aData for aliskiren 75 mg and 600 mg not included in table
Adverse events reported more frequently in patients on aliskiren compared to placebo are shown below:
aAdverse events reported more frequently in patients on aliskiren compared to placebo
Laboratory Parameters: Increases in blood urea nitrogen (BUN) or serum creatinine (sCr) were similar in patients treated with aliskiren (< 7%) compared to those on placebo (6%). In general, published results of comparison trials of aliskiren and an ACEI or ARB reported that blood chemistry levels remained normal in the majority of patients. One trial comparing the tolerability of aliskiren and the ACEI lisinopril in 183 patients with severe HTN reported one case of elevated potassium (> 5.5 mEq/L) in the aliskiren treatment group and none treated with lisinopril; approximately half the patients in each treatment group also received hydrochlorothiazide. Compared to baseline, patients in the aliskiren treatment group experienced a mean increase in sCr of 1.5 micromol/L (i.e., 0.017 mg/dl), with a mean decrease of 0.6 micromol/L (i.e., 0.0068 mg/dl) in patients receiving lisinopril.7 In a comparison trial of aliskiren and the ARB valsartan, an increase in serum potassium to > 5.5 mEq/L occurred in a similar proportion of patients in the aliskiren and valsartan treatment groups (i.e., 2% in each group), compared to 3% of patients receiving placebo, and 4% of patients on combination therapy with aliskiren and valsartan. An increase in serum potassium to > 6.0 mEq/L was reported in 1% of patients in each of the monotherapy treatment groups as well as in the placebo group; and 0.5% in patients treated with aliskiren/valsartan combination therapy. An increase in sCr to > 176.8 micromol/L (i.e., > 2 mg/dl) was reported in 0.2% of patients on aliskiren, 0.4% on valsartan, 0.9% on combination therapy, and 0% of patients on placebo. According to data on file with the manufacturer, 2.2% of patients with HTN and DM treated with aliskiren 300mg experienced an increase in potassium to > 5.5 mEq/L compared to 2.6% of patients receiving ramipril 10 mg, and 5.5% of patients on the combination.2 As with other agents that act at the RAAS (e.g., ACEIs, ARBs, aldosterone antagonists), it is recommended that kidney function be monitored in patients where kidney function depends on the RAAS (e.g., renal artery stenosis, volume depletion, severe heart failure) and in patients with prior kidney dysfunction or diabetes mellitus. Serum potassium should be monitored in patients receiving potassium-sparing diuretics, potassium supplements, or other medications that may increase serum potassium, and in patients with kidney impairment, diabetes mellitus, or heart failure. The frequency of routine monitoring should take into consideration the patient’s concomitant therapy and comorbid conditions. The manufacturer recommends that electrolytes and kidney function be routinely monitored in patients with DM receiving concomitant ACEIs due to an increase in serum potassium (5.5% of patients as previously mentioned); this is compared to 0.9% of patients with essential HTN who experienced an increase in potassium > 5.5 mEq/L on monotherapy (vs. placebo 0.6%).
Slight decreases in hemoglobin (0.08 g/dL) and hematocrit (0.16 volume percent) were found in patients receiving aliskiren, with an increase in the incidence of anemia compared to placebo (0.1% aliskiren; 0.3% aliskiren 300mg; 0% placebo).
The effect of aliskiren on uric acid levels appears to be additive with hydrochlorothiazide, increasing the risk for adverse events: elevated uric acid (0.4% vs. 0.1%), gout (0.2% vs. 0.1%), and kidney stones (0.2% vs. 0%).
Treatment with aliskiren was associated with an increase in creatine kinase (CK) of > 300% in ~ 1% of patients compared to 0.5% of patients receiving placebo. There were five cases of increased CK levels reported as adverse events in the clinical trials with aliskiren: one diagnosed as myositis; one as subclinical rhabdomyolysis; three discontinued treatment.
Look-alike/Sound-alike Error Risk Potential
As part of a pilot program, the VA PBM and Center for Medication Safety queried a multi-attribute drug product search engine for similar sounding and appearing drug names based on orthographic and phonological similarities, as well as similarities in dosage form, strength and route of administration. By incorporating similarity scores as well as clinical judgment, it was determined that the following drug names may pose as potential sources of drug name confusion.
* Identified as a High Alert Medication per ISMP (i.e., special precautions must be taken in the receipt, storage, distribution and administration of these drugs)
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