Fenofibrate interaction

Similar documents
Cholesterol Management Roy Gandolfi, MD

Metformin should be considered in all patients with type 2 diabetes unless contra-indicated

( Diabetes mellitus, DM ) ( Hyperlipidemia ) ( Cardiovascular disease, CVD )

Elements for a Public Summary

Thiazolidinedione-Associated Congestive Heart Failure and Pulmonary Edema

Royal Wolverhampton Hospital Adult Lipid Lowering Therapy Guidelines Lipid Lowering Therapy for the Prevention of Cardiovascular Disease

Rosuvastatin 5 mg, 10 mg and 20 mg Tablet

Volume 2; Number 14 September 2008 NICE CLINICAL GUIDELINE 66: TYPE 2 DIABETES THE MANAGEMENT OF TYPE 2 DIABETES (MAY 2008)

Evan A. Stein 1, David Sullivan 2, Anders G. Olsson 3, Rob Scott 4, Jae B. Kim 4, Allen Xue 4, Thomas Liu 4, Scott M. Wasserman 4

nicotinic acid 375mg, 500mg, 750mg, 1000mg modified release tablet (Niaspan ) No. (93/04) Merck

Original paper. Abstract. Abdullah S. Asia 1*, Al-Mahdi A. Modar 2, Hadi M. Ali 3

How to Handle Statin Intolerance in the High Risk Patient

Statin intolerance. Pr Franck Boccara, MD, PhD Cardiologie, INSERM UMRS938 CHU St Antoine, UPMC, Paris, France

Diabetes Mellitus Type 2

RHABDOMYOLYSIS AFTER ADDITION OF DIGITOXIN TO CHRONIC SIMVASTATIN AND AMIODARONE THERAPY

Drug Class Review HMG-CoA Reductase Inhibitors (Statins) and Fixed-dose Combination Products Containing a Statin

Abbreviations DPP-IV dipeptidyl peptidase IV DREAM Diabetes REduction Assessment with ramipril and rosiglitazone

ROSUVASTATIN CORE SAFETY PROFILE

Pharmacology Challenges: Managing Statin Myalgia

Coronary Heart Disease and Stroke, Primary and Secondary Prevention Guidelines (Cholesterol)

A factorial randomized trial of blood pressure lowering and intensive glucose control in 11,140 patients with type 2 diabetes

MOLINA HEALTHCARE OF CALIFORNIA

Fibrates. Spotlight on. Fibric acid derivatives (fibrates) have been used. When should I prescribe fibrates? In this article: Andrew s visit

PIEDMONT ACCESS TO HEALTH SERVICES, INC. Guidelines for Screening and Management of Dyslipidemia

DIABETES AND METABOLIC SYNDROME

ROSULIP. Composition Rosulip 10 mg Each tablet contains 10 mg Rosuvastatin (as calcium).

Diabetic Dyslipidemia

Oral Pharmacologic Treatment of Type 2 Diabetes Mellitus

PRODUCT MONOGRAPH. rosiglitazone (as rosiglitazone maleate) 2 mg, 4 mg and 8 mg Tablets. Professed Standard. Antidiabetic Agent

Medications for Diabetes

The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION. 6 October 2010

Index. Note: Page numbers of article titles are in boldface type.

DYSLIPIDEMIA PHARMACOLOGY. University of Hawai i Hilo Pre- Nursing Program NURS 203 General Pharmacology Danita Narciso Pharm D

RISK FACTORS AND DRUG TO STATIN-INDUCED MYOPATHY

Primary Prevention Patients aged 85yrs and over

SIGN 149 Risk estimation and the prevention of cardiovascular disease. Quick Reference Guide July Evidence

Repatha. Repatha (evolocumab) Description

Introduction. agents that have, until recently, been the only ones readily available in NZ. A Medline search from January

Volume 2; Number 11 July 2008

Eveness Rosuvastatin. Each tablet contains 5mg, 10mg, 20mg, or 40 mg of rosuvastatin (as calcium salt)

Fibrate and cardiovascular disease: Evident from meta-analysis. Thongchai Pratipanawatr

rosuvastatin, 5mg, 10mg, 20mg, film-coated tablets (Crestor ) SMC No. (725/11) AstraZeneca UK Ltd.

4/24/15. AHA/ACC 2013 Guideline Key Points

Guidelines to assist General Practitioners in the Management of Type 2 Diabetes. April 2010

Supplement Table 2. Categorization of Statin Intensity Based on Potential Low-Density Lipoprotein Cholesterol Reduction

Antihyperlipidemic Drugs

[(RS)-5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-]thiazolidinedione hydrochloride

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE. Proposed Health Technology Appraisal

CONTRAINDICATIONS: Hypersensitivity to the active substance or to any of the excipients

Cardiovascular risk reduction in diabetes Lipids (NICE CG181)

Diabetes and the Heart

Praluent. Praluent (alirocumab) Description

Oral and Injectable Non-insulin Antihyperglycemic Agents

Vexazone NAME OF THE MEDICINE DESCRIPTION PHARMACOLOGY PRODUCT INFORMATION. Pioglitazone hydrochloride

Safety and efficacy of Red Yeast Rice in dyslipidemia and cardiovascular risk reduction

PIOGLITAZONE and METFORMIN HYDROCHLORIDE Tablets, for oral use Initial U.S. Approval: 2005

Limitations of Use: Glumetza is not used for the treatment of type 1 diabetes or ketoacidosis (1).

2.0 Synopsis. Choline fenofibrate capsules (ABT-335) M Clinical Study Report R&D/06/772. (For National Authority Use Only) Name of Study Drug:

Lipid Panel Management Refresher Course for the Family Physician

ESC GUIDELINES ON DIABETES AND CARDIOVASCULAR DISEASES

Cholesterol targets and therapy Thomas C. Andrews, MD, FACC

Repatha. Repatha (evolocumab) Description

Medicinal product no longer authorised

NICE QIPP about Lipitor. Robert Trotter. Clinical Effectiveness Consultant

ATORVASTATIN VS ROSUVASTATIN; FENOFIBRATE AS AN ADD ON: AN EXPLORATORY STUDY

Repatha. Repatha (evolocumab) Description

NEW ZEALAND DATA SHEET. Each tablet contains 15 mg, 30 mg or 45 mg of pioglitazone as pioglitazone hydrochloride.

Supplementary Appendix

PRESCRIBING INFORMATION (PI)

Treating Hyperlipidemias in Adults. Lisa R. Tannock MD Division of Endocrinology and Molecular Medicine, University of Kentucky Lexington KY VAMC

Scientific conclusions

Type 2 Diabetes. Stopping Smoking. Consider referral to smoking cessation. Consider referring for weight management advice.

Best Practices for Lowering the Risk of Cardiovascular Disease in Diabetes

HIGHLIGHTS OF PRESCRIBING INFORMATION

Safety profile of Liraglutide: Recent Updates. Mohammadreza Rostamzadeh,M.D.

Elements for a public summary

Choosing a Diabetes Strategy Where to Start and Where to Go

B.C. Drug and Poison Information Centre 1081 Burrard Street, Vancouver, B.C. V6Z 1Y6 Phone: (604) ; Ext: Fax: (604)

PIOGLITAZONE and METFORMIN HYDROCHLORIDE Tablets USP, for oral use Initial U.S. Approval: 2005

Oral Hypoglycemics and Risk of Adverse Cardiac Events: A Summary of the Controversy

ORIGINAL INVESTIGATION. Screening for Statin-Related Toxicity. The Yield of Transaminase and Creatine Kinase Measurements in a Primary Care Setting

This is a lipid lowering drug strategy which should only be used within an overall lifestyle and clinical management strategy.

NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE. Single Technology Appraisal. Canagliflozin in combination therapy for treating type 2 diabetes

2.3 CONTACT HOURS. Managing. By Kristine Anne Scordo, PhD, RN, ACNP-BC, FAANP

National Horizon Scanning Centre. Saxagliptin (BMS ) for type 2 diabetes. April 2008

Challenges in Perioperative Medication Management. Learning Objectives. Case 1. » Appropriate use of beta-blockers. Management of diabetes drugs

2013 Cholesterol Guidelines. Anna Broz MSN, RN, CNP, AACC Adult Certified Nurse Practitioner North Ohio Heart, Inc.

Goal Achievement after Utilizing an Anti-PCSK9 Antibody in Statin-Intolerant Subjects (GAUSS): Results from a

Condition/Procedure Measure Compliance Criteria Reference Attribution Method

AVANDAMET PRODUCT INFORMATION (rosiglitazone & metformin hydrochloride) 2/500, 4/500, 2/1000 & 4/1000

Joshua Shepherd PA-C, MMS, MT (ASCP)

In 2008 NICE issued guidelines on lipid modification. Key points are summarised below.

Old oral antidiabetic agents in the armamentarium of diabetes mellitus treatment: Safety and efficacy

Clinical Approach to Achieving Treatment Targets: Case Vignette Discussion

Lipids Board Review. Ira Goldberg, MD New York University School of Medicine. Which of the following is the best initial therapy choice?

Elderly ( 65 years) No dose adjustments are necessary in elderly patients (see also sections 5.1 and 5.2).

Supplementary Text A. Full search strategy for each of the searched databases

COMMISSIONING POLICY RECOMMENDATION TREATMENT ADVISORY GROUP Policy agreed by (Vale of York CCG/date)

Pioglitazone and Metformin Hydrochloride Tablets USP, for oral use Initial U.S. Approval: 2005

Transcription:

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 (801030252) Fenofibrate interaction First report of an interaction with concomitant rosiglitazone leading to muscular disorders in an elderly patient: case report Release Date: 20/01/2006 801030252 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 0.116 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: 1996-1998, No. 10, Oct 2005 (English)

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 2006- 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 300 35531 227571 460 45 N/A 300 91521 150 4447 579 Study Design Release open, observational, open, parallel open, case control,, single-blind open, Date 20/08/2010 09/08/2010 23/07/2010 09/04/2010 20/02/2010 05/02/2010 04/02/2010 29/12/2009 03/12/2009 28/10/2009 04/09/2009

Rosligatzone vs pioglitazone: adverse Death, myocardial infarction, heart failure In elderly patients with type 2 diabetes mellitus 39736 31/08/2009 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) 22950 21/04/2009 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 371 159026 14291 15332 N/A 4447 27843 69 16/02/2009 19/08/2008 N/A survey 01/05/2008 case control, 19/12/2007 39 18/10/2007 open, observational 14/09/2007 22/06/2007 22/06/2007 06/06/2007 22/05/2007 16/11/2006

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 511 802 01/08/2006 03/05/2005 224 26/04/2005 N/A 17/02/2005 N/A 07/01/2005 252460 01/12/2004 139 25/11/2004 226900 20/09/2004 222217 20/09/2004 226900 10/09/2004 591 10/09/2004 48 06/09/2004 N/A 06/11/2003 2813 case control 30/09/2003 94 25/09/2003 164 prospective 25/09/2003 191 07/05/2003 203 open, 26/11/2002

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 554 8189 18/11/2002 6822 14/05/2002 12/07/2001 27 08/02/2001 5000 meta-analysis 11/07/2000 4600 meta-analysis 01/11/1999 4500 meta-analysis 01/08/1999 4598 meta-analysis 01/08/1999 102 open 01/08/1995 103 open, parallel 01/06/1994 R&D Insight Documents Rosiglitazone R&D Insight 2010 Adis Data Information BV