Tamoxifen, Raloxifene Upheld for Prevention

38 WOMEN’S HEALTH MAY 1, 2010 • FAMILY PRACTICE NEWS Tamoxifen, Raloxifene Upheld for Prevention

BY KERRI WACHTER 9,736 on tamoxifen and 9,754 on ralox- 1.24, which was significant (P = .01). Both events) did not appear to be as effective ifene. The differences in numbers are due drugs reduced the risk of invasive breast as tamoxifen (57 events) in preventing WASHINGTON — Tamoxifen and to a combination of loss during follow- cancer by roughly 50% in the original re- noninvasive breast cancer (P = .052). raloxifene offer women at high risk of up or follow-up data becoming available port (median follow-up 47 months). “Now with additional follow-up, those developing breast cancer two effective for women who were lost to follow-up “We have estimated, however, that differences have narrowed,” he said. At options to prevent the disease, based on in the original report. Women on ta- this difference in the raloxifene-treated 8 years, there was no statistical signifi- 8 years of follow-up data for more than moxifen received 20 mg/day and those group represents 76% of tamoxifen’s cance between the two groups with a 19,000 women in the STAR trial. on raloxifene received 60 mg/day. chemopreventative benefit, which trans- risk ratio of 1.22 (P = .12). The relative While tamoxifen proved significantly At an average follow-up of 8 years, the lates into at 38% reduction in invasive risk of 1.22 favors tamoxifen, but ralox- more effective in preventing invasive breast relative risk of invasive breast cancer on breast cancers,” Dr. Wickerham said. ifene preserves 78% of the chemopre- cancer, there was no significant difference raloxifene, compared with tamoxifen was In the 2006 report, raloxifene (81 ventative benefit of tamoxifen. This between the two drugs in preventing noninvasive breast cancer. And raloxifene (Evista) had significantly less toxicity, including endometrial cancer, thromboem- bolic complications, and cataracts. “These data are good news for post- Mealtime therapy can ﬁ t into menopausal women who want to reduce cubicle #8. their risk of breast cancer,” said Dr. D. Lawrence Wickerham, associate chair- man of the National Surgical Adjuvant Breast and Bowel Project (NSABP). “The important message is that both [drugs]

‘These data are good news for postmenopausal women who want to reduce their risk of breast cancer.’

DR. WICKERHAM are options. The decision is a shared one between the patient and her physician.” Dr. Wickerham presented the latest results for the Study of Tamoxifen and Raloxifene (STAR) trial during a late- breaker session at the annual meeting of the American Association for Cancer Re- search. The results were also published in the journal Cancer Prevention Re- search (April 19, 2010; doi: 10.1158/1940- 6207.CAPR-10-0076). Oncologists at the meeting expressed frustration that more women at high risk are not on the drugs, given the proven ef- ficacy of the two selective estrogen re- ceptor modulators (SERMs) in preventing breast cancer. “I have to ask, why aren’t the results of the BCPT [breast cancer prevention trial] and STAR trials more vigorously ap- plied in clinical practice?” said Dr. Gabriel Humalog® KwikPen™, part of the Humalog® approach, is designed to help fi t mealtime therapy into N. Hortobagyi, who was the discussant. your patient’s life. It’s small, doesn’t need refrigeration after the fi rst use, and can be used almost Dr. Wickerham echoed this frustration during a press conference. “I see anywhere. To fi nd out more, go to www.Humalog.com or see your Lilly sales representative. women each week, at a high risk of breast cancer, and I will end up telling one or two of them...all too often...that they have breast cancer. I’d love for that part of my job to go away. These data are a Humalog is for use in patients with diabetes mellitus for the control step in that direction” said Dr. Wicker- of hyperglycemia. Hypoglycemia is the most common adverse effect ham, chief of the cancer genetics and pre- associated with insulins, including Humalog. vention section at Allegheny General For complete safety profile, please see Important Safety Information Hospital in Pittsburgh. The randomized, and Brief Summary of full Prescribing Information on adjacent pages. double-blind federally funded STAR trial included women at least 35 years of age Please see full user manual that accompanies the pen. with a 5-year predicted breast cancer risk of at least 1.66% (based on a modified version of the Gail model). Researchers from the NSABP randomized 19, 747 women to receive either tamoxifen or raloxifene (JAMA 2006;295:2742-51). The update includes 19,490 women— MAY 1, 2010 • WWW.FAMILYPRACTICENEWS.COM WOMEN’S HEALTH 39 translates to raloxifene preventing 39% compared with tamoxifen (202). high-risk prediction tools, lack of a mark- cy between what is considered acceptable of noninvasive breast cancers. Dr. Hortobagyi, director of the breast er or measurement to monitor for risk re- risk for other preventative drugs and Raloxifene maintained its toxicity ad- cancer research duction, cost, and SERMs. For example, drugs used to pre- vantage. The relative risk of uterine can- program at the ‘The challenge insufficient public vent hypertension and coronary artery dis- cers with raloxifene vs. tamoxifen was University of today is how to and professional ed- ease have more and more serious adverse 0.55. There also were twice as many Texas M.D. Ander- communicate to ucation about the events than SERMs, he said. hysterectomies for benign disease in the son Cancer Center the public to drugs. “The challenge today is how to com- tamoxifen group. This was due in part to in Houston, iden- enhance the “There is no per- municate to the public to enhance the uti- an 80% increase in hyperplasia of the en- tified factors that utilization of fect drug. Certainly lization of SERMs and reduce further the dometrium that occurred in women on may be responsi- SERMs.’ in other areas of incidence of breast cancer,” he said. ■ tamoxifen, Dr. Wickerham said. ble for limited use preventive medi- Both drugs increase the risk of throm- of tamoxifen and DR. HORTOBAGYI cine, there seems to Disclosures: The study was supported by boembolic complications, but there were raloxifene for pre- be greater tolerance the National Cancer Institute. Dr. significantly fewer (P = .007) of these vention. He cited misinformation about for adverse effects for effective preventative Wickerham reported that he has consulted events in women on raloxifene (154), the drugs, fears about toxicities, limited interventions,” he said, noting discrepan- for Eli Lilly.

Indication Humalog (insulin lispro injection [rDNA origin]) is for use in patients with diabetes mellitus for the control of hyperglycemia. Humalog should be used with longer-acting insulin, except when used in combination with sulfonylureas in patients with type 2 diabetes.

Important Safety Information Humalog is contraindicated during episodes of hypoglycemia and in patients sensitive to Humalog or one of its excipients.

Humalog differs from regular human insulin by its rapid onset of action as well as a shorter duration of action. Therefore, when used as a mealtime insulin, Humalog should be given within 15 minutes before or immediately after a meal.

Due to the short duration of action of Humalog, patients with type 1 diabetes also require a longer-acting insulin to maintain glucose control (except when using an insulin pump). Glucose monitoring is recommended for all patients with diabetes.

The safety and effectiveness of Humalog in patients less than 3 years of age have not been established. There are no adequate and well-controlled clinical studies of the use of Humalog in pregnant or nursing women.

Starting or changing insulin therapy should be done cautiously and only under medical supervision.

Hypoglycemia Hypoglycemia is the most common adverse effect associated with insulins, including Humalog. Hypoglycemia can happen suddenly, and symptoms may be different for each person and may change from time to time. Severe hypoglycemia can cause seizures and may be life-threatening.

Other Side Effects Other potential side effects associated with the use of insulins include: hypokalemia, weight gain, lipodystrophy, and hypersensitivity. Systemic allergy is less common, but may be life-threatening. Because of the difference in action of Humalog, care should be taken in patients in whom hypoglycemia or hypokalemia may be clinically relevant (eg, those who are fasting, have autonomic neuropathy or renal impairment, are using potassium-lowering drugs, or taking drugs sensitive to serum potassium level).

For additional safety proﬁle and other important prescribing considerations, see accompanying Brief Summary of full Prescribing Information.

Please see full user manual that accompanies the pen.

Humalog® is a registered trademark of Eli Lilly and Company and is available by prescription only. Humalog® KwikPen™ is a trademark of Eli Lilly and Company and is available by prescription only.