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MBBS, MD (Pathology),
Sanjay Gandhi institute of trauma and orthopedics,
Bengaluru.
On Aug 2018




Dr. Mamta Gupta,
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Dr. Mamta Gupta
Consultant
(Ex HOD Obs &Gynae, Hindu Rao Hospital and associated NDMC Medical College, Delhi)
Aug 2018




Dr. Rajendra Kumar Ghritlaharey

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Thanking you
With sincere regards
Dr. Rajendra Kumar Ghritlaharey, M.S., M. Ch., FAIS
Associate Professor,
Department of Paediatric Surgery, Gandhi Medical College & Associated
Kamla Nehru & Hamidia Hospitals Bhopal, Madhya Pradesh 462 001 (India)
E-mail: drrajendrak1@rediffmail.com
On May 11,2011




Dr. Shankar P.R.

"On looking back through my Gmail archives after being requested by the journal to write a short editorial about my experiences of publishing with the Journal of Clinical and Diagnostic Research (JCDR), I came across an e-mail from Dr. Hemant Jain, Editor, in March 2007, which introduced the new electronic journal. The main features of the journal which were outlined in the e-mail were extensive author support, cash rewards, the peer review process, and other salient features of the journal.
Over a span of over four years, we (I and my colleagues) have published around 25 articles in the journal. In this editorial, I plan to briefly discuss my experiences of publishing with JCDR and the strengths of the journal and to finally address the areas for improvement.
My experiences of publishing with JCDR: Overall, my experiences of publishing withJCDR have been positive. The best point about the journal is that it responds to queries from the author. This may seem to be simple and not too much to ask for, but unfortunately, many journals in the subcontinent and from many developing countries do not respond or they respond with a long delay to the queries from the authors 1. The reasons could be many, including lack of optimal secretarial and other support. Another problem with many journals is the slowness of the review process. Editorial processing and peer review can take anywhere between a year to two years with some journals. Also, some journals do not keep the contributors informed about the progress of the review process. Due to the long review process, the articles can lose their relevance and topicality. A major benefit with JCDR is the timeliness and promptness of its response. In Dr Jain's e-mail which was sent to me in 2007, before the introduction of the Pre-publishing system, he had stated that he had received my submission and that he would get back to me within seven days and he did!
Most of the manuscripts are published within 3 to 4 months of their submission if they are found to be suitable after the review process. JCDR is published bimonthly and the accepted articles were usually published in the next issue. Recently, due to the increased volume of the submissions, the review process has become slower and it ?? Section can take from 4 to 6 months for the articles to be reviewed. The journal has an extensive author support system and it has recently introduced a paid expedited review process. The journal also mentions the average time for processing the manuscript under different submission systems - regular submission and expedited review.
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Dr. P. Ravi Shankar
KIST Medical College, P.O. Box 14142, Kathmandu, Nepal.
E-mail: ravi.dr.shankar@gmail.com
On April 2011
Anuradha

Dear team JCDR, I would like to thank you for the very professional and polite service provided by everyone at JCDR. While i have been in the field of writing and editing for sometime, this has been my first attempt in publishing a scientific paper.Thank you for hand-holding me through the process.


Dr. Anuradha
E-mail: anuradha2nittur@gmail.com
On Jan 2020

Important Notice

Case report
Year : 2007 | Month : June | Volume : 1 | Issue : 3 | Page : 151 - 154 Full Version

Rhabdomyolysis And Hepatitis Associated With Pravastatin Therapy


Published: June 1, 2007 | DOI: https://doi.org/10.7860/JCDR/2007/.73
KHAN F Y, MATTAR I, ALSAMAWI M, LUTF A Q

Hamad medical corporation,Hamad general hospital/ Doha-Qatar

Correspondence Address :
Dr. Khan F Y.,Senior specialist, Department of Medicine.Hamad medical corporation, Hamad general hospital/ Doha-Qatar
Tel: 00974- 5275989, Fax: 0974- 4392273
E-mail : : fakhanqal@yahoo.co.uk

Keywords

Hepatitis; myopathy; pravastatin; rhabdomyolysis

Pravastatin is a 3-hydroxy-3-methyl coenzyme A (HMG-CoA) reductase inhibitor that has significant effects on the plasma lipid and lipoprotein profile, lowering total and LDL cholesterol and triglyceride levels and raising HDL cholesterol levels. (1),(2),(3) The long-term safety profile of pravastatin, established over many years of clinical use, is excellent. Although rhabdomyolysis and hepatitis are recognized toxic effects of this medication, the occurrence of both rhabdomyolysis and hepatitis at the same time is extremely rare. A PubMed search of the literature revealed no cases of pravastatin induced rhabdomyolysis and hepatitis have been reported in the same patient. We report here an extremely rare case of a 65-year-old woman with rhabdomyolysis and hepatitis associated with pravastatin therapy.

Case Report

A 65-year-old woman admitted to the hospital with one-week history of generalized weakness and fatigability. Past medical history was remarkable for diabetes mellitus (DM) type II, hypercholesterolemia and depressive disorder. The patient had never received a blood transfusion and she denied the use of alcohol or intravenous drugs. She had a depressive disorder since 6 years and had been followed up regularly at a psychiatric clinic. DM and hypercholesterolemia were diagnosed three years ago. Her medications included gliclazide 80mg twice daily orally (PO), pravastatin 40 mg once daily PO, prozac 20 mg once daily PO, Hydroxyzine hydrochloride 25 mg once daily PO and Lorazepam 1 mg PO at night.
On examination the pulse was 110/min and the blood pressure 115/75 mmHg. Fundus examination showed background retinopathy. The remaining of the examination was unremarkable.
Initial investigations showed hemoglobin level of 12 g/dL, total leucocyte count 9500/uL and platelets, 467000/uL; urea nitrogen 10 mmol/L, creatinine 160µmol/L, sodium 135 mEq/L and potassium 5.6 mEq/L, bicarbonate 20 mmol/L, Ca 2.2 mmol/L, blood sugar 20.6 mmol/L. asparate aminotransferase level of 343 IU/L, alanine amino-transferase 967 IU/L, alkaline phosphatase 540 IU/L, total bilirubin 58 µmol/L, total proteins 7.4 g/dL, albumin 3.8 g/dL, PT and INR were normal. Arterial blood gas analysis on room air showed pH 7.30, PaO2 of 99 mm Hg, PaCO2 of 22 mm Hg, and HCO3- of 18 mEq/L. Her fasting lipid profile showed; total cholesterol, 4.1 mmol/L; LDL cholesterol, 2 mmol/L; triglyceride, 3.2 mmol/L. Her myoglobin was elevated, 1319 ng/ml and the creatine kinase (CK) level was markedly elevated (3957 U/L), with normal CK MB fraction and cardiac troponin levels. The urine myoglobin test result was positive. But there was no hematuria, pyuria, or ketonuria. Thyroid function test was normal. Hepatitis A Ig M anibodies, hepatitis C antibody and hepatitis B markers were negative. Ultrasound of the abdomen showed a normal liver and with normal gallbladder and nondilated intrahepatic and extrahepatic biliary ducts.
One month before admission the patient visited her doctor at the medical clinic. Routine laboratory data showed: hemoglobin level of 11.2 g/dL, total leucocyte count 7300/mm3, platelets, 180,000/mm3. Urea nitrogen 9.2 mmol/L, creatinine 102µmol/L, sodium 139 mEq/L and potassium 4.3 mEq/L, bicarbonate 20 mmol/L, Ca 2.4 mmol/L, random blood sugar 12.2 mmol/L.aspartate aminotransferase level of 20 IU/L, Alanine amino-transferase 12 IU/L, alkaline phosphatase 66 IU/L, total bilirubin 14 µmol/L, total proteins 7.4 g/dL, albumin 3.8 g/dL, PT and INR were normal. Her fasting lipid profile was; total cholesterol, 4.7 mmol/L; LDL cholesterol, 2.4 mmol/L; triglyceride, 3.8 mmol/L. Her creatine kinase (CK) level was 34 U/L. In view of the above findings, a diagnosis of pravastatin induced rhabdomyolysis and hepatitis was made; pravastatin was stopped on the first hospital day and rhabdomyolysis was managed with vigorous hydration and urine alkalinization, as well as cautious monitoring of serum potassium and other electrolytes levels. The patient was kept on his antidepressive medication and the blood sugar was controlled by Insulin and gliclazide. On the following days the level of creatine kinase, liver enzymes and s.creatinine returned toward normal. In order to control her hypercholesterolemia the patient was kept on atorvastatin 10 mg once daily PO. The patient was discharged after 20 days of hospitalization with stable condition. At the time of discharge, the serum AST level of 120 IU/L, ALT 177 IU/L, alkaline phosphatase 110 IU/L, total bilirubin 43 µmol/L, CK 334 U/L.
On follow-up evaluation approximately 2 months after the patient’s discharge from the hospital, the patient was symptom free. Laboratory evaluation yielded serum AST level of 40 IU/L, ALT 35 IU/L, alkaline phosphatase 105 IU/L, total bilirubin 28 µmol/L, total proteins 6.8 g/dL, albumin 3.6 g/dL

Discussion

The 3-hydroxy-3-methyl coenzyme A (HMG-CoA) reductase inhibitors or statins, specifically inhibit the enzyme HMG-CoA reductase in the liver, thereby inhibiting the rate limiting step in cholesterol biosynthesis and so reducing plasma cholesterol levels. Myopathy, myositis, rhabdomyolysis and hepatitis are the well known side effects of HMG-CoA reductase inhibitors. Most available HMG-CoA reductase inhibitors, the “statins,” have been implicated in causing rhabdomyolysis, either as monotherapy or in combination with such agents as cyclosporine, erythromycins, niacin, and antifungal drugs.(4),(5),(6),(7).
A recent study in Ireland estimated that approximately 30% of all users of statins have concomitant drugs prescribed that can inhibit statin metabolism, potentially leading to rhabdomyolysis.(8) . Hydrophilic statins such as pravastatin are considered to have the best safety profile in this class of drugs and are frequently recommended as a firstline choice for the prevention of coronary transplant vasculopathy. (9),(10),(11),
(12) .They have little potential to induce myopathy or interact adversely with other drugs because, unlike lipophilic statins, hydrophilic statins are not metabolized through the hepatic cytochrome P450 (CYP) 3A4 pathway. (13),(14) In addition to it’s effect on lipid, pravastatin has been shown to have a range of other antiatherothrombotic effects, including the restoration of endothelial function (15) and anti-inflammatory effects.(16) Pravastatin therapy has been shown unequivocally to reduce cardiovascular risk in a series of large-scale, randomized, controlled clinical trials.(1),(2),(3)
The potential mechanisms underlying statin-induced myotoxicity are complex with no clear consensus of opinion. One theory suggests that blocking the synthesis of cholesterol reduces the cholesterol content in skeletal muscle-cell membranes by making them unstable. (17) Another theory attributes muscle injury to reduced levels of regulatory proteins or isoprenoids, such as ubiquinone. (18) A higher lactate:pyruvate ratio has been observed in patients receiving statins, suggesting that anaerobic metabolism and, possibly, mitochondrial dysfunction may have a role in muscle injury. (19),(20) One study reported that mitochondrial dysfunction was observed in biopsy specimens from individuals presenting with muscle complaints, but no elevations in serum CK concentration. (21)
The mechanism of hepatitis in this case is unclear since the risk for interactions is very low. It may be due to direct liver toxicity by a mechanism, as yet, unknown.
The muscle and liver injury affecting our patient can be attributed to pravastatin because:
(1) there was no history of liver or biliary tract disease and the patient had documented normal liver enzymes one month before admission; (2) there was no alcohol abuse and no serological or circumstantial evidence for viral hepatitis; (3) obstruction of the common bile duct and sclerosing cholangitis were eliminated by abdomen ultrasound.
The temporary evolution also implicates pravastatin as the offending drug, as its withdrawal was followed by permanent improvement of laboratory findings
The differential diagnosis of rhabdomyolysis and hepatitis in this patient includes; neuroleptic malignant syndrome (NMS) and pravastatin induced rhabdomyolysis and h

Conclusion

In conclusion, although the risk of drug-drug interaction is very low with pravastatin, clinicians should be aware of the potential for serious muscle and liver injury, which associated with pravastatin. Accordingly, Emergent myalgias, with or without jaundice in patients under pravastatin necessitate immediate testing of creatine kinase, myoglobin and liver enzymes to exclude life-threatening rhabdomyolysis and drug induced hepatitis

Conflict of Interest: None declared

References

1.
Shepherd J, Cobbe SM, Ford I, et al. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. N Engl J Med. 1995;333:1301–1307.
2.
Sacks FM, Pfeffer MA, Moye LA, et al. The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. N Engl J Med. 1996;335:1001–1009.
3.
LIPID Study Group. Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of cholesterol levels. N Engl J Med. 1998;339:1349–1357.
4.
Marais GE, Larson KK. Rhabdomyolysis and acute renal failure induced by combination lovastatin and gemfibrozil therapy. Ann Intern Med 1990;112:228-30.
5.
Pierce LR, Wysowski DK, Gross TP. Myopathy and rhabdomyolysis associated with lovastatin-gemfibrozil combination therapy. JAMA 1990;264:71-5.
6.
Shepherd J. Fibrates and statins in the treatment of hyperlipidemia: an appraisal of their efficacy and safety. Eur Heart J 1995;16:5-13.
7.
Duell PB, Connor WE, Illingworth DR. Rhabdomyolysis after taking atorvastatin with gemfibrozil. Am J Cardiol 1998; 81:368-9.
8.
Heerey A, Barry M, Ryan M, et al. the potential for drug interactions with statin therapy in Ireland. Ir J Med Sci 2000; 169: 351-352.
9.
Jones T. The effect of HMG-CoA reductase inhibitors on chronic allograft rejection. Expert Opin Emerg Drugs. 2001 ; 6:95-109.
10.
Bruckert E, Hayem G, Dejager S, Yau C. Risk of muscular symptoms with high dosage statin therapy in 7924 hyperlipidemic patients in French clinical practice. J Am Coil Cardiol. 2005;45(Suppl):412A. Abstract.
11.
Mehra MR, Raval NY. Metaanalysis ofstatins and survival in de novo cardiac transplantation. Transplant Proc. 2004; 36:1539-1541.
12.
Stojanovic I, Vrtovec B, Radovancevic B, et al. Survival, graft atherosclerosis, and rejection incidence in heart transplant recipients treated with statins: S-Year followup. J Heart Lung Transplant. 2005;24:1235-1238.
13.

JCDR is now Monthly and more widely Indexed .