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

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.

Mandibular advancement device: Effectiveness and dental side effects. A real-life study

CRANIO® ◽  
2020 ◽  
pp. 1-10 ◽  
Author(s):  
Aoben Chen ◽  
Maud S. Burger ◽  
Margriet A.W.J. Rietdijk-Smulders ◽  
Frank W.J.M. Smeenk
Keyword(s):  
Side Effects ◽  
Real Life ◽  
Mandibular Advancement Device ◽  
Mandibular Advancement ◽  
Life Study ◽  
Real Life Study

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.

SS05-02 - Management of depression with agomelatine: A different perception

2011 ◽  
Vol 26 (S2) ◽  
pp. 2178-2178
Author(s):  
G. Hajak
Keyword(s):  
Side Effects ◽  
Antidepressant Treatment ◽  
Real Life ◽  
Daily Practice ◽  
Early Improvement ◽  
Real Life Setting ◽  
Treatment Of Depression ◽  
Perceived Benefit ◽  
Antidepressant Efficacy ◽  
Clinical Benefits

Agomelatine is a completely new approach to the treatment of depression thanks to its innovative mode of action. Acting as melatonergic agonist and 5-HT2C antagonist, it provides depressed patients with a distinctive antidepressant efficacy that perfectly suits patients’ needs and addresses all symptoms at each step of depression. Two years after the first launch in Europe, now is the time for an update from doctors and patients alike.The patient/doctor relation is key when initiating depression treatment, because patients are reluctant to start, fearing withdrawal symptoms, serious unwanted side effects, and “addiction”. It is important therefore that they understand that agomelatine has none of these effects.The benefits perceived by patients right from the first days of treatment are influential, because patients are reluctant to continue with classic antidepressants (delayed onset of perceived benefit, early side effects). The early improvement reported by patients on agomelatine supplements data on clinical benefits seen in clinical trials from the first week versus venlafaxine (CGI-I, rate of response, daytime alertness, feeling good) and after two weeks versus sertraline (twice as many HAM-D responders to agomelatine as to sertraline).Finally, patients are reluctant to maintain antidepressant treatment because of later side effects (weight gain, sexual dysfunction, emotional blunting). Patients on agomelatine confirm the absence of the classic side effects of antidepressants and are more likely to continue treatment than they are with other drugs. Both the antidepressant efficacy and the tolerability were confirmed in a large non-interventional study in a real-life setting in daily practice.

Long-term toxicity profile of trastuzumab emtansine (T-DM1): A multicenter real-life study.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e12507-e12507
Author(s):  
Giuseppe Buono ◽  
Alessandra Fabi ◽  
Lucia Del Mastro ◽  
Katia Cannita ◽  
Nicla Maria La Verde ◽  
...  
Keyword(s):  
Side Effects ◽  
Liver Toxicity ◽  
Real Life ◽  
Metastatic Breast ◽  
Complete Response ◽  
Median Number ◽  
Her2 Positive ◽  
Life Study ◽  
Safety Issues

e12507 Background: T-DM1 is widely used in HER2 positive metastatic breast cancer (MBC) patients (pts), often for many cycles until progression. However, little is known about its long term toxicity. The aim of this study was to evaluate the safety profile of T-DM1 when delivered for ≥12 cycles. Methods: HER2 positive MBC pts who had received ≥12 cycles of T-DM1 across 18 Italian cancer centers were enrolled from January 2017 to September 2018. The 12 cycles cut-off was chosen based on the EMILIA trial median PFS (9.6 months), to identify a patient population treated with T-DM1 for longer time. Tumor and clinical characteristics were collected. Standard haematological tests, blood chemistries and side effects (nausea, vomiting, diarrhea, stomatitis, asthenia) were recorded cycle by cycle, according CTCAE criteria version 4. Haematological and laboratory toxicities were available for 86 patients, while other toxicities for all 115 patients. Results: Overall, 115 pts were enrolled. Median age was 54.5 (range 29.6–81.9); median time from diagnosis of metastatic disease to first T-DM1 cycle was 32.5 months. T-DM1 was administered as 2nd line and 3rd line of treatment in 45.2% and 27.8% of pts, respectively. Median number of cycles was 18 (range 12-59). Complete response, partial response and stable disease rates were 11.4%, 43% and 45.6%, respectively. Treatment related side effects are shown in table 1. Interestingly, no increased liver toxicity was observed in pts with liver metastases. Analysis of mean CTCAE grade by cycle showed that no relevant incremental toxicity was observed during long term T-DM1 therapy. Conclusions: T-DM1 is safe and well tolerated in these long responding pts. We found no relevant cumulative toxicity. Patients should be treated with T-DM1 as long as their tumor responds, as no safety issues are related to its long term use. [Table: see text]

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.

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