Adverse drug reactions monitoring of anticoagulant drugs used in cardiac coronary care unit of a tertiary care hospital

Background: Cardiovascular diseases are one of the leading causes of morbidity and mortality worldwide. Anticoagulants are the most commonly implicated drugs, used in cardiology unit and they are responsible for a majority of adverse drug reactions (ADRs). The objective of the present study was to evaluate the pattern of ADRs reported with anticoagulant drugs used in the cardiology unit of a tertiary care hospital.Methods: This observational prospective study was undertaken from September 2017 to August 2018. Causality assessment of ADRs was assessed using the WHO and Naranjo scale of probability. The severity was assessed by modified Hartwig and Siegel scale, and preventability of ADRs was assessed by Schumock and Thornton scale.Results: Out of the total forty-one ADRs recorded, 40 (97.56%) were mild and 1 (2.44%) was reported as severe on the Hartwig and Siegel severity scale. Hematuria (68.29%) was the most common ADR followed by hemoptysis (14.63%). Among all anticoagulants, low molecular weight heparin was associated with the majority of ADRs (85.37%). The WHO causality and Naranjo Scale revealed that maximum of the ADRs (~80%) were possible. All ADRs reported was Type “A” reactions according to Wills and Brown classification of ADRs. Majority of ADRs (97.56%) were probably preventable.Conclusions: In the present study, hematuria was the most common ADR reported. Among all anticoagulants, Low molecular weight heparin accounted for the majority of ADRs followed by acenocoumarol and heparin. Intensive monitoring and frequent reporting need to be done in cardiac units to improve patient safety

Comparison of the efficacy and safety of Glimepiride and Glipizide as add-on therapy with metformin in patients of type 2 diabetes mellitus

Background: Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder carrying an enormous burden of morbidity and mortality because of its characteristic complications, many of which are preventable with strict glycaemic control. Initial management of T2DM consists of non-pharmacological interventions; it those fail, an oral anti-diabetic drug, most typically metformin, is started. Combination therapy is initiated only when monotherapy fails to achieve glycaemic control. Glipizide and glimepiride, a second and a third generation sulphonylurea respectively, are the commonest drugs added to metformin when the latter fails to achieve euglycaemia on its own. Aims and Objectives of the study were to compare the efficacy and safety of glimepiride and glipizide as add-on therapy to metformin in patients of uncontrolled T2DM.Methods: This prospective, observational and analytical study was conducted by the Department of Pharmacology among patients attending the Internal Medicine OPD of a tertiary-care hospital. Fifty patients were assigned to two groups of 25 patients each: Group A - Glimepiride + Metformin and Group B - Glipizide + Metformin. Patients were followed up for three months. Data were analysed by Student's t-test.Results: There was a significant decrease in the HbA1c, FBS and 2h-PPBS in both groups. However there was no significant difference between the two groups during the three-month period of follow-up.Conclusions: The combination of glimepiride and metformin is just as effective and safe as the combination of glipizide and metformin in patients not controlled on monotherapy with metformin

Comparative efficacy of pregabalin and baclofen in the rodent chronic constriction injury model of neuropathic pain

Background: Neuropathic pain is associated with prolonged disability and is usually not responsive to conventional analgesics like NSAIDs and opioids. Even the recommended first-line drugs are effective in less than 50% patients. Thus, drugs with different mechanisms of action are needed. Baclofen, a GABA-B agonist has shown benefit in different types of neuropathic pains and is compared against pregabalin.Methods: The sciatic nerve was ligated in 2 groups of 6 rats each as per the chronic constriction injury model of neuropathic pain on day 0. After 14 days the effect of single doses of pregabalin (30mg/kg) and baclofen (5mg/kg) intraperitoneally were assessed over a 2 hours period. Thermal and mechanical hyperalgesia were assessed as measures of neuropathic pain by the hotplate and pin-prick method respectively.Results: Significant thermal and mechanical hyperalgesia was produced 14 days after sciatic nerve ligation in both the groups (p <0.05). Both pregabalin (p <0.001) and baclofen (p <0.01) were effective in decreasing thermal hyperalgesia throughout the two hours study period, but pregabalin was more effective as compared to baclofen (p <0.05) at 30, 60 and 120minutes. Both the drugs produced a significant decrease in mechanical hyperalgesia (p <0.01) throughout the study period. Again, pregabalin was the more effective drug (p <0.05) at all time points.Conclusions: Significant thermal and mechanical hyperalgesia was seen 14 days after sciatic nerve ligation. Both pregabalin and baclofen were effective in reversing the hyperalgesia, but pregabalin was the more effective of the two drugs at all time points

A comparative study of the anti-nociceptive potential of duloxetine and carbamazepine in an animal model of neuropathic pain

Background: Pain is one of the most common symptoms encountered in clinical practice. Of the various types of pain, neuropathic pain represents one of the most difficult pain states to treat, with treatments being far from satisfactory. The drugs used are not fully effective and a drug that shows good efficacy in one neuropathic pain state may be ineffective in another. This study was done to compare the antinociceptive potential of duloxetine and carbamazepine, two drugs with different mechanisms of action in an animal model of neuropathic pain.Methods: Antinociceptive effect of duloxetine (15 mg/kg intraperitoneally) and carbamazepine (20 mg/kg intraperitoneally) was evaluated in the sciatic chronic constriction injury (CCI) model of neuropathic pain in rats. Thermal hyperalgesia, evaluated by the hot plate method; and mechanical hyperalgesia, evaluated by the pinprick method were used as measures of neuropathic pain.Results: A significant degree of thermal and mechanical hyperalgesia (p ≤0.05) was produced in both the drug groups. Both drugs produced a significant decrease in thermal and mechanical hyperalgesia throughout the study period (p ≤0.01 for both drugs). In comparison to duloxetine, carbamazepine was less efficacious (p ≤0.05 at 30, 60 minutes; p ≤0.01 at 120 minutes) for thermal hyperalgesia as well as for mechanical hyperalgesia (p ≤0.05 at 30, 60 minutes; p≤0.01 at 120 minutes). Only duloxetine was able to almost completely reverse both thermal &amp; mechanical hyperalgesia to near pre-neuropathy levels.Conclusions: Duloxetine showed better antinociceptive potential as compared to carbamazepine as reflected by a more complete reduction in thermal &amp; mechanical hyperalgesia in the sciatic CCI model of neuropathic pain

The study of awareness and adherence in patients receiving anti-hypertensive drugs: a hospital based study

Background: Hypertension is an important worldwide public health challenge. It has changed from a trivial cause of death and disability to one of the global burden diseases. The biggest obstacle for inadequate therapeutic control of blood pressure is meagre knowledge, poor attitude, inadequate treatment practices and lack of adherence towards antihypertensive treatment. The present study was planned to assess the awareness of hypertension on various aspects and to evaluate treatment adherence in hypertensive patients.Methods: This cross-sectional study was conducted on 100 hypertensive patients of both genders visiting medicine OPD at HIMS, Dehradun over a period of six months. A structured and validated questionnaire was used to assess the knowledge, attitude and practice (KAP) among patients. Morisky 8-Item Medication Adherence Questionnaire was used to assess the adherence towards antihypertensive medications. For statistical analysis Chi square test was used.Results: Out of the 100 patients the median KAP scores were 6(5),5(1) and 10(4) respectively. Most of the subjects had high median scores on attitude but majority of the subjects had low knowledge and self-care practice scores. Further Analysis of data revealed that a poor score in self-care practice was significantly associated to the gender(p<0.004) as well as to the level of education(p<0.006).Only 40% patients were adherent to their medication, this result was statistically associated with the level of education (p<0.00001).Conclusions: Hypertensive patients in our community have good attitude but poor knowledge and self-care practices towards management of hypertension. Patients were also found to be non-adherent to their antihypertensive medications

Antibiotic resistance pattern in intensive care unit of a tertiary care teaching hospital

Background: Antimicrobials are a major class of drugs prescribed in Intensive Care Unit (ICU). Widespread use of empirical antibiotic therapy has facilitated the emergence of drug resistance, since empirical therapy is very often initiated at the outset, even before culture and sensitivity reports are available. The problem of drug resistance is on a rise, therefore, this study was planned to assess the drug resistance and sensitivity patterns of the blood isolates recovered from ICU.Methods: An observational- prospective study was conducted in the Tertiary care teaching hospital over a period of twelve months to assess antibiotic resistance and sensitivity pattern. A total of 104 consecutive patients receiving antibiotics in the ICU and having blood cultures with significant growth were included in the study. Blood sample was collected and after obtaining a culture growth, the identification and antimicrobial sensitivity testing was done.Results: Blood stream infection by Gram-negative bacteria (50.96%) was more common than Gram-positive bacteria (49.04%). Coagulase negative Staphylococci (CoNS) was the predominant single blood culture isolate (35.58%). Klebsiella pneumoniae (13.46%), Escherichia coli (12.50%), Acinetobacter baumannii complex (7.69%) were commonly isolated gram negative organisms. Gram positive isolates were resistant to beta lactams in maximum patients whereas Tigecycline, Linezolid, Daptomycin, Vancomycin, Nitrofurantoin and Teicoplanin were sensitive against them. Common gram negative isolates were sensitive to Colistin and Tigecycline but resistant to most of the antibiotics.Conclusions: A preponderance of gram negative bacteria over gram positive bacteria was noted with a higher degree of resistance to most of the first line antimicrobial agents.

Comparative evaluation of levetiracetam and valproic acid as monotherapy on cognitive impairment in patients of epilepsy

Background: Cognitive decline with AEDs (Anti-epileptic drugs) is associated with learning and memory deficits especially in the younger age group. The data regarding the impact of levetiracetam and valproic acid as monotherapy on cognition in epileptic patients is scarce. The present study was done for evaluation of cognitive decline associated with the use of AEDs.Methods: Present study was a prospective study on 60 patients on AEDs for a period of 12 weeks. Patients were enrolled from the Department of Neurology, Swami Rama Himalayan University, Dehradun, Uttarakhand, India and divided into group A (levetiracetam) and group B (valproic acid) with 30 patients in each group. Permission from the institutional ethics committee and written informed consent was taken from all the patients. They were analyzed for cognitive impairment using MMSE and MoCA scales at baseline and 12 weeks.Results: The mean duration of disease was 2.13±1.1 years and 2.08±1.1 years and mean age of the patients was 14.67±1.9 years in group A and 16.20±1.6 years in group B. GTCS was present in 31 patients (52%) followed by partial seizures in 29 patients (48%). The mean change in the MMSE scores from baseline to 12 weeks was significant in group A 1.30±1.1 (p value <0.05) and change group B was -0.20±1.4 not statistically significant. The mean change was observed in MoCA scores from baseline to 12 weeks was significant in both groups A and B by 1.17±1.1 and -0.70±1.1 respectively (P value <0.05).Conclusions: Patients on levetiracetam showed cognitive improvement, whereas patients on valproic acid showed a decline in the MMSE and MoCA scores

Evaluation of levetiracetam and valproic acid as monotherapy on quality of life in patients of generalized tonic clonic epilepsy

Background: Quality of life plays an important role in patients of epilepsy and is the most neglected part during management. The antiepileptic drugs treatment results in seizure control but adversely affect the quality of life in patients.Methods: An observational analytical study was conducted in the Department of pharmacology with Department of Neurology of Himalayan Institute of Medical Sciences, Dehradun over 12 months. 85 patients fulfilling the inclusion criteria with diagnosis of generalized tonic clonic seizures (GTCS) were enrolled and divided into two groups based on physicians discretion and followed up for 12 weeks. Patients were evaluated for quality of life by QOLIE-10 self administered questionnaire at 0 and 12 weeks, assessed for seizure control and drug related adverse effects.Results: 85 patients were enrolled and divided into two treatment arms as per physician discretion, levetiracetam (41) and valproic acid group (44). Study drugs showed significant improvement in quality of life, levetiracetam showed mean change that was significantly greater than valproic acid (p=0.003) at 12 weeks. Patients who failed to achieve seizure control at 6 weeks were 17% patients in levetiracetam and 20% in valproic acid group, reason being non-adherence which was 17% and 20% respectively. Adverse events recorded with Levetiracetam (10), most common being increased sleep and with valproic acid (18), with most common being increased sleep and weight gain.Conclusions: Levetiracetam treatment resulted in better quality of life, with similar seizure control but decreased number of adverse effect then Valproic acid