Should YOU Implement ALL? Or Use It As Step 1 of Titration to BP & Lipid Targets?

Jim.r.dudl@gmail.comDiabetes Lead Care Management Institute, Kaiser Permanente

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What Works for CVD Prevention?

Evidence for ALL [Aspirin, Lisinopril & Lipid lowering] in Pts with CVD or DM >55yo• Archimedes modeled a 71% drop in CVD events & >$300/pt/yr

savings• In an observational study*

– “LL” was able to be implemented in ~70,000 pts in California Kaiser in 2 years

– in the 3rd year after starting LL, there were found to be 1,271 fewer strokes & MI’s than in the group w/o the bundle, [>60% decrease]

• Other literature regarding “fixed dose” benefit:– In STENO 2 the combined use of lipid lowering, ACEI use

and aspirin with other therapies achieved >59% drop in CVD deaths and higher decrease in events**

• Is this the best POSSIBLE evidence? No, but look at the alternatives:

*Am J Manag Care. 2009;15(10):e88-e94) **N Engl J Med 2008 358 580

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What Works for CVD Prevention?

Support for Treat to Target by ADA & AHA: – LDLc <100 with 30+% fewer MI & strokes if mid

strength/dose statin used &– SBP<140/90 targets & [<130/80 in DM?] with benefit

of control documented to save CVD events & lives in UKPDS, better than glucose control did.

What’s still questionable?• Targets!

– NCQA is considering • either achieving the target LDL OR being on a

statin• Not using BP 130/80 in DM

• ASA in DM: but ADA & AHA still recommend 50yo male 60yo female be considered for it.

*Am J Manag Care. 2009;15(10):e88-e94)

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Opportunity Cost of Waiting for the“Best Possible” Evidence

• What’s tragic is not starting treatments known to work:• Lots of people with CVD or DM and are over lipid goal and not

on a statin, or over BP goal and not on an ACEI, missing the benefits.

• What do we agree on? Evidence for• if LDLc is over 80 simvastatin 40 mg was shown to drop MI’s

33%*• >55yo DM pts with mean BP 133 mm hg syst, an ACEI

decreased cvd 22%**

• As the Institute of Medicine has concluded, in many areas, we need to “recommend strategies based on the best available evidence as opposed to waiting for the best possible evidence”***

• So why don’t we consider “[A]LL as therapy, or if not, at least step 1 of treating to target?

***http://www.iom.edu/CMS/3788/25044/34007.aspx

* Lancet 2003 361 529-53 **Lancet 2000 355 253-59

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Why Start With ALL NOW?

“Implementability”! • “LL” has been implemented in 2 yrs in ~70,000

Californians in Kaiser• It is simpler, cheaper, and more convenient than

Treat to target• Similar characteristics to disruptive innovation*• This may open use to those previously not treated due to

cost, titration visits and laboratory tests. • It is simple enough providers can focus on patient

barriers to initiation, titration and adherence, 55% of reasons treatments are not effective**

*C Christiansen, Health Affairs 27, no. 5 (2007):1329–1335

**Am J Gen Med

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Keys to Large Scale Implementation:

• Strong management that funds and is supportive of implementation changes

• Simplicity: no need to focus on algorithm• Fix accountability, then

• monthly quality Improvement meetings FOCUSED exactly the 1-2 metrics you want to improve

• Training practitioners on TIA [Titration Initiation Adherence] with focus on helping patients remove barriers

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Simplicity: Focus on 1 Step

• ALL implementation: essentially 1 step with three drugs. TIA behavioral focus on removing pt barriers.

Or

• LDLc<100: simvastatin 40-80 mg • BP>140:Focus on Prinzide

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Would Simvastatin Work?

Simvastatin: 40 – 80 mg initiation/titration • Simvastatin opportunity:

– No stain: ~10% or more– Less than 40 mg [of all but ceruvostatin]:

10%• Would that lower it enough: most <60 mg% to

go– 50% less than 30 mg% to target– 75% less than 60 mg% to target

• What works for lack of adherence?– One pharmacist call 40% picked up a

prescription

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Would Prinzide/Amlodipine Work?

Would adding 1-2 meds work?

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How Many DRUG Class’ Does It Take to Control BP in DM: UKPDS

BMJ 1998;317;703-713

ACCORD: <140 2.1 drugs/pers, <120 3.4 drugs per person

~70%

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Are There Enough Patients Not on Them to Increase 10% Control?

Prinzide opportunity >30%• Not on prinzide >20%• Not on max dose <10%

Is it strong enough:• Majority of pts are <10 mm Hg systolic away• Over 75% 20 mm, prinzide/amlodipine range

Can it be done:• Inside Kaiser one region 5,000 pts with

significant drop in BP correlated with use

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Summary & Conclusions:Either-Or?

Measuring effect may dictate use of:• ALL: if measuring med fills/refills or staff

education not a barrier, it’s the cheapest/simplest/easiest path.

• BP/LDLc: if HEIDS is dominant or culture demands hitting targets, this can be used

Which is best? • Consider starting with [A]LL, then increase if

you wish to treat to target

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Questions?

Contact Information:

Jim.r.dudl@kp.org

858 459 4743 [O/H]

858 220 1012 [c]