Recommended Topic Related To:

Trilipix

"Robert Lowes
WebMD Health News

Nov. 1, 2013 -- The cholesterol-lowering drug Crestor (rosuvastatin) was the nation's most prescribed drug in the past 12 months, according to a new report from research firm IMS Health. New "...

Trilipix

SIDE EFFECTS

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse event rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug.

Trilipix (fenofibric acid)

Monotherapy

Treatment-emergent adverse events reported in 3% or more of patients treated with Trilipix during the randomized controlled trials are listed in Table 1 below.

Co-Administration Therapy with Statins (Double-blind Controlled Trials)

Treatment-emergent adverse events reported in 3% or more of patients treated with Trilipix co-administered with statins during the randomized controlled trials are listed in Table 1 below.

Table 1: Treatment-Emergent Adverse Events Reported in ≥ 3% of Patients Receiving Trilipix or Trilipix Co-Administered with a Statin During Double-Blind Controlled Studies [Number (%)]

Adverse Event Trilipix
(N = 490)
Low-Dose Statin
(N = 493)
Trilipix + Low-Dose Statin
(N = 490)
Moderate-Dose Statin
(N = 491)
Trilipix + Moderate-Dose Statin
(N = 489)
High-Dose Statin
(N = 245)
Gastrointestinal Disorders
  Constipation 16 (3.3) 11 (2.2) 16(3.3) 13 (2.6) 15(3.1) 6(2.4)
  Diarrhea 19(3.9) 16(3.2) 15(3.1) 24 (4.9) 18 (3.7) 17 (6.9)
  Dyspepsia 18(3.7) 13(2.6) 13(2.7) 17 (3.5) 23 (4.7) 6(2.4)
  Nausea 21 (4.3) 18 (3.7) 17(3.5) 22 (4.5) 27 (5.5) 10(4.1)
General Disorders and Administration Site Conditions
  Fatigue  10 (2.0) 13 (2.6) 13(2.7) 13 (2.6) 16(3.3) 5(2.0)
  Pain 17 (3.5) 9(1.8) 16 (3.3) 8(1.6) 7(1-4) 8(3.3)
Infections and Infestations
  Nasopharyngitis 17(3.5) 29 (5.9) 23 (4.7) 16(3.3) 21 (4.3) 9(3.7)
  Sinusitis 16 (3.3) 4 (0.8) 14 (2.9) 8(1.6) 17 (3.5) 4(1.6)
  Upper Respiratory Tract Infection 26 (5.3) 13(2.6) 18(3.7) 23 (4.7) 23 (4.7) 7 (2.9)
Investigations
  ALT Increased 6(1.2) 2 (0.4) 15(3.1) 2(0.4) 12 (2,5) 4(1.6)
Musculoskeletal and Connective Tissue Disorders
  Arthralgia 19(3.9) 22 (4.5) 21 (4.3) 21 (4.3) 17(3.5) 12 (4.9)
  Back Pain 31 (6.3) 31(6.3) 30(6.1) 32(6.5) 20(4,1) 8(3.3)
  Muscle Spasms 8(1.6) 18(3.7) 12 (2.4) 24 (4.9) 15(3.1) 6 (2.4)
  Myalgia 16(3.3) 24 (4.9) 17 (3.5) 23 (4.7) 15 (3.1) 15(6.1)
  Pain in Extremity 22 (4.5) 24(4.9) 14(2.9) 21(4.3) 13 (2.7) 9(3.7)
Nervous System Disorders
  Dizziness 20(4.1) 8(1.6) 19 (3.9) 11 (2.2) 16(3.3) 2 (0.8)
  Headache 62 (12.7) 64(13.0) 64 (13.1) 82 (16.7) 58(11.9) 32(13.1)
Low-dose statin = rosuvastatin 10 mg, simvastatin 20 mg, or atorvastatin 20 mg
Moderate-dose statin = rosuvastatin 20 mg, simvastatin 40 mg, or atorvastatin 40 mg
High-dose statin = rosuvastatin 40 mg, simvastatin 80 mg, or atorvastatin 80 mg

Co-Administration Therapy with Statins (Long-Term Exposure for up to 64 Weeks')

Patients successfully completing any one of the three double-blind, controlled studies were eligible to participate in a 5 2-week long-term extension study where they received Trilipix co-administered with the moderate dose statin. A total of 2201 patients received at least one dose of Trilipix co-administered with a statin in the double-blind controlled study or the long-term extension study for up to a total of 64 weeks of treatment. Additional treatment-emergent adverse events (not listed in Table 1 above) reported in 3% or more of patients receiving Trilipix co-administered with a statin in either the double-blind controlled studies or the long-term extension study are provided below.

Infections and Infestations

Bronchitis, influenza, and urinary tract infection.

Investigations

AST increased, blood CPK increased, and hepatic enzyme increased.

Musculoskeletal and Connective Tissue Disorders

Musculoskeletal pain.

Psychiatric Disorders

Insomnia.

Respiratory, Thoracic, and Mediastinal Disorders

Cough and pharyngolaryngeal pain.

Vascular Disorders

Hypertension.

Fenofibrate

Fenofibric acid is the active metabolite of fenofibrate. Adverse events reported by 2% or more of patients treated with fenofibrate and greater than placebo during double-blind, placebo-controlled trials are listed in Table 2. Adverse events led to discontinuation of treatment in 5.0% of patients treated with fenofibrate and in 3.0% treated with placebo. Increases in liver tests were the most frequent events, causing discontinuation of fenofibrate treatment in 1.6% of patients in double-blind trials.

Table 2. Adverse Events Reported by 2% or More of Patients Treated with Fenofibrate and Greater than Placebo During the Double-Blind, Placebo-Controlled Trials

BODY SYSTEM
Adverse Event
Fenofibrate*
(N = 439)
Placebo
(N = 365)
BODY AS A WHOLE
  Abdominal Pain 4.6% 4.4%
  Back Pain 3.4% 2.5%
  Headache 3.2% 2.7%
DIGESTIVE
  Nausea 2.3% 1.9%
  Constipation 2.1% 1.4%
INVESTIGATIONS
  Abnormal Liver Tests 7.5% 1.4%
  Increased AST 3.4% 0.5%
  Increased ALT 3.0% 1.6%
  Increased Creatine Phosphokinase 3.0% 1.4%
RESPIRATORY
  Respiratory Disorder 6.2% 5.5%
  Rhinitis 2.3% 1.1%
* Dosage equivalent to 135 mg Trilipix

Postmarketing Experience

The following adverse events have been identified during postapproval use of fenofibrate: myalgia, rhabdomyolysis, pancreatitis, renal failure, muscle spasms, acute renal failure, hepatitis, cirrhosis, anemia, arthralgia, asthenia, and severely depressed HDL-cholesterol levels.

Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a casual relationship to drug exposure.

Read the Trilipix (fenofibric acid capsules) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Coumarin Anticoagulants

Potentiation of coumarin-type anticoagulant effect has been observed with prolongation of the PT/INR.

Caution should be exercised when oral coumarin anticoagulants are given in conjunction with Trilipix. The dosage of the anticoagulant should be reduced to maintain the PT/INR at the desired level to prevent bleeding complications. Frequent PT/INR determinations are advisable until it has been definitely determined that the PT/INR has stabilized [see WARNINGS AND PRECAUTIONS].

Bile Acid Binding Resins

Since bile acid binding resins may bind other drugs given concurrently, patients should take Trilipix at least 1 hour before or 4 to 6 hours after a bile acid resin to avoid impeding its absorption.

Immunosuppressants

Immunosuppressants such as cyclosporine and tacrolimus can produce nephrotoxicity with decreases in creatinine clearance and rises in serum creatinine, and because renal excretion is the primary elimination route of drugs of the fibrate class including Trilipix, there is a risk that an interaction will lead to deterioration of renal function. The benefits and risks of using Trilipix with immunosuppressants and other potentially nephrotoxic agents should be carefully considered, and the lowest effective dose employed.

Colchicine

Cases of myopathy, including rhabdomyolysis, have been reported with fenofibrates co-administered with colchicine, and caution should be exercised when prescribing fenofibrate with colchicine.

Read the Trilipix Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 9/14/2012
This monograph has been modified to include the generic and brand name in many instances.

A A A

Trilipix - User Reviews

Trilipix User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Trilipix sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Cholesterol Management

Tips to keep it under control.