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www.renalandurologynews.com FEBRUARY 2010 Renal & Urology News 23 Diabetes-Related ESRD Incidence Is Decreasing THE INCIDENCE of treatment for The number of individuals who began From 1996 to 2006, however, the inci- used the U.S. Renal Data System to end-stage renal disease (ESRD) in diabetes-related ESRD treatment (dial- dence decreased by 3.9% per year from obtain the number of individuals people with diabetes continues to ysis or kidney transplantation) rose 343.2 to 197.7 per 100,000 diabetic having diabetes listed as a primary decline, a trend that could be related from 17,727 in 1990 to 48,215 in 2006. population, the investigators reported diagnosis and who initiated ESRD treat- to improved treatment and care and From 1990 to 1996, the age-adjusted in Diabetes Care (2010;33:73-77). ment between 1990 and 2006. They a decrease in the prevalence of ESRD incidence of treatment for diabetes- The researchers, Nilka Ríos Burrows, calculated incidence using the esti- risk factors, according to a recently pub- related ESRD rose from 299.0 to MPH, and colleagues at the Centers mated U.S. population with diabetes lished study. 343.2 per 100,000 diabetic population. for Disease Control and Prevention, continued on page 24 administration of subcutaneous epinephrine solution 1:1000 (0.3 to 0.5 ml) of 1.0% on valsartan vs. 0.2% on placebo). In the Valsartan in Acute and measures to ensure a patent airway may be necessary. Myocardial Infarction Trial (VALIANT), discontinuation due to various types Discontinue aliskiren immediately in patients who develop angioedema and of renal dysfunction occurred in 1.1% of valsartan-treated patients and do not readminister. 0.8% of captopril-treated patients. Include assessment of renal function when evaluating patients with heart failure or post-myocardial infarction. 5.3 Hypotension An excessive fall in blood pressure (hypotension) was rarely seen (<0.5%) 5.7 Serum Electrolyte Abnormalities in patients with uncomplicated hypertension treated with Valturna in con- Valturna trolled trials. In the short-term controlled trials of various doses of Valturna, the inci- dence of hyperkalemia (serum potassium >5.5 mEq/L) was about 1%-2% In patients with an activated renin-angiotensin-aldosterone system, such as higher in the combination treatment group compared with the monothera- volume- or salt-depleted patients receiving high doses of diuretics, symp- pies aliskiren and valsartan, or with placebo. tomatic hypotension may occur in patients receiving renin-angiotensin- aldosterone system (RAAS) blockers. Correct these conditions prior to the In a long-term, uncontrolled study with median treatment duration of administration of Valturna, or start the treatment under close medical about one year, about 4% of the patients had at least one serum potassium supervision. >5.5 mEq/L at some time during the study; about 0.8% of patients discon- tinued study treatment and had a high serum potassium at some point Initiate therapy cautiously in patients with heart failure or recent myocar- during the study. Patients with hyperkalemia were older (median age 65 vs. dial infarction and in patients undergoing surgery or dialysis. Patients 55) with slightly lower mean baseline estimated creatinine clearance com- with heart failure or post-myocardial infarction patients given valsartan pared to patients without hyperkalemia. While about 25% of the hyper- commonly have some reduction in blood pressure, but discontinuation of kalemic episodes occurred in the first two months, other initial episodes therapy because of continuing symptomatic hypotension usually is not were reported throughout the study. necessary when dosing instructions are followed. In controlled trials in heart failure patients, the incidence of hypotension in valsartan-treated Periodic determinations of serum electrolytes to detect possible electrolyte patients was 5.5% compared to 1.8% in placebo-treated patients. In the imbalances is advised, particularly in patients at risk for hyperkalemia such Valsartan in Acute Myocardial Infarction Trial (VALIANT), hypotension in as those with renal impairment. post-myocardial infarction patients led to permanent discontinuation of Caution is advised with concomitant use of Valturna with potassium- therapy in 1.4% of valsartan-treated patients and 0.8% of captopril-treated sparing diuretics, potassium supplements, salt substitutes containing patients. potassium, or other drugs that increase potassium levels may lead to If an excessive fall in blood pressure occurs with Valturna, place the patient increases in serum potassium. in the supine position and, if necessary, give an intravenous infusion of 5.8 Renal Artery Stenosis normal saline. A transient hypotensive response is not a contraindication to Aliskiren further treatment, which usually can be continued without difficulty once No data are available on the use of aliskiren in patients with unilateral or the blood pressure has stabilized. bilateral renal artery stenosis or stenosis of the artery to a solitary kidney. 5.4 Patients with Severe Renal Impairment Valsartan Valturna In studies of ACE inhibitors in hypertensive patients with unilateral or bilat- Patients with severe renal impairment were excluded from clinical trials eral renal artery stenosis, increases in serum creatinine or blood urea with Valturna in hypertension. nitrogen have been reported. In a 4-day trial of valsartan in 12 hypertensive Aliskiren patients with unilateral renal artery stenosis, no significant increases in Patients with severe renal dysfunction (creatinine 1.7 mg/dL for women and serum creatinine or blood urea nitrogen were observed. There has been no 2.0 mg/dL for men and/or estimated GFR <30 mL/min), a history of dialysis, long-term use of valsartan in patients with unilateral or bilateral renal artery nephrotic syndrome, or renovascular hypertension were excluded from stenosis, but an effect similar to that seen with ACE inhibitors should be clinical trials of aliskiren in hypertension. Safety information with aliskiren anticipated. and the potential for other drugs acting on the renin-angiotensin-aldosterone 5.9 Cyclosporine system to increase serum creatinine and blood urea nitrogen are not Aliskiren available. When aliskiren was given with cyclosporine, the blood concentrations of Valsartan aliskiren were significantly increased. Concomitant use of aliskiren with In studies of ACE inhibitors in hypertensive patients with unilateral or bilat- cyclosporine is not recommended [see Drug Interactions (7)]. eral renal artery stenosis, increases in serum creatinine or blood urea 6 ADVERSE REACTIONS nitrogen have been reported. In a 4-day trial of valsartan in 12 hypertensive 6.1 Clinical Studies Experience patients with unilateral renal artery stenosis, no significant increases in The following serious adverse reactions are discussed in greater detail in serum creatinine or blood urea nitrogen were observed. There has been no other sections of the label: long-term use of valsartan in patients with unilateral or bilateral renal • Risk of fetal/neonatal morbidity and mortality [see Warnings and
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