An evaluation of the impact of antidiabetic medication on treatment satisfaction and quality of life in patients of diabetes mellitus.

AIMS: This study aims to measure the quality of life (QOL), treatment satisfaction, and tolerability of antidiabetic drugs in patients suffering from type 2 diabetes mellitus (DM). METHODS: The prospective, observational study was conducted in consenting patients of type 2 DM attending the outpatient department of a tertiary care hospital in Western India. The QOL instrument for Indian diabetes (QOLID) patients questionnaire and the Diabetes Treatment Satisfaction Questionnaire were administered to all patients at baseline, 3 months, and 6 months of treatment. Tukey-Kramer comparison test was used to analyze the difference in QOLID scores in various domains at baseline, 3 months, and 6 months. WHO-UMC scale, Naranjo's probability scale, Hartwig and Siegel, and Schumock and Thornton modified criteria were used to analyze the adverse drug reactions. RESULTS: A male preponderance was observed in 200 patients enrolled in the study. The mean duration of diabetes was 10.96 ± 5.99 years. The patients received metformin alone (40), metformin and glipizide (47), metformin, glipizide and other oral hypoglycemic agents (OHAs) (78), and OHAs and insulin (35). A significant improvement in fasting and postprandial blood sugar was observed at 6 months as compared to the baseline (P < 0.05). A total of 39 (19.5%) patients suffered from adverse effects to metformin and insulin. Physical health and physical endurance improved in patients receiving metformin alone or in combination with glipizide as compared to patients receiving other OHAs and/or insulin. Treatment satisfaction, highest in patients receiving metformin and least in those receiving insulin, was unaltered during the study period. CONCLUSIONS: While polypharmacy is evident, using lesser medicines offers better treatment satisfaction and QOL in DM. Periodic assessment of QOL and treatment satisfaction are recommended in DM.

Efficacy and Safety of Deferasirox in Pediatric Patients of Thalassemia at a Tertiary Care Teaching Hospital.

OBJECTIVE: To evaluate efficacy, safety and utilization pattern of deferasirox in paediatric patients of transfusion dependant ß Thalassemia Major at a tertiary care teaching hospital in Gujarat. MATERIALS AND METHODS: This observational, prospective-retrospective, single centre, continuous study was conducted in a tertiary care teaching hospital among paediatric patients of transfusion dependent ß Thalassemia Major. Patients treated with deferasirox for not more than 12 weeks were enrolled. Details of blood transfusions, relevant investigations performed every 3 weeks and 3 months and drugs used were recorded in a pretested case record form. Parents were provided with a diary to record the details of ADRs. Data were analyzed for demographic characteristics, number and mean volume of blood transfusions, changes in serum ferritin and iron levels, number and types of ADRs and progression, causality, severity and preventability of ADRs. RESULTS: Of the 60 patients enrolled, one patient was lost to follow up and four withdrew their consent. Of the remaining 55 patients, 36 were boys and 19 were girls (mean age: 6 ± 3.14 years), including patients of 1-3 years (11), 4-6 years (24), 7-10 years (12) and 11-12 years (8). Thirty six patients were born of consanguineous marriages. Adherence to blood transfusion guidelines and deferasirox prescribing and administration guidelines was observed. A serial and significant decrease in mean serum ferritin and serum iron at 3 weeks and 3 months with deferasirox treatment was observed in all age groups except that of 11-12 years. A total of 117 ADRs were observed in 52 patients from 19498 doses, most common being diarrhea (24), raised serum creatinine (15), raised hepatic enzymes (14), abdominal pain (14) and rashes (14). A reduction in dose was required in 32 cases, while a temporary stoppage was indicated in 41 cases. Deferasirox was the possible and probable cause of 65 and 51 ADRs respectively as assessed by WHO-UMC scale. Majority of ADRs were definitely preventable and mild in nature. CONCLUSION: ß Thalassemia Major is more common in males. A rational prescribing of deferasirox was observed. Deferasirox effectively reduced serum ferritin and serum iron levels in these patients.

A study of the use of carbamazepine, pregabalin and alpha lipoic acid in patients of diabetic neuropathy.

BACKGROUND: Diabetic peripheral neuropathy (DPN) is a common, symptomatic, long-term complication of diabetes mellitus. Many of the agents used to treat DN have not been compared with each other. This study was, therefore, undertaken to compare the efficacy and safety of carbamazepine, pregabalin and alpha-lipoic acid in diabetic neuropathy patients. METHODS: This was a prospective, observational study. The patients were categorized into three groups, Group I included those patients who were prescribed carbamazepine while group II included those on pregabalin and group III patients received alpha-lipoic acid. Each patient was followed up at every month for total duration of 6 months. Demographic details, presenting symptoms, history of diabetes, laboratory values pertaining to diabetes (Fasting blood sugar, Post prandial blood sugar and HbA1c) were recorded. Intensity of pain, using a visual analogue scale (VAS), diabetic neuropathy symptom (DNS) score and diabetic neuropathy examination (DNE) score were assessed at baseline and then at each monthly follow-up. Nerve conduction velocity (NCV) was also measured at baseline and then at the end of 3 and 6 months. RESULTS: A total of 101 patients were enrolled out of them 96 completed the study. Regarding VAS, the number of patients having pain was reduced substantially however, the speed and the quantum of this reduction were best in group II (pregabalin). Regarding DNS, also group II showed the best response in terms of number of patients as well as the speed of improvement. The results also imply that the relief from diabetic neuropathy (as per DNE score) is superior with pregabalin administration. However, no improvement in NCV was evident in any group. CONCLUSION: Results of this study suggest that treatment with pregabalin gives faster and better improvement in diabetic neuropathy.

A study of use of fixed dose combinations in Ahmedabad, India.

OBJECTIVE: The aim of this study was to evaluate the pattern of fixed dose combinations (FDCs) in Ahmedabad, a city in western part of India. MATERIALS AND METHODS: Over a period of 24 months, prescriptions were collected from 24 pharmacy stores across 6 zones of Ahmedabad city. The information was recorded in pre-formed Data Record Form after written consent from the patients (or relative (s) of the patients). The pattern of use of FDC, rationality and seasonal variation in their use were analyzed. At the end of study, results were analyzed using Chi-square test. RESULTS: Out of the total 1170 prescriptions, 941 (80.3%) contained 1647 FDC formulations. The average number of FDCs prescribed was 1.41 ± 1.04 (mean ± SD). The FDCs were more frequently prescribed in the age group of 31 to 40 years (23.7%) and in males (54.4%). FDCs were most commonly prescribed by oral route (92.7%). As per drug category analysis, a higher number of FDCs containing nutritional supplements (20.2%), and those for CNS (18.1%) complaints were prescribed. A seasonal analysis showed that FDCs were commonly prescribed for respiratory complaints (23.4%), central nervous system (CNS) complaints (20.3%) and as nutritional supplements (22.4%) in winter, monsoon and summer months, respectively. Only 5.8%, 9.8% and 10.9% FDCs prescribed were included in WHO (2010), National (2011) and Gujarat State (2011) Essential Medicines Lists (EML), respectively (P < 0.0001). Irrational FDCs that are banned or FDCs containing irrational active ingredients were 1343 (81.5%) and 203 (12.3%), respectively. CONCLUSION: FDCs are widely prescribed with seasonal influence in their use. FDCs containing banned or controversial ingredients are prescribed widely.

Intensive monitoring of adverse drug reactions in hospitalized patients of two medical units at a tertiary care teaching hospital.

OBJECTIVE: To detect incidence of adverse drug reactions (ADRs) in hospitalized patients and to assess their causality, seriousness, preventability, and the possible economic impact. MATERIALS AND METHODS: This was a prospective study carried out in two medical units at a tertiary care, teaching hospital, for about 18 months. All the admitted patients who developed an ADR after admission (group A) or who were admitted primarily for the treatment of an ADR (group B) were included. Descriptive statistics with 95% CI, χ(2), χ(2) for the trend and kappa test were used. RESULTS: Out of 6601 patients, 140 patients developed 154 ADRs with an incidence of 2.12%. Causality of the majority of the ADRs in group A was 'possible' while those in group B was 'probable'. Among 109 ADRs (34 serious) in group A, 38 were preventable. On the other hand, out of 45 serious ADRs in group B, 19 were preventable. The total cost of 154 ADRs in 140 patients was Rs. 1,49,803 with an average of Rs. 1070 per patient. The preventable cost for 57/154 ADR was Rs. 96,310. CONCLUSION: Around 2% of the hospital patients develop ADRs. A large number of these ADRs were preventable. A substantial saving can be made if adequate caution is exerted.