Design and baseline characteristics for the aminoguanidine Clinical Trial in Overt Type 2 Diabetic Nephropathy (ACTION II).

Advanced glycosylation endproduct (AGE) formation has been implicated in the development and progression of nephropathy in type 2 diabetes mellitus. In diabetic animals, aminoguanidine inhibits AGE-mediated cross-linking of proteins in vascular and renal tissue and slows the progression of renal disease. ACTION II is a randomized, double-blind, placebo-controlled trial comparing two dose levels of aminoguanidine with placebo on the progression of nephropathy in 599 type 2 diabetic patients with renal disease from 84 centers in the United States and Canada. The primary endpoint is time to doubling of serum creatinine concentration. Secondary endpoints include the effect of aminoguanidine on time to all-cause mortality, end-stage renal disease (ESRD), cardiovascular morbidity and mortality, rate of change in indices of renal function (iothalamate, Cockcroft and Gault [C&G] calculated creatinine and measured creatinine clearances), proteinuria, retinopathy, circulating and urinary AGE levels, and estimation of the relationship between plasma aminoguanidine concentrations and primary and secondary efficacy endpoints and adverse events. Progression of macrovascular disease was monitored and fundus photography performed. Type 2 diabetic patients aged 30 to 70 years were eligible for the trial if their blood pressure was < or =180 mm Hg systolic and < or =120 mm Hg diastolic, serum creatinine concentration > or =1.0 mg/dL (in women) or > or =1.2 mg/dL (in men), C&G clearance > or =40 mL/min, and proteinuria > or =500 mg/d with diabetic retinopathy or diabetic nephropathy on renal biopsy. Recruitment began in July 1995 and terminated in December 1996. The trial randomized a total of 599 subjects. At baseline, the mean (standard deviation [SD]) age was 58 (7.7) years, diabetes duration 16.5 (7.5) years, body mass index 32 kg/m2 (10-90% range 2642), arterial blood pressure 105 (12) mm Hg, C-peptide concentration 2.55 (1.71) ng/mL, serum glucose concentration 201 (89) mg/dL, hemoglobin A1c 8.7% (1.6), serum creatinine concentration 1.6 (0.5) mg/dL, iothalamate clearance 52 (25) mL/min/1.73 m2, proteinuria 4.1 (4.2) g/d, triglycerides 259 (214) mg/dL, and LDL cholesterol 144 (40) mg/dL. Patients are 72% male, 68% white, 16% black, and 16% Asian American and Native American. At baseline, 76% were receiving concomitant angiotensin-converting enzyme (ACE) inhibitors and 43% lipid-lowering agents. Follow-up in ACTION II was scheduled to continue through December 1998, so that follow-up was to be 2 years after the date of randomization of the final enrolled patient. The trial in fact ended in March 1998. This trial will contribute to our understanding of the natural history of type 2 diabetes mellitus-associated nephropathy and determine whether aminoguanidine will slow the progression of established diabetic renal disease.

A peer review of a peer review organization.

Under Medicare, one of the federally required objectives of peer review organizations is to reduce inappropriate and unnecessary admissions. We reevaluated 32 admissions approved and 32 denied by the Arizona peer review organization, Health Services Advisory Group (HSAG), in a "blind" manner to determine whether practicing physicians in the community agree with the local peer review organization. Overall, physicians at the Scottsdale Memorial Hospital (SMH) approved 72% of HSAG-approved and denied 61% of HSAG-denied admissions. Of the 64 admissions, 3 or 4 of 4 reviewers (2 physicians and 2 nurses) agreed with the HSAG decision in 38 (59%), but 2 or more reviewers disagreed in the other 26 (41%). Disagreement between the 2 physicians occurred in 48% of the cases and disagreement between the 2 nurses in 33%. Even among admissions denied by SMH physician reviewers, the physicians would have admitted 23% of those patients under similar circumstances. In 28% of the HSAG-denied admissions, the reviewing physicians thought that the patients' health care would have been compromised if the admissions had not taken place. Despite well-defined criteria for the appropriateness of hospital admissions, the review process remains subjective, with much disagreement between peer review organizations and practicing physicians.

Recognition and treatment of hypercholesterolemia in a family practice center.

Elevated levels of serum cholesterol are a major risk factor for coronary artery disease, yet few studies have investigated the extent to which practicing physicians recognize and treat their patients with hyperlipidemia. A retrospective chart review was performed on 93 patients who had documented cholesterol levels greater than or equal to 6.20 mmol/L (240 mg/dL) in an outpatient setting to determine the degree of recognition and treatment of hypercholesterolemia. Hypercholesterolemia was diagnosed in 66 percent of patients, dietary recommendations were made in 46 percent, and lipid-lowering medication was prescribed in only 6 percent. Lipid profiles or high-density lipoprotein levels were determined in 22 percent, and thiazide diuretics were being prescribed for 32 percent. There was a trend toward greater recognition and treatment in patients with cholesterol levels greater than 7.75 mmol/L (300 mg/dL) and in patients less than 70 years of age. These results suggest that physician recognition of hypercholesterolemia is greater when compared with previous studies, but more aggressive diagnosis and intervention are needed. Greater utilization of lipid-profile analysis in hypercholesterolemic patients should also be encouraged.

Digital subtraction angiography for localization of parathyroid lesions.

Transvenous digital subtraction angiography was used before surgery to evaluate seven patients with chemical evidence of hyperparathyroidism. Digital subtraction angiography identified parathyroid adenomas in six of the seven patients. This technique is a sensitive, although not specific, method to identify small vascular tumors.

Postoperative wound infections detected during hospitalization and after discharge in a community hospital.

Postoperative wound infections were evaluated in 1271 patients who had 1389 surgical procedures. There were 49 postoperative wound infections identified, of which 26 (53%) were discovered after discharge. Wound infections varied from 2.5% for clean wounds up to 13.3% for dirty wounds. Among the specialties, the infection rate ranged from no infection for otolaryngologists and urologists to 8.6% for general surgeons. With routine hospital surveillance, the overall infection rate was 1.8% or 2.2%, including readmissions for infection, but less than the actual rate of 3.8%. Persons who had three procedures had no infection rate of 27.3%; for two procedures, 8.1%; and for one procedure, 3.2%. Most postoperative wound infections detected after discharge were based on clinical grounds and not positive cultures. Rehospitalization was required for seven patients because of infection. This study demonstrates that postoperative wound infection surveillance must be continued after discharge.

Antibiotic use among medical specialties in a community hospital.

Antibiotic use in a community hospital was evaluated to demonstrate specialty variations. A chart review was performed using the Veterans Administration's "Guidelines for Peer Review" to determine appropriate antibiotic use. Of the 1,054 patients discharged in August 1977, three hundred ten (29.4%) received 479 courses of antibiotics of which two hundred eighty-seven (60%) were considered appropriate. Seventy-two percent of the therapeutic courses and 36% of the prophylactic courses were appropriate. Prophylactic antibiotics were used in 12% of the hospitalized patients and accounted for 33% of the total antibiotics. No notable difference in appropriate antibiotic use was found among general surgeons (73%), internists (72%), orthopedists (71%), and family practitioners (67%). Substantially lower levels were found among urologists (54%), otolaryngologists (44%), and obstetricians (36%). Continued education in proper antibiotic use is needed especially for prophylaxis. Educational programs directed at specific specialties may be the most fruitful way to effect improved overall antibiotic use.

Benign giant adrenal cyst and parathyroid adenoma: a case report.

An unusual case of a benign adrenal cyst and a parathyroid adenoma occurring in a 59-year-old man with hypercalcemia is reported. Excretory urography, ultrasound, renal aortography, computerized axial tomography and selective thyroid venous sampling were used to establish a diagnosis. Left adrenalectomy was done because of a suspicion of malignancy, which was followed by excision of a retrolaryngeal parathyroid adenoma.