scholarly journals 902. Unreturned Pill Bottles in the 1489 and 1490 Clinical Trials: An Important Measure of Poor Adherence that Is Often Ignored in Pill Count Calculations

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S542-S543
Author(s):  
Rima K Acosta ◽  
Grace Q Chen ◽  
Hailin Huang ◽  
Hui Liu ◽  
Kirsten L White
Keyword(s):  
Clinical Trials ◽  
Pill Count ◽  
Return Rate ◽  
Poor Adherence ◽  
Resistance Testing ◽  
Virologic Suppression ◽  
Treatment Groups ◽  
Pill Bottle ◽  
Treatment Naïve ◽  
All Treatment

Abstract Background Adherence to antiretroviral therapy is important for HIV suppression. In clinical trials, adherence is commonly measured by pill count; limitations are that unreturned pills may not have been taken and unreturned pill bottle data are omitted. This analysis focuses on the relationship between unreturned pill bottles as a measure of poor adherence and the overall effect on virologic success rates across all treatment groups. Methods Pill bottle return category (all bottles returned or ≥1 bottle unreturned) and return rates for participants across all treatment groups from two treatment-naïve INSTI clinical trials (Studies 1489 and 1490) were calculated. Association of bottle return category or rates with virologic events through week 144, including last on-treatment observation carried forward (LOCF) outcome, was determined; comparisons used Fisher’s exact or Wilcoxon rank sum test. Results Virologic suppression with ≥95% adherence by pill count can differ for those with unreturned pill bottles (Figure). In these studies, 60% of participants returned all their pill bottles through week 144; if one visit with ≥1 unreturned bottle was allowed, this percentage increased to 81%. The mean bottle return rate was 94% and did not differ by study, treatment arm, or sex. Failure to return pill bottles was significantly associated with lower suppression rates. Additionally, significant differences in pill bottle return rate (p < 0.01) were observed by week 144 LOCF outcome (95% vs 77% mean return rate for those with HIV RNA < 50 c/mL vs ≥50 c/mL), need for resistance testing (95% vs 77% return rate for those not tested vs tested), confirmed virologic failure (VF) (94% vs 90% return rate for those without VF vs with VF) and blip status (95% vs 92% return rate for those without blips vs with blips). HIV-1 Viral Loads of Two Participants with ≥95% Adherence by Pill Count through Week 144 Conclusion In these treatment-naïve INSTI clinical trials, failure to return pill bottles was associated with lower suppression rates. Although the calculated adherence rates in these studies was relatively high (median ≥95%), these calculations did not account for unreturned pill bottles. We believe that assessing adherence by both pill count and pill bottle return rate may provide a more complete picture of adherence in clinical trials. Disclosures Rima K. Acosta, BS, Gilead Sciences, Inc. (Employee, Shareholder) Grace Q. Chen, BS, Gilead Sciences, Inc. (Employee) Hailin Huang, PhD, Gilead Sciences, Inc. (Employee, Shareholder) Hui Liu, PhD, Gilead Sciences, Inc. (Employee, Shareholder) Kirsten L. White, PhD, Gilead Sciences, Inc (Employee, Shareholder)

scholarly journals 509. Clinical Characteristics and Outcomes in Patients Infected with SARS-CoV-2 Treated with Remdesivir, Tocilizumab, and/or Dexamethasone at a Mid-Atlantic Hospital Consortium

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S356-S357
Author(s):  
Nellie Darling ◽  
Kristen R Kent ◽  
Gavin Clark ◽  
Xue Geng ◽  
Marybeth Kazanas ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Length Of Stay ◽  
Ventilatory Support ◽  
Combination Group ◽  
Delivery Device ◽  
Research Support ◽  
Material Support ◽  
Treatment Groups ◽  
Treatment Regimens ◽  
All Treatment

Abstract Background Treatment strategies for COVID-19 have evolved based on clinical trials. We performed a retrospective analysis to determine treatment outcomes for Remdesivir (RDV), Tocilizumab (TOCI), and/or Dexamethasone (DEX) in a representative population from the Mid-Atlantic region. Methods A retrospective chart review was performed for patients admitted to MedStar hospitals within the D.C./Baltimore corridor from 03/01/2020 to 12/31/2020, and diagnosed with COVID-19 using a NP SARS-CoV-2 RT PCR assay. The MedStar Pharmacy Database was utilized to stratify based on any combination of RDV, TOCI, DEX treatment. Our primary endpoints included O2 delivery device, length of stay (LOS), and mortality. Results A total of 2488 patients were included. Overall, the average age of patients was 62yrs, 53% male, and the majority of patients were of Black (54%) or White (27%) race. The average length of stay was 11 days (SD = 12) with a mortality of 14%. Using univariate analyses, all combinations of RDV, TOCI, and DEX treatment regimens were evaluated. Patients who received DEX required the most ventilatory support on Day 1 (5%, p< 0.001) compared to all other groups. These same patients, however, did not go on to have higher ventilatory needs (17%, p< 0.001) compared to the group which ultimately required the most ventilatory support, TOCI plus DEX (94%, p< 0.001) at Day 28 of treatment. TOCI use alone was associated with a 4% to 63% (p< 0.001) increase in need for ventilatory support over the course of 28 days (Figure 1). The shortest LOS was seen in those treated with DEX alone (9.5 days, p< 0.001). Longer LOS outcomes were associated with all treatment groups which included TOCI use (19 to 22 days, p< 0.001, Figure 2). Mortality was similarly higher among all treatment groups which contained TOCI (30% to 62.5%, p< 0.001, Figure 3) when compared to those with RDV and/or DEX use alone (10% to 14%, p< 0.001). Barplot of Oxygen Delivery Device at Admission and within 28 Days among Treatments Figure 1. Largest increase in ventilatory support from Day 1 of treatment (left) to Day 28 of treatment (right) was seen among TOCI and DEX (0% to 93.8%), RDV and TOCI (0% to 72.2%) and TOCI alone (3.7% to 63.4%). Figure 2. LOS was higher among all treatments containing TOCI (p<0.001), with the highest being the combination group of RDV, TOCI, and DEX (22.4 days, p<0.001). Figure 3. Treatment regimens containing TOCI accounted for the highest mortality rates as seen in TOCI and DEX use (62.5%), RDV and TOCI (44.4%), and TOCI use alone (30.4%). Conclusion Our study demonstrates that “real-world” clinical outcomes for patients with COVID-19 treated with Remdesivir, Tocilizumab, and Dexamethasone are consistent with what has been reported in clinical trials. The higher mortality associated with Tocilizumab treatment may reflect the use of this agent in critically ill patients with COVID-19. Disclosures Princy N. Kumar, MD, AMGEN (Other Financial or Material Support, Honoraria)Eli Lilly (Grant/Research Support)Gilead (Grant/Research Support, Shareholder, Other Financial or Material Support, Honoraria)GSK (Grant/Research Support, Shareholder, Other Financial or Material Support, Honoraria)Merck & Co., Inc. (Grant/Research Support, Shareholder, Other Financial or Material Support, Honoraria)

scholarly journals 318. Tenofovir Alafenamide (TAF) vs. Tenofovir Disoproxil Fumarate (TDF) in Hispanic/Latinx and Black Participants: Efficacy, Bone and Renal Safety Results from a Pooled Analysis of 7 Clinical Trials

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S168-S169
Author(s):  
Edwin DeJesus ◽  
Jaime Federico Andrade Villanueva ◽  
Jose Ramon Arribas Lopez ◽  
Cynthia Brinson ◽  
Gordon Crofoot ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Pooled Analysis ◽  
Retinol Binding Protein ◽  
Virologic Suppression ◽  
Mineral Density ◽  
Art Initiation ◽  
Treatment Naïve ◽  
Tenofovir Alafenamide ◽  
Renal Tubular ◽  
Hiv 1

Abstract Background People of color are underrepresented in clinical trials. TAF has shown improved renal and bone safety vs. TDF. We pooled 7 studies to evaluate efficacy/safety of TAF vs. TDF for ART initiation/switch in Hispanic/Latinx and Black participants. Methods Data from Hispanic/Latinx and Black adults who initiated/switched to TAF or TDF in 7 randomized trials (2 treatment-naïve, 5 suppressed switch) were analyzed. TAF-based regimens (elvitegravir/cobicistat/emtricitabine [FTC]/TAF, rilpivirine/FTC/TAF, FTC/TAF, or bictegravir/FTC/TAF) were compared with TDF-based regimens. Virologic suppression (VS; HIV-1 RNA < 50 c/mL, FDA snapshot) and % change in bone mineral density (BMD) and renal tubular biomarkers urine β-2-microglobulin (B2M):creatinine (Cr) ratio and retinol binding protein (RBP):Cr ratio are reported at W96. Results The pooled population (N = 5,825) included 1138 Hispanic/Latinx and 1324 Black participants. Treatment-naïve participants (n = 1,733) were 15% female, 25% Black, 19% Hispanic/Latino, with median age 34 years, HIV-1 RNA 4.6 log10 c/mL, CD4 405 cells/mm3. Switch participants (n = 4,092) were 13% female, 22% Black, 20% Hispanic/Latino, median age 45 years, CD4 653 cells/mm3. There was no difference in VS rate with TAF vs. TDF in any group. VS rate (TAF vs. TDF) in naïve participants: 88% vs. 84% (Hispanic/Latinx); 78 vs. 79% (Black); 87% vs. 85% (overall). VS (TAF vs. TDF) was well maintained in switch participants: 91% both arms (Hispanic/Latinx); 86% vs. 87% (Black); 90% vs. 88% (overall). TAF and TDF were well tolerated with few discontinuations due to adverse events (0.6–2%) in all groups. At W96 there was less impact on renal biomarkers in all groups initiating TAF (P < 0.001; table), and decreases in BMD were smaller (P < 0.005; table) vs. TDF. All groups switching from TDF to TAF experienced decreases in tubular proteinuria and improvements in BMD (both P < 0.001; table) at W96. Conclusion Hispanic/Latinx and Black participants who initiated/switched to TAF had significantly improved bone and renal parameters vs. TDF, with similar VS rates at W96. Efficacy and biomarkers were similar to the overall study population. These data in >2,400 Hispanic/Latinx and Black PLH demonstrate noninferior efficacy and safety advantages with TAF vs. TDF. Disclosures All authors: No reported disclosures.

scholarly journals 898. Effectiveness and Tolerability of DTG + 3TC in Clinical Practice: Evidence in PLHIV from Real-world Data

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S540-S540
Author(s):  
Lee A Evitt ◽  
Rahul Kumar ◽  
Rahul Kamath ◽  
Diwakar Jha ◽  
Daniel Parks ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Real World ◽  
Virologic Failure ◽  
Meta Analysis ◽  
Resistance Testing ◽  
People Living With Hiv ◽  
Virologic Suppression ◽  
Time Points ◽  
Points Of Interest ◽  
Treatment Naïve

Abstract Background Randomized controlled trials have shown dolutegravir (DTG) + lamivudine (3TC) to be an efficacious, well-tolerated and durable regimen for treatment-naive and treatment-experienced people living with HIV (PLHIV). Several observational studies have also concluded that it is effective in clinical practice. The objective of this meta-analysis was to estimate effectiveness and tolerability of DTG + 3TC in PLHIV by combining real-world evidence from clinical practice. Methods A systematic literature review using PubMed and Embase plus 24 regional and international conferences was conducted between January 2013 and December 2020 to identify studies of DTG + 3TC in treatment-experienced and treatment-naive PLHIV in clinical practice. Eligible published articles reporting virologic suppression, virologic failure and discontinuations at Weeks 48 and 96 were identified and extracted. Identified studies were included if they had an acceptable level of publication bias and heterogeneity determined using funnel plots and I2 statistics, respectively. One-arm meta-analyses using the DerSimonian and Laird method were conducted to estimate effect sizes for outcomes of interest for DTG + 3TC. Results One study of DTG + 3TC was identified reporting outcomes of interest at time points of interest in treatment-naive PLHIV, hence no meta-analysis was undertaken in this population. Eight studies (N=2366 PLHIV) undertaken in Europe reported data on treatment-experienced, virologically suppressed PLHIV on outcomes of interest at time points of interest (not all endpoints/time points were reported by all studies). The meta-analysis of available data from these 8 studies showed that among PLHIV switching to DTG + 3TC treatment, ≥ 95% maintained virologic suppression (per protocol) with ~1% virologic failures on DTG + 3TC at Weeks 48 and 96. Five of the 8 studies reported resistance data. Among participants with baseline resistance testing, no treatment-emergent integrase strand transfer inhibitor resistance mutations were observed. Table. Meta-analysis Results in Treatment-Experienced PLHIV: Proportion with Virologic Failure, Virologic Suppression, and Discontinuations at Weeks 48 and 96 Conclusion DTG + 3TC is an effective, tolerable and durable antiretroviral regimen with low rates of discontinuation in treatment-experienced PLHIV in clinical practice. Disclosures Lee A. Evitt, MSc Health Economics, ViiV Healthcare (Employee, Shareholder of GSK) Rahul Kumar, M Pharmacy, GlaxoSmithKline (Employee) Rahul Kamath, PharmD, GlaxoSmithKline (Employee) Diwakar Jha, Masters in Pharmaceutical Sciences, GlaxoSmithKline (Employee) Daniel Parks, PhD, GlaxoSmithKline (Employee, Shareholder) Jean A. van Wyk, MB,ChB, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Annemiek de Ruiter, MBBS FRCP, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee)

Effectiveness, Durability, and Safety of Dolutegravir and Lamivudine Versus Dolutegravir, Lamivudine, and Abacavir in a Real-Life Cohort of HIV-Infected Adults

2021 ◽  
pp. 106002802110341
Author(s):  
Inés Mendoza ◽  
Alicia Lázaro ◽  
Miguel Torralba
Keyword(s):  
Viral Load ◽  
Safety Profile ◽  
Real Life ◽  
Hazard Ratio ◽  
Treatment Discontinuation ◽  
Treatment Naïve ◽  
Tn 4 ◽  
Risk Of Treatment ◽  
Hiv 1 ◽  
All Treatment

Background: Dolutegravir (DTG) plus lamivudine (2-DR) is suggested as an initial and switch option in HIV-1 treatment. Objective: To analyze the effectiveness, durability, and safety of 2-DR compared with DTG plus abacavir/lamivudine (3-DR). Methods: This was an observational, ambispective study that included all treatment-naïve (TN) and treatment-experienced (TE) patients who started 2-DR or 3-DR between July 1, 2018, and November 30, 2020. The primary end point was noninferiority, at 24 and 48 weeks, of 2-DR versus 3-DR regarding the percentage of patients with viral load (VL)≥50 and 200 copies/mL in TN (4% margin) and VL<50 and 200 copies/mL in TE (margin 12%). Durability of response, and safety were also measured. Results: 242 patients were included (53 TN and 189 TE). Two TN patients on 2-DR had VL≥50 copies/mL and 1 had VL≥200 copies/mL at week 24. In TE patients on 2-DR, 90.2% achieved VL<200 copies/mL at week 24 (difference: 3.8%; 95% CI = −6.3% to 14%) and 91.8% at week 48 (difference: 0.06%; 95% CI = −9% to 10%), meeting noninferiority criteria. Among the 53 TN patients, only 1 VF was observed in 2-DR. In TN patients, the risk of treatment discontinuation was similar between groups (hazard ratio [HR] = 0.37; P = 0.15); similar rates were also found in TE patients (HR = 0.94; P = 0.85). TE patients on 2-DR showed a better safety profile compared with 3-DR patients ( P<0.001). Conclusion and Relevance: Our results did not show noninferiority in terms of virological effectiveness. Nevertheless, all effectiveness measures support the use of 2-DR in a real-life cohort of TN and TE. Additionally, durability and safety of 2-DR were confirmed to be similar to that of 3-DR.

scholarly journals Efficacy and safety of alemtuzumab over 6 years: final results of the 4-year CARE-MS extension trial

2021 ◽  
Vol 14 ◽  
pp. 175628642098213
Author(s):  
Alasdair J. Coles ◽  
Douglas L. Arnold ◽  
Ann D. Bass ◽  
Aaron L. Boster ◽  
D. Alastair S. Compston ◽  
...  
Keyword(s):  
Disease Activity ◽  
Disease Duration ◽  
Inadequate Response ◽  
Treatment Groups ◽  
Brain Volume Loss ◽  
Disease Modifying Therapy ◽  
Core Study ◽  
Treatment Naïve ◽  
Multiple Sclerosis Patients ◽  
Extension Trial

Background: In the 2-year CARE-MS I and II trials, alemtuzumab 12 mg administered on 5 consecutive days at core study baseline and on 3 consecutive days 12 months later significantly improved outcomes versus subcutaneous interferon beta-1a (SC IFNB-1a) in relapsing–remitting multiple sclerosis patients. Here, we present the final 6-year CARE-MS extension trial results (CAMMS03409), and compare outcomes over 6 years in patients randomized to both treatment groups at core study baseline. Methods: Over a 4-year extension, alemtuzumab patients (alemtuzumab-only) received as-needed additional alemtuzumab (⩾12 months apart) for disease activity after course 2. SC IFNB-1a patients who entered the extension discontinued SC IFNB-1a and received 2 alemtuzumab 12 mg courses (IFN–alemtuzumab), followed by additional, as-needed, alemtuzumab. Results: Through year 6, 63% of CARE-MS I and 50% of CARE-MS II alemtuzumab-only patients received neither additional alemtuzumab nor other disease-modifying therapy, with lasting suppression of disease activity, improved disability, and slowing of brain volume loss (BVL). In CARE-MS I patients (treatment-naive; less disability; shorter disease duration), disease activity and BVL were significantly reduced in IFN–alemtuzumab patients, similar to alemtuzumab-only patients at year 6. Among CARE-MS II patients (inadequate response to prior treatment; more disability; longer disease duration), alemtuzumab significantly improved clinical and magnetic resonance imaging outcomes, including BVL, in IFN–alemtuzumab patients; however, disability outcomes were less favorable versus alemtuzumab-only patients. Safety profiles, including infections and autoimmunities, following alemtuzumab were similar between treatment groups. Conclusion: This study demonstrates the high efficacy of alemtuzumab over 6 years, with a similar safety profile between treatment groups. ClinicalTrials.gov identifiers: NCT00530348; NCT00548405; NCT00930553

scholarly journals Functional Monitoring after Trabeculectomy or XEN Microstent Implantation Using Spectral Domain Optical Coherence Tomography and Visual Field Indices—A Retrospective Comparative Cohort Study

Biology ◽  
2021 ◽  
Vol 10 (4) ◽  
pp. 273
Author(s):  
Marc Schargus ◽  
Catharina Busch ◽  
Matus Rehak ◽  
Jie Meng ◽  
Manuela Schmidt ◽  
...  
Keyword(s):  
Optical Coherence Tomography ◽  
Cohort Study ◽  
Visual Field ◽  
Spectral Domain ◽  
Optical Coherence ◽  
Treatment Groups ◽  
Rnfl Thickness ◽  
Comparative Cohort Study ◽  
The Mean ◽  
All Treatment

The aim of this study was to compare the efficacy of trabeculectomy (TE), single XEN microstent implantation (solo XEN) or combined XEN implantation and cataract surgery (combined XEN) in primary open-angle glaucoma cases, naïve to prior surgical treatment, using a monocentric retrospective comparative cohort study. Intraocular pressure (IOP) and the number of IOP-lowering drugs (Meds) were monitored during the first 24 months after surgery. Further disease progression was monitored using peripapillary retinal nerve fiber layer (RNFL) thickness examinations using spectral domain optical coherence tomography (OCT) as well as visual acuity (VA) and visual field (VF) tests. In the TE group (52 eyes), the mean IOP decreased from 24.9 ± 5.9 to 13.9 ± 4.2 mmHg (p < 0.001) and Meds decreased from 3.2 ± 1.2 to 0.5 ± 1.1 (p < 0.001). In the solo XEN (38 eyes) and the combined XEN groups, the mean IOP decreased from 24.1 ± 4.7 to 15.7 ± 3.0 mmHg (p < 0.001) and 25.4 ± 5.6 to 14.7 ± 3.2 mmHg (p < 0.001), while Meds decreased from 3.3 ± 0.8 to 0.8 ± 1.2 (p < 0.001) and 2.7 ± 1.2 to 0.4 ± 1.0 (p < 0.001), respectively. The VF and VA indices showed no sign of further deterioration, the RNFL thickness further decreased in all treatment groups after surgery. TE and XEN led to comparable reductions in IOP and Meds. Although the VA and VF indices remained unaltered, the RNFL thickness continuously decreased in all treatment groups during the 24-month follow-up.

scholarly journals Rates and Correlates of Short Term Virologic Response among Treatment-Naïve HIV-Infected Children Initiating Antiretroviral Therapy in Ethiopia: A Multi-Center Prospective Cohort Study

Pathogens ◽  
2019 ◽  
Vol 8 (4) ◽  
pp. 161
Author(s):  
Birkneh Tilahun Tadesse ◽  
Adugna Chala ◽  
Jackson Mukonzo ◽  
Tolosssa Eticha Chaka ◽  
Sintayehu Tadesse ◽  
...  
Keyword(s):  
Drug Resistance ◽  
Viral Load ◽  
Plasma Viral Load ◽  
Proportional Hazards ◽  
Cox Proportional Hazards ◽  
Virological Suppression ◽  
Virologic Suppression ◽  
Hiv Drug Resistance ◽  
Treatment Naïve ◽  
The Impact

There is limited data on virologic outcome and its correlates among HIV-infected children in resource-limited settings. We investigated rate and correlates of virologic outcome among treatment naïve HIV-infected Ethiopian children initiating cART, and were followed prospectively at baseline, 8, 12, 24 and 48 weeks using plasma viral load, clinical examination, laboratory tests and pretreatment HIV drug resistance (PDR) screening. Virologic outcome was assessed using two endpoints–virological suppression defined as having “undetectable” plasma viral load < 150 RNA copies/mL, and rebound defined as viral load ≥150 copies/mL after achieving suppression. Cox Proportional Hazards Regression was employed to assess correlates of outcome. At the end of follow up, virologic outcome was measured for 110 participants. Overall, 94(85.5%) achieved virological suppression, of which 36(38.3%) experienced virologic rebound. At 48 weeks, 9(8.2%) children developed WHO-defined virological treatment failure. Taking tenofovir-containing regimen (Hazard Ratio (HR) 3.1-[95% confidence interval (95%CI) 1.0–9.6], p = 0.049) and absence of pretreatment HIV drug resistance (HR 11.7-[95%CI 1.3–104.2], p = 0.028) were independently associated with earlier virologic suppression. In conclusion, PDR and cART regimen type correlate with rate of virologic suppression which was prominent during the first year of cART initiation. However, the impact of viral rebound in 38.3% of the children needs evaluation.

Abstract 5063: Cardiovascular Effects of Transdermal Testosterone in Postmenopausal Women

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
C Vitale ◽  
P Collins ◽  
G Marazzi ◽  
G Caminiti ◽  
I Lodhi ◽  
...  
Keyword(s):  
Risk Factors ◽  
Clinical Trials ◽  
Hormone Replacement ◽  
Cardiovascular Effects ◽  
Pooled Analysis ◽  
Phase Iii ◽  
Double Blind ◽  
Treatment Groups ◽  
Clinical Program ◽  
Large Phase

Testosterone Transdermal Patch (TTP) has been developed for the treatment of postmeno-pausal women (PMW) with hypoactive sexual desire disorder (HSDD). Since the cardiovascular (CV) effects of testosterone in women are still unclear we conducted a pooled analysis of the large phase III clinical program to evaluate the efficacy and safety of 300 μg/day TTP, alone or in association with hormone replacement therapy (HRT), versus placebo in surgical or natural PMW. Design & Methods: A total of 2795 women aged between 26 –70 years (mean age 52(SD=6.8) years) were included in 5 phase III randomized, double-blind, placebo-controlled clinical trials (treatment duration range 24 – 52 weeks) as part of the TTP Clinical program. 4 studies included PMW (natural and surgical, two each respectively) receiving HRT while 1 study was conducted without HRT, in either surgical or natural PMW. Women with known CV disorders were excluded from the studies. Changes from baseline in standard metabolic and CV risk factors were compared. The incidence of stroke, myocardial infarction (MI) and venous thromboembolism (VTE) alone or as a composite CV endpoint was assessed. Results: The 2795 PMW were randomized to receive either placebo (n=1297) or TTP (n=1498). Baseline mean BMI was 27 kg/m2 (SD=5.3 kg/m2) and 56% were naturally menopausal. The demographic and baseline parameters were similar among the treatment groups. No significant changes in CV risk factors (Total Cholesterol, Triglycerides, Insulin, Glucose, Systolic and Diastolic Blood Pressure) were detected during the study period, apart from a blunting of the increases in HDL-C by TTP at 24 and 52 weeks (Placebo 52-week mean change 2.59 mg/dl vs. TTP 52-week mean change 1.20 mg/dl, p<0.005) and of the decrease in LDL-C by TTP at 24 (p<0.05), but not at 52 weeks. During the double-blind (24 weeks), placebo-controlled period of the combined studies, 4 major CV events (2 MIs and 2 strokes) were reported in placebo patients and 3 (2 MIs and 1 stroke) in those receiving TTP. One VTE occurred in a patient receiving TTP and HRT. Conclusion: TTP therapy in these clinical trials did not adversely affect CV risk profile and did not change the risk of major CV events in these surgical and naturally PMW with or without concomitant HRT.

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