Tablets In Patients Research Articles

Long-term Efficacy of Cladribine Tablets in Patients with Relapsing-Remitting or Secondary Progressive Multiple Sclerosis: Analysis of Real World Data From the Italian Multiple Sclerosis Registry (CLARINET-MS) (1511)

Long-term Efficacy of Cladribine Tablets in Patients with Relapsing-Remitting or Secondary Progressive Multiple Sclerosis: Analysis of Real World Data From the Italian Multiple Sclerosis Registry (CLARINET-MS) (1511)

Pharmacokinetics and safety of olaparib in patients with advanced solid tumours and mild or moderate hepatic impairment.

Olaparib, a potent oral poly(ADP-ribose) polymerase inhibitor, is partially hepatically cleared. We investigated the pharmacokinetics (PK) and safety of olaparib in patients with mild or moderate hepatic impairment to provide dosing recommendations. This Phase I open-label study assessed the PK, safety and tolerability of single doses of olaparib 300-mg tablets in patients with advanced solid tumours. Patients had normal hepatic function (NHF), or mild (MiHI; Child-Pugh class A) or moderate (MoHI; Child-Pugh class B) hepatic impairment. Blood was collected for PK assessments for 96 hours. Patients could continue taking olaparib 300 mg twice daily for long-term safety assessment. Thirty-one patients received ≥1 dose of olaparib and 30 were included in the PK assessment. Patients with MiHI had an area under the curve geometric least-squares mean (GLSmean) ratio of 1.15 (90% confidence interval 0.72, 1.83) and a GLSmean maximum plasma concentration ratio of 1.13 (0.82, 1.56) vs those with NHF. In patients with MoHI, GLSmean ratio for area under the curve was 1.08 (0.66, 1.74) and for maximum plasma concentration was 0.87 (0.63, 1.22) vs those with NHF. For patients with mild or moderate hepatic impairment, no new safety signals were detected. Patients with MiHI or MoHI had no clinically significant changes in exposure to olaparib compared with patients with NHF. The safety profile of olaparib did not differ from a clinically relevant extent between cohorts. No olaparib tablet or capsule dose reductions are required for patients with MiHI or MoHI.

COMPARison of pre-hospital CRUSHed vs. uncrushed Prasugrel tablets in patients with STEMI undergoing primary percutaneous coronary interventions: Rationale and design of the COMPARE CRUSH trial

Dual antiplatelet therapy constitutes the cornerstone of medical treatment in patients with ST elevation myocardial infarction (STEMI). However, oral antiplatelet agents, such as prasugrel or ticagrelor, are characterized by slow gastrointestinal drug absorption in the acute phase of STEMI, leading to decreased bioavailability and therefore delayed onset of platelet inhibition. Evidence suggests that administration of crushed tablets of the P2Y12 inhibitor prasugrel improves drug absorption and achieves earlier antiplatelet effects in STEMI patients undergoing primary percutaneous coronary intervention (PCI). However, the clinical implications of these pharmacokinetic and pharmacodynamic findings are unknown. The present study is designed to test the hypothesis that patients presenting with STEMI planned for primary PCI will have improved markers of optimal reperfusion and clinical outcomes by prehospital administration of crushed tablets of prasugrel loading dose. COMPARE CRUSH (NCT03296540) is a randomized trial in a regionally organized ambulance care setting evaluating the efficacy and safety of pre-hospital loading dose with prasugrel crushed tablets versus integral tablets in approximately 674 patients presenting with STEMI planned for primary PCI. The independent primary endpoints are percentage of patients reaching thrombolysis in myocardial infarction (TIMI) flow grade 3 in the infarct-related artery at initial angiography, or achieving ≥70% ST-segment elevation resolution at 1 hour post-PCI. Secondary clinical endpoints are death, myocardial infarction, revascularization, and stent thrombosis followed up to 1 year. Moreover, the primary safety endpoint is bleeding events assessed at 48 hours. The COMPARE CRUSH trial will assess whether prehospital administration of loading dose prasugrel in form of crushed tablets - which is expected to provide faster platelet inhibition compared to standard treatment with integral tablets - results in improved reperfusion and clinical outcomes. RCT# NCT03296540.

Development and Validation of a UPLC–MS/MS Method for Simultaneous Determination of Lbpt and its Metabolites in Human Plasma

Aim: A UPLC-MS/MS method was developed to determine LBPT as well as its four metabolites in human plasma to support the clinical study aiming to evaluate the efficacy of LBPT tablet in patients undergoing hip/knee replacement. Methodology: Plasma samples were prepared by protein precipitation and then separated on a C18 analytical column using (A) acetonitrile(B) 0.1% formic acid and 10mM ammonium formate in water. The detection was performed on a triple quadrupole tandem mass spectrometer in positive electrospray ionization using multiple reactions monitoring mode. Results & conclusion: The method has been validated in accordance with the US FDA guidelines and was applied to the measurement of five analytes in human plasma samples from a Phase II clinical trial.

Safety and efficacy of extended release ketamine tablets in patients with treatment-resistant depression and anxiety: open label pilot study.

Background:Ketamine’s defining side effects are dissociation and increased blood pressure/heart rate. An oral formulation with delayed absorption could minimize these effects. We recently reported safety and tolerability data for an extended release ketamine tablet in healthy volunteers.Methods:To assess safety, tolerability, efficacy, and pharmacokinetics of an extended release oral ketamine tablet in patients with treatment-resistant depression/anxiety. This was a multiple dose open-label flexible dose uncontrolled study in seven patients with treatment-resistant depression/anxiety, who had all previously demonstrated mood improvement to subcutaneous ketamine. Assessments included ratings of anxiety, depression and dissociation, safety and tolerability, and blood samples for ketamine pharmacokinetics and brain-derived neurotrophic factor (BDNF) concentrations.Results:Improvements in anxiety and depression ratings occurred gradually over 96 h; all patients had >50% improvements in mood ratings. Ketamine was safe and well tolerated, with no changes in vital signs, and a single brief report of dissociation. Ketamine may induce its own metabolism, as the ratio of norketamine to ketamine increased out to 96 h. Serum BDNF concentrations did not change during the study.Conclusion:Ketamine’s safety/tolerability may be improved with an extended release oral formulation. Onset of mood improvement is slightly delayed compared with parenteral dosing. These data support the further development of extended release ketamine tablets for treatment of resistant depression and anxiety disorders.

Long Term Effectiveness of Cladribine in Patients Enrolled in the CLARITY Trial: Real World Experience from the Lebanese Cohort

Cladribine has been recently approved for treatment of relapsing remitting and active secondary multiple sclerosis (MS). However, long term data regarding its effectiveness beyond the trial period is still lacking. Objective: To assess retrospectively long term effectiveness of cladribine tablets in patients with relapsing remitting MS (RRMS) enrolled in the pivotal CLARITY/CLARITY Extension trial, at the American University of Beirut MS Center-Lebanon. Patients receiving at least one dose of cladribine were included in the final analysis. Baseline characteristics were extracted including age, gender,disease duration, EDSS, number of relapses in the previous 2 years and MRI lesions. The following outcome events were collected from the time of enrollment till the last follow-up visit at our MS center: EDSS, relapses conversion to secondary progressive MS (SPMS), new or Gd+ lesions on MRI and initiation of new DMTs. 24 patients were enrolled in the Clarity study, 2 of whom received placebo during Clarity and did not go into the extension. The average study duration was 3.6 (SD=1) years and the average follow up duration after study end was 6.2 years (SD=2.9). Overall the whole follow up was 9.8 years (SD=2). Out of 22 patients 13 started a new DMT during follow up. The annualized relapse rate (ARR) was 0.20 (95%CI=0.12-0.33) during the study and 0.20 (95%CI=0.14-0.29) during the post-study follow up. Out of 22 patients only 3 had an EDSS increase (+1.5, +1.5, +3.5) over the whole follow up period, 13 had a decrease and 6 were stable. Out of 22 patient, 2 converted to SPMS during follow up. MRI data will be reported. This is first report assessing the long term effectiveness of cladribine tablets in a cohort of patients enrolled in the original pivotal CLARITY/CLARITY Extension trials and followed for up to 10 years. Cladribine was highly effective inpreventing long term disability progression, relapses and conversion to SPMS.

Fixeddose combination of rosuvastatin + ezetimibe: ease of use, safety and efficacy

Today, cardiovascular diseases remain the leading cause of morbidity and mortality globally. Hyperlipidemia and dyslipidemia are key points in the occurrence and progression of CVDs, as well as the development of its complications. Elevated low density lipoprotein cholesterol (LDL-C) is the target of lipid-lowering therapy. The LDL-C target level is often not achieved in everyday clinical practice, which is especially important for patients at high and very high risk for cardiovascular complications. Furthermore, in some patient subgroups, atherogenic dyslipidemia is observed. Due to use of intensive and prolonged lipid-lowering therapy, the problem of its tolerability and patient adherence to the treatment becomes a live issue today. In addition, the use of drugs with effect that complements and enhances the effect of statin helps to achieve targets and improve long-term prognosis. Statins and ezetimibe are effective and widely used drugs to treat dyslipidemia. Clinical studies show that ezetimibe can be safely co-administered with statins to enhance lipid-lowering activity. In this regard, a statin and non-statin drug fixed-dose combination tablet may have additional advantages both for enhancing the lipidlowering effect and for greater patient convenience. Rosuvastatin is more effective than other statins in reducing low density lipoprotein cholesterol. The article provides a rationale for the possibility, efficacy, safety and convenience of using an ezetimibe and rosuvastatin fixed-dose combination tablet in patients with a high and very high risk and unattained target level of low density lipoprotein cholesterol.

Milk Products in the Treatment of Hypophosphatemic Rickets: A Pilot Study.

BackgroundStandard treatment of hypophosphatemic rickets (HR) is oral phosphate tablets plus vitamin D. Due to the rapid absorption of phosphate tablets, frequent daily doses are necessary, which is cumbersome and may cause fluctuations in plasma phosphate and risk of secondary hyperparathyroidism. It was hypothesized that phosphate from milk or cheese is less rapidly absorbed, and reduces fluctuations in plasma phosphate.ObjectivesThe current randomized, multiple crossover study aimed at investigating if an equivalent phosphate dose given as milk or cheese is comparable to phosphate tablets in patients with HR.MethodsSeven females with HR were included. They went through three different four-day treatment sessions of either oral phosphate tablets consisting of 800 mg elemental phosphorus divided into five doses over the day or an equivalent phosphorus dose ingested as skimmed milk or cheese divided over five daily doses. Blood and urine samples were taken from patients after each treatment session. Except the usual doses of vitamin D, no phosphate or calcium-modifying treatments were allowed. Statistical analyses were performed using mixed models.ResultsTreatment feasibility was independent of the phosphorus source. The study demonstrated reduced plasma levels of parathyroid hormone (PTH), reduced fluctuations in plasma phosphate and plasma PTH, and reduced renal phosphate excretion when ingesting phosphorus supplementation as milk compared to phosphate tablets. The same trend was observed when administering phosphorus as cheese, though not statistically significant.ConclusionsPhosphorus supplements can be administered as phosphate tablets, milk or cheese when given in equimolar doses. The current study findings indicated that milk may be superior to phosphate tablets as the phosphate source in patients with HR.

A Study of Oryz-Aspergillus Enzyme and Pancreatin Tablet in Patients With Cirrhosis and Malnutrition

A Study of Oryz-Aspergillus Enzyme and Pancreatin Tablet in Patients With Cirrhosis and Malnutrition

MON-PO458: A Cross-Over Trial of the Effects of Diet Rich in Vitamin K and Vitamin K Supplementation in Tablets in Patients with Vitamin K Deficiency in Hemodialysis. and the Effect of Boiling on the Content of Vitamin K in Broccoli

MON-PO458: A Cross-Over Trial of the Effects of Diet Rich in Vitamin K and Vitamin K Supplementation in Tablets in Patients with Vitamin K Deficiency in Hemodialysis. and the Effect of Boiling on the Content of Vitamin K in Broccoli

Safety and Effect Study of SHR0532 (Drug Code) Tablets in Patients With Mild Hypertension

Safety and Effect Study of SHR0532 (Drug Code) Tablets in Patients With Mild Hypertension

Adherence to Levothyroxine Tablet in Patients with Hypothyroidism.

IntroductionPatients with hypothyroidism are managed with life-long levothyroxine (LT4) therapy. However, as with other chronic illnesses, drug adherence (DA) is a prominent issue in these patients. The aim of this study is to identify the extent of DA to LT4 in hypothyroidism patients and study the clinical factors contributing to DA in these patients.MethodsThis cross-sectional study assessed patient adherence to LT4 therapy by Modified Morisky Adherence Scale (MMAS). Factors predicting the pattern of medication adherence were also assessed in all patients. Data were entered and analyzed using SPSS v. 22.0.ResultsOn MMAS, 79 (27.3%) participants indicated low adherence, 117 (40.48%) indicated medium adherence, and 93 (32.2%) participants indicated high adherence. Regular endocrinologist visits and knowledge about medication were highest in high adherent patients (p < 0.05). Need for assistance in taking medication, avoidance of medication with symptomatic relief and busy work schedule was highest in low adherent patients (p < 0.05).ConclusionPatients with hypothyroidism showed moderate adherence to their treatment.

Efficacy and safety of loxoprofen hydrogel patch versus loxoprofen tablet in patients with ankylosing spondylitis: A 4-week randomized, open-label study.

The aim of the present study was to assess the efficacy and safety of loxoprofen sodium hydrogel patch (LX-P) vs. loxoprofen sodium tablet (LX-T) in patients with active ankylosing spondylitis (AS). The study population consisted of patients who met the modified New York radiographic criteria for AS and had active disease. Patients were randomly assigned to either the LX-P group (LX-P 100 mg per day) or LX-T group (LX-T 60 mg 3 times daily) for 4 weeks. The primary efficacy endpoint was the percentage of patients reaching Assessment in Ankylosing Spondylitis 20% (ASAS20) response at week 4. Secondary efficacy outcomes included ASAS5/6 response rate and changes from baseline to week 4 for Ankylosing Spondylitis Disease Activity Score, patient's global assessment of disease activity, and pain score. Of the 70 randomized patients included, 35 patients were allocated to the LX-P group and 35 to the LX-T group. No significant differences were observed between the LX-P and LX-T groups in the proportion of patients achieving ASAS20 response at week 4 (54.3 vs. 74.3%; P=0.081), nor in the ASAS5/6 response and changes of efficacy outcomes between the two groups. Furthermore, patients without peripheral arthritis in the LX-P group were more likely to achieve ASAS20 response. There was a decreased incidence of gastrointestinal adverse events in the LX-P group, but this was not significant. There was no significant differences in efficacy and safety between topical LX-P and oral LX-T administration for patients with active AS.

Temporal profile of lymphocytes following treatment with cladribine tablets in patients switching from lymphocyte depleting or sequestering disease modifying drugs (DMDs) (P4.2-034)

Temporal profile of lymphocytes following treatment with cladribine tablets in patients switching from lymphocyte depleting or sequestering disease modifying drugs (DMDs) (P4.2-034)

Motive für die Nichtakzeptanz und Nichtnutzung einer Telemonitoring-Anwendung im häuslichen Umfeld durch multimorbide Patienten über 65 Jahre

BackgroundUser acceptance is a key indicator and driver for the use and implementation of telemonitoring applications (TMA) in healthcare. Despite various positive effects that previous studies have revealed for users of TMA, there are always patients who discontinue their participation in a telemedicine study or even decline participation. There is little evidence for the reasons for non-acceptance and non-use of TMA, especially in multimorbid patients at the age of 65 and over in their home environment. To close this research gap, this sub-study focuses on patient-reported reasons for non-acceptance and non-use of TMA in the home environment. MethodsThis study follows a mixed-method approach and focuses on patients’ perspective. Quantitative data collection took place via computer-assisted telephone interviews among all drop-outs and non-participants. Qualitative data were collected via semi-structured interviews with drop-out patients and non-users. Eligible patients were recruited consecutively by general practitioners, informed and included in the study according to the inclusion criteria. Amongst others, patients measured their vital signs (blood pressure, heart frequency, oxygen saturation, weight) via telemedical measures and sent them via tablet to a Care Coordination Center to ascertain the need for intervention. Collected data on non-acceptance and non-use of TMA were analyzed quantitatively and qualitatively. ResultsNine general practices in two German cities included a total of 177 patients according to the inclusion criteria. During the study, 61 study participants (34.5 %) dropped out, 80 patients (31.1 %) declined participation in the study. Drop-outs and non-participants were significantly older than active participants (p=.004 and p=.001, respectively). Predominant reasons for drop-out were the lack of the perceived added value and the content-related variety of the program on the patient's tablet, the missing interest/need for telemedical monitoring as well as the time spent participating in the study. Patients living alone, single and widowed patients reported significantly more difficulties in handling the hardware (tablet) (p=.040) and the program (Motiva) (p=.013) than married and cohabiting patients. These reasons were also reported mainly by female patients, patients aged 75 years and over, and those with a low level of education. ConclusionIn order to increase the acceptance and the added value of TMA for patients, the individual needs of the future target group should be analyzed at the beginning of the development. To ensure maximum user centricity, individual development steps should be continuously evaluated by the target group. TMA should be adapted to the functional abilities of elderly, multimorbid patients through, e. g., an appropriate design of the content, which is tailored to patients’ individual needs. TMA should be used to an appropriate degree to avoid overburdening and should fit unobtrusively into patients’ usual daily routine. For patient-specific acceptance of TMA, easy handling of the telemedical measuring and input devices is as important as the variety of offers on the platform and personal contact for technical queries. Special attention should be paid to patients who live alone, women, elderly patients over 75 years of age, and poorly educated patients in order to ensure full and easy access to technology-based telemonitoring for their own healthcare.

Sensory evaluation of edoxaban orally disintegrating tablets: an open-label interventional study (secondary publication)

BackgroundThis study involved a sensory evaluation of edoxaban orally disintegrating (OD) tablets in patients with nonvalvular atrial fibrillation who had been receiving the existing edoxaban film-coated tablets before the study.MethodsEdoxaban OD tablets 30 or 60 mg were prescribed for patients who had been receiving the existing 30- or 60-mg edoxaban film-coated tablets before the study. Each dose group was randomized into groups taking the tablets with or without water. After ingestion of the edoxaban OD tablet, each patient was asked to complete a sensory evaluation questionnaire (12 items).ResultsIn the evaluation of satisfaction with edoxaban OD tablets, 52.8% of the patients perceived “no difference” from the existing edoxaban film-coated tablets and 34.9% indicated that they were more satisfied with the OD tablets, thus demonstrating a relatively high degree of satisfaction. When asked about convenience and reliability in using edoxaban OD tablets, about half of the patients perceived “no difference” from the existing edoxaban film-coated tablets and the remaining half indicated preference for the OD tablets. Responses about taste, flavor, ease of ingestion, and motivation to continue taking edoxaban indicated the overall acceptance of the OD tablets. Recognition of edoxaban OD tablets was rated as “easy” by about half of the patients and “difficult” by the remaining half. Among all patients, 49.5% preferred a change to edoxaban OD tablets. The degree of satisfaction with taste, flavor, and ease of ingestion, as well as overall satisfaction, tended to be greater when the OD tablets were taken with rather than without water, and the percentage of patients who preferred a change was higher in the group taking the OD tablets with water.ConclusionsThis study indicated that the degree of satisfaction with taste, flavor, ease of ingestion, and convenience, as well as overall satisfaction, in addition to motivation to continue drug intake and sense of confidence were greater for OD tablets than for the existing edoxaban film-coated tablets. Edoxaban OD tablet is a promising formulation for inducing greater patient adherence to medication and therefore ensures better treatment response.Trial registrationUMIN-CTR UMIN000028788, registered 23-Aug-2017.

Evaluation of Tolerability of Trifluridine/Tipiracil Combination Tablet in Patients With Advanced/Recurrent Colorectal Cancer.

This study aimed to clarify the tolerability of a trifluridine/tipiracil combination tablet (TAS-102) in patients with advanced or recurrent colorectal cancer over 75 years of age. Patients were divided into groups under the age of 75 years (n=62), and 75 years and over (n=17). The treatment period with TAS-102 tablet, reasons for discontinuation, adverse events (AEs), and overall survival (OS) were compared between the groups. The incidence of AEs (including neutropenia, anemia, nausea, malaise, and anorexia) was similar for both groups and the treatment enforcement periods for different regimens were not statistically significant between the groups (p=0.207). No major differences were observed in the reasons for discontinuation, such as AEs or progressive disease, between the two groups. TAS-102 therapy for advanced/recurrent colorectal cancer is considered to be highly tolerable in patients 75 years and older. These findings are important for AE monitoring and guidance for patients taking TAS-102.

Comparison of therapeutic efficacy of antihistaminics and combinations of montelukast with allergic rhinitis

Allergic Rhinitis is basically a chronic disease that decreases quality of life. Antihistaminics have been used for the first time in allergic rhinitis. In the search for an alternative treatment in resistant allergic rhinitis, Montelukasts and their combinations have been used. Randomized double-blind controlled study. In our study, the effect on the quality of life of the compounds used recently be compared after 3 months of treatment. In this study, 7 groups of 40 patients, 18-65 years old were planned for each group. The number of females and males was equal in each group (20). The patients in group A and group B will be called for checks after 3 months of medical treatment in the C-D-E-F-G-H group without treatment for 3 months. The patients in Group C received 10 mg Rupatadin Fumarate tablets orally (1 * 1 single dose) before bedtime, 5 mg Levosetirizine Dihydrochloride tablets in the patients in Group D orally (1 * 1 single dose) before bedtime, 10 mg Montelukast Sodium tablets in patients in Group E Before oral (1 * 1 single dose), patients in Group F 5 mg Desloratadin + 10 mg Montelukast Sodium tablets orally (1 * 1 single dose) before bedtime, and patients in Group G Levocetirizine Dihydrochloride + 10 mg Montelukast Sodium tablet orally before bedtime (1 * 1 single dose) will be given. These treatments will continue for 3 months without interruption. The Rinokonjucivations Quality of Life Questionnaire (RQLQ) will be completed with a total of 28 questions. No significant superiority of the Rupatadine molecule to levocetirizine was detected. The score of the Montelukast areas was significantly low when compared to the Rupatadine and Levosetirizine groups. Combined Montelukastes were found to be much more effective than single antihistaminics and single montelukast. There was no difference in quality of life between the combined Montelukast. Antihistaminics are the first treatment option in patients with allergic rhinitis,In resistant cases, combinations with montelukast should be used.

Recomendaciones de uso de cladribina comprimidos en la esclerosis múltiple recurrente

Cladribine is a prodrug, a synthetic analogue of deoxyadenosine, approved for use as selective immune reconstitution therapy in very active recurring multiple sclerosis in adults. To review the development of the drug, its mechanism of action and the efficacy and safety data obtained to date, as well as to establish recommendations of Spanish experts for its use in clinical practice. The treatment of multiple sclerosis has been simplified with cladribine tablets, and two short courses of administration for two consecutive years (maximum 20 days) are needed to maintain an efficacy of up to four years after the first dose. Results of clinical trials have demonstrated the safety, tolerability and long-term efficacy of cladribine tablets in patients with recurring multiple sclerosis. Thus, patients treated with cladribine presented a significant reduction in the rate of flare-ups, in the risk of disability progression and in the development of new lesions in magnetic resonance imaging compared to those treated with placebo. In terms of safety, the treated patients had a higher frequency of lymphopenia, in relation to its mechanism of action, and of infections by herpes zoster virus. Long-term results with eight years' follow-up have shown that treated patients are not at greater risk of developing serious events, such as malignant neoplasms or opportunistic infections. Cladribine is the first short-course oral therapy that has been shown to be effective and safe in patients with very active recurring multiple sclerosis, and with a sustained effect over time. The recommendations of Spanish experts on its usage are a fundamental complement to the considerations described by the regulatory agencies.

Randomized clinical trial: a double-blind, placebo-controlled study to assess the clinical efficacy and safety of alginate-antacid (Gaviscon Double Action) chewable tablets in patients with gastro-oesophageal reflux disease.

The alginate-antacid Gaviscon Double Action (Gaviscon DA) has a combined acid-neutralizing and reflux-suppressing action. Response to treatment in a symptomatic gastro-oesophageal reflux disease (GERD) population has not yet been tested in a large-scale clinical study. The aim of this study was to assess the efficacy and safety of Gaviscon DA compared with matched placebo tablets in the reduction of upper gastrointestinal symptoms in patients with GERD. In this multicentre, randomized, double-blind, placebo-controlled study, adults with GERD symptoms (N=424) received Gaviscon DA or placebo tablets for 7 days. The primary endpoint was a clinically important reduction of at least 1.5 points in the Reflux Disease Questionnaire (RDQ) GERD dimension (combined heartburn/regurgitation) between baseline and the end of the treatment. Secondary endpoints included the change in RDQ score from baseline for individual RDQ dimensions and Overall Treatment Evaluation. A significantly greater proportion of patients treated with Gaviscon DA met the primary endpoint compared with placebo (47.8 vs. 33.2%, respectively, P=0.0031; odds ratio: 1.85, 95% confidence interval: 1.23-2.78). A significant treatment effect was also observed for heartburn, regurgitation and dyspepsia individually. Patients in the Gaviscon DA group rated their overall treatment response greater than patients in the placebo group [mean Overall Treatment Evaluation (SD): 3.2 (3.08) vs. 2.2 (3.34); P<0.001]. No notable differences in the incidence of adverse events were observed between treatments. The alginate-antacid combination, Gaviscon DA, is an effective and well-tolerated treatment to reduce reflux symptoms and associated dyspepsia in symptomatic GERD patients.