three treatment algorithms for diabetic patients

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THREE TREATMENT ALGORITHMS FOR DIABETIC

PATIENTS

Mayer B. Davidson, MD

Clinical Center for Research Excellence

Charles R. Drew University

1731 East 120 th Street

Los Angeles, CA 90059

Phone : (323) 357-3439

FAX : (310) 632-5236 e-mail address : madavids@cdrewu.edu

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DYSLIPIDEMIA PROTOCOL

Treatment Plan

1. Principles of treatment: Unless TG levels are >1,000 mg/dl (see #10 below), the initial approach to the patient with elevated LDL cholesterol and/or TG levels is diet, exercise, and control of glycemia for the first 2 months. If either or both are elevated after 2 months, pharmacologic therapy should be instituted to achieve the lipid guidelines above.

2. If the TG level measured after the first 2 months is ≥400 mg/dl, the calculated LDL cholesterol concentration is inaccurate. To lower the TG level to <400 mg/dl so that the

LDL cholesterol can be calculated, gemfibrozil, 600 mg twice daily is started.

3. If the TG level remains ≥400 mg/dl, obtain a direct measurement of LDL cholesterol.

4. If the TG level falls to ≤400 mg/dl and the calculated LDL cholesterol level is not at goal level or a direct measurement of LDL cholesterol is not at goal level, stop gemfibrozil and start simvastatin, 10 mg q.h.s.

5. Double the simvastatin dose each month until the goal LDL cholesterol level is met or

80 mg q.h.s. is reached.

6. If 80 mg of simvastatin q.h.s is reached and goal LDL cholesterol is not met, switch to

80 mg of atorvastatin once daily.

7. If the TG level measured after the first 2 months is <400 mg/dl, and the calculated

LDL cholesterol is not at goal level, start simvastatin, 10 mg q.h.s. Follow at #5 and #6 just above.

8. If goal level of LDL cholesterol not met with 80 mg atorvastatin once daily, add ezetimibe, 10 mg once daily.

9. If goal level of LDL cholesterol met and patient not taking a statin and TG level is

≥200 mg/dl, calculate non-HDL cholesterol (total cholelsterol minus HDL cholesterol).

If value >160 mg/dl, add gemfibrozil, 600 mg twice daily.

10. TG levels >1,000 mg/dl can cause pancreatitis and should be treated initially with gemfibrozil, 600 mg twice daily, in addition to diet, exercise and glycemic control.

11. If the combination of simvastatin and gemfibrozil is indicated, substitute micronized fenofibrate (130 mg) for gemfibrozil.

2

GLYCEMIC PROTOCOL

Treatment Plan

1.

Principles of treatment: Type 1 patients require insulin. Type 2 diabetes is a progressive disease. The initial treatment for these patients is medical nutrition therapy, increased physical activity and metformin. Over time, combinations of different classes of oral drugs are subsequently required. Over more time, insulin is often necessary.

2. Goals: a) Fasting plasma glucose (FPG) concentration <130mg/dl. b) A1C level <7% (in a DCCT standardized assay with normal range of 4-6%).

This is the most important goal.

3.

Progression of treatment in type 2 diabetic patients: a) Diet and exercise should be used initially and continuously in conjunction with all therapies. b) Monotherapy - All type 2 diabetic patients should be started on metformin ,

500 mg twice daily with meals (unless contraindicated). Measure FPG concentration in 2 weeks. If value >130mg/dl, increase by one step (500 mg).

Continue to increase by one step every 2 weeks until either:

(1) FPG <130mg/dl (then wait 3 months and measure an A1C level), or

(2) Maximal (tolerated) dose is reached and FPG still >130mg/dl. In that case, start a sulfonylurea agent, 10 mg glipizide or 5 mg glyburide.

Glipizide is preferred in patients >60 years old – less hypoglycemia. c) Dual Therapy - Continue to measure the FPG concentration every 2 weeks.

Increase the sulfonylurea agent by one step (10 mg for glipizide or 5 mg for glyburide) until either:

(1) FPG is <130mg/dl; then wait 3 months and measure an A1C level), or

(2) Maximal dose of the sulfonylurea agent is reached and FPG is still

>130 mg/dl. Measure an A1C level and if >7.0%, add a maximal dose of pioglitazone (45 mg).

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d) Triple Therapy

(1) Since it takes at least 8 weeks and can take up to 12-16 weeks before a maximal effect of a glitazone is seen, a decision on its effectiveness is made 4 months after starting pioglitazone.

(2) If A1C >7.5% 4 months later, start bedtime insulin and discontinue pioglitazone. e) Bedtime Insulin

(1) Start obese patients with 16 units of NPH insulin and lean patients with

10 units of NPH insulin at bedtime.

(2) Gradually increase insulin dose until self monitored blood glucose

(SMBG) values before breakfast are 90-130 mg/dl >50% of the time.

(3) Wait 3 months and measure an A1C level.

(4) If A1C >7.5%, switch to mixed/split regimen. f) Two or More Daily Injections of Insulin - Adjust each component of the insulin regimen until ≥50% of appropriate preprandial SMBG values are within target range (usually 90-130 mg/dl). g) Relationship of each component of the insulin regimen and SMBG test best reflecting its effect:

Insulin Time Injected Test Reflecting

Insulin Action

Regular

Lispro

Aspart

Glulisine

Before a meal Both following meal before which insulin is injected and before next meal or bedtime snack (if insulin taken before supper).

NPH

NPH

Glargine

Detemir

Before breakfast

Before supper or bedtime

Before breakfast or before supper or half of dose at each time

Before supper

Before breakfast

Before breakfast

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4. Treatment of Markedly Symptomatic Newly Diagnosed Type 2 Diabetic Patients a) These patients have marked polyuria, polydipsia and often blurring of vision and weight loss. Glucose concentrations frequently exceed 400 mg/dl. Almost all of them can be successfully treated with high doses of sulfonylurea agents.

>120% DBW

Symptons?

Start maximal dose* SA

Wait 1 wk

<120%DBW

FPG (mg/dL)

Same/worse

Insulin

*Start with half-max dose if pt>65 y old and increase to max dose at 1 week if no response

SA

– Sulfonylurea Agent; DBW – Desirable

Body Weight

Better

<130

Decrease SA

Continue SA

Wait 1 wk

FPG (mg/dL)

130 -200

Continue SA

Wait 2 wks

FPG (mg/dL)

Follow Standard Protocols

<300

>200

Start metformin

>300

Insulin

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MICROALBUMINURIA PROTOCOL

1. Subjective Data: a) Ask about the following in the history (the patient is usually asymptomatic): diabetes mellitus and duration of disease; hypertension; presence of kidney disease and proteinuria (if known); medications, both prescribed and nonprescription; smoking

2. Objective Data: a) Measure a dipstick protein in an early morning urine sample. b) If it is 1+ or greater (and infection and hematuria are ruled out), the patient has clinical proteinuria. c) If it is negative or trace, measure an albumin/creatinine ratio; if it is >300 µg albumin/mg creatinine, the patient has clinical proteinuria. d) If it is <30 µg albumin/mg creatinine, it is normal and should be repeated in one year. e) If it is between 30 and 300 µg albumin/mg creatinine, it is in the microalbuminuric range; two such values within 6 months establishes the diagnosis of microalbuminuria.

3. Assessment: a) Clinical proteinuria - ≥1+ dipstick protein or an albumin/creatinine ratio ≥300

µg/mg. b) Microalbuminuria - two albumin/creatinine ratios within 6 months between 30 and 300 µg/mg. c). Normal - an albumin/creatinine ratio <30 µg/mg.

4.

Treatment Plan

If patient is not already on an ACE inhibitor or an ARB, and has clinical proteinuria or microalbuminuria, treat with 10 mg of benazepril once daily. If patient develops a cough or angioneurotic edema, switch to 25 mg of losarten, once daily. Measure a serum creatinine and K

+

approximately 2 weeks after starting an ACE inhibitor or an ARB. Monitor blood pressure and ensure the

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blood pressure meets goal if possible (<130/80 mm Hg) and that systolic pressure is >90 mm Hg.

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