News Release

LA BioMed Medical/Research briefs – January 2005

Peer-Reviewed Publication

LA BioMed

IN THIS ISSUE

  • Insulin, physical activity, and caloric intake in postmenopausal women: breast cancer implications
  • Consumer behavior in the setting of over-the-counter statin availability: lessons from the consumer use study of OTC Mevacor
  • Psychiatric study for cancer patients to measure psychoactive medication

    Insulin, physical activity, and caloric intake in postmenopausal women: breast cancer implications
    Source: Journal of Clinical Oncology 2004 Nov 15; 22(22): 4507-13

    Increased physical activity and programs to reduce body mass index (BMI) with both increased physical activity and decreased caloric intake have been proposed to reduce insulin as a potential mediator of breast cancer and other chronic diseases. However, there are few data on the relative contribution of physical activity, caloric intake, and BMI to fasting insulin levels.

    An ethnically diverse sub-sample of 2,996 mostly healthy postmenopausal women with no prior cancer history was randomly identified from the 161,809 participants in the Women's Health Initiative clinical trials and observational study. Information was collected on diet, recreational physical activity, and anthropometrics including BMI. Fasting insulin levels were determined. Using a cross-sectional design, insulin levels were then compared across quintiles of caloric intake and physical activity in linear regression model analyses controlled for BMI and other factors. Lower BMI, higher levels of physical activity, and lower caloric intake were all independently associated with significantly lower mean fasting insulin levels throughout the range of observed values. These findings suggest that reduction in BMI achieved by increasing physical activity, reducing caloric intake, or both, should lower insulin levels, providing support for clinical trials evaluating insulin level change and breast cancer risk.

    To contact the principal investigator of the study, Rowan Chlebowski, M.D., Ph.D., please call David Feuerherd at 310-215-0234 / 310-222-2820 or e-mail him at df@issuesmanagement.com.

    Consumer behavior in the setting of over-the-counter statin availability: lessons from the consumer use study of OTC Mevacor
    SOURCE: American Journal of Cardiology 2004 Nov 4; 94(9A): 22F-29F

    Despite the proven benefits of statins, large numbers of patients meeting guideline criteria for therapy are not receiving these drugs. It has been suggested that over-the-counter (OTC) availability of statins would allow more consumers to use statins and achieve cardiovascular risk reduction. However, concerns have been raised as to the consumers' ability to self-manage hyperlipidemia and use statins safely. The Consumer Use Study of OTC Mevacor (CUSTOM) was designed to define consumer behaviors in the setting of OTC statin availability. The study was conducted in a simulated OTC setting and allowed consumers to purchase once-daily lovastatin 20 mg. The CUSTOM dataset includes >3,300 consumers who evaluated OTC lovastatin for potential purchase at study sites and follow-up information on purchasers for up to 6 months of self-managed therapy. These data have been analyzed to address consumers' knowledge of their cholesterol concentrations as well as their ability to make OTC use decisions based on their cardiovascular risk, avoid drug-drug interactions, self-manage their cholesterol treatment after deciding to use the OTC product, and maintain interactions with physicians while using lovastatin OTC. The results showed that most study participants appropriately self-selected OTC statin therapy and managed their treatment. Use of OTC statins by consumers needing more intensive statin therapy or facing the risk of potential drug-drug interactions remains an area of concern but occurred infrequently in CUSTOM. These data are important for making an informed risk-benefit decision concerning OTC statin availability.

    To contact the principal investigator of the study, Eric Brass, M.D., Ph.D, please call David Feuerherd at 310-215-0234 / 310-222-2820 or e-mail him at df@issuesmanagement.com.

    Psychiatric study for cancer patients to measure psychoactive medication
    Stage IV cancer patients who suffer from anxiety may want to investigate a research study approved by the Food and Drug Administration (FDA) taking place at LA BioMed. The specific aim of the study is to learn whether the psychoactive drug, psilocybin, might be effective in reducing anxiety, depression and physical pain, and therefore improving quality of life for Stage IV cancer patients. Psilocybin is a novel agent that produces a profound alteration in your state of consciousness.

    The FDA recently approved a similar study at Harvard University to see whether the illegal drug ecstasy can ease the debilitating anxiety that cancer patients feel as they face their final days.

    To learn more about the study, see the project web site at www.canceranxietystudy.org. To contact the principal investigator of the study, Charles Grob, M.D., please call David Feuerherd at 310-215-0234 / 310-222-2820 or e-mail him at df@issuesmanagement.com.

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