efficacy and safety of lacidipine in chronic stable angina

Conditions: Angina Pectoris

Summary: the aim of this study was to explore whether lacidipine at doses of 2 mg, 4 mg and 6 mg decreased the symptoms of angina, compared to placebo in patients with chronic stable angina


Eligibility criteria:
inclusion criteria: * age 18 to 80 years * history of stable, exertional angina pectoris (canadian cardiovascular society functional class ii to iii) for at least 3 months duration prior to enrolment in the study * patients not currently receiving treatment with antianginal medication (other than short-acting nitrates) * between visits 2 and 3 two treadmill exercise tests, demonstrating ≥ 0.1 mv of horizontal or down sloping st-segment depression, must be carried out. the difference in symptom-limited exercise duration between these two tests must not exceed 20% * total treadmill exercise duration \> 3 minutes (i.e. stage 2 or above on a standard bruce protocol) * coronary artery disease, preferably (not mandatory) documented by a history of proven myocardial infarction and/or coronary angiography indicating ≥ 50% reduction in luminal diameter of one or more coronary arteries or their primary branches exclusion criteria: * myocardial infarction within 3 months prior to enrolment in the study * percutaneous transluminal coronary angioplasty (ptca) or coronary artery bypass surgery within 6 months * other types of angina (variant, unstable) * uncontrolled hypertension (systolic blood pressure \> 180 mmhg or diastolic blood pressure \> 100 mmhg) * resting heart rate \ 100 bpm * significant valvular heart disease * heart failure new york heart association class iii or iv * chronic obstructive pulmonary disease and/or asthma with clinical symptoms requiring regular medication * significant arrhythmia (since this may interfere with the interpretation of the electrocardiogram) including wolff parkinson-white syndrome, atrial fibrillation, atrial flutter, sick sinus syndrome, significant atrio-ventricular heart block, intraventricular conduction defect (qrs \> 0.12 seconds) ventricular pre-excitation, bundle branch block, the presence of a pace-maker, the presence of an implanted automatic defibrillator, uncorrected hypokalaemia (potassium \< 3.5 mmol/litre) * insulin dependent diabetes mellitus * significant liver disease (aspartate aminotransferase or alanine aminotransferase \> twice the upper limit of reference range) * significant renal disease (creatinine \> 1.5 x upper limit of reference range) * any clinical condition which in the opinion of the investigator, would preclude the safe fulfilment of the protocol and the safe administration of trial medication * inability to perform repeated exercise testing due to extra-cardiac reasons * concomitant treatment with any other anti-anginal medication, whether or not prescribed for this indication (e.g. calcium channel blockers, β-blockers or long-acting nitrates) * concomitant treatment with anti-arrhythmic medication, digitalis or tricyclic anti-depressants or other agents known to affect st-segment morphology * known hypersensitivity to any of the components of the investigational drug * pregnant or nursing women or women of child bearing potential * participation in any other clinical trial within 2 months of enrolment * history of drug or alcohol abuse