CHICAGO—Hypertensive patients with coronary artery disease had similar outcomes when they took a beta-blocker therapy or a calcium antagonist-based therapy, according to a study in the December 3 issue of The Journal of the American Medical Association (JAMA).

According to background information in the article, despite conclusive evidence of the effectiveness of medications to treat high blood pressure in patients with hypertension in general, safety and efficacy of antihypertensive medications in patients with coronary artery disease (CAD) have been discerned only from the analyses of subgroups in large trials.

Carl J. Pepine, M.D., of the University of Florida College of Medicine, Gainesville, Fla., and colleagues designed a randomized trial, the International Verapamil-Trandolapril Study (INVEST), to compare outcomes in older hypertensive patients with CAD treated with a calcium antagonist strategy (CAS; verapamil sustained release [SR]) or a beta-blocker, non-calcium antagonist strategy (NCAS; atenolol). Because most hypertensive patients require more than 1 agent to adequately control blood pressure, INVEST was intended to compare multidrug strategies rather than individual agents. The study included 22,576 hypertensive CAD patients aged 50 years or older, and was conducted September 1997 to February 2003 at 862 sites in 14 countries.

The medications trandolapril and/or hydrochlorothiazide were administered to achieve blood pressure goals according to guidelines from the sixth report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VI) of less than 140 mm Hg (systolic) and less than 90 mm Hg (diastolic); and less than 130 mm Hg (systolic) and less than 85 mm Hg (diastolic) if diabetes or renal impairment was present. Trandolapril was also recommended for patients with heart failure, diabetes, or renal impairment.

After an average follow-up of 2.7 years per patient, 2,269 patients had a primary outcome event (death, nonfatal heart attack, or nonfatal stroke) with no statistically significant difference between treatment strategies (9.93 percent in CAS and 10.17 percent in NCAS). Two-year blood pressure control was similar between groups. The JNC VI blood pressure goals were achieved by 65.0 percent (systolic) and 88.5 percent (diastolic) of CAS patients and 64.0 percent (systolic) and 88.1 percent (diastolic) of NCAS patients. A total of 71.7 percent of CAS patients and 70.7 percent of NCAS patients achieved a systolic blood pressure of less than 140 mm Hg and diastolic blood pressure of less than 90 mm Hg.

CHICAGO—Patients with diabetes who received a solitary pancreas transplant appeared to have worse survival than patients on the transplant waiting list who received conventional therapy, according to a study in the December 3 issue of The Journal of the American Medical Association (JAMA).

According to background information in the article, pancreatic transplantation is a therapeutic option for patients with complicated diabetes mellitus. The American Diabetes Association supports the procedure for patients with diabetes who have had, or need, a kidney transplant. In the absence of kidney failure, pancreas transplantation may be considered for patients with diabetes and severe and frequent metabolic instability, i.e., episodes of very low blood glucose levels (hypoglycemia) or high blood glucose levels with buildup of blood acids (ketoacidosis).

According to the article, solitary pancreas transplantation (i.e., pancreas alone or pancreas-after-kidney) for diabetes mellitus remains controversial due to procedure-associated illness and/or death, toxicity of immunosuppression, expense, and unproven effects on the secondary complications of diabetes. Whether transplantation offers a survival advantage over conventional therapies for diabetes is unknown.

Jeffrey M. Venstrom, B.S., of the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and Human Services, Bethesda, Md., and colleagues compared the survival of pancreas transplant recipients in patients with diabetes and preserved kidney function with that of similar patients listed for a pancreas transplant, since they would have conditions similar to those who underwent the transplant procedure.

The study was conducted using data from 124 transplant centers in the United States, with 11,572 patients with diabetes mellitus on the waiting list for pancreas transplantation (pancreas alone, pancreas-after-kidney, or simultaneous pancreas-kidney) at the United Network for Organ Sharing/Organ Procurement and Transplantation Network between January 1, 1995, and December 31, 2000.

The researchers found that over four years of follow-up, the transplant recipients, compared with patients awaiting the same procedure, had a 57 percent increased risk of death for pancreas transplant alone; 42 percent increased risk of death for pancreas-after-kidney transplant patients; and 57 percent decreased risk of death for simultaneous pancreas-kidney transplant "Transplant patient 1- and 4-year survival rates were 96.5 percent and 85.2 percent for pancreas transplant alone, respectively, and 95.3 percent and 84.5 percent for pancreas-after-kidney transplant, while 1- and 4-year survival rates for patients on the waiting list were 97.6 percent and 92.1 percent for pancreas transplant alone, respectively, and 97.1 percent and 88.1 percent for pancreas-after-kidney transplant," the authors write.

"Our data suggest that patients with complicated diabetes who are considering a solitary pancreas transplant must weigh the potential benefit of insulin independence against an apparent increase in mortality for at least the first 4 years posttransplantation. Benefits not accounted for in this analysis (e.g., improved quality of life) may justify pancreas transplantation, and it is possible that transplant recipients may show a survival advantage with longer-term follow-up. Even if that is true, however, it is at best difficult to weigh the cost of an early excess mortality (spanning the first 4 years posttransplant) against what at this point is a hypothetical survival advantage beyond the 4 years we have analyzed," the researchers write.

CHICAGO—Echinacea is not effective in shortening the duration or decreasing the severity of upper respiratory tract infections in children, according to a study in the December 3 issue of The Journal of the American Medical Association (JAMA).

Upper respiratory tract infections (URIs) are a significant health burden in childhood, according to background information in the article. The average child has six to eight colds each year, each lasting seven to nine days. While children are frequently given drugs such as decongestants, antihistamines, and cough suppressants to reduce symptoms, there is little evidence that these medications are effective in children younger than 12 years. The authors add that it has been estimated that 11 percent to 21 percent of children in the United States and Canada who are receiving care from conventional physicians are also using alternative therapies. Echinacea, one of the most commonly used herbal remedies in the U.S., has been used extensively for the prevention and treatment of URIs in adults.

James A. Taylor, M.D., from the University of Washington, Seattle, and colleagues, conducted a randomized controlled trial to determine the effectiveness and safety of Echinacea purpurea (a type of echinacea used for medicinal purposes) in treating URIs in children two to 11 years old. A total of 524 children were included in the study. The patients were randomized to receive either echinacea or placebo for up to three URIs over a four-month period. The echinacea or placebo was started at the onset of symptoms and continued for a maximum of ten days.

Data were analyzed on 707 URIs that occurred in 407 children, including 337 who were treated with echinacea and 370 with placebo. There were 79 children who completed the study period without getting a URI. The median (half were more; half were less) duration of the URIs was 9 days.

"There was no difference in duration between upper respiratory tract infections treated with echinacea or placebo," the authors report. "There was also no difference in the overall estimate of severity of upper respiratory tract infection symptoms between the two treatment groups (median, 33 in both groups). In addition, there were no statistically significant differences between the two groups for peak severity of symptoms, number of days of peak symptoms (1.60 in the echinacea group and 1.64 in the placebo group), number of days of fever (0.81 in the echinacea group vs. 0.64 in the placebo group), or parental global assessment of severity of the upper respiratory tract infection." The authors note there was no difference in the rate of adverse events (unwanted side effects) reported in the two treatment groups. However, rashes occurred during 7.1 percent of the upper respiratory tract infections treated with echinacea and 2.7 percent of those treated with placebo.

ECHINACEA NOT EFFECTIVE IN TREATING COLDS IN CHILDREN