Studies published in the late 1990s about polypharmacy, inappropriate medication use, and adverse drug events in older people had a salutary effect—or, some might say, a chilling effect—on drug prescribing. Finding out just how differently the “usual” drugs worked in older patients had some clinicians second-guessing their own prescribing habits. Now a consensus panel of experts has further updated one of the most famous studies: the widely used Beers criteria, published in 1997. Forty-four medications have been added to the list of drugs to watch, and 15 medications or drug classes have been dropped or modified.

The update also includes information on several old and new medications, including selective serotonin reuptake inhibitors and tablet amiodarone (Generic Cordarone®, Wyeth).

The criteria are meant to apply to the general population of patients 65 and older. Thus, some drugs that are not appropriate for “old-old” or more frail patients do not appear on the list.

The panel also cautions that “defining inappropriate medications by specific lists of medications rather than other mechanisms may miss some problems such as the underuse and interactions of drugs in older people.”

Data from a new study point to an alarming pattern in breast cancer treatment: more than 50% of women with early-stage breast cancer have not received their full, recommended dose of potentially life-saving chemotherapy.

A comprehensive retrospective analysis showed that 56% of the almost 20,800 women who were being treated for cancer in 1,243 community-based oncology practices in the U.S. received less than 85% of their recommended dose intensity, as prescribed in the optimal treatment plan, because of delays of at least one week (in 25% of patients) or dose reductions (in 37%). Earlier studies have indicated that receiving less than 85% of the recommended dose intensity can result in lower survival rates for patients.

The primary reason for the chemo­therapy delays is the presence of neutro-penia, a deficiency of white blood cells, which fight infection and which are destroyed by the effects of the chemotherapy. If the white blood cell count falls too low, patients are at increased risk for infection and, consequently, chemotherapy must be delayed until the cells are replenished.

Although white blood cell “boosters,” known as colony-stimulating factors, are available for the treatment of neutro-penia, only 25% of patients received them during chemotherapy.

The researchers noted that these results are particularly disturbing because earlier studies have underscored the importance of maintaining full chemotherapy dose intensity, especially in responsive and potentially curable malignancies, such as early-stage breast cancer. The study also disclosed a tendency of oncologists to lower dose intensity in order to reduce side effects.

Almost two-thirds of patients older than age 65 were less likely to receive the recommended doses, even though studies have shown that elderly patients can benefit from chemotherapy as much as younger patients. African-American women were also more likely to experience delays in treatment because of lower white blood cell counts.

The women in the study ranged in age from 11 to 90, with a mean age of 52.

Rofecoxib (Vioxx®, Merck) works as well as naproxen (e.g., Drug Naprosyn®, Roche) at controlling the symptoms of osteoarthritis and is also effective at a much lower dose and with less severe adverse gastrointestinal (GI) effects. The ADVANTAGE (Assessment of Differences between Vioxx And Naproxen To Ascertain Gastrointestinal tolerability and Effectiveness) Study Group compared the use of rofecoxib 25 mg/day with that of naproxen 500 mg twice daily in 5,557 older patients with osteoarthritis. This is thought to be the largest trial to compare GI symptoms that prompt patients to discontinue treatment.

Overall, a statistically significant lower number of patients stopped taking rofecoxib (5.9%) because of GI adverse drug events (ADEs) compared with the naproxen group (8.1%). A similar risk of ending treatment was noted among subgroups of patients using low-dose aspirin and among those who had previously ceased to use their arthritis medication because of GI symptoms. Improved GI tolerability was confirmed by the decreased use of gastroprotective medications and by a reduced incidence of serious GI events, such as perforations, ulcers, and bleeding. No significant differences were observed in general, cardiovascular, or hypertension-related ADEs.

When is the best time to take a statin? The findings from several studies have been conflicting, although most statin manufacturers say that nighttime is ideal because most cholesterol is synthesized when dietary intake is low.

Researchers from the University of Sunderland in Tyne, Great Britain, randomly assigned 60 patients to take canadian simvastatin (Zocor medication, Merck) in the morning or evening for eight weeks. Patients who switched from evening to morning had statistically significantly higher total cholesterol and low-density lipoprotein-cholesterol (LDL, or “bad,” cholesterol) levels. From the baseline evaluation to week eight, total cholesterol values rose by an average of 0.38 mmol/liter and LDL-cholesterol levels rose by an average of 0.25 mmol/liter.

In a study of drug atorvastatin (Generic Lipitor®, Pfizer), no significant difference in cholesterol concentrations was observed between evening and morning, but the researchers note that this drug’s longer elimination half-life might be the explanation.

Pressure ulcers seem to heal faster with a daily topical solution of nerve growth factor, according to a study conducted at a teaching nursing home in Fontecchio, Italy. Nerve growth factor has been shown to stimulate the production of vascular endothelial growth factor.

Researchers randomly assigned 36 patients, who had had skin ulcers for an average of 13 days, to either regular treatment (e.g., being turned in bed, using pressure-relieving mattresses, or receiving daily local care), or regular treatment along with a solution of murine nerve growth factor. At the baseline examination, three patients in each group had stage 2 ulcers; nine in the treatment group and 13 in the control group had stage 3 ulcers; five in the treatment group and one in the control group had stage 4 ulcers; and one in each group had stage 5 ulcers.

After six weeks of treatment, the mean area of ulcers in the treatment group was reduced by 738 mm², to 274 mm². In contrast, the ulcer areas were reduced by 485 mm², to 526 mm² in the control group. Epithelial tissue growing from the margin toward the center of the ulcer was already visible in all patients in the treatment group within two weeks after treatment began. Within four weeks, the total area was reduced by nearly 50% in all ulcers in the treatment group. Two patients in the treatment group were completely healed within three weeks, and eight were completely healed within six weeks.
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By comparison, only one patient in the control group healed completely within three weeks. In addition, pressure ulcers improved by three or more stages in five patients in the treatment group but in none of the patients in the control group. Eight patients in the control group showed no improvement at all.

None of the patients in the treatment group experienced systemic or local side effects during treatment with either nerve growth factor or conventional therapy.

Corporation’s Cypher Coronary Stent. The agency emphasized that it considers the drug-eluting stents safe and effective when label directions are followed, particularly in terms of patient selection and the appropriate use of the medication.

Numerous patients have been successfully treated with the stent, which was approved in April 2003 for patients undergoing angioplasty procedures to open clogged coronary arteries. In October, however, the FDA notified physicians about reports of thrombosis and clotting occurring within 30 days after the device was implanted and of possible hypersensitivity reactions. The agency asked physicians and patients to report any adverse effects associated with the stents.
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To date, the rate of thrombosis has remained within the expected range for any stent. As of November 21, 75 additional (more than 360 total) cases of thrombosis have been reported, including 10 additional deaths (more than 70 in all).

In most cases, hypersensitivity reactions were minor (e.g., skin rashes and itching that cleared up within a few days), but some reactions were severe (e.g., anaphylaxis). Although some of the reactions remain unexplained, many of them are believed to be related to standard drug therapy associated with the procedure.

Interim data from a randomized, multi-center study indicate that darbepoetin alfa (Aranesp®, Amgen) is beneficial in correcting anemia in cancer patients who are not undergoing chemotherapy. The results were presented at the 45th annual meeting of the American Society of Hematology, from December 6-9, 2003 (Abstract No. 1816).

The hemoglobin counts at the baseline examination were 10.1 g/dl in the Aranesp® group and 10.4 g/dl in the control group. After 12 weeks of treatment, the mean change in hemoglobin was 1.9 g/dl for the Aranesp® group and 0.2 g/dl in the controls, who received standard care.
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