High-Intensity Statins Raise Diabetes Risk, While Fitness Strongly Protects Veterans, Finds Study

 Your competent? doctor discontinued high intensity statins a long time ago, right?

FDA announces new safety recommendations for high-dose simvastatin June 2011 

The latest here:

High-Intensity Statins Raise Diabetes Risk, While Fitness Strongly Protects Veterans, Finds Study

High-dose statins after minor stroke tied to hemorrhage risk in a Chinese cohort

Hopefully your doctor isn't using high dose statins due to the FDA safety comments. You doctor has only had 13 years to find out this and implement it!

FDA announces new safety recommendations for high-dose simvastatin June 2011

The latest here:

 High-dose statins after minor stroke tied to hemorrhage risk in a Chinese cohort

Key takeaways:

• High-intensity statin therapy may increase bleeding risk after minor stroke.(Why are you researching this? Known for 13 years and your doctors don't follow worldwide research?)
  
• Statin dose, moderate or high, did not appear to have an effect on stroke recurrence.

Initiation of high-intensity statin therapy during the acute phase of minor, noncardiogenic stroke may increase bleeding risk, according to the results of a Chinese cohort study published in the Journal of the American Heart Association.

“The 2021 American Heart Association/American Stroke Association guidelines recommend high-intensity statin therapy for individuals at high risk for atherosclerotic cardiovascular disease. However, some randomized controlled trials have demonstrated that among Asian populations, more aggressive statin-based low-density lipoprotein cholesterol (LDL-C)-lowering treatments did not improve clinical outcomes or reduce the risk of stroke recurrence,” Hai-mei Fan, MD, PhD, from the department of neurology at First Hospital of Shanxi Medical University in Taiyuan, China, and colleagues wrote. “Therefore, it is unknown whether Asian populations benefit more from intensive statin therapy for secondary stroke prevention.”

High-intensity statin therapy may increase bleeding risk after minor stroke. Image: Adobe Stock

For the secondary report from the SEACOAST study, Fan and colleagues analyzed outcomes data from 2,950 patients with mild ischemic stroke who presented within 72 hours of symptom onset to eight hospitals in Shanxi province, China.

Moderate or intensive statin dose was defined in accordance with the 2018 AHA/American College of Cardiology cholesterol guideline.

Daily rosuvastatin 20 mg or atorvastatin 40 mg to 80 mg were considered high-intensity statin treatments. Daily atorvastatin 10 mg to 20 mg, rosuvastatin 5 mg to 10 mg, simvastatin 20 mg to 40 mg, pitavastatin 2 mg to 4 mg or pravastatin 40 mg to 80 mg were considered moderate-intensity statin treatments.

The primary efficacy outcome was stroke recurrence and the primary safety endpoint was intracranial hemorrhage.

After adjusting for potential confounders in a matched Cox multivariate analysis, the researchers found that risk for stroke recurrence at 3 and 12 months was similar in the high- and moderate- intensity statin groups (adjusted HR at 3 months = 1.12; 95% CI, 0.85-1.49; P = .424; aHR at 12 months = 1.08; 95% CI, 0.86-1.34; P = .519). However, high-intensity statin therapy was associated with increased risk for intracranial hemorrhage compared with moderate-intensity statin therapy at both time points (aHR at 3 months = 1.81; 95% CI, 1-3.25; P = .048; aHR at 12 months = 1.86; 95% CI, 1.1-3.16; P = .021). It was also associated with elevated risk for any bleeding events (aHR = 1.44; 95% CI, 1.08-1.93; P = .013).

The researchers also utilized propensity-score matching to control for imbalances in baseline factors, which produced results consistent with the Cox multivariate analysis.

“This cohort study suggests that compared with moderate-intensity statin therapy, high-intensity statin medication in the acute period may not positively influence clinical outcome of patients with minor, noncardiogenic ischemic stroke,” the researchers wrote. “In practice, maybe a moderate dosage of statins is appropriate for the secondary prevention of mild stroke.”

Due to the study being mainly completed during the COVID-19 pandemic, the researchers noted a lack of follow-up data for variables such as lipids, liver function, muscle enzymes and kidney function. Lack of these data prevented the researchers from completing a more comprehensive analysis of the adverse reaction rate of different statin doses after minor stroke.

Published by:

Sources/Disclosures

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Source:

Fan HM, et al. J Am Heart Assoc. 2024;doi:10.1161/JAHA.124.035337.

Statins and ICH – Ongoing Controversy

But aren't you not supposed to start new patients on high doses of statins? Or do you incompetently not know that? 

Except that high intensity statins are not recommended by the FDA since 2011.

FDA announces new safety recommendations for high-dose simvastatin June 2011

The latest here:

Statins and ICH – Ongoing Controversy

22/09/2023/in ESO, Stroke Research /by Carine Legio

Author: Dr Enache Iulia-Ioana, MD

National Institute of Neurology and Neurovascular Diseases, Bucharest, Romania

Ever since the SPARCL trial, the use of statins in patients that have suffered an intracerebral hemorrhage (ICH) has become controversial. The most recently published AHA/ASA guideline for the management of spontaneous ICH places the decision for statin usage in the hands of the clinician. It elaborates on the necessity to compare the patient’s risk for recurrent ICH versus ischemic events before a treatment decision is made.⁽¹⁾

The SPARCL study randomized patients with a previous stroke or TIA to a high dose of atorvastatin treatment or placebo. Despite the overall benefit of treatment, a post-hoc analyses showed an increased number of patients with intracerebral hemorrhage (ICH) in the treatment arm (n=55 for active treatment vs n=33 for placebo; unadjusted HR 1.68, 95% CI 1.09 – 2.59). These ICH were, however, equally fatal regardless of treatment (n=17 in the atorvastatin and n=18 in the placebo group). The highest contributing risk factor for an ICH was found to be a previous hemorrhagic stroke and the contribution of atorvastatin was minimal.⁽²⁾ Doubts particularly arose with the appearance of new studies that contradicted this key finding of SPARCL; for example, one large Danish cohort study suggested that the risk for ICH may even be reduced by statin usage in patients with a previous ischemic stroke, raising concern that withholding treatment may be damaging.⁽³⁾

The molecular mechanisms underlying statin influence on cerebral hemorrhage risk have been looked into and it seems they can tip the scales in one of two ways. On the one hand, statins have pro-fibrinolytic, anti-aggregating properties, which could explain a pro-ICH effect.⁽⁴⁾ On the other hand, by reducing inflammation, oxidative stress, and strengthening atherosclerotic plaque stability and endothelial function, statins could reduce the vessel wall susceptibility for hemorrhage.^(5,6)

The two main etiologies of ICH – hypertensive arteriopathy and cerebral amyloid angiopathy (CAA) – may be differently impacted by statin usage and, therefore, should be taken into account in the decision-making process.⁽⁷⁾ Whereas the medication may lead to a higher occurrence of lobar (cortico-subcortical) cerebral microbleeds, this association was not found with deep, (hypertension related) microbleeds.⁽⁸⁾ Other authors found that there may be a genetic susceptibility as well as patients with certain ApoE genotypes associated with CAA seemed to have an increased risk of lobar ICH under statins.⁽⁹⁾

With these dilemmas at hand, certain studies have attempted to conceive algorithms to assist clinical decisions. Those with evidence of a high risk for ICH, such as those with CAA, should probably be informed of the potential hazards of statin continuation.⁽⁷⁾ If patients with ICH were taking statins, they should not be stopped suddenly, as there may be rebound effects: discontinuation leads to a proinflammatory status, with excessive thrombocyte activation^(10–12). Some have found increases in vascular events (although they are not clinically important in a short term cessation)^(12,13) and one other study identified higher risks of neurological deterioration and poor outcome after ischemic stroke.⁽¹⁴⁾ Cessation should probably be left for the post-acute phase (after about 6-12 months) should the patient have lobar ICH and should the hemorrhagic risk prevail over the risk  of ischemic stroke.^(7,15) Statin-naïve patients with ICH should not receive statins unless they are clearly indicated for the prevention of ischemic stroke.^(1,7,15)

In conclusion, uncertainty remains about the relationship between statins and the risk of ICH. Clinicians should base their decision on both the risk for future ischemic stroke and the risk for ICH. As PCK9 inhibitors are currently emerging as a possible lipid-lowering alternative, their risk of ICH should also be investigated before they can be recommended in patients with increased risk for ICH.^(1,15)

High-intensity statins confer reduced clinical, cerebral events in AF, stroke

Except that high intensity statins are not recommended by the FDA since 2011. You'll have to ask your doctor to clear up the discrepancy.

FDA announces new safety recommendations for high-dose simvastatin June 2011

 The latest here:

High-intensity statins confer reduced clinical, cerebral events in AF, stroke

Choi KH, et al. J Am Heart Assoc. 2019;doi:10.1161/JAHA.119.013941.

December 21, 2019

High-intensity statins may reduce adverse clinical and/or cerebral events in patients with acute ischemic stroke and atrial fibrillation, with particularly strong efficacy in patients who underwent revascularization and are younger than 75 years, according to findings published in the Journal of the American Heart Association.
Researchers found that patients with acute ischemic stroke and AF receiving low- to moderate-intensity statins (adjusted HR = 0.64; 95% CI, 0.52-0.78) and high-intensity statins (HR = 0.51; 95% CI, 0.4-0.66) experienced fewer net adverse clinical and cerebral events, including death from any cause, stroke, ACS or major bleeding, than those who did not receive any statin therapy.

Moreover, high-intensity statins were associated with a lower risk for net adverse clinical and cerebral events than low- to moderate-intensity statins (HR = 0.76; 95% CI, 0.59-0.96) in this population, according to the study.
“Our findings suggest that statin therapy, particularly high-intensity statin therapy, could be associated with a reduced risk for adverse events, reduced mortality rates and increased probability of favorable functional outcomes compared with no-statin therapy in patients with acute ischemic stroke and AF,” Kang-Ho Choi, MD, PhD, of the department of neurology at the Chonnam National University Hwasun Hospital, South Korea, and colleagues wrote. “These benefits of statin therapy were consistent across various subgroups of patients, including those who are older patients, had low baseline LDL levels, receiving anticoagulant treatment and without clinical atherosclerotic CVD.”
Statin intensity by subgroup
The benefit of high-intensity statins compared with low- to moderate-intensity statins was greatest for patients treated with revascularization therapy (HR = 0.52; 95% CI, 0.32-0.84; P for interaction = .042) and in patients aged 75 years or younger (HR = 0.57; 95% CI, 0.39-0.86; P for interaction = .044), according to the researchers.
Study design and looking forward
Researchers enrolled 2,153 patients (mean age, 73 years; 52% men; 69.9% with hypertension; 27.4% with diabetes) with acute ischemic stroke and AF into this nationwide, multicenter cohort study. The primary composite endpoint was occurrence of adverse clinical and/or cerebral events during a 3-year period, and participants were stratified by statin intensity.
“Our results support the beneficial effect of statins, particularly high-intensity statins, in patients with acute ischemic stroke and AF, including the subgroup of patients who may be vulnerable to statin therapy and those without clinical ASCVD,” the researchers wrote. “These findings require further investigation and confirmation in prospective randomized controlled trials.” – by Scott Buzby
Disclosures: One author reports he received honoraria for lectures from Bayer, Boryung Pharmaceutical, Daewoong Pharmaceutical Co. Ltd., Daiichi Sankyo Korea Co. Ltd., Dong-A Pharmaceutical Co. Ltd., Otsuka Korea, Pfizer and Sanofi Aventis; study grants from Daiichi Sankyo Korea Co. Ltd.; and a consultant fee from OBELAB Inc.

Comparison of statins for secondary prevention in patients with ischemic stroke or transient ischemic attack: a systematic review and network meta-analysis

Yet you seem to recommend high dose statins even though the FDA suggests they not be prescribed anymore from 8 years ago.  How out of date are you? And you still have a job?

FDA announces new safety recommendations for high-dose simvastatin June 2011

Comparison of statins for secondary prevention in patients with ischemic stroke or transient ischemic attack: a systematic review and network meta-analysis

• Irene TramacereEmail author,
• Giorgio B. Boncoraglio,
• Rita Banzi,
• Cinzia Del Giovane,
• Koren H. Kwag,
• Alessandro Squizzato and
• Lorenzo Moja

BMC Medicine201917:67

https://doi.org/10.1186/s12916-019-1298-5

©  The Author(s). 2019

• Received: 18 October 2018
• Accepted: 5 March 2019
• Published: 26 March 2019

Open Peer Review reports

Abstract

Background

Statins may prevent recurrent ischemic events after ischemic stroke. Determining which statin to use remains controversial. We aimed to summarize the evidence for the use of statins in secondary prevention for patients with ischemic stroke by comparing benefits and harms of various statins.

Methods

We searched for randomized controlled trials (RCTs) assessing statins in patients with ischemic stroke or transient ischemic attack (TIA) in MEDLINE, EMBASE, and CENTRAL up to July 2017. Two authors extracted data and appraised risks of bias. We performed pairwise meta-analyses and trial sequential analyses (TSA) to compare statins versus placebo/no statin, and network meta-analyses using frequentist random-effects models to compare statins through indirect evidence. We used GRADE to rate the overall certainty of evidence. Primary outcomes were all-cause mortality and all strokes. Secondary outcomes were different types of strokes, cardiovascular events, and adverse events.

Results

We identified nine trials (10,741 patients). No head-to-head RCTs were found. The median follow-up period was 2.5 years. Statins did not seem to modify all stroke and all-cause mortality outcomes; they were associated with a decreased risk of ischemic stroke (odds ratio, OR, 0.81 [95% CI, 0.70 to 0.93]; absolute risk difference, ARD, − 1.6% [95% CI, − 2.6 to − 0.6%]), ischemic stroke or TIA (OR, 0.75 [95% CI, 0.64 to 0.87]; ARD, − 4.2% [95% CI, − 6.2 to − 2.1%]), and cardiovascular event (OR, 0.75 [95% CI, 0.69 to 0.83]; ARD, − 5.4% [95% CI, − 6.8 to − 3.6%]), and did not seem to modify rhabdomyolysis, myalgia, or rise in creatine kinase. In the comparison of different statins, moderate- to high-quality evidence indicated that differences between pharmaceutical products seemed modest, with high doses (e.g., atorvastatin 80 mg/day and simvastatin 40 mg/day) associated with the greatest benefits. TSA excluded random error as a cause of the findings for ischemic stroke and cardiovascular event outcomes. Evidence for increased risk of hemorrhagic stroke was sensitive to the exclusion of the SPARCL trial.

Conclusions

Evidence strongly suggests that statins are associated with a reduction in the absolute risk of ischemic strokes and cardiovascular events. Differences in effects among statins were modest, signaling potential therapeutic equivalence.

Trial registration

PROSPERO CRD42018079112

High-intensity statin therapy less likely in women after MI

Should these doctors even be prescribing this?

FDA announces new safety recommendations for high-dose simvastatin June 2011

High-intensity statin therapy less likely in women after MI 

Peters SAE, et al. J Am Coll Cardiol. 2018;doi:10.1016/j.jacc.2018.02.032.

Volgman AS, et al. J Am Coll Cardiol. 2018;doi:10.1016/j.jacc.2018.02.044.

April 16, 2018

Sanne A.E. Peters

Women were less likely to fill a prescription for high-intensity statins after hospitalization for MI compared with men, according to a study published in the Journal of the American College of Cardiology.

“While the use of high-intensity statins increased in both sexes who filled any statin prescription following MI between 2007 and 2015, our study shows that women continue to be less likely than men to fill a prescription for high-intensity statins,” Sanne A.E. Peters, PhD, research fellow in epidemiology at The George Institute for Global Health at University of Oxford in the United Kingdom, told Cardiology Today. “The underutilization of high-intensity statins in women can be expected to result in a substantial additional number of preventable vascular events.”

See Also

• Acute MI symptoms similar among men, women
• Social isolation, loneliness increase risk for stroke…
• Greater waist, hip measurements increase risk for MI…

Patients with MI hospitalizations

In this retrospective cohort study, researchers reviewed data from 16,898 patients (26% women) younger than 65 years with commercial health insurance and 71,358 patients (49% women) aged at least 66 years with Medicare. Both groups of patients had an overnight hospitalization for MI between 2014 and June 2015. Medicare beneficiaries were alive 30 days after hospital discharge and had continuous insurance coverage during the study.

This study included statin fills of any dosage within 30 days of hospital discharge for MI. High-intensity statins of interest were 40 mg or 80 mg of atorvastatin and 20 mg or 40 mg of rosuvastatin.

Men were more likely to fill a prescription for high-intensity statin after hospital discharged compared with women (56% vs. 47%).

After adjusting for comorbidities, demographic characteristics and health care use, the women-to-men RRs for high-intensity statins were the following:

• 0.91 for the total population using statins (95% CI, 0.9-0.92);

• 0.91 in those who did not previously use statins (95% CI, 0.89-0.92);

• 0.87 for those with prior low- or moderate-intensity statin use (95% CI, 0.85-0.9); and

• 0.98 in those who previously took high-intensity statins (95% CI, 0.97-1).

Sex disparities in statins

Compared with men, women were less likely to fill prescriptions for high-intensity statins in all subgroups. This disparity was most evident in patients without prevalent comorbid conditions and in the youngest and oldest adults.

“Clinicians should communicate the benefits of high-intensity statins to their female patients in terms of reducing the risk of recurrent MI and discuss possible concerns about side effects,” Peters said in an interview. “Moreover, clinicians themselves should also be aware of the risk of recurrent MI in their female patients and the persistent sex disparity in the utilization of high-intensity statins. Although the ‘Go Red for Women’ initiative and evidence-based guidelines for the prevention of CVD in women may have contributed to the decline in CVD rates in women, the results from the current study suggest that they have not led to elimination of the sex differences in high-intensity statin use after MI among individuals who filled any statin prescription. Further efforts are needed to eliminate sex disparities in high-intensity statin use and to improve the use of high-intensity statin therapy following hospital discharge for MI for all patients.”

In a related editorial, Annabelle Santos Volgman, MD, FACC, FAHA, professor of medicine at Rush Medical College in Chicago, senior attending physician at Rush University Medical Center and medical director of the Rush Heart Center for Women, and colleagues wrote: “We think sex should matter, as well as age, race and ethnicities, when it comes to patient care and adherence to guidelines. Implementation of such sex-specific strategies will improve CVD outcomes for women and, by doing so, may also improve outcomes for men.” – by Darlene Dobkowski

For more information:

Sanne A.E. Peters, PhD, can be reached at

Statins for Neuroprotection After Acute Ischemic Stroke ASSORTed Results But More Trials Needed

Using the Rankin scale for any comparison of intervention effects is the height of stupidity.  You not only have to train your doctor on statin dose usage, you need to train your researchers also.

FDA announces new safety recommendations for high-dose simvastatin June 2011

Was this earlier research not good enough to write a stroke protocol on it? OR didn't you know about it? Incompetence for either answer. 

tested in rats from 2003
http://oc1dean.blogspot.com/2011/09/statins-induce-angiogenesis.html 
 

http://oc1dean.blogspot.com/2013/02/simvastatin-attenuates-stroke-induced.html
 

Or,
http://oc1dean.blogspot.com/2012/10/simvastatin-attenuates-axonal-injury.html
 

tested in humans, March, 2011
http://www.medwirenews.com/39/91658/Stroke/Acute_statin_therapy_improves_survival_after_ischemic_stroke.html

http://stroke.ahajournals.org/content/48/11/2922?etoc=

Peter Kelly, Shyam Prabhakaran

Download PDF

https://doi.org/10.1161/STROKEAHA.117.018725

Stroke. 2017;48:2922-2923

Originally published October 13, 2017

• Article
• Info & Metrics

• Editorials
• animals
• follow-up studies
• humans
• stroke

See related article, p 3057

The pivotal SPARCL trial (Stroke Prevention by Aggressive Reduction in Cholesterol Levels) randomized clinical trial demonstrated that atorvastatin 80 mg daily(high-dose) begun at 1 to 6 months after the index event in patients with noncardioembolic transient ischemic attack, and nonsevere ischemic stroke was effective and safe for the prevention of recurrent stroke and major cardiovascular events.¹ (But shit, that high dose of statins is But in addition to their benefits for vascular prevention, might statins also enhance neuroprotection or promote stroke recovery in the acute setting?

Experimental studies in animal models have reported that 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) reduce infarct volumes and stroke severity.² Potentially beneficial nonlipid lowering (pleiotropic) effects of statins include actions on the vascular wall (induction of angiogenesis, upregulation of endothelial nitric oxide synthase), improved cerebral blood flow, enhanced neural repair, antiplatelet, anti-inflammatory, and antioxidant effects.^2,3 Observational studies and meta-analyses have reported that statin use either immediately before or shortly after stroke onset is associated with improved functional outcome and lower fatality at early follow-up.⁴ However, no matter how tempting, inferences about therapeutic efficacy cannot be made from observational studies because of selection bias and other limitations. Randomized clinical trials are needed.

In this issue of Stroke, Yoshimura et al⁵ describe the results of the ASSORT trial (Administration of Statin on Acute Ischemic Stroke Patient)—a prospective, open-label, blinded, end-point assessed, randomized clinical trial, which compared the efficacy of early (<24 hours) versus later (day 7) initiation of statin therapy to improve functional outcome at 90 days in patients with noncardioembolic stroke and dyslipidemia. Statin therapy included low-dose atorvastatin, rosuvastatin, or pitavastatin, and outcome was measured by shift across the modified Rankin Scale. Among 270 included patients, no differences in modified Rankin Scale distribution, National Institutes of Health Stroke Scale score, or early major cardiovascular event recurrence were observed between groups. The adjusted common odds ratio for functional outcome for the early statin group was 0.84 (95% confidence interval, 0.53–1.3). This neutral result is consistent with the recently reported neutral finding from the STARS trial (Stroke Treatment With Acute Reperfusion and Simvastatin).⁶

Should these results be interpreted as sufficient to close the case on the question of whether acute statin therapy might improve functional outcome after ischemic stroke? We think that such a conclusion may be premature, at least for now. Although the authors should be commended for conducting the trial, unfortunately some methodological limitations may have contributed to the neutral findings in ASSORT. A major limitation was a highly optimistic estimation of effect size (twice the likelihood of improved modified Rankin Scale in statin-treated patients), which likely led to an underpowered trial. Although the effect size was estimated based on similar effect size observed in observational studies, sufficient account was not given to the problem that observational studies reporting acute statin benefits are highly likely to be affected by prescribing bias, where patients with less-severe stroke, healthier lifestyle, or fewer comorbid illnesses are more likely to receive statin treatment. Other possible contributors to the neutral results include the low doses and various statins used, high number of patients with subcortical strokes (44% were lacunar), milder-than-anticipated stroke severity of included patients, and lack of quantitative outcome measures, such as motor strength and final infarct volume.

An analysis of the SPARCL trial found that among 492 patients with ischemic stroke outcomes at follow-up, a strong statistical trend toward improved modified Rankin Scale at 90 days was evident in the group assigned atorvastatin 80 mg daily compared with patients taking placebo (P=0.0647).⁷ Although this analysis was post hoc, and not clearly supported by benefit measured by the National Institutes of Health Stroke Scale and Barthel Index, these data are the largest to date in a randomized trial of treatment with a standardized high-dose statin in the acute phase at stroke onset. This intriguing signal from SPARCL, when combined with supportive experimental and epidemiological data, suggests that more randomized trials of acute statin therapy are needed.

Others have evaluated the appropriate dose of statin therapy in acute neuroprotection. In the Neu-START dose escalation study, a lovastatin dose of 8 mg/kg per day for 3 days was identified as the maximum tolerable dose.⁸ The follow-up Neu-START-2 phase 2b trial randomized 130 patients with lovastatin 680 mg for 3 days starting within 24 hours poststroke versus placebo (or lovastatin 80 mg for patients already taking statins before stroke). The results of Neu-START-2 have not yet been published but are expected soon (personal communication from Dr Elkind, Columbia University).

Nevertheless, ASSORT and other trials have provided reassuring data on the safety of acute statin treatment after stroke. The design of new trials investigating this question should be carefully considered. We support the STAIR recommendations (Stroke Therapy Academic Industry Roundtable) for phase 2b trials of neuroprotective agents.⁹ For statin trials, these might incorporate early standardized acute statin treatment at the appropriate dose, with surrogate outcome measures, such as infarct growth on brain imaging, to increase the likelihood of detecting signals of efficacy. If phase 2 trials suggest benefit, further phase 3 trials with adequate sample sizes to assess functional measures should be conducted. Indeed, a properly designed study testing high-dose acute statin therapy in moderate-to-severe nonlacunar patients with stroke may still be warranted.

Statin intensification sufficient for most with atherosclerotic CVD

Well shit, is this in the USA?  The FDA has basically banned high potency statins due to side effects. Are you that incompetent that you don't know regulations? 

Once again it is up to you to train your doctor.

FDA announces new safety recommendations for high-dose simvastatin June 2011

The latest here:

Statin intensification sufficient for most with atherosclerotic CVD

Cannon CP, et al. JAMA Cardiol. 2017;doi:10.1001/jamacardio.2017.2289.
Smith Jr SC. JAMA Cardiol. 2017;doi:10.1001/jamacardio.2017.2290.

September 1, 2017

Christopher P. Cannon

Most individuals with atherosclerotic CVD could reach an LDL level of less than 70 mg/dL with intensification of oral lipid-lowering therapy, with only a small amount requiring a PCSK9 inhibitor, according to a study published in JAMA Cardiology.
Christopher P. Cannon, MD, senior physician at Brigham and Women's Hospital and professor of medicine at Harvard Medical School, and colleagues identified a cohort of 105,269 participants (57% men; mean age, 65 years) with atherosclerotic CVD from a database of U.S. medical and pharmacy claims from 2012 to 2013. For the simulation cohort, the researchers used replacement (in the bootstrapping method) to enter 1 million participants into a Monte Carlo simulation.

See Also

• CAC testing useful for guiding statin therapy under certain...
• Analyses question cost-effectiveness of PCSK9 inhibitors
• Elusive Target: A Rundown of the Drug Pipeline for Systemic...

Those not receiving statins were given atorvastatin 20 mg. Intensification occurred in the following sequence: up-titration to atorvastatin 80 mg; add-on ezetimibe therapy; add-on alirocumab (Praluent, Sanofi/Regeneron) 75 mg; and up-titration to alirocumab 150 mg.
Before treatment intensification, in the simulation cohort of 1 million patients (55% men; mean age, 66 years), 51.5% used statin monotherapy and 1.7% used statins plus ezetimibe, and 25.2% reached an LDL level of less than 70 mg/dL.
After lipid-lowing treatment intensification, 99.3% could reach an LDL level less than 70 mg/dL, according to the simulation. This level was reached in 67.3% of participants with statin monotherapy, in 18.7% with statins plus ezetimibe and in 14% with an add-on PCSK9 inhibitor.

Sidney C. Smith Jr.

“Fundamental to the recommendations for the new nonstatin therapies to lower cholesterol levels will be an exerted program to increase use of intensive statin therapies as recommended by the current 2013 ACC/AHA cholesterol guidelines,” Sidney C. Smith Jr., MD, of the heart and vascular center at the School of Medicine at University of North Carolina, Chapel Hill, and past president of the American Heart Association and the World Heart Federation, wrote in an accompanying editorial. “Too many patients with [atherosclerotic CVD] do not receive intensive statin therapy as recommended. As noted in the VA study, a nearly 50% reduction in cost or $1 billion savings would be the benefit of optimizing intensive statin therapy and adding ezetimibe for those patients with persisting LDL levels above 70 mg/dL.” – by Cassie Homer
Disclosures: Cannon reports receiving grants from Amgen, Arisaph, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Janssen, Merck and Takeda, and consultant fees from Alnylam, Amarin, Amgen, Arisaph, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, GlaxoSmithKline, Kowa, Merck, Lipimedix, Pfizer, Regeneron Pharmaceuticals, Sanofi and Takeda. Please see the study for all other authors’ relevant financial disclosures. Smith reports no relevant financial disclosures.

Well shit, is this in the USA?  The FDA has basically banned high potency statins due to side effects. Are you that incompetent that you don't know regulations?  And you trust your doctors?

FDA announces new safety recommendations for high-dose simvastatin June 2011

http://www.onlinejacc.org/content/69/22/2696?sso=1&sso_redirect_count=2&access_token=

Volume 69, Issue 22, June 2017 DOI: 10.1016/j.jacc.2017.03.585

PDF Article

Trends in Use of High-Intensity Statin Therapy After Myocardial Infarction, 2011 to 2014

Robert S. Rosenson, Michael E. Farkouh, Matthew Mefford, Vera Bittner, Todd M. Brown, Ben Taylor, Keri L. Monda, Hong Zhao, Yuling Dai, Paul Muntner

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Abstract

Background Data prior to 2011 suggest that a low percentage of patients hospitalized for acute coronary syndromes filled high-intensity statin prescriptions upon discharge. Black-box warnings, generic availability of atorvastatin, and updated guidelines may have resulted in a change in high-intensity statin use.

Objectives The aim of this study was to examine trends and predictors of high-intensity statin use following hospital discharge for myocardial infarction (MI) between 2011 and 2014.

Methods Secular trends in high-intensity statin use following hospital discharge for MI were analyzed among patients 19 to 64 years of age with commercial health insurance in the MarketScan database (n = 42,893) and 66 to 75 years of age with U.S. government health insurance through Medicare (n = 75,096). Patients filling statin prescriptions within 30 days of discharge were included. High-intensity statins included atorvastatin 40 or 80 mg and rosuvastatin 20 or 40 mg.

Results The percentage of beneficiaries whose first statin prescriptions filled following hospital discharge for MI were for high-intensity doses increased from 33.5% in January through March 2011 to 71.7% in October through November 2014 in MarketScan and from 24.8% to 57.5% in Medicare. Increases in high-intensity statin use following hospital discharge occurred over this period among patients initiating treatment (30.6% to 72.0% in MarketScan and 21.1% to 58.8% in Medicare) and those taking low- or moderate-intensity statins prior to hospitalization (from 27.8% to 62.3% in MarketScan and from 12.6% to 45.1% in Medicare). In 2014, factors associated with filling high-intensity statin prescriptions included male sex, filling beta-blocker and antiplatelet agent prescriptions, and attending cardiac rehabilitation within 30 days following discharge.

Conclusions The use of high-intensity statins following hospitalization for MI increased progressively from 2011 through 2014.

Most patients fail to receive high-potency statins after ACS

Well shit you fucking idiots, the FDA has basically banned high potency statins due to side effects. Are you that incompetent that you don't know regulations? 5.5 years later?

FDA announces new safety recommendations for high-dose simvastatin June 2011

http://www.healio.com/cardiology/chd-prevention/news/online/%7B68bd8490-6230-4791-90fa-e71ea119cfe1%7D/most-patients-fail-to-receive-high-potency-statins-after-acs?utm_source=maestro&utm_medium=email&utm_campaign=cardiology%20news

Researchers examined data from a large, multinational, contemporary, randomized trial with patients who experienced ACS and found that most were not treated with a high-potency statin regimen after ACS.

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This was noted both early and late after the event and despite the prevalent use of statins after ACS. 

Alon Eisen, MD, from the cardiovascular division at Brigham and Women’s Hospital, and colleagues assessed patient characteristics related to nonuse of a high-potency statin regimen using data from the SOLID-TIMI 52 trial. The trial enrolled 12,446 patients after an ACS from 36 countries between 2009 and 2011. In the patient population, 95.2% (n = 11,850) were prescribed a statin at baseline after ACS. Of those patients, 41.9% (n = 5,212) were prescribed a high-potency statin.

High-potency statins were defined as: ≥ 40 mg atorvastatin, ≥ 20 mg rosuvastatin or 80 mg simvastatin daily.

Certain patient characteristics were linked to nonuse of high-potency statins: age at least 75 years (OR = 1.39, 95% CI, 1.24-1.56), female sex (OR = 1.11, 95% CI 1.02-1.22), renal dysfunction (OR = 1.17; 95% CI 1.03-1.32) and in-hospital HF (OR = 1.43; 95% CI, 1.27-1.62).

“Notably, many of the patient characteristics that were associated with failure to administer a high-potency statin were features that, paradoxically, are often associated with higher patient risk including older age, renal dysfunction and [HF]. In addition, both female sex and nonwhite race were associated with the absence of high-potency statin use, even after adjusting for age and relevant comorbidities. This study highlights the need to intensify the educational process of physicians, both in hospitals and in the community, who are treating patients during and after ACS. It demonstrates that the crossover between use and nonuse of high-potency statins over time is very low and emphasizes the importance of treatment with high-potency statins during the initial hospitalization for ACS,” Eisen and colleagues wrote. – by Suzanne Reist

Disclosure: Eisen reports no relevant financial disclosures. Please see the full study for a list of the other researchers’ relevant financial disclosures.

Greater intensity of statin therapy confers increased mortality benefit

But high-dose statins are against FDA recommendations. Don't researchers have to follow FDA guidelines? Be careful out there.

FDA announces new safety recommendations for high-dose simvastatin Sept. 2015

Greater intensity of statin therapy confers increased mortality benefit

Bonow RO, Yancy CW. JAMA Cardiol. Published online before print, Nov. 9, 2016.
Rodriguez F, et al. JAMA Cardiol. 2016;doi:10.1001/jamacardio.2016.4052.

Cardiology Today, December 2016

In a retrospective analysis published in JAMA Cardiology, high-intensity statin use was associated with a survival benefit compared with moderate-intensity statin use, especially if maximal doses of high-intensity statins were taken.

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The researchers analyzed 509,766 adults aged 21 to 84 years (mean age, 69 years; 499,598 men) with atherosclerotic CVD treated in the Veterans Affairs health care system from April 2013 to April 2014 to assess the relationship between intensity of statin therapy and mortality.
In the cohort, 29.6% of patients were prescribed a high-intensity statin, 45.6% a moderate-intensity statin, 6.7% a low-intensity statin and 18.2% no statins.
After mean follow-up of 492 days, 4% of those prescribed a high-intensity statin died vs. 4.8% of those receiving a moderate-intensity statin, 5.7% of those receiving a low-intensity statin and 6.6% of those receiving no statins (P < .001), Fatima Rodriguez, MD, MPH, from the division of cardiovascular medicine and the Cardiovascular Institute, Stanford University, and colleagues wrote.
When Rodriguez and colleagues adjusted for propensity to receive high-intensity statin therapy, those who received high-intensity statins remained at lower risk for death vs. those who received moderate-intensity statins (adjusted HR = 0.91; 95% CI, 0.88-0.93).
Among patients who had received their first statin prescription within the prior 6 months, the effect of intensity on survival was slightly less (adjusted HR = 0.93; 95% CI, 0.85-1.01), according to the researchers.
The effect of statin intensity on survival was similar in those aged 75 years or younger (HR = 0.9; 95% CI, 0.88-0.93) and in those aged 76 to 84 years (HR = 0.91; 95% CI, 0.87-0.95).

Robert O. Bonow

Among those receiving high-intensity statins, those taking maximal doses had less risk for death compared with those not taking maximal doses (HR = 0.9; 95% CI, 0.87-0.94), the researchers wrote.
Although the relationship between statin intensity and mortality was not seen in randomized controlled trials, “it is ... possible that this study detected a signal not found in the [randomized controlled trials] because of its very large sample size relative to [randomized controlled trials] and because it involves a broader population, including patients older than 75 years,” Robert O. Bonow, MD, MS, editor of JAMA Cardiology, and Clyde W. Yancy, MD, MSc, deputy editor of JAMA Cardiology, wrote in an editor’s note.

Clyde W. Yancy

“We find these findings confirmatory that high-intensity statin therapy when appropriate is beneficial for secondary prevention, and these benefits are seen even in older persons,” Bonow and Yancy, both from Northwestern University Feinberg School of Medicine, wrote. – by Erik Swain
Disclosure: The researchers, Bonow and Yancy report no relevant financial disclosures.

High-intensity statin treatments increase survival rates in patients with cardiovascular disease

But high-intensity statins are against FDA recommendations. Don't researchers have to follow FDA guidelines? Be careful out there.

FDA announces new safety recommendations for high-dose simvastatin Sept. 2015

http://www.news-medical.net/news/20161109/High-intensity-statin-treatmentsc2a0increase-survival-rates-in-patients-with-cardiovascular-disease.aspx

A large national study has confirmed the value of high-intensity statin treatments for people with cardiovascular disease, according to researchers at the Stanford University School of Medicine.
Over the duration of a year, the researchers found that patients taking high-intensity statins had an increased chance of survival over those on moderate-intensity statins. The study will be published online Nov. 9 in JAMA Cardiology.
Statins, a class of drugs that lowers cholesterol levels in the blood, are commonly prescribed for preventing the acceleration of cardiovascular disease caused by the buildup of plaque in the arteries, which can lead to heart attacks and stroke.
Health-care providers have long debated the benefits of prescribing high-intensity statins to their patients with cardiovascular disease. Patients, in turn, have been hesitant to take them because of equivocal messages from their doctors and internet searches of patient and doctor perspectives.
"Previously, there was definitely a certain amount of fear on the patient's part because most people don't like taking medication," said Paul Heidenreich, MD, professor of cardiovascular medicine and the study's senior author. Some studies have shown an increased risk of side effects, such as diabetes or muscle damage, associated with higher-intensity statins.
Conflicting recommendations
In 2013, the American College of Cardiology and American Heart Association jointly recommended high-intensity statin therapy for patients with atherosclerotic cardiovascular disease who were no older than 75. The ACC/AHA guidelines differed, however, from guidelines established in 2014 by the Veterans Affairs Health Care System, which recommended only moderate-intensity statins, noting the lack of conclusive evidence that higher-intensity statins are more beneficial than those of moderate intensity.
In their study, Heidenreich and his team found evidence to support the ACC/AHA guidelines. They determined that high-intensity statins do in fact increase rates of survival, not only in younger and middle-aged patients with cardiovascular disease, but also in a patient population not well-studied: adults over 75.
"The greatest strength of this study is that we used a very large, well-defined clinical cohort," said Fatima Rodriguez, MD, a cardiology fellow at Stanford and the study's lead author. "The results show that high-intensity statins confer a survival advantage for patients with cardiovascular disease, including older adults."
Large sample size reduces possibility of chance
The researchers studied the medical records of 509,766 patients across the country receiving care from the Veterans Affairs Health Care System. "This is a very large patient population rich in cardiovascular disease," said Rodriguez. "In addition to defining this large, national patient population, we also had access to their detailed clinical data, including comorbidities and cholesterol values."
The primary purpose was to look at overall patient death rates from 2013 to 2014, the researchers said. They included patients with coronary artery disease, cerebrovascular disease and peripheral artery disease. "These are basically the three main areas affected by plaque buildup -- the heart, the brain and the large arteries of the rest of the body," Heidenreich said.
Patients were taking high-intensity, moderate-intensity or low-intensity statins in many different but commonly prescribed forms, such as rosuvastatin and atorvastatin. The researchers also followed one group that wasn't taking any statins. Patients had different severities of cardiovascular disease, making some more likely to be prescribed higher-intensity statins than others. So the researchers assigned each patient a score for the propensity to receive high-intensity statins and adjusted the results of the study accordingly.

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The results showed a 9 percent increased chance of survival for patients taking high-intensity statins compared to those receiving moderate-intensity treatments. "We found basically the same risk reductions reviewed by the Veterans Affairs guidelines, but they didn't think the benefit was significant because the sample size was small," Heidenreich said. "We have so many more patients, we can be confident that it wasn't due to chance."
Examining specific patient groups
The study considered data from patients over 75 -- a group little studied in clinical trials. It found that patients between the ages of 75 and 85 taking high-intensity statins had a survival-rate benefit comparable to that of younger patients: a 9 percent higher chance of survival compared to those on moderate-intensity statins.
"Our results suggest that clinical trial data from heart studies for those younger than 75 could also be applied to this older population," Heidenreich said.
Finally, they studied the effect of different doses within the high-intensity statin group. Patients treated with the maximum dose of statins were 10 percent more likely to survive than patients on submaximal doses. "This suggests to practitioners that instead of starting a patient on a low dose, just to go ahead and put them on the maximum dose they can tolerate," Rodriguez said.
A limitation of the study was that the researchers were unable to determine whether patients died of cardiovascular disease or another cause.
Settling the debate
The next step, researchers said, is to find out why some patients who should be on high-intensity statins are not. They hope doctors will take their study's results into consideration when prescribing statins. "There are a lot of guidelines and recommendations out there, so I think we also have to make the system better," Rodriguez said. "Maybe hospitals can employ a clinical reminder to doctors, a message that pops up on the doctor's screen that asks why a cardiovascular patient isn't on a high-intensity statin."
The researchers also hope to follow up on longer-term data from these patient populations. "Not only do we hope to continue studying this population, but we also hope to study patients without prior cardiovascular disease but who are at high risk for it," said Rodriguez.
Finally, they hope these results will help to settle the debate on which guidelines doctors should use when prescribing statins to patients. Heidenreich said, "We think this should give clinicians, physicians and nurse practitioners more comfort in following the American College of Cardiology and American Heart Association guidelines and putting people with prior cardiovascular disease on a high-intensity statin."
The work is an example of Stanford Medicine's focus on precision health, the goal of which is to anticipate and prevent disease in the healthy and precisely diagnose and treat disease in the ill.

Source:

Stanford University Medical Center

Use of high-intensity statins for patients with atherosclerotic cardiovascular disease in the veterans affairs health system: Practice impact of the new cholesterol guidelines

Well shit , this just proves doctors and researchers don't keep up-to-date in their areas. Something I have been proving for years.

The USDA is recommending that simvastatin 80 mg be used only in patients who have been taking this dose for 12 months or more and have not experienced any muscle toxicity. It should not be prescribed to new patients. June 8, 2011.

The latest here: 10/04/2016

Use of high-intensity statins for patients with atherosclerotic cardiovascular disease in the veterans affairs health system: Practice impact of the new cholesterol guidelines

Statins and Risk of Rheumatoid Arthritis - A Nested Case-Control Study

But high-intensity statins should not be used anymore.

FDA announces new safety recommendations for high-dose simvastatin 

http://onlinelibrary.wiley.com/doi/10.1002/art.39774/abstract;jsessionid=F552C59330C812204052C6CFA1304DDC.f03t02

1. Koray Tascilar MD^1,2,
2. Sophie Dell'Aniello MSc¹,
3. Marie Hudson MD, MPH, FRCPC^1,3,4 and
4. Samy Suissa PhD^1,5,*

DOI: 10.1002/art.39774

© 2016, American College of Rheumatology

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Arthritis & Rheumatology

Accepted Article (Accepted, unedited articles published online and citable. The final edited and typeset version of record will appear in future.)

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Keywords:

• Rheumatoid arthritis;
• statins;
• prevention

Abstract

Objective: Statins have anti-inflammatory/immunomodulatory effects that may be useful to prevent rheumatoid arthritis (RA) but previous observational studies about the risk of RA with statin use provided conflicting results. The aim of this study was to determine whether high-intensity statin treatment is associated with a lower risk of rheumatoid arthritis.

Methods: Using data from the UK Clinical Practice Research Datalink, we performed a nested case-control analysis in a population-based cohort of new statin users between 1997 and 2009, followed until a first diagnosis of RA, death, end of registration or end of 2009. For each case of RA, 10 age, sex and calendar year-matched controls were randomly selected from risk sets. We estimated the hazard ratio (HR) of incident RA in the highest quintile of duration-weighted average statin intensity compared with the lowest, using conditional logistic regression. Models were adjusted for smoking status, total cholesterol levels, obesity, history of cardiovascular disease, coexistent autoimmune diseases, hypothyroidism and persistence with treatment.

Results: The cohort included 528,654 new users of statins, with 1,357 new RA cases during a mean 3.3 years of follow-up, for an incidence rate of 7.9 per 10,000 person-years. Cases were more likely to be smokers, have other autoimmune diseases and lower total cholesterol levels at baseline. The incidence of RA was lower in the highest statin intensity quintile (adjusted HR 0.77; 95% CI: 0.63-0.95) in comparison to the lowest quintile.

Conclusions: In this large population-based study, high-intensity statin treatment was associated with a reduced risk of RA in comparison with low-intensity statins. This article is protected by copyright. All rights reserved.

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