The liver and lovastatin

Tolman, Keith G.

doi:10.1016/s0002-9149(02)02355-x

Cited by 188 publications

(101 citation statements)

References 18 publications

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“…The doses used in human trials were far lower, and, as noted by Hyman Zimmerman, ''caused little injury'' [29]. Moreover, the toxicology studies pointed to the physiologic effects of cholesterol lowering being the cause of the enzyme elevations rather than any direct toxic effect of the statin itself [7]. Indeed, replenishing the mevalonic acid deficiency that results from HMG co-A reductase-inhibition in the cholesterol-lowering cascade was shown to prevent hepatic injury in animals [27,28].…”

Section: History Of Statin-associated Hepatotoxicitymentioning

confidence: 99%

“…A reading of the recent published literature contains a not so subtle war of words over the risk and magnitude of statin-related hepatotoxicity [5][6][7][8][9][10][11][12][13][14]. It almost appears as if each new case series of statin-associated hepatic injury [5,6,15] can be matched with or accompanied by editorial comments to place the risk into perspective [11][12][13].…”

Section: Introductionmentioning

confidence: 99%

“…When the semantic duel over the degree of drug-induced liver injury (DILI) from statins is fought over the number needed to harm compared to the expected number who will benefit from statin treatment, the pendulum can be seen swinging much further toward the latter. Indeed, it is ironic that there have been nearly twice as many articles, studies, and commentaries arguing against statins being a significant risk to the liver [7][8][9][10][11][12][13][14][16][17][18][19][20][21][22][23][24] as there have been new reports of statin-associated hepatic injury [5,6,14,25,26] in just the past few years alone. Furthermore, the FDA has reviewed post-marketing data, cases from US registries of drug-induced liver injury as well as acute liver failure, and other sources of information on statin-related hepatotoxicity, and has concluded that the risk of serious liver injury from all currently marketed statins is ''very low'' (including a risk of less than or equal to just 2 per 1 million patient-years in the Adverse Event Reporting System (AERS) database) [1].…”

Section: Introductionmentioning

confidence: 99%

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Clinical Perspective: Statins and the Liver—Harmful or Helpful?

Lewis

2012

Dig Dis Sci

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Section: History Of Statin-associated Hepatotoxicitymentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Clinical Perspective: Statins and the Liver—Harmful or Helpful?

Lewis

2012

Dig Dis Sci

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“…Only the 48-week trials were chosen because all these drugs are used in long-term treatments (37). Serum ALT and AST levels were used as the biomarker of liver injury in this meta-analysis and ALT was more deterministic than AST (38,39). They concluded that placebo and statins gave similar results.…”

Section: Meta Analyses On Statinsmentioning

confidence: 99%

Hepatotoxicity associated with statins

Karahalıl

Hare

Koç

et al. 2017

Archives of Industrial Hygiene and Toxicology

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Treatment with statins is known all over the world. They are generally considered safe at therapeutic doses. Nevertheless, clinical trials are not enough to assess their scarce adverse effects such as idiosyncratic drug induced liver injury (DILI). Due to some conditions, such as concomitant usage (drug-drug interaction using an identical metabolising enzyme) and genetic polymorphisms, there is an increasing concern about their safety. Hepatotoxicity and rhabdomyolysis have begun to appear in published studies. Most of investigations have focused on both these adverse effects and mechanisms of drug induced toxicity. The present review has attempted to compile almost all of the existing studies on the hepatotoxicity of statins but not rhabdomyolysis. The aim of our study is to provide an overview of the studies on the statin-associated hepatotoxicity and to discuss the published studies. The researchers are of the opinion that the research on this topic is incomplete but extremely necessary.

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“…6 Cohen has indicated that this degree in half-tablet weight variability is acceptable since therapeutic outcomes would likely be unchanged. 5 Given the wide therapeutic index of lovastatin 12,13 and lisinopril, 14 it would appear that splitting these 2 products is acceptable. Gee at al.…”

Section: Lovstatin and Lisinopril: Clinical Considerationsmentioning

confidence: 99%

Weight Uniformity of Split Tablets Required by a Veterans Affairs Policy

Polli

Kim²,

Martin³

2003

JMCP

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OBJECTIVE: To split several tablet products relevant to the Veterans Affairs (VA) Maryland Healthcare System and assess whether the resulting half tablets provide equal doses.METHODS: From a VA list of products that are required to be split, 7 products were evaluated, along with 5 other commonly split tablet products. A trained pharmacy student split tablets using a tablet splitter provided by the VA. Half tablets were assessed for weight uniformity.RESULTS: Of the 12 products subjected to splitting, 8 products (atorvastatin, citalopram, furosemide, glipizide, metoprolol, paroxetine, sertraline, and warfarin) yielded half tablets that passed the weight-uniformity test. The 4 failing products were lisinopril, lovastatin, rofecoxib, and simvastatin. Unusual tablet shape and high tablet hardness predisposed products to failing the weight-uniformity test. The 4 failing products resulted in half tablets that were generally within 20% of their target weight range, suggesting that splitting these specific products would not result in adverse therapeutic effects due to dose variation created by tablet-splitting.CONCLUSION: Split-tablet results were relatively favorable and generally support a VA practice to split specific tablets. Public quality standards for half tablets, including their content uniformity, are needed to better delineate the policies for acceptable tablet splitting.

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The liver and lovastatin

Cited by 188 publications

References 18 publications

Clinical Perspective: Statins and the Liver—Harmful or Helpful?

Clinical Perspective: Statins and the Liver—Harmful or Helpful?

Hepatotoxicity associated with statins

Weight Uniformity of Split Tablets Required by a Veterans Affairs Policy

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