12 — Follow-Up Protocol

Table of Contents

1.0 Overview

This document describes the follow-up visit structure, monitoring parameters, and discharge criteria for patients managed at The Sandusky Dyslipidemia Model clinic. Follow-up visits are 20 minutes in duration and follow the structure outlined in 01 — Clinic Overview, Section 4.2.

2.0 Follow-Up Schedule

2.1 Visit Intervals

Patient Status Interval Rationale
New medication or dose change 4–8 weeks Assess response, tolerability, and safety labs
Titrating to goal, not yet stable Every 3–6 months Ongoing optimization
At goal, stable on therapy Annually Maintenance monitoring
Inclisiran patients Every 6 months Aligns with injection schedule

2.2 Lab Timing

Laboratories are ordered at the conclusion of each visit and completed prior to the next scheduled visit so results are available for review at the encounter. The specific tests ordered are at the provider’s discretion.

3.0 Follow-Up Visit Components

3.1 Nursing Intake (5 minutes)

  • Vital signs (blood pressure, weight, BMI)
  • Medication reconciliation: confirm current medications, doses, adherence
  • Interval symptom inquiry (medication side effects, new symptoms)

3.2 Provider Encounter (12 minutes)

Component Details
Lab review Lipid panel, ApoB (if ordered), safety labs
Goal assessment LDL-C and ApoB vs. risk-appropriate targets
Medication tolerability Side effects, adherence barriers, injection site reactions (if applicable)
Treatment adjustment Dose titration, agent addition, or no change
Risk factor update New diagnoses, medication changes by other providers, lifestyle changes
Patient education Reinforce treatment rationale, address questions

3.3 Wrap-Up (3 minutes)

  • Place orders (labs, imaging, prescriptions)
  • Schedule next follow-up
  • Provide updated patient education materials if applicable

4.0 Monitoring Parameters by Drug

4.1 Monitoring Schedule

Agent Labs at Each Follow-Up Additional Monitoring
Statins Lipid panel ± ApoB ALT only if hepatotoxicity symptoms; CK only if myalgia; HbA1c periodically
Ezetimibe Lipid panel ± ApoB No specific additional monitoring
PCSK9 inhibitors Lipid panel ± ApoB Injection site assessment; no routine lab safety monitoring
Inclisiran Lipid panel ± ApoB Injection site assessment; administered in-office
Bempedoic acid Lipid panel ± ApoB Uric acid; creatinine
Icosapent ethyl Lipid panel (including TG) AF symptoms assessment; bleeding assessment if on anticoagulants
Fenofibrate Lipid panel; renal function CBC; hepatic panel periodically
Niacin Lipid panel ± ApoB Hepatic panel; fasting glucose / HbA1c; uric acid

4.2 When to Check ApoB

ApoB should be checked:

  • At each follow-up during active titration (to assess atherogenic particle response)
  • At least annually once stable (to confirm ongoing adequacy)
  • Whenever treatment intensification is being considered (to justify “lower is better” approach)

5.0 Goal Assessment at Follow-Up

5.1 Primary Assessment

At each follow-up, assess:

Parameter Target (varies by risk category) Action if Not at Target
LDL-C Per 05 — Treatment Pathways, Section 1.2 Escalate per treatment algorithm
ApoB Per 04 — Risk Stratification, Section 5.2 Escalate even if LDL-C at target
Non-HDL-C 30 mg/dL above LDL-C target Secondary target

5.2 Response Assessment

Scenario Interpretation Action
LDL-C at target, ApoB at target At goal Maintain; transition to maintenance schedule
LDL-C at target, ApoB above target Residual atherogenic burden Intensify therapy per “lower is better” philosophy
LDL-C above target, adequate % reduction Partial response Add next agent per treatment escalation
LDL-C above target, poor % reduction Possible non-adherence or secondary cause Assess adherence; evaluate for secondary causes
LDL-C unexpectedly rising New secondary cause, non-adherence, or drug interaction Investigate; reassess medications and comorbidities

6.0 Adherence Assessment

6.1 Adherence Red Flags

Indicator Action
Unexpected rise in LDL-C Ask directly about missed doses; assess barriers
Missed follow-up appointments Outreach call; reschedule promptly
Prescription refill gaps Review pharmacy fill records if accessible
Patient reports difficulty with self-injection Consider switching from PCSK9 mAb to inclisiran (in-office, q6 month)
Financial barriers Explore manufacturer assistance programs, generic alternatives, or formulary options

6.2 Strategies for Improving Adherence

Strategy Details
Simplify regimen Use fixed-dose combinations (e.g., Nexlizet) where appropriate
Align dosing with routine Once-daily medications with a consistent time
Address side effect concerns Discuss nocebo effect; offer rechallenge if appropriate
In-office injectable Inclisiran eliminates daily/biweekly adherence burden
Patient education Reinforce ASCVD risk reduction benefits

7.0 When to Escalate Treatment

Escalate therapy at follow-up when:

Trigger Action
LDL-C not at target after adequate trial (≥ 4 weeks) Add next agent per 05 — Treatment Pathways, Section 11.0
ApoB above target despite LDL-C at goal Intensify per “lower is better”
New ASCVD event while on therapy Reclassify to very high risk; target LDL-C < 55, ApoB < 65
New risk enhancer identified Consider more aggressive targets
Previously deferred therapy (de-risked patient) with new findings Reassess; initiate treatment if no longer qualifies for de-risking

8.0 When to Discharge Back to Referring Provider

8.1 Discharge Criteria

Patients may be discharged back to their primary care provider or referring specialist when:

Criterion Details
At LDL-C and ApoB targets Sustained over ≥ 2 consecutive visits
Stable on therapy No medication changes in ≥ 6 months
No ongoing specialty needs No pending PA, no FH cascade screening in progress, no unresolved diagnostic workup
Referring provider comfortable managing Regimen is straightforward (e.g., statin ± ezetimibe)

8.2 Patients Who Should Remain in Clinic

Category Rationale
On PCSK9 inhibitor or inclisiran Specialty management, ongoing PA renewals
FH patients Lifelong monitoring, cascade screening, potential emerging therapies
Multi-agent regimens (≥ 3 lipid-lowering drugs) Complexity warrants specialist oversight
Recurrent ASCVD events despite therapy Ongoing risk optimization
Statin-intolerant patients on alternative regimens Specialty management

8.3 Discharge Communication

Upon discharge, provide the referring provider with:

  1. Summary of diagnosis, risk category, and treatment rationale
  2. Current medication regimen with doses
  3. Current lipid values and targets
  4. Recommended monitoring frequency and parameters
  5. Triggers for re-referral (e.g., loss of lipid goal, new ASCVD event, medication intolerance)
  6. Contact information for the clinic if questions arise

9.0 Special Follow-Up Scenarios

9.1 Post-ASCVD Event

  • Schedule follow-up within 4–6 weeks of hospital discharge
  • Verify lipid-lowering therapy was initiated or optimized during hospitalization
  • Reclassify to very high risk if not already
  • Aggressive targets: LDL-C < 55 mg/dL, ApoB < 65 mg/dL

9.2 Post-Genetic Testing (FH)

  • Schedule follow-up within 2–4 weeks of results
  • Review results and implications with patient
  • Initiate or adjust therapy based on confirmed diagnosis
  • Begin cascade screening discussion

9.3 Inclisiran Injection Visits

  • Align follow-up visits with inclisiran injection schedule (Day 0, Day 90, then q6 months)
  • Administer injection during visit
  • Check lipid panel prior to each injection visit

10.0 Version History

Version Date Description
1.0.0 2026-03-30 Initial release

References

  1. 2026 ACC/AHA/Multisociety Guideline on the Management of Dyslipidemia. J Am Coll Cardiol. 2026.
  2. Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol. Circulation. 2019;139(25):e1082–e1143.

© 2026 The Sandusky Dyslipidemia Model. For clinical decision support only. Not a substitute for clinical judgment.