Evaluate the prevalence of risk factors among patients of myocardial infarction in our population: review of one hundred forty-seven cases

Background: CAD is disease of persons older than 45 years of age. In India, CAD in males, it manifests earlier than west European and North American males. This study is designed to study prevalence of risk factors (and angiographic profiles) amongst patients of Myocardial infarction in our population. Methods: Total of 147 consecutive patients of AMI were studied for risk factors.Results: Out of 147 patients, 116 (79%) were males and 31 (21%) were females. 11 (9.5%) of males and 01 (3.2%) of females were below 40 years of age. Whereas 34 (29.3%) of males and 06 (19.4%) females were of below 50 years of age. Median age for males was 54 years while that for females was 63 years. Smoking remains most prevalent amongst males while high LDL and HT remain most prevalent amongst young and overall females respectively. 108 patients had STEMI while 39 had NSTEMI.Conclusions: AMI occurs much frequently in males. Median age for males is almost one decade earlier than West European males and nearly 5 years earlier than North American males. Smoking is most common and hypertension second most common risk factors amongst males. In females median age for AMI is almost one decade later than Indian males. It is similar to North American females while nearly 5 years earlier than Western Europe females. HT and DM remain first and second common risk factors amongst females.

Ethics committee laws, penalty comparison across globe: a mandatory thought before accreditation process in India

To have a better quality of life and to fight with the diseases evolved the concept of clinical trials. A test of any new or existing drug on human being through different phases to check the efficacy and safety of the molecule is clinical trial. To cope up with the defects in drug system, India introduced Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules in 1945. Objective: To compare and contrast the different GCP guidelines and law suits, penalties, worldwide. We reviewed different internet databases and resources to find out the various penalties. The death occurring during clinical trials shook the pillars of credibility of clinical trials and led the government to make some regulatory provisions. The outcome is that now the ethics committee has to be accredited by a competent authority. This step led many problems for upcoming as well as the existing ethics committee and trial sites. The objective of the review article is to know the roles and responsibilities of different players of clinical trials i.e. the investigator, the sponsor and the ethics committee and to know the laws governing their responsibilities and the penalties affiliated to it. Since now the clinical trials in India are becoming more and more stricter there is a dire need to make aware the ethics committee members, sponsor and the investigator of their rights and duties towards one another and towards the patient/subject, so the tragedies in the clinical trials can be minimized.

Comparison of analgesic, anti-inflammatory and anti-pyretic efficacy of diclofenac, paracetamol and their combination in experimental animals

Background: Various combinations of analgesics antipyretic drugs are available in the market for treatment of various musculoskeletal disorders and pain relief. Diclofenac and paracetamol combination is most commonly used combination and its rationality is questionable. The objective of this study was to compare the analgesic, anti-inflammatory and anti-pyretic activities of diclofenac, paracetamol and their combination.Methods: Experimental animals were divided into 4 different groups – control, diclofenac, paracetamol and their combination. Analgesic activity was compared by using tail-clip method in rats and writhing test in mice, anti-inflammatory activity was compared by carrageenan paw edema method using plethysmometer and anti-pyretic action was compared using TAB vaccine induced pyrexia and measuring the rectal temperature. Different doses of diclofenac (1mg/kg and 2mg/kg) and paracetamol (10mg/kg and 20mg/kg) used and same doses were used in combination group.Results: Diclofenac sodium (1mg/kg) showed significantly higher analgesic activity using tail-clip and writhing method compared to paracetamol (10mg/kg) (p<0.0001) and the combination group (p<0.05). Diclofenac sodium (2mg/kg) showed significantly higher analgesic activity using tail-clip and writhing method compared to paracetamol (20mg/kg) (p<0.0001) and the combination group (p<0.1). Diclofenac has no significant difference in anti-inflammatory activity using carrageenan induced paw edema when compared to the combination group (p<0.1) for both doses. But diclofenac when compared to paracetamol for anti-inflammatory effect, it was highly significant (p<0.0001 and p<0.0004) for both doses at 1st and 3rd hour. Paracetamol 20mg/kg was superior antipyretic (p<0.05,0.01 and 0.01 ) when compared to the combination group at 1hr, 2hr and 3hr duration after injecting TAB vaccine.Conclusion: Diclofenac and paracetamol combination was either equal or inferior in all three activities studied as compared to the individual drugs

Comparative efficacy between ketamine, memantine, riluzole and d-cycloserine in patients diagnosed with drug resistant depression: a meta-analysis

Background: Glutamate modulators are having immense potential and are newer entities for treating drug resistant depression. The objectives were to generate statistical evidence on basis of existing data of ketamine, memantine, riluzole and d-cycloserine in resistant depression.Methods: A total of 14 RCTs following PRISMA guidelines and matching inclusion and exclusion criteria were collected of ketamine (5), memantine (3), riluzole (2) and d-cycloserine (4) vs placebo in drug resistant depression. Only RCTs with primary diagnosis of drug resistant depression (Previously on two standard antidepressant therapy) were included. Studies with treatment response rate, 50% reduction in total score of the depression rating scale-Montgomery-Åsberg Depression Rating Scale or the Hamilton Depression Rating Scale or Beck Depression Inventory was chosen as clinical outcome measure. RevMan 5.3 software was used for the analysis.Results: In ketamine group using random effect model SMD was 2.122 (95% CI 0.659-3.584). P-value was statistically significant (random effect p <0.005 and in fixed effect <0.001). In memantine group, using random effect model -0.963 was SMD and (95% CI -1.958-0.0324). P-value was <0.001, significant in fixed effect. In riluzole group, SMD was -0.564 with (95% CI -3.927-2.799) in random effect. P-value was 0.741. In d-cycloserine group SMD was 0.316 with (95% CI -1.252-1.885) in random effect. P-value was 0.690.Conclusions: Ketamine showed best efficacy followed by memantine. Riluzole and DCS as such have no efficacy although its acts by same glutamate pathway. More molecular based research is required in use of glutamate modulators in resistant depression

Study of potential drug-drug interactions between benzodiazepines and four commonly used antiepileptic drugs in mice

Background: Benzodiazepines (BZD) is one of the commonly used drug groups for certain neurological diseases. As sometimes, the anti-epileptic drugs (AEDs) may be used concomitantly with BZD there is a potential for drug-drug interactions. Study aimed to study potential drug-drug interactions between four commonly used AEDs (phenytoin, carbamazepine (CBZ), phenobarbitone, sodium valproate) and BZD (diazepam, clonazepam) in mice using maximal electroshock seizure (MES) method and pentylenetetrazole (PTZ) method.Methods: Adult male albino mice were divided into four different groups of six animals each and anti-epileptic activity was assessed using MES method and PTZ method. Group I acted as a control, Group II received any one of the four AEDs (phenytoin, CBZ, phenobarbitone or sodium valproate) in sub-effective doses, Group III received diazepam or clonazepam alone, Group IV received a combination of diazepam or clonazepam with any one of the AEDs.Results: In MES method, the groups receiving combination of diazepam with phenytoin and CBZ showed significant protection compared to the control group (p<0.01 and p<0.02), respectively. However, diazepam in combination with sodium valproate and phenobarbitone did not show any significant protection compared to the control group and individual antiepileptic group. All the four antiepileptic showed significant protection against MES seizure in combination with clonazepam when compared to control group. In PTZ method, combination of sodium valproate with clonazepam showed significant protection compared to control group (p<0.02). However, this was not observed with diazepam-valproate combination.Conclusion: Clonazepam potentiates the action of all the four anti-epileptics while diazepam potentiates only phenytoin and CBZ against MES seizures. Clonazepam but not diazepam potentiates the action of sodium valproate against PTZ seizures

Evaluation of differences in health-related quality of life in patients receiving conventional versus newer anti-epileptic drugs

Background: Epilepsy is associated with stigma and bad health-related quality of life (HR-QOL) due to this, and side effects of the drug therapy. Newer anti-epileptics are claimed to be better than the conventional. We evaluated this based on comparison of HR-QOL in patients taking the respective therapy.Methods: An observational, cross-sectional, single point study involved 127 consenting patients from Neurology OPD at V.S. General Hospital. Quality of life in epilepsy-10 (QOLIE-10) questionnaire was used to measure HR-QOL in patients. SPSS software and Graphpad prism were used to analyze the variables.Results: Patients of 20-30 age group were commonly affected (37.80%) with a male predominance (56.69%). 41.73% were unemployed. The difference in HR-QOL between patients and controls in all three domains (epilepsy effects, mental effects, role function domains) of QOLIE-10 was significant (p=0.0002), indicating better HR-QOL in controls. The worst HR-QOL scores were found in Epilepsy effects domain. Metabolic adverse effects (38.58%) were the common ADRs. Sodium valproate was the most effective in controlling seizures (last seizure episode: 15 months). HR-QOL correlation between patients receiving monotherapy and polytherapy was significant (p=0.026) with monotherapy rendering a better HR-QOL. Comparison of HR-QOL between patients taking the conventional and the newer drugs was not significant (p=0.1768).Conclusions: Our study nullifies the claims that newer drugs are better than the conventional since no such benefit was seen in HR-QOL as well as ADRs. Our findings ruled out the belief that cases of epilepsy are better controlled with polytherapy

Prescription and cost-analysis of antiemetic medication use in pediatric wards: a prospective observational study

Background: Use of anti-emetic drugs in pediatric population is often warranted, but choice of drug remains questionable within pediatricians. Objective of current study is: to study prescribing pattern and to calculate cost of antiemetic drug therapy in pediatric wards.Methods: A prospective, observational study was conducted in pediatric wards of a tertiary care hospital of over 14 month’s duration. Institutional ethics committee approval was obtained and written informed consent of parents/guardians was taken. Data of any pediatric patient receiving anti-emetic agent were included in the study.Results: A total of 218 prescriptions were collected. Mean age of patients was 4.39±3.16 (range 4 months to 12 years). Gastroenteritis was the most frequently diagnosed disease in 137(63%) patients. Domperidone was prescribed in 52.4% and ondansetron in 47.6% children. Oral liquid dosage formulation was prescribed in 109 (48.4%) followed by solid dosage form 47 (20.9%). Mean cost of domperidone therapy was 25.34±6.55 INR and for ondansetron it was 36.62±17.94 INR.Conclusions: Gastroenteritis was most frequent indication for use of anti-emetics. Domperidone pharmacotherapy was cheaper and most frequently prescribed than ondansetron

Evaluation of management in acute coronary syndrome and extent of adherence to standard treatment guidelines

Background: India has the highest burden of acute coronary syndrome (ACS) in the world. This research is to evaluate prescriptions pattern and extent of adherence to American College of Cardiology (ACC)\American Heart Association (AHA) guidelines in the management of ACS with patient outcome.Methods: Case record form containing patient’s demographic, clinical profile, diagnosis, prescription drugs (with dose, duration and frequency) were noted. Pharmacotherapy was compared to ACC/AHA guidelines, to evaluate adherence, guideline adherence index (GAI-5) was used for 5 major drug groups for ACS. GAI was calculated as: number of patients using the prescribed medications/number of eligible patients multiplied by 100.Results: A total of 172 patients diagnosed with ACS. 64 (37.20%) Patients with the highest preponderance to ACS belonged to 51-60 years age group with a 4.73:1 male to female ratio. ST-elevation myocardial infarction (STEMI) (44.77%) was the most common diagnosis and an average of 14.66±4.34 drugs were prescribed. Majority of the patients opted for percutaneous coronary intervention (PCI) with or without having received fibrinolytic therapy at onset. Adherence to the ACC/AHA guidelines being 93.75% and 118 prescriptions being 100% adherent to the guidelines. A positive correlation between adherence and number of drugs was statistically significant.Conclusions: The success of evidence-based medicine (EBM) was well noted with a 0% in hospital mortality rate i.e. all of the 172 patients were discharged with therapeutic success. Despite the concept of EBM and its proven effectiveness, there is a paucity of availability of such guidelines in India, so this study, a first of its kind can serve as a starting point of generating national as well as local guidelines

Off-Label Medicine Use in Pediatric Inpatients: A Prospective Observational Study at a Tertiary Care Hospital in India

Background. In the absence of standard pediatric prescribing information, clinicians often use medicines in an off-label way. Many studies have been published across the globe reporting different rates of off-label use. There is currently no study based on Indian drug formulary. Methods. The prospective observational study included pediatric patients in ages between 0 and 12 years admitted in a tertiary care hospital. Off-label use was assessed using the National Formulary of India (NFI). Predictors of off-label use were determined by logistic regression. Results. Of the 1645 medications prescribed, 1152 (70%) were off-label based on 14 possible off-label categories. Off-label medicines were mainly due to dose difference and use in restricted age limits as indicated in NFI. Respiratory medicines (82%), anti-infectives (73%), and nervous system medicines (53%) had higher off-label use. Important predictors of off-label prescribing were pediatric patients in age of 0 to 2 years (OR 1.68, 95% CI; P<0.001) and hospital stay of six to 10 days (OR 1.91, 95% CI; P<0.001). Conclusion. Off-label prescribing is common among pediatric patients. There is need to generate more quality data on the safety and efficacy of off-label medicines to rationalize pediatric pharmacotherapy

Assessment of quality of life in Indian patients with vitiligo, an observational study

Background: Vitiligo is the most common hypopigmentary disorder. In India, the incidence of vitiligo is 0.25-2.5%. It considerably influences the patient’s quality‑of‑life (QoL) and psychological well‑being.Methods: A prospective, observational study was conducted from April 2016 to September 2016 in dermatology outpatient department. Patients clinical characteristic were noted and Quality of life was assessed by using Vitiligo Quality of Life Questionnaires [VQLQ]. During item development, none of the questions were changed according to the results of cognitive and understand ability testing. The scale consisted of 25 questions. The answer to each question was scored as ‘never = 1’, ‘sometimes = 2’, ‘often = 3’ and ‘all the time = 4’, so the total score ranged between 25 and 100. Higher scores represented more severely impaired quality of life.Results: We enrolled 78 Vitiligo patients who were attending dermatology department for phototherapy. Out of them 53 were female. Mean age was 37.12±12.270. Most common age group was 31-40 years. Mean VLQL score 40.92±6.081. Patients were divided based on VQLQ score in Moderate (50-75) and Low score group (25-50). Vitiligo patients presented with symptoms of pain, irritation and itching (P<0.0001). Vitiligo patients when assessed for feeling domain were significantly embarrassed for their overall look and appearance. (P < 0.0001). When Personal relationship domain was analysed physical contact was a major concern (P <0.002). Patients suffering from Vitiligo were significantly worried about spread of vitiligo and occurrence of cancer (P<0.0001). Therapy for Vitiligo was time consuming time and was a work place challenge for the patients (P <0.0001). The reliability of VQLQ in our study was Cronbach’s α coefficient was 0.876.Conclusions: QoL impairment was relatively high in vitiligo patients. Medical intervention and counselling should focus to improve feelings, personal relationship, anxiety, school/work, leisure and symptom domains