Systematic Review: Comparative Effectiveness and Harms of Combination Therapy and Monotherapy for DyslipidemiaFREE
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Abstract
Background:
Purpose:
Data Sources:
Study Selection:
Data Extraction:
Data Synthesis:
Limitations:
Conclusion:
Primary Funding Source:
Methods
Data Sources and Searches
Study Selection
Data Extraction and Quality Assessment
Data Synthesis and Analysis
Role of the Funding Source
Results
Characteristics of Included Studies
Mortality
Other Clinical Outcomes
Serious Adverse Events
Cancer Incidence
Attainment of ATP III LDL Cholesterol Goals
LDL Cholesterol Levels
HDL Cholesterol Levels
Measures of Atherosclerosis
Treatment Adherence and Harm
Discussion
References
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Systematic Review: Comparative Effectiveness and Harms of Combination Therapy and Monotherapy for Dyslipidemia. Ann Intern Med.2009;151:622-630. [Epub 3 November 2009]. doi:10.7326/0003-4819-151-9-200911030-00144
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Polypharmacy and risk of rhabdomyolysis
The study by Sharma et al highlights the fact that achieving treatment goals with fewer medications may prevent the risk of side effects and interactions from polypharmacy. However, caution is required when maximizing statin dose in some of our high risk aging population as more side effects may occur due to reduced plasma clearance (1). We recently admitted a 72 year old female with statin induced rhabdomyolysis. She had been on multiple chronic medications including simvastatin 10mg daily for hyperlipidemia and amiodarone and warfarin for atrial fibrillation without adverse reactions. Two months prior to her latest admission, she was hospitalized with a non ST elevation myocardial infarction and her simvastatin was increased to 80mg daily to comply with the current guidelines. Two weeks following the statin dose adjustment and the addition of the new medications, she started complaining of generalized weakness more so in the lower extremities but no myalgia. She was admitted to the hospital; however, the work up was negative including normal creatine kinase level, TSH and electromyogram and the patient was discharged with generalized weakness of unknown etiology. One month later she was admitted for myalgia and marked proximal muscle weakness in all four extremities. Her creatine kinase was 6791U/L, which raised up to 9213U/L the next day, with a positive urine myoglobin. Serum creatinine level was 2.18mg/dL, slightly higher than the baseline of 1.7mg/dL. She had a normal repeat electromyogram, which was in favor of statin-induced myopathy. Upon discontinuation of simvastatin and intravenous hydration, the creatine kinase returned to normal and she recovered her strength within two weeks with physical therapy. Statin induced myopathy is a concerning side effect but rhabdomyolysis is rare with an average incidence rate per 10000 persons-year of 0.44 (2). Among the available statins, simvastatin appears to have the most reported cases of myopathy. This may be due to the lipophilic nature allowing easy penetration of muscle membranes. Simvastatin is also metabolized by the enzyme CYP3A4 which metabolizes many other medications including warfarin and amiodarone, thereby carrying the risk for interaction(3,4). It is recommended that simvatatin dosage should not exceed 20mg daily when used in combination with amiodarone because of increased risk of myopathy. The current recommendation is to continue statins if the creatine kinase level is less than ten times the normal limit; however, clinical judgment is warranted as biopsy proven muscle damage has been found with lower levels of creatine kinase (5).
References:
1. Carlos Escobar, Rocio Echarri, Vivencio Barrios. Relative safety profiles of high dose statin regimens. Vascular health and risk management 2008:4 (3) 525-533
2. D. J. Graham,J. A. Staffa; Deborah Shatin et al. Incidence of Hospitalized Rhabdomyolysis in Patients Treated With Lipid-Lowering Drugs JAMA. 2004;292:2585-2590
3. Molecular basis of statin-associated myopathy C. Vaklavas a, Y.S. Chatzizisis b, et al. Elsevier. Atherosclerosis 202 (2009) (18-28)
4. Miranda R. Andrus .Oral Anticoagulant Drug Interactions With Statins: Discussion. Pharmacotherapy. 2004;24(2)
5. Markus G., Mohaupt, R.H. Karas, E. B. Babiychuk et al . Association between statin-associated myopathy and skeletal muscle damage cmaj.081785 July 2009;181 (1-2)
Conflict of Interest:
None declared
Risks and Benefits
Anti-hyperlipidemic drugs prescribed at the right hour offer benefits but their long term risks go unidentified since their adverse events manifest in such weird ways that the clinician may get carried away with newer diagnosis and also get swept away with newer shadows in the investigations!!!
If only the clinician keeps an extremely low threshold to do away with these drugs he may find that the symptoms disappear within six weeks. Symptoms may range from “slow loss of memory,tinnitus,wry neck, carpal tunnel syndrome, sciatica” to “metatarsalgia,plantar fasciitis and peripheral ( glove and stocking) neuritis” !!
We have withdrawn these drugs in over 3500 patients till date and what a relief my patients had! Relief from advices to decompresse the spinal canal stenosis,chronic carpal tunnel syndrome and steroid injections for tennis elbow !!!
Its rewarding to stop these medications before surgical procedures and blood investigations to assess the thyroid .
Ref:
Anti-lipid drug menace, Published September 14, 2009, Ann Intern Med published ahead of print August 31, 2009, doi:10.1059/0003-4819-151-9-200911030-00144
Regards
Milind M Deshpande
Poornima M Deshpande
Growing Clinical Experience
The number of patients in whom the anti-cholesterol drugs have been withdrawn from their drug box has now reached 5000!!!
A 50 year old lady was being treated with omega -3-fatty acids and 2 capsules bd was her dosage for the last 5 years and it was prescribed by the dermatology fraternity for her perennial problem of developing multiple painful fissures on the pulps of her all ten fingers. She had presented to me with acute onset of anterior hip pain and I had offered her the most probable diagnosis of it being statin induced which got clinically proven when the hip pain disappeared after 3 weeks of statin withdrawal and off course the pulp fissures slowly stopped recurring after 10 weeks of statin ban. She has now withdrawn the omega too!!
A 45 year old gentleman was advised L 4-5 diskectomy for his sciatica. He had episodes of unexplained itching all over the body on and off for which he consumed montelukast at least 15 days in a month for the last 3 years. I stopped his statins following which both sciatica and itching disappeared in 6 weeks!!
Regards
Milind M Deshpande
Poornima M Deshpande
Statopathic,Not Idiopathic
Today, we would like to place our bet on statin induced pathy/statopathy.
We have now reached the 7000 mark, patients in whom we stopped statins.Our study is simply a clinical “Both eyes open” study rather than any blind one.
A 60 year old lady, non diabetic, non hypertensive developed a feeling of a marginally heavy and a sagging left cheek for about six months and was under investigation at other services. Her blood tests, CT and MRI brain, skin biopsy didn’t throw any light. The nerve conduction study revealed a diagnosis of paralysis of the buccal branch of the left facial nerve and it was labeled Idiopathic by the neurologist.
She was referred to me for neck pain and I happened to see all her above stated medical records. I quickly pulled out my favorite weapon from my armamentarium and asked her my leading question -----Are you on statins?? Yes was her reply. She was on statins for about a year for dyslipidemia.
After 12 weeks of stopping statins her cheek felt near normal to her and the smiley on her face felt more proportionate!!!!!
Reference
Drug Saf. 2014 Sep; 37(9):735-42. doi: 10.1007/s40264-014-0212-5.
Association between statin use and Bell's palsy: a population-based study.
Hung SH1, Wang LH, Lin HC, Chung SD.
Regards
Milind,Poornima