2017.03.17 07:18
https://www.nytimes.com/2017/03/17/health/cholesterol-drugs-repatha-amgen-pcsk9-inhibitors.html?smid=nytcore-ipad-share&smprod=nytcore-ipad
Patients who took the drug, Repatha, were significantly less likely to have heart attacks or strokes, researchers concluded. But its high cost will be an issue.
2017.03.17 11:38
2017.03.17 23:52
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3991204/
The story of how PCSK9 was discovered.
2017.03.18 15:37
This thing sounds too good to be real. I have a feeling that it will turn out to be somekind of fiasco once the practice gets wide spread for a certain length of time. Such thing has happened before many times.
LDL cholesterol must have certain duty or purpose for our body and mind for it to be present in our blood.
When the cholesterol level gets pushed too low, there has to be some undesirable effect that they (the naive-hungry researchers and the profit-driven biotech companies) failed (intentionally or accidentally) to notice in the studies.
In the papers, they never mentioned any bad effects of abnormally lower blood level of cholesterol.
For example, lower cholesterol is known to make people dumb and forgetful.
God created us in such way that we need certain amount of cholesterol in our blood.
They only paid attention to the lowering of cardiovascular morbidity and mortality.
2017.03.18 18:22
No significant between-group differences were seen in the overall rates of adverse events, serious adverse events, or adverse events thought to be related to the study agent and leading to discontinuation of the study regimen (Table 3TABLE 3Adverse Events and Laboratory Test Results.). Likewise, the rates of muscle-related events, cataract, neurocognitive adverse events, and hemorrhagic stroke did not differ significantly between the two groups. Injection-site reactions were rare, but they were more frequent with evolocumab (2.1% vs. 1.6%). The large majority of reactions (approximately 90% in each group) were classified as mild, and only 0.1% of the patients in each group stopped receiving the study agent because of an injection-site reaction. The rates of adjudicated cases of new-onset diabetes did not differ significantly between the two groups (hazard ratio, 1.05; 95% CI, 0.94 to 1.17). The rates of allergic reactions also did not differ significantly between the groups (3.1% vs. 2.9%). In the evolocumab group, new binding antibodies developed in 43 patients (0.3%), and development of neutralizing antibodies did not occur in any patient."( The above is from the article in full text which you have access by clicking the words highlighted)
Please note ".... no significant difference in neurocognitive adverse events, etc. ..."
In addition, in the second article quoted above in regard to how the PCSK9 was discovered, they mentioned
some families where the genes producing PCSK9 are missing and LDL levels are congenitally low around 20 or 30,
and atherosclerotic disease is very rare, and everything else including brain function is normal, further indicating
the fact that the extremely low LDL does not affect neurocognitive function.
The question regarding what the lowest ideal LDL level is has been around in Cardiology community
for a long time.
Certainlly the lowest LDL level statins could bring down has not affected neurocognitive function statistically
in all the numerous double blind studies.
One of the commonly accepted recommended lowest LDL level was that of cord blood
of the newborn, which is between 40 and 50.
I understand what you are saying, however, WM.
What you said has been in the minds of these researchers as well as all the cardiologists
for a long time.
So far this study says that the lower the LDL is, the better.
They have not found the lower limit of the LDL below which is dangerous.
No. | Subject | Date | Author | Last Update | Views |
---|---|---|---|---|---|
Notice | How to write your comments onto a webpage [2] | 2016.07.06 | 운영자 | 2016.11.20 | 17770 |
Notice | How to Upload Pictures in webpages | 2016.07.06 | 운영자 | 2018.10.19 | 31853 |
Notice | How to use Rich Text Editor [3] | 2016.06.28 | 운영자 | 2018.10.19 | 5495 |
Notice | How to Write a Webpage | 2016.06.28 | 운영자 | 2020.12.23 | 43427 |
8832 | 돌아오는 기러기 [1] | 2024.03.27 | 정관호*63 | 2024.03.28 | 13 |
8831 | 이강인-손흥민 ‘골 합작’ 한국, 태국 3-0 완승…월드컵 최종 예선 진출 성큼 [2] | 2024.03.26 | 황규정*65 | 2024.03.27 | 9 |
8830 | 1945년 8월 15일 오후 강릉 홍제정 안마을에서 [2] | 2024.03.19 | 정관호*63 | 2024.03.24 | 55 |
8829 | 이승만은 왜 김구를 제거 했을까? [1] | 2024.03.17 | 온기철*71 | 2024.03.18 | 34 |
8828 | My Grandson [1] | 2024.03.15 | 노영일*68 | 2024.03.18 | 77 |
8827 | 蜀相(촉상): 촉한 승상 제갈량 [1] | 2024.03.15 | 정관호*63 | 2024.03.15 | 34 |
8826 | 1945년 8월15일에는 서울에 아무일도 없었다. [1] | 2024.03.13 | 온기철*71 | 2024.03.14 | 34 |
8825 | 왕소군 고향에서 [1] | 2024.03.08 | 정관호*63 | 2024.03.20 | 37 |
8824 | 정약용; 늙어가면 친구가 점점 없어진다. [5] | 2024.03.06 | 온기철*71 | 2024.03.08 | 65 |
8823 | Trump is OK to be a candidate. | 2024.03.04 | 온기철*71 | 2024.03.17 | 46 |
8822 | AMAZING GRACE [1] | 2024.03.01 | 정관호*63 | 2024.03.08 | 50 |
8821 | 한국에의 복수국적 - 이중국적이 더 불리한 경우를 알려 드립니다 [1] | 2024.02.24 | 운영자 | 2024.02.24 | 67 |
8820 | 신진서, 농심배 16연승... 중국 기사 올킬로 한국 4연속 우승 [1] | 2024.02.23 | 황규정*65 | 2024.02.23 | 39 |
8819 | 古朝鮮:고조선 [1] | 2024.02.23 | 정관호*63 | 2024.02.26 | 41 |
8818 | 한국진공작전; Eagle Project and Napko Project [2] | 2024.02.22 | 온기철*71 | 2024.02.28 | 87 |
8817 | 일제의 김구 암살 공작과 밀정 [2] | 2024.02.19 | 온기철*71 | 2024.02.22 | 73 |
8816 | 장개석은 한국에 친중정부가 수립 되게 하려고 임정을 도왔다. [1] | 2024.02.17 | 온기철*71 | 2024.02.24 | 80 |
8815 | 봄날의 원망 [1] | 2024.02.16 | 정관호*63 | 2024.02.16 | 36 |
8814 | 내 마음은 가을 달 [1] | 2024.02.08 | 정관호*63 | 2024.02.14 | 470 |
8813 | 1945년8월15일은 과연 해방이었을까? [2] | 2024.02.06 | 온기철*71 | 2024.02.07 | 62 |
ORIGINAL ARTICLE
Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease
Marc S. Sabatine, M.D., M.P.H., Robert P. Giugliano, M.D., Anthony C. Keech, M.D., Narimon Honarpour, M.D., Ph.D., Stephen D. Wiviott, M.D., Sabina A. Murphy, M.P.H., Julia F. Kuder, M.A., Huei Wang, Ph.D., Thomas Liu, Ph.D., Scott M. Wasserman, M.D., Peter S. Sever, Ph.D., F.R.C.P., and Terje R. Pedersen, M.D., for the FOURIER Steering Committee and Investigators*
March 17, 2017DOI: 10.1056/NEJMoa1615664
Comments open through March 24, 2017
BACKGROUND
Evolocumab is a monoclonal antibody that inhibits proprotein convertase subtilisin–kexin type 9 (PCSK9) and lowers low-density lipoprotein (LDL) cholesterol levels by approximately 60%. Whether it prevents cardiovascular events is uncertain.
Full Text of Background...
METHODS
We conducted a randomized, double-blind, placebo-controlled trial involving 27,564 patients with atherosclerotic cardiovascular disease and LDL cholesterol levels of 70 mg per deciliter (1.8 mmol per liter) or higher who were receiving statin therapy. Patients were randomly assigned to receive evolocumab (either 140 mg every 2 weeks or 420 mg monthly) or matching placebo as subcutaneous injections. The primary efficacy end point was the composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. The key secondary efficacy end point was the composite of cardiovascular death, myocardial infarction, or stroke. The median duration of follow-up was 2.2 years.
Full Text of Methods...
RESULTS
At 48 weeks, the least-squares mean percentage reduction in LDL cholesterol levels with evolocumab, as compared with placebo, was 59%, from a median baseline value of 92 mg per deciliter (2.4 mmol per liter) to 30 mg per deciliter (0.78 mmol per liter) (P<0.001). Relative to placebo, evolocumab treatment significantly reduced the risk of the primary end point (1344 patients [9.8%] vs. 1563 patients [11.3%]; hazard ratio, 0.85; 95% confidence interval [CI], 0.79 to 0.92; P<0.001) and the key secondary end point (816 [5.9%] vs. 1013 [7.4%]; hazard ratio, 0.80; 95% CI, 0.73 to 0.88; P<0.001). The results were consistent across key subgroups, including the subgroup of patients in the lowest quartile for baseline LDL cholesterol levels (median, 74 mg per deciliter [1.9 mmol per liter]). There was no significant difference between the study groups with regard to adverse events (including new-onset diabetes and neurocognitive events), with the exception of injection-site reactions, which were more common with evolocumab (2.1% vs. 1.6%).
Full Text of Results...
CONCLUSIONS
In our trial, inhibition of PCSK9 with evolocumab on a background of statin therapy lowered LDL cholesterol levels to a median of 30 mg per deciliter (0.78 mmol per liter) and reduced the risk of cardiovascular events. These findings show that patients with atherosclerotic cardiovascular disease benefit from lowering of LDL cholesterol levels below current targets. (Funded by Amgen; FOURIER ClinicalTrials.gov number, NCT01764633.)