scholarly journals Trust the Blinded Randomized Evidence That Statin Therapy Rarely Causes Symptomatic Side Effects

Circulation ◽  
2018 ◽  
Vol 138 (15) ◽  
pp. 1499-1501 ◽  
Author(s):  
Richard Peto ◽  
Rory Collins
Keyword(s):  
Side Effects ◽  
Statin Therapy ◽  
Symptomatic Side

Abstract 531: Is Earlier Hepatitis A Associated with Abnormal Hepatic Response to Statin Therapy?

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Helmut Sinzinger ◽  
Simona Marchesi ◽  
Graziana Lupattelli
Keyword(s):  
Side Effects ◽  
Alcohol Abuse ◽  
Statin Therapy ◽  
Hepatic Steatosis ◽  
Hepatitis A ◽  
Hepatic Enzyme ◽  
Steatosis Hepatis ◽  
Enzyme Elevation ◽  
Drug Free ◽  
Statin Response

Hepatic enzyme elevation is low (< 3%) in large statin trials. Elevations are reversible after dose reduction or statin withdrawal. Very rare cases of hepatitis have been reported. No data are available how predisposing risk factors /diseases might influence hepatic statin response. Among the patients suffering from hepatic side effects during statin therapy 896 (477 m, 419 f; aged 31–76 years) admitted with (one or more) elevated hepatic enzyme, anamnestic data on hepatitis A, B, C, hepatic steatosis, alcohol abuse, hepatobiliary problems, abnormal enzymes (GOT, GPT, γGT) were assessed. The prevalence (% vs. % statin use in Austria) was for lovastatin n= 4; 0,2 (0,7), fluvastatin n = 111; 12,4 (14,0), simvastatin n = 297; 33,1 (34,8), pravastatin n = 82; 9,2 (11,8), rosuvastatin n = 69; 7,9 (1,5), atorvastatin n = 333; 37,2 (37,2). Only 41 patients (4,27%) had concomitant muscle complaints (21 cramps, 16 aches, 3 stiffness, 1 weakness), 12 (1,33%) CK elevation, 261 (29,13%) elevated isoprostane 8epiPGF 2α . Those with muscle complaints had normal CK levels and vice versa. Pretherapeutic findings (more than one possible) were hepatitis A 326 (36,4% !!), hepatitis B 7 (0,8%), hepatitis C 3 (0,3%), hepatic steatosis 141 (15,7%), alcohol abuse 104 (11,6%) and /or hepatobiliary problems 17 (1,9%). Abnormal enzymes GOT 116 (12,9%), GPT 113 (12,6%), γGT 147 (16,4%) persisted for < 1 week. Patients after hepatitis A had significantly (p < 0,001) higher transaminases as compared to the other patients. Withdrawal of the respective statin normalized transaminases within 4 weeks in 129 patients (14,4%), in only 7 elevation persisted for a longer period (up to 7 months). After 1 year all were in the normal range. Transaminase levels due to steatosis hepatis even sometimes showed improvement after statin therapy (mean: −12,7% GOT; −14,1 GPT; −16,0 γGT). Reexposure to another statin compound after a 4 weeks drug free interval caused recurrence of side effects in 87 patients (49 with earlier hepatitis A = 56,3%). Hepatitis A seems to represent a high risk for abnormal liver function response on statin therapy and reexposure to other compounds of this family. The combination of abnormal hepatic response with muscle complaints is very rare.

Discontinuation of statin therapy due to muscular side effects: A survey in real life

2013 ◽  
Vol 23 (9) ◽  
pp. 871-875 ◽  
Author(s):  
D. Rosenbaum ◽  
J. Dallongeville ◽  
P. Sabouret ◽  
E. Bruckert
Keyword(s):  
Side Effects ◽  
Statin Therapy ◽  
Real Life

scholarly journals An insight into statin use and its association with muscular side effects in clinical practice

2015 ◽  
Vol 53 (2) ◽  
pp. 153-160 ◽  
Author(s):  
Andreea Farcas ◽  
Camelia Bucsa ◽  
D. Leucuta ◽  
Cristina Mogosan ◽  
M. Bojita ◽  
...  
Keyword(s):  
Internal Medicine ◽  
Side Effects ◽  
Statin Therapy ◽  
Prospective Observational Study ◽  
Muscle Power ◽  
Statin Treatment ◽  
Lower Limbs ◽  
Time To Onset ◽  
Insight Into ◽  
Statin Use

Abstract Background. Muscular complaints are known side-effects of statin therapy, ranging from myalgia to clinically important myositis and rhabdomyolysis. We investigated the statin use and association with the presence and characteristics of muscular complaints. Methods. We conducted a prospective observational study in internal medicine departments. Patients with statin therapy before hospitalization were interviewed for muscular complaints. When muscular complaints were reported, information on type and severity of muscular symptoms, location and time to onset was collected. Results. We identified 85 patients with statin treatment at hospital admission out of 521 included. Nine (10.59%) patients reported muscular complaints associated with statin therapy. A cluster of symptoms (cramps, stiffness, decreased muscle power) was reported, affecting both upper and lower limbs. The severity of pain was in most of the cases moderate or severe. All patients reported that pain was intermittent. Five reported that pain was generalized. Symptoms appeared in the first month of treatment or three months after the drug initiation. Creatine kinase was raised in one patient. In two cases drug interactions were probably responsible for muscular complaints. Conclusion. In the studied set of patients muscular symptoms were a rather frequent effect of statin therapy. As this side-effect could be troublesome for patients and could lead to more severe outcomes, their timely detection and management is important.

scholarly journals Cardiovascular outcomes trials with statins in diabetes

2018 ◽  
Vol 18 (1) ◽  
pp. 7-13 ◽  
Author(s):  
Fariha Naeem ◽  
Gerard McKay ◽  
Miles Fisher
Keyword(s):  
Cardiovascular Disease ◽  
Side Effects ◽  
Primary Prevention ◽  
Secondary Prevention ◽  
Statin Therapy ◽  
Cardiovascular Events ◽  
Atherosclerotic Disease ◽  
Lipid Lowering ◽  
High Dose ◽  
Drug Side Effects

Treatment with statins is one of the most effective ways of reducing cardiovascular events in those with diabetes. Many studies containing thousands of subjects with diabetes have demonstrated that statins reduce cardiovascular events when there is no known cardiovascular disease (primary prevention) and in those with confirmed atherosclerotic disease (secondary prevention). High-dose statins appear to be even more effective in established cardiovascular disease, but at the expense of increased drug side effects. In this paper we review the evidence for the benefits of statins in diabetes. In a second review we will examine the evidence for possible benefits of other lipid-lowering therapies when these are added to background statin therapy in diabetes.

scholarly journals Adverse effects of statin therapy: real evidence

2019 ◽  
Vol 10 (1) ◽  
pp. 51-61 ◽  
Author(s):  
Marina G. Bubnova
Keyword(s):  
Side Effects ◽  
Adverse Effects ◽  
Statin Therapy ◽  
Treatment Compliance ◽  
Lipid Lowering ◽  
Current View ◽  
Tolerability Profile ◽  
Lipid Lowering Therapy ◽  
Statin Intolerance ◽  
Good Tolerability

Aim. To provide a current view on the tolerability and safety of statin therapy. Materials and methods. The data of 73 scientific sources from Russian and foreign literature published within 1996-2018 are considered. Results. It is generally accepted that statins are first-line therapeutic agents for hypercholesterolemia and combined hyperlipidemia. Today there in growing evidence that lowering of low-density lipoprotein cholesterol levels prevents atherosclerotic diseases and reduces a risk of cardiovascular and overall mortality. Main issues of current statin therapy include a use of inadequate dosage for atherosclerotic diseases prevention, low treatment compliance and drug intolerance. In recent years the issue of statin intolerance has become of great importance. Criteria were proposed for determining an inability to tolerate statins, some experts suggest replacing definition of “statin intolerance” with the term “statin-associated side-effects”. Most discussed adverse effects due to statins include muscle-related symptoms (myalgia/myopathy), hepatotoxicity (hepatic hyperenzymemia) new-onset diabetes, dementia and cognitive impairment. Mechanisms of development of these adverse effects are still unclear. Certain factors and conditions capable of triggering some adverse effects as well as absolute contraindications to statin therapy were established. Some factors and conditions capable of triggering some adverse effects as well as absolute contraindications to statin therapy were identified. Occurrence of statin-associated side-effects depends on statin dose, a patient's age, gender, comorbidity and concomitant therapy. Many adverse effects of statins are drug class effect. At the same time each of statins has specific features of its structure, metabolism, drug interactions and pharmacokinetics. Pitavastatin belongs to the last generation of statins and it has distinct pharmacological features and neutral diabetogenic effects, etc. Risk of adverse effects due to statins is often exaggerated while benefit from the use of statins for preventing atherosclerotic diseases outweighs potential risks. Real occurrence of some adverse effects due to statin therapy requires additional evidence. Conclusion. Overall, statins have a good tolerability profile and are approved for use in the vast majority of patients who required lipid-lowering therapy.

scholarly journals Rhabdomyolysis Occurring under Statins after Intense Physical Activity in a Marathon Runner

2015 ◽  
Vol 2015 ◽  
pp. 1-2 ◽  
Author(s):  
Éric Toussirot ◽  
Fabrice Michel ◽  
Nicolas Meneveau
Keyword(s):  
Physical Activity ◽  
Side Effects ◽  
Statin Therapy ◽  
Marathon Runner ◽  
Sports Activity ◽  
Acute Rhabdomyolysis ◽  
Intense Physical Activity

Statins are widely used in the treatment of hypercholesterolemia and their side effects on muscles are well established. Conversely, data are sparse regarding the safety of this class of drugs in subjects who engage in sports, particularly those who have intense sports activity. We report the case of a marathon runner who presented with acute rhabdomyolysis during competition while being under rosuvastatin treatment. This case raises the question of the need for temporary discontinuation of statin therapy when intense physical activity is planned.

scholarly journals HOUT-04. ASSOCIATION OF COMMON PATIENT-REPORTED IMMUNOTHERAPY SYMPTOMATIC SIDE EFFECTS AND PSEUDOPROGRESSION IN PATIENTS WITH PRIMARY CENTRAL NERVOUS SYSTEM (CNS) TUMORS

2019 ◽  
Vol 21 (Supplement_6) ◽  
pp. vi112-vi112
Author(s):  
Yamini Vyas ◽  
Elizabeth Vera ◽  
Christine Bryla ◽  
Sonja Crandon ◽  
Jing Wu ◽  
...  
Keyword(s):  
Side Effects ◽  
Checkpoint Inhibitors ◽  
Single Agent ◽  
Symptom Burden ◽  
Disease Status ◽  
Shortness Of Breath ◽  
Tumor Patients ◽  
Common Diagnosis ◽  
Patient Reported ◽  
Symptomatic Side

Abstract BACKGROUND Immunotherapy agents have unique symptomatic side effects; patient-reported outcomes (PROs) can help to characterize the benefits and burdens associated with therapy. Common immunotherapy-associated symptoms include pain, fatigue, shortness of breath, and irregular bowel patterns. The purpose of this study was to assess the severity of symptoms and their association with imaging changes in CNS tumor patients undergoing single agent or combination treatment with immune checkpoint inhibitors (ICIs). METHODS Patients completed the MDASI-BT or MDASI-SP at baseline and longitudinally (every 8 weeks), and results through cycle 4 are reported. Neuro-imaging was categorized as stable, possible ICI-related pseudoprogression, or progression by clinical team review. RESULTS 29 Brain Tumor (BT) and 6 Spinal Tumor patients participated; the majority of which were male (62%) and white (91%), ranging 24-74yo (mean = 46). Glioblastoma was the most common diagnosis (31%) followed by medulloblastoma (16%), with 56% of patients having greater than 2 recurrences prior to the study. At baseline, both brain and spine tumor patients reported moderate to severe fatigue (Brain=4, Spine=6) and pain (Spine=5) with shortness of breath and pain worsening over time. BT patients with pseudoprogression were more likely to report increased fatigue (87%) and pain (63%) compared to those with stable (29%) or true progressive (17%) disease on imaging. BT patients with pseudoprogression also reported worsening of cognitive (43%) and neurologic (57%) symptom burden. CONCLUSIONS In contrast to the common pseudoprogression after chemoradiation, treatment-specific symptoms were worse with ICI-related pseudoprogression by MRI where an immunologic reaction was the likely cause of the imaging worsening. These results suggest that commonly used symptom and functional assessments to distinguish true progression from pseudoprogression may not be helpful with immunotherapy. Additional studies including those with pathologic confirmation of progression or pseudoprogression combined with outcomes measures are needed to develop more accurate determinations of disease status.

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