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Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
The following adverse reactions (events 2% greater on PRINIVIL than on placebo) were observed with PRINIVIL vs placebo: headache (5.7% vs 1.9%), dizziness (5.4% vs 1.9%), cough (3.5% vs 1.0%).
In controlled studies in patients with heart failure, therapy was discontinued in 8.1% of patients treated with PRINIVIL for 12 weeks, compared to 7.7% of patients treated with placebo for 12 weeks.
The following adverse reactions (events 2% greater on PRINIVIL than on placebo) were observed with PRINIVIL vs placebo: hypotension (4.4% vs 0.6%), chest pain (3.4% vs 1.3%).
In the ATLAS trial [see Clinical Studies] in heart failure patients, withdrawals for adverse reactions were similar in the low-and high-dose groups. The following adverse reactions, mostly related to ACE inhibition, were reported more commonly in the high dose group:
Table 1 : Dose-related Adverse Drug Reactions: ATLAS
Acute Myocardial Infarction
Patients in the GISSI-3 study treated with PRINIVIL had a higher incidence of hypotension (9.0%% vs 3.7%%) and renal dysfunction (2.4%% vs 1.1%%) compared with patients not taking PRINIVIL.
Other clinical adverse reactions occurring in 1% or higher of patients with hypertension or heart failure treated with PRINIVIL in controlled clinical trials and do not appear in other sections of labeling are listed below:
Body as a whole: Fatigue, asthenia, orthostatic effects.
Miscellaneous: A symptom complex has been reported which may include a positive ANA, an elevated erythrocyte sedimentation rate, arthralgia/arthritis, myalgia, fever, vasculitis, eosinophilia, leukocytosis, paresthesia and vertigo. Rash, photosensitivity or other dermatological manifestations may occur alone or in combination with these symptoms.
Clinical Laboratory Test Findings
Serum Potassium: In clinical trials hyperkalemia (serum potassium > 5.7 mEq/L) occurred in 2.2% and 4.8% of PRINIVIL-treated patients with hypertension and heart failure, respectively [see WARNINGS AND PRECAUTIONS].
Creatinine, Blood Urea Nitrogen: Minor increases in blood urea nitrogen and serum creatinine, reversible upon discontinuation of therapy, were observed in about 2% of patients with hypertension treated with PRINIVIL alone. Increases were more common in patients receiving concomitant diuretics and in patients with renal artery stenosis [see WARNINGS AND PRECAUTIONS]. Reversible minor increases in blood urea nitrogen and serum creatinine were observed in 11.6% of patients with heart failure on concomitant diuretic therapy. Frequently, these abnormalities resolved when the dosage of the diuretic was decreased.
Patients with acute myocardial infarction in the GISSI-3 trial treated with PRINIVIL had a higher (2.4% versus 1.1% in placebo) incidence of renal dysfunction in-hospital and at 6 weeks (increasing creatinine concentration to over 3 mg/dL or a doubling or more of the baseline serum creatinine concentration).
Hemoglobin and Hematocrit: Small decreases in hemoglobin (mean 0.4 mg/dL) and hematocrit (mean 1.3%) occurred frequently in patients treated with PRINIVIL but were rarely of clinical importance in patients without some other cause of anemia. In clinical trials, fewer than 0.1% of patients discontinued therapy for anemia.
Rarely, elevations of liver enzymes and/or serum bilirubin have occurred [see WARNINGS AND PRECAUTIONS].
The following adverse reactions have been identified during post-approval use of lisinopril that are not included in other sections of labeling. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Other reactions include:
Metabolism and Nutrition Disorders
Nervous System and Psychiatric Disorders
Mood alterations (including depressive symptoms), mental confusion
Read the Prinivil (lisinopril) Side Effects Center for a complete guide to possible side effects
Initiation of PRINIVIL in patients on diuretics may result in excessive reduction of blood pressure. The possibility of hypotensive effects with PRINIVIL can be minimized by either decreasing or discontinuing the diuretic or increasing the salt intake prior to initiation of treatment with PRINIVIL. If this is not possible, reduce the starting dose of PRINIVIL [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].
PRINIVIL attenuates potassium loss caused by thiazide-type diuretics. Potassium-sparing diuretics (spironolactone, amiloride, triamterene, and others) can increase the risk of hyperkalemia. Therefore, if concomitant use of such agents is indicated, monitor the patient's serum potassium frequently.
Concomitant administration of PRINIVIL and antidiabetic medicines (insulins, oral hypoglycemic agents) may cause an increased blood-glucose-lowering effect with risk of hypoglycemia.
Non-Steroidal Anti-Inflammatory Agents Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors)
In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors, including lisinopril, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving lisinopril and NSAID therapy.
Dual Blockade Of The Renin-Angiotensin System (RAS)
Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or direct renin inhibitors (such as aliskiren) is associated with increased risks of hypotension, syncope, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy.
The Veterans Affairs Nephropathy in Diabetes (VA NEPHRON-D) trial enrolled 1448 patients with type 2 diabetes, elevated urinary-albumin-to-creatinine ratio, and decreased estimated glomerular filtration rate (GFR 30 to 89.9 ml/min), randomized them to lisinopril or placebo on a background of losartan therapy and followed them for a median of 2.2 years. Patients receiving the combination of losartan and lisinopril did not obtain any additional benefit compared to monotherapy for the combined endpoint of decline in GFR, end stage renal disease, or death, but experienced an increased incidence of hyperkalemia and acute kidney injury compared with the monotherapy group.
In general, avoid combined use of RAS inhibitors. Monitor blood pressure, renal function and electrolytes in patients on PRINIVIL and other agents that affect the RAS.
Do not co-administer aliskiren with PRINIVIL in patients with diabetes. Avoid use of aliskiren with PRINIVIL in patients with renal impairment (GFR < 60 ml/min).
Lithium toxicity has been reported in patients receiving lithium concomitantly with drugs, which cause elimination of sodium, including ACE inhibitors. Lithium toxicity was usually reversible upon discontinuation of lithium and the ACE inhibitor. Monitor serum lithium levels during concurrent use.
Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor therapy including PRINIVIL.
Read the Prinivil Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 8/26/2015
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