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Antiarrhythmic Drugs and Polyneuropathy J Neurol Neurosurg Psychiatry: First Published As 10.1136/Jnnp.57.3.340 on 1 March 1994

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Antiarrhythmic Drugs and Polyneuropathy J Neurol Neurosurg Psychiatry: First Published As 10.1136/Jnnp.57.3.340 on 1 March 1994 34030ournal ofNeurology, Neurosurgery, and Psychiatry 1994;57:340-343 Antiarrhythmic drugs and polyneuropathy J Neurol Neurosurg Psychiatry: first published as 10.1136/jnnp.57.3.340 on 1 March 1994. Downloaded from The Collaborative Group for the Study of Polyneuropathy Istituto di Ricerche Farmacologiche factors of polyneuro- "Mario Negri", Abstract prevalence and risk Milano, Italy A total of 151 patients on chronic treat- pathy, using standard clinical and electro- E Beghi ment with amiodarone and other anti- physiological techniques. M L Monticelli arrhythmic drugs were subjected to Ospedale "San standard clinical and electrophysiologi- Gerardo", Monza, Italy cal investigation to assess the prevalence Materials and methods 15 to and seen consec- Clinica Neurologica and specificity of polyneuropathy. Subjects aged 70 years A Bono Twenty two untreated patients with car- utively in four cardiological outpatient E Beghi diac disorders and 246 normal subjects services in Italy (Monza, Turin, Rome, and G Bogliun as controls. Abnormal electro- San Giovanni Rotondo) were considered for N Curt6 served L Marzorati physiological findings supporting the inclusion if they had been first treated for no L Frattola diagnosis of polyneuropathy were pre- less than six months with the following drugs, Divisione Cardiologica sent in 38 subjects (25%) given antiar- singly or in combination: amiodarone, F Achilli rhythmic drugs, with even distribution propafenone, atenolol, flecainide, mexiletine, A Bozzano A small A Cadel among drugs, and four untreated propanolol, verapamil, quinidine. A Cazzaniga patients (18%). Concurrent clinical sample of patients who were considered B Pria abnormalities were present in five candidates for antiarrhythmic treatment, but A Vincenti treated patients (one each with amio- had not yet been treated, was included as a Ospedale "Molinette", darone, propafenone, and flecainide, and reference group. Torino, Italy two with multiple drugs). Therefore, A preliminary screening investigation was DEA Neurologia G Chianale electrophysiological abnormalities are a made by the consultant cardiologist during M De Mattei common, although non-specific, feature routine ambulatory practice. The cardiologist P Zaina in patients taking antiarrhythmic drugs. retained the patients fulfilling the inclusion Istituto di Cardiologia Amiodarone users do not seem at higher criteria and excluded those with other con- F Colivicchi risk of polyneuropathy than subjects current factors or disorders causing poly- R Fanelli F Gaita treated with other drugs or even un- neuropathy (indicated on a check list). The C Giosetto treated patients with cardiac disorders. reasons for exclusion were: diabetes, liver dis- Universita Cattolica, ease, porphyria, amyloidosis, uraemia, thyroid Roma, Italy (7 Neurol Neurosurg Psychiatry 1994;57:340-343) disorders, paraproteinaemia, collagen disease, Clinica Neurologica neoplasms (checked by history, reports of S Magi abnormal biochemical assays, or specific http://jnnp.bmj.com/ T Mignogna A Ciervo Several adverse effects of amiodarone have treatments). Patients treated with potentially P Tonali been reported, including neurological toxi- neurotoxic agents'5 were also excluded. All Clinica Cardiologica city.12 The commonest neurological symp- the eligible patients were invited by appoint- F Bellocci toms and signs include tremor, ataxia, and ment to undergo a detailed neurological eval- Ospedale "Casa polyneuropathy with or without spinal cord uation, which included a standardised active Sollievo della involvement.34 Clinical and electrophysio- search for symptoms of polyneuropathy and a Sofferenza", San Giovanni Rotondo, logical data supporting polyneuropathy have formal clinical and electrophysiological on September 24, 2021 by guest. Protected copyright. Italy been confirmed by pathological findings in assessment. A clinical diagnosis of poly- Divisione di animals and humans, showing demyelination neuropathy was made when there was evi- Neurologia or axonal loss with lysosomal inclusions in dence of bilateral impairment of strength, or P Di Viesti data to case sensation, or deep tendon reflexes, or a com- P Simone different cell types.'5 Most refer M Zarrelli reports and selected clinical series, of which bination in the upper, or lower, or both Divisione di only two screened as many as 50 to 54 extremities with fairly symmetrical distribu- Cardiologia patients.3 tion. P Lanna Despite the recognition of common elec- The electrophysiological screening was D Potenza trophysiological effects of the antiarrhythmic done on the right limbs according to a stan- Centro Ricerche have been dard Briefly, motor and sensory Cliniche in drugs,'011 only a few reports pub- procedure.'6 Biomagnetismo- lished on the potential neurotoxicity of agents nerve conduction velocity, distal latency, and Fisiologia, Roma, Italy other than amiodarone."2-'4 It is therefore not potential amplitude of median, ulnar, com- R Fenici possible to estimate the risk of polyneuro- mon peroneal, and sural nerves were mea- G Melillo pathy in patients on chronic amiodarone sured with surface stimulating and recording Correspondence to: Ettore Beghi, MD, Istituto di treatment, the specificity of that risk, or the techniques. Room temperature was main- Ricerche Farmacologiche factors that may be accompanied by a higher tained at 22-24°C. Skin temperature was "Mario Negri", Via Eritrea, 62-20157 Milano, Italy. risk. measured in the presence of cool limbs. Limb Received 31 December 1992 We screened a fairly unselected group of warming was performed when specifically and in revised form patients treated with different antiarrhythmic indicated. All the electrophysiological vari- 8 June 1993. Accepted 21 June 1993 drugs, including amiodarone, to assess the ables were compared with normal reference Antiarrhythmic drugs and polyneuropathy 341 values obtained from each centre separately Thirty six patients (19%) were not given J Neurol Neurosurg Psychiatry: first published as 10.1136/jnnp.57.3.340 on 1 March 1994. Downloaded from and measured according to the same proce- neurological assessment. The commonest dure. reasons for exclusion were refusal and resi- In Monza there were 54 normal subjects dence far from the hospital. These patients (27 men, 27 women) aged 18 to 69 (mean 42 were similar to those completing the neuro- years). In Rome there were 60 patients (35 logical assessment in terms of age, sex, and men, 25 women) aged 22 to 67 (mean 44 centre. Ninety six men and 55 women under- years), in Turin 60 (31 men, 29 women) aged went complete neurological assessment. In 20 to 69 (mean 44 years), and in San these cases the underlying cardiac disorders Giovanni Rotondo 72 (47 men, 25 women) were atrial arrhythmia (74 cases), Wolff- aged 17 to 69 (mean 47 years). No significant Parkinson-White disease (22), coronary differences or age trends were detected within artery disease (21), ventricular arrhythmia centres for any of the values. The normal lim- (19), arterial hypertension (five), sinus tachy- its for conduction velocity and distal latency cardia (four), and miscellaneous cardiac dis- were set at 2-5 SD from the mean for the orders (six). The distribution of treated controls. The action potential was abnormal patients and the commonest drugs by centre if the amplitude was below the lowest value were: Monza 54 (amiodarone 30, polytherapy found in the controls. An electrophysiological six); Turin 47 (propafenone 15, verapamil diagnosis of polyneuropathy was made when and flecainide 10); Rome 36 (propafenone conduction velocity, or distal latency, or 10, amiodarone eight); San Giovanni potential amplitude, or a combination were Rotondo 14 (flecainide four, amiodarone and abnormal in at least two nerves. Specific atenolol three). Untreated patients were strategies were adopted to exclude mononeu- evenly distributed among centres. Table 1 ropathies or multineuritides of diverse origin: shows the general characteristics of the sam- (1) Patients with clinical findings suggesting ple by treatment group. Untreated patients mononeuropathy or profoundly asymmetric and subjects receiving flecainide were gener- polyneuropathy were excluded; (2) abnormal ally younger and those receiving mexiletine electrophysiological variables were to be were older. Treatment duration ranged from recorded from different nerves; (3) when 6 months to 10 years and was more than 3 entrapment neuropathies (for example, carpal years in 38% of the cases. Mean treatment tunnel syndrome) were suspected, the contra- duration varied for the different drugs. The lateral (left) limbs were examined; (4) mixed daily doses of the drugs were within the stan- (sensory-motor) nerves (median, ulnar) were dard therapeutic range for all the patients. considered a single entity. Plasma concentrations of the antiarrhythmic Statistical analysis was carried out with the drugs were not routinely measured. Statistical Package for the Social Sciences Forty six patients (30%) complained of (SPSS). The prevalence of clinical and elec- one or more symptoms of polyneuropathy, trophysiological polyneuropathy was esti- the commonest being paresthesiae (27 cases), mated in the whole sample, in different followed by muscle cramps (18), restless legs treatment groups, and in the untreated sub- (nine), standing or gait disturbances (five), jects. The presence of polyneuropathy was burning feet, muscle pain, and troubles with correlated with age, sex, and treatment object handling (four cases each). Abnormal http://jnnp.bmj.com/
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