What is the difference between myopathy and myalgia

The RR for cerivastatin which was withdrawn in was The differences between cerivastatin and atorvastatin RR for myopathy were found to be statistically significant at 12 weeks RR 2. At 12 weeks, further differences in RR were identified for atorvastatin versus fluvastatin and pravastatin RR 0. Data was analysed for fibrate class alone 12 week exposure with RR as follows: bezafibrate Using a 26 week exposure cut-off, the number of exposed events in years in 16, patients suggests an annual incidence of around To assess if there was any confounding by temporality; data were analysed in 3 time periods.

Using a 26 week exposure period the RR showed possible evidence of a secular decrease across each of the time periods: —8;— and —5; This pattern was similar using other exposure cut offs for 12 and 52 weeks. The difference in RR from —98 compared with —5 26 week data was found to be statistically significant RR 1.

Re-challenge data revealed 2 statin associated myopathy events following a drug re-challenge after 6 months or more from the primary episode, with no intervening coding listed for myopathy events. Figure 2 shows temporal trend of statin associated myopathy from — based on cumulative numbers of exposed and unexposed events all classes of statin and fibrate. Figure 3 represents a frequency histogram showing for patients with myopathy following statin: time distribution back to most recent increase or start of new statin.

The data shown suggests that most of the cases occur within the first 12 weeks of statin exposure, although a 26 week exposure cut-off will allow less misclassification of exposed and unexposed cases. This analysis used a case-crossover design to compare risks associated with each class of statin and fibrate. We were able to demonstrate a risk which persisted after exposure and time trend analyses which indicated signals had the potential to be picked up early.

Both datasets have independently shown that case-crossover designs are able to identify associations of myopathy related codes. Using 12 week exposures: for IMS data, the rate ratio was 8. For THIN data, the combined result for all myopathy codes and statin exposure was Both RRs were of comparable magnitude.

Statins are increasingly prescribed which may lead to greater number of events in more recent years, following DOH and NICE recommendations. Until recently laboratory results had to be manually entered onto the electronic record which is likely to result in the relatively low number of CK values being captured. Statins have significant health benefits in patients with high risk for cardiovascular disease reducing cardiovascular mortality and morbidity, [3] , and serious side effects are rare.

When prescribing statins, any drug risk and benefit must be taken into account. For most individuals with high cardiovascular risk, benefits will substantially outweigh any risk from statin prescribing. Graham et al. Using this UK primary care data, atorvastatin and simvastatin reflect their place as the most commonly prescribed statins and carry similar risk ratios for myopathy for 26 week exposure: Although the largest risks of myopathy were for fluvastatin RR Similarly there were significant differences in RR for myopathy for rosuvastatin and fluvastatin at 12 weeks and 26 weeks RR 3.

At 12 weeks, further differences in RR were identified for atorvastatin vs. A study in a US managed care group showed the RR of myositis associated with statin monotherapy to be 2. Although large relative risks for myopathy were found for simvastatin RR 6. Although this study has a number of strengths, there are some possible limitations. Comparison of THIN patient-demographic statistics with census data indicates that patients included are representative of the general population.

People who are not registered with a GP and temporary residents are not included in this study; however this is a small percentage of the overall study population. To eliminate repeated codes for the same event we analysed re-challenge data as having 6 months without any preceding myopathy code and a statin prescription within the preceding 2 weeks; although it is possible this may be biased if the patient did not report symptoms to the GP in the interim period.

Other conditions such as rare rheumatic diseases were excluded; however due to the insidious nature of these diseases, these could have been missed if symptoms were sub-clinical. Hence, it is plausible that some cases of myopathy may have been due to undiagnosed rheumatic disease, although we would not expect this to inflate the RR associated with statin induced myopathy greatly.

One key advantage of the case-crossover design is that it considerably reduces confounding as each case acts as its own control. Conventional confounders such as age, sex, BMI, and additional existing co morbidities such as renal and liver diseases can therefore be accounted for. The case-crossover approach is particularly suitable for detecting acute conditions, such as ADRs of relatively acute onset. For case-crossover comparisons the main confounder is any secular trend in prescribing which will give rise to confounding by age.

Analysis examining RR of statin associated myopathy, stratifying by calendar time periods showed possible secular trend of decreasing RR.

The adjusted RR The difference in RR from —98 compared with —5 12 week data was found to be statistically significant RR 1. Where there are large RR associated with drug exposures; any contamination of unexposed with exposed groups will affect the estimates.

So in effect we expect the true estimate for the RR of statin associated myopathy will be higher than These and other techniques could be used to develop and apply methods for exploiting primary care databases to infer causal relationships between classes of drugs and classes of adverse events. In the longer term, the development of computerised integrated health records could allow the methods to applied to a much wider population and thus greatly improve the detection rates of ADRs.

Because of the computerisation of general practice, the UK is well placed to develop these new methods and compare them with existing methods, although other European countries are also adapting to computerised medical records. This would lead to the development and testing of new methods of detecting adverse drug reactions, which if successfully introduced, would have great public health, clinical and economic benefits.

We thank Chris Cates for his advice on statistical testing. We would like to thank all the GPs that contributed data for their collaboration. Conceived and designed the experiments: MM PM. Performed the experiments: MM PM. Wrote the paper: MM. Other: Contributed to writing and interpretation of results: AM. Provided help with interpretation of results: PM. Browse Subject Areas? Click through the PLOS taxonomy to find articles in your field. Abstract Background Statins are widely used as a cholesterol lowering medication, reduce cardiovascular mortality and morbidity in high risk patients; and only rarely cause serious adverse drug reactions ADRs.

Methods Case-crossover design in detecting statin associated myopathy ADR in 93, patients, using two independent primary care databases — Results Using a 12 and 26 week exposure period, large risk ratios RR are associated with all classes of statins and fibrates for myopathy: RR Conclusion There may be differential risks associated with some classes of statin and fibrate. Introduction Existing approaches to detection of rare but serious adverse drug reactions ADRs have limitations.

Methods Study design Case-crossover retrospective study from — Polymyalgia rheumatica is a disorder that causes muscle pain and stiffness in different areas of the body, particularly the neck, shoulders, and hips.

The stiffness is typically worse after resting. It's usually treated with an oral corticosteroid, such as prednisone. Myalgia due to statins may have multiple causes that interact with each other. Though the exact mechanism is not well understood, one study from found that statins cause calcium leaks from storage compartments in muscle cells.

The leaks can cause damage to muscle cells, sometimes leading to muscle pain. Dealing with joint pain can cause major disruptions to your day. Sign up and learn how to better take care of your body. Click below and just hit send! Chapter Johns Hopkins Medicine. Holder K.

FP Essent. National Institute of Allergy and Infectious Disease. Updated July 13, Centers for Disease Control and Prevention. Lyme disease. Updated September 3, Cleveland Clinic. Muscle pain: Possible causes. Updated December 3, Paganoni S, Amato A. Electrodiagnostic evaluation of myopathies.

The Myositis Association. Exercise and physical therapy. Duloxetine for the treatment of fibromyalgia. Expert Rev Clin Immunol. A mechanism for statin-induced susceptibility to myopathy. Your Privacy Rights. To change or withdraw your consent choices for VerywellHealth. At any time, you can update your settings through the "EU Privacy" link at the bottom of any page.

These choices will be signaled globally to our partners and will not affect browsing data. We and our partners process data to: Actively scan device characteristics for identification. I Accept Show Purposes. Table of Contents View All. Table of Contents. Frequently Asked Questions What is the difference between arthralgia and myalgia? What is polymyalgia rheumatica?

Why do statins cause myalgia? Who Gets Fibromyalgia? Additionally, randomized, controlled trials evaluating the use of CoQ 10 as prevention have yielded equivocal results.

This agent contains lovastatin and has been tolerated in those patients with an aversion to standard statin treatment. Clinical studies have not yielded significant results. Additionally, the role of vitamin D has been somewhat controversial, as low levels are associated with both myalgia and poor muscle function.

Studies evaluating vitamin D supplementation as prevention have been limited in their design and require validation through a larger randomized, double-blind, placebo-controlled trial. Educating the patient on the warning signs and risks of myopathy can prevent serious complications. While many patients may self-treat their symptoms with analgesics or pain relievers, any sudden unexplained muscle weakness or other symptoms should be conveyed to their physician. Statins play a vital role in the prevention of atherosclerotic cardiovascular complications, and statin therapy continues to be a mainstay in treating patients with dyslipidemia.

While some patients may elect to discontinue therapy after consulting their health care provider, many patients may be able to continue statins with proper management of the adverse effects. Pharmacists in the inpatient and outpatient setting may be directly involved in the monitoring of medication therapy and tolerability, and therefore should be aware of the signs and symptoms of statin-associated myopathy.

Proper assessment of patients will assist in the recognition of patients at risk. Knowledge of the currently available statins and their properties will enable pharmacists to provide appropriate recommendations for individualized treatment regimens.

Once patients are initiated on statin therapy, pharmacists have the opportunity to monitor patient adherence, treatment response, and medication safety, in addition to providing ongoing patient education on statin therapy and its adverse effects. Pharmacists should continue to counsel patients on the risk and warning signs of statin-associated myopathy, as the incidence underscores the need for pharmacists to play a direct role in the monitoring of statin therapy in the inpatient and outpatient setting.

Updated April Accessed September 21, Narrative review: statin-related myopathy. Ann Intern Med. Evidence-based management of statin myopathy. Curr Atheroscler Rep. Mild to moderate muscular symptoms with high-dosage statin therapy in hyperlipidemic patients—the PRIMO study. Cardiovasc Drugs Ther. For consumers. FDA: Limit use of 80 mg simvastatin. Updated June Accessed January 10, The broad spectrum of statin myopathy: from myalgia to rhabdomyolysis.

Curr Opin Lipidol. Risk factors and drug interactions predisposing to statin-induced myopathy. Drug Saf. Hodel C. Myopathy and rhabdomyolysis with lipid-lowering drugs. Toxicol Lett. Statin-induced myopathy: a review and update.

Expert Opin Drug Saf. Circ Res. Decreases in serum ubiquinone do not result in reduced levels in muscle tissue during short-term simvastatin treatment in humans. Clin Pharmacol Ther.