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ATORVASTATIN CALCIUM


DIR Classification


Classification:Most-DIR concern
Severity Score:4

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

  • WARNINGS AND PRECAUTIONS
  • Skeletal Muscle
  • Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with atorvastatin calciumand with other drugs in this class. A history of renal impairment may be a risk factor for the development of rhabdomyolysis. Such patients merit closer monitoring for skeletal muscle effects.
  • Atorvastatin, like other statins, occasionally causes myopathy, defined as muscle aches or muscle weakness in conjunction with increases in creatine phosphokinase (CPK) values > 10 times ULN. The concomitant use of higher doses of atorvastatin with certain drugs such as cyclosporine and strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, and HIV protease inhibitors) increases the risk of myopathy/rhabdomyolysis.
  • There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use. IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; muscle biopsy showing necrotizing myopathy without significant inflammation; improvement with immunosuppressive agents.
  • Myopathy should be considered in any patient with diffuse myalgias, muscle tenderness or weakness, and/or marked elevation of CPK. Patients should be advised to report promptly unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever or if muscle signs and symptoms persist after discontinuing atorvastatin calcium. Atorvastatin calcium therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected.
  • The risk of myopathy during treatment with drugs in this class is increased with concurrent administration of cyclosporine, fibric acid derivatives, erythromycin, clarithromycin, the hepatitis C protease inhibitor telaprevir, combinations of HIV protease inhibitors, including saquinavir plus ritonavir, lopinavir plus ritonavir, tipranavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, and fosamprenavir plus ritonavir, niacin, or azole antifungals. Physicians considering combined therapy with atorvastatin calcium and fibric acid derivatives, erythromycin, clarithromycin, a combination of saquinavir plus ritonavir, lopinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, or fosamprenavir plus ritonavir, azole antifungals, or lipid-modifying doses of niacin should carefully weigh the potential benefits and risks and should carefully monitor patients for any signs or symptoms of muscle pain, tenderness, or weakness, particularly during the initial months of therapy and during any periods of upward dosage titration of either drug. Lower starting and maintenance doses of atorvastatin should be considered when taken concomitantly with the aforementioned drugs (see Drug Interactions(7)). Periodic creatine phosphokinase (CPK) determinations may be considered in such situations, but there is no assurance that such monitoring will prevent the occurrence of severe myopathy.
  • Prescribing recommendations for interacting agents are summarized in Table 1 [see also Dosage and Administration (2.6), Drug Interactions (7), Clinical Pharmacology (12.3)].
  • Cases of myopathy, including rhabdomyolysis, have been reported with atorvastatin co-administered with colchicine, and caution should be exercised when prescribing atorvastatin with colchicine [see Drug Interactions (7.11)].
  • Atorvastatin calcium therapy should be temporarily withheld or discontinued in any patient with an acute, serious condition suggestive of a myopathy or having a risk factor predisposing to the development of renal failure secondary to rhabdomyolysis (e.g., severe acute infection, hypotension, major surgery, trauma, severe metabolic, endocrine and electrolyte disorders, and uncontrolled seizures).
  • ADVERSE REACTIONS
  • Clinical Trial Adverse Experiences
  • Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
  • In the atorvastatin calcium placebo-controlled clinical trial database of 16,066 patients (8755 atorvastatin calcium vs. 7311 placebo; age range 10 to 93 years, 39% women, 91% Caucasians, 3% Blacks, 2% Asians, 4% other) with a median treatment duration of 53 weeks, 9.7% of patients on atorvastatin calcium and 9.5% of the patients on placebo discontinued due to adverse reactions regardless of causality. The five most common adverse reactions in patients treated with atorvastatin calcium that led to treatment discontinuation and occurred at a rate greater than placebo were: myalgia (0.7%), diarrhea (0.5%), nausea (0.4%), alanine aminotransferase increase (0.4%), and hepatic enzyme increase (0.4%).
  • The most commonly reported adverse reactions (incidence ≥ 2% and greater than placebo) regardless of causality, in patients treated with atorvastatin calcium in placebo controlled trials (n = 8755) were: nasopharyngitis (8.3%), arthralgia (6.9%), diarrhea (6.8%), pain in extremity (6%), and urinary tract infection (5.7%).
  • Other adverse reactions reported in placebo-controlled studies include:
  • Body as a whole: malaise, pyrexia; Digestive system: abdominal discomfort, eructation, flatulence, hepatitis, cholestasis; Musculoskeletal system: musculoskeletal pain, muscle fatigue, neck pain, joint swelling; Metabolic and nutritional system: transaminases increase, liver function test abnormal, blood alkaline phosphatase increase, creatine phosphokinase increase, hyperglycemia; Nervous system: nightmare; Respiratory system: epistaxis; Skin and appendages: urticaria; Special senses: vision blurred, tinnitus; Urogenital system: white blood cells urine positive.
  • Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT)
  • In ASCOT [see Clinical Studies (14.1)] involving 10,305 participants (age range 40 to 80 years, 19% women; 94.6% Caucasians, 2.6% Africans, 1.5% South Asians, 1.3% mixed/other) treated with atorvastatin calcium 10 mg daily (n = 5,168) or placebo (n = 5,137), the safety and tolerability profile of the group treated with atorvastatin calcium was comparable to that of the group treated with placebo during a median of 3.3 years of follow-up.
  • Collaborative Atorvastatin Diabetes Study (CARDS)
  • In CARDS [see Clinical Studies (14.1)] involving 2,838 subjects (age range 39 to 77 years, 32% women; 94.3% Caucasians, 2.4% South Asians, 2.3% Afro-Caribbean, 1% other) with type 2 diabetes treated with atorvastatin calcium 10 mg daily (n = 1,428) or placebo (n = 1,410), there was no difference in the overall frequency of adverse reactions or serious adverse reactions between the treatment groups during a median follow-up of 3.9 years. No cases of rhabdomyolysis were reported.
  • Postmarketing Experience
  • The following adverse reactions have been identified during postapproval use of atorvastatin calcium. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • Adverse reactions associated with atorvastatin calcium therapy reported since market introduction, that are not listed above, regardless of causality assessment, include the following: anaphylaxis, angioneurotic edema, bullous rashes (including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), rhabdomyolysis, fatigue, tendon rupture, fatal and non-fatal hepatic failure, dizziness, depression, peripheral neuropathy, and pancreatitis.
  • There have been rare reports of immune-mediated necrotizing myopathy associated with statin use [see Warnings and Precautions (5.1)].
  • There have been rare postmarketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. These cognitive issues have been reported for all statins. The reports are generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).
  • DRUG INTERACTIONS
  • The risk of myopathy during treatment with statins is increased with concurrent administration of fibric acid derivatives, lipid-modifying doses of niacin, cyclosporine, or strong CYP 3A4 inhibitors (e.g., clarithromycin, HIV protease inhibitors, and itraconazole) [see Warnings and Precautions, Skeletal Muscle (5.1) and Clinical Pharmacology (12.3)].
  • Gemfibrozil
  • Due to an increased risk of myopathy/rhabdomyolysis when HMG-CoA reductase inhibitors are co-administered with gemfibrozil, concomitant administration of atorvastatin calcium with gemfibrozil should be avoided [see Warnings and Precautions (5.1)].
  • Colchicine
  • Cases of myopathy, including rhabdomyolysis, have been reported with atorvastatin co-administered with colchicine, and caution should be exercised when prescribing atorvastatin with colchicine.

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
Rhabdomyolysis
2973
39939
Other ADRs
78982
14038297

Odds Ratio = 13.231

Drug Property Information



ATC Code(s):
  • C10AA05 - atorvastatin calcium
    • C10AA - HMG CoA reductase inhibitors
    • C10A - "LIPID MODIFYING AGENTS, PLAIN"
    • C10 - LIPID MODIFYING AGENTS
    • C - CARDIOVASCULAR SYSTEM
  • C10BA05 - atorvastatin calcium
    • C10BA - HMG CoA reductase inhibitors in combination with other lipid modifying agents
    • C10B - "LIPID MODIFYING AGENTS, COMBINATIONS"
    • C10 - LIPID MODIFYING AGENTS
    • C - CARDIOVASCULAR SYSTEM
  • C10BX06 - atorvastatin calcium
    • C10BX - "HMG CoA reductase inhibitors, other combinations"
    • C10B - "LIPID MODIFYING AGENTS, COMBINATIONS"
    • C10 - LIPID MODIFYING AGENTS
    • C - CARDIOVASCULAR SYSTEM
  • C10BX11 - atorvastatin calcium
    • C10BX - "HMG CoA reductase inhibitors, other combinations"
    • C10B - "LIPID MODIFYING AGENTS, COMBINATIONS"
    • C10 - LIPID MODIFYING AGENTS
    • C - CARDIOVASCULAR SYSTEM
  • C10BX03 - atorvastatin calcium
    • C10BX - "HMG CoA reductase inhibitors, other combinations"
    • C10B - "LIPID MODIFYING AGENTS, COMBINATIONS"
    • C10 - LIPID MODIFYING AGENTS
    • C - CARDIOVASCULAR SYSTEM
  • C10BX08 - atorvastatin calcium
    • C10BX - "HMG CoA reductase inhibitors, other combinations"
    • C10B - "LIPID MODIFYING AGENTS, COMBINATIONS"
    • C10 - LIPID MODIFYING AGENTS
    • C - CARDIOVASCULAR SYSTEM
Active Ingredient:atorvastatin calcium
Active Ingredient UNII:48A5M73Z4Q
Drugbank ID:DB01076
PubChem Compound:60823
CAS Number:134523-00-5
Dosage Form(s):tablet, film coated
Route(s) Of Administrator:oral
Daily Dose:
  • 20.0 mg/day C10AA05
Chemical Structure:
SMILE Code:
CC(C)C1=C(C(=C(N1CC[[email protected]](C[[email protected]](CC(=O)O)O)O)C2=CC=C(C=C2)F)C3=CC=CC=C3)C(=O)NC4=CC=CC=C4

Reference

COHORT STUDY:

1: Incidence of hospitalized rhabdomyolysis in patients treated with lipid-lowering drugs.

[Graham DJ, Staffa JA, Shatin D, Andrade SE, Schech SD, La Grenade L, Gurwitz JH, Chan KA, Goodman MJ, Platt R, JAMA. 2004 Dec 1;292(21):2585-90.]
ABSTRACT
CONTEXT: Lipid-lowering agents are widely prescribed in the United States. Reliable estimates of rhabdomyolysis risk with various lipid-lowering agents are not available.
OBJECTIVE: To estimate the incidence of rhabdomyolysis in patients treated with different statins and fibrates, alone and in combination, in the ambulatory setting.
DESIGN, SETTING, AND PATIENTS: Drug-specific inception cohorts of statin and fibrate users were established using claims data from 11 managed care health plans across the United States. Patients with at least 180 days of prior health plan enrollment were entered into the cohorts between January 1, 1998, and June 30, 2001. Person-time was classified as monotherapy or combined statin-fibrate therapy.
MAIN OUTCOME MEASURE: Incidence rates of rhabdomyolysis per 10,000 person-years of treatment, number needed to treat, and relative risk of rhabdomyolysis.
RESULTS: In 252,460 patients treated with lipid-lowering agents, 24 cases of hospitalized rhabdomyolysis occurred during treatment. Average incidence per 10,000 person-years for monotherapy with atorvastatin, pravastatin, or simvastatin was 0.44 (95% confidence interval [CI], 0.20-0.84); for cerivastatin, 5.34 (95% CI, 1.46-13.68); and for fibrate, 2.82 (95% CI, 0.58-8.24). By comparison, the incidence during unexposed person-time was 0 (95% CI, 0-0.48; P = .056). The incidence increased to 5.98 (95% CI, 0.72-216.0) for combined therapy of atorvastatin, pravastatin, or simvastatin with a fibrate, and to 1035 (95% CI, 389-2117) for combined cerivastatin-fibrate use. Per year of therapy, the number needed to treat to observe 1 case of rhabdomyolysis was 22,727 for statin monotherapy, 484 for older patients with diabetes mellitus who were treated with both a statin and fibrate, and ranged from 9.7 to 12.7 for patients who were treated with cerivastatin plus fibrate.
CONCLUSIONS: Rhabdomyolysis risk was similar and low for monotherapy with atorvastatin, pravastatin, and simvastatin; combined statin-fibrate use increased risk, especially in older patients with diabetes mellitus. Cerivastatin combined with fibrate conferred a risk of approximately 1 in 10 treated patients per year.
PMID: 15572716

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[Simons Janet E,Holbrook Anne M,Don-Wauchope Andrew C]
J Clin Lipidol.2015 Jul-Aug;9(4):594-6. doi: 10.1016/j.jacl.2015.03.005. Epub 2015 Mar 28. PMID: 26228678

14: Ask the doctor. I am 61 and had been on atorvastatin for 10 years with no problems. Recently, I've had disabling muscle pain with both the generic atorvastatin and the brand-name version, Lipitor. My doctor says that I can no longer take statin drugs. Since strokes run in my family, I am concerned. Is there anything else I can do to decrease my risk of stroke?

[Fabiny Anne]
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22: Safety and tolerability of the use of atorvastatin 40 mg in common daily practice in short-term observation in 3,227 patients.

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[Eshraghian Ahad,Kamyab Amir A'lam]
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45: Statins and fibrate target ClC-1 - from side effects to CLC pharmacology.

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46: Rhabdomyolysis a result of azithromycin and statins: an unrecognized interaction.

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47: Synergistic action of statins and nitrogen-containing bisphosphonates in the development of rhabdomyolysis in L6 rat skeletal myoblasts.

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48: Impact of high-dose atorvastatin in coronary heart disease patients age 65 to 78 years.

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49: [Metabolic rhabdomyolysis during statin therapy].

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50: Efficacy and safety of ABT-335 (fenofibric acid) in combination with atorvastatin in patients with mixed dyslipidemia.

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51: [Statin therapy and muscle disorders].

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52: Should high creatine kinase discourage the initiation or continuance of statins for the treatment of hypercholesterolemia?

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53: Primary prevention of cardiovascular mortality and events with statin treatments: a network meta-analysis involving more than 65,000 patients.

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54: The efficacy and safety of ezetimibe for treatment of dyslipidemia after heart transplantation.

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55: Relative safety profiles of high dose statin regimens.

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56: Rhabdomyolysis with atorvastatin and fusidic acid.

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57: Risk management of simvastatin or atorvastatin interactions with CYP3A4 inhibitors.

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58: The creatine kinase response to eccentric exercise with atorvastatin 10 mg or 80 mg.

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59: Oral nanoparticulate atorvastatin calcium is more efficient and safe in comparison to Lipicure in treating hyperlipidemia.

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60: Estimating the extent of reporting to FDA: a case study of statin-associated rhabdomyolysis.

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61: [Ishikawa diagram and barrier analysis implemented to a medication error that induces rhabdomyolysis].

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Farm Hosp.2007 Sep-Oct;31(5):318-20. PMID: 18052637

62: CYP2D6*4 polymorphism is associated with statin-induced muscle effects.

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63: [Rhabdomyolysis associated to combined ezetimibe-statin treatment].

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64: A multicentre, open study to assess the effect of individualizing starting doses of atorvastatin according to baseline LDL-C levels on achieving cholesterol targets: the Achieve Cholesterol Targets Fast with Atorvastatin Stratified Titration (ACTFAST-2) study.

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65: Letter by Rosenberg and Uretsky regarding article, "Risks associated with statin therapy: a systematic overview of randomized clinical trials".

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66: Use of maximum-dose simvastatin or atorvastatin in an ethnically diverse population.

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67: Atorvastatin-induced early-onset rhabdomyolysis in a patient with nephrotic syndrome.

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68: Safety of lovastatin/extended release niacin compared with lovastatin alone, atorvastatin alone, pravastatin alone, and simvastatin alone (from the United States Food and Drug Administration adverse event reporting system).

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69: [Rhabdomyolysis after treatment with atorvastatin detected by bone scintigraphy].

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70: Risk factors for rhabdomyolysis with simvastatin and atorvastatin.

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71: Risk factors for rhabdomyolysis with simvastatin and atorvastatin.

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72: Effects of chronic treatment with statins and fenofibrate on rat skeletal muscle: a biochemical, histological and electrophysiological study.

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73: Atorvastatin for stroke prevention.


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74: Media report of rare rhabdomyolysis cases seems to have triggered reluctance among some New Zealanders to use statins.

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75: Comparison of rosuvastatin versus atorvastatin in Hispanic-Americans with hypercholesterolemia (from the STARSHIP trial).

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76: Tolerability of atorvastatin in a population aged > or =65 years: a retrospective pooled analysis of results from fifty randomized clinical trials.

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77: [A case of interstitial lung disease with atorvastatin (Tahor) and a review of the literature about these effects observed under statins].

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78: Quinine-induced renal failure as a result of rhabdomyolysis, haemolytic uraemic syndrome and disseminated intravascular coagulation.

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79: Rhabdomyolysis in a patient treated with colchicine and atorvastatin.

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80: Exposure of atorvastatin is unchanged but lactone and acid metabolites are increased several-fold in patients with atorvastatin-induced myopathy.

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81: The statins: drug interactions of significance to the dental practitioner.

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82: Muscle symptoms associated with statins: a series of twenty patients.

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83: Safety of statins when response is carefully monitored: a study of 336 heart recipients.

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84: Comparative safety of atorvastatin 80 mg versus 10 mg derived from analysis of 49 completed trials in 14,236 patients.

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85: High-dose atorvastatin vs usual-dose simvastatin for secondary prevention after myocardial infarction: the IDEAL study: a randomized controlled trial.

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86: How common is rhabdomyolysis in patients receiving lipid-lowering therapy?

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87: Statin-induced apoptosis linked with membrane farnesylated Ras small G protein depletion, rather than geranylated Rho protein.

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88: Changes in ubiquitin proteasome pathway gene expression in skeletal muscle with exercise and statins.

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89: Conversion to atorvastatin in patients intolerant or refractory to simvastatin therapy: the CAPISH study.

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90: Safety of high-dose atorvastatin therapy.

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91: Pharmacologic options for aggressive low-density lipoprotein cholesterol lowering: benefits versus risks.

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92: Analysis of the global RNA expression profiles of skeletal muscle cells treated with statins.

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J Atheroscler Thromb.2005;12(3):121-31. PMID: 16020911

93: Intensive lipid lowering with atorvastatin in coronary disease.

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N Engl J Med.2005 Jul 7;353(1):93-6; author reply 93-6. PMID: 16003834

94: Relative impact of CYP3A genotype and concomitant medication on the severity of atorvastatin-induced muscle damage.

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95: Prevalence of potentially severe drug-drug interactions in ambulatory patients with dyslipidaemia receiving HMG-CoA reductase inhibitor therapy.

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96: A literature search on pharmacokinetic drug interactions of statins and analysis of how such interactions are reflected in package inserts in Japan.

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J Clin Pharm Ther.2005 Feb;30(1):21-37. PMID: 15659001

97: Exertion-induced rhabdomyolysis in a patient on statin therapy.

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Nephrol Dial Transplant.2005 Jan;20(1):244. PMID: 15632363

98: Rhabdomyolysis in a patient receiving atorvastatin and fluconazole.

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99: The grapefruit challenge: the juice inhibits a crucial enzyme, with possibly fatal consequences.

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Am J Nurs.2004 Dec;104(12):33-5. PMID: 15621963

100: Potential for conflict of interest in the evaluation of suspected adverse drug reactions: use of cerivastatin and risk of rhabdomyolysis.

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JAMA.2004 Dec 1;292(21):2622-31. Epub 2004 Nov 22. PMID: 15572720

101: Formulary conversion programs: the need for patient-specific risk assessment.

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MedGenMed.2004 Sep 14;6(3):28. PMID: 15520652

102: Comparative pharmacokinetic interaction profiles of pravastatin, simvastatin, and atorvastatin when coadministered with cytochrome P450 inhibitors.

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103: Long-term safety and tolerability profile of ezetimibe and atorvastatin coadministration therapy in patients with primary hypercholesterolaemia.

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104: Rhabdomyolysis triggered by cytomegalovirus infection in a heart transplant patient on concomitant cyclosporine and atorvastatin therapy.

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J Gastroenterol Hepatol.2004 Aug;19(8):952-3. PMID: 15242511

105: Atorvastatin decreases the coenzyme Q10 level in the blood of patients at risk for cardiovascular disease and stroke.

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106: Clinical pharmacokinetics of atorvastatin.

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107: Safety of atorvastatin derived from analysis of 44 completed trials in 9,416 patients.

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108: Influence of 3-hydroxy-3-methylglutaryl-CoA (HMG-CoA) reductase inhibitors on endothelial nitric oxide synthase and the formation of oxidants in the vasculature.

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Atherosclerosis.2003 Jul;169(1):19-29. PMID: 12860247

109: Drug-induced rhabdomyolysis after concomitant use of clarithromycin, atorvastatin, and lopinavir/ritonavir in a patient with HIV.

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AIDS Patient Care STDS.2003 May;17(5):207-10. PMID: 12816614

110: Rhabdomyolysis causing AV blockade due to possible atorvastatin, esomeprazole, and clarithromycin interaction.

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111: Rhabdomyolysis and myalgia associated with anticholesterolemic treatment as potential signs of malignant hyperthermia susceptibility.

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112: Treating dyslipidemia with statins: the risk-benefit profile.

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113: Efficacy and safety of atorvastatin after pediatric heart transplantation.

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114: The HMG Co-A reductase inhibitors ('statins') and myotoxic effects.


S Afr Med J.2002 Aug;92(8):596-7. PMID: 12244613

115: Rhabdomyolysis with concurrent atorvastatin and diltiazem.

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116: Pharmacological interactions of statins.

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117: Rhabdomyolysis with acute renal failure probably related to the interaction of atorvastatin and delavirdine.

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118: A study of the interaction potential of azithromycin and clarithromycin with atorvastatin in healthy volunteers.

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119: Safety and efficacy of atorvastatin in heart transplant recipients.

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120: Safety of HMG-CoA reductase inhibitors: focus on atorvastatin.

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121: . . . from the 40th Interscience Conference on Antimicrobial Agents and Chemotherapy.


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123: Metabolism and drug interactions of 3-hydroxy-3-methylglutaryl coenzyme A-reductase inhibitors (statins).

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125: Short-term effect of atorvastatin in hypercholesterolaemic renal-transplant patients unresponsive to other statins.

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127: Atorvastatin compared with simvastatin-based therapies in the management of severe familial hyperlipidaemias.

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129: Safety of low-density lipoprotein cholestrol reduction with atorvastatin versus simvastatin in a coronary heart disease population (the TARGET TANGIBLE trial).

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