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Thread: [Case] A Clinical Case of New Diagnosed Diabetes

  1. #11
    PharmD Year 1 TomHsiung's Avatar
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    Exclamation Contraindications and Warnings

    References:
    1.DailyMed - ATORVASTATIN CALCIUM- atorvastatin calcium tablet

    Contraindications

    4.1 Active Liver Disease which may include Unexplained Persistent Elevations of Hepatic Transaminase Levels
    4.2 Hypersensitivity to any component of this medication
    4.3 Pregnancy
    and
    4.4 Nursing mothers

    Warnings

    5.1 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. 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.

    Drug Interactions Associated with Increased Risk of Myopathy/Rhabdomyolysis
    Interacting Agents Prescribing Recommendations
    Cyclosporine, HIV protease inhibitors (tipranavir plus ritonavir), hepatitis C protease inhibitor (telaprevir) Avoid atorvastatin
    HIV protease inhibitor (lopinavir plus ritonavir) Use with caution and lowest dose necessary
    Clarithromycin, itraconazole, HIV protease inhibitors (saquinavir plus ritonavir*, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir) Do not exceed 20 mg atorvastatin daily
    HIV protease inhibitor (nelfinavir)
    Hepatitis C protease inhibitor (boceprevir)
    Do not exceed 40 mg atorvastatin daily

    5.2 Liver Dysfunction
    Statins, like some other lipid-lowering therapies, have been associated with biochemical abnormalities of liver function. Persistent elevations (>3 times the upper limit of normal [ULN] occurring on 2 or more occasions) in serum transaminases occurred in 0.7% of patients who received atorvastatin calcium in clinical trials. The incidence of these abnormalities was 0.2%, 0.2%, 0.6%, and 2.3% for 10, 20, 40, and 80 mg, respectively.

    One patient in clinical trials developed jaundice. Increases in liver function tests (LFT) in other patients were not associated with jaundice or other clinical signs or symptoms. Upon dose reduction, drug interruption, or discontinuation, transaminase levels returned to or near pretreatment levels without sequelae. Eighteen of 30 patients with persistent LFT elevations continued treatment with a reduced dose of atorvastatin calcium.

    It is recommended that liver enzyme tests be obtained prior to initiating therapy with atorvastatin calcium and repeated as clinically indicated. There have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins, including atorvastatin. If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment with atorvastatin calcium, promptly interrupt therapy. If an alternate etiology is not found, do not restart atorvastatin calcium.

    Atorvastatin calcium should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of liver disease. Active liver disease or unexplained persistent transaminase elevations are contraindications to the use of atorvastatin calcium [see Contraindications (4.1)].

    5.3 Endocrine Function
    Increased in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including atorvastatin calcium.

    Statins interfere with cholesterol synthesis and theoretically might blunt adrenal and/or gonadal steroid production. Clinical studies have shown that atorvastatin calcium does not reduce basal plasma cortisol concentration or impair adrenal reserve. The effects of statins on male fertility have not been studied in adequate numbers of patients. The effects, if any, on the pituitary-gonadal axis in premenopausal women are unknown. Caution should be exercised if a statin is administered concomitantly with drugs that may decrease the levels or activity of endogenous steroid hormones, such as ketoconazole, spironolactone, and cimetidine.

    5.4 CNS Toxicity
    Brain hemorrhage was seen in a female dog treated for 3 months at 120 mg/kg/day. Brain hemorrhage and optic nerve vacuolation were seen in another female dog that was sacrificed in moribund condition after 11 weeks of escalating doses up to 280 mg/kg/day. The 120 mg/kg dose resulted in a systemic exposure approximately 16 times the human plasma area-under-the-curve (AUC, 0-24 hours) based on the maximum human dose of 80 mg/day. A single tonic convulsion was seen in each of 2 male dogs (one treated at 10 mg/kg/day and one at 120 mg/kg/day) in a 2-year study. No CNS lesions have been observed in mice after chronic treatment for up to 2 years at doses up to 400 mg/kg/day or in rats at doses up to 100 mg/kg/day. These doses were 6 to 11 times (mouse) and 8 to 16 times (rat) the human AUC (0-24) based on the maximum recommended human dose of 80 mg/day.

    CNS vascular lesions, characterized by perivascular hemorrhages, edema, and mononuclear cell infiltration of perivascular spaces, have been observed in dogs treated with other members of this class. A chemically similar drug in this class produced optic nerve degeneration (Wallerian degeneration of retinogeniculate fibers) in clinically normal dogs in a dose-dependent fashion at a dose that produced plasma drug levels about 30 times higher than the mean drug level in humans taking the highest recommended dose.

    5.5 Use in Patients with Recent Stroke or TIA
    In a post-hoc analysis of the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) study where atorvastatin calcium 80 mg vs. placebo was administered in 4,731 subjects without CHD who had a stroke or TIA within the preceding 6 months, a higher incidence of hemorrhagic stroke was seen in the atorvastatin calcium 80 mg group compared to placebo (55, 2.3% atorvastatin vs. 33, 1.4% placebo; HR: 1.68, 95% CI: 1.09, 2.59; p=0.0168). The incidence of fatal hemorrhagic stroke was similar across treatment groups (17 vs. 18 for the atorvastatin and placebo groups, respectively). The incidence of nonfatal hemorrhagic stroke was significantly higher in the atorvastatin group (38, 1.6%) as compared to the placebo group (16, 0.7%). Some baseline characteristics, including hemorrhagic and lacunar stroke on study entry, were associated with a higher incidence of hemorrhagic stroke in the atorvastatin group [see Adverse Reactions (6.1)].
    Last edited by TomHsiung; Sat 27th June '15 at 12:14am.
    B.S. Pharm, West China School of Pharmacy, Class of 2007, Health System Pharmacist, RPh. Hematology, Infectious Disease.

  2. #12
    PharmD Year 1 TomHsiung's Avatar
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    Exclamation Pharmacokinetics Considerations

    Basic pharmacokinetics parameters,

    Absorption:Atorvastatin calcium is rapidly absorbed after oral administration.

    The absolute bioavailability of atorvastatin (parent drug) is approximately 14%.

    Distribution:Mean volume of distribution of atorvastatin calcium is approximately 381 liters. Atorvastatin calcium is ≥98% bound to plasma proteins.

    Metabolism:Atorvastatin calcium is extensively metabolized to ortho- and parahydroxylated derivatives and various beta-oxidation products. In vitro inhibition of HMG-CoA reductase by ortho- and parahydroxylated metabolites is equivalent to that of atorvastatin calcium. Approximately 70% of circulating inhibitory activity for HMG-CoA reductase is attributed to active metabolites.

    In vitro studies suggest the importance of atorvastatin calcium metabolism by cytochrome P450 3A4.

    Excretion:Atorvastatin calcium and its metabolites are eliminated primarily in bile following hepatic and/or extra-hepatic metabolism; however, the drug does not appear to undergo enterohepatic recirculation.

    Mean plasma elimination half-life of atorvastatin calcium in humans is approximately 14 hours, but the half-life of inhibitory activity for HMG-CoA reductase is 20 to 30 hours due to the contribution of active metabolites. Less than 2% of a dose of atorvastatin calcium is recovered in urine following oral administration.

    According to the information above, we get the primary pharmacokinetic parameters as follows,

    Original data from references,
    F: 14%
    tin: approximately 2 hours
    V: 381 L
    fu: 2%
    t1/2: approximately 14 hrs (besides, there exists active metabolites and enterohepatic recirculation)

    Estimated data according to original data,
    k: 0.0495
    Cl: 18.86 L/hr

    As the tin <1/6 of t1/2, we use bolus model as the pharmacokinetic mode for this patient. So relevant equations are below,

    Css ave =(S)(F)(Dose/τ)/Cl
    Cl: Clearance represents the theoretical volume of blood or plasma which is completely cleard of drug in a given period.
    Css ave: The average steady-state drug concentration
    τ: Dosing interval


    Css max =[(S)(F)(Dose)/V]/(1-e-kτ)
    τ(tau): Dose interval, a period
    k: k is the fraction or percentage of the total amount of drug in the body removed per unit of time and is a function of clearance and volume of distribution (k=Cl/V).
    (1-e-kτ): (1-e-kτ) represents the fraction of drug that is eliminated in the dosing interval
    Cl: Clearance
    F: Bioavailability factor
    S: Fraction of the administered dose that is the active drug
    V: Volume of Distribution

    Css min =[(S)(F)(Dose)/V]/(1-e-kτ)*(e-kτ)
    τ(tau): Dose interval, a period
    k: k is the fraction or percentage of the total amount of drug in the body removed per unit of time and is a function of clearance and volume of distribution (k=Cl/V).
    (1-e-kτ): (1-e-kτ) represents the fraction of drug that is eliminated in the dosing interval
    Cl: Clearance
    F: Bioavailability factor
    S: Fraction of the administered dose that is the active drug
    V: Volume of Distribution

    Css 1 =[(S)(F)(Dose)/V]/(1-e-kτ)*(e-kt1)
    Css 1 is concentration obtained at time (t1) other than the peak or trough, within a dose interval
    τ(tau): Dose interval, a period
    k: k is the fraction or percentage of the total amount of drug in the body removed per unit of time and is a function of clearance and volume of distribution (k=Cl/V).
    (1-e-kτ): (1-e-kτ) represents the fraction of drug that is eliminated in the dosing interval
    Cl: Clearance
    F: Bioavailability factor
    S: Fraction of the administered dose that is the active drug
    Last edited by TomHsiung; Sat 27th June '15 at 12:48am.
    B.S. Pharm, West China School of Pharmacy, Class of 2007, Health System Pharmacist, RPh. Hematology, Infectious Disease.

  3. #13
    PharmD Year 1 TomHsiung's Avatar
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    Cool Predicated Plasma Concentrations of Atorvastatin with Different Dosage Regimens

    Regimen 1, 20 mg Q24h

    Css ave = 1*0.14*20/24/18.86 = 0.0062 ug/mL
    Css max = 1*0.14*20/381/[1-e(-0.0495*24)] = 0.0106 ug/mL
    Css min = 1*0.14*20/381/[1-e(-0.0495*24)]*e(-0.0495*24) = 0.0035 ug/mL

    Regimen 2, 40 mg Q24h

    Css ave = 1*0.14*40/24/18.86 = 0.0124 ug/mL
    Css max = 1*0.14*40/381/[1-e(-0.0495*24)] = 0.0211 ug/mL
    Css min = 1*0.14*40/381/[1-e(-0.0495*24)]*e(-0.0495*24) = 0.0070 ug/mL

    Regimen 3, 80 mg Q24h

    Css ave = 1*0.14*80/24/18.86 = 0.0247 ug/mL
    Css max = 1*0.14*80/381/[1-e(-0.0495*24)] = 0.0423 ug/mL
    Css min = 1*0.14*80/381/[1-e(-0.0495*24)]*e(-0.0495*24) = 0.0141 ug/mL
    Last edited by TomHsiung; Sat 27th June '15 at 1:05am.
    B.S. Pharm, West China School of Pharmacy, Class of 2007, Health System Pharmacist, RPh. Hematology, Infectious Disease.

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    Early Jun 2015

    A1c: 6.6%

    Hepatic function

    Total bilirubin: 12.3 umol/L (0.72 mg/dL)
    Direct bilirubin: 4.2 umol/L (0.25 mg/dL)
    In-direct bilirubin: 8.1 umol/L (0.47 mg/dL)

    ALT: 62 U/L
    AST: NA IU/L

    Albumin: NA g/L
    Globulin: NA g/L

    Lipid Profile

    Triglyceride: 5.33 mmol/L (471.7 mg/dL)
    Total cholesterol: 4.15 mmol/L (160.2 mg/dL)
    High density lipoprotein: 0.67 mmol/L (25.9 mg/dL)
    Low density lipoprotein: 1.48 mmol/L (57.1 mg/dL)
    B.S. Pharm, West China School of Pharmacy, Class of 2007, Health System Pharmacist, RPh. Hematology, Infectious Disease. Chengdu, Sichuan, China.

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    Patient history changed.

    On early Jun 2015, regular annually checkup. Primary medical condition was microscopic hematuria.

    Urinary analysis

    Color: yellow
    Transparency: Transparent
    pH: 7.0
    Nitrite: (-)
    Glucose: (-)
    Specific gravity: 1.010
    Blood: (+++)
    Protein: (+)
    Bilirubin: (-)
    Urobilinogen: (-)
    Ketones: (-)
    White cell: (+), 5-10/HP
    Red cell: 10-20/HP
    Urinary crystal: no seen
    Hyaline cast: no seen
    Granular cast: no seen

    Renal function

    Serum nitrogen: 3.4 mmol/L (9.5 mg/dL)
    Serum creatinine: 85 umol/L (0.96 mg/dL)
    Serum uric acid: 249 umol/L (4.2 mg/dL)
    Last edited by admin; Tue 14th July '15 at 7:27pm.
    B.S. Pharm, West China School of Pharmacy, Class of 2007, Health System Pharmacist, RPh. Hematology, Infectious Disease. Chengdu, Sichuan, China.

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    Patient history changed.

    On 17 Jun 2015, the patient sought for medical examination because the urinary protein (+) of the regular annually checkup. Primary medical condition was microscopic hematuria. The physician prescribed amoxicillin 500 mg Q12h.

    Urinary analysis

    Color: faint yellow
    Transparency: Transparent
    pH: 7.0
    Nitrite: (-)
    Glucose: (-)
    Specific gravity: 1.010
    Blood: (++)
    Protein: (-)
    Bilirubin: (-)
    Urobilinogen: (-)
    Ketones: (-)
    White cell: (+-), 72.70/HP
    Red cell: 727.5/HP
    Epithelial cell: 7.8/HP
    Bacteria: 28.20 /HP
    Urinary crystal: 0.3
    Cast: 0.77
    Pathologic cast: 0.12
    Last edited by admin; Tue 14th July '15 at 7:42pm.
    B.S. Pharm, West China School of Pharmacy, Class of 2007, Health System Pharmacist, RPh. Hematology, Infectious Disease. Chengdu, Sichuan, China.

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    Patient history changed.

    On Jun 20th 2015 the patient discovered that the color of his blood looked like tea (after 4 days therapy of amoxicillin 500 mg Q12h). Therefore the suspected microscopic hematuria became macroscopic hematuria on that day. After two days of continued therapy of amoxicillin regimen, the patient went to the hospital seeking for medical help again, on Jun 23rd 2015. The physician prescribed a urinary dialysis.

    According to the following result of urinary analysis, the patient was hospitalized on Jun 23rd 2015.

    Urinary analysis

    Color: faint red
    Transparency: muddy
    pH: 6.5
    Nitrite: (-)
    Glucose: (-)
    Specific gravity: 1.020
    Blood: (+++)
    Protein: (+)
    Bilirubin: (-)
    Urobilinogen: (-)
    Ketones: (-)
    White cell: (+), 87.80/HP
    Red cell: 3332.2/HP
    Epithelial cell: 24.1/HP
    Bacteria: 27.20 /HP
    Urinary crystal: 0.0
    Cast: 0.88
    Pathologic cast: 0.44
    B.S. Pharm, West China School of Pharmacy, Class of 2007, Health System Pharmacist, RPh. Hematology, Infectious Disease. Chengdu, Sichuan, China.

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  8. #18
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    After hospitalized, the surgeons thought the macroscopic hematuria was caused by kidney calculus. Both kidney has big calculus, primarily located on renal pelves of both sides. And on Jun 29th 2015 the patient received a surgery (PCNL/Percutaneous Nephrolithotomy) on the right side kidney. Stones were removed from the right side renal pelvis and calyxes.

    A stone analysis was performed later. The result surprised me that the stones were not made up of uric acid and uric acid relative substances.

    During the hospitalization, we found that the patient's BP was abnormal. The patient was diagnosed with hypertension.

    Surgery on the right side kidney on Jun 29th 2015, finished.

    Hospitalization during Jun 23rd 2015 to Jul 7th 2015.




    All diagnoses

    1.Urinary calculus
    2.Urinary tract infection (clinical diagnosis, not laboratory diagnosis)
    3.Gout
    4.Hypertension
    5.Type 2 diabetes
    6.Hyperlipidemia


    BP records

    The highest systolic BP was: 174 mm Hg and the highest diastolic BP was 98 mm Hg. The average BP was: 149/83 mm Hg (n=25).

    Renal Stone Analysis

    Result: Calcium oxalate monohydrate and carbonate apatite.

    Liver function (Jun 24th 2015)

    ALT: 54 U/L
    AST: 51 U/L
    Albumin: 48.5 g/L
    Globin: 28.3 g/L

    Total bilirubin: 8.4 umol/L (0.49 mg/dL)
    Direct bilirubin: 3.8 umol/L (0.21 mg/dL)
    In-direct bilirubin: 4.6 umol/L (0.27 mg/dL)

    gamma-Glutamy transpeptidase: 68 U/L
    Alkaline phosphatase: 81 U/L
    Lactate dehydrogenase: 216 U/L
    5-Nucleotidase: 6.60 U/L

    Renal function (Jun 24th 2015)

    Serum urea: 4.3 mmol/L
    Creatinine: 84 umol/L (0.95 mg/dL)
    Uric acid: 259 umol/L (4.4 mg/dL)

    Lipid profile

    Triglyceride: 7.83 mmol/L (692.9 mg/dL)
    Total cholesterol: 4.69 mmol/L (181.1 mg/dL)
    High density lipoprotein: 0.80 mmol/L (30.9 mg/dL)
    Low density lipoprotein: 1.37 mmol/L (52.9 mg/dL)

    ApoA1: 0.88 g/L
    apoB: 0.54 g/L
    LPa: 52 mg/L

    Others


    Serum Glucose: 7.36 mmol/L (132.6 mg/dL), fasting

    Serum potassium: 3.90 mmol/L
    Serum sodium: 138.0 mmol/L
    Serum chlorine: 103.0 mmol/L
    Serum Calcium: 2.27 mmol/L
    Serum magnesium: 0.93 mmol/L
    Serum phosphorus: 0.80 mmol/L
    Serum bicarbonate: 22.7 mmol/L

    Medication history

    Note: Some of the medications are not available in United States so they are not listed out here.

    Part 1 Long-time medications

    1.Allopurinol 200 mg b.i.d, long time

    Part 2 Medications during these new medical conditions (not during the surgery)

    1.Amoxicillin 500 mg, q12h, Jun 16-23, 7 days
    2.Cefoxitn
    3.Pantoprazole

    Part 3 Medications during these new medical conditions (during the surgery)

    1.Phenylephrine
    2.Midazolam
    3.Flumazenil
    4.Cefoxitin
    5.Rocuronium
    6.Propofol
    7.Sevoflurane
    8.Dyclonine mucilage
    9.Neostigmine
    10.Pantoprazole
    11.Metoclopramide
    12.Iohexol
    Last edited by admin; Tue 14th July '15 at 9:10pm.
    B.S. Pharm, West China School of Pharmacy, Class of 2007, Health System Pharmacist, RPh. Hematology, Infectious Disease. Chengdu, Sichuan, China.

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  9. #19
    PharmD Year 1 TomHsiung's Avatar
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    Today we begin the drug therapy indicating for dyslipidemia. We start the Atorvastatin Calcium tablet at dosage of 20 mg Qd. We will increase the dose of the drug from 20 mg gradually to 80 mg per day, in order to use the drug safely.

    Rx:

    Atorvastatin 20 mg Qd
    B.S. Pharm, West China School of Pharmacy, Class of 2007, Health System Pharmacist, RPh. Hematology, Infectious Disease.

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    The patient went to hospital owing to seek help for his hypertension on Sep 22nd 2015. Physical examination and some laboratory testes had been interpreted that day. Below are their results:

    All diagnoses

    1.Urinary calculus
    2.Urinary tract infection (clinical diagnosis, not laboratory diagnosis)
    3.Gout
    4.Hypertension
    5.Type 2 diabetes
    6.Hyperlipidemia


    BP records

    The highest systolic BP was: waiting for updating mm Hg and the highest diastolic BP was waiting for updating mm Hg. The average BP was: waiting for updating mm Hg (n=25).


    Liver function (Sep 22nd 2015)

    ALT: 77 U/L
    AST: 60 U/L
    Albumin: 51.9 g/L
    Globin: 31.7 g/L

    Total bilirubin: 13.5 umol/L (0.79 mg/dL)
    Direct bilirubin: 4.9 umol/L (0.29 mg/dL)
    In-direct bilirubin: 8.6 umol/L (0.50 mg/dL)


    Renal function (Sep 22nd 2015)

    Serum urea: 3.9 mmol/L (10.92 mg/dL)
    Creatinine: 101 umol/L (1.14 mg/dL)
    Uric acid: 261 umol/L (4.39 mg/dL)

    Lipid profile

    Triglyceride: 2.81 mmol/L (248.67 mg/dL)
    Total cholesterol: 2.76 mmol/L (106.56 mg/dL)
    High density lipoprotein: 0.93 mmol/L (35.91 mg/dL)
    Low density lipoprotein: 1.20 mmol/L (46.33 mg/dL)

    Others

    Serum Glucose: 8.08 mmol/L (145.59 mg/dL), fasted.
    Last edited by admin; Sat 26th September '15 at 10:54pm.
    B.S. Pharm, West China School of Pharmacy, Class of 2007, Health System Pharmacist, RPh. Hematology, Infectious Disease. Chengdu, Sichuan, China.

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