory complications, elective Caesarean delivery before 39 weeks usually is discouraged in the absence of clear evidence of fetal lung maturity. Even so, the rate of Caesarean delivery in the U.S. increased by 50% from 1996 to 2006, the authors noted.

Approximately 40% of Caesarean deliveries are repeat procedures. As the number of procedures increases, so do the public health implications related to the timing of delivery, the authors continued.

“Elective Caesarean delivery may be scheduled to accommodate patient and physician convenience, and here is a risk that it may be performed earlier than is appropriate,” they said.

To examine the implications of repeat elective Caesarean, the authors analyzed data from 19 centers participating in an NIH fetal medicine network. They identified women who had viable singleton pregnancies delivered electively from 1999 through 2002.

Of 24,077 women who had repeat Caesarean deliveries at term, 13,258 had elective procedures, of which 35.8% were performed before 39 weeks of gestation, said the authors.

The primary outcome was the composite of neonatal death and adverse events, including respiratory complications, treated hypoglycemia, newborn sepsis, and admission to a neonatal ICU.

Compared with births at 39 weeks, births at 37 weeks had more than a two-fold increased risk of the primary outcome (OR 2.1, 95% CI 1.7 to 2.5). For births at 38 weeks, the hazard remained increased (OR 1.5, 95% CI 1.3 to 1.7). Combining results for births at 37 and 38 weeks resulted in a significant difference from births at 39 weeks (P

FORT LAUDERDALE, Fla., Jan. 30 — Women having coronary bypass surgery are more likely than men to be anemic, and intraoperative transfusions may be a factor that increases their early-mortality rate, researchers said here.

In a retrospective review of 6,348 CABG patients, unadjusted 30-day mortality was 4.5% for women versus 2.8% for men (P

CHICAGO, Oct. 27 — An endocrinologist of 1994 would scarcely recognize today’s world of type 2 diabetes, according to researchers here.

The number of office visits for diabetes therapy rose from 25 million in 1994 to 36 million in 2007, and the increased use of glitazones and combination therapies have contributed to the jump in drug expenditures from $6.7 billion in 2001 to $12.5 billion in 2007, G. Caleb Alexander, M.D., of the University of Chicago Hospitals, and colleagues reported in the Oct. 27 issue of Archives of Internal Medicine.

The study documented “large shifts in patterns of diabetes treatment and pharmaceutical expenditures across treatment classes,” the authors said.

In 2000, 11 million Americans — a prevalence of 4% — were diagnosed with diabetes, but by 2050, the authors expect that number to soar to 29 million, or a prevalence of 7%.

Before 1995, most diabetes patients were treated with sulfonylureas, isophane insulin, and regular insulins. But many new pharmacotherapy options have been introduced since then, including nonsulfonylurea insulin secretagogues, incretins, DDP-4 inhibitors, glitazones, and long-acting insulin.

To evaluate trends in diabetes care, the researchers analyzed prescription data from the National Disease and Therapeutic Index for patients ages 35 and older treated for type 2 diabetes from 1994 through 2007. They used the National Prescription Audit to asses medication costs from 2001 through 2007.

The authors found “significant shifts” in the medications used for diabetes therapy. In 1994, patients were treated either with insulin preparations (38% of treatments, 95% CI 34% to 42%) or sulfonylureas (67% of treatment, 95% CI 67% to 73%).

But by 2007, newer drug classes were used, including metformin (54%, 95% CI 49% to 59%), sulfonylureas (34%, 95% CI 31% to 37%), glitazones 28%, 95% CI 25% to 32%), insulin (28%, 95% CI 25% to 31%), sitagliptin phosphate, or the only available DPP-4 inhibitor (8%, 95% CI 7% to 9%), and exenatide, or the only available incretin (4%, 95% CI 3% to 4%).

Insulin use dropped between 1994 and 2000, but began to increase again with the rise of ultrashort-acting and long-acting insulin analogs, the researchers said.

“With the increase of these newer insulins,” the researchers said, “use of older insulin preparations has continued to decrease.”

While sulfonylureas once accounted for the majority of diabetes treatment, monotherapy dropped from 94% in 1994 to 30% in 2007. Combination therapy involving this class — especially with metformin — has become more common, accounting for 18% of all sulfonylurea use in 2007.

Metformin alone has been rapidly adopted, surpassing sulfonylureas as the leading class of diabetes treatment in 2004 (48%, 95% CI 44% to 52%), and continues to increase. This drug in combined treatments with sulfonylureas, glitazones, and sitagliptin have accounted for 12% of treatment visits or 23% of all metformin use in 2007.

Treatment with glitazones increased every year until peaking at 34% (95% CI 31% to 37%) in 2005, with a significant reduction in 2007. The first glitazone approved in 1997, troglitazone, was associated with hepatotoxicity and removed from the market in 2000, and today the most commonly prescribed glitazone is pioglitazone. Use of rosiglitazone dropped 63% by 2007.

Other new classes of diabetes treatments have been rapidly adopted into practice, including sitagliptin, a DPP-4 inhibitor, exenatide, an injectable incretin initially derived from Gila monster saliva, and three other classes: alpha-glucosidase inhibitors (less than one-half percent of treatments), short-acting metaglinide secretagogues (2%), and pramlintide acetate, an injectable amylin analog (less than 0.5%).

Patient characteristics have also changed, the researchers said. Subgroups of patients that had an increased number of office visits for diabetes from 1994 to 2007 included ethnic minorities (23% to 33%), women (45% to 51%), and patients younger than 60 (32% to 41%).

The mean number of annual physician visits per patient during that time decreased from 2.9 to 2.4, while the mean number of medications prescribed per visit increased from 1.06 to 1.45.

Drug expenditures and prescription prices have increased as well. From 2001 through 2007, expenditures increased by 87%, from $6.7 billion in 2001 to $12.5 billion in 2007.

The researchers said that major contributors to this increase were glitazones and combination products.

The mean cost per prescription of diabetes drugs increased from $56 in 2001 to $76 in 2007, also likely because of the increasing use of glitazones, as well as costly newer drugs such as long- and ultrashort-acting insulins, exenatide, and sitagliptin.

“Although increasing costs of therapy are partly attributable to more patients with diabetes and more medications per patient,” the researchers said, “the greatest contributor to increasing costs is the substantially greater use of newer, more costly medications.”

Researchers said that while these therapies have become increasingly convenient and have lower rates of complications, further research of their long-term benefits is needed.

As glitazones and exenatide have become more widespread, there has been a rise in their off-label use, the researchers said. Though they are approved by the FDA as adjuncts to other diabetes medications, they are commonly used as monotherapy.

“Rapid diffusion of these drugs creates the potential for substantial exposure to these medications before definitive assessment of their safety,” the authors said.

The researchers also said that the rapid adoption of glitazones is a concern, given the removal of troglitazone and the potential cardiovascular risks of rosiglitazone, which needs further research.

The study was limited by the inability to assess outcomes, medication nonadherence, and the appropriateness of therapy.

Still, the researchers concluded that diabetes care has become increasingly complex because of more combined products, more medications per patient, and greater numbers of drugs and drug classes available.

Dr. Alexander is a Robert Wood Johnson Faculty Scholar and is supported by a career development award from the Agency for Healthcare Research and Quality.

A co-author was supported by an award from the National Heart, Lung, and Blood Institute.

The authors reported no disclosures.

Primary source: Archives of Internal Medicine

Source reference:

Alexander CG, et al “National trends in treatment of type 2 diabetes mellitus, 1994-2007″ Arch Intern Med 2008; 168(19): 2088-2094.

DALLAS, Dec. 30 – In 2005 heart disease killed more Americans than cancer, accidents or HIV infection, and it did so despite continued advances in heart disease diagnosis and treatment.

Those advances have made a dent in mortality, which declined from 322 per 100,000 in 1990 to 241 per 100,000 in 2002, but heart disease is unlikely to lose its No. 1 killer title any time soon.

The reason, authorities say, is that prevention is an elusive goal, not yet within the grasp of the cardiology’s considerable reach.

For example, according to the CDC’s National Center for Health Statistics, about half of America’s aging baby boomers have hypertension and almost 40% are obese-a combination that is likely to spell cardiovascular mortality for many.

And yet another study found that nearly one in five Americans from the age of 12 through 49 — an estimated 16 million — can’t pass a simple physical fitness treadmill test.

Nearing Medicare, Boomers Need Diets and Blood Pressure Control

Americans in Droves Flunk Fitness Test

While the diet-and-fitness message continues to be ignored by many Americans, researchers have been investigating mechanisms of heart disease progression as way to develop secondary prevention strategies.

Inflammation is considered a major contributor to plaque instability, which led many researchers to suggest that infection may be a trigger for cardiovascular events. And if infection could trigger an event, then antibiotics might prevent events.

That was the theory anyway, and 2005 was the year that it was debunked.

In a National Heart, Lung, and Blood Institute (NHLBI) trial, patients with stable coronary artery disease who underwent a year-long course of weekly azithromycin therapy were no less likely to have a heart attack or stroke than patients taking placebo.

Likewise, in a study sponsored by Bristol-Myers Squibb and Sankyo, acute coronary syndrome patients treated with Tequin (gatifloxacin) for a mean of two years had no reduction in cardiac events compared to patients randomized to placebo.

In announcing the negative results, NHLBI Director Elizabeth G. Nabel, M.D., said it was clear the antibiotics did not work, and it is time to focus prevention efforts on “the controllable risk factors for preventing coronary events.”

No Role for Antibiotics in Cardiovascular Secondary Prevention

Another popular theory, that aggressive lipid lowering with high-dose Lipitor (atorvastatin) is better than standard therapy with Zocor (simvastatin) or other less potent statins, retained its adherents even though it was not confirmed in one major study.

That study, Incremental Decrease in End Points Through Aggressive Lipid Lowering (IDEAL) trial, found that high dose Lipitor did not achieve a statistically significant benefit compared with usual-dose treatment with Zocor (simvastatin) in patients with a history of acute myocardial infarction.

Patients randomized to 80 mg of Lipitor had an 11% relative reduction in major coronary events versus patients randomized to 20 mg of Zocor (P=0.07).

Moreover the aggressive treatment failed to achieve a significant benefit even though high-dose Lipitor lowered LDL to 81 mg/dL versus 104 mg/dL in the Zocor group. There were no significant differences in either cardiovascular or all-cause mortality.

But those results did little to dampen the enthusiasm of many cardiologists who said they will stick to high=dose Lipitor regimens, and they have solid evidence to back up that clinical decision. In the Treating to New Targets (TNT) trial, which enrolled 10,001 patients with stable coronary disease, treatment with high-dose Lipitor to mean LDL levels of 77 mg/dL was associated with a 22% reduction in risk of major cardiovascular events compared with patients treated to a mean LDL of 101 mg/dL.

When he reported the TNT findings at the American College of Cardiology meeting in March, principal investigator John C. LaRosa, M.D., of the State University of New York Health Science Center in Brooklyn said, “We have entered a new era in the treatment of established coronary disease from starting at an LDL of 100.”

AHA: High-Dose Lipitor Does Not Outdo Standard-Dose Zocor

ACC: LDL Cholesterol of Less than 80 mg/dL Reduces Risk of Heart Attack and Stroke

But a big-stick statin may not always be the safest treatment choice, according to an analysis of post-marketing safety reports from patients using Crestor (rosuvastatin), a super-potent statin, Lipitor (atorvastatin), Zocor (simvastatin), or Pravachol (pravastatin).

Patients taking Crestor were eight times more likely to develop rhabdomyolysis, nephropathy, renal failure or proteinuria than patients taking Pravachol, and 6.5 times more likely to develop those complications than patients taking Lipitor.

Richard H. Karas, M.D., Ph.D., director of preventive cardiology and the Woman’s Heart Center at Tuft-New England Medical Center, noted that the absolute risk remains low: 28 events per million prescriptions for Crestor, versus 13 per million for Zocor, 3.5 per million for Pravachol, and 4.3 per million for Lipitor.

Safety and efficacy of devices was also a big issue this year, and most of the news for Guidant was bad. The device maker was forced to recall 170,000 pacemakers and implantable defibrillators, which was more than half of the company’s devices. Moreover, Guidant’s problems triggered a months’ long series of events that included a demand by cardiologists for a reworking of device safety alerts and recalls and a two-day FDA conference on device safety.

Implantable Devices Take a Licking but Don’t Always Keep on Ticking

Cardiologists Urge Changes in Safety Regs and Guidelines for ICD Use

Crestor Called Less Safe Than Other Statins

But while the year was a rocky one for the heart-device industry, it was another boom year for drug-eluting stents. These stents-Cypher, which delivers sirolimus to the endothelium and Taxus, which carries a payload of paclitaxol-now are the stents of choice for most interventionists. What remains, of course, is heavy competition between the two.

In this head-to-head race, Cypher came away as the winner in trials reported this year.

ACC: Cypher Stent Edges Ahead of Taxus in Head-to-Head Trials

ACC: Cypher Bests Taxus in All Comers Comparison Study

Just as Cypher was the odds-on-favorite in the world of stents, Plavix (clopidogrel) was this year’s winner for the drug reporting the most positive trial results. It was difficult to find a cardiology journal, or a cardiology conference that didn’t feature a positive Plavix study. The take home message was clear: give it early and often.

ACC: Adding Plavix to Clot-Busting Regimen Saves Lives

ESC: Pretreatment with Plavix Reduces MI, Stroke, and Death Before and After Stenting

Plavix-Aspirin Combo Reduces Acute Heart Attack Deaths

Finally, a pair of low-tech but significant observations: dyspnea is not a benign symptom, and for men heart rate reveals volumes.

First, a study of almost 18,000 patients referred for cardiac stress testing found that people with no known coronary artery disease who report a history of dyspnea are four times more likely to die from heart disease than asymptomatic patients.

Second, a study of 5,713 French men found that when a man’s heart rate is too fast at rest, he had a 3.5-fold increase in risk of sudden cardiac death. Moreover, if a man had less than an optimum increase in heart rate during exercise, his risk of sudden death was 20% higher than men whose hearts speeded up appropriately during exercise.

Dyspnea Is Predictive of Cardiac and All-Cause Mortality

Sudden Death in Healthy Men Can Be Predicted by Heart Rate