International Journal of Basic & Clinical Pharmacology
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Chief Editor: Dr. Bhaven Kataria
Print ISSN: 2319-2003 (Print)
Frequency: 6 issues a year
Language: English
Open Access Peer-reviewed journal
Web site: https://www.ijbcp.com/index.php
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Item Lorcaserin: a selective serotonin receptor (5-HT2C) agonist for the treatment of obesity.(2012-07) Kataria, Bhaven CLorcaserin is a selective serotonin receptor (5-HT2C) agonist that recently received the U.S. Food and Drug Administration (FDA) approval for chronic weight management. The efficacy of this drug in reducing body weight and improving metabolic parameters of obese patients has been demonstrated in three phase-3 clinical trials. The available evidence indicates that this drug does not show heart valve abnormalities, and the treatment improves the risk factors for type 2 diabetes and cardiovascular diseases. However, the drug’s manufacturer will be required to conduct postmarketing studies, including a long-term cardiovascular outcomes trial to assess the effect of Lorcaserin on the risk for major adverse cardiac events such as heart attack and stroke.Item Approval of antineoplastic agents in India: comparison with the US and EU regions.(2012-07) Kataria, Bhaven C; Mehta, Dimple S; Chhaiya, Sunita BBackground: The antineoplastic drugs are prescribed for the treatment of cancer, which is an important cause of mortality in India; therefore, a drug lag in the availability of antineoplastic drugs is a direct threat to life. The present study was undertaken to assess the drug lag for new antineoplastic agents in India compared with that in the United States (US) or European Union (EU). Methods: The new antineoplastic agents approved in the United States, European Union and India between 1999 and 2011 were identified and information was gathered primarily from the websites of regulatory agencies of the three regions. We assessed absolute and relative drug lag for new antineoplastic agents approved in the three regions. Results: Of the 70 new antineoplastic agents, 64 (91.42%) were approved in the United States, 54 (77.14%) in the European Union and 44 (62.85%) in India. The US was the first to approve 59 (84.28%) out of the 70 new antineoplastic agents, the EU was the first to approve 9 (12.85%) and India was the first to approve 2 (2.85%). The median approval lag for India (26.35 months) was higher as compared to the United States (0 month) and European Union (7.3 months). Conclusions: This study confirms that India’s drug lag in the case of new antineoplastic agents is higher as compared to the US and EU. Further detailed analyses are necessary to find the reasons and impacts of drug lag for antineoplastic agents in India.Item Digoxin toxicity: crucial to diagnose.(2012-07) Acharya, Tejas A; Mehta, Dimple S; Vekariya, Ritesh SDigoxin is mainly used for heart failure and arrhythmias like atrial flutter and fibrillation. Digoxin is like double edged sword because of its potency to cause life threatening complications like various arrhythmias. Furthermore, it is difficult and important to recognize cardio toxicity caused by digoxin to prevent threat to life. We report a case which was initially diagnosed as arrhythmia and later turned as digoxin toxicity.Item Small size sampling.(2012-07) Pathak, Rakesh RBased on the law of large numbers which is derived from probability theory, we tend to increase the sample size to the maximum. Central limit theorem is another inference from the same probability theory which approves largest possible number as sample size for better validity of measuring central tendencies like mean and median. Sometimes increase in sample-size turns only into negligible betterment or there is no increase at all in statistical relevance due to strong dependence or systematic error. If we can afford a little larger sample, statistically power of 0.90 being taken as acceptable with medium Cohen’s d (<0.5) and for that we can take a sample size of 175 very safely and considering problem of attrition 200 samples would suffice.Item A study to evaluate the clinical outcome of drug-eluting vs. bare-metal stents for acute coronary syndrome patients during commercial use in real setting.(2012-07) Patel, Chetan R; Patel, Mandev BBackground: This study compared clinical outcome of Drug Eluting Stents (DES) versus Bare Metal Stents (BMS) in coronary arteries in patients with Acute Coronary Syndromes. Methods: A retrospective, observational study was carried out in an inpatient setting of the private tertiary care hospital. Patients with >18 years, diagnosed for Acute Coronary Syndromes (ACS), required intervention in coronary artery with implantation of Drug Eluting Stents (DES) or Bare Metal Stents (BMS) were recruited in the study. The data had been collected from file or database of the hospital. All subjects were followed for major adverse cardiac event. Results: A total of 202 patients who underwent percutaneous coronary intervention (PCI) were enrolled into DES group (n=101) and BMS group (n=101). All patients were followed up at 1 month, 3 months, 6 months & 12 months for Major Adverse Cardiac Events (MACE). Clinical outcomes during 12 months were compared between DES group & BMS group. Overall MACE rates were reported non-significantly high in BMS group patients (14.85%) compare to DES group patients (8.91%) (p=0.458). However, DES group had lower rates of death (0.99% vs 1.98%, p=0.57), rate of MI (3.96% vs 4.95% p=0.73), rate of revascularization (1.98% vs 3.96% p=0.42) & rate of sub acute thrombosis (1.98% vs 3.96% p=0.42) and higher rate of bleeding (1.98% vs 0.99% p=0.57) compare to cohort-II. Conclusions: The use of DES in the setting of Acute Coronary Syndrome is associated with lower Major Adverse Cardiac Event (MACE) rate compared to BMS without compromising the overall safety over the course of one-year follow-up. The long-term safety of drug-eluting stents needs to be ascertained in large, randomized trials.Item Grade 4 oral mucositis and prolonged pancytopenia with high dose intravenous methotrexate in a patient of philadelphia positive acute lymphoblastic leukemia.(2012-07) Shah, Vidisha M; Mehta, Dimple SAntimetabolite drugs are rarely associated with grade 3 or 4 mucositis. However specific side effects such as bone marrow suppression, pancytopenia, hospitalization, high cost limit the use of intravenous methotrexate. Here we report a case of 25-year-old girl patient with Acute Lymphoblastic Leukemia (ALL) treated with 24 hour methotrexate in her continuous phase of chemotherapy. After 12 hours of completing the treatment she developed oral mucosal pain & she was not able to speak. After a week, her White Blood Cell (WBC) count was 600/cumm with fever and she could not speak and eat or drink. So she was hospitalized for few days till she can drink something. We report high grade mucositis with methotrexate. Hematologists should be aware of this possible side effect to undertake early intervention.Item To study the antihyperglycaemic and lipid lowering effect of garlic as an adjunct to metformin in patients of type 2 diabetes mellitus with obesity.(2012-07) Chhatwal, Simran; Sharma, Rahat Kumar; Sharma, Geeta; Khurana, AshokBackground: Diabetes mellitus is a metabolic disorder of multiple aetiology characterized by chronic hyperglycaemia associated with disturbances of carbohydrate, fat and protein metabolism. The treatment constitutes lifestyle management, exercise, weight control and antihyperglycaemic drugs like sulfonylureas, biguanides, alpha-glucosidase inhibitors, thiazolidinediones, and meglitinide. Garlic has shown to have anti-hyperglycaemic and lipid lowering effects in various animal and human studies. Thus, this study was conducted to assess the antihyperglycaemic and lipid-lowering properties of Garlic in type2 diabetes patients with obesity. Methods: This was an open labelled prospective comparative study conducted on Type 2 diabetes mellitus patients with obesity where a total of 60 patients divided into two groups of 30 each (of either sex) were enrolled. Group 1 was given Tab. metformin 500mg BD/TDS after meals. Group 2 was given Tab. metformin in a dose of 500mg BD/TDS after meals along with Cap. Garlic (Allium sativum) 250mg BD. Patients were routinely investigated for fasting blood sugar, HbA1c and lipid profile i.e. Serum Cholesterol, HDL-C, Triglycerides and LDL-C at the start of the study. Patients were followed up at an interval of two weeks upto 12 weeks. Data obtained at the end of the study was statistically analysed using Student’s –t test. Results: It was observed that both metformin and garlic reduced FBG and HbA1c significantly but percentage reduction in FBG was more with garlic but, change in HbA1c was not significant. Fall in total CHL, TG, LDL and an increase in HDL were more pronounced in patients treated with Garlic when given along with Metformin. Conclusions: Therefore, garlic showed better results as an antihyperglycaemic and lipid lowering agent.Item A case of refractory multiple myeloma.(2012-07) Vekariya, Ritesh; Satadiya, Vishal; Bavaliya, Manish; Shah, ShyamMultiple myeloma is a plasma cell cancer in which antibody-producing plasma cells grow in an uncontrolled and invasive way. The known incidence of multiple myeloma in India ranges from 0.5 to 1.2 per 100,000 & is a rare in India. It usually occurs in persons older than 55 years and the ratio of men: women is 3:2. Multiple myeloma affects the bones, immune system, kidneys and red blood cell count. We report a case of refractory multiple myeloma.Item Toxicities of anticancer drugs and its management.(2012-07) Remesh, AmbiliOne of the characteristics that distinguish anticancer agents from other drugs is the frequency and severity of side effects at therapeutic doses. Most cytotoxic drugs target rapidly multiplying cells and the putative targets are the nucleic acids and their precursors, which are rapidly synthesised during cell division. Many solid tumours have a lower growth fraction than the normal bone marrow, gastro intestinal lining, reticuloendothelial system and gonads. Drugs affect these tissues in a dose dependant manner and there is individual susceptibility also. So toxicities are more frequently associated with these tissues. The side effects may be acute or chronic, self-limited, permanent, mild or potentially life threatening. Management of these side effects is of utmost importance because they affect the treatment, tolerability and overall quality of life. This paper gives an overview of different toxicities of anticancer drugs and its management.Item Editorial.(2012-07) Kataria, Bhaven CItem Current scenario of rational usage of various drugs in indoor patients.(2012-07) Saeed, Shaheen; Saeed, Parvez; Sharma, VarunBackground: Irrational prescribing of drugs is of common occurrence in clinical practice. Rational drug prescribing is defined as “the use of the least number of drugs to obtain the best possible effects in the shortest period and at a reasonable cost”. The present study was designed to evaluate the practice of rational prescription in patients (cases) admitted in various wards of G.S.V.M. Medical College and associated hospitals at Kanpur. Methods: This study was carried out on patients admitted in different wards. For the study of drug prescribing patterns, each prescribed drug was counted only once for a patient, irrespective of change in dose and route of administration. WHO guidelines were taken into consideration. Both distribution of type of drug as well as drug category were evaluated in different departments thereafter. The characteristics chosen on each prescription provided the incidence of poly pharmacy and frequencies of prescribing of individual drug were analyzed. The data obtained were subsequently categorized systematically and analyzed by taking WHO guidelines into consideration. Results: The most commonly prescribed drugs were vitamins and tonics (57.5%) followed by anti-microbial agents (12.7%), non-steroidal anti-inflammatory drugs (10.5%), anti-hypertensive (5.2%), anti cough remedies and acid peptic disease drugs. Generic drug prescription was very low as most of drugs prescribed were proprietary. A low number of Fixed Dose Combinations (FDCs) were prescribed, this finding was in accordance with the WHO recommended list of FDCs. Items on the WHO model list of essential drugs were prescribed frequently. The use of drugs has been found to be in accordance with the disease, the patient had. Conclusions: Present study highlighted that there was a high incidence of irrational prescribing practice that increased with the total number of drugs per prescription.Item Mirabegron: first β3 agonist in treatment of overactive bladder.(2012-09) Gill, Paramdeep Singh; Grewal, NipunjotMirabegron is the first and only β3 agonist approved by US FDA in June 2012 for treatment of Overactive bladder with symptoms of urge incontinence, urgency and urinary frequency. It is the first oral OAB treatment with a distinct mechanism of action since the launch of anticholinergic agents 30 years ago. It causes relaxation of detrusor smooth muscle by its agonist action at β3 receptors leading to increased storage capacity of bladder. It has been studied extensively in more than 10,000 individuals over 10 years.Item A comparative study of tranexamic acid and ethamsylate in menorrhagia.(2012-09) Patel, Nita K; Pandya, Manish RBackground: Menorrhagia interferes with the woman's physical, social, emotional, and/or material quality of life. Antifibrinolytic drugs are effective in decreasing excessive menstrual bleeding. The objective of this study was to compare the effects of tranexamic acid and ethamsylate on quality of life in women with menorrhagia. Methods: The 50 women with menorrhagia were randomised to receive either tranexamic acid or ethamsylate. Twenty five patients were allocated to receive tranexamic acid 500 mg six hourly, and 25 patients to receive ethamsylate 500 mg six hourly. Among the parameters measured by the MIQ were impairment in social activities, work performance, physical activities, productivity, hygienic condition, psychological condition. Health-related quality-of-life question scores (MIQ scores) at baseline and after treatment were calculated as mean for tranexamic acid group and ethamsylate group. Results: Tranexamic acid and ethamsylate treatment groups showed mean improvement in MIQ scores compared to baseline. However, the total mean score was higher in tranexamic acid group compared to ethamsylate group after three treatment cycles (21 Vs 17). Conclusions: Use of tranexamic acid and ethamsylate improved health-related quality of life in patients with menorrhagia. Tranexamic acid showed better improvement in health-related quality of life compared to ethamsylate in patients with menorrhagia.Item Pediatrics pharmacovigilance: need of a new sub-unit.(2012-09) Chaurasia, Rakesh CPharmacovigilance is a new discipline of pharmacology concerned with adverse drug reaction (ADR) monitoring. Being an emerging section, it gains widespread global popularity within a short span of time. Pediatrics is very special branch of medical science deals with innocent aspect of growing life. As most of their body physiology are varies in accordance to age, therefore ADRs detection needs special attention.Item A prospective, open labeled, comparative study to assess the efficacy of montelukast as add on to β2-agonist and inhaled corticosteroid in patients of moderate persistent asthma.(2012-09) Hihoriya, Nikunj H; Shelat, Prakash R; Kagathara, Jaydeep D; Kumbar, ShivaprasadBackground: Steroid, bronchodilator and the leukotriene receptor antagonist montelukast have demonstrated efficacy in children with mild persistent asthma, but comparative long-term studies in adult patient with moderate persistent asthma is needed. A randomized and prospective study was undertaken to find out the efficacy of montelukast as add on to β2-agonist and inhaled corticosteroids in patients of moderate persistent asthma. Methods: This was a continuous, longitudinal, prospective study carried out at a tertiary care teaching hospital. Newly diagnosed patients of moderate persistent asthma attending the chest out patient department (OPD) were enrolled. Group I was treated with salbutamol 200 mcg rotacap SOS and formoterol 6 mcg + budesonide 400 mcg rotacap BD. In addition to these medicines group II also received montelukast 10 mg OD. The patients were followed up every two months. Clinical examination and pulmonary function tests (PFT) were carried out at baseline and during each visit. Unpaired ‘t’ test was used for statistical analysis. Results: Comparison of clinical symptoms revealed a better improvement in group II as compare to group I [cough - 83% vs. 33%; breathlessness - 75% vs. 33%; and wheezing - 83% vs. 78%] at the end of one year. A significantly better (p < 0.05) improvement in forced expiratory volume (FEV1) was also observed in group II. Conclusions: Treatment with montelukast leads to better improvement in clinical symptoms and PFT in the patients of moderate persistent asthma.Item Buclizine- old wine in new bottle.(2012-09) Chaurasia, Rakesh C; Chandra, SandhyaItem Pharmacology Focus.(2012-09) Pathak, Rakesh Ranjan; Bhavsar, Vinayak HItem Wound healing and anti-inflammatory activity of extract of Ficus racemosa linn. bark in albino rats.(2012-09) Mehta, Dimple S; Kataria, Bhaven C; Chhaiya, Sunita BBackground: F. racemosa is an indigenous plant having anti-secretory, anti-diabetic, anti-ulcer etc. properties. It is used widely in the ayurvedic medicines. Methods: The experimental models of wound and inflammation were used to assess the wound healing and anti-inflammatory properties of F. racemosa. The significance of differences was analyzed using students’ ‘t’ test. Results: In the strength of 10% local application it could apparently enhanced the process of healing. At the dose of 20 mg/100 gm intraperitoneally it could show inhibition of carageenan induced acute inflammation at 3rd, 5th and 7th hour and at the dose of 30 mg/100 gm intraperitoneally, formalin induced subacute inflammation was inhibited till 4th day. The results were found statistically significant. Conclusions: Aqueous extract of F. racemosa has got wound healing and anti-inflammatory activity. It is likely that the duration of action may be shorter.Item Small size sampling.(2012-09) Pathak, Rakesh RThough small size samples can be planned and justified based on scarcity of time, money and manpower, there are situations making more accuracy a must and needing larger samples sizes. That’s why rare adverse drug reactions are identified only after a drug comes into the market and a large population is exposed to it. There are many more reasons for increasing the sample size and requirement of the study decides which criteria of accuracy should be tightened the most (e.g. avoiding type I error is more important or type II error).Item Knowledge and attitude towards the use of emergency contraceptive pills among college students.(2012-09) Shelat, Prakash R; Hihoriya, Nikunj H; Kumbar, ShivaprasadBackground: Emergency contraception is applied to prevent pregnancy after 72-120 hours of unprotected sexual intercourse. Emergency contraceptive (EC) pill is used to reduce unwanted pregnancy and unsafe abortion. EC pill is available as OTC in India since 2005. As EC pill highly used among adolescents we carried out to this study among college students. Methods: The study was conducted among female college students. A pre-validated questionnaire was used as tool for the study. It contains consent form and questions knowledge and attitude regarding EC pill. Results: We divided students into group A (medical, paramedical and pharmacy colleges) and group B (nonmedical colleges like science, arts and engineering). In group A 470 and group B 280 students were participated. Knowledge about appropriate time of taking EC pill (within 72 hours after sexual intercourse) was 44% in group A which is significant than 15% in group B. Knowledge about brand name, availability cost and side effects were more in group A than group B. Electronic media was the most common source of information mentioned by both the groups. Attitude regarding advice to use of EC pill to other was more in group A than group B. Conclusions: Knowledge about use of EC pill was higher in group A than group B. Attitude was not positive regarding availability of EC pill as OTC. So education about EC pill among young population is necessary.