The efficacy and safety of once-daily nifedipine: the coat-core formulation compared with the gastrointestinal therapeutic system formulation in patients with mild-to-moderate diastolic hypertension

Comparison of 24‐Hour Ambulatory Blood Pressure Data in Hypertensive Patients Switched from Nifedipine‐GITS to Nifedipine‐CC

“…Several authors recommended that Nif-CC could be substituted for Nif-GITS, based on similar 24-hour blood pressure averages. 6,7 Our data confirm there are no differences in 24-hour blood pressure averages between the two formulations. The release profile of the coat core formulation causes a greater reduction in blood pressure initially, but gradual loss of control occurs after about 16 hours compared with Nif-GITS.…”

“…In a double-blind, parallel, crossover study comparing these two formulations, changes in trough systolic and diastolic blood pressures from baseline during parallel group treatment were statistically significant in favor of Nif-GITS for both 30-and 60-mg doses (p<0.05). 6 Patients were force titrated to 60 mg after taking 30 mg for 4 weeks. Both formulations were associated with a similar overall adverse event rate, with the exception a significantly higher frequency of dizziness with NIF-CC (p<0.05).…”

“…To promote this practice further, several studies concluded that the two products are interchangeable based primarily on average 24hour blood pressures. 6,7 The different delivery systems cause significant differences in nifedipine plasma concentrations during various times during the dosing interval. 4,5 Nif-CC has a biphasic profile with an initial peak at approximately 3-4 hours postdose that is 3 times greater than that of a comparable dose of Nif-GITS.…”

Special Invited Papers Section: Therapeutic Equivalence – Clinical Issues and Statistical Methodology in Noninferiority Trials

“…Estimates of the standard-placebo difference formed the basis for the choice of the irrelevance margin in only 20 trials (Anonymous 1995(Anonymous , 1997bAbrams et al, 1998;Benkert, Diehm et al, 1996;Emery et al, 2000;Glasser et al, 1995a;Hawkey et al, 2000;Koopman et al, 1996;Lefebvre et al, 1996;Mattson et al, 2000;Moliterno and Topol, 2000;Peuskens et al, 1999;Pfeffer et al, 2000;Philipp, Kohnen and Hiller, 1999;Schnitzer et al, 2000;Sierakowski et al, 1997;Tyring et al, 1998). Further six trials used estimates of the difference between a new (more effective) and an old (less effective) standard treatment as a basis (Anonymous 1997a(Anonymous , 1999Clarke et al, 1998;Garcia et al, 2000;McCarty et al, 1999;Moore et al, 1999).…”

Comparison of Two Formulations of Nifedipine During 24‐Hour Ambulatory Blood Pressure Monitoring—A Comment

“…In a paralleldesign, multicenter, randomized, double-blind study, 228 patients with mild to moderate hypertension were assigned to either N-GITS or N-CC. 6 Mean changes in trough systolic and diastolic blood pressures from baseline during the parallel-group treatment period were statistically significant in favor of N-GITS for both the 30-and 60-mg doses (p<0.05). "Above all else, do no harm," comes to mind when examining the adverse event rates among the completed trials.…”