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Fungi and Water
Published in Chuong Pham-Huy, Bruno Pham Huy, Food and Lifestyle in Health and Disease, 2022
Chuong Pham-Huy, Bruno Pham Huy
In animals, statins produce significant toxicity at high doses: increases in hepatic transaminases, atypical focal hyperplasia of the liver, cataracts, vascular lesions in the central nervous system (CNS), skeletal muscle toxicity, testicular degeneration, and more (164). Fortunately, except for rare cases of myopathy and marked but asymptomatic increases in hepatic transaminases, none of the adverse effects found in animals occur at human therapeutic doses (162–164). Muscle complaints or myalgia are common in statin users, occurring in about 7% of statin users (164). Cerivastatin was introduced in 1998 but was withdrawn in August 2001 by the manufacturer because of a large number of reports of rhabdomyolysis, of which more than 50 cases were fatal (164). In 2010, the British Medical Journal published a study that statins may raise cataract and kidney risk (164). Therefore, the use of statins must be prescribed by physicians only.
Impotent drug regulation
Published in Peter C. Gøtzsche, Richard Smith, Drummond Rennie, Deadly Medicines and Organised Crime, 2019
Peter C. Gøtzsche, Richard Smith, Drummond Rennie
I’ll stop here, but it’s important to realise that drugs are never safe. Life jackets on boats are good to have, as they may save your life. They won’t kill you. Drugs are not like that. Taking a statin may reduce your risk of dying from heart disease, but it will also increase your risk of dying from some other causes. Not much, but one of the statins, cerivastatin (Baycol), was taken off the market after patients had died because of muscle damage and renal failure.
Determination of Toxicity
Published in David Woolley, Adam Woolley, Practical Toxicology, 2017
Expression of toxicity at unexpected target sites, or at unexpected intensities, by drugs or other chemicals has been a major factor in their withdrawal from the market. While clinical human toxicity at major target organs may be predicted from appropriate nonclinical studies, some target organs may be less easily predictable. For instance, cerivastatin (Baycol), a statin intended to reduce cholesterol levels, showed an unexpected risk of rhabdomyolysis (severe muscle damage) especially when used at a high dose or with gemfibrozil, another lipid-regulating agent. It is unlikely that such an effect would be predicted by any of the routinely used test systems, particularly those in vitro, as there is unlikely to be any routine test for such an endpoint. The diversity of toxicological endpoints will always be a massive hurdle to successful prediction of target organ effect in vivo from in vitro assays, covering single effects or mechanisms.
A systematic review and meta-analysis of the effect of statin treatment on sVCAM-1 and sICAM-1
Published in Expert Review of Clinical Pharmacology, 2022
Angelo Zinellu, Arduino A Mangoni
Univariate meta-regression analyses were conducted to investigate associations between the effect size and the following study and patient characteristics: age, proportion of males, publication year, body mass index, sample size, the continent where the study was conducted, baseline concentration and the difference between baseline and post-treatment concentration (delta) of total cholesterol, low-density lipoproteins (LDL)-cholesterol, high-density lipoproteins (HDL)-cholesterol, and triglycerides, specific statin used, statin class (lipophilic: atorvastatin, simvastatin, lovastatin, fluvastatin, cerivastatin, and pitavastatin; hydrophilic: rosuvastatin, pravastatin), and treatment duration. Preplanned subgroup analyses investigated the effects of specific statins, statin classes, continent where the study was conducted, use of placebo, and presence of clinically overt atherosclerotic cardiovascular disease. Statistical analyses were performed using Stata 14 (STATA Corp., College Station, TX, USA).
Statin use and safety concerns: an overview of the past, present, and the future
Published in Expert Opinion on Drug Safety, 2020
Rubina Mulchandani, Tanica Lyngdoh, Ashish Kumar Kakkar
The analysis of case reports from the FDA AERS database after the change in the statin drug label in 2012 also showed that the risk of cognitive dysfunction was significantly higher among patients being prescribed highly potent lipophilic statins like atorvastatin and simvastatin, compare to those on less lipophilic statins (fluvastatin, lovastatin) as well as those on hydrophilic statins such as rosuvastatin and pravastatin [122]. Results from the PRIMO study also reported that the likelihood of myalgia and other muscle ailments was the greatest among those on simvastatin – a highly lipophilic statin, when compared to other hydrophilic statins [43]. Even the cerivastatin withdrawal from the market owing to cases of severe muscle toxicity, rhabdomyolysis, and renal failure might be attributed to its potent lipophilicity.
Statins and muscle pain
Published in Expert Review of Clinical Pharmacology, 2020
Joseph V. Pergolizzi, Flaminia Coluzzi, Robert D. Colucci, Hanna Olsson, Jo Ann LeQuang, Jonathan Al-Saadi, Peter Magnusson
Rhabdomyolysis may be considered the most severe form of muscle disease and it has been associated with statins. Since it affects approximately 3.4 patients per 100,000 patients treated per year depending on the type of statin [54], it may be considered a rare disorder. Rhabdomyolosis is characterized by myoglobinuria and acute and potentially fatal renal impairment (caused by tubular necrosis due to myoglobin precipitation in the renal tubules) [55]. Muscle weakness may be present and persistent or transitory. Dark urine is a clinical sign of rhabdomyolysis, but it is often overlooked or misdiagnosed. Since rhabdomyolysis is a life-threatening condition, statins should be discontinued at once [38]. Although differences among statins for other forms of SAMS have not yet emerged, the incidence of statin-induced rhabdomyolysis might be higher in some statins than others. An observational study reported the incidence rate for several statins, for example, 0.3 for lovastatin vs. 8.4 for cerivastatin per 10,000 person-years; note that cerivastatin has been withdrawn from the market for having a higher risk for muscle symptoms [56,57]. The literature reports a case study in which a statin patient was diagnosed with hypothyroidism and rhabdomyolysis, but it was his underlying Hashimoto’s thyroiditis that was implicated in the rhabdomyolysis rather than statin use [58]. Thus, even in statin patients, rhabdomyolosis may be caused by factors other than statin therapy.