Thiazolidinedione safety and efficacy in ambulatory patients receiving hemodialysis.

STUDY OBJECTIVES: To determine whether thiazolidinediones cause significant changes in intravascular volume, anemia, or chronic heart failure; to determine which thiazolidinedione, rosiglitazone or pioglitazone, has a greater propensity to cause these adverse effects; and to evaluate thiazolidinedione efficacy in patients with diabetes mellitus and end-stage renal disease who require hemodialysis. DESIGN: Retrospective chart review. SETTING: Ambulatory hemodialysis clinic. PATIENTS: Forty ambulatory patients receiving hemodialysis. MEASUREMENTS AND MAIN RESULTS: Of the 40 patients (26 men, 14 women, mean +/- SD age 64.8 +/- 11.5 yrs), diabetes mellitus was the cause of end-stage renal disease in 37 (92.5%). The men were older than the women (mean +/- SD age 67.65 +/- 11.43 yrs and 59.58 +/- 10.6 yrs, respectively, p=0.03). Additional demographic data collected were start date and cause of end-stage renal disease, comorbid conditions, drug profile, hospitalization dates, and reason for admission. Laboratory values were obtained for hematocrit, iron indexes (transferrin saturation and ferritin), mean corpuscular volume, and hemoglobin A1c (A1C); body weight before and after dialysis, and predialysis systolic and diastolic blood pressures were measured. All monitoring parameters were evaluated for 3 months before and after the start of therapy. Three patients were hospitalized for new or worsening chronic heart failure (two were receiving rosiglitazone therapy, one pioglitazone, p=0.555). Changes in A1C values were reviewed to determine thiazolidinedione efficacy; no statistical difference was observed between thiazolidinedione agents prescribed. Combined thiazolidinedione data yielded nonsignificant effects for all clinical and laboratory findings except A1C (-0.61%, p=0.05) and blood pressure (systolic -5.57 +/- 12.09 mm Hg, p=0.01; diastolic -3.24 +/- 6.17 mm Hg, p=0.002). CONCLUSION: Thiazolidinedione therapy is safe and effective for ambulatory patients receiving hemodialysis. However, as we found that these drugs reduced systolic and diastolic blood pressure, further investigation into this drug effect is warranted.

Irbesartan substitution for valsartan or losartan in treating hypertension.

OBJECTIVE: To determine whether subjects whose therapy was converted from losartan or valsartan to irbesartan maintained equivalent blood pressure measurements, determine the safety and tolerability of irbesartan in the veteran population, and assess the number of subjects attaining their goal blood pressure before and after conversion. METHODS: A retrospective review of medical records for subjects whose antihypertensive was converted to irbesartan was conducted. Demographic data were collected, and subjects' past medical histories were used to determine their goal blood pressure. Blood pressures were compared at baseline, 2 weeks, and 2 months after conversion to determine efficacy, and adverse effect occurrence was compared between visits to assess safety. RESULTS: Conversion was attempted in 79 subjects; 72 met the criteria for review. Mean baseline, 2-week, and 2-month blood pressures for all subjects were 143/74, 139/72, and 139/73 mm Hg, respectively (p values NS). The number of subjects achieving their goal blood pressure at each assessment visit was similar: 37.5% at baseline, 43.4% at 2 weeks, and 31.9% at 2 months. Thirteen of the 72 subjects discontinued irbesartan due to adverse events. CONCLUSIONS: Irbesartan is an appropriate substitution for valsartan or losartan.