Product
TriLipix
Approval Date
December
15, 2008
Company
Abbott Laboratories
Class
Fibrate
Indication
Adjunct to
diet: In combination with a statin, to reduce triglycerides (TG) and increase
high-density lipoprotein cholesterol (HDL-C) in patients with mixed
dyslipidemia and CHD or a CHD risk equivalent who are on optimal statin therapy
to achieve LDL-C goal; as monotherapy to reduce TG in severe
hypertriglyceridemia, and to reduce elevated LDL-C, total cholesterol
(total-C), TG and apolipoprotein B (Apo B); and to increase HDL-C in primary
hyperlipidemia or mixed dyslipidemia.
Active Ingredient
Fenofibric
acid
Agency Roster
Intouch
Solutions
RTC
Relationship Marketing (RTCRM)
Marketing Strategy/Execution
TriLipix
will be marketed for use in combination with a statin along with diet to lower
triglycerides and LDL (bad) cholesterol, and increase HDL (good) cholesterol in
adults.
Physician Outlook
TriLipix is
Abbott's next-generation fenofibrate; one that Abbott is hoping will help the
Company face Tricor generic competition in 2011. Achieving FDA approval now
allows Abbott the opportunity to transition its current Tricor patient load to TriLipix,
hoping that the fenofibrate's unique and specific indication for use with a
statin will be a competitive advantage. Abbott's challenge is to convince
managed care organizations to pay for the agent – and in 2011, over a generic –
though labeling currently states that it offers no incremental CV benefit over
a statin alone. Abbott is also planning a fixed-dose combination of TriLipix
with rosuvastatin, AZ's Crestor, which will help tout the ability to address
all lipid parameters for patients who need it.
–Anna Marie
Napolitano, VP, category business leader, cardiology, GfK Market Measures
Also in the Pipeline (courtesy of
Adis R&D Insight)
Drug: AEGR-733
Manufacturer: Bristol-Myers Squibb/ Aegerion Pharmaceuticals
Indication: Hyperlipoproteinaemia type II
Active
Ingredient: AEGR-733
Phase: III
Drug: AVE5530
Manufacturer: sanofi-aventis
Indication: Hypercholesterolaemia
Active
Ingredient: AVE5530
Phase: III
Drug: Pravafen
Manufacturer: Galephar Pharmaceutical Research/ Sciele Pharma
Indication: Hyperlipidaemia
Active
Ingredient: Fenofibrate/pravastatin
Phase: III
Drug: Cordaptive
Manufacturer: Merck & Co
Indication: Hypercholesterolaemia
Active
Ingredient: Laropiprant/niacin
Phase: Registered
Drug: MK
0524B
Manufacturer: Merck & Co
Indication: Hyperlipidaemia
Active
Ingredient: Laropiprant/niacin/simvastatin
Phase: III
Drug: ISIS
147764
Manufacturer: Isis Pharmaceuticals/ Genzyme
Corporation
Indication: Hypercholesterolaemia
Active Ingredient:
Mipomersen sodium
Phase: III
Drug: MPC-028
Manufacturer: URL Pharma
Indication: Hypercholesterolaemia
Active
Ingredient: MPC 028
Phase: Preregistration
Drug: Itavastatin
Manufacturer: Nissan Chemical Industries/ Choongwae Pharma Corporation
Indication: Hypercholesterolaemia
Active
Ingredient: Pitavastatin
Phase: Launched
Drug: ABT
143
Manufacturer: Abbott Laboratories
Indication: Hyperlipidaemia
Active
Ingredient: Rosuvastatin/choline fenofibrate
Phase: III
Source:
Wolters Kluwer Health
Recent MM&M Coverage
Abbott,
AZ extend co-promotion to Trilipix
Statins:
Making New Friends
Abbott,
AZ team up to promote Crestor
AstraZeneca
teams up with Abbott on Crestor co-promote
Pharmacology
Elevated
blood levels of total-C, LDL-C, and Apo B and decreased levels of HDL-C have
been shown to increase the risk for atherosclerosis. Fenofibric acid, the
active moiety of fenofibrate, is a lipid modifying agent that increases
lipolysis and the elimination of TG-rich particles from plasma by activating
lipoprotein lipase and reducing the production of apolipoprotein CIII.
TriLipix
can be used in combination with a statin in patients with mixed dyslipidemia
and CHD or a CHD risk equivalent, which include other forms of atherosclerotic
disease, diabetes, and multiple risk factors that confer a 10-year risk for CHD
>20%. It has not been established that the use of TriLipix reduces morbidity
and mortality more than the use of a statin alone.
Clinical Trials
Three
12-week Phase 3 studies and one 52-week, open label extension study were
conducted to evaluate safety and efficacy of this product. In the Phase 3
studies, TriLipix was studied in combination with rosuvastatin, atorvastatin or
simvastatin. A total of 1,895 patients who completed one of the Phase 3 studies
were then treated in the open-label study in which 568 patients completed 52
weeks of treatment with TriLipix plus a statin. The primary endpoints for each
of the studies were the mean % change from baseline to final value in HDL-C,
TG, and LDL-C. The results of these studies indicated that combination therapy
with low-dose and moderate-dose statins significantly improved HDL-C and TG
compared to statin therapy alone, and significantly improved LDL-C compared to TriLipix
alone. The use of each of the combinations and the statins resulted in
significant reductions in LDL-C.
Adverse Reactions
Headache,
back pain, nasopharyngitis, myalgia, GI upset, URI, elevated LFTs, serum
creatinine; myopathy, rhabdomyolysis, hematological changes (eg, hgb, hct),
cholelithiasis, pancreatitis.
Adults
Mixed
dyslipidemia, primary hyperlipidemia: 135mg once daily. Hypertriglyceridemia:
45–135mg once daily. Titrate at 4–8week intervals; max 135mg/day. Mild to
moderate renal impairment: initially 45mg once daily.
Children
Not
recommended.
Contraindications
Severe
renal dysfunction (including dialysis). Active liver disease. Primary biliary
cirrhosis. Gallbladder disease. Nursing mothers.
Precautions
Renal
failure, diabetes, hypothyroidism, elderly: increased risk of myopathy with
concomitant statins. Monitor liver function; discontinue if LFTs >3xULN
persist. Discontinue if markedly elevated CPK levels, myopathy, or gallstones
occur. Pregnancy (Cat.C).
Interactions
Avoid with
max doses of a statin (myopathy). Potentiates warfarin (monitor). Separate
dosing of bile acid sequestrants. Caution with cyclosporine.