Product
TriLipix
Approval Date
December15, 2008
Company
Abbott Laboratories
Class
Fibrate
Indication
Adjunct todiet: In combination with a statin, to reduce triglycerides (TG) and increasehigh-density lipoprotein cholesterol (HDL-C) in patients with mixeddyslipidemia and CHD or a CHD risk equivalent who are on optimal statin therapyto achieve LDL-C goal; as monotherapy to reduce TG in severehypertriglyceridemia, and to reduce elevated LDL-C, total cholesterol(total-C), TG and apolipoprotein B (Apo B); and to increase HDL-C in primaryhyperlipidemia or mixed dyslipidemia.
Active Ingredient
Fenofibricacid
Agency Roster
IntouchSolutions
RTCRelationship Marketing (RTCRM)
Marketing Strategy/Execution
TriLipixwill be marketed for use in combination with a statin along with diet to lowertriglycerides and LDL (bad) cholesterol, and increase HDL (good) cholesterol inadults.
Physician Outlook
TriLipix isAbbott’s next-generation fenofibrate; one that Abbott is hoping will help theCompany face Tricor generic competition in 2011. Achieving FDA approval nowallows Abbott the opportunity to transition its current Tricor patient load to TriLipix,hoping that the fenofibrate’s unique and specific indication for use with astatin will be a competitive advantage. Abbott’s challenge is to convincemanaged care organizations to pay for the agent – and in 2011, over a generic –though labeling currently states that it offers no incremental CV benefit overa statin alone. Abbott is also planning a fixed-dose combination of TriLipixwith rosuvastatin, AZ’s Crestor, which will help tout the ability to addressall lipid parameters for patients who need it.
–Anna MarieNapolitano, VP, category business leader, cardiology, GfK Market Measures
Also in the Pipeline (courtesy ofAdis R&D Insight)
Drug: AEGR-733
Manufacturer: Bristol-Myers Squibb/ Aegerion Pharmaceuticals
Indication: Hyperlipoproteinaemia type II
ActiveIngredient: AEGR-733
Phase: III
Drug: AVE5530
Manufacturer: sanofi-aventis
Indication: Hypercholesterolaemia
ActiveIngredient: AVE5530
Phase: III
Drug: Pravafen
Manufacturer: Galephar Pharmaceutical Research/ Sciele Pharma
Indication: Hyperlipidaemia
ActiveIngredient: Fenofibrate/pravastatin
Phase: III
Drug: Cordaptive
Manufacturer: Merck & Co
Indication: Hypercholesterolaemia
ActiveIngredient: Laropiprant/niacin
Phase: Registered
Drug: MK0524B
Manufacturer: Merck & Co
Indication: Hyperlipidaemia
ActiveIngredient: Laropiprant/niacin/simvastatin
Phase: III
Drug: ISIS147764
Manufacturer: Isis Pharmaceuticals/ GenzymeCorporation
Indication: Hypercholesterolaemia
Active Ingredient:Mipomersen sodium
Phase: III
Drug: MPC-028
Manufacturer: URL Pharma
Indication: Hypercholesterolaemia
ActiveIngredient: MPC 028
Phase: Preregistration
Drug: Itavastatin
Manufacturer: Nissan Chemical Industries/ Choongwae Pharma Corporation
Indication: Hypercholesterolaemia
ActiveIngredient: Pitavastatin
Phase: Launched
Drug: ABT143
Manufacturer: Abbott Laboratories
Indication: Hyperlipidaemia
ActiveIngredient: Rosuvastatin/choline fenofibrate
Phase: III
Source:Wolters Kluwer Health
Recent MM&M Coverage
Abbott,AZ extend co-promotion to Trilipix
Abbott,AZ team up to promote Crestor
AstraZenecateams up with Abbott on Crestor co-promote
Pharmacology
Elevatedblood levels of total-C, LDL-C, and Apo B and decreased levels of HDL-C havebeen shown to increase the risk for atherosclerosis. Fenofibric acid, theactive moiety of fenofibrate, is a lipid modifying agent that increaseslipolysis and the elimination of TG-rich particles from plasma by activatinglipoprotein lipase and reducing the production of apolipoprotein CIII.
TriLipixcan be used in combination with a statin in patients with mixed dyslipidemiaand CHD or a CHD risk equivalent, which include other forms of atheroscleroticdisease, 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 morbidityand mortality more than the use of a statin alone.
Clinical Trials
Three12-week Phase 3 studies and one 52-week, open label extension study wereconducted to evaluate safety and efficacy of this product. In the Phase 3studies, TriLipix was studied in combination with rosuvastatin, atorvastatin orsimvastatin. A total of 1,895 patients who completed one of the Phase 3 studieswere then treated in the open-label study in which 568 patients completed 52weeks of treatment with TriLipix plus a statin. The primary endpoints for eachof 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 therapywith low-dose and moderate-dose statins significantly improved HDL-C and TGcompared to statin therapy alone, and significantly improved LDL-C compared to TriLipixalone. The use of each of the combinations and the statins resulted insignificant reductions in LDL-C.
Adverse Reactions
Headache,back pain, nasopharyngitis, myalgia, GI upset, URI, elevated LFTs, serumcreatinine; myopathy, rhabdomyolysis, hematological changes (eg, hgb, hct),cholelithiasis, pancreatitis.
Adults
Mixeddyslipidemia, primary hyperlipidemia: 135mg once daily. Hypertriglyceridemia:45–135mg once daily. Titrate at 4–8week intervals; max 135mg/day. Mild tomoderate renal impairment: initially 45mg once daily.
Children
Notrecommended.
Contraindications
Severerenal dysfunction (including dialysis). Active liver disease. Primary biliarycirrhosis. Gallbladder disease. Nursing mothers.
Precautions
Renalfailure, diabetes, hypothyroidism, elderly: increased risk of myopathy withconcomitant statins. Monitor liver function; discontinue if LFTs >3xULNpersist. Discontinue if markedly elevated CPK levels, myopathy, or gallstonesoccur. Pregnancy (Cat.C).
Interactions
Avoid withmax doses of a statin (myopathy). Potentiates warfarin (monitor). Separatedosing of bile acid sequestrants. Caution with cyclosporine.
