Comparative study on efficacy and safety of atorvastatin in combination with ezetimibe and atorvastatin monotherapy among patients with dyslipidemia – A randomized and double-blind study

Background: Dyslipidemia is defined as the high-density lipoprotein and apolipoprotein A (apo A) levels <10th percentile and/or total cholesterol, triglycerides, low-density lipoprotein (LDL), apolipoprotein B, or Lipoprotein (a) levels more than the 90th percentile. Aim and Objectives: This study aimed to compare the efficacy and safety of the fixed-dose combination of Atorvastatin and Ezetimibe with Atorvastatin monotherapy among patients with dyslipidemia. Materials and Methods: The present study was a randomized, double-blinded, prospective, and parallel-group study. Ninety-two outpatients of age in between 18 and 70 years from the Department of General Medicine who attended the hospital for the treatment of dyslipidemia were selected as study participants. Among 92 patients, 12 patients did not meet the study criteria. The remaining 80 patients were divided into two treatment groups at random and under double-blind conditions (39 in Group A and 41 in Group B). Each patient in both groups was followed for a period of 4 weeks after initiation of therapy. Total cholesterol and LDL-cholesterol levels were recorded at day 1, 2 weeks, and 4 weeks of therapy. Results: In this study, by the end of the study period (4 weeks), tablet Atorvastatin + tablet Ezetimibe combination therapy showed statistical significance difference in reducing mean total cholesterol and mean serum LDL levels in dyslipidemia cases than the group receiving Atorvastatin monotherapy. Conclusion: Atorvastatin in combination with Ezetimibe was more efficacious than Atorvastatin monotherapy in reducing total blood cholesterol and serum LDL levels. Atorvastatin plus Ezetimibe is equally safer as Atorvastatin monotherapy and well tolerated with fewer adverse effects.

A comparative study on efficacy and safety of tablet duloxetine 60 mg and tablet gabapentin 300 mg among patients with diabetic polyneuropathy – A randomized double-blind study

Background: Diabetic peripheral neuropathy is defined as the presence of symptoms and signs of peripheral nerve damage among patients with diabetes, after ruling out other potential causes. Diabetic neuropathies are one among the most common long-term complications of diabetes. About 60% of diabetic patients are affected by neuropathy. Aim and Objectives: This study aims to study the efficacy and safety of tablet duloxetine 60 mg and tablet gabapentin 300 mg among patients with diabetic polyneuropathy. Materials and Methods: This study was randomized, comparative, double-blind parallel group study which was conducted for a period of 6 months. Sixty patients with diabetic polyneuropathic pain were randomly allocated into two groups. One group received duloxetine 60 mg and other group received gabapentin 300 mg. Efficacy was assessed using visual analog scale (VAS), short form of McGill pain questionnaire, and patients global impression of change score. Safety was assessed using adverse drug reaction profile. Results: In the duloxetine group, the mean VAS score at the baseline was 54.97 ± 6.75, and at 3 months, it was 20.07 ± 5.32 which was statistically significant. In the gabapentin group, the mean score at baseline was 53.57 ± 7.85, and at 3 months, it was 26.57 ± 4.39 which was also statistically significant. The difference between the baseline and 3rd month mean McGill score in both groups was statistically significant. Conclusions: We found that both duloxetine 60 mg once daily and gabapentin 300 mg once daily are effective in the treatment of diabetic polyneuropathic pain. However, duloxetine 60 mg once daily is more efficacious than gabapentin 300 mg once daily in the treatment of diabetic neuropathic pain. Both the drugs are well tolerated but gabapentin is better tolerated than duloxetine.

Effectiveness of a new non-hydrogen peroxide bleaching agent after single use - a double-blind placebo-controlled short-term study

Abstract Tooth whitening represents perhaps the most common aesthetic procedure in dentistry worldwide. The efficacy of bleaching depends on three aspects: bleaching agent, bleaching method, and tooth color. Objective: This in vivo study aimed to examine whitening effects on frontal teeth of the upper and lower jaws using an over-the-counter (OTC) non-hydrogen peroxide bleaching agent in comparison to a placebo after one single use. Material and methods: Forty subjects (25 female; 15 male) participated in this double-blind randomized placebo-controlled trial. The subjects were randomly allocated to two groups (n=20). The test group received the OTC product (iWhite Instant) and the placebo group received an identically composed product except for the active agents. Each subject was treated with a prefilled tray containing iWhite Instant or the placebo for 20 minutes. The tooth shade of the front teeth (upper and lower jaws) was assessed before (E_0), immediately after (E_1) and 24 h after treatment (E_2), using a shade guide (VITA classical). Statistical testing was accomplished using the Mann-Whitney U test (p<0.001). The dropout rate was 0%. Results: There were no significant differences at E_0 between placebo and test groups regarding the tooth color. Differences in tooth color changes immediately after (ΔE1_0) and 24 h after treatment (ΔE2_0) were calculated for both groups. The mean values (standard deviations) of tooth color changes for ΔE1_0 were 2.26 (0.92) in the test group and 0.01 (0.21) in the placebo group. The color changes for ΔE2_0 showed mean values of 2.15 (1.10) in the test group and 0.07 (0.35) in the placebo group. For ΔE1_0 and ΔE2_0 significant differences were found between the groups. Conclusion: In this short-term study, the results showed that a non-hydrogen peroxide bleaching agent has significant whitening effects immediately and 24 h after a single-use treatment.

Effects of Escitalopram on Anxiety in Patients with Acute Coronary Syndrome: A Randomized Controlled Trial

OBJECTIVE: There are no evidence-based practices for treating anxiety in patients with acute coronary syndrome (ACS). Thus, we investigated the effects of escitalopram on anxiety in this population. METHODS: We enrolled 217 patients with ACS who met Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for depressive disorders into a randomized double-blind placebo-controlled study. Patients received either escitalopram or placebo over a 24-week period. Anxiety symptoms were evaluated using the Hospital Anxiety and Depression Scale-anxiety subscale (HADS-A). A HADS-A score >7 was classified as an anxiety disorder. Baseline evaluations included sociodemographic and clinical characteristics, such as depressive symptoms, cardiovascular risk factors, and current cardiac status. RESULTS: Independent of improvements in depression and without any differences in safety profiles, escitalopram treatment was significantly more efficacious in treating and reducing anxiety than placebo over a 24-week period. CONCLUSION: Escitalopram can be recommended as an effective and safe treatment option for anxiety in patients with ACS.

Evaluation of the Efficacy and Safety of DA-9601 versus Its New Formulation, DA-5204, in Patients with Gastritis: Phase III, Randomized, Double-Blind, Non-Inferiority Study

This study compared the efficacy of DA-9601 (Dong-A ST Co., Seoul, Korea) and its new formulation, DA-5204 (Dong-A ST Co.), for treating erosive gastritis. This phase III, randomized, multicenter, double-blind, non-inferiority trial randomly assigned 434 patients with endoscopically proven gastric mucosal erosions into two groups: DA-9601 3 times daily or DA-5,204 twice daily for 2 weeks. The final analysis included 421 patients (DA-5204, 209; DA-9601, 212). The primary endpoint (rate of effective gastric erosion healing) and secondary endpoints (cure rate of endoscopic erosion and gastrointestinal [GI] symptom relief) were assessed using endoscopy after the treatment. Drug-related adverse events (AEs), including GI symptoms, were also compared. At week 2, gastric healing rates with DA-5204 and DA-9601 were 42.1% (88/209) and 42.5% (90/212), respectively. The difference between the groups was −0.4% (95% confidence interval, −9.8% to 9.1%), which was above the non-inferiority margin of −14%. The cure rate of gastric erosion in both groups was 37.3%. The improvement rates of GI symptoms with DA-5204 and DA-9601 were 40.4% and 40.8%, respectively. There were no statistically significant differences between the two groups in both secondary endpoints. AEs were reported in 18 (8.4%) patients in the DA-5204 group and 19 (8.8%) in the DA-9601 group. Rates of AE were not different between the two groups. No serious AE or adverse drug reaction (ADR) occurred. These results demonstrate the non-inferiority of DA-5204 compared to DA-9601. DA-5204 is as effective as DA-9601 in the treatment of erosive gastritis. Registered randomized clinical trial at ClinicalTrials.gov (NCT02282670)

The Effect of Nefopam on Postoperative Fentanyl Consumption: A Randomized, Double-blind Study

BACKGROUND: Nefopam is a non-opioid, non-steroidal, centrally acting analgesic drug. The concomitant use of opioids and nefopam is believed to have many advantages over the administration of opioids alone for postoperative pain management. We conducted a randomized, double-blind study to determine the fentanyl-sparing effect of co-administration of nefopam with fentanyl for postoperative pain management via patient controlled analgesia (PCA). METHODS: Ninety female patients who underwent laparoscopic total hysterectomy under general anesthesia were randomized into 3 groups, Group A, fentanyl 1,000 µg; Group B, fentanyl 500 µg + nefopam 200 mg; and Group C, fentanyl 500 µg + nefopam 400 mg, in a total volume of 100 ml PCA to be administered over the first 48 h postoperatively without basal infusion. The primary outcome was total fentanyl consumption during 48 h; secondary outcomes included pain scores and incidence of side effects. RESULTS: Eighty-one patients were included in the analysis. The overall fentanyl-sparing effects of PCA with concomitant administration of nefopam during the first 48 h postoperatively were 54.5% in Group B and 48.9% group C. Fentanyl use was not significantly different between Groups B and C despite the difference in the nefopam dose. There were no differences among the three groups in terms of PCA-related side effects, although the overall sedation score of Group B was significantly lower than that of Group A. CONCLUSIONS: The concomitant administration of nefopam with fentanyl for postoperative pain management may allow reduction of fentanyl dose, thereby reducing the risk of opioid-related adverse effects.

Comparison of Mirtazapine and Paroxetine in Patients with First-episode Climacteric Depression / 中国心理卫生杂志

Objective:To study the efficacy and safety of mirtazapine and paroxetine in patients with first-episode climacteric depression. Methods:A 8-week double-blind study was conducted with 90 female patients suffered with climacteric first-episode depression. Subjects were randomly assigned to either mirtazapine (n=45) or paroxetine (n=45). All subjects were evaluated with Hamilton Rating Scale for Depression-17 (HAMD-17), Hamilton Rating Scale for Anxiety,and Treatment Emergent Symptom scale (TESS) at baseline, the end of week 1, 4 and 8 after treatment. The study had lasted for 8 weeks.Results:The response rate between two groups (mirtazapine 88.9% vs paroxetine 82.2%) was similar. There were significant differences on the scores of HAMD between the two groups at the end of 1st and 8th week, and HAMA at the 1st week after treatment(21.3?3.5/25.2?2.9,18.2?3.2/21.5?2.4,t=-2.367、-3.514,P=0.042、0.032;7.2?3.5/9.8?2.3,t=-3.258,P=0.035). Mirtazapine had increased food appetite(15.6%), body weight(13.3%), hydropsia(8.9%), dry mouth(6.7%), sleep disorder and nausea(4.4%). Meanwhile paroxetine had dry mouth(22.2%), sleep disorder(20.0%), nausea(17.8%), tremor(15.6%), restlessness/agitation(13.3%) and sexual disturbance(11.1%).Conclusion:Mirtazapine has rapid response, strongly antidepressive effect in female climacteric first-episode patients and less side-effects.