Rationale--Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT): evolving the management of cardiovascular risk in patients with chronic kidney disease

BACKGROUND: Patients with chronic kidney disease (CKD) have a high burden of mortality and cardiovascular morbidity. Additional strategies to modulate cardiovascular risk in this population are needed. Data suggest that anemia is a potent and potentially modifiable risk factor for cardiovascular disease in patients with CKD, but these data remain unsubstantiated by any randomized controlled trial (RCT). Furthermore, the clinical practice guidelines for anemia management in patients with CKD are based on limited data. The need for new RCTs to address critical knowledge deficits, particularly with regard to the impact of anemia therapy on cardiovascular disease and survival, is recognized within the guidelines and independent comprehensive reviews of the existing published trial data. STUDY DESIGN: The Trial to Reduce Cardiovascular Events with Aranesp (Amgen Inc, Thousand Oaks, Calif) (darbepoetin alfa) Therapy (TREAT) is a 4000-patient, multicenter, double-blind RCT, designed to determine the impact of anemia therapy with darbepoetin alfa on mortality and nonfatal cardiovascular events in patients with CKD and type 2 diabetes mellitus. Subjects will be randomized in a 1:1 manner to either darbepoetin alfa therapy to a target hemoglobin (Hb) of 13 g/dL or control, consisting of placebo for Hb > or =9 g/dL or darbepoetin alfa for Hb <9 g/dL until Hb is again Hb > or =9 g/dL. TREAT is event-driven and has a composite primary end point comprising time to mortality and nonfatal cardiovascular events, including myocardial infarction, myocardial ischemia, stroke, and heart failure. TREAT will provide data that are critical to evolution of the management of cardiovascular risk in this high-risk population.     

Diagnostic laparoscopy in gastroenterology

Between 1970 and 1983, we performed 1121 diagnostic laparoscopies in 1119 patients. More than 50% of the examinations were performed for malignant disease. An adequate examination was accomplished in 917 (82%) procedures. The most frequent reason for inadequate evaluation was the presence of dense intraabdominal adhesions from previous surgery. We observed 105 (9.4%) minor complications and 20 (1.8%) major complications including one death following hemorrhage from liver biopsy. Major complications included abdominal wall hematoma, perforated abdominal viscus, hemoperitoneum, bleeding from liver biopsy, and respiratory depression. We observed a trend to decreased use of laparoscopy. Ascites of unknown origin and certain specific situations in patients with chronic liver disease remain as major indications for this diagnostic technique.     

Treatment of basal-cell carcinoma: comparison of radiotherapy and cryotherapy

A prospective randomised trial to compare radiotherapy and cryotherapy in the treatment of basal-cell carcinomas was carried out in 93 patients. Two years after treatment, 4% of tumours treated with radiotherapy and 39% of those treated with cryotherapy had recurred. It is concluded that cryotherapy does not offer a satisfactory alternative to radiotherapy in the treatment of basal-cell carcinomas.     

Prevalence of heart failure and systolic ventricular dysfunction in older Australians: the Canberra Heart Study

OBJECTIVE: To estimate the prevalence of heart failure (HF) and left ventricular (LV) systolic dysfunction in a population-based sample of older Australians. DESIGN, SETTING AND PARTICIPANTS: A cross-sectional survey of 2000 randomly selected residents of Canberra, aged 60-86 years, conducted between February 2002 and June 2003. Participants were assessed by history, physical examination by a cardiologist, and echocardiography. MAIN OUTCOME MEASURES: Age- and sex-specific prevalence rates of clinical HF and LV systolic dysfunction (defined as LV ejection fraction < or = 50%). RESULTS: Of 1846 people eligible for our study, 1388 (75%) agreed to participate and 1275 completed all investigations (mean age, 69.4 years; 50% men). In the study sample, 72 subjects (5.6%; 95% CI, 4.4%-7.1%) had clinical HF that had been previously diagnosed and was confirmed by our assessment. A further 0.6% (95% CI, 0.3%-1.2%) had undiagnosed clinical HF (ie, evidence of structural heart disease and symptoms/signs of cardiac insufficiency without a previous diagnosis of clinical HF). Thus, the overall prevalence of clinical HF in the sample was 6.3% (95% CI, 5.0%-7.7%). Clinical HF increased in prevalence with advancing age (a 4.4-fold increase from the 60-64-years age group to the 80-86-years age group; P < 0.0001). Of the 75 subjects (5.9%; 95% CI, 4.7%-7.3%) with LV systolic dysfunction, 44 (59%) were in the preclinical stage of disease. CONCLUSION: Diagnosed HF cases represent the "tip of the iceberg" for the national burden of HF and LV systolic dysfunction. Clinically identifiable HF cases can remain undiagnosed, and the majority of people with LV systolic dysfunction are in a preclinical stage of the disease.