A RANDOMISED, PROSPECTIVE, PARALLELAND OPEN LABEL STUDY TO COMPARE EFFICACY AND SAFETY OF METFORMIN PLUS ROSUVASTATIN AND GLIMEPIRIDE PLUS ROSUVASTATIN IN PATIENTS OF COEXISTING NON-ALCOHOLIC FATTY LIVER DISEASE (NAFLD) AND TYPE 2 DIABETES MELLITUS (T2DM)

2021 ◽  
pp. 46-49
Author(s):  
Prabhsimran kaur ◽  
Gurpreet Kaur Randhawa ◽  
Surinder Kumar Salwan
Keyword(s):  
Insulin Resistance ◽  
Treatment Options ◽  
Antidiabetic Drugs ◽  
Open Label ◽  
Alcoholic Fatty Liver ◽  
Open Label Study ◽  
Label Study ◽  
Group A ◽  
Group B ◽  
Lipid Parameters

Background and Objectives: NAFLD and T2DM has global prevalence of 55.5% with currently no approved treatment. There is insufcient data for its pharmacotherapy. The sharing of risk factors, most common being the insulin resistance between NAFLD and T2DM, makes the antidiabetic drugs, with effect on insulin resistance, the potential treatment options. The aim was to compare efcacy and safety of antidiabetic drugs i.e. Metformin and Glimepiride with concomitant Rosuvastatin in NAFLD coexistent with T2DM. Methods: Randomized, prospective, parallel and open-label study recruited 60 patients of concomitant NAFLD and T2DM after getting Institutional Review Board approval. Patients of either sex (20-60 years) with NAFLD (ultrasound diagnosed & raised AST 50-150 U/L) and T2DM(FBS> 126mg/dl) were recruited in medicine OPD after obtaining written informed consent. Chronic alcohol users and pregnancy cases were excluded. Patients were randomised into Group A[Rosuvastatin(10mg OD)+ Metformin(1gm BD)] & Group B[Rosuvastatin(10mg OD)+Glimepiride(3mg BD)]. Primary outcome was improvement in hepatic parameters and ultrasound grading of liver. Secondary outcomes were improvement in anthropometric, glycaemic and lipid parameters and assessment of safety. Results: Group A caused signicant(p<0.05) reduction in hepatic parameters(S.Bilirubin & AST). Group A and B showed non-signicant improvement(p>0.05) in ultrasound grading of liver, respectively (24% vs 20% patients). Intergroup difference was signicant(p<0.05) for weight and BMI in Group A. Both groups showed highly signicant(p<0.001) reduction in glycaemic parameters and signicant(p<0.05) reduction in lipid parameters. Both treatments were safe. Conclusion: Metformin plus Rosuvastatin seems to be more efcacious in NAFLD and T2DM over 90 days. These drugs could improve prognosis because of insulin sensitising action and additional benets in cancers, cardiovascular diseases. Further studies are required to strengthen these ndings which may help in nding a standard treatment for NAFLD and T2DM.

scholarly journals Pharmacokinetics of Oral Cholecalciferol in Healthy Subjects with Vitamin D Deficiency: A Randomized Open-Label Study

Nutrients ◽  
2020 ◽  
Vol 12 (6) ◽  
pp. 1553 ◽  
Author(s):  
Angelo Fassio ◽  
Giovanni Adami ◽  
Maurizio Rossini ◽  
Alessandro Giollo ◽  
Cristian Caimmi ◽  
...  
Keyword(s):  
Vitamin D ◽  
Vitamin D Deficiency ◽  
Healthy Subjects ◽  
High Dose ◽  
Open Label ◽  
Serious Adverse Events ◽  
Open Label Study ◽  
Label Study ◽  
Group A ◽  
Group B

Background: The aim of this study was to investigate the pharmacokinetic (PK) and safety profile of high-dose vitamin D supplementation, comparing different schedules (daily, weekly, or bi-weekly) in an otherwise healthy vitamin D-deficient population. Methods: Single-center, open-label study on healthy subjects deficient in vitamin D (25 (OH)D < 20 ng/mL), randomized to receive cholecalciferol (DIBASE®, Abiogen Pharma, Italy) using three different schedules: Group A: 10,000 IU/day for eight weeks followed by 1000 IU/day for four weeks; Group B: 50,000 IU/week for 12 weeks, Group C: 100,000 IU/every other week for 12 weeks. Total cumulative doses were: 588,000 IU, 600,000 IU, 600,000 IU. The treatment regimens corresponded to the highest doses allowed for cholecalciferol for the correction of vitamin D deficiency in adults in Italy. Results: mean 25 (OH)D plasma levels significantly increased from baseline 13.5 ± 3.7 ng/mL to peak values of 81.0 ± 15.0 ng/mL in Group A, 63.6 ± 7.9 ng/mL in Group B and 59.4 ± 12 ng/mL in Group C. On day 28, all subjects showed 25 (OH)D levels ≥20 ng/mL and 93.1% had 25 (OH)D levels ≥30 ng/mL. On day 56 and 84, all subjects had 25 (OH)D levels ≥30 ng/mL. No serious adverse events occurred during the study. Conclusions: normalization of 25 (OH)D serum levels was quickly attained with all the studied regimens. A more refracted schedule provided a higher systemic 25 (OH)D exposure.

scholarly journals Hyaluronic Acid/Trehalose Ophthalmic Solution in Reducing Post-Cataract Surgery Dry Eye Signs and Symptoms: A Prospective, Interventional, Randomized, Open-Label Study

2021 ◽  
Vol 10 (20) ◽  
pp. 4699
Author(s):  
Rita Mencucci ◽  
Eleonora Favuzza ◽  
Giulia Decandia ◽  
Michela Cennamo ◽  
Fabrizio Giansanti
Keyword(s):  
Hyaluronic Acid ◽  
Cataract Surgery ◽  
Dry Eye ◽  
Ophthalmic Solution ◽  
Signs And Symptoms ◽  
Ocular Surface Disease Index ◽  
Open Label ◽  
Open Label Study ◽  
Group A ◽  
Group B

The purpose of this prospective study was to evaluate the efficacy of the perioperative use of a hyaluronic acid (HA) and trehalose ophthalmic solution (Thealoz® Duo) in reducing post-cataract surgery dry eye signs and symptoms in patients with mild/moderate dry eye disease (DED). One hundred and twenty patients, scheduled for unilateral cataract surgery, were randomized into three groups: (1) group A: HA/trehalose three times/day in the preoperative week and for 5 postoperative weeks; (2) group B: HA/trehalose for only 5 postoperative weeks; (3) group C: no artificial tears. In groups A and B, OSDI (Ocular Surface Disease Index) questionnaire scores were significantly lower than group C at all the postoperative visits; in group A they were significantly lower than group B on the day of surgery, with similar results in the first and fifth weeks after surgery. In groups A and B, break-up time (BUT) was significantly higher than group C during the postoperative period (p ≤ 0.001). In comparison to the preoperative values, BUT in group A remained stable 7 days after surgery; however, in groups B and C, it significantly decreased. In conclusion, the HA/trehalose ophthalmic solution effectively reduced post-cataract surgery DED signs and symptoms in patients with mild/moderate DED, particularly if also administered in the preoperative period.

XP-828L in the Treatment of Mild to Moderate Psoriasis: Randomized, Double-Blind, Placebo-Controlled Study

2006 ◽  
Vol 10 (5) ◽  
pp. 241-248 ◽  
Author(s):  
Yves Poulin ◽  
Robert Bissonnette ◽  
Christina Juneau ◽  
Kim Cantin ◽  
Rejean Drouin ◽  
...  
Keyword(s):  
Severity Index ◽  
Controlled Study ◽  
Open Label ◽  
Double Blind ◽  
Open Label Study ◽  
Double Blind Placebo ◽  
Sweet Whey ◽  
Severity Index Score ◽  
Group A ◽  
Group B

Background: XP-828L, a protein extract obtained from sweet whey, has demonstrated potential benefit for the treatment of mild to moderate psoriasis in an open-label study. Objective: To study in a randomized, double-blind, placebo-controlled study the safety and efficacy of XP-828L in the treatment of mild to moderate psoriasis. Design: XP-828L 5 g/d (group A, n = 42) or placebo (group B, n = 42) was given orally for 56 days followed by XP-828L 5 g/d in group A and by XP-828L 10 g/d in group B for an additional 56 days. Results: Patients receiving XP-828L 5 g/d for 56 days had an improved Physician's Global Assessment (PGA) score compared with patients under placebo ( p < .05). Considering the data of group A only, the PGA score improved from day 1 to day 56 ( p < .01); the Psoriasis Area and Severity Index score improved as well, but to a lesser extent ( p < .05). Conclusion: Oral administration of 5 g/d XP-828L compared with a placebo significantly improved the PGA score of patients with mild to moderate psoriasis.

scholarly journals The efficacy of saxagliptin in T2DM patients with non-alcoholic fatty liver disease: preliminary data

2019 ◽  
Vol 65 (1) ◽  
pp. 33-37 ◽  
Author(s):  
Juan-Juan Li ◽  
Ping Zhang ◽  
Bing Fan ◽  
Xiu-Li Guo ◽  
Zhe-Shu Zheng
Keyword(s):  
Insulin Resistance ◽  
Liver Disease ◽  
Fatty Liver ◽  
Fatty Liver Disease ◽  
Liver Steatosis ◽  
Quantitative Detection ◽  
Alcoholic Fatty Liver ◽  
Group A ◽  
Group B ◽  
Alcoholic Fatty Liver Disease

SUMMARY OBJECTIVE To investigate the clinical efficacy and the possible mechanisms of saxagliptin in the treatment of type 2 diabetes mellitus (T2DM) combined with non-alcoholic fatty liver disease (NAFLD). METHODS A total of 95 T2DM and NAFLD patients were randomly divided into group A (saxagliptin group), group B (glimepiride group), and group C (glimepiride combined with polyene phosphatidylcholine group). RESULTS After intervention treatment for 24 w, body mass index (BMI), waist-to-hip ratio (WHR), glycated haemoglobin (HbA1c), fasting plasma glucose (FPG), fasting insulin (FINS), homeostatic model assessment of insulin resistance (HOMA-IR), interleukin-6 (IL-6), triglyceride (TG), total cholesterol (TC), alanine aminotransferase (ALT), aspartate aminotransferase (AST), γ-glutamyltransferase (γ-GT), and quantitative detection of liver steatosis of study subjects were observed, the action of liver steatosis in subjects of groups A and C were significantly different from those of group B; however, there were no differences between groups A and C. The FINS, HOMA-IR, and IL-6 of subjects in group A was lower than those in groups B and C; however, there were no significant differences between the latter two groups. CONCLUSION For T2DM combined with NAFLD patients, the saxagliptin treatment could not only effectively control blood glucose but also attenuate insulin resistance and inflammatory injury of the liver to improve fatty liver further.

scholarly journals The effect of Ramipril and Telmisartan on blood pressure and insulin resistance in hypertensive patients

2019 ◽  
Vol 8 (6) ◽  
pp. 1262
Author(s):  
Vaibhav Watts ◽  
Bhupinder Singh ◽  
Jaswant Rai
Keyword(s):  
Insulin Resistance ◽  
Blood Pressure ◽  
Angiotensin Ii Receptor ◽  
Open Label ◽  
Hypertensive Patients ◽  
Medical College ◽  
Group A ◽  
Receptor Blockers ◽  
Fasting Plasma Insulin ◽  
Group B

Background: Angiotensin converting enzyme (ACE) inhibitors and Angiotensin II Receptor Blockers (ARBs) have become keystones of therapy for hypertension but there are very few studies where they have been compared with each other. This study attempted to compare the effect of Ramipril and Telmisartan on Blood Pressure and Insulin Resistance in Hypertensive patients (JNC 8).Methods: An open label, randomized, prospective and comparative study of twelve- week duration was conducted on 60 patients of hypertension (JNC-8), with the collaboration of Department of Pharmacology and Department of Medicine, Government Medical College, Amritsar. Group A and B were given Telmisartan 40mg and Ramipril 2.5 mg OD respectively. Blood Pressure was recorded on every visit, whereas, fasting plasma insulin and HOMA-IR values were recorded at the baseline and at the end of the study. Fasting blood sugar was done at 0, 4 and 12 weeks.Results: At the end of 12 weeks, a significant reduction in Systolic/Diastolic blood pressure was observed in group A with a drop of ~14/9 mmHg (p<0.001) and in group B too, the fall of ~11.6/7.2 mmHg was significant (p<0.001). However, in inter-group comparison only SBP difference was significant between two groups (p<0.05). Change in HOMA-IR value was also significant in both the groups (p<0.001). The inter-group difference for HOMA-IR between both the groups (A vs B) was also statistically significant (p<0.01).Conclusions: Telmisartan 40 mg OD was more effective than Ramipril 2.5 mg OD in controlling the SBP and improving Insulin resistance at the end of 12 weeks.

scholarly journals A comparative study on safety and efficacy of tolperisone with etodolac and thiocolchicoside with etodolac in patients of acute low back pain with musculoskeletal spasm

2019 ◽  
Vol 8 (11) ◽  
pp. 2459
Author(s):  
Tanu Garg ◽  
Vijay K. Yadav
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Side Effects ◽  
Low Back ◽  
Open Label ◽  
Open Label Study ◽  
Acute Low Back Pain ◽  
Group A ◽  
Group B

Background: Low back pain is one of the most common health problems in society which leads to considerable disability, loss of work days, and puts a huge burden on socioeconomic and healthcare system. It is often associated with musculoskeletal spasm. The aim of the study was to compare the efficacy and safety of tolperisone and thiocolchicoside in combination with etodolac in patients of acute low back pain associated with musculoskeletal spasm.Methods: it was a prospective, randomized, open label study which included patients of either sex between age 18-50 years of acute low back pain with musculoskeletal spasm. Patients were allocated in two groups. Patients in ‘Group A’ were given tolperisone 150 mg + etodolac 400 mg twice a day and patients in ‘Group B’ were given thiocolchicoside 4 mg + etodolac 400 mg twice a day. Efficacy of two drugs was assessed by decrease in finger to floor distance (FFD), decrease in pain as per visual analog scale (VAS) and global assessment of efficacy of treatment by physician. Follow-up of the patients was done on day 3 and 7 of treatment. Various side effects reported by patients in both the groups were also recorded and compared.Results: Both tolperisone and thiocolchicoside caused significant decrease in FFD, reduced pain score thus indicating decrease in pain and spasm. Side effects reported in both groups were mild and did not result in discontinuation of therapy.Conclusions: Tolperisone was found to have efficacy similar to that of thiocolchicoside though number of side effects reported was more with tolperisone.

scholarly journals The effect of orlistat versus metformin on body composition and insulin resistance in obese premenopausal women: 3-month randomized prospective open-label study

2017 ◽  
Vol 4 ◽  
pp. 725-731 ◽  
Author(s):  
Magdalena Kujawska-Łuczak ◽  
Katarzyna Musialik ◽  
Monika Szulińska ◽  
Ewelina Swora-Cwynar ◽  
Angelina Kargulewicz ◽  
...  
Keyword(s):  
Insulin Resistance ◽  
Body Composition ◽  
Premenopausal Women ◽  
Open Label ◽  
Open Label Study ◽  
Label Study
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