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How were step-up drugs selected and used in ALLHAT?

This study analyzes the selection and usage of step-up drugs in the ALLHAT trial, providing insights into the considerations and patterns of drug addition in different treatment arms.

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How were step-up drugs selected and used in ALLHAT?

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  1. How were step-up drugs selected and used in ALLHAT?

  2. ALLHAT Step-up Drugs: General Considerations • Avoided drugs of blinded first-step classes (unless compelling indications), so as not to confound first step-comparisons • Drugs provided by study all had different mechanisms than first-step drugs, i.e. 3 antiadrenergics, 1 direct vasodilator • Other drugs at investigators’ discretion, not paid for by ALLHAT

  3. ALLHAT Step-up Drugs: Patterns of Use by Arm at One Year* Of participants taking blinded drug, % on step-up drugs *Refers to addition of step-up drugs to blinded drugs

  4. ALLHAT Step-up Drugs: Patterns of Use by Arm at Three Years* Of participants taking blinded drug, % on step-up drugs *Refers to addition of step-up drugs to blinded drugs

  5. ALLHAT Step-up Drugs: Patterns of Use by Arm at Five Years* Of participants taking blinded drug, % on step-up drugs *Refers to addition of step-up drugs to blinded drugs

  6. ALLHAT Step-up/Open-Label Drugs: Number Used by Arm at One Year % taking step-up and/or open-label drugs SUD=step-up or open-label drugs

  7. ALLHAT Step-up/Open-Label Drugs: Number Used by Arm at Three Years % taking step-up and/or open-label drugs SUD=step-up or open-label drugs

  8. ALLHAT Step-up/Open-Label Drugs: Number Used by Arm at Five Years % taking step-up and/or open-label drugs SUD=step-up or open-label drugs

  9. Open-Label Therapy: Patterns of Use by Arm at One Year by Participants Taking Step 1 Drug Of those taking blinded drug, % on OL therapy *Other OLT refers to meds other than the step 1 classes or the step 2-3 drugs

  10. Open-Label Therapy: Patterns of Use by Arm at Three Years by Participants Taking Step 1 Drug Of those taking blinded drug, % on OL therapy *Other OLT refers to meds other than the step 1 classes or the step 2-3 drugs

  11. Open-Label Therapy: Patterns of Use by Arm at Five Years by Participants Taking Step 1 Drug Of those taking blinded drug, % on OL therapy *Other OLT refers to meds other than the step 1 classes or the step 2-3 drugs

  12. Conclusions • Although distribution of specific add-on drugs was generally similar across randomized groups, more drugs were consistently added in the lisinipril group. • The greater use of add-on drugs, especially clonidine and hydralazine, may reflect the lesser blood pressure lowering of lisinopril (in the absence of a diuretic or CCB).

  13. Conclusions(continued) • The greater use of open-label diuretics in the amlodipine and lisinopril groups may have led to underestimating the outcome differences between the groups. • Given the lesser need for adding drugs to diuretics for BP lowering, and in the absence of advantages for CVD or renal outcomes for ACE-I, ALLHAT results suggest little justification for ACE-I to be preferred over diuretics as initial therapy.

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