Tailored clinical management after blinded statin challenge improved long-term lipid control in coronary patients with self-perceived muscle side-effects

2021 ◽  
Vol 28 (Supplement_1) ◽  
Author(s):  
E Sverre ◽  
K Peersen ◽  
O Kristiansen ◽  
MW Fagerland ◽  
J Perk ◽  
...  
Keyword(s):  
Side Effects ◽  
High Intensity ◽  
Ldl Cholesterol ◽  
Lipid Lowering ◽  
Long Term Effects ◽  
Pcsk9 Inhibitor ◽  
Coronary Patients ◽  
Lipid Control

Abstract Funding Acknowledgements Type of funding sources: Public hospital(s). Main funding source(s): Helse Sør-Øst, Vestre Viken Trust Background Statin discontinuation due to self-perceived muscle side-effects is a major challenge in clinical practice. Strategies are needed to improve lipid control in these patients. Purpose We studied if information about the results of a blinded statin challenge experiment, followed by tailored lipid lowering treatment, had long-term effects on lipid control in coronary patients with self-perceived muscle side-effects. Methods A post-trial intervention study of patients classified with statin dependent (N = 20) and independent (N = 50) muscle complaints in the MUscle Side-Effects of atorvastatin (MUSE), a randomized, double-blinded, crossover trial. All participants were informed of the MUSE trial results in an individual consultation and provided tailored lipid-lowering treatment according to protocol with 1-2 follow-up calls. Lipids were controlled at the end of follow-up. Results Mean age was 64 (SD 9.5) years and 33% (N = 23) were females. During an average follow-up of 13 months (SD 3.3), mean LDL-cholesterol was reduced by 0.3 (SD 0.6) mmol/L (p = 0.005) in patients with statins and by 1.7 (SD 1.0) mmol/L (p = 0.005) in patients without statins at inclusion in the MUSE trial (Table). We found no changes in the overall use of high-intensity statins, but ezetimibe was used by 11 additional patients and 4 patients were prescribed a PCSK9-inhibitor. Participants in the subgroup without statins at inclusion used; atorvastatin (N = 2), rosuvastatin (N = 3) or a PCSK9-inhibitor (N = 2) at follow-up. 90% found their own trial results useful in making decisions about future statin use. Conclusions Information about the results of a statin challenge experiment combined with tailored and systematical prescription of lipid-lowering agents had favourable long-term effects on lipid control in coronary patients with self-perceived muscle side-effects. Characteristics of the study population Using statins at inclusion (n = 62) Not using statins at inclusion (n = 8) Classified with statin-dependent side-effects, n (%) 15 (24) 5 (63) LDL-cholesterol at inclusion, mean (SD) 2.2 (0.8) 4.2 (1.1) LDL-cholesterol at follow-up, mean (SD) 1.9 (0.7) 2.5 (0.8) High intensity statin (ie. ≥40 mg atorvastatin or ≥20 mg rosuvastatin) at inclusion, n (%) 40 (55.6) 0 (0) High intensity statin at follow-up, n (%) 38 (61) 2 (25) Ezetimibe at inclusion, n (%) 13 (21) 3 (38) Ezetimibe at follow-up, n (%) 26 (42) 1 (13) PCSK-9 inhibitor at follow-up, n (%) 2 (3) 2 (25) Usefulness of own trial result in making decisions about future statin use on a 0 to 10 Likert scale, mean (SD) 8.1 (2.0) 9.6 (0.6)

scholarly journals Sudden Fall in the Lipid-Lowering Effect of Evolocumab: The Butler Is Not Always Guilty

Medicina ◽  
2021 ◽  
Vol 57 (9) ◽  
pp. 857
Author(s):  
Federica Fogacci ◽  
Claudio Borghi ◽  
Antonio Di Micoli ◽  
Arrigo Cicero
Keyword(s):  
Serum Lipids ◽  
Continuous Treatment ◽  
Lipid Lowering ◽  
Multivessel Coronary Artery Disease ◽  
Pcsk9 Inhibitor ◽  
Artery Disease ◽  
Lipids And Lipoproteins ◽  
Lipid Lowering Effect

A 78-year-old man came to our attention after undergoing coronary computed tomography angiography documenting multivessel coronary artery disease. He was started on treatment with the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab 140 mg subcutaneously every 2 weeks. Treatment-emergent changes in lipids and lipoproteins were long-lasting, and the medication was well tolerated by the patient in the long-term. Unexpectedly, after 2 years of continuous treatment with evolocumab, serum lipids increased, apparently without any reasonable explanation. During the follow-up visit, the patient was found to have habitually injected evolocumab into his right thumb instead of into the appropriate injection sites (i.e., abdomen, thighs or upper arms) after turning the injector upside down.

scholarly journals Sudden Fall in the Lipid-Lowering Effect of Evolocumab: The Butler Is Not Always Guilty

Medicina ◽  
2021 ◽  
Vol 57 (8) ◽  
pp. 857
Author(s):  
Federica Fogacci ◽  
Claudio Borghi ◽  
Antonio Di Micoli ◽  
Arrigo F. G. Cicero
Keyword(s):  
Serum Lipids ◽  
Continuous Treatment ◽  
Lipid Lowering ◽  
Multivessel Coronary Artery Disease ◽  
Pcsk9 Inhibitor ◽  
Artery Disease ◽  
Lipids And Lipoproteins ◽  
Lipid Lowering Effect

A 78-year-old man came to our attention after undergoing coronary computed tomography angiography documenting multivessel coronary artery disease. He was started on treatment with the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab 140 mg subcutaneously every 2 weeks. Treatment-emergent changes in lipids and lipoproteins were long-lasting, and the medication was well tolerated by the patient in the long-term. Unexpectedly, after 2 years of continuous treatment with evolocumab, serum lipids increased, apparently without any reasonable explanation. During the follow-up visit, the patient was found to have habitually injected evolocumab into his right thumb instead of into the appropriate injection sites (i.e., abdomen, thighs or upper arms) after turning the injector upside down.

Control of cardiovascular risk factors in a vascular retinopathy population and its long-term impact

2021 ◽  
Vol 28 (Supplement_1) ◽  
Author(s):  
D Aguila Gordo ◽  
M Marina Breysse ◽  
J Piqueras Flores ◽  
J Martinez Del Rio ◽  
C Mateo Gomez ◽  
...  
Keyword(s):  
Risk Factors ◽  
Cardiovascular Risk ◽  
Cardiovascular Risk Factors ◽  
Ldl Cholesterol ◽  
Hdl Cholesterol ◽  
Hypertensive Retinopathy ◽  
Percutaneous Revascularization ◽  
Lipid Control

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Control of cardiovascular risk factors is the cornerstone of secondary prevention. However, in patients with retinopathy of vascular etiology (hypertensive, diabetic or atherosclerotic) the benefit of stricter control of lipid in the long term has been little studied. Methods Prospective study of a cohort of 107 patients who underwent fundus and coronary angiography, of which 42 (39.3%) required percutaneous revascularization. During the follow-up, new cardiovascular events and analytical control of cardiovascular risk factors were recorded. Results Mean age was 75.19 ± 11.53 years. 60.7% were men, 78.5% were hypertensive, 32.7% were diabetic, and dyslipidemia was observed in 57%. Initially, 28% had 1-vessel disease, 14% 2-vessel, 8.4% 3-vessel, and 3.8% left common trunk. 0.9% had diabetic retinopathy, 3.7% had hypertensive retinopathy, 1.9% atherosclerotic, 70.1% had a combination of hypertensive and atherosclerotic retinopathy, and 7.5% signs compatible with all types. Initial and final mean values of LDL-c and HDL-c by type of retinopathy are in Table 1.  During follow-up, a significant improvement in LDL-c and HDL-c levels was observed in total patients and in patients with hypertensive and atherosclerotic retinopathy, however globally lipid control was poor and only 18.9% of the total of the sample reached the recommended levels for very high-risk people (<55 LDL-C).  Advanced hypertensive retinopathy patients with a greater reduction in LDL-C during follow-up, recorded lower mortality (p = 0.004). Besides, patients with previous percutaneous revascularization showed a greater decrease in LDL levels at the end of follow-up (69.5 ± 26.1 vs 103 ± 41.47; p <0.001); without significant changes in the rest of parameters.  Conclusions In patients with vascular etiology retinopathy, long-term lipid control is poor. However, patients with hypertensive retinopathy and a greater reduction in LDL-c had lower long-term mortality. Hypertensive retinopathy Initial Final Sig. LDL-Cholesterol (mg / dl) 102,8+/-35,5 75,65+/-28,9 <0,001 HDL-Cholesterol (mg / dl) 42,1+/-10,3 43,46+/-13,1 0,04 Atherosclerotic retinopathy LDL-Cholesterol (mg / dl) 101,2+/-36,8 79,8+/-32,98 <0,001 HDL-Cholesterol (mg / dl) 42,8+/-11,6 45,73+/-13,9 0,03 Diabetic retinopathy LDL-Cholesterol (mg / dl) 89,1+/-35,8 69,8+/-18 0,73 HDL-Cholesterol (mg / dl) 35,2+/-8,7 31,51+/-12,7 0,73

Long-Term Follow-Up of Early Cochlear Implant Device Activation

2021 ◽  
pp. 1-11
Author(s):  
Stefanie Bruschke ◽  
Uwe Baumann ◽  
Timo Stöver
Keyword(s):  
Speech Recognition ◽  
Side Effects ◽  
Cochlear Implant ◽  
Surgical Techniques ◽  
Control Group ◽  
First Year ◽  
Safe Procedure ◽  
Sound Processor

Background: The cochlear implant (CI) is a standard procedure for the treatment of patients with severe to profound hearing loss. In the past, a standard healing period of 3–6 weeks occurred after CI surgery before the sound processor was initially activated. Advancements of surgical techniques and instruments allow an earlier initial activation of the processor within 14 days after surgery. Objective: Evaluation of the early CI device activation after CI surgery within 14 days, comparison to the first activation after 4–6 weeks, and assessment of the feasibility and safety of the early fitting over a 12 month observation period were the objectives of this study. Method: In a prospective study, 127 patients scheduled for CI surgery were divided into early fitting group (EF, n = 67) and control group (CG, n = 60). Individual questionnaires were used to evaluate medical and technical outcomes of the EF. Medical side effects, speech recognition, and follow-up effort were compared with the CG within the first year after CI surgery. Results: The early fitting was feasible in 97% of the EF patients. In the EF, the processor was activated 25 days earlier than in the CG. No major complications were observed in either group. At the follow-up appointments, side effects such as pain and balance problems occurred with comparable frequency in both groups. At initial fitting, the EF showed a significantly higher incidence of medical minor complications (p < 0.05). When developing speech recognition within the first year of CI use, no difference was observed. Furthermore, the follow-up effort within the first year after CI surgery was comparable in both groups. Conclusions: Early fitting of the sound processor is a feasible and safe procedure with comparable follow-up effort. Although more early minor complications were observed in the EF, there were no long-term wound healing problems caused by the early fitting. Regular inspection of the magnet strength is recommended as part of the CI follow-up since postoperative wound swelling must be expected. The early fitting procedure enabled a clear reduction in the waiting time between CI surgery and initial sound processor activation.

scholarly journals Impact of comprehensive management on clinical outcomes in hypertensive patients with coronary artery disease: HIJ-CREATE sub-study

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
H Ogawa ◽  
H Sekiguchi ◽  
K Jujo ◽  
E Kawada-Watanabe ◽  
H Arashi ◽  
...  
Keyword(s):  
Coronary Artery Disease ◽  
Primary Outcome ◽  
Ldl Cholesterol ◽  
Lipid Lowering ◽  
Hypertensive Patients ◽  
Mean Values ◽  
Comprehensive Management ◽  
The Mean ◽  
Artery Disease

Abstract Background There are limited data on the effects of blood pressure (BP) control and lipid lowering in secondary prevention of coronary artery disease (CAD) patients. We report a secondary analysis of the effects of BP control and lipid management in participants of the HIJ-CREATE, a prospective randomized trial. Methods HIJ-CREATE was a multicenter, prospective, randomized, controlled trial that compared the effects of candesartan-based therapy with those of non-ARB-based standard therapy on major adverse cardiac events (MACE; a composite of cardiovascular death, non-fatal myocardial infarction, unstable angina, heart failure, stroke, and other cardiovascular events requiring hospitalization) in 2,049 hypertensive patients with angiographically documented CAD. In both groups, titration of antihypertensive agents was performed to reach the target BP of &lt;130/85 mmHg. The primary endpoint was the time to first MACE. Incidence of endpoint events in addition to biochemistry tests and office BP was determined during the scheduled 6, 12, 24, 36, 48, and 60-month visits. Achieved systolic BP and LDL-Cholesterol (LDL-C) level were defined as the mean values of these measurements in patients who did not develop MACEs and as the mean values of them prior to MACEs in those who developed MACEs during follow-up. Results During a median follow-up of 4.2 years (follow-up rate of 99.6%), the primary outcome occurred in 304 patients (30.3%). Among HIJ-CREATE participants, 905 (44.2%) were prescribed statins on enrollment. Kaplan–Meier curves for the primary outcome revealed that there was no relationship between statin therapy and MACEs in hypertensive patients with CAD. The original HIJ-CREATE population was divided into 9 groups based on equal tertiles based on mean achieved BP and LDL-C during follow-up. For the analysis of subgroups, estimates of relative risk and the associated 95% CIs were generated with a Cox proportional-hazards model (Figure 1). The relation between LDL cholesterol level and hazard ratios for MACEs was nonlinear, with a significant increase of MACEs only in the patients with inadequate controlled LDL-C level even in the patients with tightly controlled BP. Conclusions The results of the post-hoc analysis of the HIJ-CREATE suggest that clinicians should pay careful attention to conduct comprehensive management of lipid lowering even in the contemporary BP lowering for the secondary prevention in hypertensive patients with CAD. Figure 1 Funding Acknowledgement Type of funding source: None

scholarly journals The course of subjective and objective chemosensory dysfunction in hospitalized patients with COVID-19: a 6-month follow-up

2021 ◽  
Author(s):  
Mattis Bertlich ◽  
Clemens Stihl ◽  
Enzo Lüsebrink ◽  
Johannes C. Hellmuth ◽  
Clemens Scherer ◽  
...  
Keyword(s):  
Long Term Effects ◽  
Initial Examination ◽  
Initial Cohort ◽  
Negative Controls ◽  
Chemosensory Function ◽  
Analogue Scales ◽  
Smell Identification ◽  
Snot 22

Abstract Purpose It has been established that the infection with SARS-CoV-2 may cause an impairment of chemosensory function. However, there is little data on the long-term effects of SARS-CoV-2 infection on chemosensory function. Methods Twenty three SARS-CoV-2-positive patients diagnosed in spring 2020 with subjective hyposmia (out of 57 positive patients, 40.3%) were compared to SARS-CoV-2-positive patients without hyposmia (n = 19) and SARS-CoV-2-negative patients (n = 14). Chemosensory function was assessed by the Brief Smell Identification Test (BSIT), Taste Strips (TS), Visual Analogue Scales (VAS), and the SNOT-22. The initial cohort with hyposmia were also examined at 8 weeks and 6 months after initial examination. Results There were no differences between the SARS-CoV-2-positive cohort without hyposmia and negative controls in terms of BSIT (8.5 ± 2.6 vs. 10.2 ± 1.8), TS (3.4 ± 0.6 vs. 3.9 ± 0.3) or VAS (2.1 ± 1.3 vs. 1.1 ± 0.5); yet the SNOT-22 was significantly elevated (27.7 ± 11.2 vs. 16.4 ± 10.8). The SARS-CoV-2-positive group with hyposmia performed significantly poorer in BSIT (4.0 ± 1.7 vs. 8.5 ± 2.6/10.2 ± 1.8), TS (2.6 ± 1.3 vs. 3.4 ± 0.6/3.9 ± 0.3), and VAS (7.9 ± 2.2 vs. 2.1 ± 1.3/1.1 ± 0.5) compared to both control groups. At week 8 and month 6 control, six and five patients, respectively, still suffered from subjectively and objectively impaired chemosensory function. The other patients had recovered in both respects. Conclusion SARS-CoV-2 patients with subjectively impaired chemosensory function regularly perform poorly in objective measurements. About 70% of patients suffering from olfactory dysfunction in SARS-CoV-2 quickly recover—the rest still suffers from considerable impairment 6 months after infection.

scholarly journals Rituximab-Containing Risk-Adapted Treatment Strategy in Nodular Lymphocyte Predominant Hodgkin Lymphoma: 7-Years Follow-Up

Cancers ◽  
2021 ◽  
Vol 13 (8) ◽  
pp. 1760
Author(s):  
Novella Pugliese ◽  
Marco Picardi ◽  
Roberta Della Pepa ◽  
Claudia Giordano ◽  
Francesco Muriano ◽  
...  
Keyword(s):  
Side Effects ◽  
Hodgkin Lymphoma ◽  
Prognostic Score ◽  
Single Agent ◽  
Response To Therapy ◽  
Baseline Risk ◽  
Historical Cohort ◽  
Treatment Groups

Background: Nodular lymphocyte predominant Hodgkin lymphoma (NLPHL) is a rare variant of HL that accounts for 5% of all HL cases. The expression of CD20 on neoplastic lymphocytes provides a suitable target for novel treatments based on Rituximab. Due to its rarity, consolidated and widely accepted treatment guidelines are still lacking for this disease. Methods: Between 1 December 2007 and 28 February 2018, sixteen consecutive newly diagnosed adult patients with NLPHL received Rituximab (induction ± maintenance)-based therapy, according to the baseline risk of German Hodgkin Study Group prognostic score system. The treatment efficacy and safety of the Rituximab-group were compared to those of a historical cohort of 12 patients with NLPHL who received Doxorubicin, Bleomycin, Vinblastine, Dacarbazine (ABVD) chemotherapy followed by radiotherapy (RT), if needed, according to a similar baseline risk. The primary outcome was progression-free survival (PFS) and secondary outcomes were overall survival (OS) and side-effects (according to the Common Terminology Criteria for Adverse Events, v4.03). Results: After a 7-year follow-up (range, 1–11 years), PFS was 100% for patients treated with the Rituximab-containing regimen versus 66% for patients of the historical cohort (p = 0.036). Four patients in the latter group showed insufficient response to therapy. The PFS for early favorable and early unfavorable NLPHLs was similar between treatment groups, while a better PFS was recorded for advanced-stages treated with the Rituximab-containing regimen. The OS was similar for the two treatment groups. Short- and long-term side-effects were more frequently observed in the historical cohort. Grade ≥3 neutropenia was more frequent in the historical cohort compared with the Rituximab-group (58.3% vs. 18.7%, respectively; p = 0.03). Long-term non-hematological toxicities were observed more frequently in the historical cohort. Conclusion: Our results confirm the value of Rituximab in NLPHL therapy and show that Rituximab (single-agent) induction and maintenance in a limited-stage, or Rituximab with ABVD only in the presence of risk factors, give excellent results while sparing cytotoxic agent- and/or RT-related damage. Furthermore, Rituximab inclusion in advanced-stage therapeutic strategy seems to improve PFS compared to conventional chemo-radiotherapy.

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