Wyeth’s hormone replacement therapy, a menopause treatment whose use has declined after being linked to heart attack, stroke and breast cancer, increases the risk of death from lung tumors, a study found.
After five years on Wyeth’s Prempro, a combination of the hormones estrogen and progestin, 67 women died from non-small cell lung cancer, compared with 39 on placebo, the research showed. Results of the trial, which examined women age 50 to 79 and included current and former smokers, were presented today at the American Society of Clinical Oncology meeting in Orlando.
Sales of the pills plunged in 2002 after a U.S. study linked the therapy to breast cancer and cardiovascular risks. As many as 6 million women took the menopause treatments before the study curbed use. The products generated $1.1 billion last year, down from more than $2 billion in 2001.
“This is a new finding that tells us women who smoke shouldn’t take estrogen and progestin for menopause symptoms,” said Rowan Chlebowski, the study author and a researcher at Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, in an interview.
Tobacco use causes almost 80 percent of lung cancer deaths in women, according to the Atlanta-based U.S. Centers for Disease Control and Prevention. More lung cancer cases were also diagnosed in women on hormones, though the difference wasn’t statistically significant, today’s study found.
‘See the Logic’
“I can see the logic of that kind of recommendation,” for women smokers to avoid hormone pills, said Joseph Camardo, head of medical affairs at Madison, New Jersey-based Wyeth, in an interview. “I would absolutely advise women not to smoke.” Camardo said he had not seen the data.
About 200,000 Americans are diagnosed with lung cancer each year, and 160,000 die from it, more than any other tumor, according to the CDC.
About 85 to 90 percent of lung malignancies are of a variety called non-small cell, the type in today’s study, according to the American Cancer Society, an advocacy group.
The trial analyzed lung cancer diagnosis and death among 16,608 patients who participated in the Women’s Health Initiative, the same U.S. research project that identified other risks of hormone therapy seven years ago.
Among current and former smokers studied in the research, there were 56 deaths for women treated with hormones and 34 deaths with placebo. Among non-smokers, there were 9 deaths for women on hormones and 5 deaths for patients taking a placebo.
Menopause Symptoms
Reduced estrogen levels during menopause cause the part of the brain responsible for temperature control to malfunction. Hot flashes strike suddenly and can be accompanied by rapid heart beat, nausea, dizziness, headaches, muscle weakness and fatigue.
Patients today take lower doses of Wyeth’s hormones to reduce their risk of breast cancer and heart attacks. Prempro combines two hormones, estrogen and progestin, to curb the risk of uterine cancer that is linked to taking estrogen alone. Premarin, an estrogen-only pill, is given to women who have had hysterectomies, surgery removing the uterus.
Prescribing information on the label for Wyeth’s hormones details risks identified by earlier research from the WHI study, including breast cancer and heart attacks. No warnings about lung cancer are currently included.
More than 5,000 lawsuits have been filed against Wyeth, alleging its hormones caused cancer.
New York-based Pfizer Inc., the world’s largest drugmaker, said in January it would buy Wyeth for about $65 billion.
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