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A case of myositis with immunological background associated with statin use

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Protić D., Baltić S., Stupar N., Pavlov-Dolijanović S., Mugoša S., Todorović Z.
Open Medicine
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2014
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vol. 9
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issue 5
619-624
EN
Statins might cause and/or aggravate the immune-mediated myositis in patients on long-term, stable treatment. We provide a case of polymyositis with an immunological background and gastrointestinal and urinary manifestations in patient on long-term, stable atorvastatin treatment for the past six years. The diagnose of polymyositis was established based on clinical symptoms and signs, electromyography and laboratory test results (elevated aspartate aminotransferase 279 U/L, reference range 0–40 U/L; alanine aminotransferase 198 U/L, 0–33 U/L; lactate dehydrogenase 2200 U/L, 103-227 U/L; creatine kinase 7820 U/L, 15–84 U/L; and positive antinuclear antibodies test, titer of 1:160, with suspect antisynthetase antibodies). Polymyositis was probably related to atorvastatin treatment (Naranjo score, 5). Other probable causes of the myositis were rejected. Coricosteroid therapy, methotrexate and supplementation with vitamin D did not improve the condition. The patient remained bedridden and died two months after the hospital discharge due to the acute myocardial infarction.
2
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Efficacy of alternate day dosing of atorvastatin

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Aghasadeghi K., Zare D.
Open Medicine
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2008
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vol. 3
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issue 2
163-166
EN
Atorvastatin is a synthetic inhibitor of 3-hydroxy 3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor. It has a longer half life and longer duration of action than that of all other available HMG-CoA inhibitors. We evaluated the efficacy of alternate-day dosing of atorvastatin in comparison with the standard one-daily dose on total cholesterol, low and High-density lipoprotein (LDL and HDL) and triglycerides. This study is a randomized, blinded, and controlled clinical trial. Sixty-six patients with LDL cholesterol of more than 100 mg/dl were enrolled. Baseline fasting lipid profile (total cholesterol, LDL, HDL and triglyceride), liver function tests and creatine kinase were drawn. Patients were randomized to three atorvastatin dose groups. Group I received 10 mg of atorvastatin every day, group II received 20 mg of atorvastatin every day, and group III received 20 mg every other day. After 6 weeks of treatment with atorvastatin, fasting lipid profiles, liver function tests and creatine kinase concentrations were re-taken. Compliance to treatment was assessed at each visit. Of the sixty-six patients enrolled, sixty completed the study. All three regimens significantly reduced total cholesterol and LDL compared to baseline. No statistically significant difference existed between the three groups in regards to total or a percentage decrease in total cholesterol and LDL cholesterol at 6 weeks compared to baseline. All regimens were well tolerated and none of the patients showed significant elevation of liver enzyme or creatine kinase during the course of the study. In conclusions the alternate-day dosing of atorvastatin is an efficacious and safe alternate to daily dosing and yet inexpensive.
3
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ATORVASTATIN ADSORPTION STUDIES ON CHITOSANS IN AN in vitro PHARMACEUTICAL MODEL

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Meler J., Grimling B., Szcześniak M., Karolewicz B., Biernat P.
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vol. 23
140 - 148
EN
During the pharmacological therapy of specific diseases, drugs are used which, with other preparations or foods, can create connections, in many cases changing or even blocking their action. On the other hand, the use of unsuitable polymers as excipients may result in drug-polymer incompatibilities. Interactions consisting mainly of the occurrence of the adsorption phenomenon and on the formation of complex bonds that reduce the effect of the drugs are of particular importance. The aim of the study was to investigate whether the active substance atorvastatin is incompatible with dietary supplements containing chitosan. The phenomenon of the adsorption of the drug was examined using a static model of a pharmaceutical gastrointestinal tract, in the concentration range generally ingested in a single dose. Measurement results of the amount of bound drug were used to determine the average percentage of adsorbed drug dose. The results of the study prove that the anticholinesterase drug is adsorbed on chitosan in the pH ranges used, and that the binding capacity depends on the chitosan variety, which indirectly affects the reaction of the environment. It was observed that the average size of sorption depending on the chitosan variety ranged from 38% to 86%. The fact that the lowest value of adsorption was at pH 6.4 can be explained by the chemical properties of chitosan, which shows a charge only at pH >6.7. Under such conditions, the phenomenon of electrostatic adsorption may occur in relation to the healing substances of weak acids. At a pH above 7.6, corresponding to the intestinal fluid-filled intestine, the mean sorption for the highest dose of chitosan was from 38–86%. The increase in the adsorbed amount of anticholinesterase drugs on the polymer along with the increase in pH from 7.6 to 8.0 can be explained by the chitosan swelling properties, which increase with an increase in the pH. As a result, the specific surface area of the polymer and its sorption capacity increase. Based on the above considerations, it can be concluded that there is an antagonistic interaction between the drug and the polymer studied, which involves the adsorption of a drug from this group on the polymer (chitosan) and a decrease in its bioavailability
4
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Atorvastatin improves tubular status in non-diabetic patients with chronic kidney disease - placebo controlled, randomized, cross-over study

88%
Renke M., Tylicki L., Rutkowski P., Neuwelt A., Larczyński W., Ziętkiewicz M., Aleksandrowicz E., Łysiak-Szydłowska W., Rutkowski B.
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2010
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vol. 57
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issue 4
547-552
EN
Background. There is evidence that dyslipidemia is associated with chronic kidney disease (CKD) and it has been implicated in the progression of renal damage. Optimal management of dyslipidemia should therefore lead to renal benefits. A number of experimental models demonstrate a beneficial effect of statins in ameliorating renal damage. However, the exact mechanism by which statins protect against renal damage remains unclear. Methods. In a placebo-controlled, randomized, cross-over study we evaluated the influence of atorvastatin (ATO) 40 mg/day added to the renin-angiotensin-aldosterone systeme (RAAS) blockade on proteinuria and surrogate biomarkers of tubular damage or injury in 14 non-diabetic patients with proteinuria (0.4-1.8 g per 24 h) with normal or declined kidney function (eGFR 55-153 ml/min). In the eight-week run-in period, therapy using angiotensin converting enzyme inhibitors (ACEI) and/or angiotensin II subtype 1 receptor antagonists (ARB) was adjusted to achieve a blood pressure below 130/80 mm Hg. Next, patients were randomly assigned to one of two treatment sequences: ATO/washout/placebo or placebo/washout/ATO. Clinical evaluation and laboratory tests were performed at the randomization point and after each period of the study. The primary end point of this study was a change in proteinuria measured as 24-h urine protein excretion (DPE). Secondary end points included urine N-acetyl-β-d-glucosaminidase (NAG) and α1-microglobulin (α1m) excretion. Results. The ATO therapy significantly reduced urine excretion of α1m (p=0.033) and NAG (p=0.038) as compared to placebo. There were no differences in proteinuria, blood pressure, eGFR and serum creatinine between the ATO and placebo groups. Conclusion. Atorvastatin treatment is safe and improves biomarkers of tubular damage or injury in non-diabetic patients with CKD.
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