© 2004 by Oxford University Press
© 2004 Oxford University Press
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In Brief
Study Concludes Vioxx Should Have Been Withdrawn Years Ago
A meta-analysis of studies of rofecoxib (Vioxx) has found that there was evidence as early as 2000 that the drug increased the risk of myocardial infarction. Merck, the makers of Vioxx, recently announced the drug's withdrawal because of an increased risk of cardiovascular events among participants in a colon polyp prevention trial who had taken the drug for more than 18 months.
In a study published online November 5 in The Lancet, researchers performed a meta-analysis of 18 randomized controlled trials and 11 observational studies of Vioxx. They found that, by the end of 2000, patients taking Vioxx had double the risk of having a myocardial infarction compared with patients taking placebo, naproxen, or a non-naproxen non-steroidal anti-inflammatory drug. In addition, patients were at increased risk even if they had been taking Vioxx for only a short time.
The researchers concluded that data existed to warrant the withdrawal of Vioxx at least 4 years ago.
See related News story, p. 1734.
Cancer Patients in Phase I Trials Less Likely to Die From Treatments Being Tested
A review of phase I clinical trials for cancer drugs that were conducted from 1991 through 2001 found that the rate of death from drug toxicity decreased sharply during this time.
In a review of 213 phase I studies that involved nearly 6,500 cancer patients, the overall rate of treatment-related death was 0.54%, while the overall response rate was 3.8%. The rate of death decreased from 1.1% during the first 4 years examined in the study (1991–1994) to 0.06% during the last 4 years (1999–2002). The response rate also decreased during this time, from 6.2% to 2.5%.
The decrease in treatment-related deaths can be attributed to a number of factors, including the use of new targeted, less toxic therapies and increasing attention to the safety of the clinical trial process, the authors wrote.
However, the authors of an accompanying editorial noted that reduction in treatment-related deaths may not be so straightforward because the results of many phase I studies are not published.
The article and editorial were published in the November 3 issue of the Journal of the American Medical Association.
No Need for Colposcopy in Screening of Young Women for Cervical Cancer, Study Suggests
A new study concludes that monitoring adolescents and young women with low-grade squamous intra-epithelial lesions (LSIL) would be better done with regular Pap smear tests than colposcopies.
In a longitudinal study of human papillomavirus in females aged 13 to 22 who were examined every 4 months by cytology (Pap smears), colposcopy (internal examination of the vagina and cervix), and HPV DNA status, researchers found that, after 1 year, lesions had regressed in 60% of the women; this increased to 90% by 3 years. The authors concluded that adolescents and young women with LSIL would be better monitored by regular Pap smears and that performing colposcopies on all young women with LSIL is unnecessary.
The results of the study were published in the November 6 issue of the Lancet.
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