Adverse drug reactions related to the use of non-steroidal anti-inflammatory drugs: results of spontaneous reporting from central India.

To assess the adverse drug reactions to non-steroidal anti-inflammatory drugs through spontaneous reporting system in IGGMC&H, Nagpur and to analyse them using WHO assessment scales, an observational, prospective study was conducted in patients attending outpatient department, inpatient department and casualty of IGGMC and H Nagpur from 1st June 2005 to 31st May 2009. Data were collected by spontaneous adverse drug reactions reporting system. Among 2639 total adverse drug reactions reported, 336 (12.7%) were due to non-steroidal anti-inflammatory drugs. The non-steroidal anti-inflammatory drugs most frequently implicated with adverse drug reactions were ibuprofen (51.19%) followed by diclofenac (27.08%), paracetamol (6.55%), nimesulide (6.25%), aspirin (5.95%). The most commonly affected organ systems were skin and appendages and gastro-intestinal system. Maculopapular rashes were the most frequent skin Involvement. Non-steroidal anti-inflammatory drugs are the most frequently used drugs. As they are commonly associated with adverse drug reactions, their limited and careful use is needed. Considering their prominent role in therapeutics, close clinical observations are very important in minimising adverse drug reactions and demands need for vigilant surveillance of adverse drug reactions in patients, receiving established as well as newer non-steroidal anti-inflammatory drugs.

Evaluation of Cutaneous Drug Reactions in Patients Visiting Out Patient Departments of Indira Gandhi Government Medical College and Hospital (IGGMC and H), Nagpur.

OBJECTIVES: To detect cutaneous drug reactions through spontaneous reporting system in IGGMCand H, Nagpur and analyze them using standard assessment scales. MATERIALS AND METHODS: An observational, prospective study was performed in patients attending dermatology OPD of IGGMC and H, Nagpur from 1(st) June 05 to 31(st) May 09. Patients were examined for cutaneous drug reactions (CDRs) by spontaneous Adverse Drug Reaction reporting system. RESULTS: Among 2693 total ADRs reported, 872 (33.04%) were CDRs. Antimicrobials (55.5%) were the main drugs involved followed by NSAIDs (18.56%) and steroids (12.61%). Maculopapular rash (37.73%) followed by fixed drug eruption (17.2%) and urticaria (14.56%) were the most frequently observed CDRs. The common drugs causing CDRs were cotrimoxazole (20.41%), topical steroids (betamethasone), ibuprofen (7.91%), ampicillin (6.54%), diclofenac (4.7%) and iron dextran (3.44%). CONCLUSION: It was observed that commonly used drugs like antibiotics and NSAIDs lead to maximum number of CDRs. Hence strict vigilance is required while using them. This study provides a database of ADRs due to common drugs, which will help clinicians in safe use of these drugs.

Comparison of nebivolol and atenolol on blood pressure, blood sugar, and lipid profile in patients of essential hypertension.

BACKGROUND: Nebivolol is a third-generation ß-blocker, with highest ß(1) selectivity and nitric-oxide-derived vasodilatation. It also exhibits antiproliferative and antioxidant property that has beneficial metabolic profile compared to second-generation ß blockers like atenolol. This study was planned to study the comparative effects of nebivolol and atenolol on metabolic parameters in patients with essential hypertension. MATERIALS AND METHODS: A prospective, randomized, parallel, open-label clinical study was carried out on patients with essential hypertension. The patients were randomly assigned to receive tablet atenolol (Group A) and nebivolol (Group B) for a period of 24 weeks. Investigations were carried out at baseline and at the end of study period, that is, 24 weeks. Out of 69 patients, 60 completed the study and the data was analyzed using student's t-test. P < 0.05 was considered statistically significant. RESULTS: Atenolol and nebivolol both showed significant (P < 0.001) antihypertensive action after 24 weeks. Mean blood sugar and lipid profile were found to be significantly (P < 0.001) elevated after 24 weeks of treatment with atenolol but not with nebivolol. Heart rate was significantly (P < 0.001) decreased in both groups at 24 weeks. CONCLUSION: In view of metabolic adverse effects of atenolol, nebivolol is the better choice whenever ß-blockers have to be used in essential hypertension.

Adverse drug reactions reported in Indira Gandhi Government Medical College and Hospital, Nagpur.

OBJECTIVE: To detect the adverse drug reactions (ADRs) through spontaneous reporting system in IGGMC&H, Nagpur and analyze them using World Health Organization (WHO) assessment scales. METHOD: An observational, prospective study was conducted based on ADRs reported between 1st June '05 to 31st May '09 to the ADR reporting unit of the hospital. The ADRs reported by spontaneous reporting system were from patients attending outpatient department (OPD), in-patient department (IPD) and casualty of IGGMC&H Nagpur. Evaluation of the data was done for various parameters which included patient demographics, drug and reaction characteristics, and outcome of the reactions. Assessment was also done for causality and severity. RESULT: Total 2639 ADRs were reported with in the period from 1st June '05 to 31st May '09. Antimicrobial agents (AMA) were the drug class most commonly involved and Non Steroidal Anti-inflammatory Drugs (NSAIDs) were next to AMA. Cotrimoxazole a well established agent was the individual drug most frequently reported in this study. Upon causality assessment, majority of the reports were rated as probable (55.89%). CONCLUSION: The pattern of ADRs reported in our hospital is comparable with the results of studies conducted in hospital set up elsewhere. AMAs were causing maximum ADRs. This study provides a database of ADRs due to common drugs used in our hospital, which will help clinicians for optimum and safe use of these drugs. Hence strict vigilance is required for the use of these likely drugs and their safety assessment.

Supplementation of vitamin C reduces blood glucose and improves glycosylated hemoglobin in type 2 diabetes mellitus: a randomized, double-blind study.

No study has ever examined the effect of vitamin C with metformin on fasting (FBS) and postmeal blood glucose (PMBG) as well as glycosylated hemoglobin (HbA1c) in the treatment of type 2 diabetes mellitus (DM). The goal was to examine the effect of oral vitamin C with metformin on FBS, PMBG, HbA1c, and plasma ascorbic acid level (PAA) with type 2 DM. Seventy patients with type 2 DM participated in a prospective, double-blind, placebo-controlled, 12-week study. The patients with type 2 DM were divided randomly into placebo and vitamin C group of 35 each. Both groups received the treatment for twelve weeks. Decreased PAA levels were found in patients with type 2 diabetes mellitus. This level was reversed significantly after treatment with vitamin C along with metformin compared to placebo with metformin. FBS, PMBG, and HbA1c levels showed significant improvement after 12 weeks of treatment with vitamin C. In conclusion, oral supplementation of vitamin C with metformin reverses ascorbic acid levels, reduces FBS, PMBG, and improves HbA1c. Hence, both the drugs in combination may be used in the treatment of type 2 DM to maintain good glycemic control.

Comparison of effects of olanzapine and risperidone on body mass index and blood sugar level in schizophrenic patients.

Schizophrenia is one of the most debilitating disorders with devastating effects on its victims and their families. Atypical antipsychotics (AAPs) because of their superior efficacy, reduced side effects, & better compliance, have rapidly become the mainstay of treatment. But, because of paucity of research & literature on the long-term metabolic side effect profile of these AAPs in Indian setup, this prospective study has been carried out to compare the effects of olanzapine & risperidone on body weight, body mass index, & blood sugar level in schizophrenic patients. Among 60 newly diagnosed DSM-IV patients of schizophrenia enrolled, it was observed that mean body weight & BMI were significantly increased from baseline to 6 & 12 weeks in both olanzapine (n = 30) & risperidone groups (n = 30) (P < 0.001). Also, mean blood sugar was found to be significantly elevated after 6 & 12 weeks of treatment with olanzapine (P < 0.001) but not in risperidone group. Thus, the present study underscores the need for baseline and six weekly monitoring of body weight and blood glucose in routine clinical practice with AAPs.

Relapse of tardive dyskinesia due to reduction in clozapine dose.

Clozapine is a second-generation (atypical) antipsychotic agent, which has been proven efficient against the positive and negative symptoms of schizophrenia, with a low propensity to induce tardive dyskinesia (TD). Compared with typical antipsychotics, it has a greater affinity for dopamine D4 than D2 receptors and additional action on serotonin 5-HT(2A) receptors. Due to its weak D(2) blocking action, it produces few extra pyramidal side effects and TD is rare. TD is one of the muscular side effects of antipsychotic drugs, especially the older generation like haloperidol. TD does not occur until after many months or years of taking antipsychotic drugs. TD is primarily characterized by abnormal involuntary movements of the tongue, lips or jaw, as well as facial grimacing or extremities that develop in association with the use of antipsychotic medications. TD can be embarrassing to the affected patient in public. The movements disappear during sleep and women are at greater risk than men for developing TD.