Efficacy and safety of fixed dose combination of atorvastatin and hydroxychloroquine: a randomized, double-blind comparison with atorvastatin alone among Indian patients with dyslipidemia

2015 ◽  
Vol 31 (11) ◽  
pp. 2105-2117 ◽  
Author(s):  
Anil Pareek ◽  
Nitin Chandurkar ◽  
N. K. Thulaseedharan ◽  
R. Legha ◽  
Manish Agarwal ◽  
...  
Keyword(s):  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Indian Patients ◽  
Dose Combination ◽  
Blind Comparison

scholarly journals POST-MARKETING SURVEILLANCE STUDY TO SUBSTANTIATE THE EFFICACY AND SAFETY FOR THE COMBINATION OF PARACETAMOL, PHENYLEPHRINE AND CHLORPHENIRAMINE MALEATE IN INDIAN PATIENTS OF COMMON COLD

2021 ◽  
Vol 5 (7) ◽  
Author(s):  
Mayuresh Kiran ◽  
Lalit Pawaskar ◽  
Shaheen Sheikh ◽  
Pramita Waghambare
Keyword(s):  
Common Cold ◽  
Symptomatic Treatment ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Efficacy And Safety ◽  
Chlorpheniramine Maleate ◽  
Phenylephrine Hydrochloride ◽  
Indian Patients ◽  
Post Marketing Surveillance ◽  
Dose Combination

Introduction: Common cold is frequently occurring medical condition in developing countries like India. Common cold is self-limiting in nature so symptomatic treatment is always suggested. This study was conducted to test the efficacy and safety for the fixed dose combination of Paracetamol 500 mg, Phenylephrine Hydrochloride 10 mg and Chlorpheniramine Maleate 2 mg per tablet for the treatment of common cold. Methodology: Total 180 patients were enrolled out of which 159 completed the study. Efficacy assessment was done by decrease in total symptom score (TSS) of common cold at day 3 and 5 as compared to the baseline (day 1). Safety assessment was made by analyzing the reported adverse events through the study. Results: Mean TSS at baseline was 6.62 which was decreased to 3.55 at day 3 and was further decreased to 0.68 at day 5. Majority of patients had complete relief from the symptoms of common cold and nearly all the patients had >50 % reduction in TSS. Also no unexpected or serious adverse event was found to be reported in the study duration of 5 days. Conclusion:  Fixed dose combination of Paracetamol 500 mg, Phenylephrine Hydrochloride 10 mg and Chlorpheniramine Maleate 2 mg per tablet was found to be efficacious and safe for the symptomatic treatment of common cold in Indian patients. Keywords: Common cold, Paracetamol, Chlorpheniramine Maleate and Phenylephrine

scholarly journals Correction of vitamin D insufficiency with combined strontium ranelate and vitamin D3 in osteoporotic patients

2014 ◽  
Vol 170 (3) ◽  
pp. 441-450 ◽  
Author(s):  
R Rizzoli ◽  
B Dawson-Hughes ◽  
J-M Kaufman ◽  
P Fardellone ◽  
M L Brandi ◽  
...  
Keyword(s):  
Vitamin D ◽  
Strontium Ranelate ◽  
Vitamin D Insufficiency ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Primary Osteoporosis ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Hydroxyvitamin D ◽  
Dose Combination

ObjectiveThis study aims to investigate the efficacy and safety of oral fixed-dose combination of strontium ranelate 2 g/vitamin D31000 IU daily vs strontium ranelate 2 g daily for correcting vitamin D insufficiency in osteoporosis.DesignA 6-month international, randomized, double-blind, parallel-group, phase 3 study.MethodsA total of 518 men and postmenopausal women aged ≥50 years with primary osteoporosis (T-score ≤−2.5s.d.) and serum 25-hydroxyvitamin D (25(OH)D) >22.5 nmol/l were included. Patients were allocated to strontium ranelate 2 g/vitamin D31000 IU daily (n=413) or strontium ranelate 2 g daily (n=105). The participants received calcium 1 g daily. The primary endpoint was serum 25(OH)D at last post-baseline evaluation during 3 months.ResultsBoth groups were comparable at baseline. Mean baseline of 25(OH)D was 44.1±14.6 nmol/l. After 3 months, the percentage of patients with 25(OH)D ≥50 nmol/l was higher with strontium ranelate/vitamin D3vs strontium ranelate (84 vs 44%,P<0.001; adjusted between-group odds ratio=6.7; 95% CI, 4.2–10.9). The efficacy of the fixed-dose combination on 25(OH)D was maintained at 6 months (86 vs 40%,P<0.001). Mean 25(OH)D was 65.1 and 49.5 nmol/l, respectively, after 3 months and 66.9 and 45.4 nmol/l after 6 months. Physical performance improved in both groups. Falls were 17 and 20% in the strontium ranelate/vitamin D3and strontium ranelate groups respectively. Parathyroid hormone levels were inversely correlated with 25(OH)D. No clinically relevant differences in safety were observed.ConclusionsThis study confirms the efficacy and safety of fixed-dose combination of strontium ranelate 2 g/vitamin D31000 IU for correction of vitamin D insufficiency in osteoporotic patients.

Sign in / Sign up

Export Citation Format

Share Document