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Medications effective in reducing risk of breast cancer but increase risk of adverse effects

Electronic Newsletter, Issue 282

Electronic Newsletter

September 23, 2009

AHRQ News and Numbers

The number of Americans admitted to hospitals for treatment of coronary artery disease declined by 31 percent between 1997 and 2007.  In people with coronary heart disease, fatty deposits clog heart arteries, restricting the flow of blood to the heart and increasing the risk of a heart attack.  As a result of this decrease, coronary heart disease no longer ranks as the leading disease treated in hospitals. It is now ranked number three.  [Source: Agency for Healthcare Research and Quality, HCUP, HCUP Facts and Figures: Statistics on Hospital-Based Care in the United States, 2007.]

Today's Headlines

  1. Medications effective in reducing risk of breast cancer but increase risk of adverse effects
  2. AHRQ announces new video to help patients use blood thinner pills safely and effectively
  3. New comparative effectiveness report of lipid modifying agents is available
  4. AHRQ consent and authorization toolkit for minimal risk research is available
  5. New AHRQ evidence report on family history is available
  6. HCUP facts and figures
  7. Highlights from our most recent monthly newsletter
  8. AHRQ in the professional literature

1.  Medications Effective in Reducing Risk of Breast Cancer but Increase Risk of Adverse Effects

Three drugs—tamoxifen, raloxifene, and tibolone—reduce a woman's chance of getting breast cancer, but each drug carries distinct potential harms, according to a new AHRQ report. The comparative effectiveness review found that all three drugs significantly reduce invasive breast cancer in midlife and older women who have not previously had breast cancer, but that benefits and adverse effects can vary depending on the drug and the patient. The report, Comparative Effectiveness of Medications to Reduce Risk of Primary Breast Cancer in Women, compared tamoxifen with another Selective Estrogen Receptor Modulator (SERM), raloxifene, which is primarily used to prevent and treat osteoporosis and is FDA-approved for breast cancer risk reduction. Tibolone, which has not been approved by the FDA for use in the United States but is used in other countries to treat menopausal symptoms and osteoporosis, also was included in the study. The most common side effects for tamoxifen are flushing and other vasomotor symptoms (e.g., night sweats, hot flashes), vaginal discharge, and other vaginal symptoms such as itching or dryness; for raloxifene, side effects include vasomotor symptoms and leg cramps; and for tibolone, side effects include vaginal bleeding. The report also summarized the drugs' potential risk for other health problems. Tamoxifen, the report found, increases risk for endometrial cancer, hysterectomies, and cataracts compared with the other drugs. Tamoxifen and raloxifene increase risk of blood clots, although tamoxifen's risk is greater. Tibolone carries an increased risk of stroke. The report called for more research to more clearly identify characteristics of patients who would benefit from these drugs while suffering the least harm. Select to access the report.

2.  AHRQ Announces New Video to Help Patients Use Blood Thinner Pills Safely and Effectively

AHRQ released "Staying Active and Healthy with Blood Thinners," a free bilingual 10-minute video in English and Spanish. This video helps educate patients about how to use anticoagulant drugs, commonly called "blood thinners," safely. Nearly 2 million Americans are prescribed a blood thinner each year to reduce their risk of forming dangerous blood clots. Blood clots can lead to serious conditions such as deep vein thrombosis (clots that form in the deep veins of the legs or groin) and pulmonary embolism (clots that travel to the lungs and can be fatal). Designed to complement education that patients receive in their doctor's office, clinic, pharmacy, or hospital, the new video helps patients better understand blood thinners and how to manage them effectively. Any patient on blood thinner therapy, regardless of the initial cause and or specific medical regimen, can benefit from the video. The video is available as a DVD and can be obtained by sending an e-mail to ahrqpubs@ahrq.hhs.gov A companion print brochure, Blood Thinner Pills: Your Guide to Using Them Safety/Pastillas que diluyen la sangre: Guía para su uso seguro, is also available. Select to access the video and brochure on the .

3.  New Comparative Effectiveness Report of Lipid Modifying Agents Is Available

Statins are an invaluable tool in fighting cardiovascular disease, but it is unclear whether to use high doses of statins alone for patients who need cholesterol treatment or to combine them with other cholesterol drugs, according to a new AHRQ comparative effectiveness report. The report compares the effectiveness of high dose statins when used alone and in combination with other cholesterol lowering drugs. The study found that the number of Americans being identified as potentially benefiting from intensive cholesterol treatment is rising, and that combination therapy is therefore likely to increase. The study found, however, that there is not enough evidence to guide clinical decisions to support the use of combination therapies over higher dose statin therapy. More research is needed to determine the risks and benefits of combination therapies.

Despite those uncertainties, the report did find that combination therapies may be appropriate for some patients, such as those who don't achieve a targeted cholesterol level even after taking a higher dose of statins. Because all patients are different, it is likely that different therapies are better suited for different populations, so the report's authors urged future research be targeted to specific clinical profiles. The report, "Comparative Effectiveness of Lipid Modifying Agents," also was published in the September 1 issue of the Annals of Internal Medicine. Select to access the report.

4.  AHRQ Consent and Authorization Toolkit for Minimal Risk Research Is Available

AHRQ now has available a free toolkit to help researchers obtain potential research participants' informed consent and authorization to use their health data in accordance with the Privacy Rule of the Health Insurance Portability and Accounting Act (HIPAA). The toolkit provides information on how to ensure that people of all health literacy levels understand what studies entail and to what they are consenting when they agree to participate. AHRQ developed the toolkit because researchers often use long consent forms that potential study participants can find difficult to comprehend. Research also shows that a large proportion of study participants did not understand what they had consented to when they joined a study. The AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research, which was tested by researchers from Boston University, includes recommendations for improving the informed consent and authorization process; sample consent and HIPAA authorization documents in English and Spanish; recommendations for adapting and testing the documents; statutory requirements and exceptions; and a tool for researchers' certification of consent and authorization. Select to access the toolkit.

5.  New AHRQ Evidence Report on Family History Is Available

AHRQ has released a new evidence report that found a positive family history is associated with increased risk of disease, but its ability to predict future disease was modest. There is very limited evidence to support or refute that routinely obtaining patients' family history will result in benefit or harms. Researchers, co-led by Nadeem Qureshi, D.M., Brenda Wilson, Ch.B., and Pasqualina Santaguida, Ph.D., of AHRQ's McMaster University Evidence-based Practice Center in Hamilton, Ontario, also found that people report the absence of most diseases with greater accuracy than the presence of disease, with limited evidence to suggest better reporting of first degree relatives' health than second degree relatives. Although family history collection is a core activity in primary care, little is known about the factors that encourage or inhibit family history collection. The report, Family History and Improving Health, was requested and funded by NIH's Office of the Medical Applications of Research, for a State-of-the-Science Conference on the topic on August 24-26. Select to access the report.

6. HCUP Facts and Figures

AHRQ announces the release of HCUP Facts and Figures: Statistics on Hospital-Based Care in the United States, 2007 (PDF File) (Plugin Software Help) available online at the HCUP-US Website. This report presents data from the Nationwide Inpatient Sample database on hospital care in 2007, as well as trends in care from 1997 to 2007. HCUP Facts and Figures features an overview of numerous hospital-related topics, including general characteristics of U.S. hospitals and the patients being treated; the most common diagnoses, conditions, and procedures associated with inpatient stays; the costs and charges associated with hospitalizations; and a special section that details trends in hospital care by expected payer, including Medicare, Medicaid, private insurance, and the uninsured.

7.  Highlights from Our Most Recent Monthly Newsletter

The September issue of Research Activities is available online. Key articles include:

  • Study examines outpatient use of medication and lifestyle counseling to manage osteoporosis

    An estimated 12.5 percent of Americans aged 50 years and older have osteoporosis. Women are particularly affected, with one in two expected to have a fracture related to bone loss during their lifetime. Use of medication for osteoporosis does not differ significantly among patients in physician offices or hospital-based clinics. However, those treated in clinics are less likely to receive nonmedication interventions to manage the condition. Patients aged 80 years or older were 40 percent less likely to receive nonmedication therapy than those aged 60 to 69 years. Visits by publicly insured patients were 30 percent less likely to involve medication than visits by patients with other sources of payment. However, no racial differences in treatment were observed.

Other articles include:

  • Disparities persist in primary care referrals to cardiologists for cardiovascular disease.
  • Dysfunctional uterine bleeding carries large financial and quality-of-life costs.
  • States vary greatly in nursing home admissions for people with mental illnesses.
  • U.S. emergency plan for AIDS relief in Africa has reduced HIV-related deaths, but not HIV prevalence.

Select to read these articles and others.

8.  AHRQ in the Professional Literature

We are providing the following hyperlinks to journal abstracts through PubMed® for your convenience. Unfortunately, some of you may not be able to access the abstracts because of firewalls or specific settings on your individual computer systems. If you are having problems, you should ask your technical support staff for possible remedies.

Spain P, Carpenter WR, Talcott JA, et al. Perceived family history risk and symptomatic diagnosis of prostate cancer: the North Carolina Prostate Cancer Outcomes Study. Cancer 2008 Oct 15; 113(8):2180-7. Select to access the abstract in PubMed.®.

Lee GM, Lorick SA, Pfoh E, et al. Adolescent immunizations: missed opportunities for prevention. Pediatrics 2008 Oct; 122(4):711-17. Select to access the abstract in PubMed.®.

Hebert PL, Sisk JE, Wang JJ, et al. Cost effectiveness of nurse-led disease management for heart failure in an ethnically diverse urban community. Ann Intern Med 2008 Oct 21;149(8):540-8. Select to access the abstract in PubMed.®.

Zettel-Watson L, Ditto PH, Danks JH, et al. Actual and perceived gender differences in the accuracy of surrogate decisions about life-sustaining medical treatment among older spouses. Death Stud 2008; 32(3):273-90. Select to access the abstract in PubMed.®.

Cohen KA, Lautenbach E, Weiner MG, et al. Coadministration of oral levofloxacin with agents that impair absorption: impact on antibiotic resistance. Infect Control Hosp Epidemiol 2008 Oct; 29(10):975-7. Select to access the abstract in PubMed.®.

Esnaola NF, Hall BL, Hosokawa PW, et al. Race and surgical outcomes: it is not all black and white. Ann Surg 2008 Oct; 248(4):647-55. Select to access the abstract in PubMed.®.

Alexander GC, Sehgal NL, Moloney RM, et al. National trends in treatment of type 2 diabetes mellitus, 1994-2007. Arch Intern Med 2008 Oct 27; 168(19):2088-94. Select to access the abstract in PubMed.®.

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Current as of September 2009
Internet Citation: Medications effective in reducing risk of breast cancer but increase risk of adverse effects: Electronic Newsletter, Issue 282. September 2009. Agency for Healthcare Research and Quality, Rockville, MD. http://archive.ahrq.gov/news/newsletters/e-newsletter/282.html

 

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