Gonasun L M, Langrall H
Am Heart J. 1982 Aug;104(2 Pt 2):482-6.
More than 1200 patients who received pindolol for the treatment of hypertension, angina pectoris, and various arrhythmias in studies conducted in the United States were included in the New Drug Application submitted to the FDA. Nearly 1000 of these patients received pindolol as monotherapy. The side effects reported were generally transient and of mild or moderate severity. The most frequently reported side effects seen after pindolol administration, compared to those seen after placebo, were in decreasing order of incidence: headache, dizziness, insomnia, muscle pain, fatigue, weakness, nervousness, joint pain, edema, nausea, and muscle cramps. Other side effects that occurred more frequently with pindolol than with placebo but at a rather low incidence induced weight gain, bizarre dreams, visual disturbances, lethargy, and diarrhea. Nasal congestion, throat discomfort, nocturia, impotence, pruritus, anxiety, hypotension, bradycardia, and heart failure occurred only rarely. Of the 323 patients who received pindolol alone for the treatment of mild to moderate hypertension, only 20 (6.2%) were withdrawn from the study because of side effects. Overall, 3.4% of the patients treated with pindolol were withdrawn because of side effects, most of which involved the central nervous system, that is, insomnia, anxiety, dizziness, and headache. However, a few patients manifested some edema and weight gain while receiving pindolol alone. Review of the side effects data did not reveal a tendency for the incidence of side effects to be dose related. One placebo-controlled, double-blind study designed to evaluate the fixed dosages of 15, 30, and 60 mg in the treatment of mild to moderate hypertension suggested that only the incidences of insomnia and nervousness increased with increasing doses. However, these side effects were generally transient and of mild or moderate severity. The evidence indicates that pindolol has an acceptable safety profile and that any side effects that appear are generally well tolerated and disappear with continued treatment.
在美国开展的研究中，超过1200名接受吲哚洛尔治疗高血压、心绞痛及各种心律失常的患者被纳入提交给美国食品药品监督管理局（FDA）的新药申请中。其中近1000名患者接受吲哚洛尔单药治疗。报告的副作用通常是短暂的，严重程度为轻度或中度。与安慰剂相比，吲哚洛尔给药后最常报告的副作用按发生率从高到低依次为：头痛、头晕、失眠、肌肉疼痛、疲劳、虚弱、紧张、关节疼痛、水肿、恶心和肌肉痉挛。吲哚洛尔比安慰剂更常出现但发生率相当低的其他副作用包括体重增加、怪异梦境、视觉障碍、嗜睡和腹泻。鼻充血、咽喉不适、夜尿症、阳痿、瘙痒、焦虑、低血压、心动过缓和心力衰竭仅偶尔出现。在323名仅接受吲哚洛尔治疗轻度至中度高血压的患者中，仅有20名（6.2%）因副作用退出研究。总体而言，3.4%接受吲哚洛尔治疗的患者因副作用退出，其中大多数涉及中枢神经系统，即失眠、焦虑、头晕和头痛。然而，少数患者在单独接受吲哚洛尔治疗时出现了一些水肿和体重增加。对副作用数据的审查未发现副作用发生率与剂量相关的趋势。一项旨在评估15、30和60毫克固定剂量治疗轻度至中度高血压的安慰剂对照双盲研究表明，仅失眠和紧张的发生率随剂量增加而增加。然而，这些副作用通常是短暂的，严重程度为轻度或中度。证据表明吲哚洛尔具有可接受的安全性，出现的任何副作用通常耐受性良好，并会随着持续治疗而消失。
