Fenofibrate interaction
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1 Search Query (DRUGGENERICNAME = Avandia ) AND (RECORDTYPE = Case Report ) 1 Documents Exported 1. Fenofibrate interaction First report of an interaction with concomitant rosiglitazone leading to muscular disorders in an elderly patient: case report ( ) Fenofibrate interaction First report of an interaction with concomitant rosiglitazone leading to muscular disorders in an elderly patient: case report Release Date: 20/01/ NARRATIVE A 75-year-old man, who had a history of hypertension, diabetic neuropathy, mild asymptomatic creatine kinase (CK) elevation and hepatic steatosis, developed acute muscular disorders while receiving fenofibrate for hyperlipidaemia and rosiglitazone for diabetes mellitus. Twelve weeks after switching from simvastatin to fenofibrate 200 mg/day, the man started treatment with rosiglitazone 2mg twice daily. He was hospitalised 23 days later with acute-onset pain and cramps in his calf muscles. Laboratory investigations revealed a CK level of 6897 U/L, a myoglobin level of 902 ng/ml, a lactate dehydrogenase level of 285 U/L, serum creatinine and blood urea nitrogen levels of and 2.3 mmol/l, respectively, and elevated liver enzyme levels. Electromyography demonstrated no spontaneous muscular activity of the right rectus femoris muscle, and nerve conduction studies were consistent with polyneuropathy. A muscle biopsy showed disruption of the myofibrillar architecture and scattered defects of oxidative enzyme activity. Fenofibrate and rosiglitazone was discontinued, as was concomitant metformin. The man received IV fluids and mannitol over the next 13 days, and his CK, myoglobin and creatinine levels returned to pre-treatment levels, with resolution of his symptoms. Author Comment "The present case indicates that simultaneous treatment with fenofibrate and rosiglitazone might lead to severe myopathy in diabetic patients who are already at increased risk because of pre-existing polyneuropathy and impaired renal function." Editorial Comment A search of AdisBase and Medline did not reveal any previous case reports of an interaction between fenofibrate and rosiglitazone. The WHO Adverse Drug Reactions database contained 623 reports involving the concomitant use of fenofibrate and rosiglitazone. REFERENCE COUNTRY Austria CITATION DETAILS Ledl M, Hohenecker J, Francesconi C, Roots I, Bauer MF, Roden M. Acute myopathy in a type 2 diabetic patient on combination therapy with metformin, fenofibrate and rosiglitazone. Diabetologia 48: , No. 10, Oct 2005 (English)
2 Descriptors & Links ADIS DESCRIPTORS Fenofibrate drug interactions Fenofibrate drug interactions (serious) Rosiglitazone drug interactions Rosiglitazone drug interactions (serious) Muscular-disorders drug induced Drug interactions Elderly RELATED DOCUMENTS Clinical s Insight Document Rosiglitazone vs pioglitazone vs acarbose: adverse Diabetic macular oedema, diabetic nephropathies Myocardial infarction, cardiovascular disorders, death Systematic and meta-analysis (56 trials) Pioglitazone vs rosiglitazone: adverse Heart failure, myocardial infarction, stroke In elderly Medicare patients initiating treatment from July June 2009 Cardiovascular disorders Comparing effects with or without exercise and diet control in patients with type-2 diabetes mellitus Diet modification to prevent drug-induced weight gain in patients with uncontrolled diabetes mellitus Pioglitazone, rosiglitazone, troglitazone: adverse Fracture Alone or in combination with spironolactone and/or amiloride in patients with type 2 diabetes mellitus Rosuvastatin + fenofibrate vs rosuvastatin vs fenofibrate: adverse Female sexual dysfunction, Male sexual dysfunction Antihyperglycaemics: adverse Myocardial infarction, congestive heart failure, death Rosiglitazone: pharmacodynamics Effects on cardiovascular performance, structure, and function and cardiovascular disease or at least one risk factor Rosiglitazone, metformin, sulfonylureas: adverse Cardiovascular safety in patients with inadequately controlled type 2 diabetes mellitus: the RECORD trial Rosiglitazone vs donepezil: adverse In patients with mild-to-moderate Alzheimer's disease Type No. Patients N/A Study Design Release open, observational, open, parallel open, case control,, single-blind open, Date 20/08/ /08/ /07/ /04/ /02/ /02/ /02/ /12/ /12/ /10/ /09/2009
3 Rosligatzone vs pioglitazone: adverse Death, myocardial infarction, heart failure In elderly patients with type 2 diabetes mellitus /08/2009 Rosiglitazone, metformin, sulfonylureas: adverse In patients with inadequately controlled type 2 diabetes mellitus: final planned analysis of the RECORD trial 4447 open, 11/06/2009 Thiazolidinediones: adverse Heart failure, oedema In patients with pre-diabetes or type 2 diabetes mellitus: (35 trials) /04/2009 Myocardial infarction, chronic heart failure Systematic and meta-analysis (86 trials) Insulin suspension isophane, insulin aspart, metformin, rosiglitazone: adverse In patients with type 2 diabetes: the SDDS trial Cardiovascular disorders, myocardial infarction Effects on prescribing rates of the Avandia formulation in the USA following results of a published meta-analysis Rosiglitazone, pioglitazone: adverse Congestive heart failure, myocardial infarction Compared with other oral antihyperglycaemics in elderly patients with diabetes mellitus Rosiglitazone vs metformin: adverse Cardiovascular disorders Myocardial infarction, heart failure, death In patients with glucose intolerance or type 2 diabetes mellitus: and meta-analysis (4 trials) Pioglitazone, rosiglitazone: adverse As monotherapy or in combination with antihyperglycaemics in patients with type 2 diabetes mellitus: and meta-analysis (26 trials) Rosiglitazone, pioglitazone: adverse : meta-analysis (13 studies) Rosiglitazone, metformin, sulfonylureas: adverse In patients with inadequate glycaemic control: unplanned interim analysis of RECORD Myocardial infarction, death : meta-analysis (42 trials) Thiazolidinediones: adverse Osteoporosis In elderly patients with type 2 diabetes mellitus: cohort analysis of the Health-ABC trial N/A N/A /02/ /08/2008 N/A survey 01/05/2008 case control, 19/12/ /10/2007 open, observational 14/09/ /06/ /06/ /06/ /05/ /11/2006
4 In patients with Alzheimer's disease Pioglitazone vs rosiglitazone: adverse and weight gain In patients with type 2 diabetes and lipid metabolism disorders and congestive heart failure Fenofibrate + statins vs gemfibrozil + statins: adverse Rhabdomyolysis Gemfibrozil vs fenofibrate: adverse Statins, fibric acid derivatives: adverse Rhabdomyolysis Heart failure In elderly patients with type 2 diabetes mellitus receiving insulin Rosiglitazone, pioglitazone, troglitazone: adverse Heart failure, liver dysfunction In patients with diabetes mellitus in a Veterans Affairs setting Antihyperlipidaemics: adverse Muscular disorders Rosiglitazone, pioglitazone, troglitazone vs metformin: adverse Hyperlipidaemia In Veterans Affairs patients with diabetes mellitus Pioglitazone, rosiglitazone: adverse Liver dysfunction in Taiwan Rosiglitazone vs glibenclamide: pharmacodynamics Effects on BP, lipid and insulin levels and sympathetic nervous activity In hypertensive, dyslipidaemic patients with type 2 diabetes mellitus Insulin ± rosiglitazone: adverse Congestive heart failure HMG-CoA reductase inhibitors, antihyperlipidaemics: adverse Depression, suicidal behaviour Add-on treatment in patients with type 2 diabetes mellitus Pioglitazone, rosiglitazone: adverse Thiazolidinediones: adverse and chronic heart failure Rosiglitazone vs glibenclamide: therapeutic use Type 2 diabetes mellitus /08/ /05/ /04/2005 N/A 17/02/2005 N/A 07/01/ /12/ /11/ /09/ /09/ /09/ /09/ /09/2004 N/A 06/11/ case control 30/09/ /09/ prospective 25/09/ /05/ open, 26/11/2002
5 Long-term efficacy and tolerability Rosiglitazone, HMG-CoA reductase inhibitors: adverse Elevated liver enzymes Incidence study in patients with type 2 diabetes mellitus In patients with previous exposure to hepatitis B or C Bezafibrate vs ciprofibrate vs fenofibrate vs gemfibrozil: adverse Nephrotoxicity Hepatotoxicity Hepatotoxicity No association in patients with type 2 diabetes mellitus Rosiglitazone ± sulphonylureas, metformin: adverse Adverse drug Bezafibrate, fenofibrate + pravastatin, simvastatin: adverse Long term tolerability In patients with hypercholesterolaemia and coronary artery disease Bezafibrate, fenofibrate, pravastatin, simvastatin: adverse Myositis Incidence study /11/ /05/ /07/ /02/ meta-analysis 11/07/ meta-analysis 01/11/ meta-analysis 01/08/ meta-analysis 01/08/ open 01/08/ open, parallel 01/06/1994 R&D Insight Documents Rosiglitazone R&D Insight 2010 Adis Data Information BV
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