Speed of accrual into published phase III oncology trials: A comparison across geographic locations.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 6074-6074
Author(s):  
Nancy R. Ruther ◽  
Alcee Jumonville ◽  
Michelle A. Mathiason ◽  
Ann E. Emmel ◽  
Sandra K Wee ◽  
...  
Keyword(s):  
Phase Iii ◽  
Funding Source ◽  
Cancer Type ◽  
Cooperative Groups ◽  
Geographic Locations ◽  
Funding Sources ◽  
Therapeutic Trials ◽  
Number Of Patients ◽  
The Us ◽  
The Mean

6074 Background: There is a perception that patient accrual may be slower in the US than it is in Europe (Wang-Gillam A et al, J Clin Oncol 2010;28:3803-3807). However, a systematic study has not been performed. We seek to determine the speed at which patients are accrued into published phase III oncology trials across geographic locations and to identify factors that may influence this process. Methods: We searched MEDLINE and identified all original phase III oncology therapeutic trials published in 2006-2010 (N = 567). Trials with no reported activation and completion dates were excluded (n = 20). Accrual speed per trial was expressed as patients per month and was calculated by dividing the number of patients enrolled by number of months a trial was open. Results: The 547 trials included in our study enrolled 281,340 patients. Most trials were for adults only (95.6%), late stage cancers (77.5%), and involved multinational participation (44.1%). Funding sources were cooperative groups (45.5%), industry (33.8%) and academic centers (20.5%). The top 5 cancers studied were hematologic (19.2%), gastrointestinal (16.5%), lung (16.3%), breast (15.4%), and gynecologic (8.4%). Trial results were negative (57.4%), positive (38.2%), or equivalent (4.4%). The mean (+SD) accrual speeds varied according to trial location (multinational [25.0+25.4], US [13.3+16.5], other countries [11.4+15.7], Europe [8.7+11.8]; [P= .001]), funding source (industry [28.3+24.7], cooperative groups [13.3+19.0], academic [6.8+6.5]; [P= .001]), and cancer type (breast [24.0+29.4], gastrointestinal [20.2+24.2], lung [19.3+22.7], gynecologic [15.3+19.2], hematologic [11.2+10.7]; [P= .001]). After adjusting for funding source, accrual speeds were significantly different across trial locations only in 2 cancers: gastrointestinal (multinational [25.2+3.7], US [24.1+8.2], Europe [11.5+3.7], other [7.5+8.5]; P= .046) and gynecologic (multinational [28.9+5.4], other [10.5+7.8], US [6.6+5.3], Europe [4.2+5.9]; P= .004) studies. Conclusions: Among published phase III oncology trials, multinational studies accrued patients faster in gastrointestinal and gynecologic cancers and at a similar speed in other cancers.

Sex and funding trends in phase 3 oncology trials registered with clinicaltrials.gov.

2014 ◽  
Vol 32 (30_suppl) ◽  
pp. 295-295
Author(s):  
Nicholas M. Moloci ◽  
Sarah Yee ◽  
David Tomczyk ◽  
Gordon Sun
Keyword(s):  
Gynecological Cancer ◽  
Gynecologic Cancer ◽  
Temporal Trends ◽  
Funding Source ◽  
Cancer Type ◽  
Private Industry ◽  
Phase 3 ◽  
Funding Sources ◽  
Primary Investigator ◽  
Cancer Trials

295 Background: Women have been historically underrepresented as authors of clinical research, which may obscure important scientific interpretations and perspectives. We examined whether primary investigator sex was associated with funding sources of registered phase 3 oncology trials. Methods: We searched ClinicalTrials.gov, identifying completed phase 3 oncology trials registered from 1/1/2005 to 12/31/2010. The first investigator sex and nationality, funding source, and cancer type were collected. Bivariate associations between first investigator and funding source were analyzed with chi-square tests. Temporal trends were analyzed using the Cochran Armitage test. Results: Of 1,365 trials, 882 listed an individual as first investigator and were eligible for analysis; 195 (22.1%) listed a woman as first investigator. From 2005 to 2010 the proportion of women as first investigator across all funding sources did not change significantly (p for trend >.05). The proportion of breast and gynecological cancer trials led by women was significantly higher than the proportion led by men (29.3% of all trials led by women vs. 17.8% of all trials led by men, p<.001). In contrast, the proportions of prostate cancer trials led by women and men were similar (7.7% vs. 6.8%, p>.05). The National Institutes of Health (NIH) funded 95 trials with 32.6% led by women. Private industry funded 305 trials with 19.3% led by women. Of 659 trials funded by other sources such as universities and community-based organizations, 22.6% were led by women. The proportion of women leading industry trials increased from 11.3% to 27.3% (p for trend=.02), while the proportion of women leading trials by the NIH or other sources remained stagnant (p for trend>.05). However, the odds of a woman leading a trial funded by the NIH were 1.84 (95% confidence interval: 1.16-2.92) times greater than the odds for a man (15.9% vs. 9.3%). Conclusions: Women may be underrepresented as lead investigators of oncologic clinical trials, though they do appear to lead a substantial number of breast and gynecologic cancer trials. Primary investigator sex was associated with both funding source and cancer type.

Hematopoietic Stem Cell Transplantation Phase III Clinical Trials for Patients with Hematological Malignancies in the US: Lessons To Be Learned from the European Experience.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 229-229
Author(s):  
Sejal S. Kuthiala ◽  
Gary H. Lyman ◽  
Oscar F. Ballester
Keyword(s):  
Multivariate Analysis ◽  
Stem Cell ◽  
Hematological Malignancies ◽  
Care Delivery ◽  
Physician Attitudes ◽  
Phase Iii ◽  
Cell Transplant ◽  
Hematopoietic Stem ◽  
Number Of Patients ◽  
The Us

Introduction: Evidence-based medicine defines standard therapies primarily from Phase III randomized controlled trials (RCT), when available. In this report we examined trends in ther number and characteristics of phase III RCT addressing the management of adult patients with hematological malignancies, comparing the patterns of activity in the US and Europe. Materials and Methods: We attempted to identify all phase III RCT published in the English medical literature from 1/1992 to 12/2003. A systematic search of Medline and published references was conducted using multiple keywords for each malignancy as well as for hematopoeitic stem cell transplant (HSCT). We cross-referenced the data by searching individual journals, as well as the ASH education books from 1998–2003. Studies published in abstract form only were not included. Results: We identified 306 published RCT that accrued a total of 4899 patients. Eighty-three of these studies included HSCT with a total accrual of 2081 patients. Country of origin included: US (n= 25), Europe (n=54), other (n=4). Four European countries (France, Italy, Germany and UK: FIGU) with a combined population similar to that of the US produced 32 studies. This figure for FIGU does not include their contributions to 12 separate European cooperative trials. There were no significant trends in the number of trials published per year during the study period. However, significant differences emerged when the focus of the studies and the accrual numbers were analyzed. RCTs comparing HSCT to standard dose therapy represented 34.9% of the 83 trials and 59.4% of FIGU trials, but only 4% (1 out of 25) of US studies (p <.001). US trials accrued a mean of 110.2 patients per study, as compared to 205.3 in other countries and 222.6 in FIGU studies (p= .006). In multivariate analysis, only focus of study was independently related to greater study size (p<.001). Among the remaining 223 trials not involving HSCT (US produced 68 and FIGU 77), a significant trend for increasing numbers of trials published per year during the study period was documented (p=.015). No significant differences in the mean number of patients accrued per trial (US= 279.5, other countries= 302.8 and FIGU= 347.8), or in the focus of the studies were observed in univariate or multivariate analysis. Conclusions: While there has been an increase in the number of Phase III RTCs in patients with hematological malignancies published during 1992–2003, the activity for HSCT trials has remained stationary. US HSCT trials have focused on issues other than the comparison of HSCT to standard therapies, such as graft manipulation, growth factors and graft versus host disease. US HSCT have accrued significantly fewer patients per study. The reasons for these differences are not apparent from our data, and may include patient and/or physician attitudes/biases toward phase III trials, issues of financial coverage for the HSCT procedure and/or health care delivery policies. There is a serious paucity of US trials defining the role of HSCT in the management of hematological malignancies.

scholarly journals Routine follow-up of native valve disease: real life data from a physiologist-led valve clinic

2021 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
K Hyams ◽  
K Balkhausen ◽  
C Townsend
Keyword(s):  
Real Life ◽  
Heart Association ◽  
Native Valve ◽  
Conservative Strategy ◽  
Funding Sources ◽  
Real Life Data ◽  
Number Of Patients ◽  
The Mean ◽  
Funding Acknowledgements

Abstract Funding Acknowledgements Type of funding sources: None. Purpose The 2014 American Heart Association (AHA) guidelines for the management of Valvular Heart Disease (VHD) suggest that patients with mild and moderate native VHD should be followed up with echocardiography at regular intervals. Following audits at our hospital in 2016, dedicated Physiologist Led Valve Clinics (PLVC) were initiated to improve guideline adherence. A conservative strategy for follow-up frequency based on AHA guidelines was chosen (3 years for mild VHD, and 1 year for moderate VHD). This audit aimed to ascertain adherence to this conservative follow-up strategy, and to assess the progression of VHD between echocardiographic assessments to inform a strategy for safe follow-up in our PLVC. Methods Our echocardiography database Cognos was searched for patients with isolated mild and moderate native VHD, seen in our PLVC between 2016-2018 and followed up between 2017-2019. Patients with severe, prosthetic, combined or significant mixed VHD were excluded. Echocardiography reports on McKesson were reviewed and the follow-up interval recorded for each patient. The severity of VHD at the index visit, and then at follow-up, was recorded to determine whether there had been a progression in VHD severity. For patients with progression, it was recorded whether they were symptomatic at follow-up or subsequently underwent valvular intervention. Results 466 index echocardiograms were reviewed; 134 patients were included (mean age 73.4) after removing those with exclusion criteria. The mean follow-up interval in mild VHD ranged between 587.6 ± 188.3 days, and 667.3 ± 174.6 days, well above the recommended 3 years (or 1095 days). The majority of patients with moderate VHD received follow-up well before the upper limit of AHA guidance (2 years, or 730 days). Mean follow-up ranged between 408.3 ± 80.8 days (in moderate aortic stenosis (AS)) and 504.0 ± 29.0 days (in moderate mitral stenosis (MS)). The number of patients followed up with mild VHD was very low. 1 patient in each group progressed to moderate VHD (out of 2, 3 and 5 respectively); none became symptomatic, and none progressed from mild to severe VHD. In moderate VHD, progression rates were highest in AS (34.8%). Patients with progressive disease were more frequently symptomatic (43%) or underwent valve intervention (25%). Fewer with mitral regurgitation (MR) (22%) progressed, 44.5% of whom were symptomatic, 11% undergoing intervention. Patients with moderate aortic regurgitation (AR) saw the lowest progression rates (11.4%), 50% of whom were symptomatic. There was no progression in moderate MS. Conclusions Patients with mild VHD can safely be followed up less conservatively in the PLVC setting, adhering to AHA guidance (3-5 years). Patients with moderate AS should be considered to remain under conservative follow-up (12-18 months). Follow-up for moderate AR, MR and MS can safely be adjusted towards the less conservative end of the AHA guidance (2 years). Abstract Figure.

scholarly journals Proportion of Patients with FLT3 Positive AML Required to Enroll on Clinical Trials to Satisfy the Recruitment Needs of FLT3 Inhibitor Trials: Are We Running out of Patients?

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 713-713
Author(s):  
Taylor Bucy ◽  
John Zoscak ◽  
Motomi Mori ◽  
Vinayak Prasad ◽  
Uma Borate
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cooperative Group ◽  
Participation Rates ◽  
Therapeutic Trials ◽  
Fda Approval ◽  
Number Of Patients ◽  
The Us ◽  
Flt3 Mutations ◽  
Flt3 Inhibitors

Abstract Introduction. The push for personalized medicine in oncology has generated an influx of therapies targeting similar pathways, despite only 5% of clinically tested agents receiving FDA approval (Mattina 2017). Acute myeloid leukemia (AML) is a malignancy where identification of prognostically significant mutations suggests growing potential for therapeutic inhibition. FMS-like tyrosine kinase 3 (FLT3) mutations are deemed one of few "actionable" mutations and include 30% of de novo AML cases (25% ITD, 5% TKD) (Garcia 2017; Fathi 2016). In 2017 there will be approximately 21000 new AML cases, roughly 6000 of these patients will be FLT3+ (ACS 2017). In line with prior research in melanoma elucidating the growing number of trials aimed at personalized medicine, we sought to identify the total number of therapeutic trials studying FLT3 inhibitors (Tang 2018). We analyzed the total number of FLT3+ patients required for recruitment to these trials to ensure successful completion compared to incidence of this molecular abnormality within the AML patient population. Methods.A systematic review of therapeutic clinical trials focusing on adult FLT3+ AML from 2000-2017 was conducted using the PRISMA 2009 guidelines (Figure 1). We identified 78 therapeutic trials of FLT3 targeted therapies by cross-referencing ClinicalTrials.gov (66) and PubMed publications (12). Assuming constant accrual rate over the duration of each trial and constant rate of FLT3 mutations at 30% since 2000, statistical analysis was performed using the study start dates and primary completion dates of all trials from ClinicalTrials.gov. Incidence data was collected from the CDC, SEER database, and literature review (De Kouchkovsky 2016; ASCO 2018). Projections of discrepancies between anticipated clinical trial enrollment were provided using consistently cited rates of adult participation of 1%, 3% and 5% versus participant enrollment needed to satisfy current projected trends (Rinde 2018; Unger 2016). Results. Twenty-four therapeutic FLT3 inhibitors being investigated were identified in 78 distinct clinical trials. Pharmaceutical versus cooperative group support was 2.23:1, with 29 different pharmaceutical sponsors and 13 cooperative group/non-profit/academic sponsors(Table 1). Thirty-eight (48.7%) trials/publications accrued in the US only, 21 (26.9%) at international sites only, 15 (19.2%) accrued in both the US and internationally, and 4 (5.1%) had no location listed at time of search. Only one study (NCT03258931) proposed a head-to-head comparison of midostaurin versus crenolanib. The number of patients needed to satisfy enrollment began to surpass the upper bound of estimated participation in 2010, dropping slightly from 2013-2014 and noticeably surpassing projected participation rates from 2015-2016 (Figures 2 & 3). In 2017, approximately 21380 patients were diagnosed with AML, roughly 6414 were FLT3 positive. Assuming 5% participation rate, 320.7 FLT3 positive patients would be expected to enroll in clinical trials. However, the total number of patients needed to satisfy enrollment in 2017 was 1235; after excluding international and completed trials, the total number needed is 844.49 patients. Based on statistical analyses, we estimate that 13.2% of all US patients with FLT3 pos AML would have to enroll to satisfy eligibility in 2017; roughly 3 times the upper level of historical clinical trial participation rates in the US. Conclusions. The current clinical trial process investigating targeted therapies in AML requires an unusually high and unsustainable enrollment, given the discrepancy between the incidence of AML patients with targetable mutations and the number of pharmaceutical agents being studied for these small patient populations. This discrepancy becomes even more startling when considering barriers to enrollment, including insurance market restrictions, geographical, socioeconomic, and demographic factors. Most of these trials do not compare available agents to identify the drug that may provide the most patient benefit. Whether this method of finding new therapies eventually leading to FDA approval continues to be sustainable or whether such duplicative trials dilute the valuable resource of AML patients with rare, targetable mutations, thus impeding development of the most effective therapeutic agents, must considered by the research and regulatory community. Disclosures Borate: Novartis: Consultancy; Agios: Consultancy.

Optimism bias in the design of phase III randomized control trials (RCTs) evaluating PD-1/PD-L1 targeting monoclonal antibodies (mAbs).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18616-e18616
Author(s):  
Laith Al-Showbaki ◽  
Fahad Almugbel ◽  
Husam Alqaisi ◽  
Eitan Amir ◽  
Eric Xueyu Chen
Keyword(s):  
Monoclonal Antibodies ◽  
Hazard Ratio ◽  
Phase Iii ◽  
Randomized Control Trials ◽  
Optimism Bias ◽  
Number Of Patients ◽  
Cancer Types ◽  
The Mean ◽  
Randomized Control ◽  
Palliative Setting

e18616 Background: PD-1/PD-L1 targeting monoclonal antibodies (mAbs) improve outcomes in multiple cancer types. Multiple mAbs are in clinical development, and many randomized control trials (RCTs) have been completed or are in progress. These RCTs compete for limited clinical trials infrastructure, human resources and patients. Since the hypothesized benefit of an intervention is a critical determinant of the number of patients required for an RCT, it is crucial that the expected benefit be estimated appropriately. We examined the hypothesized hazard ratio (HHR) and the observed hazard ratio (OHR) in RCTs evaluating PD-1/PD-L1 targeting mAbs. Methods: Publications of RCTs evaluating at least one PD-1/PD-L1 targeting mAbs approved by the US Food and Drug Administration were identified through PubMed searches. The primary publication for each RCT and its associated protocol were retrieved. Two investigators independently extracted HHR, OHR for the primary endpoint among other data elements. The differences (∆HR) in HHR and OHR were analyzed statistically. Updated OHRs (uOHR) were extracted from reports with extended follow-ups. Results: 49 RCTs enrolling 36867 patients were included. 45/49 RCTs were in the palliative setting. HHR was met or exceeded in 22 (45%) RCTs. The mean HHR and OHR were 0.672 and 0.738, respectively. The mean ∆HR was 0.067 (range: -0.300 to 0.895, 95% confidence interval = 0.003 – 0.130). A lower magnitude of effect than hypothesized in 12/29 RCTs in non-small cell lung cancer, melanoma and renal cell carcinoma, but in 15/20 RCTs in other cancer types. OHR was ≥ 1.0 in 6 RCTs (12%). In the palliative setting, ∆HR was larger in more heavily pre-treated patients. PD-L1 expression was not associated with magnitude of effect. However, a higher magnitude of effect was observed for RCTs published in the New England Journal of Medicine. For 18 RCTs with extended follow-ups, uOHR was higher than OHR in 8. Conclusions: The majority of published RCTs evaluating PD-1/PD-L1 targeting mAbs did not achieve their hypothesized magnitude of effect. Investigators’ optimism regarding these agents should be combined with more realistic expectations. The optimism bias requires attention from the cancer clinical research community given the number of these agents in development and the intense interest in evaluating these agents in various disease settings.

Bempedoic Acid: A First-in-Class Agent for Lowering Cholesterol Levels

2021 ◽  
Vol 36 (7) ◽  
pp. 331-336
Author(s):  
Candis M. McGraw-Senat ◽  
Nakoasha Dillard ◽  
Taylor Guelda ◽  
Essie Samuel ◽  
Hua Ling
Keyword(s):  
Statin Therapy ◽  
Outcome Data ◽  
Phase Iii ◽  
Lipid Disorders ◽  
Cholesterol Levels ◽  
Citrate Lyase ◽  
Number Of Patients ◽  
The Us ◽  
Phase Iii Trials

Despite statin therapy being the cornerstone for the treatment of hypercholesterolemia, a significant number of patients do not tolerate statin therapy because of muscle-related adverse effects or cannot achieve their individual low-density lipoproteincholesterol (LDL-C) goals with statin therapy alone. Several nonstatin agents have been evaluated for the management of LDL-C levels and reduction of cardiovascular (CV) risk in these patients, but there are some limitations with their use. Bempedoic acid is a novel nonstatin agent for the management of lipid disorders, via the inhibition of adenosine triphosphate citrate lyase (ACL). It was recently approved by the US Food and Drug Administration based on several phase III trials which showed promising results regarding safety and efficacy. Though CV outcome data are not available yet, bempedoic acid may be a useful adjunct therapy for select patients. The purpose of this review is to evaluate the major findings in these clinical trials and discuss the potential role of bempedoic acid in clinical practice and its use in older people.

Bempedoic Acid: A First-in-Class Agent for Lowering Cholesterol Levels

2021 ◽  
Vol 36 (7) ◽  
pp. 331-336
Author(s):  
Candis M. McGraw-Senat ◽  
Nakoasha Dillard ◽  
Taylor Guelda ◽  
Essie Samuel ◽  
Hua Ling
Keyword(s):  
Statin Therapy ◽  
Low Density Lipoprotein ◽  
Density Lipoprotein ◽  
Outcome Data ◽  
Phase Iii ◽  
Cholesterol Levels ◽  
Citrate Lyase ◽  
Number Of Patients ◽  
The Us ◽  
Phase Iii Trials

Despite statin therapy being the cornerstone for the treatment of hypercholesterolemia, a significant number of patients do not tolerate statin therapy because of muscle-related adverse effects or cannot achieve their individual low-density lipoprotein-cholesterol (LDL-C) goals with statin therapy alone. Several nonstatin agents have been evaluated for the management of LDL-C levels and reduction of cardiovascular (CV) risk in these patients, but there are some limitations with their use. Bempedoic acid is a novel nonstatin agent for the management of lipid disorders, via the inhibition of adenosine triphosphate citrate lyase (ACL). It was recently approved by the US Food and Drug Administration based on several phase III trials which showed promising results regarding safety and efficacy. Though CV outcome data are not available yet, bempedoic acid may be a useful adjunct therapy for select patients. The purpose of this review is to evaluate the major findings in these clinical trials and discuss the potential role of bempedoic acid in clinical practice and its use in older people.

Phase III randomized clinical trials global distribution and funding: Trends and disparities.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18563-e18563
Author(s):  
Karina Pinheiro ◽  
Mauricio Ribeiro ◽  
Luiza Lara Gadotti ◽  
Fabiane Marson ◽  
Carlos Diego Holanda Lopes ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Phase Iii ◽  
Funding Source ◽  
Pharmacological Interventions ◽  
World Region ◽  
Funding Sources ◽  
Phase Iii Clinical Trials ◽  
Disease Site ◽  
Background Phase

e18563 Background: Phase III clinical trials (PIIICT) constitute the cornerstone of the progress and development of new therapeutic strategies. However, their complexity and costs in a scenario of limited funding sources impose important limitations in their scope and reach. Methods: We searched in clinicaltrials.gov to identify PIIICT evaluating pharmacological interventions in adjuvant, neoadjuvant and metastatic settings between 2010-2020 in breast, cervix, colorectal cancer (CRC), lung, melanoma, prostate and penile cancer. Trials identified were categorized according to disease site, funding source and world region/country (R/C). Case incidence in 2020 was collected from the IARC website. Results: Of 825 clinical trials, 72.7% were industry-sponsored (IS). Trials by R/C, not including multicentric studies (61.8%): (A) USA 76 trials, 53.9% non-industry sponsored (NIS); (B) Europe/UK 112, 59.8% NIS; (C) Asia (excluding China) 62, 27.4% NIS and (D) China 183, 43.7% NIS. There was a statistically significant association between location and funding source (p= 0.0003). NIS source was detected in higher proportion of trials ongoing in regions A and B (59%). IS was statistically less frequent in uterine cervix/penis (42.8%) and CRC (49.6%) IS was significantly higher in lung and prostate trials (both 81%) (p<0.0001). Table summarizes our results by tumor sites. We also found a statistically significant association between the incidence of malignancies in the selected primary sites and the amount of registered clinical trials, overall (p<0.0001) and IS as well (p<0.0001). The database is under expansion to include other disease sites as well as other geographic areas separately (Africa, Russia, South America, India, and Oceania). Cervix and penile results were combined given their biological and epidemiological similarities. Conclusions: There is a significant disparity between the number of clinical trials and tumor prevalences as well as among the distribution of IS trials funding.[Table: see text]

Differences in Funding Sources of Phase III Oncology Clinical Trials by Treatment Modality and Cancer Type

2017 ◽  
Vol 40 (3) ◽  
pp. 312-317 ◽  
Author(s):  
Vikram Jairam ◽  
James B. Yu ◽  
Sanjay Aneja ◽  
Lynn D. Wilson ◽  
Shane Lloyd
Keyword(s):  
Clinical Trials ◽  
Treatment Modality ◽  
Phase Iii ◽  
Cancer Type ◽  
Funding Sources ◽  
Oncology Clinical Trials

scholarly journals Avanafil for the treatment of erectile dysfunction: initial data and clinical key properties

2012 ◽  
Vol 5 (1) ◽  
pp. 35-41 ◽  
Author(s):  
George T. Kedia ◽  
Stefan Ückert ◽  
Farhang Assadi-Pour ◽  
Markus A. Kuczyk ◽  
Knut Albrecht
Keyword(s):  
Erectile Dysfunction ◽  
Initial Data ◽  
Treatment Options ◽  
Pharmacokinetic Profile ◽  
Phase Iii ◽  
Onset Of Action ◽  
Number Of Patients ◽  
First Choice ◽  
The Us ◽  
Phosphodiesterase Type

Orally active, selective inhibitors of phosphodiesterase type 5 (PDE 5, cyclic GMP PDE), such as sildenafil, tadalafil and vardenafil, are currently the first-choice treatment options for the clinical management of erectile dysfunction (ED) of various etiologies and severities. However, a significant number of patients remain dissatisfied with the available therapies due a lack of efficacy or discomfort arising from adverse events. Several new PDE5 inhibitors, among which are avanafil (TA-1790), lodenafil, mirodenafil, udenafil, SLX-2101, JNJ-10280205 and JNJ-10287069, have recently been approved and introduced into the market or are in the final stages of their clinical development. Avanafil (marketed in the US under the brand name STENDRA™) has been developed by VIVUS Inc. (Mountain View, CA, USA) and has recently received approval from the US Food and Drug Administration (FDA) for use in the treatment of male ED. The drug has demonstrated improved selectivity for PDE5, is rapidly absorbed after oral administration with a fast onset of action and a plasma half-life that is comparable to sildenfil and vardenafil. In phase II and phase III clinical trials that included a large number of patients, avanafil has been shown to be effective and well tolerated. Owing to its favorable pharmacodynamic and pharmacokinetic profile, avanafil is considered as a promising new option in the treatment of ED. The present article summarizes the initial data and clinical key properties of avanafil.

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