Preoperative Amlodipine Is Efficacious in Preventing Intraoperative HDI in Pheochromocytoma: Pilot RCT

J Clin Endocrinol Metab. 2021 Jul 13;106(8):e2907-e2918. doi: 10.1210/clinem/dgab231.

Abstract

Context: Preoperative blockade with α-blockers is recommended in patients with pheochromocytoma/paraganglioma (PPGL). The data on calcium channel blockade (CCB) in PPGL are scarce.

Objective: We aimed to compare the efficacy of CCB and α-blockers on intraoperative hemodynamic instability (HDI) in PPGL.

Methods: In the interim analysis of this monocentric, pilot, open-label, randomized controlled trial, patients with solitary, secretory, and nonmetastatic PPGL were randomized to oral prazosin gastrointestinal therapeutic system (GITS) (maximum 30 mg, n = 9) or amlodipine (maximum 20 mg, n = 11). The primary outcomes were the episodes and duration of hypertension (systolic blood pressure ≥ 160 mmHg) and hypotension (mean arterial pressure < 60 mmHg) and duration of HDI (hypertension and/or hypotension) as a percentage of total surgical time (from induction of anesthesia to skin closure).

Results: The median (IQR) episodes (2 [1-3] vs 0 [0-1]; P = 0.002) and duration of hypertension (19 [14-42] vs 0 [0-3] minutes; P = 0.001) and intraoperative HDI duration (22.85 ± 18.4% vs 2.44 ± 2.4%; CI, 8.68-32.14%; P 0.002) were significantly higher in the prazosin GITS arm than the amlodipine arm, whereas episodes and duration of hypotension did not differ between the 2 groups. There was no perioperative mortality. One patient had intraoperative ST depression on the electrocardiogram. The drug-related adverse effects were pedal edema (1 in amlodipine), dizziness (1 in prazosin GITS), and tachycardia (6 in prazosin GITS and 3 in amlodipine).

Conclusion: Preoperative blockade with amlodipine is an efficacious alternative to prazosin GITS in preventing intraoperative HDI in PPGL. Larger studies that compare preoperative blockade by amlodipine with other α-blockers like phenoxybenzamine and/or doxazosin in PPGL patients are warranted.

Keywords: amlodipine; hemodynamic instability; pheochromocytoma.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adrenal Gland Neoplasms / physiopathology
  • Adrenal Gland Neoplasms / surgery*
  • Adult
  • Aged
  • Amlodipine / administration & dosage*
  • Amlodipine / therapeutic use
  • Blood Pressure / drug effects*
  • Calcium Channel Blockers / administration & dosage*
  • Calcium Channel Blockers / therapeutic use
  • Female
  • Hemodynamics / drug effects*
  • Hemodynamics / physiology
  • Humans
  • Male
  • Middle Aged
  • Monitoring, Intraoperative
  • Pheochromocytoma / physiopathology
  • Pheochromocytoma / surgery*
  • Treatment Outcome
  • Young Adult

Substances

  • Calcium Channel Blockers
  • Amlodipine

Associated data

  • CTRI/CTRI/2018/06/014604