Tablets In Patients Research Articles

The Analgesic and Side Effects of Tramadol Hydrochloride Immediate-Release and Extended-Release Tablets in Patients With Chronic Low Back Pain.

There are no established treatments for low back pain. Conventional treatments includephysiotherapyand pharmacological treatments, such as non-steroidal anti-inflammatory drugs (NSAIDs). Recently, analgesics with mechanisms of action different from those of NSAIDs have emerged. Tramadol formulations have especially attracted attention for being effective among patients in whom NSAIDs are not entirely effective. However, they are associated with side effects that can disrupt treatment. Tramadol hydrochloride immediate-release and extended-release tablets havebeen recently launched. Herein, we report our experience with these formulations in chronic low back pain patients. To investigate the incidence of side effects and the analgesic effect of tramadol hydrochloride immediate-release and extended-release tablets in patients with chronic low back pain. This was a multicenter retrospective observational study. The study included patients prescribed tramadol hydrochloride immediate-release and extended-release tablets for chronic low back pain at 13 facilities in Japan between January 2021 and December 2023. The primary outcome was the incidence of side effects observed during the study period. The secondary outcomes were changes in the visual analog scale (VAS) score. The incidence of side effects was 37.7% (40/106 cases), which included constipation, nausea, drowsiness, and dizziness in 23 (21.7%), 13 (12.3%), 4 (3.8%), and 2 (1.9%) cases, respectively. The rate of treatment discontinuation owing to side effects was relatively low (16/106 cases, 15.1%). Furthermore, after four weeks of treatment, we found a significant reduction in the VAS scores for low back pain from baseline. This study shows the incidence of side effects following the administration of tramadol hydrochloride immediate-release and extended-release tablets. Regarding the breakdown of side effects, constipation, nausea, drowsiness, and dizzinesswere noted. Regarding pain evaluation, we found a significant reduction in the VAS scores for low back pain from baseline after four weeks of treatment, suggesting that tramadol hydrochloride immediate-release and extended-release tablets may provide excellent analgesic effects owing to their pharmacokinetic properties that ensure stable tramadol concentrations in the bloodstream.

The Superiority of Compressed Colchicine Tablets over Coated Colchicine Tablets for Familial Mediterranean Fever.

Background and Objectives: Familial Mediterranean fever (FMF) is an inherited autoinflammatory disease characterized by recurrent febrile attacks and serosal inflammation. The goals of FMF treatment are to prevent acute attacks and the development of amyloidosis. This study aimed to investigate the benefit of switching to compressed colchicine tablets in patients with FMF who are resistant or intolerant to the pharmaceutical preparation of coated colchicine tablets in terms of attack frequency and side effects. Materials and Methods: Patients who developed resistance and intolerance under coated colchicine tablet treatment and, therefore, switched to compressed colchicine tablets were identified. The attack frequencies and drug-related side effects in patients using the two different pharmaceutical colchicine preparations were compared. Results: The mean age of the 172 patients treated with compressed tablets alone following coated tablets was 36.3 ± 11.4 years, and 75 (43.6%) were male. The most common genetic mutation was detected as M694V in 111 (64.5%) patients, and 36 (20.9%) of them were homozygous. A decrease in the daily colchicine dose was found after switching to compressed colchicine tablets in patients followed for 7 years (2.1 ± 0.7 mg vs. 1.7 ± 0.5 mg; p < 0.001). Episodes lasted for one to three days and then resolved spontaneously. After treatment with the compressed tablet form of colchicine, 129 (75%), 33 (19%), and 10 (6%) patients had 0-3, 4-6, and more than 7 attacks, respectively (p < 0.001). Diarrhea and aminotransferase elevation, the most common side effects in patients using coated colchicine tablets, decreased after using compressed colchicine tablets (p < 0.001). Conclusions: Compressed colchicine tablets were shown to be effective in patients who did not respond to coated colchicine therapy and those with pre-treatment intolerance to biological agents.

Efficacy of Danlou tablets in patients with acute coronary syndrome undergoing percutaneous coronary intervention: a multicenter prospective cohort study.

Danlou tablets (DLTs) have been widely used to treat coronary heart disease in China. However, the benefits associated with DLT for patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) in routine practice require further investigation. To investigate the effectiveness of DLT in patients with ACS undergoing PCI. This multicenter prospective cohort study for patients with ACS undergoing PCI was conducted in 40 centers in mainland China from February 2012 to December 2018. This trial is registered under ChiCTR-OOC-14005552. Patients were assigned to either the DLT group or the conventional medicine (CM) group based on whether they used DLT prior to enrollment. The duration of DLT use (1.5 g, three times a day) was 12 months. The primary endpoint comprised of cardiac death, non-fatal myocardial infarction, and urgent revascularization. Secondary endpoint included rehospitalization owing to ACS, heart failure, stroke, and other thrombotic events. The Seattle Angina Questionnaire (SAQ) was used to assess quality of life (QOL). Primary and secondary endpoints were followed up for 36 months, and the SAQ was followed up for 12 months. The Cox proportional hazards regression model was used to analyze the independent effect of DLT on primary and secondary endpoints. Propensity score matching (PSM) analyses were performed to mitigate bias. Survival estimation was performed using Kaplan-Meier survival curves and log-rank tests in the PSM cohort, and landmark analyses were used for further evaluation of primary and secondary endpoints. Subgroup analyses and interactions confirmed the robustness of the findings. Linear mixed effects models were used to assess the QOL. Overall, 936 patients were enrolled in this cohort study, of whom 875 completed follow-up. The primary and secondary endpoints had no significantly difference between the DLT and CM groups after Cox proportional hazards models. Kaplan-Meier survival curves and log-rank tests performed in the PSM cohort also found no significant differences between the two groups on primary and secondary endpoints. However, landmark analysis showed significant benefit in the primary endpoint for the DLT group after 200 days (hazard ratio [HR] 0.46, 95% confidence interval [CI] 0.22-0.93, P = 0.03). Landmark analysis also showed a significant benefit in the secondary endpoint in the DLT group within 200 days (HR 0.33, 95% CI 0.15-0.73, P = 0.006). Moreover, DLT improves the SAQ summary score, and scores in the physical limitation, treatment satisfaction, and disease perception domains for patients with ACS undergoing PCI. DLT combined with conventional treatment reduced the risk of the primary endpoint after 200 days and the secondary endpoint within 200 days during the 3-year follow-up. Additionally, DLT can improve the QOL without adverse effects.

Evaluation of therapy satisfaction with cladribine tablets in patients with RMS: Final results of the non-interventional study CLEVER

BackgroundCladribine tablets for the treatment of relapsing multiple sclerosis (RMS) are administered in two pulsed treatment courses in two consecutive years, totalling a maximum of 20 treatment days. Here we present data collected shortly after the launch of cladribine tablets, focusing on the patient's perspective. The objective was to investigate patients’ perceived effectiveness, tolerability, and convenience, as well as global satisfaction of and with cladribine tablets. MethodsCLEVER was a non-interventional multicentre study conducted in Germany from 12/2017 to 7/2020. Adult patients with RMS initiating therapy with cladribine tablets were included. Observation time per patient was 24 weeks, comprising 3 visits (baseline, week 4 and 24). The primary endpoint was overall treatment satisfaction at week 24, assessed by the Treatment Satisfaction Questionnaire for Medication 14 items (TSQM 1.4). Subgroup analyses included stratification by prior treatment. ResultsIn total, 491 patients (69.2 % female; mean (±SD) age 40.3 (±11.5) years, 85.1 % pre-treated, median EDSS 2.5) initiated therapy with cladribine tablets and were included in the analysis. At week 24, the mean (±SD) global TSQM satisfaction score was 75.6 (±19.0). For patients switching from either injectables or oral medication, the change in therapy satisfaction from baseline to week 24 was positive in all TSQM domains with clinically meaningful effect sizes in the global satisfaction and side effects domains. Most patients (85.5 %) remained relapse-free over 24 weeks. Out of 491 patients, 187 (38.1 %) experienced at least one adverse event and 8 patients (1.6 %) one serious adverse event. ConclusionTreatment satisfaction with cladribine tablets was high. The switch from prior injectables or oral medication translated into increased treatment satisfaction at week 24 with clinically meaningful effects in the global satisfaction and side effects domains. Effectiveness and safety were consistent with results from clinical studies.

Safety of 300IR house dust mite sublingual tablet from pooled clinical trial and post-marketing data

BackgroundThe 300IR house dust mite (HDM) sublingual immunotherapy (SLIT) tablet is approved for treatment of HDM-induced allergic rhinitis (AR). To provide a comprehensive review of the 300IR HDM-SLIT tablet safety profile based on randomized controlled trial (RCT) pooled data and post-marketing (PM) pharmacovigilance data. MethodsSubjects (5–65 years) with confirmed HDM-AR with or without controlled asthma were treated with 300IR or placebo in 8 RCTs. Reported treatment-emergent adverse events (TEAEs) were pooled and analyzed descriptively in subsets of adults/adolescents and children. Adverse reactions (ADRs) collected from spontaneous reporting and PM studies through a pharmacovigilance system since the first marketing authorization were also analyzed. ResultsAcross RCTs, 1853 subjects were treated with the 300IR HDM-SLIT tablet and 1846 with placebo. In both subsets of adults/adolescents and children whichever their asthma status, treatment-related TEAEs of higher incidence in active groups vs placebo were mostly consistent with mild or moderate local application-site reactions. They were mainly reported on the first days of treatment and decreased over time. 4 severe laryngopharyngeal reactions (2 requiring adrenaline/epinephrine) and 1 moderate eczema considered serious rapidly resolved with medications; no anaphylaxis was reported. In PM settings, ADRs reported in more than 235,000 patients were in line with RCT findings. Severe systemic reactions occurred rarely; 12 anaphylactic reactions resolved safely (5 with adrenaline). No new safety signal was raised. ConclusionSafety data from RCTs and more than 7 years of real-life experience confirmed the favorable safety profile of 300IR HDM-SLIT tablet in patients across different regions, regardless of age and asthma status. Clinical trial registrationsNCT00674700; Retrospectively registered 06 May 2008.NCT01199133; Retrospectively registered 09 September 2010.NCT01527188; Retrospectively registered 01 February 2012.NCT02443805; Registered 29 April 2015/EudraCT 2014-004223-46; Registered 16 September 2015.jRCT2080221872/JapicCTI-121917; Registered 01 August 2012.jRCT2080222929/JapicCTI-15298; Registered 04 August 2015.

Treatment Preferences for Acute Allergic Reactions: A Discrete Choice Experiment

Background: Timely treatment of acute allergic reactions (AARs) is important to minimize reaction severity. Corticosteroid tablets dissolved in water are commonly used in mainstay treatment. A new oral film that dissolves on the tongue provides a faster and less cumbersome alternative to tablets for corticosteroid administration during AARs. This study evaluated patients’ preferences for attributes related to administration mode of corticosteroids in AARs. Methods: A web-based survey was sent to a sample from the adult Swedish population (≥18 years) with experience of corticosteroid treatment for AAR. We assessed the willingness to pay (WTP) for attributes related to corticosteroid treatment by applying a discrete choice experiment (DCE) approach. DCE attributes were administration mode, time to symptom relief, and price. The WTP for each attribute was derived using the attribute’s coefficient in a logistic regression analysis. We specified a forced choice (FC) and an unforced choice (UC) model. In the FC model, the respondents chose between 2 hypothetical treatments and in the UC model, between any of 2 hypothetical treatments and their current treatment. Results: The final study population included 348 subjects, of which 80% were women. All the evaluated DCE attributes were significant predictors for the treatment choice (p&lt;.001). In the FC model, the incremental WTP for an oral film compared with tablets was 409 Swedish kronor (SEK [≈€36.7]), with no other factors considered. In the UC model, the incremental WTP for the oral film compared with tablets was 574 SEK (≈€51.7). After considering the value of the respondents’ current treatment, the WTP for the oral film decreased to 336 SEK (≈€30.3). The total WTP was reduced by 17 SEK (≈€1.5) per minute of shorter time to symptom relief. Subgroup analyses showed that people with circulatory symptoms and experience of swallowing difficulties related to allergy medication had higher WTP for the oral film than the average respondent. Conclusion: The findings show a substantial economic benefit of the oral film vs tablets for patients with AARs in Sweden. This result remained also after compensation for the full value of the patients’ current treatment.

Treatment Preferences for Acute Allergic Reactions: A Discrete Choice Experiment

Background: Timely treatment of acute allergic reactions (AARs) is important to minimize reaction severity. Corticosteroid tablets dissolved in water are commonly used in mainstay treatment. A new oral film that dissolves on the tongue provides a faster and less cumbersome alternative to tablets for corticosteroid administration during AARs. This study evaluated patients’ preferences for attributes related to administration mode of corticosteroids in AARs. Methods: A web-based survey was sent to a sample from the adult Swedish population (≥18 years) with experience of corticosteroid treatment for AAR. We assessed the willingness to pay (WTP) for attributes related to corticosteroid treatment by applying a discrete choice experiment (DCE) approach. DCE attributes were administration mode, time to symptom relief, and price. The WTP for each attribute was derived using the attribute’s coefficient in a logistic regression analysis. We specified a forced choice (FC) and an unforced choice (UC) model. In the FC model, the respondents chose between 2 hypothetical treatments and in the UC model, between any of 2 hypothetical treatments and their current treatment. Results: The final study population included 348 subjects, of which 80% were women. All the evaluated DCE attributes were significant predictors for the treatment choice (p&lt;.001). In the FC model, the incremental WTP for an oral film compared with tablets was 409 Swedish kronor (SEK [≈€36.7]), with no other factors considered. In the UC model, the incremental WTP for the oral film compared with tablets was 574 SEK (≈€51.7). After considering the value of the respondents’ current treatment, the WTP for the oral film decreased to 336 SEK (≈€30.3). The total WTP was reduced by 17 SEK (≈€1.5) per minute of shorter time to symptom relief. Subgroup analyses showed that people with circulatory symptoms and experience of swallowing difficulties related to allergy medication had higher WTP for the oral film than the average respondent. Conclusion: The findings show a substantial economic benefit of the oral film vs tablets for patients with AARs in Sweden. This result remained also after compensation for the full value of the patients’ current treatment.

Comparison of Clinical Effects of Sacubitril Valsartan Sodium Tablets and Nifedipine Controlled-Release Tablets in the Treatment of Chronic Renal Insufficiency Complicated with Hypertension

Objective: To compare the clinical effects of using sacubitril valsartan sodium tablets with nifedipine controlled-release tablets in patients with chronic renal insufficiency combined with hypertension. Methods: 110 patients with chronic renal insufficiency combined with hypertension treated in our hospital from April 2023 to February 2024 were taken as the study subjects. They were divided into the test group (n = 55) and the comparison group (n = 55) by randomized numerical table method. The test group was provided with sacubitril valsartan sodium tablets and the comparison group was treated with nifedipine controlled-release tablets. The urine excretion rate of albumin and blood urea nitrogen levels as well as adverse effects were compared before and after treatment in both groups. Results: In the test group, the urinary albumin excretion rate was 101.77 ± 7.42 μg/min and the blood urea nitrogen level was 15.81 ± 1.76 mmol/L, which was much lower than that of the comparison group; the total rate of adverse reactions in the test group was 1.82%, which was significantly lower than that of the comparison group, the difference between the data of the test group and the comparison group after treatment is statistically significant (P &lt; 0.05). Conclusion: By providing treatment with sacubitril valsartan sodium tablets for patients with chronic renal insufficiency combined with hypertension, their urinary albumin excretion rate and blood urea nitrogen level are significantly improved, and the total occurrence rate of adverse reactions is low.

Post-marketing surveillance of quetiapine fumarate extended-release tablets in patients with bipolar depression.

This study aimed to verify the real-world efficacy and safety of quetiapine fumarate extended-release tablets (Bipresso® 50 mg and 150 mg; marketing authorization holder is KYOWA Pharmaceutical Industry Co., Ltd., Osaka, Japan) in patients with bipolar depression. We performed a post-marketing surveillance with an observation period of 12 weeks. In the safety analysis group (n = 345), adverse drug reactions (ADRs) occurred in 111 patients (32.17%). The most common ADRs (>1%) were somnolence in 55 patients (15.94%), akathisia in 11 (3.19%), dizziness in 10 (2.90%), weight increase in 6 (1.74%), thirst in 5 (1.45%), and hypersomnia, constipation, and nausea in 4 patients each (1.16%). The only severe ADR was one patient of suicidal ideation, and "longer time since the onset of the first episode" (p = 0.011) and "presence of complications" (p < 0.001) were identified as significant risk factors for the occurrence of ADRs. In the efficacy analysis group (n = 265), the average changes from baseline in the total Montgomery-Åsberg Depression Rating Scale (MADRS) score were -7.3 ± 8.8, -12.2 ± 10.7, -16.8 ± 12.7, and -13.2 ± 12.7 points after 4, 8, and 12 weeks, and at the last evaluation, respectively. The mean MADRS total score decrease had no significant association with maximum daily dose, diagnosis, and presence or absence of prior or concomitant treatment for bipolar disorder with mood stabilizers/antipsychotics/antidepressants. The efficacy of quetiapine fumarate extended-release tablets was confirmed in clinical practice, and no new safety concerns or risks were identified.

A randomized, double-blind, placebo-controlled, phase IIa, clinical study on investigating the efficacy and safety of SPH3127 tablet in patients with essential hypertension

Around 70% of patients diagnosed with hypertension exhibit increased levels of renin. SPH3127, an inventive renin inhibitor, has shown favorable tolerability and sustained pharmacodynamic inhibitory impact on plasma renin activity (PRA) during previous phase I trials. This phase II study was conducted to investigate the efficacy and safety of SPH3127 in patients with essential hypertension. This study was conducted in patients with mild to moderate essential hypertension, utilizing a randomized, double-blind, placebo-controlled design. The patients were administered either tablet of SPH3127 at doses of 50 mg, 100 mg, or 200 mg, or a placebo. A total of 122 patients were included in the study, with 121 patients included in the full analysis set. Among these patients, there were 30 individuals in each subgroup receiving different dosage regimens of SPH3127, and 31 patients in the placebo group. The reductions in mean sitting diastolic blood pressure (msDBP) after 8 weeks compared to baseline were 5.7 ± 9.5, 8.6 ± 8.8, and 3.8 ± 10.6 mmHg in the SPH3127 50-, 100-, and 200 mg groups, respectively. In the placebo group, the reduction was 3.1 ± 8.4 mmHg. The corresponding reductions in mean sitting systolic blood pressure (msSBP) were 11.8 ± 13.0, 13.8 ± 11.2, 11.1 ± 13.1, and 7.7 ± 9.7 mmHg in each respective group. SPH3127 is a promising drug for the treatment of patients with essential hypertension. The recommended dosage is 100 mg daily.Clinical trial registration: This study was registered in ClinicalTrials.gov (NCT03756103).

Prospective observational study to evaluate treatment satisfaction and effectiveness in patients with relapsing multiple sclerosis starting cladribine tablets (CLADREAL) in Italy.

Disease-modifying therapies (DMTs) for multiple sclerosis (MS) reduce relapse frequency, magnetic resonance imaging (MRI) activity, and slow disability progression. Numerous DMTs are approved for relapsing forms of MS although real-world data on patient-reported outcomes (PROs) and quality of life (QoL) are needed to inform treatment choice. Immune reconstitution therapy with cladribine tablets is a highly effective treatment for relapsing MS (RMS). We present the protocol for an observational study to prospectively assess the effectiveness of cladribine tablets on clinical and MRI parameters as well as on PROs, including treatment satisfaction, QoL, sleep quality, self-perceived health, fatigue, and physical function. Enrolled patients at study sites in Italy will be adults with RMS (including relapsing-remitting and active secondary progressive MS) who are either treatment naïve or have received at least one first-line disease modifying DMT or no more than one second-line DMT. The primary objective will be change in global treatment satisfaction measured with the Treatment Satisfaction Questionnaire for Medication Version 1.4 approximately 24 months after initiating cladribine tablets in patients switching from previous DMTs. Secondary objectives will include global treatment satisfaction at earlier timepoints, will comprise treatment naïve patients, and will quantify treatment effectiveness and tolerability. We will also assess relapses, disability progression, MRI activity, and other PROs at approximately 12 and 24 months. The findings will provide insight from daily clinical practice into the patient's experience to complement data from controlled trials and inform treatment choice. EU PAS Registration Number EUPAS49334 filed 17/10/2022.

Clonazepam tablets prescription in Santa Clara Municipality

Introduction: benzodiazepines are drugs used for anxiety and sleep disorders, as well as muscle relaxants and anticonvulsive. Despite being discouraged in prolonged treatments, some patients have chronic use, which is associated with the development of physical dependence, manifested in moderate to severe withdrawal symptoms when treatments is discontinued. Objective: to characterize the consumption profile of clonazepam 1mg tablets in patients with outpatient prescription in Santa Clara Municipality. Methods: a Medication Utilization Study was conducted aimed at assessing the prescription of the medication clonazepam 1mg tablets in the Santa Clara Municipality during the period from June 2021 to June 2023. Results: an increase of 198% was evidenced with respect to the initial number of reported outpatients and a predominance of patients over 60 years of age. Conclusions: the results showed the need to be more careful in the use of clonazepam due to the risk it presents in elderly patients together with the appearance of undesirable adverse effects.

The safety and efficacy of Houtou Jianweiling tablet in patients with chronic non-atrophic gastritis: a double-blind, non-inferiority, randomized controlled trial.

Background: Common symptoms of Chronic Non-atrophic Gastritis (CNAG) include nausea, stomach distension, and abdominal pain. The Houtou Jianweiling Tablet (HTJWT) is a chinese patent medicine (CN1368229A) and it has been used clinically for more than 20years with proven clinical efficacy in treating CNAG, prompted us to establish the clinical efficacy and safety of HTJWT on patients with mild to moderate CNAG symptoms in Pakistani population. Methods: This phase II, double-blind, randomized, parallel-controlled trial was conducted in a single center between November 2022 and February 2023 in Pakistan. In a ratio of 1:1, total 240 CNAG patients with erosion identified by pathological biopsy and gastroscopy were randomly assigned to control (Omeprazole) group (n = 120) and the treatment (HTJWT) group (n = 120). Patients in the treatment group received orally four HTJWT (0.38g/tablet), three times a day and one placebo of Omeprazole enteric-coated tablet prior to breakfast, daily. On the other hand, patients in the control group received one Omeprazole enteric-coated tablet (20 mg/tablet) prior to breakfast and four placebo of HTJWT, thrice a day. The patients consumed the investigated drugs (i.e., treatment and control) treatment regimen was followed for a duration of 28days. The safety of the patients were evaluated through adverse events, serious adverse events and laboratory tests such as blood biochemistry, urine analysis, liver and renal function tests. Vital signs like; blood pressure, pulse rate, body temperature, respiratory rate for all the patients were recorded. The cardiac status of the patients were assessed through electrocardiogram (ECG). The primary efficacy indicators were the improvement rate of gastric distention and gastralgia as the main clinical symptoms. Secondary indicators were visual analogue score (VAS); improvement rate of secondary clinical symptoms and signs; improvement rate of total clinical signs and symptoms; the disappearance/remission rate of Gastric pain and, remission/disappearance time of gastric distension; and the negative conversion rate of Helicobacter pylori (H. pylori). The outcomes among each group were compared using the chi-square test. Results: Patients in both groups had good drug compliance (80%-120%), and there was no statistically significant difference in the patients' baseline characteristics. The clinical improvement rate was found to be 91.1% in the treatment group and 91.0% in the control group with negligible variation among the two groups (p = 0.9824; 95% confidence interval: -0.0781-0.0798). Similarly, hardly no difference was found in the negative conversion rate of H. pylori between the treatment group and the control group (i.e., 70.1% and 71.8% respectively, p = 0.8125). There were no significant differences in respiratory rate, vital signs, blood pressure, laboratory results for blood biochemistry, urine analysis, liver and renal function tests between the two groups. The ECG assessment carried out for the treatment and control group revealed no considerable difference. Margin variation in the disappearance time of gastric pain (p = 0.1860) and remission rate (p = 0.5784) between the two groups were observed. The control group exhibited a faster remission period for gastrointestinal discomfort indications as compared to treatment group (p = 0.0430). Only one patient in the control group experienced mild to moderate adverse events, namely,; epigastric pain and dyspepsia. The results were consistent with the intention-to-treat and per-protocol analysis that included patients who were 100% compliant to the assigned therapy. Conclusion: The lower limit of confidence interval (CI, 95%) for the differences in the effective rate between the treatment and the control groups was found to be -0.0781 which is greater than -0.15, hence the treatment group is non-inferior to the control group. The therapeutic dosage used in the trial and treatment period did not cause any significant adverse event, and there were no obvious changes in the ECG profile, vital signs and biochemistry of the patients. Based on the clinical efficacy evaluation and reported adverse events, it can be concluded that the HTJWT is a safe and effective traditional chinese medicine for the treatment of patients suffering from chronic non-atrophic gastritis with mild to moderate symptoms. Clinical Trial Registration: [www.clinicaltrials.gov], identifier [NCT04672018].

Cladribine tablets after treatment with natalizumab (CLADRINA) - rationale and design.

Individual disease modifying therapies approved for multiple sclerosis (MS) have limited effectiveness and potentially serious side effects, especially when administered over long periods. Sequential combination therapy is a plausible alternative approach. Natalizumab is a monoclonal therapeutic antibody that reduces leukocyte access to the central nervous system that is associated with an increased risk of progressive multifocal leukoencephalopathy and disease reactivation after its discontinuation. Cladribine tablets act as a synthetic adenosine analog, disrupting DNA synthesis and repair, thereby reducing the number of lymphocytes. The generation of prospective, rigorous safety, and efficacy data in transitioning from natalizumab to cladribine is an unmet clinical need. To test the feasibility of transitioning patients with relapsing forms of MS natalizumab to cladribine tablets. Cladribine tablets after treatment with natalizumab (CLADRINA) is an open-label, single-arm, multicenter, collaborative phase IV, research study that will generate hypothesis regarding the safety, efficacy, and immunological impact of transition from natalizumab to cladribine tablets in patients with relapsing forms of MS. Participants will be recruited from three different sites. The primary endpoint is the absolute and percent change from baseline of lymphocytes and myeloid cell subsets, as well as blood neurofilament light levels. The secondary endpoint is the annualized relapse rate over the 12- and 24-month trial periods. Exploratory endpoints include the expanded disability status scale, and magnetic resonance imaging outcomes. The CLADRINA trial will generate data regarding the safety, efficacy, and immunological impact of the transition from natalizumab to cladribine. As the pace of immunological knowledge of MS continues, insight into disease modifying therapy transition strategies is needed.

Clinical Pharmacology of Pemafibrate Extended-release Formulation in Patients with Hypertriglyceridemia-A Phase 2, Multicenter, Active-controlled, Randomized, Single-blind, Crossover study.

Efficacy, safety, and pharmacokinetics of the selective PPARα modulator pemafibrate as once-daily extended-release (XR) tablets were compared with those of twice-daily immediate-release (IR) tablets in patients with hypertriglyceridemia. A multicenter, randomized, single-blind, active-controlled crossover, phase 2 clinical pharmacology study was performed in patients with hypertriglyceridemia. Patients were randomly assigned to IR 0.2 mg/day, XR 0.4 mg/day, or XR 0.8 mg/day before/after meals (fasted/fed) and treated for a total of eight weeks. The primary endpoint was percentage change in fasting serum triglycerides (TG). Of 63 randomized patients, 60 received the study drug. Patients were 78.3% male, mean age (±SD) 57.5±9.8 years, BMI 25.5±3.7 kg/m2, and fasting TG 221.3±68.1 mg/dL. Fasting serum TG decreased significantly from baseline in all groups (LS mean [95% CI];-43.6 [-47.7, -39.5] % for IR 0.2 mg/day, -41.1 [-45.1, -37.0] % for XR 0.4mg/day, -39.7 [-43.8, -35.6] % for XR 0.8 mg/day), indicating that XR 0.4 and XR 0.8 mg/day were not inferior to IR 0.2 mg/day. TG-lowering effects tended to be stronger for fed than fasted administration. MRTss, tmax, and t1/2 were longer for XR than for IR. Adverse events showed no major inter-group differences: 12.5% (5/40 patients) for IR 0.2, 17.5% (7/40) for XR 0.4, and 20.0% (8/40) for XR 0.8 mg/day. In patients with hypertriglyceridemia, XR substantially lowered TG at all doses, with maximum effectiveness at 0.4 mg/day, the dose approved in Japan, to a level comparable to IR 0.2 mg/day. There were no safety concerns up to 0.8 mg/day.

Efficacy of Sacubitril Valsartan sodium tablets in patients with heart failure combined with pulmonary infection and long-term recurrence rate.

To observe the therapeutic effect of Sacubitril Valsartan sodium tablets (SVST) on heart failure (HF) complicated by pulmonary infection (PI), and to provide a reference for future medication. A total of 89 patients with HF complicated by PI who were treated at Dongying People's Hospital from January 2019 to May 2020 were selected as study subjects in this retrospective study. The control group consisted of 41 patients who received conventional treatment, while the study group included 48 patients who received SVST in addition to conventional treatment. The time to disappearance/improvement of chest tightness, shortness of breath, cough, and moist rales in both groups were recorded. The levels of brain natriuretic peptide (BNP), interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), and procalcitonin (PCT) were measured before and after treatment. Changes in cardiac function were observed, and the Clinical Pulmonary Infection Score (CPIS) and Sequential Organ Failure Assessment (SOFA) were used to assess PI. The clinical efficacy and adverse reactions were evaluated after treatment. Follow-up lasted 2 years, during which the readmission rate due to HF and mortality rate were calculated. Patients in the study group experienced a shorter time to disappearance/improvement of chest tightness, shortness of breath, cough, and moist rales compared to the control group (all P<0.05). The study group also showed reduced levels of BNP, IL-6, TNF-α, and PCT, as well as lower CPIS and SOFA scores after treatment (all P<0.05), with significantly improved cardiac function (P<0.05). Additionally, the total effective rate was higher in the study group than in the control group (P<0.05), and there was no significant difference in adverse reactions between the two groups (P>0.05). Follow-up revealed no difference in mortality between the two groups (P>0.05), but the study group had a lower readmission rate (P<0.05). SVST is effective in treating HF complicated by PI, ensures a good prognosis for patients, and is recommended for clinical use.

Clinical Effect of Ilaprazole Enteric-Coated Tablets in Patients with Peptic Ulcer

Clinical Effect of Ilaprazole Enteric-Coated Tablets in Patients with Peptic Ulcer

Touch-screen automatisms in the digital age

ObjectiveTo describe a novel set of gestural automatisms related to the use of digital screens on smartphones and tablets in patients with epilepsy. MethodsRepresentative patients were selected from among those admitted to the Epilepsy Monitoring Unit at the Toronto Western Hospital between April 2016 and January 2020, and included if they exhibited automatisms clearly related to or mimicking digital device use. ResultsIn total 5 patients were included, 4 female. All had temporal lobe epilepsy: 2 had left mesial temporal sclerosis and 3 had normal imaging. Nearly equal numbers of seizures began with right (5/9) and left (4/9) temporal onsets, with most automatisms occurring after seizure propagation to bilateral temporal involvement (6/9). Left-handed automatisms were most common (8/9). The majority of the automatisms (7/9) were perseverative on device usage prior to the seizure. ConclusionGestural automatisms appear related to the contemporary lived experience, culture, and habitual behaviour of patients with epilepsy. In the modern era, the use of smartphones and tablets are both common and habitual for many, and this case series shows that touch-screen automatisms may be added to the semiological panoply of temporal lobe seizures.

Phase III study of bilayer sustained-release tramadol tablets in patients with cancer pain: a double-blind parallel-group, non-inferiority study with immediate-release tramadol capsules as an active comparator

PurposeWe investigated whether twice-daily administration of a bilayer tablet formulation of tramadol (35% immediate-release [IR] and 65% sustained-release) is as effective as four-times-daily IR tramadol capsules for managing cancer pain.MethodsThis randomized, double-blind, double-dummy, active-comparator, non-inferiority study enrolled opioid-naïve patients using non-steroidal anti-inflammatory drugs or acetaminophen (paracetamol) to manage cancer pain and self-reported pain (mean value over 3 days ≥ 25 mm on a 100-mm visual analog scale [VAS]). Patients were randomized to either bilayer tablets or IR capsules for 14 days. The starting dose was 100 mg/day and could be escalated to 300 mg/day. The primary endpoint was the change in VAS (averaged over 3 days) for pain at rest from baseline to end of treatment/discontinuation.ResultsOverall, 251 patients were randomized. The baseline mean VAS at rest was 47.67 mm (range: 25.6–82.7 mm). In the full analysis set, the adjusted mean change in VAS was − 22.07 and − 19.08 mm in the bilayer tablet (n = 124) and IR capsule (n = 120) groups, respectively. The adjusted mean difference was − 2.99 mm (95% confidence interval [CI] − 7.96 to 1.99 mm). The upper 95% CI was less than the predefined non-inferiority margin of 7.5 mm. Other efficacy outcomes were similar in both groups. Adverse events were reported for 97/126 (77.0%) and 101/125 (80.8%) patients in the bilayer tablet and IR capsule groups, respectively.ConclusionTwice-daily administration of bilayer tramadol tablets was as effective as four-times-daily administration of IR capsules regarding the improvement in pain VAS, with comparable safety outcomes.Clinical trial registrationJapicCTI-184143/jRCT2080224082 (October 5, 2018).

Clinical benefits with 300 IR HDM SLIT tablet in Europeans with house dust mite allergic rhinitis: Post hoc analysis of a large phase 3 trial

BackgroundHouse dust mite (HDM)-induced allergic rhinitis (AR) is a major cause of allergic respiratory disease. The efficacy and safety of the 300 IR HDM sublingual immunotherapy (SLIT) tablet in patients with moderate-to-severe HDM-AR was confirmed in a large, international, phase 3 randomized controlled trials (RCTs). Here, we analyzed the results in the European population. MethodsData from 91 European centers that participated in the international, double-blind, RCT (EudraCT 2014-004223-46, NCT02443805) with the 300 IR HDM SLIT tablet versus placebo over 12 months were analyzed post hoc. The treatment effect in European adults and adolescents was notably assessed through the European Academy of Allergy and Clinical Immunology (EAACI)-recommended combined symptom and medication score (CSMS0-6, pre-defined endpoint) and the total combined rhinitis score (TCRS0-24, post hoc endpoint, also balanced) during the primary evaluation period (4 weeks at the end of treatment period) using analysis of covariance (ANCOVA). ResultsThere were 818 patients who comprised the modified full analysis set in Europe. Over the primary period, the differences in CSMS0-6 and TCRS0-24 between the 300 IR and placebo groups were statistically significant (p < 0.0001): −0.32 (95%CI [-0.46; −0.17]) and −1.28 (95%CI [-1.63; −0.94]), respectively, with relative differences of −20.9% and −21.2%. All post hoc and the rhinoconjunctivitis quality of life endpoints were significantly improved with 300 IR versus placebo. The 300 IR HDM tablet was generally well tolerated. ConclusionThis RCT sub-analysis confirmed the 300 IR HDM SLIT tablet is an effective and safe treatment for European adults and adolescents with HDM-AR with clinically meaningful benefits from the patients' perspective. Trial registrationNCT02443805. Registered on April 29, 2015./EudraCT 2014-004223-46. Registered on September 16, 2015.