Several studies suggest the distinctive advantages of ACE-inhibitors and calcium-channel blockers in protecting the residual renal function in hypertensive patients. Pre-clinical and clinical studies have shown rare adverse events in the treatment with manidipine, which is commonly used as antihypertensive drug. We therefore decided to compare the effects of manidipine and nifedipine, on blood pressure, and renal function. One hundred and one hypertensive patients with chronic renal failure were randomly assigned to receive either manidipine 20 mg daily or nifedipine 60 mg daily, respectively. Patients were assessed every two weeks during the active treatment period with the final follow-up after three months. The primary endpoint was the achievement of DBP < or = 90 mmHg or a 10 mmHg DBP reduction from the baseline values, whilst the secondary endpoints was the improvement of the renal function assessed through the creatinine clearance, creatinine blood levels, protein and sodium urine excretion. Significant reduction in SBP (p < ) and DBP (p < ), compared to the baseline values, was reached in both treatments. Creatinine blood levels (p < ) and creatinine clearance (p < ) significantly increased in the manidipine group. Protenuria did not significantly change in the manidipine group but increased in the nifedipine group (p < ). The number of patients with severe adverse reactions differed significantly (p < ) between the groups with the highest frequency for nifedipine (%) compared to manidipine (%). The withdrawal rate was not significantly different between the groups. Manidipine is equally safe and effective as nifedipine and it may have more activity on renal function and less severe side effects compared to nifedipine.
The adverse event profile of CellCept Intravenous was determined from a single, double-blind, controlled comparative study of the safety of 2 g/day of intravenous and oral CellCept in renal transplant patients in the immediate posttransplant period (administered for the first 5 days). The potential venous irritation of CellCept Intravenous was evaluated by comparing the adverse events attributable to peripheral venous infusion of CellCept Intravenous with those observed in the intravenous placebo group; patients in this group received active medication by the oral route.
(n=673) Incidence (discontinuation) Placebo
(n=339) Incidence Body As A Whole Orthostatic Effects () Syncope () Chest Pain () Fatigue () Abdominal Pain () Asthenia () Cardiovascular Hypotension () Orthostatic Hypotension () Angina Pectoris () Myocardial Infarction () Digestive Diarrhea () Nausea () Vomiting () Nervous/Psychiatric Dizziness () Headache () Vertigo () Respiratory Cough () Bronchitis () Dyspnea () Pneumonia () Skin Rash () Urogenital Urinary Tract Infection ()