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Trilipix (Choline Fenofibrate) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Clinical Studies 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 52-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

The following adverse events have been identified during postapproval use of fenofibrate: myalgia, rhabdomyolysis, increased creatine phosphokinase, pancreatitis, increased alanine aminotransaminase, increased aspartate aminotransaminase, renal failure, muscle spasms, acute renal failure, hepatitis, cirrhosis, nausea, abdominal pain, anemia, headache, arthralgia, and asthenia. 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.



REPORTS OF SUSPECTED TRILIPIX SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Trilipix. The information is not vetted and should not be considered as verified clinical evidence.

Possible Trilipix side effects / adverse reactions in 41 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-05

Patient: 41 year old female weighing 124.1 kg (273.1 pounds)

Reactions: Drug Dose Omission, Upper Respiratory Tract Infection, Treatment Noncompliance, Hypertriglyceridaemia

Suspect drug(s):
Lipitor
    Dosage: daily at bedtime
    Indication: Hypertriglyceridaemia
    Start date: 2010-03-18
    End date: 2011-04-21

Neratinib; Placebo (Blinded)
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2010-02-17
    End date: 2011-02-12

Trilipix
    Start date: 2011-05-25

Trilipix
    Dosage: daily at bedtime
    Indication: Hypertriglyceridaemia
    Start date: 2010-03-18
    End date: 2010-04-21

Other drugs received by patient: Vitamin D; Vitamin B Complex CAP; Multivitamin ^lappe^; Glucovance; Aspirin; Imodium Jassen; Coricidin; Femara; Calcium with Vitamin D; Lantus; Coricidin; Magnesium



Possible Trilipix side effects / adverse reactions in 62 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-16

Patient: 62 year old male

Reactions: Confusional State, Hypoglycaemia, Hunger, Tremor, Paraesthesia, Hypoaesthesia Oral, Dizziness, Vision Blurred

Adverse event resulted in: hospitalization

Suspect drug(s):
Blinded Therapy
    Dosage: 2.5 mg (2.5 mg,1 in 1 d),oral
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-10-28
    End date: 2010-11-22

Glyburide
    Dosage: 2 mg (2 mg,1 in 1 d),oral
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2000-01-01

Metformin HCL
    Dosage: 2000 mg (1000 mg,2 in 1 d),oral
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2000-01-01

Trilipix
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-01-01

Other drugs received by patient: Lisinopril; Simvastatin; Meloxicam; Piroxicam; Aspirin



Possible Trilipix side effects / adverse reactions in 45 year old female

Reported by a physician from United States on 2011-12-16

Patient: 45 year old female

Reactions: Blood Triglycerides Increased, Blood Glucose Abnormal

Suspect drug(s):
Trilipix

Other drugs received by patient: Dilantin; Unknown List



See index of all Trilipix side effect reports >>

Drug label data at the top of this Page last updated: 2011-12-14

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