ramipril and Headache

We conducted 3 open-label, multiple-dose, 3-period, randomized, crossover studies in healthy subjects to assess the potential pharmacokinetic interaction between vildagliptin, a novel dipeptidyl peptidase IV inhibitor for the treatment of type 2 diabetes, and representatives of 3 commonly prescribed antihypertensive drug classes: (1) the calcium channel blocker, amlodipine; (2) the angiotensin receptor blocker, valsartan; and (3) the angiotensin-converting enzyme inhibitor, ramipril. Coadministration of vildagliptin 100 mg with amlodipine 5 mg, valsartan 320 mg, or ramipril 5 mg had no clinically significant effect on the pharmacokinetics of these drugs. The 90% confidence intervals of the geometric mean ratios for area under the plasma concentration-time curve from time zero to 24 hours (AUC0-24h) and maximum plasma concentration (Cmax) for vildagliptin, amlodipine, and ramipril (and its active metabolite, ramiprilat) were contained within the acceptance range for bioequivalence (0.80-1.25). Valsartan AUC0-24h and Cmax increased by 24% and 14%, respectively, following coadministration of vildagliptin, but this was not considered clinically significant. Vildagliptin was generally well tolerated when given alone or in combination with amlodipine, valsartan, or ramipril in healthy subjects at steady state. No adjustment in dosage based on pharmacokinetic considerations is required should vildagliptin be coadministered with amlodipine, valsartan, or ramipril in patients with type 2 diabetes and hypertension.

Topics: Adamantane; Administration, Oral; Adult; Amlodipine; Angiotensin II Type 1 Receptor Blockers; Angiotensin-Converting Enzyme Inhibitors; Antihypertensive Agents; Area Under Curve; Cross-Over Studies; Dipeptidyl-Peptidase IV Inhibitors; Drug Interactions; Female; Half-Life; Headache; Humans; Male; Middle Aged; Nausea; Nitriles; Pyrrolidines; Ramipril; Tablets; Tetrazoles; Valine; Valsartan; Vildagliptin

The hypertension is a civilization disease, slowly destroying the cardio-vascular system and leading to serious complications, which may result in patient death. Critical factors enhancing the proper functioning of the body are: properly selected pharmacotherapy and the self-control of the blood pressure.. was to evaluate the effectiveness and safety of the hypertension treatment with generic and original formulations of angiotensin converting enzyme (ACE) inhibitors.. To the study, which consisted of an interview and completed a joint survey were enrolled 120 patients with hypertension therapy based on formulations of ACE inhibitors group. Data for the analysis were obtained from surveys conducted in: Department of Angiology, Hypertension and Diabetology, Department and Clinic of Endocrinology, Diabetology and Isotope Therapy and its Clinic for Diabetic Outpatients, in the period from 03/02/2011 to 20/04/2011.. Out of 120 surveyed hypertensive patients treated with ACEI, 79 persons (66%) received the original preparations and 41 (34%) generic medications. Most preparations contained ramipril: 78 patients, of whom 50 received the original formulations and 28 a generic one. In this population no differences were found in the reduction of the systolic and the diastolic blood pressure between groups of patients receiving original and generic formulations. The most common adverse effects (AE) reported by patients were cough (n = 16), hypotension (n = 7), paresthesia (n = 6), skin lesions (n = 6), weakness (n = 5), headache and dizziness (n = 5). Some of these, i.e.: cough, weakness, headaches and dizziness, occurred more frequently in patients receiving therapy with generic preparations.. Both the reference and generic preparations showed similar efficacy in reducing systolic and diastolic pressure. The therapy with original drugs leads less frequently to adverse effects such as cough, weakness, headaches and dizziness.

Topics: Angiotensin-Converting Enzyme Inhibitors; Antihypertensive Agents; Cough; Dizziness; Drug Eruptions; Drugs, Generic; Female; Headache; Humans; Hypertension; Hypotension; Male; Muscle Weakness; Paresthesia; Population Surveillance; Ramipril