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Response
Submit responseThe recent review article by Sharma et al., "Comparative Effectiveness and Harms of Combinations of Lipid-Modifying Agents and High-Dose Statin Monotherapy" (1) does a credible job of summarizing the much longer Comparative Effectiveness Review from the Agency for Healthcare Research and Quality Effective Healthcare program (2). While we do not disagree with the conclusions of the review, we are concerned that the wording of these conclusions, especially in the report abstract, may lead to confusion, specifically regarding the meaning and criteria ascribed to the term "quality."
In the abstract of the review, Sharma et al. follow the recommendations of the GRADE working group, which use the same word, "quality" to describe both the quality of the individual studies being assessed and the overall quality of the evidence underlying the conclusions of the assessment (3). More recent conventions use a different word, such as "strength" to describe the overall body of evidence (4) and indeed, for the majority of the report, Sharma et al. follow this convention. Strength of evidence includes not only the quality of the individual studies, but also the number and size of the studies, the consistency and precision of study results and the direct relevance of the studies to the research question being addressed. It is critical to understand that the statement that "Very-low-quality evidence" favors statin-ezetimibe treatment for attainment of low-density lipoprotein cholesterol goals (1) does not indicate that the studies are of poor quality. It means that very few (two) studies make the very specific comparison of interest in the very specific population of interest. The assessment is thus a matter of quantity rather than quality.
We further note that when the study inclusion criteria are relaxed to include a greater range of statin doses and patient characteristics, an additional 21 trials comparing treatment with a combination of ezetimibe and statin vs. statin alone can be added to the evidence pool. All but one of these studies favor the combination treatment (1). Failure to understand the precise meaning of the terms used in this evidence-based review could lead to misinterpretation of the findings of the review article.
Richard Chapell PhD
Andrew Tershakovec MD MPH
Richard Pasternak MD
1. Sharma M, Ansari MT, Abou-setta AM, Soares-Weiser K, Ooi TC, Sears M, et al., Systematic Review: Comparative Effectiveness and Harms of Combinations of Lipid-Modifying Agents and High-Dose Statin Monotherapy. Ann. Int. Med. 2009;151
2. Sharma M, Ansari MT, Soares-Weiser K, Abou-setta AM, Ooi TK, Sears M, Yazdi F, Tsertzvadze A, Moher D. Comparative Effectiveness of Lipid- Modifying Agents. Comparative Effectiveness Review No. 16. (Prepared by the University of Ottawa Evidence-based Practice Center under contract No. 290-02-0021.) Rockville, MD: Agency for Healthcare Research and Quality. September 2009. Available at: www.effectivehealthcare.ahrq.gov/reports/final.cfm.
3. The Grade Working Group. Grading quality of evidence and strength of recommendations. BMJ. 2004; 228:1-8.
4. Treadwell JR, Tregear SJ, Reston JT and Turkelson CM. A system for rating the strength and stability of medical evidence. BMC Med. Res. Methodol. 2006; 6:52
Conflict of Interest:
Authors are employees of Merck
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Anti-lipid drug menace
Submit responseSir
Physician prescriptions, based on newer and lowered lipid targets are misleading surgeons to undertake the knife crime since surgeons, like physicians are not having a high index of suspicion about the anti-lipid drug menace.
I have deleted, either statins (most common), fibrates or ezetimibe from the patients drug box and have achieved alarming success in over 400 patients who were either referred to me or came directly to me for a 2nd/3rd/4th opinion about a labeled orthopedic diagnosis following investigations like x-rays,MRI etc.
The labeled diagnosis list goes as follows:
1.Recurrent wryneck 2.Cervical Spondylosis unresponsive to physiotherapy. 3.Fibromyalgia scapular region. 4.Teitz syndrome. 5.Frozen shoulder. 6.Tennis elbow. 7.Wrist sprain (which diagnostically was extensor carpi ulnaris tendinitis) 8.Carpal tunnel syndrome 9.Lumbar Spondylosis (one of the patients MRI showed retroperitoneal fibrosis and he was on atorvastatin+fenfibrate for over a year). 10.An anesthetic patch of skin around the greater trochanter femur without any skin changes (he had a normal skin biopsy report with him too) 11.Meralgia paraesthetica. 12.Bilateral thigh pain 13.Lumbar canal stenosis 14.Sciatica 15.Osteoarthritis knees (one of the patients was on atorvastatin 40mg OD for about 8 months and had knee flexion only upto 50 degrees). 16.Tibialis anterior tendinitis. 17.Metatarsalgia 18.Plantar fasciitis.
All the patients were above 40years and had either or combination of diabetes, hypertension, hyperlipidemia with an ESR above 30mm/1st hour.
The symptoms started resolving approximately after about 3 weeks of stopping the offending drug and by 10 weeks the patient could smile at his best!!
None of my patients were subjected to further tests like CPK, liver function tests to prove the adverse drug event.
To conclude:
1.Think, Be a Clinician rather than investigate and label.
2.Whether my experience is published or not (and I cannot provide more proof than being honest), my patients are happy and will testify to all those who are ready to meet them!!!!
Conflict of Interest:
None declared