Saturday, May 28, 2005



A study from the Danish Cancer Society found that participating in online support groups can help breast cancer patients ease the feelings of social isolation that come with having the disease, according to Women's Health Weekly. Researchers observed and interviewed 15 women with breast cancer who chose the Internet as a way to relieve the feelings of isolation. The women were empowered by their online interactions and exchange of knowledge with other patients and the researchers concluded that the Internet may be an important tool for breast cancer patients' recovery. The study was published in the March issue of Psycho-Oncology. AstraZeneca (AZ) is at the helm of the "Redefining Hope and Beauty" campaign and Web site, an international effort to fight breast cancer (ePharm5, 12/16/04).  

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Thursday, May 26, 2005

Novo Nordisk launches Spanish-language diabetes Web site

Novo Nordisk and the Entertainment Industry Foundation have launched an interactive Spanish-language Web site about diabetes, the pharma reports. Diabetes strikes Hispanic Americans 1.5 times more often than similarly aged whites and affects 8.2% of all Hispanic Americans aged 20 years or older, says the report. About 25%-30% of those aged 50 and older suffer from either diagnosed or undiagnosed diabetes. The site, , is a Spanish translation of a similar one launched in English in February and features celebrities such as Maria Menounos and James Avery (ePharm5, 3/4/05). Novo Nordisk launched in March a Spanish-language print campaign featuring diabetic star Halle Berry, says the report.



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Wednesday, May 25, 2005

AACE Announces New A1c Standard of 6.5% or Lower

AACE Announces New A1c Standard of 6.5% or Lower

Medscape Medical News 2005. © 2005 Medscape

Terry Hartnett

May 24, 2005 (Washington) — Physicians need to take a stronger, more relentless approach to the treatment of patients with diabetes and to diagnose aggressively the disease in at-risk patients, said Paul Jellinger, MD, MACE, at a briefing here prior to the start of the American Association of Clinical Endocrinologists (AACE) 14th Annual Meeting and Clinical Congress.

Dr. Jellinger is the current president of the American College of Endocrinology (ACE), the educational and research group of AACE, former president of AACE, and professor of medicine on the voluntary faculty at the University of Miami in Florida.

Dr. Jellinger announced a new A1c standard of 6.5% or lower for patients with type 2 diabetes. The new standard is part of a more comprehensive effort to prevent diabetes complications. AACE is embarking on this effort following the results of a report outlined at the briefing that showed two thirds of Americans with type 2 diabetes are not in control of treating the disease. The majority of people with diabetes in all 50 states had A1c levels above the guideline, and 61% had no knowledge of the A1c test or of their own personal A1c level.

"The medical community needs to intervene earlier and more aggressively to control patients' blood sugar levels because of the link between high A1c levels and diabetes-related complications," said Jaime A. Davidson, MD, chairman of the AACE/ACE consensus conference that issued the report. "This may mean adding a medicine or a combination of medicines that help treat diabetes in different ways to a person's treatment regimen of diet and exercise," Dr. Davidson told attendees.

Daily blood sugar levels should be lower than 110 mg/dL before eating breakfast in the morning and lower than 140 mg/dL two hours after eating a meal, said Dr. Jellinger. "Blood sugar control is worsening today while blood pressure and cholesterol levels are improving," Dr. Jellinger said.

Dr. Jellinger stressed the importance of diagnosing diabetes early. AACE is recommending that physicians routinely give a two-hour 75-g glucose challenge test to all patients who have risk factors for diabetes. These include the following: family history, obesity, sedentary lifestyle, race/ethnicity (African Americans, American Indians, Asians, Pacific Islanders, and Hispanic Americans are all at high risk for diabetes), gestational diabetes during pregnancy, delivery of a larger than average-weight baby, polycystic ovary syndrome, peripheral vascular disease, high blood pressure, high cholesterol levels, and coronary heart disease.

"Even if the high-risk patient has a normal fasting blood sugar level, the physician should conduct the glucose challenge test," Rhoda H. Cobin, MD, clinical professor of medicine at Mount Sinai School of Medicine in New York, cochief of Mount Sinai's Thyroid/Endocrinology Clinic and the incoming ACE president, told Medscape. "In the average practice, the physician has so little face time with the patient," Dr. Cobin noted. "That is why AACE urges physicians to quickly bring diabetes to the forefront with the patient. Stress the importance of diagnosis and of managing the condition," Dr. Cobin urged.

Once a diagnosis is made, AACE advised frontline physicians to "be relentless" in treating diabetes. "'Do not tell the patient to watch their blood sugar levels and come back in six months," said Dr. Cobin. AACE is also recommending combination drug therapy for patients who do not have control of their blood sugar levels.

Dr. Cobin's message to practitioners regarding diabetes management, including drug therapy, is "Do not be too slow. Stay up-to-date on your patient's condition and use all tools possible to control the disease." Dr. Cobin also noted that all of the AACE recommendations including glucose tolerance testing for at-risk patients are covered under Medicare and most healthcare plans. Dr. Cobin urged primary care physicians to seek assistance from AACE to help code the test correctly for reimbursement purposes.

GlaxoSmithKline provided funding and other support to AACE for the report conducted by Surveillance Data Inc., and the national "State of Diabetes in America: Striving for Better Control" campaign.

AACE 14th Annual Meeting and Clinical Congress: Preconference Briefing. Presented May 18, 2005.

Reviewed by Gary D. Vogin, MD

Terry Hartnett is a freelance writer for Medscape.


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Tuesday, May 24, 2005

Trastuzumab Trials in HER2-positive Breast Cancer Stopped Early Due to Superior Efficacy

Paula Moyer, MA

May 23, 2005 (Orlando) — Treatment with trastuzumab (Herceptin) in HER2-positive breast cancer provides a clear and striking benefit to patients with HER2-positive breast cancer, according to findings presented here the annual meeting of the American Society of Clinical Oncology 2005 Annual Meeting.

The results were significant, with a 52% risk reduction for a recurrence compared with controls. The investigators halted two simultaneous studies early, in accordance with the study protocols.

"This benefit should change the standard of care," said Edward Romond, MD, in the presentation at a late-breaking session. "The addition of trastuzumab to standard treatment reduced the risk of distant recurrence by 53% at three years, and the hazard of developing distant metastases appears to decrease over time." Dr. Romond presented the findings on behalf of the National Surgical Adjuvant Breast and Bowel Project B-31 (NSABP B-31).

Dr. Romond summarized the findings of two studies that have been approved for joint analyses of their respective datasets: the NSABP B-31 and the North Central Cancer Treatment Group N-9831 (NCCTG N-9831). Both trials were initiated to assess the use of paclitaxel and trastuzumab following anthracycline chemotherapy in the adjuvant treatment of high-risk HER2-positive breast cancer. Both trials were launched in the year 2000 to test whether addition of HER2 is superior to chemotherapy alone.

The NSABP B-31 investigators randomized patients into two treatment groups. The controls received four cycles of standard doxorubicin at 60 mg/m2 and cyclophosphamide at 600 mg/m2 every three weeks, followed by four cycles of paclitaxel at 175 mg/m2 every three weeks. The investigative group had the same chemotherapy regimen, but with trastuzumab added weekly for 52 weeks, starting with the first paclitaxel dose. Trastuzumab was given at an initial loading dose of 4 mg/kg the first week and 2 mg/kg for the remaining 51 weeks. The dose of paclitaxel was later reduced to 80 mg/m2 weekly for 12 weeks. Patients who were hormone-receptor positive also received tamoxifen or anastrozole.

NCCTG N-9831 followed a similar protocol that patients with hormone-receptor–positive tumors received either tamoxifen or an aromatase inhibitor. Also, the study had a third group in which patients received trastuzumab at the completion of all chemotherapy so that investigators could assess the risks and benefits of giving trastuzumab sequentially vs concurrently. That group was not included in the analysis, Dr. Romond said.

The studies' design called for the trials to terminate early if the interim analysis showed a clear benefit of one treatment strategy over the others at a probability value of 0.0005. This interim analysis reflected the findings on 3,351 patients; 1,736 from NSABP B-31, who had been followed up for a median of 2.4 years; and 1,615 from N-9831, who had been followed up for a median of 1.5 years. Half of the participants were younger than 50 years.

"The first review, involving 353 recurrence events, determined that the threshold for efficacy had been crossed," said Dr Romond. He noted that the first analysis involved 395 events that had been recorded, including 261 in the paclitaxel groups and 134 in the trastuzumab groups, had a hazard ratio of 0.48 and a P value of 3 x 10-12. "This represents an overall reduction at three years of 52% for a first breast cancer event," Dr. Romond said. "The prolongation of disease-free survival was 12% at three years and 18% at four years."

The results were the same in both studies, with a risk reduction in NCCTG N-9831 of 45% and 55% in NSABP B-31. Distant metastases occurred in 198 patients, 102 in control groups, and 96 in investigational groups and reflected a 53% reduction. "The hazard rate is 0.67, corresponding to a 33% reduction in mortality," Dr. Romond said. "Surprisingly, despite the fact that the median follow-up is only two years, it is significant at P = .015.

Earlier research had shown that cardiotoxicity was associated with trastuzumab, and the events observed in the two studies were consistent with previous findings, Dr. Romond said. In the NSABP B-31 cohort, approximately 19% of those who started trastuzumab had to withdraw due to cardiac dysfunction, including 15% who did not have clinical congestive heart failure.

The findings provide a new approach in the treatment of breast cancer, said Gabriel N. Hortobagyi, MD. "Trastuzumab is the first drug developed to treat women with HER2-positive tumors," said Dr. Hortobagyi, the president-elect of ASCO and the chair of the breast medical oncology department at the University of Texas M. D. Anderson Cancer Center in Houston. "The risk of recurrence was reduced by 50% and prolonged survival by 20%. In oncology we get excited about improvements of 2% to 4%. We have not seen anything of this magnitude in breast cancer research in 30 years."

ASCO 2005 Annual Meeting: Late-breaking session. Presented May 19, 2005.

Reviewed by Gary D. Vogin, MD

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HealthAmerica and HealthAssurance have added an online asthma center to their Web site to help parents better manage their children's asthma, the health plan reports. Although 89% of asthma caregivers believe their child's asthma is under control, 49% of children have missed days of school or work and 49% of children have had to stop exercising midway through their routine due to asthma, according to an Asthma and Allergy Foundation study. The new tool addresses this issue, featuring articles and news about asthma, as well as personal health management tools, such as a diary to track peak flow readings and medicines. The new addition also features an asthma dictionary to help with complicated terms. The original site launched last year with the potential to reach 730,000 members with informative articles, news, and quizzes for parents, kids, and teens.

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E-mail marketing's influence on consumers is tied to their search engine preference, according to a survey from online marketing and intelligence firm BIGresearch, whose clients include several top 10 pharmas. For example, Yahoo! users are the "most susceptible group to e-mail marketing," Joe Pilotta, vice president of research for online marketing and intelligence firm BIGresearch, tells ePharmaceuticals. Although more than 20% of Yahoo! users say their electronic purchases are influenced by e-mails about those products, only 5.7% of those users are influenced by pharma e-mail messages. An online survey of 14,000 respondents found that pharmaceutical e-mail messages had the least influence over consumers when compared with other industries. Pharma messages were most effective among Ask Jeeves users, with 6.8% reporting that such e-mails influenced them, but least effective with MSN users, with 3.6% reporting being influenced. Search engine preference can also indicate users' age and from which diseases they suffer. MSN users are generally older and tend to suffer more from high blood pressure, high cholesterol, and arthritis. To read more, including tips from Pilotta for improving the effectiveness of e-mail marketing, click the link below.

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