β-Blocker Results Vary With Risk
β-Blockers clearly cut mortality in patients at high risk for cardiac events who are undergoing major surgery, and may benefit patients at moderate cardiac risk. But these drugs do not benefit, and may even harm, low-risk patients undergoing surgery.
These results are from a large observational study undertaken while the medical community awaits the results of randomized trials that are expected to settle the issue of whether β-blockers should be given routinely to prevent perioperative cardiac events. This observational study involved a diverse population of more than 660,000 patients undergoing a wide variety of surgeries at more than 300 hospitals throughout the country, said Peter K. Lindenauer, M.D., of Tufts University, Boston, and his associates (N. Engl. J. Med. 2005;353:349–61).
Perioperative β-blocker therapy reduced the risk of cardiac mortality by 10%–44% in patients who scored 2 or higher (out of a possible 5) on the Revised Cardiac Risk Index. The number needed to treat to prevent a single death in these moderate- and high-risk patients was only 33. In contrast, the drugs did not cut mortality and were actually associated with a slight increase among low-risk patients who scored 0 or 1 on the index, indicating that patient selection is critical, the researchers said.
Prayer, Healing Touch Fail to Help
For patients undergoing cardiac catheterization or percutaneous coronary intervention, neither congregational prayer nor a therapy involving calming music, positive imagery, and healing touch improved outcomes, according to Mitchell W. Krucoff, M.D., of Duke Clinical Research Institute, Durham, N.C., and his associates.
Such noetic therapies “are used extensively by the general population,” although their safety and effectiveness is difficult to evaluate (Lancet 2005;355:211–7). The researchers assessed these interventions in a study of 748 patients undergoing catheterization or PCI at nine U.S. medical centers. The subjects were randomly assigned to receive standard care (192 subjects); bedside music, imagery, and touch therapy (185); off-site prayer involving large congregations of Christians, Muslims, Jews, and Buddhists (182); or combined noetic therapy plus prayer (189).
None of the interventions showed any effect on the rates of in-hospital major adverse cardiovascular events or in-hospital mortality, nor did they affect event, readmission, or death rates over 6 months of follow-up, the investigators noted.
Beware Warfarin Overdosing in Elderly
Warfarin dose requirements vary so dramatically with patient age and gender that almost all elderly women and most elderly men are overdosed from the very start of treatment, according to David Garcia, M.D., of the University of New Mexico, Albuquerque, and his associates.
Noting that data are scarce to guide clinicians in the dosing of warfarin for the elderly, the researchers assessed established dosing practices in two large cohorts of more than 12,000 ambulatory patients with INR target ranges of 2.0–3.0. This included 2,359 patients aged 80 or older. All patients had achieved stable warfarin dosing (Chest 2005;127:2049–56).
“Based on the actual warfarin maintenance doses observed in our study populations, the often-recommended 5 mg daily warfarin starting dose would be too high for up to 82% of women and 65% of men who were over 70 years of age. Our data suggest that the higher rates of bleeding and erratic INR values that have been reported in the early phase of warfarin therapy may in part be explained by overly aggressive dosing in the elderly,” they said.
Physicians should be cautious in empiric dose selection, particularly in older women.
Counterfeit Lipitor Batch Is Recalled
The U.S. Food and Drug Administration alerted Americans that its British counterpart has recalled a batch of Lipitor (atorvastatin) because it was found to contain counterfeit tablets. Initial test results do not indicate that the fake drug poses any immediate risks.
The product is not sold through “legitimate” pharmacies, but it may have been purchased by some Americans through other online or storefront operations, or through state-run programs that purchase foreign drugs, according to the FDA.
The United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) discovered counterfeit 20-mg Lipitor tablets sold in packages of 28 pills in blister packs. The batch number 004405K1 is printed on the end of the outer package, near the expiration date of “11 2007,” as well as on the foil backing of the blister pack. In concert with Lipitor's manufacturer, Pfizer Ltd., the MHRA recalled this entire batch of Lipitor even though there is genuine Pfizer Lipitor with the same batch number.