The drug scene

National Consumers League launches campaign to educate consumers about dangers of OTC pain medications 

More than half (64%) of all respondents in a national survey are unconcerned about the possibility of suffering serious side effects, including stomach bleeding or ulcers, as a result of taking popular over-the-counter (OTC) anti-inflammatory pain medications, such as Advil or Aleve, according to the National Consumers League (NCL). The survey was part of a new NCL campaign to educate the 30 million consumers who take nonsteroidal anti-inflammatory drugs (NSAIDs) daily about the possible dangers of these products.

“People mistakenly assume that, if a prescription is not required for a medication that is sold in a drugstore or a supermarket, it must be safe,” said Linda Golodner, president of the NCL, the nation's oldest consumer advocacy organization. “As a result, consumers who too often self-diagnose and self-treat without seeking a doctor's advice unwittingly put themselves at risk for potentially deadly consequences.”

Research has demonstrated that more than 16,500 people die each year and 103,000 are hospitalized from serious NSAID-related complications. Additionally, studies have shown that the use of OTC NSAIDs increases the risk of stomach bleeding 2 to 3 times and that most serious side effects can occur without warning symptoms. Although an advisory committee to the Food and Drug Administration (FDA) met last year to discuss the need for label changes for OTC NSAID products after considering these potential risks and voted to require additional information on product labeling, action on these safety recommendations is still pending before the FDA.

The survey revealed that:

The survey results and a free brochure for consumers, “Over-the-Counter Pain Meds: What Helps, What Hurts,” are available at www.nclnet.org.

Research indicates acetaminophen more cost-effective for osteoarthritis pain 

NEW ORLEANS—Research presented last fall at the American College of Rheumatology's Annual Scientific Meeting suggested that acetaminophen should be the initial therapy for the treatment of osteoarthritis (OA) pain based on cost, safety, and efficacy versus other common OTC and prescription drugs.

Clinical studies demonstrated comparable effectiveness of acetaminophen compared with prescription anti-inflammatory medications and some doses of celecoxib and rofecoxib. According to researchers, this study confirmed the college's guidelines, which support acetaminophen as initial drug therapy for OA pain, the most common form of arthritis among Americans.

Investigators obtained data on drug efficacy, tolerance, and complications from reviews of published studies, with a particular focus on data from long-term randomized controlled clinical trials. Eight medication strategies were examined and included combinations of NSAIDs, NSAIDs and misoprostol 200 mg 4 times per day, a selective COX-2 inhibitor (celecoxib 200 mg twice a day or rofecoxib 25 mg a day), or acetaminophen 650 mg 4 times per day. Costs for each therapeutic combination were derived from published databases. Outcome measures were quality-adjusted life expectancy and incremental cost-effectiveness ratios.

The research was supported by an unrestricted grant from McNeil Consumer & Specialty Pharmaceuticals, an American College of Rheumatology Clinical Investigator Fellowship Award, and National Institutes of Health grant AR47782. For details, call (908) 273-1400.

New data suggest certain atypical antipsychotics increase diabetes risk 

Data published last year in the Journal of Clinical Psychiatry suggest that although the atypical antipsychotic risperidone (Risperdal) does not increase patients' chances of developing Type II (adult-onset) diabetes, the risk is increased with olanzapine (Zyprexa), clozapine (Clozaril), and some older, conventional medications.

In the study, the association with newly diagnosed diabetes was numerically lower in people taking risperidone than in untreated patients, although not significantly different. However, the other antipsychotics showed an opposite trend. The odds of being diagnosed with diabetes were 7 times greater for patients taking clozapine than those receiving no treatment (odds ratio of 7.44), more than 3 times greater for those taking olanzapine (3.10) or low-potency conventionals, such as chlorpromazine (3.46), and slightly more than double (2.13) for those receiving high-potency conventionals, such as haloperidol.

Individuals with schizophrenia are known to be up to 4 times more likely to have diabetes develop than the population at large. The study looked at medical and prescription claims data from 2 health plans covering 2.5 million individuals. Records for 4308 patients diagnosed with psychosis who received at least 60 days of antipsychotic treatment between April 1, 1996, and December 31, 1997, were compared with 3625 patients who received no such therapy. Patients with pre-existing Type 2 diabetes were excluded from the analysis. The claims analysis was supported by Janssen Pharmaceutica Products, LP, maker of Risperdal.

For more information, visit www.risperdal.com.

FDA approves Metaglip for type 2 diabetes 

Bristol-Myers Squibb Company announced last fall that the FDA had approved Metaglip for use, along with diet and exercise, as initial drug therapy for people with type 2 diabetes whose hyperglycemia cannot be satisfactorily managed with diet and exercise alone. The drug also was approved as second-line therapy for patients with type 2 diabetes who are taking either metformin or a sulfonylurea with a regimen of diet and exercise but whose blood sugar levels are inadequately controlled.

Metaglip combines glipizide and metformin hydrogen chloride (HCl), 2 widely prescribed oral antidiabetic agents, in a single pill. These agents work in complementary fashion to improve blood sugar in this population. In clinical trials, Metaglip was shown to be more effective at lowering blood sugar levels than either glipizide or metformin used alone. The medicine will be available in 3 dosage strengths: 2.5 mg/250 mg, 2.5 mg/500 mg, and 5 mg/500 mg tablets. For full prescribing information, contact Brian Henry at (609) 252-3337. Bristol-Myers Squibb's website is www.bms.com.

Study finds arthritis patients remain on infliximab therapy longer than etanercept 

TUCSON—Patients with immune-mediated inflammatory disorders who are treated with infliximab (Remicade) are twice as likely to remain on therapy as those treated with etanercept (Enbrel), according to research by the Arizona Arthritis Center at the University of Arizona College of Medicine.

Presented at the annual American College of Rheumatology (ACR) meeting in October, the study followed 242 patients treated with an antiTNF (tumor necrosis factor) during a 4-year period at the arthritis center. The data found 64% of patients (61/96) treated with etanercept discontinued therapy, compared with 28% (41/146) in the infliximab group. Lack of efficacy, adverse events, and patient preference were among the top reasons cited for discontinuation.

“Providing sustained clinical efficacy is essential in preventing joint destruction and restoring quality of life among patients living with these potentially debilitating diseases,” said principal investigator Deborah Jane Power, DO, assistant professor of clinical medicine at the UA College of Medicine. “The ability of infliximab to provide greater long-term control may be the result of flexible dosing.”

For nearly 20 years, the Arizona Arthritis Center has been studying the role of TNF, a chemical messenger involved in the inflammatory process. TNF overproduction is believed to be involved in a variety of immune-mediated inflammatory disorders, including rheumatoid arthritis and spondyloarthropathies, such as ankylosing spondylitis and psoriatic arthritis. The antiTNF therapies etanercept and infliximab are administered through subcutaneous injection and infusion (intravenous injection), respectively.

The study objective was to investigate the duration of therapy for both infliximab and etanercept in a context different from clinical trials. An electronic medical record (EMR) system was used to review all patients treated with an antiTNF therapy between February 1998 and May 2002. Complete data, including diagnosis, disease duration, dates of therapy, reason for discontinuation, adverse events, and serious adverse events, were collected.

Among patients included in the study, 203 had rheumatoid arthritis, 17 had psoriatic arthritis, 18 had juvenile RA, and 4 were classified as other. Kaplan-Meier estimates for discontinuation of therapy showed the mean time on medication was 741 days with a maximum follow-up time of 1255 days.

The mean time to discontinuation of etanercept was 533 days. Among the 61 patients who stopped etanercept therapy, 41% cited loss of efficacy, 36% cited adverse events, and 3% cited patient preference. However, the mean time to discontinuation of infliximab was 809 days. Among the 41 patients who stopped infliximab therapy, 24% cited loss of efficacy, 44% cited adverse events, and none cited patient preference.

For details, call Jean Spinelli, University of Arizona, at (520) 626-7301.

FDA approves Pravachol for use in pediatric patients 

In October, the FDA approved a new indication for Pravachol (pravastatin sodium) for use in treating pediatric patients with heterozygous familial hypercholesterolemia (HeFH). Approval for this new indication provides an additional treatment option for children ages 8 years and older who have this condition and whose low-density lipoprotein cholesterol levels are above the indicated limits after an adequate trial of diet. Familial heterozygous hypercholesterolemia is an inherited disorder that causes very high cholesterol levels beginning at birth and significantly increases the risk of having a heart attack early in life. This condition affects an estimated 1 in 500 children.

The FDA approval was based on the results of clinical studies that were conducted to assess the safety, efficacy, and pharmacokinetic profile of Pravachol in this patient population. Bristol-Myers Squibb conducted these studies after receiving a written request from the FDA. In return for complying with the FDA request, Bristol-Myers Squibb was also granted a 6-month extension to the company's exclusivity for Pravachol through April 2006.

For details, go to www.bms.com.