Comparative assessment of the effectiveness and tolerability of lornoxicam 8 mg BID and diclofenac 50 mg TID in adult indian patients with osteoarthritis of the hip or knee: A 4-week, double-blind, randomized, comparative, multicenter study.

BACKGROUND: Reports of cardiovascular adverse events (AEs) associated with the use of cyclooxygenase-2 inhibitors for the treatment of osteoarthritis (OA) have prompted the quest for a better-tolerated NSAID. OBJECTIVE: The aim of this study was to compare the effectiveness and tolerability of lornoxicam 8 mg BID and diclofenac 50 mg TID in adult Indian patients with OA of the hip or knee. METHODS: This 4-week, double-blind, randomized, comparative, multicenter study was undertaken to compare oral lornoxicam and diclofenac in patients with OA. Patients who met the selection criteria were enrolled consecutively from the outpatient clinics of each of the participating hospitals in India. Participants completed the Western Ontario and McMasters Individual Osteoarthritis Index (WOMAC-OA), WOMAC Composite Index (WOMAC-CI) (for pain, stiffness, and physical function), and a 10-cm visual analog scale (VAS) (0-10 where 0 = no pain and 10 = worst possible pain or severe or excruciating pain) at each study visit (weeks 0 [baseline], 2, and 4 [or at early termination]). Patients' and physicians' global assessments of arthritis control were measured at each study visit when laboratory and clinical AEs were also monitored. The primary end points were the WOMAC-OA, the WOMAC-CI, and VAS scores for pain among the patients who completed the study. RESULTS: Of the 273 patients (159 men, 114 women; mean [SD] age, 44.73 [10.72] years; range, 28-68 years) enrolled in the study, 13 (7 in the lornoxicam group and 6 in the diclofenac group) were lost to follow-up and their effectiveness and tolerability results were not included in the study analysis. Over the 4-week study period, both drugs provided significant (P < 0.05) sustained relief of OA symptoms compared with baseline. Compared with baseline, the mean pain score (WOMAC-CI) decreased 90.6% (13.88 [4.47] vs 1.30 [1.49]; P < 0.05) in the lornoxicam group and 88.9% (14.15 [4.56] vs 1.57 [1.49]; P < 0.05) in the diclofenac group after 4 weeks of treatment. After 4 weeks of treatment, the VAS pain score decreased from baseline 83.1% (8.04 [2.70] vs 1.36 [1.43]; P < 0.05) in the lornoxicam group and 79.3% (7.98 [2.98] vs 1.65 [1.47]; P < 0.05) in the diclofenac group. Compared with baseline, the improvement rated at 2 weeks was not significantly different between the 2 groups. Lornoxicam and diclofenac were well tolerated. The rate of mild to moderate adverse gastrointestinal events was not significantly different in the lornoxicam group compared with the diclofenac group (14.6% vs 18.4%). Similarly, overall tolerability between the 2 groups was not significantly different. None of the patients experienced cardiovascular AEs (eg, edema or increased blood pressure). CONCLUSION: The results of the present study suggest that lornoxicam was comparable to diclofenac in effectiveness and tolerability after 4 weeks of treatment in these adult Indian patients with OA of the hip or knee who completed the study.

Efficacy, safety and tolerability of salbutamol + guaiphenesin + bromhexine (Ascoril) expectorant versus expectorants containing salbutamol and either guaiphenesin or bromhexine in productive cough: a randomised controlled comparative study.

Patients with acute bronchitis, acute exacerbations of chronic bronchitis and asthmatic bronchitis suffer from cough with tenacious bronchial secretions requiring expectorants in addition to bronchodilating therapy. The present one-week, multicentric, prospective, randomised, double-blind study compared the efficacy and tolerability of three expectorant formulations in 426 patients with productive cough associated with varied aetiology after approval by the institutional review boards. Selected patients received 7 days' treatment with either fixed dose combination (FDC) of salbutamol 2 mg + bromhexine HCI 8 mg + guaiphenesin 100 mg (group A) or salbutamol 2 mg+ guaiphenesin 100 mg expectorant (group B) or salbutamol 2 mg + bromhexine 8 mg (group C) thrice daily after obtaining their informed consent. In group A, there was improvement of symptoms in a larger number of patients and earlier onset of action in reducing cough frequency and severity and improving sputum characteristics as compared to the other two groups. More patients in group A reported excellent efficacy (44.4%) as compared to only 14.6% in Group B and 13% in Group C. Cough expectorant containing salbutamol + bromhexine +guaiphenesin could be the expectorant of choice in alleviating productive cough since it scored in terms of efficacy as well as tolerability over salbutamol with either bromhexine or guaiphenesin alone.

Assessment of the efficacy and tolerability of a fixed dose combination of atorvastatin 10 mg + metformin SR 500 mg in diabetic dyslipidaemia in adult Indian patients.

Type 2 diabetes mellitus is associated with a marked increase in the risk of coronary heart disease (CHD) or stroke (by a factor of two to three compared with non-diabetic patients), and cardiovascular disease (CVD) accounts for the majority of deaths among patients with diabetes. A new fixed dose combination containing atorvastatin 10 mg + metformin SR 500 mg is being introduced in the Indian market for the treatment of dyslipidaemia in diabetic patients. The present study was therefore undertaken to assess efficacy, safety and tolerability of a fixed dose combination of atorvastatin 10mg + metformin SR 500mg in adult Indian patients with diabetic dyslipidaemia. The final protocol was approved by relevant ethics committee before the initiation of study. Informed consent was obtained from all the patients prior to enrollment in study. The total duration of study was 14 weeks including two weeks dietary run in period. Patients fulfilling the selection criteria received a single oral tablet of fixed dose combination of atorvastatin 10mg + metformin SR 500mg once daily for 12 weeks. The primary efficacy parameters were assessed by evaluating reduction in fasting and postprandial plasma glucose concentration levels at baseline and thereafter at each follow up visit at 2, 4, 8 and 12 weeks and plasma lipid profile and glycosylated Hb levels at baseline and end of study. The secondary efficacy parameters were assessed by evaluating percentage change from baseline at the end of the study (week 12) in the plasma concentration of the various lipid parameters such as total, HDL-, LDL- and very low density (VLDL)-cholesterol, triglycerides, Apo B, Apo A1, TC/LDL ratio, LDL/ HDL ratio, and percentage of patients achieving LDL-cholesterol goals as per NCEP ATP III guidelines. A total of 213 patients were enrolled in the study. Of these seven patients were lost to follow-up and considered as drop-outs. Therapy with the fixed dose combination of atorvastatin 10 mg + metformin SR 500 mg resulted in a significant reduction in the mean plasma fasting and postprandial glucose levels (35 and 38.8% respectively). There was a steep fall in the HbA1c levels from baseline levels of 8.76% to 6.74% (23.1%). There was also a significant (p < 0.05) reduction in mean total cholesterol (31.2%), LDL cholesterol (35.4%), VLDL-cholesterol (19.6%) and a significant increase HDL-cholesterol (9.5%). Thus there appeared to be trend towards reducing atherosclerosis following therapy with the fixed dose combination of atorvastatin 10 mg + metformin SR 500 mg. Mean body mass index was significantly reduced in the patients in the present study following therapy with the study drugs. The fixed dose combination of atorvastatin with metformin was well tolerated with mostly gastro-intestinal adverse events being reported in the current study. Moreover, most of the adverse events were mild to moderate in intensity and disappeared with continued treatment. In conclusion, the results of the present study suggest that, the fixed dose combination of atorvastatin 10 mg + metformin SR 500 mg is efficacious and well tolerated therapeutic modality in patients with diabetic dyslipidaemia. Furthermore this combination offers dosage convenience to the patient and by virtue of its dual mode of action is a useful addition to the therapeutic armamentarium for patients with diabetic dyslipidaemia.