Changing stroke rehab and research worldwide now.Time is Brain! trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 523 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.

What this blog is for:

My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.

Tuesday, June 12, 2012

Effects of Statins on Energy and Fatigue With Exertion: Results From a Randomized Controlled Trial

So ask your doctor.
 http://archinte.jamanetwork.com/article.aspx?doi=10.1001/archinternmed.2012.2171


No drug is without adverse effect potential, and fatigue and exertional intolerance are adverse effects reported by patients receiving statins.1 2 Little direct information is available regarding the typical or average impact of statins on energy or exertional fatigue.

Although many observational reports have cited fatigue and exertional fatigue with statin use, to our knowledge, no randomized trials have addressed this issue to date. Energy and exertional fatigue were measured as tertiary and/or exploratory outcomes in the University of California, San Diego (UCSD) Statin Study, which aimed to examine a range of noncardiac outcomes.3 We capitalized on these data to evaluate whether moderate-dose statins affected energy and exertional fatigue in a broadly sampled primary prevention population.

METHODS

Methods

A total of 1016 subjects (692 men 20 years or older and 324 nonprocreative women, with screening low-density lipoprotein cholesterol levels 115-190 mg/dL [to convert to millimoles per liter, multiply by 0.0259] and no cardiovascular disease or diabetes) were randomized equally to 20-mg simvastatin (lipophilic statin), 40-mg pravastatin (hydrophilic statin), or microcrystalline-cellulose placebo, to be taken at bedtime in identical blinding capsules for 6 months.
Methods

The off-site study pharmacist matched sequentially numbered bottles to sequential computer-generated randomization assignment stratified by sex (block size, 20; designed by statistician [H.L.W.]). Bottles were transferred to the study site and given to successive eligible subjects by staff blinded to the randomization schedule.4
Methods

The protocol was approved by the UCSD Human Subjects Protection Program. All subjects (seen exclusively at UCSD) gave written informed consent. The data and safety monitoring board provided independent study oversight.
Methods
Outcome

Single-item self-ratings of change from baseline in “energy” and “fatigue with exertion” were used, assessed on 6-month follow-up, and rated (5-point scale) from “much less”(−2) to “much more”(+2) vs baseline.
Outcome

Energy and fatigue with exertion were rated at baseline from 0 (none) to 10 (maximum possible). All subjects rated energy; the final 397 subjects (a randomized subset) rated baseline fatigue with exertion (omitted initially to limit subject burden, restored for the final 40% of subjects). Missing values of baseline and change score were imputed using the Stata “impute” command (StataCorp). “EnergyFatigEx” values were generated by summing ratings for the energy and fatigue with exertion measures, aligning signs with lower values worse (ie, recoding such that for both variables lower values signified worse status), for baseline and on-treatment, yielding a single outcome (on-treatment score range, −4 to +4).
Methods
Statistical Analysis

We assessed the correlation of EnergyFatigEx with actual exercise (baseline assessment: episodes per week of vigorous exercise >20minutes). The unpaired t test was used to examine the difference in mean on-treatment EnergyFatigEx in all subjects and women separately. Ordinal logistic regression with robust (“White”) standard errors5 adjusted for baseline values of the combined variable, addressing baseline disparities and regression to the mean (a source of power-eroding variance). The χ2 test was used to examine whether statins shifted, relative to placebo, the proportion reporting changes of subjectively large magnitude (“much worse” or “much better” vs placebo on both outcomes; the same principle that guides sign tests). Analyses used Stata statistical software versions 8.0 and 11.0 (StataCorp). A 2-sided α level of .05 designated significance.

RESULTS

Results

For CONSORT (Consolidated Standards for Reporting of Trials) and study baseline characteristics, see eFigure and eTable. Energy and predictors of exertional fatigue were comparable at baseline; however, in the subsample with measured baseline exertional fatigue, pravastatin values differed from other arms and influenced imputed baseline values (Table). There was a significant relation between measured baseline EnergyFatigEx and actual exercise (r = 0.20; P < .001). The drop in low-density lipoprotein cholesterol level with 20-mg simvastatin (49 mg/dL) exceeded that with 40-mg pravastatin (40 mg/dL) (P < .001).
Results

Results of t tests of difference in mean on-treatment change in EnergyFatigEx were significant for combined statins vs placebo. Each statin contributed (effects separately significant for simvastatin) (Table). Women were disproportionately affected. The 0.4 mean difference observed for women receiving simvastatin vs placebo would arise if 4 in 10 treated women cited worsening in either energy or exertional fatigue; 2 in 10 characterized both as “worse” or either as “much worse”; 1 in 10 characterized both components as “much worse”; or combinations of these conditions, with the fractions of subjects for which each statement holds, summing to 1. Adjusted for baseline EnergyFatigEx (via ordinal logit), effects on EnergyFatigEx were significantly unfavorable for combined statins and each statin separately.
Results

The balance of those reporting maximal worsening vs maximal improvement (“much worse” vs baseline on each component vs “much better” on each) was adversely shifted for statins vs placebo (P = .002) and for each statin separately (simvastatin, P = .03; pravastatin, P = .01). These are based on small numbers, and findings are provisional.

COMMENT

Comment

To our knowledge, this is the first randomized evidence affirming unfavorable statin effects on energy and exertional fatigue. Effects were seen in a generally healthy sample given modest statin doses, and both simvastatin and pravastatin contributed to the significant adverse effect of statins on energy and fatigue with exertion. Particularly for women, these unfavorable effects were not uncommon. Findings support case reports citing adverse effects to these outcomes and are buttressed by literature rationale.1 ,6 These findings are important, given the central relevance of energy and functional status to well-being.
Comment

These effects, germane to quality of life, merit consideration when prescribing or contemplating use of statins, particularly in groups without expected net morbidity/mortality benefit, extending to “high-risk” primary prevention and women and elderly persons (including those with coronary artery disease).7 9 There was a significant relation between EnergyFatigEx and actual activity: reduced activity and exertional tolerance (irrespective of activity) in turn predict hard adverse outcomes. Effects may take time to manifest, as may benefits of statin use. Thus, long-term trials are important, if statin use is to be recommended in younger individuals. Meanwhile, physicians should be alert to patients' reports of exertional fatigue or diminished energy during statin use.

A news report on it.
http://www.msnbc.msn.com/id/47772793/ns/health/#.T9bdzsVPGxM

A blogger writing about it.
 http://www.medrants.com/archives/6864

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