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Trandolapril

A Review of its Pharmacodynamic and Pharmacokinetic Properties, and Therapeutic Use in Essential Hypertension

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Summary

Synopsis

Trandolapril is a non-sulfhydryl prodrug which, after oral administration, is hydrolysed in the liver to its active diacid, trandolaprilat. Trandolaprilat inhibits the angiotensin converting enzyme (ACE) and displays similar pharmacodynamic properties to other ACE inhibitors, improving haemodynamic and cardiac parameters in patients with essential hypertension.

Trandolapril 2 to 4mg once daily effectively controls blood pressure for at least 24 hours in patients with mild to moderate hypertension. In a small number of double-blind comparative trials, trandolapril had similar antihypertensive efficacy to that of atenolol, enalapril, hydrochlorothiazide, lisinopril and sustained release nifedipine, but was more effective than captopril. Combined therapy with trandolapril and hydrochlorothiazide or sustained release nifedipine had a significantly greater antihypertensive effect than either drug treatment alone. Further comparative trials are warranted to confirm these preliminary findings.

The tolerability profile of trandolapril is similar to that of other ACE inhibitors, most adverse events being generally mild and transient in nature, and trandolapril lacks adverse effects on carbohydrate and lipid metabolism.

Thus, trandolapril, with its favourable pharmacological profile and antihypertensive activity similar to that of agents currently used to treat patients with mild to moderate hypertension, is likely to provide a well tolerated option for the treatment of this disease. The results of ongoing and future clinical trials will determine its potential as a cardioprotective agent in patients following myocardial infarction.

Pharmacodynamic Properties

Trandolaprilat showed high affinity for angiotensin converting enzyme (ACE) in in vitro and ex vivo studies, in which it was a more potent inhibitor of this enzyme than quinaprilat, enalaprilat and captopril. In normotensive and hypertensive individuals, single oral doses of trandolapril ≥2mg inhibited plasma ACE activity by 85 to 100% within 2 to 4 hours of administration.

Trandolapril increased total and active plasma renin levels in normotensive and hypertensive individuals, whereas plasma aldosterone levels were generally reduced.

A single dose of trandolapril effectively reduced systolic and diastolic blood pressure throughout a 24-hour postdose period in patients with essential hypertension. Multiple-dose administration (1 to 8 mg/day for up to 12 months) provided satisfactory blood pressure control, while having little or no effect on heart rate, cardiac output or stroke volume. Significant reductions in left ventricular mass index, interventricular septal and posterior wall thicknesses, and afterload were observed during long term treatment (6 to 12 months), as was an improvement in left ventricular contractility and arterial compliance in patients with essential hypertension and left ventricular hypertrophy. Trandolapril 1 mg/day caused a similar reduction in left ventricular mass to that produced by enalapril 10 mg/day after 6 months.

Long term trandolapril administration significantly prolonged survival in animal models of hypertension and congestive heart failure, and the formation of vascular fibrinoid necrosis and occurrence of stroke were both prevented by trandolapril in spontaneously hypertensive stroke-prone rats.

Trandolapril 2 mg/day for 2 months reduced renal plasma flow (13%), without significantly altering renal vascular resistance, and a dose of 0.5 to 2.5 mg/day for 2 to 8 weeks had no significant effect on renal perfusion rate or plasma levels of creatinine or uric acid in hypertensive patients. No adverse effects on carbohydrate or lipid metabolism were observed in healthy volunteers or patients with essential hypertension with or without non-insulin-dependent diabetes.

Pharmacokinetic Properties

After oral administration, trandolapril is rapidly absorbed and converted to its active diacid, trandolaprilat, by nonspecific hydrolysis in the liver. Peak plasma concentrations (Cmax) of trandolapril in healthy volunteers were reached in approximately 1 hour (tmax), whereas tmax for trandolaprilat was about 4 to 6 hours. Cmax values were dose-proportional. After a single 2mg dose values ranged between 1.7 and 2.9 μg/L for trandolapril and 2.5 and 2.9 μg/L for trandolaprilat. Cmax values for trandolapril and trandolaprilat appeared higher in patients with mild to moderate hypertension after a single 2mg dose, but were similar to values in healthy volunteers during multiple-dose administration (1 to 2mg once daily for up to 10 days). Steady-state was achieved after 4 days and modest drug accumulation (accumulation index 1.5 to 2) was evident during therapy for 7 to 10 days.

While the absolute bioavailability of trandolapril after a single oral 2mg dose was only 9.5%, that of trandolaprilat was 40 to 60%, suggesting adequate absorption. Concomitant food intake reduced the rate of trandolapril absorption, but did not affect its bioavailability, or that of trandolaprilat.

Approximately 82% of a radiolabelled dose of trandolapril is excreted within 48 hours: about 33% in urine and 66% in faeces. Excretion is accounted for by trandolapril (negligible in urine) and trandolaprilat, their glucuronide conjugates and inactive diketopiperazine derivatives. The mean elimination half-life of trandolapril is about 0.7 to 1.3 hours, while trandolaprilat shows a biphasic elimination pattern, the prolonged terminal elimination phase (16 to 24 hours) probably representing the strong binding of trandolaprilat to ACE. Impaired renal function decreases the excretion of trandolaprilat, and hepatic impairment may decrease excretion of both trandolapril and trandolaprilat. Thus, initial dosage reduction is recommended in patients with severe renal or hepatic impairment. The dosage may then be increased as necessary to achieve a therapeutic response.

Therapeutic Use

In noncomparative and placebo-controlled studies, trandolapril 0.5 to 8 mg/day for 2 weeks and up to 12 months significantly reduced blood pressure in patients with mild to moderate hypertension. Maximal blood pressure reduction was achieved with a single daily dose of trandolapril 2mg and the antihypertensive effect was maintained for 12 months in patients treated with trandolapril 2 or 4 mg/day. The addition of a thiazide diuretic or calcium antagonist improved the response rate in a further 13% of patients not showing a satisfactory response to monotherapy with trandolapril.

The small number of double-blind comparative trials (mostly single comparisons) which have compared the antihypertensive efficacy of trandolapril (0.5 to 4 mg/day) with that of other ACE inhibitors and antihypertensive agents indicate that it is as effective as enalapril (2.5 to 20 mg/day) and lisinopril (10 mg/day), and more effective than captopril (100 mg/day) in reducing blood pressure to normalised levels (≤160/90mm Hg), or achieving a satisfactory blood pressure reduction (≥20/10mm Hg) in hypertensive patients. Trandolapril (2 to 4 mg/day) also appeared to be as effective as atenolol (100 to 200 mg/day), hydrochlorothiazide (25 mg/day) or sustained release nifedipine (40 mg/day), and antihypertensive activity was further enhanced during combined treatment with trandolapril and hydrochlorothiazide or sustained release nifedipine.

Trandolapril appeared equally effective in elderly (≥ 65 years) and younger hypertensive patients, as well as in obese hypertensive patients or those with glucose intolerance, non-insulin-dependent diabetes mellitus or renal dysfunction.

Tolerability

Trandolapril has been well tolerated in patients with mild to moderate hypertension in clinical trials of up to 12 months’ duration (> 2200 recipients), showing a similar adverse effect profile to that of other ACE inhibitors. The overall incidence of adverse events in a large multicentre study (n = 786) was 10.9%, cough being the most common (2.9%). Other adverse events included headache (1.9%), dizziness (1.8%), weakness (1.4%), palpitations (0.4%), hypotension (0.5%), nausea (0.6%), gastrointestinal disorders (0.5%), pruritus (0.4%) and rash (0.5%). Adverse events were generally mild and transient. However, treatment withdrawal due to severe events was necessary in 4.5% of patients in a large scale study (47/1049).

In large-scale comparative trials, trandolapril was at least as well tolerated as atenolol, enalapril, lisinopril and hydrochlorothiazide, and was better tolerated than captopril and sustained release nifedipine.

Dosage and Administration

In patients with mild to moderate hypertension, the recommended starting dosage of trandolapril is 2mg once daily. If necessary to achieve maximum response, this may be increased to 4mg once daily. In patients with severe renal or hepatic impairment, trandolapril should be initiated at a dosage of 0.5mg once daily.

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    Lynda R. Wiseman & Donna McTavish

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Various sections of the manuscript reviewed by: H.R. Brunner, Division d’Hypertension, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland; L. Burrell, Department of Medicine, University of Melbourne, Heidelberg, Victoria, Australia; P.W. de Leeuw, Department of Medicine, University Hospital Maastricht, Maastricht, The Netherlands; F. De Ponti, Department of Internal Medicine and Therapeutics, University of Pavia, Pavia, Italy; J-L. Freslon, Département de Pharmacodynamie, Université de Bordeaux II, Bordeaux, France; T. Ishizaki, Clinical Research Institute, National Medical Center, Tokyo, Japan; C.I. Johnson, Department of Medicine, University of Melbourne, Heidelberg, Victoria, Australia; T. Kawamoto, Department of Pharmacology, Osaka Medical College, Takatsuki, Japan; G.T. McInnes, University Department of Medicine and Therapeutics, Gardiner Institute, Western Infirmary, Glasgow, Scotland; T. Ogihara, Department of Geriatric Medicine, Osaka University Medical School, Osaka, Japan; H. Okunishi, Department of Pharmacology, Osaka Medical College, Takatsuki, Japan; P.A. Phillips, Department of Medicine, Austin and Repatriation Hospital, Heidelberg, Victoria, Australia; P. Sleight, Department of Cardiovascular Medicine, University of Oxford, Oxford, England; M.H. Weinberger, Hypertension Research Center, Indiana University, Indianapolis, Indiana, USA.

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Wiseman, L.R., McTavish, D. Trandolapril. Drugs 48, 71–90 (1994). https://doi.org/10.2165/00003495-199448010-00007

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