Comparison of efficacy of high dose inhaled corticosteroids with a combination of low dose inhaled corticosteroids and long acting β2 agonists in patients of moderate persistent asthma : a randomised prospective comparative study

Background: Asthma has global prevalence varying from 2-25%. Among various subtypes, moderate persistent asthma is a subtype currently managed by a combination therapy of low dose inhaled corticosteroids and LABA (long acting β2 agonists). Search is on for LABA free regime because of safety concerns and increased risk of exacerbations as reported in meta-analysis conducted by FDA in 2008.Methods: Patients (new and old) of either sex and age having moderate persistent asthma as per GINA 2004 guidelines were enrolled and allocated in two groups using block randomization. DPIs (dry powder inhalation) were used in the study. Budecort group subjects were treated with budesonide 400 µg rotacaps twice a day. Foracort group subjects were treated with combination rotacaps of formoterol 6 µg with budesonide 200 µg twice a day. Follow up period in study was nine months with quarterly spirometry assessment.Results: In 63 enrolled cases, there was no significant difference in intergroup spirometry comparison at baseline and at 9 months. The difference at 9 months in spirometry as compared from baseline in each group was also not statistically significant. Numerically, budecort group showed slightly better values.Conclusions: The therapy in each group was comparable in terms of efficacy. This is important due to the fact that therapy in current use for moderate persistent asthma is combination therapy. So use of high dose inhaled steroid therapy used as 400 µg rotacaps with matching revolizer twice a day (800µg daily) may be good alternative to use of combination therapy particularly in patients where LABA cannot be used

An unusual case of trifluoperazine induced hypoglycemia

Hypoglycemia is a serious condition which if not diagnosed and treated urgently may cause irreversible damage to the brain and may be life threatening. There are various causes attributed to hypoglycemia, but drugs are one of the most important one of them. Various drugs are documented to cause hypoglycemia but we present a rare case report of a 52-year-old male patient with schizoaffective disorder on trifluoperazine who presented in emergency department with documented hypoglycemia and this hypoglycemic episode improved when the drug was withdrawn. When WHO causality assessment scale was applied, trifluoperazine was found as the probable cause of the episodes of hypoglycemia. Therefore, this possibility of hypoglycemia should always be kept in mind while prescribing trifluoperazine

Comparison of efficacy of azilsartan with olmesartan in patients of hypertension: randomized controlled trial

Background: Azilsartan and olmesartan are members of ARBs, used in the management of hypertension. Objective was to evaluate efficacy of azilsartan with olmesartan in patients of hypertension. Methods: A randomized, prospective, open label, comparative study was carried out in Pharmacology and Medicine department at Dr. RPGMC Kangra at Tanda, HP. The study stretched over one year and blood pressure was monitored at first, third and sixth month. Out of 69 patients, 35 patients in group A were prescribed tablet azilsartan 40 mg/day and 34 patients in group B patients were prescribed tablet olmesartan 20 mg/day. Tablet chlorthalidone 12.5 mg/day was add on in both the groups. Data was presented as mean+SD. Student’s t test was used and p value <0.05 was considered significant. Results: In group A, systolic blood pressure (SBP) values improved from baseline of 153±10 mmHg to 111±18 mmHg (p<0.001) at 3 months and 109±6.1 mmHg (p<0.001) at 6 months and diastolic blood pressure (DBP) values from baseline of 87±7 mmHg to 67.1±4.6 mmHg (p<0.001) at 3 months and 67.6±2.5 mmHg (p < 0.001) at 6 months. In group B, SBP values improved from baseline of 154±8.5 mmHg to 127±3.6 mmHg (p<0.001) at 3 months and 123±4 mmHg (p<0.001) at 6 months and DBP values from baseline of 85±6.5mm Hg to 75.7±3.3 mmHg (p<0.001) at 3 months and 73±3.3 mmHg (p<0.001) at 6 months. On intergroup comparison improvement in hypertension was better in azilsartan group (p<0.001). Conclusions: The study concluded that azilsartan is significantly better than olmesartan in controlling the hypertension

Comparison of the safety and efficacy of caroverine and betahistine in patients of subjective tinnitus

Background: Owing to lack of any established treatment and handicap assessment methods, subjective tinnitus can be a debilitating disorder. This study was carried out to compare the safety and efficacy of caroverine and betahistine in patients of subjective tinnitus.Methods: A total of 60 patients of subjective tinnitus were randomized into two groups and followed-up for 12 weeks using tinnitus handicap inventory (THI) questionnaire. One group received 8 mg betahistine tablet TDS for a month whereas the other group was given supervised intravenous (IV) infusion of 160 mg of caroverine dihydrochloride. Data for the safety were also recorded.Results: Both the drugs showed significant improvement in severity of symptoms at 1 week, 4 weeks and 12 weeks individually as assessed by the THI scores. The response to caroverine was significant up to 4 weeks, but it was not significant at 12 weeks; whereas the response to betahistine was significant up to 12 weeks. A total of 28 adverse drug reactions (ADRs) were reported (53.6% with caroverine, 46.4% with betahistine). 24 ADRs were mild and 4 were moderate in intensity. There was no serious adverse event.Conclusions: Both the drugs are safe and efficacious in reducing the handicap of subjective tinnitus. A single IV infusion of caroverine may suffice for 4-6 weeks, so it may be repeated after 6 weeks to maintain the relief

A case of nevirapine-induced exfoliative dermatitis in an immunocompromised patient: a case report

Nevirapine is a non-nucleoside reverse transcriptase inhibitor used as one of the first-line drugs for the highly active antiretroviral therapy (HAART) in human immunodeficiency virus positive patients. The side effects range from skin rashes to fulminant hepatotoxicity. The most of the side effects are manifested in the first 6-10 weeks indicating a need for close monitoring and follow-up of the patient in first few weeks. We hereby are presenting a case of a 41-year-old female who developed exfoliative dermatitis after 4 weeks of therapy

To study the pattern of adverse drug reactions among patients hospitalized in the medical wards of a tertiary care hospital

Background: ADRs have a major impact on public health, quality of life.  ADRs are a recognized hazard of drug therapy. Although some ADRs are minor and resolve without squeal, others can cause permanent disability or death. Despite the methodological rigor of clinical trials, it is generally not possible to identify all safety issues associated with drugs during the pre-marketing research phase.  The only way to find out such occurrences is to be on active-look out for adverse events over a long time horizon in large population and in different host conditions. The information may be useful in identifying and minimizing preventable ADRs, while generally enhancing the knowledge of the prescribers to deal with them more efficiently.Methods: This retro-prospective study was conducted in a tertiary care hospital for one year.  Data of those patients who experienced ADRs was recorded in detail from internal Medicine ward. An assessment of causality was done. Data was evaluated to determine the class of drugs and the organ systems frequently associated with ADR within the settings of the institute.Results: The total incidence of ADRs was 7.59% in hospitalized patients with male predominance. Most common system involved was GIT followed by CNS and CVS. Antibiotics were most common culprits for ADRs followed by NSAIDS and hypoglycemic agents. In causality assessment probable ADRs were much more than possible ADRs. Severity of reaction in most of the patients was moderate. Majority of ADRs were Type A and maximum were probably preventable.Conclusions: There is need to explore the reasons for this relatively low incidence rate of ADR’s in the Indian population. Under­reporting is one of the major factors with a lack of proper pharmacovigilance system which is still in budding state in India

Carbamazepine-induced Stevens Johnson syndrome: a case series of three case reports

Carbamazepine is an iminostilbene derivative that was initially used as an antiepileptic but has been used with increased frequency for different indications including chronic pain, trigeminal neuralgia, and herpetic neuralgias. This has resulted in increased incidence of carbamazepine related adverse effects such as nausea, vomiting, and serious hematological toxicities such as aplastic anemia, agranulocytosis, eosinophilia, lymphadenopathy, and splenomegaly. Life-threatening hypersensitivity reactions such as Steven Johnson syndrome (SJS) and toxic epidermal necrolysis can also occur. We hereby present a series of three cases that were prescribed carbamazepine for different indications and presented with SJS

A study on the effectiveness of nicotine and counselling in tobacoo smoking cessation

Background: Effectiveness of pharmacotherapy and counselling has been suggested by various research workers in smoking cessation, but studies show variable results with pharmacotherapy. Also efficacy of counselling and pharmacological intervention differs from centre to centre. So we conducted this study, to observe the role of counselling and nicotine gums in our setup.Methods: 86 smokers willing to quit smoking were enrolled. Baseline counselling was provided at the time of enrolment, then at 1 week, 1 month, 3 months and at 6 months. Telephonic counselling was given to those who did not come for face to face counselling. Nicotine gums were prescribed for 3 months duration. At the end of 12 months, follow up outcome was measured.Results: At 1 week 24% smokers, at 1 month 23%, at 3 months 12% and at 6 months 33% smokers attended face to face counselling session. At 1 week 66%, at 1 month 57%, at 3 months 63% and at 6 months 59% smokers received telephonic counselling. Nicotine gums were used by only 76% smokers. Out of those who used nicotine gums, only 3% used gums for 3 months duration and 97% stopped prematurely. Among those who used gums, 29% experienced side effects. Total 22 (26%) smokers stopped smoking at 12 months.Conclusions: Less number of smokers coming for follow up counselling visits, suggest lack of motivation. Alternative counselling, like telephonic counselling, was much more accepted and was found to be helpful. Acceptance of nicotine gums was very less which also shows the lack of motivation. Abstinence rate of 26% shows that counselling and nicotine gums help in quitting smoking

Allopurinol inappropriate use in case of asymptomatic hyperuricemic patient causes fatal Allopurinol hypersensitive syndrome: lesson to all

Allopurinol is used to treat hyperuricemia (HU) in a patient of gout. It is also used to prevent HU in a patient of hematological malignancies who are about to undergo chemotherapy. Allopurinol is usually well-tolerated but it occasionally induces hypersensitivity reactions that manifest after few months of therapy. Cutaneous reactions are pruritic, erythematous, or maculopapular eruptions. Rarely fatal toxic epidermal necrolysis or Stevens-Johnson syndrome may occur. Transient leukopenia or leukocytosis, eosinophilia and elevated transaminases may also occur. HU is not a disease in itself. Its level is highly variable in the general population. Uric acid level is influenced by many factors such as dietary intake of proteins, hypertension, and obesity. Only very rarely patients of AHU may progress to gout and renal stones. Not much data is available that support HU alone in an asymptomatic patient in later life shows the diseases which are associated with HU. Sometimes only lifestyle changes, diet restrictions, alcohol restrictions, and treatment of underlying acquired cause may correct HU. Here, we are presenting a rare case of allopurinol hypersensitivity syndrome in an AHU patient. Our aim is to raise awareness among physicians so that they avoid using unnecessarily allopurinol in AHU patients and also titrate the dose of allopurinol in patients of renal failure. Risk-benefit ratio must be considered in these patients before starting allopurinol

Socio-demographic profile of multi-drug resistant tuberculosis patients and its association with severity of adverse drug reactions in DOTS plus centre at tertiary hospital in Himachal Pradesh, India

Background: Multi-drug resistant tuberculosis has become major public health problem and obstacle to effective control of tuberculosis. Objectives was to study the socio-demographic profile of multi- drug resistant tuberculosis patients and its association with severity of ADR (adverse drug reactions) in DOTS plus centre at tertiary hospital in Himachal Pradesh.Methods: It was a prospective observational study carried out from November 2012 to October 2013 on multi-drug resistant tuberculosis (MDR-TB) patients after approved from Institutional Ethics Committee.Results: Out of 104 patients the mean age of patients was 39.9 ±14.26 years. Majority of the patients were in the economically productive age groups. Multi-drug resistant tuberculosis was more in male (76%) than female (24%) and 96% of patients were belonged to rural area. The educational status of the MDR-TB shows 24% patients were illiterate. 63.46% MDR-TB patients were underweight (BMI<18.5%) according to WHO guidelines for obesity. Severity of ADR assessed by Hart wig and Siegel’s scale showed 21% patients experienced mild ADRs, 49% patients had moderate and 17% patients had severe ADRs. Severity of ADR is seen more in male, economically productive age group, subjects on vegetarian diet, patients who were underweight (BMI<18.5%) and with lower educational status.Conclusions: MDR-TB is a rapidly increasing health problem with major socio-economic and individual consequences. Multi-drug resistant tuberculosis mainly affects middle age that is in the economically productive age group which hampers the social and economic development of individual, society and nation