scholarly journals 2482. Clinical Outcomes of Once-Daily Darunavir in Treatment-Experienced Patients with Darunavir Resistance Associated Mutations Through 48 Weeks of Treatment

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S859-S860
Author(s):  
Charlotte-Paige M Rolle ◽  
Omar Marquez ◽  
Vu Nguyen ◽  
Federico Hinestrosa ◽  
Edwin DeJesus
Keyword(s):  
Clinical Outcomes ◽  
Treatment Guidelines ◽  
Patient Adherence ◽  
Cd4 Count ◽  
Lipid Lowering ◽  
Virologic Suppression ◽  
Lipid Lowering Therapy ◽  
Number Range ◽  
Once Daily ◽  
Hiv 1

Abstract Background Darunavir (DRV) is a well-tolerated, potent protease inhibitor used once-daily in patients with no DRV resistance-associated mutations (RAMs) and twice-daily in those with DRV RAMs. Treatment guidelines encourage use of once-daily regimens to optimize patient adherence, convenience and tolerability. Several studies suggest that once-daily DRV retains efficacy in the setting of 1–2 DRV RAMs whereas 3 or more DRV RAMs (with multiple background PI RAMs) is needed for DRV resistance. Currently, there is little clinical data to support the long-term use of once-daily DRV in patients with DRV RAMs. Methods This is a retrospective study evaluating the 48-week clinical outcomes of 22 treatment-experienced patients with DRV RAMs switched to once-daily DRV between 2014 and 2017 at the Orlando Immunology Center. The primary endpoint was the proportion with virologic suppression (HIV-1 RNA< 50 copies/mL) at Week 48. Adherence, adverse events (AEs) and laboratory parameters were analyzed throughout the study. Results The median age (range) of the sample was 53 (21–77) years, median baseline CD4+ count was 609 cells/mm3, 18 (82%) had baseline HIV-1 RNA <50 copies/mL, 15 (69%) had previously used 1 or more PIs and median number (range) of baseline DRV RAMs was 2 (1–5) (Table 1). At Week 48, 20 (91%) had HIV-1 RNA <50 copies/mL; 2 (9%) virologic non-responders had HIV-1 RNA of 82 and 59,637 copies/mL and reported noncompliance (Figure 1). There was no significant change in median CD4+ count from baseline to Week 48 (+22, 95% confidence interval (CI): [−116.5; 56.0]). Once-daily DRV was associated with a significant median increase in HDL cholesterol (+82, 95% CI: [37.0; 101.0]) and a significant median decrease in LDL cholesterol (-60, 95% CI: [-89.5; -31.0]). There were no significant changes in the proportion of patients on lipid lowering therapy at baseline and week 48 (p = 0.33). There were no self-reported AEs or Grade 3–4 lab abnormalities through Week 48. Conclusion Once-daily DRV maintained virologic control in this cohort of treatment-experienced patients with 1 or more baseline DRV RAMs and was safe and well-tolerated. This suggests that once-daily DRV may be effective in this population however further data are needed to validate this as a viable treatment option. Disclosures All authors: No reported disclosures.

scholarly journals 2486. Clinical Outcomes of Patients Treated with Dolutegravir Functional Monotherapy or Dolutegravir plus an Active Non-cytosine Nucleoside Analog: A Retrospective Observational Cohort Study of Treatment-Experienced Patients

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S861-S862
Author(s):  
Charlotte-Paige M Rolle ◽  
Beth Bryant ◽  
Colton J Tucker ◽  
Maria Camila Castro ◽  
Vu Nguyen ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Real World ◽  
Virologic Failure ◽  
Subsequent Development ◽  
Nucleoside Analog ◽  
Cd4 Count ◽  
Virologic Suppression ◽  
Count Range ◽  
Virologic Control ◽  
Hiv 1

Abstract Background Dual dolutegravir (DTG)-containing regimens (DCRs) are currently approved for the treatment of antiretroviral (ARV) naïve and experienced patients with HIV-1 infection. DTG monotherapy has resulted in unacceptable rates of virologic failure and subsequent development of DTG resistance. Here, we evaluate the “real-world” efficacy and “barrier to resistance” of DCRs containing 0–1 active ARVs. Methods This is a retrospective observational study evaluating clinical outcomes of treatment-experienced patients on combination DCRs found to be on DTG functional monotherapy or DTG plus an active non-cytosine analog between 2013 and 2014. The primary endpoint was virologic suppression (HIV-1 RNA< 50 copies/mL) at week 48. Virologic failure (VF) was defined as confirmed HIV-1 RNA≥ 50 copies/mL 12 weeks after initiating DTG or any time after achieving HIV-1 RNA< 50 copies/mL. Adherence, adverse events (AEs) and laboratory parameters were analyzed throughout the study. Results Thirty-nine patients were included in the analysis, 19 (49%) were on DTG functional monotherapy and 20 (51%) were on DTG plus a non-cytosine nucleoside analog. The median age (range) was 53 (40–74) years, median baseline CD4+ count (range) was 564 (92–1217) cells/mm3, 22 (56%) had baseline HIV-1 RNA< 50 copies/mL, and 24 (62%) had previously used INSTIs (Table 1). At Weeks 48 and 96, virologic suppression was observed in 78.3% and 86% of patients respectively (Figures 1 and 2). Among 7 VFs (2 on DTG functional monotherapy, 5 on DTG plus a non-cytosine nucleoside analog), there was no evidence of treatment-emergent resistance to DTG. There was a significant median increase in CD4+ count from baseline to Week 48 (+90 cells/mm3, 95% confidence interval: [14.18, 165.9]). No significant changes in lipid parameters were observed. Treatment-related AEs occurred in 17/39 (44%) patients (all Grade 1–2) and 1 patient discontinued DCR treatment due to rash. Conclusion In this “real-world” cohort of treatment-experienced patients, we observed that DTG functional monotherapy and DTG plus a non-cytosine nucleoside analog maintained long-term virologic control and was well tolerated. These data supports use of DTG as a partner for dual DCRs given its high efficacy in patients with underlying ARV resistance. Disclosures All authors: No reported disclosures.

Lipid-lowering therapy and patient adherence in the MULTI GAP 2013 trial

2014 ◽  
Vol 155 (17) ◽  
pp. 669-675
Author(s):  
Gábor Simonyi
Keyword(s):  
Health Insurance ◽  
National Health Insurance ◽  
National Health ◽  
Ldl Cholesterol ◽  
Patient Adherence ◽  
Lipid Lowering ◽  
Insurance Fund ◽  
Lipid Lowering Therapy ◽  
Health Insurance Fund ◽  
National Health Insurance Fund

Introduction: Dyslipidemia is a well-known cardiovascular risk factor. To achieve lipid targets patient adherence is a particularly important issue. Aim: To assess adherence and persistence to statin therapy in patients with atherosclerotic disease who participated in the MULTI Goal Attainment Problem 2013 (MULTI GAP 2013) study. Patient adherence was assessed using estimation by the physicians in charge and analysis of pick up rate of prescribed statins in 319 patients based on data of National Health Insurance Fund Administration of Hungary. Method: In the MULTI GAP 2013 study, data from standard and structured questionnaires of 1519 patients were processed. Serum lipid values of patients treated by different healthcare professionals (general practitioners, cardiologists, diabetologists, neurologists, and internists), treatment adherence of patients assessed by doctors and treatment adherence based on data of National Health Insurance Fund Administration of Hungary were analysed. Satisfaction of doctors with results of statin therapy and the relationship between the level of adherence and serum lipid values were also evaluated. Results: Considering the last seven years of survey data, the use of more effective statins became more prevalent with an about 70% increase of prescriptions of atorvastatin and rosuvastatin from 49% to 83%. Patients with LDL-cholesterol level below 2.5 mmol/l had 8 prescriptions per year. In contrast, patients who had LDL-cholesterol levels above 2.5 mmol/l had only 5.3–6.3 prescriptions per year. Patients who picked up their statins 10–12 or 7–9 times per year had significantly lower LDL-cholesterol level than those who had no or 1–3 pick up. The 100% persistence assessed by doctors was significantly lower (74%) based on data from the National Health Insurance Fund Administration of Hungary. About half of the patients were considered to display 100% adherence to lipid-lowering therapy by their doctors, while data from the National Health Insurance Fund Administration of Hungary showed only 36%. In patients with better adherence (90–100%) LDL-cholesterol levels below 2.5 mmol/l were more frequent (59.5%) compared to those with worse adherence. Satisfaction of doctors with lipid targets achieved was 69–80% in patients with total cholesterol between 4.5 and 6 mmol/l, and satisfaction with higher cholesterol values was also high (53–54%). Conclusions: The results show that doctors may overestimate patient adherence to lipid-lowering treatment. Based on data from the National Health Insurance Fund Administration of Hungary, satisfaction of doctors with high lipid level appears to be high. There is a need to optimize not only patient adherence, but adherence of doctors to lipid guidelines too.

scholarly journals Abordagem aos Doentes com Intolerância às Estatinas: Revisão Baseada na Evidência

2020 ◽  
Vol 33 (1) ◽  
pp. 49 ◽  
Author(s):  
Joana Tendais Almeida ◽  
Ana Luísa Esteves ◽  
Filipa Martins ◽  
Isabel Palma
Keyword(s):  
Systematic Reviews ◽  
Patient Adherence ◽  
Management Strategies ◽  
Lipid Lowering ◽  
Lipid Lowering Therapy ◽  
Level Of Evidence ◽  
Mortality And Morbidity ◽  
Number Of Patients ◽  
Pubmed Database ◽  
Meta Analyses

Introduction: Statins are among the most effective drugs in lowering cholesterol levels and, consequently, in reducing cardiovascular mortality and morbidity. Although generally well tolerated, they have adverse effects that may reduce patient adherence to therapy. The objective of this evidence-based review is to summarize the evidence on the effectiveness of alternative management strategies in patients with intolerance to statins.Material and Methods: A literature search including clinical practice guidelines, systematic reviews and meta-analyses was conducted, in January 2017, in major international databases, and considered articles published in the last 10 years. The search was complemented with research papers published over the past three years and found in the PubMed database. The level of evidence and strength of recommendation were determined using the scale Strength of Recommendation Taxonomy - SORT.Results: We included eight guidelines, six systematic reviews and one research paper.Discussion: The strategies proposed by the different studies vary according to the severity of symptoms of intolerance including maintenance of the statin therapy (dose reduction, addition of a statin of equal or lower intensity or alternate days’ uptake) and lipid-lowering therapy with other drugs (ezetimibe monotherapy or association with statin tolerated dose). Supplementation with coenzyme Q10 or vitamin D, in order to improve adherence to treatment with statins, is not recommended.Conclusion: This review highlights some alternatives to address patients’ intolerance to statins; however, these are mostly based on recommendations with low to moderate evidence. Therefore, further research with randomized studies involving greater number of patients is required, in order to obtain a more robust recommendation.

scholarly journals LB2. Switch to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) Maintains Virologic Suppression Through 48 Weeks: Results of the DRIVE-SHIFT Trial

2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S759-S760 ◽  
Author(s):  
Princy Kumar ◽  
Margaret Johnson ◽  
Jean-Michel Molina ◽  
Giuliano Rizzardini ◽  
Pedro Cahn ◽  
...  
Keyword(s):  
Tenofovir Disoproxil Fumarate ◽  
Stock Options ◽  
Advisory Board ◽  
Current Therapy ◽  
Virologic Suppression ◽  
Once Daily ◽  
Single Tablet Regimen ◽  
Hiv 1 ◽  
Switch Group ◽  
Research Grant

Abstract Background Doravirine is a novel, non-nucleoside reverse-transcriptase inhibitor (NNRTI) that has demonstrated efficacy in two Phase 3 trials in treatment-naïve adults with HIV-1. Methods This open-label, active-controlled, noninferiority (NI) trial evaluated a once-daily single-tablet regimen of doravirine 100 mg, lamivudine 300 mg, and tenofovir disoproxil fumarate 300 mg (DOR/3TC/TDF) vs. continuation of current therapy in adults with HIV-1 virologically suppressed for ≥6 months on a stable regimen of two NRTIs plus a boosted protease inhibitor (PI), boosted elvitegravir, or NNRTI. Participants with screening HIV-1 RNA &lt;40 copies/mL, no history of virologic failure on any regimen, and no resistance to DOR/3TC/TDF were randomized (2:1) to start DOR/3TC/TDF on Day 1 (immediate switch group, ISG) or after 24 weeks (delayed switch group, DSG). The primary endpoint was the proportion (%) of participants with HIV-1 RNA &lt;50 copies/mL (FDA snapshot approach), with the primary comparison between ISG at Week 48 and DSG at Week 24 and a secondary comparison between the groups at Week 24; the NI margin was -8%. The % of participants with HIV-1 RNA ≥50 copies/mL was also analyzed (FDA snapshot approach; NI margin 4%). Results A total of 670 participants (447 ISG, 223 DSG) were treated and included in the analyses; 84.5% were male, 76.4% were white, and mean age was 43.3 years. At Week 24, 93.7% (419/447) of ISG vs. 94.6% (211/223) of DSG had HIV-1 RNA &lt;50 copies/mL (difference −0.9% [−4.7, 3.0]), and 1.8% of each group had HIV-1 RNA ≥50 copies/mL. At Week 48, 90.8% (406/447) of ISG maintained HIV-1 RNA &lt;50 copies/mL (vs. 94.6% of DSG at Week 24; difference −3.8%, 95% CI [−7.9%, 0.3%]), and 1.6% of ISG had HIV-1 RNA ≥50 copies/mL. In the ritonavir-boosted PI stratum, mean changes in fasting LDL-C and non-HDL-C at Week 24 were significantly lower (P &lt; 0.0001) in ISG vs. DSG (table). Rates of any AE and of drug-related AEs at Week 24 were higher in ISG vs. DSG. AEs were mild in most ISG participants (64% of those with any AE; 80% of those with drug-related AEs). Conclusion A once-daily single-tablet regimen of DOR/3TC/TDF demonstrated non-inferior efficacy and acceptable safety compared with continuing therapy, and is an option for maintaining viral suppression in patients considering a change in therapy. Disclosures P. Kumar, Merck, Pfizer, Janssen,: Grant Investigator and Shareholder, Research grant. GSK, Gilead, Teratechnologies, TaiMed,: Grant Investigator, Scientific Advisor and Shareholder, Consulting fee and Research grant. J. M. Molina, Merck GIlead ViiV Janssen Teva: Ad Board and Speaker’s Bureau, Consulting fee. Gilead Sciences: Grant Investigator, Research support. G. Rizzardini, ViiV, Gilead Science, MSD, Angelini, and Abbvie: Board Member and Speaker’s Bureau, Speaker honorarium. Gliead, ViiV, and MSD: Research Contractor, Research grant. P. Cahn, Abbvie: Grant, Research grant. Merck: Grant, Advisory Board. ViiV Healthcare: Grant, Advisory Board. M. Bickel, Merck & Co., Inc.: Research Contractor, Research grant. Y. Zhou, Merck & Co., Inc.: Employee, Salary. C. Morais, Merck Sharp & Dohme, a subsidiary of Merck & Co., Inc.: Employee and Shareholder, May hold stock/stock options in the company and Salary. S. Kumar, Merck & Co., Inc.: Employee and Shareholder, Salary. P. Sklar, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.: Employee and Shareholder, Salary. G. J. Hanna, Merck Sharp & Dohme, a subsidiary of Merck & Co., inc.: Employee and Shareholder, May hold stock/stock options in the company. and Salary. C. Hwang, Merck Sharp & Dohme, a subsidiary of Merck & Co., Inc.: Employee and Shareholder, Salary. W. Greaves, Merck Sharp & Dohme, a subsidiary of Merck & Co., Inc.: Employee, May hold stock/stock options within the company.

Antiplatelet Treatment with Aggressive Lipid Lowering Therapy and Reduction of Clinical Event after Ischemic Stroke.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 4141-4141
Author(s):  
Giorgio Corinaldesi ◽  
Christian Corinaldesi
Keyword(s):  
Ischemic Stroke ◽  
Combined Treatment ◽  
Clinical Problem ◽  
Lipid Lowering ◽  
Clinical Event ◽  
Lipid Lowering Therapy ◽  
Protective Effects ◽  
Total Period ◽  
Once Daily ◽  
D Dimer

Abstract The objective of the present study is to investigate the effects of anticoagulation and inhibition of platelet aggregation, which is strongly related with ischemic stroke, with aspirin 100 mg/once daily and clopidogrel 75 mg/once daily together with atorvastatin 80 mg/once daily then evaluating the event free survival in patients who had stroke with LDL-C &gt; 130 mg/dl. An hypolipidaemic diet was given to every patient. As known statins other than reducing LDL-C (silent killer), has many other effects characterized by a wider and wider checklist: reduction of plasmatic levels of C-reactive protein, of MCP-1, and the monocyte traffic, of IL-6, TNF-alfa, of S-VCAM-1, of COX-2 and MMP-9, and upregulate the TPA, and downregulate the PAI-1, statins also reduce the expression of CD40 on the endothelial surface, thus augmenting the EPC (endothelial progenitor cells) involved in neo-vascularization of ischemic tissue, with a final protective effects over the vascular endothelium, including the plaque stabilization. We have studied 67 patients with a previous ischemic stroke aged between 58 and 72 years (25% smoker, 32% with hypertension, 14% with diabetes, 6% with obesity), with LDL-C higher than 130 mg/dl, evaluating in particular the lipidic profile (total cholesterol, HDL, LDL, TG, Lpa), fibrinogen and d-dimer for a total period of 36 months. We observed a clear reduction of lipidic parameters: Total-C &lt;42%, LDL-C &lt;46%, TG &lt;30%, ApoB &lt;35%, d-dimer &lt;10%, and we did not observe any increase in transaminases, CPK, or fibrinogen. We observed 12 patients with relapsing clinical events requiring emergency hospitalization: 1 exitus for second stroke two months after the first event, 11 cases of RIND, with less than 4 transitory ischemic episodes, with the total length of events significantly reduced after the first 18 weeks of treatment. We have observed 22 adverse effects events: 4 cases of epistaxis, 2 case of tooth bleeding, 3 of abdominal pain, 9 of muscular pain, 2 of chest pain, 2 case of headache, however, these events did not influence the course of the pharmacological treatment; 55 patients did not refer any clinical problem, every patient has been followed on the basis of a three months period, and on demand. The present study has demonstrated a secure efficacy of the aggressive combined treatment (antiplatelet + statin) in the management of patients with a previous stroke, showing a symptomatologic benefit (reduction of the total ischemic events and of the emergencies) with an overall improvement of the quality of life. PARAMETER BEFORE AFTER TOTAL-C 320.0 mg/dl 180.0 mg/dl LDL-C 148.0 mg/dl 82.4 mg/dl HDL-C 38.6 mg/dl 44.2 mg/dl TG 180.0 mg/dl 108.2 mg/dl FIBRINOGEN 460.0 mg/dl 370.0 mg/dl FASTING GLUCOSE 110.0 mg/dl 96.0 mg/dl

scholarly journals 877. North American Phase 3/3b Experience with Long-Acting Cabotegravir and Rilpivirine: Efficacy, Safety, and Virologic Outcomes

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S530-S531
Author(s):  
Babafemi O Taiwo ◽  
Darrell Tan ◽  
Parul Patel ◽  
Paula Teichner ◽  
Joseph Polli ◽  
...  
Keyword(s):  
Treatment Guidelines ◽  
Virologic Failure ◽  
Descriptive Analysis ◽  
Injection Site Reaction ◽  
Treatment Preference ◽  
Virologic Suppression ◽  
Research Support ◽  
Phase 3 ◽  
Long Acting ◽  
Hiv 1

Abstract Background Cabotegravir (CAB) plus rilpivirine (RPV) is the first complete long-acting (LA) regimen recommended by treatment guidelines for the maintenance of HIV-1 virologic suppression. CAB+RPV LA dosed every 4 weeks (Q4W) or every 8 weeks (Q8W) demonstrated noninferior efficacy in multinational Phase 3/3b trials. This post hoc descriptive analysis summarizes efficacy, virologic outcomes, safety, and treatment preference for US and Canadian (CAN) participants through Week (W) 48. Methods This analysis focuses on data for US/CAN participants naive to CAB+RPV (n=376) from the larger pooled population of the ATLAS, FLAIR, and ATLAS-2M Phase 3/3b studies (N=1245). Endpoints included the proportion of participants with plasma HIV-1 RNA ≥ 50 and &lt; 50 c/mL at W48 (FDA Snapshot algorithm), incidence of confirmed virologic failure (CVF; 2 consecutive HIV-1 RNA ≥ 200 c/mL), safety, and treatment preference through W48. Results 376 US/CAN participants received CAB+RPV LA Q4W or Q8W. Median (range) age was 39y (20–74); 14.9% were female, 66.0% were White. At W48, 93.1% (350/376) maintained virologic suppression (HIV-1 RNA &lt; 50 c/mL), 1.9% (7/376) had HIV-1 RNA ≥ 50 c/mL, and 0.8% (3/376) met the CVF criterion, consistent with the overall global pooled population (Table 1). Two of the three participants with CVF had ≥ 2 of the three baseline factors (archived RPV resistance-associated mutations [RAMs], HIV subtype A6/A1, body mass index [BMI] ≥ 30 kg/m2) previously associated with CVF. Among the US/CAN participants with a single baseline factor, none met CVF. Overall, archived RPV RAMs were observed in 3.2% (12/376), HIV subtype A6/A1 in 1.1% (4/376), and BMI ≥ 30 kg/m2 in 26.3% (99/376) of participants. Safety and injection site reaction findings were similar to the overall pooled population (Table 2). Most participants (120/134, 89.6%) preferred LA over oral dosing (7/134, 5.2%). Table 1. Snapshot outcomes following CAB+RPV LA Q4W and Q8W at Week 48 in participants naive to CAB+RPV from ATLAS, FLAIR, and ATLAS-2M (ITT-E population) Table 2. Safety summary through Week 48 following CAB+RPV LA Q4W and Q8W or comparator ART in participants naive to CAB+RPV from ATLAS, FLAIR, and ATLAS-2M Conclusion In US/CAN Phase 3/3b trial participants, CAB+RPV LA was highly effective and well tolerated, with outcomes consistent with the overall pooled population. Baseline prevalence of archived RPV RAMs and subtype A6/A1 was low and aligned with regional prevalence/surveillance data. CAB+RPV LA provides a tolerable and effective injectable LA treatment option for virologically suppressed US/CAN individuals with HIV. Disclosures Babafemi O. Taiwo, MBBS, Gilead (Consultant)Merck (Consultant)ViiV Healthcare (Consultant) Darrell Tan, MD PhD, Abbvie (Grant/Research Support)Gilead (Grant/Research Support)GlaxoSmithKline (Scientific Research Study Investigator)ViiV Healthcare (Grant/Research Support) Parul Patel, PharmD, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Paula Teichner, PharmD, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Joseph Polli, PhD, FAAPS, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Louise Garside, PhD, GlaxoSmithKline (Employee) Ronald D’Amico, DO, MSc, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Christine L. Talarico, M.S., GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Rodica Van Solingen-Ristea, MD, Janssen Research and Development (Employee)ViiV Healthcare (Employee) Bryan Baugh, MD, Janssen, Johnson & Johnson (Employee, Shareholder) William Spreen, PharmD, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Michael Aboud, MBChB, MRCP, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Matthew Bosse, DO, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee)

Impact of long-term lipid-lowering therapy on clinical outcomes in breast cancer

2019 ◽  
Vol 176 (3) ◽  
pp. 669-677 ◽  
Author(s):  
Yun Rose Li ◽  
Vicky Ro ◽  
Laura Steel ◽  
Elena Carrigan ◽  
Jenny Nguyen ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Outcomes ◽  
Lipid Lowering ◽  
Lipid Lowering Therapy ◽  
Lowering Therapy

Abstract W MP117: Intracarebral Hemorrhage Volume Growth and Lipid Lowering Agent use: Pooled Analysis of Interact Studies

Stroke ◽  
2015 ◽  
Vol 46 (suppl_1) ◽  
Author(s):  
Miriam L Priglinger ◽  
Hisatomi Arima ◽  
Craig Anderson ◽  
Martin Krause ◽  
Keyword(s):  
Clinical Outcomes ◽  
Volume Growth ◽  
Pooled Analysis ◽  
Lipid Lowering ◽  
Lipid Lowering Therapy ◽  
Prior Therapy ◽  
Hematoma Growth ◽  
Hemorrhage Volume ◽  
Lipid Lowering Agents ◽  
Multivariable Adjustment

Background and rationale: Despite several recent reviews of randomised trials, there remains controversy of the risks of intracerebral hemorrhage (ICH) associated with regular use of statins for prevention of cardiovascular disease, particular in populations with a high risk of ICH. We aimed to determine the risk of poor outcome and hematoma growth from use of lipid lowering agents among participants of the INTERACT substudies. Design: Pooled analyses of INTERACT 1 and 2, international, multicenter, prospective, open, blinded endpoint, randomized controlled trials, of patients with ICH (<6 hr) and elevated systolic BP (SBP 150-180 mmHg). Associations between lipid lowering treatment and clinical outcomes (n=3184) were estimated in analyses of co-variance. Digital images from CT substudies participants (n=1310) underwent blinded central analyses comparing measurements from standardized baseline and 24 hrs CTs. Associations between lipid lowering treatment and hematoma volume growth from baseline to 24 hrs were estimated in analyses of co-variance. Results: Among 204 patients (9%) with lipid lowering treatment at ICH onset, both death and dependency were higher after 90 days, but this was not significant with multivariable adjustment for baseline imbalances and confounding factors (p=0.783). In analysis of CT substudies, absolute ICH volume was larger among 124 patients (9%) with lipid lowering therapy compared to patients without prior therapy but again, multivariate-adjustment made this difference non-significant (9.2ml vs 6.8ml, p=0.13), with antithrombotic use being the main confounder. Conclusion: In the INTERACT studies, there was no association between lipid lowering use and adverse clinical outcomes.

Abstract 15913: Two-year Results of the Getting to an Improved Understanding of Low-density Lipoprotein Cholesterol and Dyslipidemia Management (GOULD) Registry of Patients With Atherosclerotic Cardiovascular Disease (ASCVD)

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Christopher P Cannon ◽  
James A De Lemos ◽  
Christie M Ballantyne ◽  
Robert S Rosenson ◽  
Shushama Alam ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Statin Therapy ◽  
Treatment Guidelines ◽  
Low Density Lipoprotein ◽  
Density Lipoprotein ◽  
Lipid Lowering ◽  
Atherosclerotic Cardiovascular Disease ◽  
Lipid Lowering Therapy ◽  
Pcsk9 Inhibitor ◽  
Statin Dose

Background: Atherosclerotic cardiovascular disease (ASCVD) treatment guidelines recommend intensive statin therapy and adding non-statin therapy if LDL-C ≥70 mg/dL. Methods: We designed the GOULD registry to assess lipid-lowering therapy (LLT) over time: At 120 U.S. centers, 5006 ASCVD patients on any (LLT) were enrolled in 1 of 3 cohorts: 1) currently on PCSK9 inhibitor (PCSK9i), 2) no PCSK9i and LDL-C ≥100 mg/dL, and 3) no PCSK9i and LDL-C 70-99 mg/dL. Results: Over the two years, only 16.8% had some type of LLT intensification, In the cohorts of patients with baseline LDL-C ≥ 100 and 70-99 mg/dL, LLT intensification was present in 21.9% and 14.3% respectively: statin dose was intensified in 6.1% and 6.1%, ezetimibe was added in 6.8% and 4.3% and PCSK9i was added in 6.3% and 2.2% respectively. Conversely, out of the total population, statins were discontinued in 246/4275 (5.8%), ezetimibe in 81/535 (15.1%), and PCSK9i in 47/544 (8.6%). At 24 months, 83.7% were on statin (43.4% high-intensity), with 14.2% on ezetimibe. Lipid panels were measured in 73% by 1 year and 84% by 2 years. Among Pts in the LDL-C ≥100 and 70-99 mg/dL cohorts, 18.6% and 30.4% achieved an LDL-C <70 mg/dL by 1 year, with little further change by 2 years: 21.3% and 33.5% respectively. In the PCSK9 cohort, 53.2% had LDL-C<70 mg/dl. Overall, only 31.7% had LDL-C <70 mg/dL at 2 years (an increase from 6.7% at baseline), while 25.0% had LDL-C >100 mg/dL. Conclusion: Of ASCVD patients with suboptimal LDL-C at baseline, even after 2 years of follow up, strikingly only 16% had LLT intensification, and thus most remained uncontrolled. Further intensive efforts are needed to achieve optimal LDL management in patients with ASCVD.

Clinical outcomes of once-daily darunavir in treatment-experienced patients with darunavir resistance-associated mutations through 48 weeks of treatment

2020 ◽  
Vol 31 (10) ◽  
pp. 958-966
Author(s):  
Charlotte-Paige Rolle ◽  
Omar Marquez ◽  
Vu Nguyen ◽  
Federico Hinestrosa ◽  
Edwin DeJesus
Keyword(s):  
Clinical Outcomes ◽  
Median Number ◽  
Drug Reactions ◽  
Once Daily ◽  
Safety Parameters ◽  
Virologic Control ◽  
Few Data ◽  
Hiv 1 ◽  
Viable Treatment

Darunavir (DRV) is approved for once-daily use in patients with no DRV resistance-associated mutations (RAMs) and twice-daily use in those with DRV RAMs. Several studies suggest that once-daily DRV retains efficacy in the setting of 1–2 DRV RAMs whereas three or more DRV RAMs are needed for DRV resistance. There are few data to support the long-term use of once-daily DRV in patients with DRV RAMs. This observational study evaluated 48-week clinical outcomes of 22 treatment-experienced patients with ≥1 DRV RAMs switched to once-daily DRV between 2014 and 2017. The primary endpoint was HIV-1 RNA <50 copies/ml at week 48. Safety parameters were analyzed throughout the study. The median age of the sample was 53 years, 18 (82%) had baseline HIV-1 RNA <50 copies/ml, and the median number of historical DRV RAMs was 2. At week 48, 20 (91%) had HIV-1 RNA < 50 copies/ml, and 2 (9%) had HIV-1 RNA of 82 and 59,637 copies/ml and reported non-adherence. No adverse drug reactions were observed through week 48. Once-daily DRV maintained virologic control in patients with ≥1 historical DRV RAMs and was safe and well-tolerated. Further data are needed to validate this as a viable treatment option in this population.

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