Comparative study of efficacy and safety of cetirizine and bilastine in patients of chronic spontaneous urticaria: Open-label, randomized, parallel-group study.

Purpose: Bilastine is a novel second-generation antihistaminic. Very few studies in Indian population have compared the safety and efficacy of bilastine with other second-generation antihistaminic like cetirizine. Hence, the present study was planned. Materials and Methods: This was a randomized, open-label comparative parallel group study conducted on 70 patients of chronic spontaneous urticaria (CSU). Patients either received cetirizine 10 mg or bilastine 20 mg once daily for 6 weeks. The primary endpoint was to find out the difference in the mean total symptom score (MTSS) at baseline and 6 weeks. The secondary endpoint was to find out changes in the scale of the number of wheals, change in pruritus scale, scale for size of wheal, change for interference of wheals with sleep, change in visual analog scale (VAS) for sedation, change in scale for intensity of erythema, and change in Scale for Extent of Skin Area Involvement (SESI). Results: Bilastine and cetirizine offer a significant reduction in MTSS, mean number of wheals, and mean pruritus scale at baseline to 1, 3, and 6 weeks. The mean difference in MTSS was significantly more in bilastine. Cetirizine showed a significant increase in VAS score for sedation as compared to bilastine. Both the drugs were well tolerated and safe. Adverse events like headache, gastric irritation, dryness of mouth, and sedation were more reported in cetirizine group. Conclusion: Bilastine was more efficacious than cetirizine in patients of CSU and the efficacy was seen earlier at 1 week, which was not seen in the cetirizine group.

Comparative evaluation of efficacy and tolerability of apremilast and methotrexate in patients of moderate-to-severe palmoplantar psoriasis: A randomized, parallel, open-label clinical trial.

BACKGROUND: Variable results about efficacy as well as safety of apremilast compared to methotrexate are reported in different trials. Hence, it is necessary to collect more evidence to prove the role of Apremilast in palmoplantar psoriasis. METHODOLOGY: The study was a randomized, prospective, parallel-group, open-label study conducted in patients with moderate-to-severe palmoplantar psoriasis. They were randomized into two groups, methotrexate (n = 19) or apremilast (22) for 16 weeks. Primary efficacy parameter was reduction in modified palmoplantar psoriasis area and severity index (mPPPASI) score from week 0 to week 16. Other parameters were proportion of patients attaining Static Physician Global Assessment score of 0 (clear) or 1 (almost clear), proportion of patients attaining mPPPASI75 (75% reduction in mPPPASI score) at the end of 16 weeks, and proportion of patients showing at least 5-point decline in dermatology life quality index from baseline. RESULTS: Decline in m-PPPASI score from 0 week to 16 weeks within the group was significant statistically though decline in score of m-PPPASI between these two groups was not statistically significant at 16 weeks. Similar results were obtained with the secondary efficacy parameters. In methotrexate group, there were 24 adverse events recorded including abnormal liver function tests in three patients. In apremilast group, 19 adverse events were recorded, in which two patients suffered from upper respiratory tract infection. CONCLUSION: Apremilast is as effective as methotrexate for the management of moderate-to-severe palmoplantar psoriasis with better tolerability. Hence, it can be considered alternative to established drugs in patients having palmoplantar psoriasis not responding to or tolerating other drugs. REGISTRATION: The study was registered with Clinical Trial Registry of India (CTRI/2020/05/025198).

Assessment of adherence to medication during chronic illnesses in pregnancy.

PURPOSE/AIM: To evaluate adherence to medication in chronic illnesses during pregnancy and to identify factors responsible for non-adherence. METHODS: This was a prospective, cross-sectional, questionnaire based study initiated after approval of the institutional ethics committee. Pregnant women suffering from any chronic illness (except HIV) were questioned to evaluate adherence to medication in chronic illnesses during pregnancy and to detect factors responsible for non-adherence using a semi-structured, open-ended questionnaire. Adherence to medication was also assessed using 4-item Morisky's medication adherence scale. RESULTS: Rate of high adherence was significantly more (58.77%) with medications for chronic illness compared to medications for normal pregnancy (15.78%). Majority of women were more concerned about the chronic illness and believed that keeping the chronic illness under control is more important for normal growth of the baby. Unawareness about usefulness of each medicine and forgetfulness were the most common reasons for non-adherence to medications. Not taking prescribed dose was the most common type of non-adherence. Level of adherence positively correlated with level of education while it was inversely related to number of tablets per day. CONCLUSION: Higher adherence to medications for chronic illnesses during pregnancy is an encouraging finding but at the same time poor adherence to medications for normal pregnancy is a matter of concern. Most of the issues responsible for non-adherence to medication as reported in this study can be resolved to a significant extent by planning and implementing interventions aimed at improving adherence to treatment during pregnancy in which health professionals play a major role.

Comparative evaluation of efficacy and tolerability of vilazodone, escitalopram, and amitriptyline in patients of major depressive disorder: A randomized, parallel, open-label clinical study.

OBJECTIVES: To evaluate and compare efficacy and tolerability of Vilazodone with Escitalopram and Amitriptyline in patients of major depressive disorder(MDD). METHODS: This was a randomized, prospective, parallel-group, open label clinical study in which newly diagnosed patients of MDD were randomized to receive Tab Vilazodone 20 mg daily or Tab Escitalopram 20mg daily or Tab Amitriptyline 75mg daily for 12 weeks. Antidepressant activity was assessed by change in score from baseline to week 12 on HAMD-17 and MADRS scales while change in score on HAM-A scale was used to assess antianxiety effect. Change in scores on the three scales was also compared between the three treatment groups. Severity and causality of adverse events were assessed by the modified Hartwig & Siegel scale and Naranjo scale respectively. Data was analyzed in accordance with per protocol analysis. RESULTS: Reduction in HAMD-17 and MADRS scores was significantly more in vilazodone group compared to the other two drugs indicating that vilazodone is more efficacious antidepressant. Number of remitters were also significantly more in the vilazodone group (n=11) compared to escitalopram (n=4) (p<0.05) and amitriptyline (n=0) (p<0.001) at 12 weeks. Similar results were also obtained with HAM-A score. Number of patients showing MADRS sustained response at 12 weeks was statistically significantly more in vilazodone (n=12) and escitalopram (n=12) groups compared to amitriptyline (n=01) (p<0.001). Reported adverse events were constipation and sedation(amitriptyline group); nausea and headache(escitalopram and vilazodone groups). These adverse events were of mild severity. Most adverse events belonged to probable category. CONCLUSION: Vilazodone is more efficacious and well tolerated antidepressant compared to escitalopram and amitriptyline.

Efficacy and Tolerability of Olmesartan, Telmisartan, and Losartan in Patients of Stage I Hypertension: A Randomized, Open-label Study.

OBJECTIVES: To compare the efficacy and tolerability of losartan, telmisartan, and olmesartan as antihypertensive agents and evaluate and compare their effects on lipid profile and blood glucose. MATERIALS AND METHODS: This was a randomized, open-label, parallel-group, comparative study conducted in sixty patients of Stage I hypertension. The eligible patients were randomly allocated into three treatment groups: (1) Tablet olmesartan (20 mg), (2) Tablet telmisartan (40 mg), and (3) Tablet losartan (50 mg). Blood pressure (BP) was assessed at an interval of 2 weeks for 3 months. Fasting blood glucose (FBG) and lipid profile were estimated at baseline and then at 12 weeks. RESULTS: Olmesartan and telmisartan were more efficacious than losartan in reducing diastolic BP (DBP). There was a statistically significant decrease in mean blood glucose level (P < 0.02) after 12 weeks of treatment in telmisartan group when compared to baseline. Serum total cholesterol, triglycerides, and low-density lipoproteins decreased significantly after 12-week treatment with olmesartan and telmisartan. CONCLUSIONS: The most efficacious drug in reducing BP is Olmesartan whereas telmisartan and losartan show equal efficacy. Telmisartan shows the most favorable effects on FBG and lipid profile.

Assessment of quality of life in epilepsy patients receiving anti-epileptic drugs in a tertiary care teaching hospital.

OBJECTIVES: Health-related quality of life (QOL) is an important outcome in epilepsy treatment. Very few studies have been carried out on the quality of life in epilepsy (QOLIE-31) in India. The present study aimed to determine the level of health-related QOLIE-31 in patients of epilepsy. MATERIALS AND METHODS: This was a cross-sectional, questionnaire-based study conducted in a tertiary care teaching hospital. Respondents were adults aged at least 18-year-old with a diagnosis of epilepsy. QOLIE-31 was used for collecting data on health-related QOL. The unpaired t-test or one-way analysis of variance was used to compare means of QOL scores between groups. RESULTS: Totally, 60 patients of epilepsy were included in the study. The mean (standard deviation) total score of QOLIE-31 was 64.61. A score of cognitive and medication effect were significantly better in carbamazepine group as compared to valproate group. CONCLUSIONS: Patients on monotherapy had a better QOL as compared to patients receiving polytherapy.

Evaluation of adherence to therapy in patients of chronic kidney disease.

OBJECTIVE: To evaluate adherence to medication and study factors associated with non-adherence in chronic kidney disease (CKD) patients. METHODS: A prospective, cross-sectional, questionnaire based study was conducted in Nephrology department of a super specialty hospital. Patients above 18 years of age, suffering from CKD from six months or more were interviewed using self-designed, semi-structured questionnaire to get information about adherence to medication, diet restriction and lifestyle modification (n = 150). Morisky medication adherence questionnaire was used to calculate overall adherence. In this higher score indicates poor adherence. Main outcome measures included prevalence of non-adherence and factors associated with the same. RESULTS: Average number of medicines taken by each patient was 8.0+1.612 (mean+SD) per day. Non-adherence to medication schedule was reported in 34% patients. Common causes of non-adherence were high cost (21.3%), complex dosing schedule (20%), fear of adverse effects (16%). Sixty-eight% patients were not aware about importance of taking each medicine. Sixteen% stopped taking medicines due to high cost. Forty-two% suggested that government should adopt measures to provide free medicines to poor patients. In Morisky medication adherence questionnaire high, medium and low adherence was reported in 7.3%, 55.3% and 37.3% of patients, respectively. Moderately positive correlation was observed between poor adherence and number of concurrent illnesses and number of medicines taken. CONCLUSION: Since majority of patients were not aware about importance of taking each medicine, creating awareness about the same is essential for improving adherence to therapy. Measures to provide free medicines to non-affording patients need to be implemented since high cost was other major cause of non-adherence.

Impact of medicine-related information on medicine purchase and use by literate consumers.

AIMS: To measure impact of information, education, and communication intervention (IEC) on rational medicine use, purchase, and stocking behavior. MATERIALS AND METHODS: This was a pre- and post-design, interventional study. Base data were collected in first visit, using pre tested questionnaire from 500 respondents, who were of either gender, English speaking, at least graduates, permanent residents, and willing to participate. IEC was framed based on problems identified from this data. First intervention was handouts distributed in the second visit, containing information on cost saving in medicine purchase. Second intervention was a lecture session on medicine prices, rational use of medicines, and tips on saving on medicine purchase. Five articles about medicine use and price differences were published in the local newspaper, over 10 days, formed third intervention. After 1 month, post-intervention data was collected using same instrument with some additional questions. Results were analyzed by Chi-square test using Graph Pad prism Version 3.0. RESULTS: Awareness about price variation, self-medication, expiry period, generic and brand quality increased post-intervention. Attitudes toward new, costly, brands, injections, sharing and reusing old prescriptions changed post-intervention. Behavioral changes in stocking habits, adherence to doctors' advice, getting cash memo, comparing prices, reading labels, were seen post-intervention. CONCLUSION: People carry false notions about medicines which influence their use and habits. This intervention successfully changed behavior and could bring awareness on many aspects of medicine use.

Prescribing pattern of medicines in chronic kidney disease with emphasis on phosphate binders.

OBJECTIVES: Patients with chronic kidney disease (CKD) suffer with multiple comorbidities and complications like secondary hyperparathyroidism and hyperphosphotemia. Altered mineral metabolism contributes to bone disease and cardiovascular disease. In patients of CKD, despite dietary phosphorus restriction, phosphate binders (PBs) are recommended to control phosphorous level. No studies about the utilization pattern of PBs in CKD patients have been reported from India. This study analyses the current prescribing trends in the management of CKD patients undergoing tertiary care with focus on PBs. MATERIALS AND METHODS: This cross-sectional, observational study was conducted in nephrology department of a government super speciality hospital over 8-month period from January to August 2011. Demographic, clinical, and medication details were collected in a specially designed proforma. RESULTS: A total 111 prescriptions were included in the study. Average number of drugs per prescription was 9.47. About 41.53% of the prescribed drugs were from the World Health Organization essential medicines list. Out of total prescribed drugs (1052), most commonly prescribed were vitamins and minerals (24.71%), cardiovascular drugs, (22.14%), and hematopoietic agents (20.15%). Considering individual drugs, five most commonly prescribed drugs were multivitamins (14.82%), iron (8.65%), folic acid (8.55%), calcium carbonate (8.17%), and calcitriol (5.60%). A total of 11.02% of prescribed drug were PBs. Among PBs, calcium carbonate was the most frequently prescribed and sevelamer was the least prescribed PB. No patient was prescribed lanthanum carbonate. CONCLUSION: This study identified a wide variety of drug classes including PBs prescribed in CKD patients. Although sevelamer hydrochloride has less side effects as compared to calcium salts, it was less prescribed since it is costlier.

Experimental evaluation of analgesic and anti-inflammatory activity of simvastatin and atorvastatin.

AIM: The aim of this study is to evaluate the analgesic and anti-inflammatory activities of atorvastatin and simvastatin in different experimental models in mice and rats. MATERIALS AND METHODS: Analgesic activity of simvastatin and atorvastatin was assessed in tail flick model in rats (n = 6), where it was compared with aspirin and tramadol and in acetic acid induced writhing in mice (n = 6), where it was compared with aspirin. Anti-inflammatory activity of statins was evaluated using carrageenin induced paw edema and formalin induced arthritis in rats. RESULTS: In the tail flick method, analgesic effect of tramadol was significantly more than the other drugs except at two observation times, when it was comparable to simvastatin and atorvastatin. Effect of simvastatin was found to be comparable to aspirin. In acetic acid induced writhing method, analgesic activity of simvastatin was comparable to that of aspirin while that of atorvastatin was significantly less. In carrageenin induced paw edema in rats, both simvastatin and atorvastatin showed anti-inflammatory activity which was comparable to aspirin. Both the statins exhibited significant anti-inflammatory activity (P < 0.01) in formalin induced arthritis model though less than aspirin (P < 0.05). CONCLUSION: The results of this study if substantiated by further experimental and clinical research suggest that simvastatin and atorvastatin may play an adjuvant role, which may be particularly beneficial in the treatment of inflammatory disorders, especially when there is coexisting dyslipidemia.

Study of impact of antitubercular therapy on quality of life.

INTRODUCTION: Many aspects of tuberculosis (TB) and its treatment can compromise patients' quality of life (QOL). Treatment of active TB requires prolonged therapy with multiple drugs that can lead to adverse reactions. There is considerable social stigma associated with TB, leaving the individual feeling shunned and isolated. Hence, it is necessary that for a thorough assessment of patients' health status, overall impact of TB on patient's QOL should be considered. MATERIALS AND METHODS: Thirty newly diagnosed smear positive cases of pulmonary TB, of either gender were interviewed using - WHO QOL BREF, which is a 26-item scale designed by WHO. It has four domains viz.: Physical health, psychological health, social relationships, and environment. Interviews were conducted thrice: Before starting treatment, after 2 months, and after 4 months of treatment. Controls ( n = 30) were selected from the general population and interviewed using same questionnaire. RESULTS: Before treatment, scores in all domains were significantly lower in patients than controls. Worst affected were physical domain followed by psychological. Gradual increase in scores was observed over the course of treatment, indicating positive effect of medical intervention on QOL. Despite improvements, the scores in physical and psychological domain after 4 months of treatment were still significantly lower in patients than in controls. CONCLUSION: Measurement of QOL in TB is essential to have an in-depth understanding of effect of disease on various dimensions of health. This would enable health care professionals to devise relevant interventions such as patient counselling which would be useful in further improving quality of TB control programs.

Effect of information, education and communication intervention on awareness about rational pharmacy practice in pharmacy students.

BACKGROUND: There is a growing indifference among the pharmacy practitioners towards their duty as information providers to the patients. The patients do not always get enough desired information about proper use of medicines from the prescribers also. This contributes to improper use of medicines by the patients. OBJECTIVES: To bring about awareness about rational pharmacy practice in pharmacy students for better service to the patients. MATERIAL AND METHODS: The final year students of Bachelor of Pharmacy (B. Pharm) from four colleges of Nagpur were enrolled for the study after informed consent. Their base knowledge was assessed through a written test which comprised of 27 objective questions related to rational pharmacy practice. This was followed by a series of seven articles on rational medicine use, published in leading local English news daily. The participants were reminded to read them on the day of publication of each article. As a backup, the articles were displayed on the notice board of respective colleges. Second intervention was a half day interactive session where series of six lectures were delivered to the participants on the right and wrong approaches in pharmacy practice. Posters about the do's and dont's of rational pharmacy practice were also displayed at the venue. The session was followed by a repeat test using the same pre-test to assess the change. Pre and post intervention data was compared using Fisher's Exact test. RESULTS: It was observed that the intervention did bring about a positive change in the attitude and knowledge of the final year Pharmacy students about rational pharmacy practice. DISCUSSION: The role of a pharmacist in health care provision is usually overlooked in India. Hence there is strong need for reinforcement in final year B. Pharm when most of the students go in for community service. Such interventions will be helpful in bringing about a positive change towards rational practice of pharmacy. CONCLUSION: This study showed that a properly timed and meticulously implemented intervention brings about a positive change in the attitude and knowledge of pharmacy students.

Pre and post-interventional pattern of self medication in three common illnesses in staff of a tertiary hospital.

OBJECTIVE: To find the pattern of self medication in three common illnesses (diarrhea, sore throat, common cold) in nonmedical staff of a tertiary care teaching hospital and to study the effect of IEC. MATERIALS AND METHODS: This was a cross sectional study carried out in 100 randomly selected nonmedical staff members. Participants were interviewed by a semi structured questionnaire to obtain information about practice of self medication in the three illnesses. In the second phase participants were educated about proper self medication using Information, Education, and Communication (IEC) intervention. In post test the same information was obtained from the participants using the same questionnaire. Pre and post intervention data was compared to see whether intervention has resulted in any change in the pattern of self medication. RESULTS: For all the three diseases the use of medicines including anti microbials did not decrease significantly after intervention. During post test significantly more number of participants were aware about warning symptoms of the disease and precautions to be taken in children and pregnant women. Even during pre intervention many participants were aware about non-pharmacological measures to be adopted in the treatment of these diseases which increased after intervention, though not significantly. CONCLUSION: It is possible to improve self medication practices for the treatment of common illnesses if appropriate IEC intervention is adopted. This requires that all related stakeholders should intensify efforts to educate the general public and ensure appropriate use of OTC medicines.