Monotherapy For Treatment Of Patients Research Articles

Combining Antidepressants vs Antidepressant Monotherapy for Treatment of Patients With Acute Depression

Combining antidepressants is frequently done in the treatment of acute depression, but studies have yielded conflicting results. To conduct a systematic review and meta-analysis assessing efficacy and tolerability of combination therapy. Combinations using presynaptic α2-autoreceptor antagonists or bupropion were investigated separately. MEDLINE, Embase, PsycINFO, and the Cochrane Central Register of Controlled Trials were systematically searched from each database inception through January 2020. Randomized clinical trials (RCTs) comparing combinations of antidepressants with antidepressant monotherapy in adult patients with acute depression were included. Following guidelines from Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) and recommendations from the Cochrane Handbook, 2 reviewers independently performed a literature search, study selection, data extraction, and evaluation of risk of bias. Data were pooled in random-effects analyses. Primary outcome was efficacy measured as standardized mean difference (SMD); secondary outcomes were response, remission, change from baseline in rating scale scores, number of dropouts, and number of dropouts due to adverse events. Thirty-nine RCTs including 6751 patients were eligible. Combination treatment was statistically significantly associated with superior treatment outcomes relative to monotherapy (SMD = 0.31; 95% CI, 0.19-0.44). Combining a reuptake inhibitor with an antagonist of presynaptic α2-autoreceptors was superior to other combinations (SMD = 0.37; 95% CI, 0.19-0.55). Bupropion combinations were not superior to monotherapy (SMD = 0.10; 95% CI, -0.07 to 0.27). Numbers of dropouts and dropouts due to adverse events did not differ between treatments. Studies were heterogeneous, and there was indication of publication bias (Egger test result was positive; P = .007, df = 36), but results remained robust across prespecified secondary outcomes and sensitivity and subgroup analyses, including analyses restricted to studies with low risk of bias. In this meta-analysis of RCTs comparing combinations of antidepressants with antidepressant monotherapy, combining antidepressants was associated with superior treatment outcomes but not with more patients dropping out of treatment. Combinations using an antagonist of presynaptic α2-autoreceptors may be preferable and may be applied as a first-line treatment in severe cases of depression and for patients considered nonresponders.

Effectiveness of hymecromone monotherapy in treatment of patients with various pathologies of biliary tract

The aim of the study. To evaluate the effectiveness and safety of the use of hymecromone in the treatment of patients with diseases of the biliary tract.Materials and methods 40 patients with various pathologies of the biliary tract were under observation: 20 patients (group 1) with functional disorders of the biliary tract (the diagnosis of functional disorders of the gallbladder was established on the basis of Roman criteria IV) and 20 patients (group 2) with post-cholecystectomy syndrome (the diagnosis was established on the basis of anamnesis data on cholecystectomy surgery and the results of ultrasound examination of the abdominal organs [absence of a gallbladder]). Before the start of therapy with hymecromonum, after the end of treatment and a month after treatment, patients underwent examinations: assessment of complaints (abdominal pain, bitterness in the mouth, constipation, abdominal heaviness, flatulence, appetite), assessment of dyspepsia on the GIS scale and assessment on the visual-analog scales of abdominal pain and general well-being), quantitative assessment of the severity of gastroenterological complaints according to the GSRS questionnaire, assessment of quality of life (SF‑36 questionnaire), ultrasound of the gallbladder with a trial breakfast for the assessment of bile excretion, clinical blood test, biochemical blood test (ALT, AST, bilirubin, alkaline phosphatase, GGTP, glucose, cholesterol), as well as an assessment of side effects. All patients were prescribed a diet necessary in the complex treatment of diseases of the biliary tract and monotherapy: hymecromone 400 mg three times a day 30 minutes before meals for 3 weeks. Statistical processing was carried out using the computer software package SPSS Statistics 17.0.Results. After the treatment with hymecromone there was a significant decrease or complete relief of abdominal pain and dyspepsia, while 47.5 % of the subjects noted the disappearance of abdominal pain, and the remaining patients indicated a significant decrease in pain syndrome with only minor discomfort. The assessment on the visual-analog scales of abdominal pain and general well-being showed a significant reduction in pain (from 65 to 13 points) and an improvement in general well-being (from 65 to 6 points). When assessing dyspepsia on the GIS scale and gastroenterological complaints according to the GSRS questionnaire, there was a significant decrease in the severity of symptoms. The assessment of the quality of life (questionnaire SF-36) showed a significant improvement in the quality of life on all scales. According to the ultrasound of the abdominal organs with a trial breakfast, there was a restoration of the contractile ability of the gallbladder (p < 0.05). When analyzing possible side effects, it was noted that no side effects were observed either clinically or according to the results of blood tests.Conclusions. As a result of treatment, it was found that the administration of hymecromone is highly effective and safe both for patients with functional disorder of the gallbladder and for patients with post-cholecystectomy syndrome. While maintaining a high efficiency, hymecromonum is characterized by a safe choleretic effect, which is especially important when

Practical guidance on the use of olaparib capsules as maintenance therapy for women with BRCA mutations and platinum-sensitive recurrent ovarian cancer.

Olaparib is the first oral poly(ADP-ribose) polymerase inhibitor to be approved as maintenance monotherapy for treatment of patients with platinum-sensitive relapsed BRCA-mutated (BRCAm) serous ovarian cancer. This review provides practical guidance on the use of olaparib (capsule formulation) in the maintenance setting. The article focuses on the key toxicities that can arise with olaparib therapy and recommendations for their management. Nausea, vomiting, fatigue and anemia are the most commonly reported adverse events in olaparib clinical trials and are generally mild to moderate and transient in nature in most patients. Implementation of an effective and timely management plan can control many of the side effects. It is vital that health care providers effectively communicate the potential side effects of olaparib, as well as educate patients on management strategies to combat these symptoms. To this end, realistic expectations regarding the potential side effects need to be set, with an understanding that dose interruptions and modifications may be required to allow patients to continue receiving treatment.

Topiramate for Treatment in Patients With Migraine and Epilepsy.

Antiepileptic drugs (AED) are often considered first line for monotherapy in treatment of patients with migraines, and also those with comorbid migraine and epilepsy. Topiramate, a newer generation AED, has broad mechanism of action and evidence of benefit in patients with either episodic or chronic migraine along with epilepsy, both generalized and focal. Our goal is to review the relevant mechanisms of action along with any supportive evidence published to date on the use of topiramate (TPM) in patients with both migraine headache and epilepsy. There has been very little published to date on the use of TPM in patients diagnosed with both disorders. Despite this, TPM has been adopted as first line therapy in this patient population. Future studies investigating the effectiveness of this treatment strategy are warranted in order to determine the most effective use of this medication in patients diagnosed with migraine headaches and epilepsy.

Erlotinib in monoterapia nel trattamento di mantenimento del carcinoma polmonare non a piccole cellule dopo chemioterapia a base di platino

The UK National Institute for Health and Clinical Excellence (NICE) invited the manufacturer of erlotinib (Roche) to submit evidence for the clinical and cost effectiveness of erlotinib as monotherapy for the maintenance treatment of patients with non-small cell lung cancer (NSCLC) and stable disease following previous treatment with four cycles of platinum containing therapy. The Liverpool Reviews and Implementation Group (LRiG) at the University of Liverpool was commissioned to act as the Evidence Review Group (ERG) for this appraisal.

An International, Randomized, Double-blind, Placebo-controlled, Phase III Trial of Pregabalin Monotherapy in Treatment of Patients with Fibromyalgia

To evaluate the efficacy and safety of pregabalin monotherapy versus placebo for symptomatic pain relief and improvement of patient global assessment in patients with fibromyalgia (FM) enrolled from countries outside the United States. This international, multicenter, double-blind, placebo-controlled trial randomly assigned 747 patients with FM to placebo or 300, 450, or 600 mg/day pregabalin twice daily for 14 weeks. Primary efficacy measures were endpoint mean pain scores and Patient Global Impression of Change (PGIC). Secondary outcomes included assessments of sleep and function. Patients in the 450 mg/day pregabalin group showed significant improvements versus placebo in endpoint mean pain score (-0.56; p = 0.0132), PGIC (73% improved vs 56% placebo; p = 0.0017), and function [Fibromyalgia Impact Questionnaire (FIQ) total score -5.85; p = 0.0012]. PGIC was also significant for 600 mg/day pregabalin (69% improved; p = 0.0227). Results for these endpoints were nonsignificant for pregabalin at 300 mg/day and for pain and FIQ score at 600 mg/day. Early onset of pain relief was seen, with separation from placebo detected by Week 1 in all pregabalin groups. All pregabalin doses demonstrated superiority to placebo on the Medical Outcomes Study-Sleep Scale Sleep Disturbance subscale and the Sleep Quality diary. Dizziness and somnolence were the most frequently reported adverse events. Pregabalin demonstrated modest efficacy in pain, global assessment, and function in FM at 450 mg/day, and improved sleep across all dose levels, but it did not provide consistent evidence of benefit at 300 and 600 mg/day in this study. Pregabalin was generally well tolerated for the treatment of FM. (Clinical trial registry NCT00333866).

Ofatumumab Monotherapy for Treatment of Patients with Relapsed/Progressive Diffuse Large B-Cell Lymphoma: Results From a Multicenter Phase II Study

AbstractAbstract 3955 Background:Patients (pts) with relapsed diffuse large B-cell lymphoma (DLBCL) ineligible for autologous stem cell transplant (ASCT) or relapsing after ASCT have a poor prognosis and limited therapeutic options. New treatment options are needed for these pts. Ofatumumab is a human monoclonal antibody that targets a membrane-proximal epitope comprising both the large loop and small loop of CD20, and has shown effective lysis of chemotherapy-refractory DLBCL cells in vitro (Teeling et al. Blood 2004; Cillessen et al. Blood 2007; abstract 2346). We report the first results from an open-label, single-arm, international Phase II trial that evaluated ofatumumab monotherapy in relapsed or progressive DLBCL. Methods:Pts (age ≥18 years) with relapsed or progressive CD20+ DLBCL ineligible for ASCT or with relapsed or progressive disease after ASCT were enrolled between December 2007 and August 2009 (N=81). Relapsed or progressive disease was defined as relapse after a complete remission (CR) or disease progression after partial remission (PR). Pts received 8 weekly infusions of ofatumumab (dose 1, 300 mg; doses 2–8, 1000 mg). The primary endpoint was overall response rate (ORR) evaluated during the 6 months from the start of treatment, as assessed by an Independent Endpoint Review Committee according to the revised response criteria (Cheson et al. J Clin Oncol 2007). Secondary endpoints included duration of response, progression-free survival (PFS), overall survival (OS) and safety. Results:Baseline characteristics are shown in the Table. Pts were heavily pretreated (median 3 prior systemic therapies), and 32% of pts did not respond to their last prior therapy. Nearly all pts (96%) had received prior rituximab-containing treatment; 54% had received 2 or more courses of prior rituximab therapy (Table). Overall, 58% of pts completed all 8 infusions of ofatumumab, 65% received at least 6 infusions, and 81% received at least 4 infusions. The primary reason for treatment discontinuation was disease progression. The ORR (95% CI) was 11% (4–18%), including 3 CRs (4%) and 6 PRs (7%). Of these 9 responding pts, 8 had responded to their last systemic therapy. The median duration of response (95% CI) was 6.9 months (5.3–6.9) and median PFS (95% CI) was 2.5 months (2.3–2.9). Infusion-related events occurred in 59% of pts, primarily occurred during infusion 1 (40% of pts) and infusion 2 (22%), and subsided during subsequent infusions; these events were predominantly grade 1–2 in severity (96% of pts). The most common (>10% of pts) adverse events (AEs; any grade) were diarrhea (17%), fatigue (15%), peripheral edema (15%), neutropenia (14%), abdominal pain (12%), constipation (12%), nausea (12%), pyrexia (11%), anemia (11%) and leukopenia (11%). Of these, ≥ grade 3 events included neutropenia (10%), leukopenia (6%), anemia (5%) and fatigue (1%). Grade 3 or greater thrombocytopenia and febrile neutropenia were reported in 6% and 4% of pts, respectively. The most common infectious events were upper respiratory tract infections (7% of pts), all of which were grade 1–2 events. In total, 13 pts died during the study; 3 pts died during the treatment period and 10 pts died during post-treatment follow up (until 24 months from study start). Deaths were due to disease progression (n=10), sepsis (n=1), circulatory collapse (no further details; n=1) and multi-organ failure (n=1). Conclusions:Single-agent ofatumumab was well tolerated with an ORR of 11% in heavily pretreated pts with relapsed or progressive DLBCL, nearly all of whom had received prior rituximab therapy. Response to last systemic treatment appeared to influence response to ofatumumab in this pt population. Further studies of ofatumumab in combination with chemotherapy in relapsed DLBCL are currently underway. Disclosures:Off Label Use: Ofatumumab is an investigational anti-CD20 monoclonal antibody, currently under development for the treatment of B-cell malignancies (chronic lymphocytic leukemia, diffuse large B-cell lymphoma, Waldenstroms macroglobulinemia and follicular lymphoma) as well as autoimmune diseases (rheumatoid arthritis and multiple sclerosis). Davies:GlaxoSmithKline: Consultancy, Membership on an entity's Board of Directors or advisory committees. Padmanabhan:GlaxoSmithKline: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding. Gupta:GlaxoSmithKline: Employment. Lin:GlaxoSmithKline: Consultancy, Employment. Davis:GlaxoSmithKline: Consultancy, Membership on an entity's Board of Directors or advisory committees. Losic:Genmab A/S: Employment, Equity Ownership. Lisby:Genmab A/S: Employment. Radford:GlaxoSmithKline: Equity Ownership; Genmab: Consultancy, Honoraria.

Extracorporeal shock wave lithotripsy monotherapy for treatment of patients with urethral and bladder stones presenting with acute urinary retention

ObjectivesTo present our experience with extracorporeal shock wave lithotripsy (ESWL) monotherapy for the treatment of patients with urethral and bladder stones presenting with acute urinary retention. MethodsA total of 64 patients (62 male and 2 female) with urethral or bladder stones underwent ESWL monotherapy. All patients presented to the emergency department with acute urinary retention. The mean patient age was 40 ± 13.2 years (range 11 to 74). The exclusion criteria were urethral strictures, associated bladder growths detected by pelvic ultrasonography, and bladder stones larger than 25 mm in the largest diameter. After fixation of a Foley catheter, ESWL monotherapy was performed with a Storz SL 20 lithotriptor. The catheter was removed after confirmation of stone fragmentation. ResultsFine fragmentation was obtained and uncomplicated spontaneous evacuation occurred without the need for adjuvant procedures in 60 patients. Four patients developed acute urinary retention due to urethral stone impaction. In 3 patients, the urethral catheter was successfully refixed, and an additional session of ESWL resulted in fine fragmentation of the stones, with spontaneous evacuation after catheter removal. In the remaining patient, the stone could not be pushed into the bladder and crushing was performed endoscopically. ConclusionsESWL monotherapy is safe and effective for the treatment of urethral and bladder stones in patients with no other causes of infravesical obstruction.