Cohort Analysis of Randomized Clinical Trials on long acting GLP-1 receptor agonists versus DPP4 inhibitors

2016 ◽  
Author(s):  
Thuy Pham ◽  
Mukunda Singh ◽  
Marvin Dao ◽  
Griselda Herrera ◽  
Katherine Asuncion
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Cohort Analysis ◽  
Receptor Agonists ◽  
Dpp4 Inhibitors ◽  
Long Acting

DPP4 Inhibitors in the Management of Hospitalized Patients With Type 2 Diabetes: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

2020 ◽  
Vol 37 (9) ◽  
pp. 3660-3675
Author(s):  
Soghra Rabizadeh ◽  
Mohammad Ali Tavakoli Ardakani ◽  
Marjan Mouodi ◽  
Masoume Bitaraf ◽  
Sakineh Shab-Bidar ◽  
...  
Keyword(s):  
Systematic Review ◽  
Type 2 Diabetes ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Hospitalized Patients ◽  
Dpp4 Inhibitors

Comparative effectiveness of treatment options in elderly patients with colon cancer receiving adjuvant chemotherapy.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 470-470
Author(s):  
Sacha Satram-Hoang ◽  
Devi Ramanan ◽  
Luen F. Lee ◽  
Shui Yu ◽  
Carolina M. Reyes ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Clinical Trials ◽  
Propensity Score ◽  
Elderly Patients ◽  
Older Patients ◽  
Randomized Clinical Trials ◽  
Cohort Analysis ◽  
Risk Of Death ◽  
Morbidity Score ◽  
Co Morbidity

470 Background: While colon cancer (CC) is predominantly a disease of the elderly, older patients are underrepresented in clinical trials. We sought to evaluate whether the treatment patterns and benefits realized by trial participants pertain to older patients in the real-world setting. Methods: Using the linked Surveillance, Epidemiology, and End Results (SEER)-Medicare database, we conducted a retrospective cohort analysis of 3390 stage II and III CC patients diagnosed between 1/1/ 2004 to 12/31/2007, who were >66 years, enrolled in Medicare Parts A and B, and received adjuvant treatment with 5FU/LV (n=1368), FOLFOX (n=1398), CAP (capecitabine; n=507), and CAPOX (CAP + oxaliplatin; n=117) within 3 months after surgery. Date of last follow-up was 12/31/2007. Chi-square test and ANOVA or t-test assessed differences in patient and disease characteristics by treatment. Propensity score weighted Cox regression assessed the relative risk of death by treatment. Results: Patients treated with CAP were older (mean age 77 years; p<.0001), more likely female (61%; p<.05), more likely non-white (19%; p<.05) and had higher co-morbidity score (p<.0001) compared to the other treatment groups. The mean time to chemo initiation after surgery were similar between the groups (mean 46-49 days) while mean duration of treatment were longer for 5FU/LV (149 days) and FOLFOX (144 days), compared to CAP (121 days) and CAPOX (111 days); p<.0001. The incidence of adverse events (AEs) within 180 days after initiation of treatment were higher in patients treated with FOLFOX (82%) and 5FU/LV (78%) compared to CAP (74%) and CAPOX (71%); p=0.0002. Propensity score adjusted multivariate analysis demonstrated comparable survival for CAP-based regimens vs. 5-FU/LV- based regimens ( table ). Conclusions: Treatment outcomes for elderly patients observed in routine clinical practice were comparable between CAP-based and 5FU/LV-based regimens and consistent with results reported in randomized clinical trials. AEs associated with medical resource utilization were less frequent with CAP-based regimens. [Table: see text]

An Analysis of Potentially Prolactin-Related Adverse Events and Abnormal Prolactin Values in Randomized Clinical Trials with Paliperidone Palmitate

2012 ◽  
Vol 46 (10) ◽  
pp. 1322-1330 ◽  
Author(s):  
Thomas R Einarson ◽  
Michiel EH Hemels ◽  
Isaac Nuamah ◽  
Srihari Gopal ◽  
Danielle Coppola ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Adverse Events ◽  
Randomized Clinical Trials ◽  
Descriptive Statistics ◽  
Paliperidone Palmitate ◽  
Serum Prolactin ◽  
Clinical Trial Database ◽  
Long Acting ◽  
Monthly Dose

Background: Paliperidone palmitate has been associated with serum prolactin elevations in some patients. However, few individuals with elevated prolactin levels (hyperprolactinomia) have symptomatic potentially prolactin-related adverse events (PPR-AEs). Objective: To quantify rates of hyperprolactinemia in subjects treated with the newly marketed paliperidone palmitate long-acting injection (PP-LAI) in randomized clinical trials, summarize rates of PPR-AEs in those trials by sex and dose, and determine how many PPR-AEs required treatment. Methods: Numbers and rates of investigator-reported hyperprolactinemia and PPR-AEs wore obtained from the sponsor's clinical trial database and have been included in regulatory filings. Results were tabulated for males, females, and overall, and by dose administered, using descriptive statistics. Those requiring treatment were described as well. Results: There were 3173 subjects (61.4% males) exposed to PP-LAI in 10 clinical trials; 2831 (89.2%) patients had recorded prolactin levels, including 1759 males (90, 3% of exposed males) and 1072 females (87.5% of exposed females). Overall, at any time, prolactin levels were elevated for 38.8% of the subjects (39.5% for males and 37.7% for females; p = 0.354 between sexes). However, them was no significant correlation between monthly dose and proportion of subjects with elevated prolactin levels (p = 0.109). There were 115 PPR-AEs in 107 patients (3.4%); 51 (44.3% of PPR-AEs) cases represented asymptomatic hyperprolactinemia. The remaining 64 symptomatic PPR-AEs affected 2.0% of the total number of subjects. Fifteen events in 13 participants (0.41% of patients or 4.7 events/1000 patients) required treatment. Conclusions: Clinicians should periodically assess patients on paliperidone palmitate for any PPR-AEs and carefully assess the benefits and risks when managing these effects.

scholarly journals Impact of Short-Acting vs Long-Acting Testosterone Therapy on Intratesticular Testosterone Using Data From Two Open-Label Randomized Clinical Trials of Testosterone Pellets, Injections, and Intranasal Gel in Hypogonadal Men

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. A758-A759
Author(s):  
Eliyahu Kresch ◽  
Daniel Gonzalez ◽  
Jesse Ory ◽  
Sirpi Nackeeran ◽  
Ruben Blachman-Braun ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Wilcoxon Test ◽  
Testis Size ◽  
Open Label ◽  
Hpg Axis ◽  
Short Acting ◽  
Men 2 ◽  
Long Acting

Abstract Introduction & Objective: Exogenous testosterone (T) replacement therapy (TRT) is typically long-acting and can potentially cause infertility in a majority of men due to suppression of HPG axis. Intratesticular testosterone is vital for spermatogenesis and can be reliably evaluated with serum 17-hydroxyprogesterone (17-OHP). Based on this observation, we hypothesized that we used serum 17-OHP as a serum biomarker for evaluating intratesticular T in men receiving TRT. We hypothesized that long-acting TRT will have a significant impact on suppressing HPG axis as compared to short-acting preparations. We evaluated data from two simultaneous open-label, randomized, two-arm clinical trials amongst different treatment preparations (Trial I) subcutaneous T pellets and (Trial II) Intranasal Testosterone (Natesto) or Intramuscular Testosterone cypionate (TC). Subject & Methods: Hypogonadal men (2 AM serum T &lt; 300 ng/dL assayed by LC-MS/MS) aged 18-65 years were randomized into open-label randomized clinical trials. Eligible subjects received: 800mg subcutaneous Testopel T pellets (n=47); or 11mg TID Intranasal testosterone (Natesto) (n=10) or 200mg x 2 weeks TC (n=10) for 2 months. Serum T and 17-OHP were collected at baseline and after 2 months of therapy. Data are presented as a post-hoc analysis of the two randomized clinical trials and reported as the median and interquartile range [25th-75th], paired sample analysis (baseline versus follow-up) was performed with the Wilcoxon test to determine change during time within the different TRT modalities, with p&lt;0.05 considered significant. Results: Median change for serum T between baseline and 2mo follow-up to subcutaneous T pellets was 542 [454-757] ng/dL, Intranasal Testosterone 706 [517-1010] ng/dL, and TC 525 [280-712]ng/dL.; 96% of subjects in each trial achieved mean T concentrations in the eugonadal range. We demonstrated that serum T levels were within normal range among men receiving the various therapies. As expected, we found a statistically significant decrease amongst the different T preparations in serum 17-OHP. Longer acting T preparations such as T pellets and TC demonstrated the greatest decrease in 17-OHP, from 41 [20.3-65.6] to 14 [10.3-20.8] ng/dL and 80 [48-121] ng/dL to 20 [17-36] ng/dL (p&lt;0.001), respectively. Shorter acting T preparations such as Natesto demonstrated a statistically significant decrease in 17-OHP, from 52.5 [26-67] ng/dL to 26.5 [18-39.8]ng/dL (p=0.007), but to a lesser extent as compared to the longer-acting preparations. Conclusions: Natesto, and other short acting forms of TRT may help hyogonadal men maintain Intratesticular T that is critical for maintaining spermatogenesis. The differential effects of TRT on intratesticular T based on their half-lives is novel and should be considered during the decision making for hypogondal men who wish to preserve fertility and / or testis size.

scholarly journals Glucagon-Like Peptide-1 Receptor Agonists and Cardiovascular Events: A Meta-Analysis of Randomized Clinical Trials

2011 ◽  
Vol 2011 ◽  
pp. 1-10 ◽  
Author(s):  
Matteo Monami ◽  
Francesco Cremasco ◽  
Caterina Lamanna ◽  
Claudia Colombi ◽  
Carla Maria Desideri ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cardiovascular Events ◽  
Randomized Trials ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Diabetic Patients ◽  
Cardiovascular Safety ◽  
Type 2 Diabetic Patients ◽  
Receptor Agonists

Objective. Data from randomized clinical trials with metabolic outcomes can be used to address concerns about potential issues of cardiovascular safety for newer drugs for type 2 diabetes. This meta-analysis was designed to assess cardiovascular safety of GLP-1 receptor agonists.Design and Methods. MEDLINE, Embase, and Cochrane databases were searched for randomized trials of GLP-1 receptor agonists (versus placebo or other comparators) with a duration ≥12 weeks, performed in type 2 diabetic patients. Mantel-Haenszel odds ratio with 95% confidence interval (MH-OR) was calculated for major cardiovascular events (MACE), on an intention-to-treat basis, excluding trials with zero events.Results. Out of 36 trials, 20 reported at least one MACE. The MH-OR for all GLP-1 receptor agonists was 0.74 (0.50–1.08),P=.12(0.85 (0.50–1.45),P=.55, and 0.69 (0.40–1.22),P=.20, for exenatide and liraglutide, resp.). Corresponding figures for placebo-controlled and active comparator studies were 0.46 (0.25–0.83),P=.009, and 1.05 (0.63–1.76),P=.84, respectively.Conclusions. To date, results of randomized trials do not suggest any detrimental effect of GLP-1 receptor agonists on cardiovascular events. Specifically designed longer-term trials are needed to verify the possibility of a beneficial effect.

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