Table 1

Excluded medications for NILVAD trial

NifedipineBisoprololAmyl nitratePrazosin
NimodipineAtenololIsosorbide dinitrateDoxazosin
VerapamilAll other β-blockersPentaerythyitol tetranitrateAll other α-antagonists
All other CCB
Other agents/excluded agents
 Anticonvulsants: phenytoin, carbamazepine
Medications that are not excluded but drug interactions are noted for:
Other vasodilators: nitroprusside and hydralazine. Monitor for risk of antihypertensive effect
Tricyclic Antidepressants: monitor for risk of antihypertensive effect.
Antiarrhythmics: amiodarone, quinidine and disopyramide. Monitor levels of quinidine
Digoxin: nilvadipine may increase plasma digoxin levels. Monitor digoxin levels
Ciclosporin: monitor ciclosporin levels with concomitant use with nilvadipine
Cytochrome P450 3A4 inhibitors: indinavir, nelfinavir, ritonavir, itraconazole, ketoconazole, voriconazole, posaconazole, nefazodone, saquinavir, telithromycin and cimetidine. Nilvadipine is metabolised by CYP450 3 A4 and thus any agent that inhibits this enzyme system may potentially cause elevated levels of nilvadipine in the plasma. All patients will be monitored throughout, as per the study protocol, for any possible adverse drug interactions
Cytochrome P450 3A4 inducers: rifampicin, gemfibrozil and some antihyperglycaemics such as troglitazone. CPY450 3A4 inducers may potentially decrease the bioavailability of nilvadipine
 Patients will be advised of the possible interaction with grapefruit juice (CPY450 3A4 inhibitor) and requested to avoid taking the trial medication with it
This list is not exhaustive and therefore investigators should contact the sponsor's medical advisor for clarification regarding the acceptability and safety of these and other agents. All participants will be advised of potential interactions with other medications and the GP will also be provided with the list of exclusionary and precautionary medications. Any patient prescribed any of the above medications will be monitored closely throughout the study
  • CCB, calcium channel blockers; GP, general practitioner.