Safety and efficacy of donepezil hydrochloride in patients with mild to moderate Alzheimer's disease: Findings of an observational study.

BACKGROUND: Alzheimer's disease (AD), a progressive brain disorder, is the most common cause of dementia among the elderly. Donepezil hydrochloride is a potent, reversible, and highly selective inhibitor of acetylcholinesterase (AChE). It is chemically distinct from other cholinesterase (ChE) inhibitors which are effective in the treatment of AD. OBJECTIVES: To evaluate the safety and efficacy of donepezil hydrochloride therapy over a 12 weeks period in patients with mild to moderate AD in Indian population. MATERIALS AND METHODS: In this post-marketing study, patients with mild to moderate AD received oral donepezil hydrochloride 5 mg/day for 4 weeks followed by 10 mg/day for 8 weeks. Patients were assessed 4 times weekly for cognition on 'Mini Mental Status Examination (MMSE) scale', and function on 'Activities of Daily Living (ADL) index'. Clinicians and caregivers assessment of safety and efficacy was assessed on a 5-point rating scale. RESULTS: One hundred and seventy two of one hundred and eighty two patients completed 12 weeks of study period. MMSE score significantly improved (P<0.0001) from 16.72 at baseline to 19.77 after 12 weeks, and there was significant improvement (P<0.05) in ADL index in 13 of 17 domains after 12 weeks. Caregivers and clinicians rated the therapy as very good to good in >80% and >90% patients, respectively. Adverse events were consistent with the known pharmacological and safety profile of donepezil. CONCLUSIONS: Donepezil is well tolerated in Indian patients with mild to moderate AD with significant improvement in cognition and function.

Evaluation of eperisone hydrochloride in the treatment of acute musculoskeletal spasm associated with low back pain: a randomized, double-blind, placebo-controlled trial.

BACKGROUND: Eperisone hydrochloride is a centrally acting muscle relaxant inhibiting the pain reflex pathway, having a vasodilator effect. AIMS: To evaluate the efficacy and tolerability of eperisone in patients with acute musculoskeletal spasm associated with low back pain. SETTINGS AND DESIGN: Prospective, randomized, double-blind, placebo-controlled, multicentric trial conducted at five tertiary care orthopedic centers across India. MATERIALS AND METHODS: It was planned to enroll 240 patients of either sex between 18-60 years with acute musculoskeletal spasm (AMSP) with low back pain (LBP) due to spondylosis deformans, prolapsed disc or muscle sprain. Patients with other associated unrelated spasm conditions were excluded. Assessments were done for finger-to-floor distance (FFD), lumbar pain, Lasegue's sign, tenderness of vertebral muscles, need for rescue medication and response to therapy for efficacy and tolerability. STATISTICAL ANALYSIS: Parametric data were analyzed by 't' test and ANOVA, and non-parametric data were analyzed using Mann-Whitney 'U' test and Kruskall-Wallis test. Proportions were compared using Fischer's (Chi-square) test. RESULTS: Two hundred and forty patients were randomized to receive eperisone 150 mg/day in three divided doses (n=120) or placebo (n=120) for 14 days, of which 15 patients did not complete and 225 patients completed the study (eperisone, 112 and placebo, 113). Significantly greater improvement in FFD (P<0.001) from baseline on Day 14 was seen with eperisone (150.66 to 41.75) compared to placebo (138.51 to 101.60). Improvements in other parameters were greater with the eperisone group. For 89 (79.46%) patients the therapy was rated as good-excellent with eperisone compared to 43 (38.05%) patients with placebo. Nausea, abdominal pain, headache and dizziness were the common adverse events with both therapies. Rescue drug was needed by 40 (35.71%) eperisone patients and 83 (73.45%) placebo patients. CONCLUSIONS: Eperisone hydrochloride was effective and well tolerated for the treatment of patients with AMSP with LBP.

Randomised study to compare the efficacy and safety of isapgol plus atorvastatin versus atorvastatin alone in subjects with hypercholesterolaemia.

Soluble fibre has been shown to augment the cholesterol-lowering effects of low-fat diets in individuals with mild to moderate hypercholesterolaemia. Combination therapy with a statin poses advantages in certain settings and may allow use of lower doses of multiple drugs rather than maximum doses of a single drug. The primary objective of the study was to compare the efficacy of combination of isapgol and atorvastatin versus atorvastatin alone, in the same dose, in reduction of low-density lipoprotein cholesterol (LDL-C), total-cholesterol levels in hypercholesterolaemic patients after 12 weeks of therapy. In a 12-week study, 100 subjects from both sexes and of > 20 years having hyperlipidaemia, with LDL-C level > 130 mg/dl and total cholesterol > 220 mg/dl were included, and were randomised to receive either a combination of isapgol powder (Naturolax) 5.6 g twice daily and atorvastatin 10 mg once daily or atorvastatin 10 mg once daily alone orally. Serum levels of total cholesterol, LDL-C, high-density lipoprotein cholesterol (HDL-C), and triglyceride were assessed at 8 and 12 weeks. Ninety-seven patients completed the study. At the end of the 8th week, both the groups had a significant reduction in mean LDL-C (20.5% in isapgol + atorvastatin group and 16.0% among atorvastatin alone group) as compared to baseline. But between the groups, however, the difference was not significant. At the end of the 12th week fall in LDL-C at 31.4% for isapgol + atorvastatin was significantly greater than 22.8% among the atorvastatin group (p < 0.05). Serum total cholesterol, HDL-C and triglyceride were significantly lowered within the groups at 8th and 12th weeks but between groups, the difference was not significant. Comparison of adverse events profile in both the groups shows that more number of patients from atorvastatin alone group (n = 14, 28%) had adverse reactions than the number of patients from the combination group (n = 4, 8%; p < 005).

Evaluation of efficacy and safety of fixed dose combination of glimepiride 2 mg pluspioglitazone 15 mg plus metformin SR 500 mg in the management of patients with type-2 diabetes mellitus.

An estimated 25 million Indians currently have diabetes and the projections indicate Indians would be the largest group by the year 2025 AD. An open, phase III, multicentric study was conducted to determine the efficacy and tolerability of the triple drug combination glimepiride 2 mg plus pioglitazone hydrochloride 15 mg plus metformin SR 500 mg for 8 weeks in 101 Indian patients with type 2 diabetes mellitus. The study revealed that the triple drug combination could achieve the recommended goals, recommended by American Diabetic Association, for fasting blood glucose < or = 140 mg/dl and glycosylated haemoglobin (HbA1c) of < or = 8%. After 8 weeks, the mean fasting blood glucose (baseline 189.61) was reduced to 111.68 (41% reduction); the mean glycosylated haemoglobin (baseline 10.32) was significantly reduced to 7.54 (26% reduction). The triple drug combination significantly reduced the levels of triglyceride, low density lipoproteins and total cholesterol. These significant levels were achieved within 8 weeks and all patients tolerated the drug well with no reported case of serious adverse events including hypoglycaemia. There were also no reported drug interactions in the study. Since the decrease in HbA1c was continuous and throughout the study, a further decrease in the HbA1c levels would have been noted since the present trial was designed for a period of 8 weeks. Thus, the present study confirms the efficacy and safety of FDC of the triple drug combination in patients with type 2 diabetes.

Prescribing patterns among medical practitioners in Pune, India.

In 1975 the World Health Assembly requested the Director-General to advise Member States on the selection and procurement of essential drugs corresponding to their national health needs. We report here the results of a study of the prescribing patterns and rational drug utilization of medical practitioners of Pune, an industrial city in the west of India, which was undertaken by analysing their prescriptions. The results indicated a lack of rational prescribing practices by a significant number of practitioners. Fixed-dose formulations dominated the prescribing pattern and generic prescriptions were negligible, with prescriptions for essential drugs accounting for less than 60% of the total number of drugs prescribed. More than 30% of prescriptions were irrational, with the probability of such prescriptions increasing significantly with the number of drugs per prescription. A study of sources of drug formulations available for prescription revealed significantly more fixed-dose combinations, many of which were irrational. These results call for intervention strategies to promote rational drug therapy in India.