News Potpourri (*). (Special Feature).

NEW GUIDELINES ISSUED FOR ARTHRITIS DRUGS

Source: BMJ 2001; 323:251

The National Institute for Clinical Excellence has recommended that patients with osteoarthritis or rheumatoid arthritis, who are at high risk of gastrointestinal complications, have access to COX 2 (cyclo-oxygenase-2) selective inhibitors. The institute's report applies to patients in England and Wales who are over age 65, have a previous history of gastrointestinal bleeding, and those who need prolonged use of the maximum recommended doses of standard non-steroidal anti-inflammatory drugs. The report revealed evidence that COX 2 inhibitors are as effective as other non-steroidal anti-inflammatory drugs in reducing inflammation and pain. It also said that all non-steroidal drugs are associated with a risk of gastrointestinal side effects, including peptic ulceration and hemorrhage, which are thought to cause about 2,000 deaths annually in the United Kingdom. However, the institute reported that research has revealed that COX 2 inhibitors are associated with a lower risk of such occurrences.

THALIDOMIDE BATTLES MYELOMA

Source: JAMA 2001; 286:909

Thalidomide halts or slows the progression of multiple myeloma in patients newly diagnosed with bone marrow cancer. Researchers at the Mayo Clinic found that 14 of 16 patients with previously untreated early-stage multiple myeloma had or continue to have a positive response to thalidomide. Of the 14 patients that showed improved results, 11 had a 25% or greater reduction in myeloma protein 1evels with thalidomide and six had a reduction of 50% or more. Only two of the patients had progressive worsening of myeloma. The researchers caution that no medication, including thalidomide, can be used routinely, as of yet, to treat myeloma at its very early stage because some patients can be stable for months or years without any therapy.

US FDA IMPROVES WARNING ON ABUSED DRUG

Source: Lancet 2001; 358:568

The US Food and Drug Administration has strengthened the warning label on OxyContin (controlled-release oxycodone HCl). Due to the increasing evidence of abuse of the drug, the manufacturer, Purdue Pharma, worked in conjunction with the FDA to develop the changes in prescribing information. The information was sent out in the form of a "Dear Healthcare Professional" letter and in the drug's labeling as a "black-box warning, which is the strongest type of warning label. As a pure opioid agonist analgesic, OxyContin, which is indicated for managing moderate to severe chronic pain, has a similar potential for addiction as morphine. Abusers have learned that crushing the tablet causes rapid release of the active ingredient producing a powerful high. Purdue Pharma has announced that an abuse-resistant form of the drug is in development.

NEW ADVICE FOR WOMEN PATIENTS ABOUT HORMONE THERAPY AND THE HEART

Source: JAMA 2001; 286:907

The American Heart Association is recommending that hormone replacement therapy (HRT) not be initiated for secondary prevention of cardiovascular disease (CVD) in postmenopausal women. The association's recommendation is based on clinical trials that showed no overall cardiovascular benefits and a possible early increased risk of CVD events in women with atherosclerosis who begin HRT. The two main trials cited in the recommendation are the Heart and Estrogen/Progestin Replacement Study and the Estrogen Replacement and Atherosclerosis Trial. Researchers found that after an average of 4.1 years of follow-up, there was no difference in the primary outcome of nonfatal myocardial infarction and coronary death between the hormone and a placebo. In fact, a post hoc time-trend analysis showed a 52% increase in cardiovascular events in the first year in the HRT group compared with the placebo group.

CHILDHOOD OBESITY MAY BE RELATED TO FATHER'S GENES

Source: Lancet 2001; 358:564

Children who inherit a paternal polymorphism associated with altered expression of the insulin gene have a higher risk of developing early-onset obesity. Researchers from France (Hopital St Vincent de Paul, Paris, France) examined the parental transmission of two variable nucleotide tandem repeat polymorphisms, class I and class III, which regulate the expression of the insulin gene and insulin-like growth factor 2 gene. Genotyping was conducted on 238 obese children and 106 lean siblings of central European and north African descent. The children who inherited the class I allele from their father, but not those who inherited it from their mother, had a higher risk of developing early-onset obesity compared with children who inherited the class III allele.

DIET AND EXERCISE DELAY ONSET OF TYPE 2 DIABETES, SAY US EXPERTS

Source: Lancet 2001; 358:565

Diet and exercise may stave off type 2 diabetes for at least three years. A large multicenter, multiethnic US trial of overweight people with impaired glucose tolerance participated in the Diabetes Prevention Program sponsored by the US National Institute of Diabetes and Digestive and Kidney Diseases. The randomized, controlled study included 3,234 overweight people aged 25-84 years old (45% from minority groups). A lifestyle intervention (training in diet, exercise, and behavior modification in 16 sessions over 24 weeks, then monthly) was compared with treatment of 850 mg of metformin twice daily or a placebo. During the study 29% of the individuals in the placebo group, 22% of the metformin group, and 14% of the lifestyle intervention group developed type 2 diabetes. The lifestyle intervention reduced the risk of developing diabetes by 58%. Metformin reduced the risk by 31%. Those in the lifestyle group also lost 5% to 7% of their body weight while following a low-fat diet and walking or doing some form of moderate intensity exercise for about 30 minutes a day.

DRUG FIRM WITHDRAWS STATIN FROM THE MARKET

Source: Lancet 2001; 358:568

Bayer AG has taken its cholesterol-lowering drug, cerivastatin, off of the market after it was linked to deaths of 52 patients in the United States and Europe. Cerivastatin has been used to lower serum-cholesterol by blocking the enzyme HMG-CoA-reductase. Since 1987, statins have been associated with rare reports of rhabdomyolysis. The muscle tissue breakdown in this condition is often reversible, but can be fatal if organ failure develops. The fatal cases were seen most often when the drug was used at higher doses in elderly patients and in combination with gemfibrozil, a lipid-lowering drug. The withdrawal has raised concerns about the safety of the other statins. However, the FDA said the millions of patients taking statins should not panic since rhabdomyolysis is a very rare side effect which does not outweigh the clinically proven benefits that statins offer.

(*.) Originally prepared for presentation on Southern Medical Association's Web site (http://www.sma.org) by Elaine McClellan-Holm.