Liv.52 DS Tablets
Evaluation of Liv.52 DS tablet as a hepatoprotective agent in prophylaxis with statin therapy
Dr. JKL Das Associate Professor, Department of Medicine, Patna Medical College, Patna, India. Dr. S.R. Prasad*, Medical Advisor, Dr. S.K. Mitra, Executive Director, R&D Center, The Himalaya Drug Company, Bangalore-562 123, India. *Corresponding author: Dr. S.R. Prasad, M.D, Medical Advisor, R&D Center, The Himalaya Drug Company, Bangalore, India. Phone : 91 080-2371 4444 Fax : 91 080-2371 4471 E-mail : dr.prasad@himalayahealthcare.com
All patients aged between 18 to 70 years, and on antihyperlipidemic therapy with statins were included in the study.
Exclusion criteria
Patients having evidence of extensive disease that requires hospitalization, and pregnant women were excluded from the study.
Study procedure
The study was an open, randomized, comparative and prospective clinical trial conducted at the Department of Medicine, Patna Medical College, Patna, India from January 2007 to February 2007 as per the ethical guidelines of Declaration of Helsinki. The study protocol, case report forms (CRFs), regulatory clearance documents, product-related information and informed consent forms (in English and Hindi) were submitted to the institutional ethics committee and were approved by the same.
The patients who attended the OPD general medical unit of Department of Medicine, Patna Medical College, Patna, India were informed about the study drug, its effects, duration of the trial, and overall plan of the study. The patients were included in the clinical study only after written informed consent was obtained from each of them.
The history was noted by interviewing the patient. Thorough clinical examination and symptomatic evaluation was carried out and the details were noted down in the CRF. The patients were randomly divided into two groups of 25 members each; Liv.52 DS tablet + Atorvastatin group and Atorvastatin alone group. Patients were advised to take Liv.52 DS tablet at a dose of 1 tablet twice a day and Atorvastatin 10 mg, 1 tablet twice a day for a period of three months.
DISCUSSION
Cardiovascular disease is the single largest killer of both men and women in the world. The World Health Organization estimates that more than 16 million adults/year die of cardiovascular disease. Furthermore, an estimated 32 million adults/year have a new or recurrent myocardial infarction.10
The major risk factors for CHD, in addition to old age, are hypertension, diabetes mellitus, tobacco use, elevated total and low-density lipoprotein cholesterol (LDL-C), and reduced high-density lipoprotein cholesterol (HDL-C).
Epidemiologic trials have established a direct relationship between LDL and cardiovascular events, and many clinical trials have confirmed that lipid-lowering therapy reduces the risk of cardiovascular events.11
To address the dyslipidemia aspect of CHD, lipid-lowering agents are typically used. The most potent lipid-lowering agents are HMG-CoA reductase inhibitors (statins). These medications are highly effective as monotherapy for dyslipidemia and may be combined with other agents, such as niacin or fibric acid derivatives (fibrates), when further reductions in triglycerides and/or elevations in HDL-C are required. HMG-CoA reductase inhibitors have become one of the most commonly prescribed classes of medications. The most common adverse events associated with statin therapy are gastrointestinal disturbances, fatigue, localized pain, and headache. Serious adverse events that have been reported in major statin trials include myopathy, elevated transaminase levels and rhabdomyolysis.
The term "transaminitis" represents liver enzyme leakage without hepatotoxic consequences in patients receiving drug therapy of any kind.8 Asymptomatic increases in transaminases to greater than 3 times normal occur in about 1 to 3% of patients and appear to be dosedependent.8,12 These elevations are felt to be most common during the first 3 months of therapy but can happen at any time.3,14 Hepatic failure rarely occurs with statin therapy and is an idiopathic event.15
Due to concerns about liver toxicity, the Food and Drug Administration and drug manufacturers have recommended that LFTs be monitored before and 12 weeks after the start of therapy (or an statins is warranted if an increase in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level is greater than 3 times the upper limit of normal (ULN).16
Statin therapy requires ALT monitoring because animal studies and premarketing clinical trials showed signs of hepatotoxicity that were primarily minor elevations of ALT.
The present clinical study observed that in the Atorvastatin alone group, there was a significant increase in the mean values of SGPT , SGOT and total bilirubin after 3 months, whereas no such increase in SGPT, SGOT and total bilirubin was observed in the group receiving Liv.52 DS tablet + Atorvastatin, after 3 months of therapy. There were no significant differences between the groups in terms of physical examination like skin, general state, temperature, liver size, weight and subjective signs like coating of the tongue, loss of appetite, nausea, vomiting, and pain and discomfort in the right hypochondrium.
Hepatoprotective effect of Liv.52 DS tablet could be due to the synergistic actions of its individual ingredients.
The diuretic effect of Terminalia arjuna and anti-inflammatory and anti-immunotoxicity effect of Cichorium intybus have been shown in clinical and experimental studies.17-19
The anti-oxidative and anti-hepatotoxic property of esculetin and p-methoxybenzoic acid, the main constituents of Cichorium intybus and Capparis spinosa, respectively, have been reported in chemically-induced hepatotoxicity in experimental animals.20-22 Achillea millefolium, another component of Liv.52 DS tablet, contains several bioactive constituents including flavonoids and terpenoids with anti-oxidative and anti-inflammatory properties.23-25 The curative and hepatoprotective effect of Mandur bhasma and Cassia occidentalis, the other two components of Liv.52 DS tablet, were observed against chemically-induced liver damage in experimental animals.26,27 Furthermore, the anti-oxidative property of flavonoid content of Tamarix gallica and inhibitory effect of Solanum nigrum crude extracts on free radical-mediated DNA damage increase the hepatoprotective effect of Liv.52 DS tablet.28,29 In addition, the anti-oxidative and antilipoproxidative effects, and increase in glutathione content of liver cells was observed with arjunolic acid and flavonoids present in Terminalia
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