scholarly journals Optimal dose of aripiprazole for augmentation therapy of antidepressant-refractory depression: preliminary findings based on a systematic review and dose–effect meta-analysis

2021 ◽  
pp. 1-8
Author(s):  
Yuki Furukawa ◽  
Tasnim Hamza ◽  
Andrea Cipriani ◽  
Toshi A. Furukawa ◽  
Georgia Salanti ◽  
...  
Keyword(s):  
Meta Analysis ◽  
Dose Range ◽  
Drop Out ◽  
Dose Effect ◽  
High Dose ◽  
Optimal Dosage ◽  
Inadequate Response ◽  
Augmentation Therapy ◽  
Refractory Depression ◽  
Significant Difference

Background Aripiprazole augmentation is proven effective for antidepressant-refractory depression, but its licensed dose range is wide and optimal dosage remains unclear. Aims To find the optimal dosage of aripiprazole augmentation. Method Multiple electronic databases were searched (from inception to 16 February 2021) to identify all assessor-masked randomised controlled trials evaluating aripiprazole augmentation therapy in adults (≥18 years old, both genders) with major depressive disorder showing inadequate response to at least one antidepressant treatment. A random-effects, one-stage dose–effect meta-analysis with restricted cubic splines was conducted. Outcomes were efficacy (treatment response: ≥50% reduction in depression severity), tolerability (drop-out due to adverse effects) and acceptability (drop-out for any reason) after 8 weeks of treatment (range 4–12 weeks). Results Ten studies met the inclusion criteria. All were individually randomised, placebo-controlled, multi-centre, parallel studies including 2625 participants in total. The maximum target dose–efficacy curve showed an increase up to doses between 2 mg (odds ratio OR = 1.46, 95% CI 1.15–1.85) and 5 mg (OR = 1.93, 95% CI 1.33–2.81), and then a non-increasing trend through the higher licensed doses up to 20 mg (OR = 1.90, 95% CI 1.52–2.37). Tolerability showed a similar trend with greater uncertainty. Acceptability showed no significant difference through the examined dose range. Certainty of evidence was low to moderate. Conclusions Low-dose aripiprazole as augmentation treatment might achieve the optimal balance between efficacy, tolerability and acceptability in the acute treatment of antidepressant-refractory depression. However, the small number of included studies and the overall moderate to high risk of bias seriously compromise the reliability of the results. Further research is required to investigate the benefits of low versus high dose.

scholarly journals Dose dependence of efficacy but not of safety in sublingual immunotherapy

2016 ◽  
Vol 65 (1) ◽  
Author(s):  
F. Frati ◽  
C. Incorvaia ◽  
F. Marcucci ◽  
L. Sensi ◽  
G. Di Cara ◽  
...  
Keyword(s):  
Sublingual Immunotherapy ◽  
Clinical Symptoms ◽  
Meta Analysis ◽  
Dose Dependence ◽  
Subcutaneous Immunotherapy ◽  
High Dose ◽  
Systemic Reactions ◽  
Significant Difference

Sublingual immunotherapy (SLIT) currently represents, as indicated by meta-analysis of its efficacy and safety, a valid option to the generally used traditional subcutaneous immunotherapy (SCIT) for treating respiratory allergy. Regarding efficacy, recent studies demonstrated that, similar to what has already been observed in SCIT as well as in experimental and clinical studies about the magnitudo of allergen exposure, the effectiveness on both clinical symptoms and immunologic changes depends on the amount of allergen administered during treatment. In addition, in vitro studies addressed with the role of dendritic cells, currently considered to be of pivotal importance in orienting toward tolerance the immune response to allergens, showed that the internalisation of allergen molecules, which is followed by tolerogenic presentation to T cells, depends on the amount of allergen. However, such dose dependence is not apparent concerning the safety. In fact, the comparison of studies respectively conducted with high and low allergen doses did not show differences in the rate of systemic reactions, which in any case never had the presentation of anaphylaxis, and instead a significant difference in the rate of local reactions, following the oral and gastrointestinal contact with the allergen extract, in favour of high dose studies.

scholarly journals Effectiveness of Valganciclovir 900mg Versus 450mg for Cytomegalovirus Prophylaxis in Renal Transplantation: A Systematic Review and Meta-Analysis

2017 ◽  
Vol 20 ◽  
pp. 168 ◽  
Author(s):  
Wang Xin ◽  
Yang Hui ◽  
Zhang Xiaodong ◽  
Cui Xiangli ◽  
Wang Shihui ◽  
...  
Keyword(s):  
Renal Transplantation ◽  
Acute Rejection ◽  
Low Dose ◽  
Opportunistic Infections ◽  
Meta Analysis ◽  
High Dose ◽  
Renal Transplant Recipients ◽  
Significant Difference ◽  
Allograft Loss ◽  
Cmv Disease

Objectives: Valganciclovir 900 mg/day is approved for cytomegalovirus (CMV) prophylaxis, but 450 mg/day is seems also effective. We systematically reviewed the efficacy and safety of low-dose versus high-dose valganciclovir prophylaxis in renal transplantation recipients. Methods: An electronic search was conducted up to November 29, 2016. The primary outcomes were incidences of CMV, CMV disease, mortality and opportunistic infection. The second outcomes were acute rejection, allograft loss, adverse drug reaction (ADR). Results: 7 cohort studies, all with high quality involving (1431 patients) were included. There was no significant difference of the incidence of following CMV disease (1271 patients, odds ratio [OR] 0.74, 95% confidence interval [CI], 0.38-1.43, p=0.36), acute rejection (1343 patients, OR 0.77, 95%CI 0.53-1.14, p=0.19), allograft loss (1271 patients, OR 0.64, 95%CI 0.31-1.35, p=0.24), mortality (1271 patients, OR 0.55, 95%CI 0.20-1.47, p=0.23) and opportunistic infections (OI) (985 patients, OR 0.76, 95%CI 0.52-1.10, p=0.14) between the low-dose and the high-dose valganciclovir  prophylaxis. And no significant difference was observed for premature valganciclovir discontinuation (1010 patients, OR 0.81, 95%CI 0.52-1.25, p=0.33) and the incidence of leukopenia (1082 patients, OR 0.65, 95%CI 0.34-1.22, p=0.18) between the two regimens. Conclusion: 450 mg and 900 mg doses of valganciclovir are equipotent for CMV universal prophylaxis. CMV 450 mg prophylaxis should be used for renal transplant recipients. This article is open to POST-PUBLICATION REVIEW. Registered readers (see “For Readers”) may comment by clicking on ABSTRACT on the issue’s contents page.

Ferulic Acid Dose Effect on Pharmacokinetics of Glimepiride and its Metabolite Hydroxy Glimepiride in Rats

2021 ◽  
Vol 17 ◽  
Author(s):  
Yuxian Lin ◽  
Faxin Sun ◽  
Jinlai Liu ◽  
Qinghua Weng ◽  
Lijun Jin ◽  
...  
Keyword(s):  
Ferulic Acid ◽  
Low Dose ◽  
Dose Effect ◽  
High Dose ◽  
Intragastric Administration ◽  
Healthy Male ◽  
Sprague Dawley ◽  
Sd Rats ◽  
High Dose Treatment ◽  
Significant Difference

Background: To mitigate diabetes and its complications in cardiovascular diseases, the antidiabetic agent glimepiride is usually administered with ferulic acid concomitantly in clinics. However, both drugs are prone to be metabolized partly by CYP2C9, thus they have the potential drug-drug interaction affecting the safety and efficacy. Objective: This project aimed to evaluate the pharmacokinetic (PK) effects of ferulic acid (FA) on glimepiride (GLM) and its metabolite hydroxy glimepiride (OH-GLM) in plasma by using the HPLC-MS/MS method. Methods: Healthy male Sprague Dawley (SD) rats were randomly divided into three groups. They received intragastric administration of 0.5% sodium carboxymethyl cellulose (CMC), low-dose FA (20 mg•kg-1), and high-dose FA (40 mg•kg-1) for 8 days, respectively. Rats were given 0.5% sodium CMC or FA on the last day and then uniformly given 1.0 mg•kg-1 glimepiride by gavage. Blood samples were obtained from retro-orbital plexus at the time points of 0.167, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h after administration. Plasma samples were analyzed for GLM and its metabolite OH-GLM on an HPLC-MS/MS system. Results: No statistically significant difference was found in the effect of low-dose FA on the pharmacokinetics of GLM. High-dose FA significantly decreased Cmax of GLM by 30.05% and CLz/F of OH-GLM by 47.45%. It also increased Tmax and t1/2z of GLM by 95.87% and 140.00%. Conclusion: Low-dose FA did not alter GLM metabolism, while high-dose treatment of FA caused pharmacokinetics interaction with GLM in rats.

P06 A study to assess the effectiveness of vitamin d supplementation in paediatric cystic fibrosis patients

2018 ◽  
Vol 103 (2) ◽  
pp. e1.9-e1
Author(s):  
Christiansen Nanna ◽  
Ashraf Saleha
Keyword(s):  
Cystic Fibrosis ◽  
Vitamin D ◽  
Vitamin D Deficiency ◽  
Dose Range ◽  
Vitamin D Supplementation ◽  
High Dose ◽  
List Type ◽  
Current Guideline ◽  
Paediatric Patients ◽  
Significant Difference

AimsPatients with cystic fibrosis (CF) require supplementation of fat-soluble vitamins due to the effects of the disease on the pancreas and the resulting inability of absorb fat effectively.1The study aimed to assess the effectiveness of current of vitamin D supplementation to achieve adequate serum Vitamin D (25OHD) levels in paediatric CF patients.2 Secondly, this study assessed the effectiveness of ‘Stoss’ therapy (a high dose vitamin D therapy administered every three months) as an alternative to daily vitamin D supplementation for patients with known poor compliance.3MethodsVitamin D doses and serum 25OHD levels between January and December 2016 were reviewed for paediatric CF patients at a UK centre. Data was collected for 138 paediatric patients. The ‘clinical record summary’ system was used to extract the data which included age, hospital number, weight in 2015 and 2016, 25OHD levels from 2015 and 2016, vitamin D dose before each level and pancreatic status.Data was entered onto Statistical Package for the Social Sciences (SPSS) system for analysis. A paired T-test was conducted to ascertain if there was a significant difference in weekly/kg doses between patients that were sufficient (25OHD>50 nmol/L) and insufficient (25OHD<50 nmol/L).ResultsData was collected for a total of 138 patients. The data from only 70 patients was analysed when investigating the first objective, as all other patients did not have 25OHD levels available for both 2015 and 2016. A further five patients wereexcluded and analysed seperately due to receiving Stoss therapy. The weekly Vitamin D dose range was very wide for both years with 43% (n=40) of patients requiring additional vitamin D in addition to Aquadeks (CF multivitamin preparation). There was no significant difference in Vitamin D doses between patients with sufficient and insufficient 25OHD levels. This was thecase for both 2015 (p=0.432) and 2016 (p=0.192). The daily supplementation doses were successful at maintaining vitamin D sufficiency for 83% of patients in 2015 and 93% in 2016.Out of the 5 patients who received ‘Stoss’ therapy, 3 had an increase in 25OHD levels. However, only one of the patients had a significant increase leading to sufficient 25OHD levels. In 2 cases there was actually a 60%–68% decrease in 25OHD levels, which lead to these patients developing vitamin D deficiency.ConclusionThis study was useful in determining the effectiveness of current Vitamin D dosing. The results suggest that patients having insufficient 25OHD levels may not be due to an inadequacy of doses provided in the current guideline, as there was no significant difference in dose between patients with sufficient and insufficient 25OHD levels. Given the patient group, the difference could be attributable to a lack of compliance to daily therapies in the patients with insufficient 25OHD levels or even differences in individual responses to therapy.In this sample, ‘Stoss’ therapy is not effective in maintaining sufficient 25OHD levels. Although the data for this part of the study was very limited, it identifies a need to investigate the effectiveness of ‘Stoss’ therapy further.ReferencesFerguson JH, Chang AB. Vitamin D supplementation for cystic fibrosis. Cochrane Database of Syst Rev [Internet] 2014. http://onlinelibrary.wiley.com/ & doi:10.1002/14651858.CD007298.pub3/pdf [Available: 2017April 12].Green D, Carson K, Leonard A, et al. Current treatment recommendations for correcting vitamin D deficiency in paediatric patients with cystic fibrosis is inadequate. J Pediatr2008;4:554–559.Shepherd D, Belessis Y, Katz, et al. Single high-dose oral vitamin D3 (stoss) therapy: A solution to vitamin D deficiency in children with cystic fibrosis?J Cyst Fibros2013;2:177–182.

scholarly journals EFEK HEPATOTOKSIK ANTI TUBERKULOSIS TERHADAP KADAR ASPARTATE AMINOTRANSFERASE DAN ALANINE AMINOTRANSFERASE SERUM PENDERITA TUBERKULOSIS PARU

2018 ◽  
Vol 12 (1) ◽  
pp. 1
Author(s):  
Delita Prihatni ◽  
Ida Parwati ◽  
Idaningroem Sjahid ◽  
Coriejati Rita
Keyword(s):  
Clinical Trial ◽  
Serum Level ◽  
Aspartate Aminotransferase ◽  
Alanine Aminotransferase ◽  
Standard Dose ◽  
Dose Effect ◽  
High Dose ◽  
Antituberculosis Drugs ◽  
Antituberculosis Treatment ◽  
Significant Difference

Tuberculosis (TB) is still a major health problem, especially in the developing countries. The combination of antituberculosis drugs are generally recommended for the treatment of tuberculosis. Van Crevel study in Jakarta found that most (70%) of patients with pulmonary TB who received combined antituberculosis drugs with standard (450 mg) dose rifampicin had very low plasma rifampicin level. Based on this results, TB Research and Clinical Trial Centre Bandung & University Medical Centre Nijmegen, The Netherlands conduct the study which compared clinical outcome between standard and high (600 mg) dose of rifampicin. Most of antituberculosis drugs currently available are very low in causing acute and chronic toxicities, however we must keep aware of side effect during the treatment. The most serious adverse effect of several drugs is liver damage (drug induced hepatitis) and potentially fatal hepatitis. To detect liver demage earlier aspartate aminotransferase( AST) and alanine aminotransferase (ALT) serum level were examined during antituberculosis treatment. The aim of this study was to determine AST and ALT serum level at intensif phase of antituberculosis treatment with standard and high dose rifampicin. The study had been done from August 2003 to September 2004 at Dr Hasan Sadikin Hospital and Balai Pengobatan Penyakit Paruparu, Bandung. The subjects were divided randomly into 2 groups. The first group consisted of patients with category I antituberculosis drugs with standard dose rifampicin and the second group patients also category I with high dose rifampicin. Aspartate aminotransferase and ALT serum level were examined at week 0 (before treatment), 2nd, 4th, and 8th. This was randomized clinical trial with paralel design study. Statistical analysis used paired t test to compare the dose effect of rifampicin to AST and ALT serum level changes, t independent test to compared mean difference of AST and ALT serum level changes which is projected by profile analysis. p value < 5%.. The prevalence of the hepatotoxicity were 17.39% of standard dose and 18.17% of high dose rifampicin. The hepatotoxicity were mild and moderate level,and it was already present at 2 weeks of therapy. There were no significant difference of AST and ALT serum level beetween those two groups. Conclusion: In this study antituberculosis drugs with high dose rifampicin were safe for TB patients.

scholarly journals Efficacy of low or high-dose rituximab treatment in membranous nephropathy: a systematic review and meta-analysis

2021 ◽  
Author(s):  
Naresh Kharbuja ◽  
Min Wu ◽  
Yu-Chen Han ◽  
Dan Liu ◽  
Bin Wang ◽  
...  
Keyword(s):  
Membranous Nephropathy ◽  
Low Dose ◽  
Control Strategies ◽  
Therapeutic Option ◽  
Meta Analysis ◽  
Biological Indicators ◽  
High Dose ◽  
Serious Adverse Events ◽  
Protein Levels ◽  
Significant Difference

Abstract Background: Rituximab (RTX) has emerged as a promising therapeutic option in patients with primary membranous nephropathy (MN). But the optimal dosing of RTX protocol has not been established. Recently, favorable outcomes even with low-dose of RTX has been described in MN patients. Thus, the aim of this meta-analysis is to compare the efficacy and safety between high-dose and low-dose RTX in patients with MN.Methods: After literature search, eligible studies were further classified into high-dose and low-dose groups according to the dosage of one cycle RTX therapy. A meta-analysis was performed to evaluate remission rates and changes in biological indicators in two groups. Results: Eight studies involving 588 patients were included in this meta-analysis. In comparison to the control groups (including cyclosporin, cyclophosphamide, chlorambucil, prednisone, non-immunosuppressive anti-proteinuria treatment), RTX significantly improved the complete remission (CR) rate. Furthermore, there is no significant difference between high-dose and low-dose RTX in inducing total remission (TR) and CR. Also, high-dose RTX did not significantly improve serum albumin, creatine and urinary protein levels when compared with the low-dose RTX group. However, high-dose RTX did reduce the serum PLA2R antibody titers in patients. Even the difference was not significant, there was a tendency for low-dose RTX to have less serious adverse events (SAEs) than high-dose RTX groups. Conclusion: RTX administration indicated a better efficacy than the control strategies for the treatment of primary MN. And a low-dose regimen of RTX was non-inferior to high-dose usage in inducing long-term TR up to 24 months and holds the superior tendency in preventing SAEs in MN patients.

Efficacy and safety of pharmacological cachexia interventions: systematic review and network meta-analysis

2020 ◽  
pp. bmjspcare-2020-002601
Author(s):  
Manit Saeteaw ◽  
Phitjira Sanguanboonyaphong ◽  
Jukapun Yoodee ◽  
Kaitlyn Craft ◽  
Ratree Sawangjit ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Meta Analysis ◽  
Total Body Weight ◽  
Megestrol Acetate ◽  
High Dose ◽  
Efficacy And Safety ◽  
Pharmacological Interventions ◽  
Serious Adverse Events ◽  
Significant Difference

AimsRandomised controlled trials (RCTs) demonstrated benefits of pharmacological interventions for cachexia in improving weight and appetite. However, comparative efficacy and safety are not available. We conducted a systematic review and network meta-analysis (NMA) to evaluate the relative efficacy and safety of pharmacological interventions for cachexia.MethodsPubMed, EmBase, Cochrane, and ClinicalTrials.gov were searched for RCTs until October 2019. Key outcomes were total body weight (TBW) improvement, appetite (APP) score and serious adverse events. Two reviewers independently extracted data and assessed risk of bias. NMA was performed to estimate weight gain and APP score increase at 8 weeks, presented as mean difference (MD) or standardised MD with 95% CI.Results80 RCTs (10 579 patients) with 12 treatments were included. Majority is patients with cancer (7220). Compared with placebo, corticosteroids, high-dose megestrol acetate combination (Megace_H_Com) (≥400 mg/day), medroxyprogesterone, high-dose megestrol acetate (Megace_H) (≥400 mg/day), ghrelin mimetic and androgen analogues (Androgen) were significantly associated with MD of TBW of 6.45 (95% CI 2.45 to 10.45), 4.29 (95% CI 2.23 to 6.35), 3.18 (95% CI 0.94 to 5.41), 2.66 (95% CI 1.47 to 3.85), 1.73 (95% CI 0.27 to 3.20) and 1.50 (95% CI 0.56 to 2.44) kg. For appetite improvement, Megace_H_Com, Megace_H and Androgen significantly improved standardised APP score, compared with placebo. There is no significant difference in serious adverse events from all interventions compared with placebo.ConclusionsOur findings suggest that several pharmacological interventions have potential to offer benefits in treatment of cachexia especially Megace_H and short-term use corticosteroids. Nonetheless, high-quality comparative studies to compare safety and efficacy are warranted for better management of cachexia.

Bayesian network meta-analysis (NMA) of complete remission without or with incomplete hematologic recovery (CR/CRi) to CPX-351, FLAG, and standard 7+3 (7+3) chemotherapy in the treatment of newly diagnosed secondary acute myeloid leukemia (sAML).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18514-e18514
Author(s):  
Mok Oh ◽  
Bernard Marini ◽  
Anthony Perissinotti ◽  
Lydia Benitez ◽  
Patrick William Burke ◽  
...  
Keyword(s):  
Meta Analysis ◽  
Random Effect ◽  
Indirect Comparison ◽  
Credible Interval ◽  
Molar Ratio ◽  
High Dose ◽  
Newly Diagnosed ◽  
Comparative Efficacy ◽  
Secondary Acute Myeloid Leukemia ◽  
Significant Difference

e18514 Background: Patients (pts) sAML have poor outcomes (CR/CRi= 25-35%) with standard 7+3 induction chemotherapy (7+3). CPX-351 (liposomal encapsulated daunorubicin + cytarabine at a synergistic 5:1 molar ratio) was approved recently for sAML based on improvements in CR/CRi and survival but high cost and toxicity has discouraged its use. FLAG (fludarabine + high-dose cytarabine + granulocyte colony stimulating factor) have emerged as a lower cost, safe alternatives; however, outcomes between CPX-351 and FLAG have yet to be compared. In the absence of a direct trial, we aimed to estimate indirectly by Bayesian NMA the comparative efficacy of CPX-351, FLAG, and 7+3 therapy for sAML patients. Methods: Publications that compared FLAG or CPX-351 to 7+3 in newly diagnosed sAML were identified through a search of PubMed. CR/CRi rates were used in a Bayesian NMA to assess the direct (CPX-351 vs 7+3; FLAG vs 7+3) and indirect (CPX-351 vs FLAG) comparative efficacy of these regimens. Fixed (FE) and random effect (RE) analyses were conducted to estimate pooled odds ratios (OR) with 95% credible interval (CrI). Results: Of 169 identified articles, four studies (three RCT and one retrospective cohort) on a total of 781 pts in three treatment arms were retained. NMA showed no significant difference in pooled CR/CRi rates between CPX-351 and FLAG in both FE and RE models. However, pts receiving either FLAG or CPX-351 had significantly higher CR/CRi than those receiving 7+3 in both FE and RE models as shown in the table. Conclusions: This NMA suggests that both CPX-351 and FLAG prevail in CR/CRi efficacy over 7+3. In indirect comparison, CPX-351 and FLAG are equivalent in efficacy. The cost implications of these results remain to be established. [Table: see text]

Analgesic use and the risk of renal cell carcinoma (RCC): Results from a large up-to-date meta-analysis.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 395-395
Author(s):  
Eunyoung Cho ◽  
Youjin Je ◽  
Toni K. Choueiri
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Meta Analysis ◽  
Specific Effect ◽  
Case Control ◽  
High Dose ◽  
Increased Risk ◽  
Significant Difference ◽  
Analgesic Use

395 Background: Analgesics have been linked to an increased risk of developing renal cell carcinoma (RCC), but the evidence is mixed. Using a meta-analysis design of all available studies, we investigated the association between analgesic use and RCC risk. Methods: We searched the MEDLINE database to identify eligible case-control or cohort studies published in English from 1966 to July 1, 2011 for 3 categories of analgesics: acetaminophen, aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs). Study-specific effect estimates were pooled to compute an overall relative risk (RR) and its 95% confidence interval (CI), using a random effects model, for each category of the analgesics. Analyses were conducted according to regular/any use and high dose or long-duration of use, separately. Results: We identified 18 studies (12 for acetaminophen, 12 for aspirin, and 5 for other NSAIDs) that were performed in 6 countries. Regular/any use of acetaminophen and other NSAIDs were each associated with an increased risk of RCC: pooled RR, 1.33 (95% CI 1.18-1.49) for acetaminophen and 1.26 (95% CI, 1.09-1.44) for other NSAIDs, respectively. For use of aspirin, we found no significant increased risk (pooled RR, 1.14 [95% CI, 0.98-1.33]). Similar risk trends were seen with high dose of analgesics intake. No significant difference in associations was found by study design (case-control vs. cohort), type of controls in case-control study (population based vs. hospital based), outcome (RCC vs. kidney cancer), and gender (male vs. female). There was no indication of publication bias for the 3 analgesics. Conclusions: In this meta-analysis of analgesics use and RCC risk, we found that use of acetaminophen and non-aspirin NSAIDs was associated with a significant increased risk of developing RCC.

scholarly journals Analysis of Time-Course, Dose-Effect, and Influencing Factors of Antidepressants in the Treatment of Acute Adult Patients With Major Depression

2019 ◽  
Vol 23 (2) ◽  
pp. 76-87 ◽  
Author(s):  
Qingqing Cheng ◽  
Jihan Huang ◽  
Ling Xu ◽  
Yunfei Li ◽  
Huafang Li ◽  
...  
Keyword(s):  
Time Course ◽  
Rating Scale ◽  
Meta Analysis ◽  
Dose Range ◽  
Drug Efficacy ◽  
Dropout Rate ◽  
Dose Effect ◽  
Pure Drug ◽  
Study Sites ◽  
The Impact

Abstract Objective Model-based meta-analysis was used to describe the time-course and dose-effect relationships of antidepressants and also simultaneously investigate the impact of various factors on drug efficacy. Methods This study is a reanalysis of a published network meta-analysis. Only placebo-controlled trials were included in this study. The change rate in depression rating scale scores from baseline was used as an efficacy indicator because a continuous variable is more likely to reflect subtle differences in efficacy between drugs. Results A total 230 studies containing 64 346 patients were included in the analysis. The results showed that the number of study sites (single or multi-center) and the type of setting (inpatient or noninpatient) are important factors affecting the efficacy of antidepressants. After deducting the placebo effect, the maximum pure drug efficacy value of inpatients was 18.4% higher than that of noninpatients, and maximum pure drug efficacy value of single-center trials was 10.2% higher than that of multi-central trials. Amitriptyline showed the highest drug efficacy. The remaining 18 antidepressants were comparable or had little difference. Within the approved dose range, no significant dose-response relationship was observed. However, the time-course relationship is obvious for all antidepressants. In terms of safety, with the exception of amitriptyline, the dropout rate due to adverse events of other drugs was not more than 10% higher than that of the placebo group. Conclusion The number of study sites and the type of setting are significant impact factors for the efficacy of antidepressants. Except for amitriptyline, the other 18 antidepressants have little difference in efficacy and safety.

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