Extended-release nifedipine and the risk of intestinal obstruction: a population-based study (original) (raw)
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Deutsches Ärzteblatt international, 2012
Immediate-release nifedipine is on the PRISCUS list of drugs that should not be given to elderly patients. We studied the use of this calcium-channel blocker under real-life conditions. In 2009, we carried out a cross-sectional study based on the Statutory Health Insurance Sample AOK Hesse/KV Hesse with a sample size of 260 672 insurees. We used an anatomic-therapeutic-chemical classification (C08) to identify prescriptions for calcium-channel blockers. We determined from brand names and dosage forms whether nifedipine was prescribed in an immediate-release or sustained-release formulation. Among insurees over age 65, the prevalence of treatment with immediate-release and sustained-release nifedipine was 0.9% and 1.0%, respectively. Immediate-release nifedipine was usually (75%) given in a single administration. 46% of patients receiving immediate-release nifedipine also received another calcium-channel blocker. Patients who received immediate-release nifedipine tended to take more ...
TURKISH JOURNAL OF INTERNAL MEDICINE, 2023
Background Irritable bowel syndrome is a very common condition in the elderly, and it can also be extremely disabling being able to go to undermine the patient's independence. We wanted to conduct a study on the Territory to test a recently approved molecule for treating a variant with constipation-predominant irritable bowel syndrome, testing the treatment in a cohort of elderly subjects and comparing the results with those of other existing therapies. Here we exposed the results of our experience. Material and Methods We conducted an open-label study in the general medicine setting, enrolling patients who appeared eligible for drug treatment with the study drug during the medical examination. So we examined 20 elderly patients. Half of the patients were treated with linaclotide 290 mcg, the other 50% with macrogol 27.6 g (25%) and psyllium 2 sachets/day (25%), continuing the treatment up to 12 weeks. Results There was a reduction of bloating in 70% of the Linaclotide group and 80% of the macrogol and psyllium group, an improvement/reduction of tenesmus in 100% of patients in the three groups, with a change in the quality of stool occurring with Bristol Stool Scale assessment. 60% of patients failed to complete therapy in 3 months. Conclusions Linaclotide is an innovative drug increasingly gaining space in the pharmacopoeia in the possession of doctors for treating intestinal disorders on a functional basis. The limited experience has shown little tolerance of Linaclotide compared to treatments for longer in force, especially in the elderly.
Effect of nifedipine on gastric emptying in normal subjects
Digestive Diseases and Sciences, 1985
We studied the effects of the calcium-channel blocker, nifedipine, on solid and liquid phases of gastric emptying in 10 healthy male volunteers. Each subject underwent a dual-isotope radionuclide gastric emptying determination with and without the preadministration of nifedipine, 30 mg orally, given 20 min prior to ingestion of the test meal over 10 min, following which the subject lay supine under the gamma-counter for 2 hr. Blood samples for measurement of plasma nifedipine concentration were obtained at the time of drug administration and every 30 min throughout the gastric emptying determination. There was a threefold variation in the areas under the plasma nifedipine concentration vs time curve (AUC) obtained in these 10 subjects. Percent gastric retention of either the liquid (water) or the solid (chicken liver) marker was not significantly different after 30 mg oral nifedipine, as compared to the nontreatment day. We concluded that plasma nifedipine concentrations previously reported to be associated with significant esophageal motility effects in humans were not associated with effects on gastric emptying of either liquids or solids.
Effect of nifedipine on gastric emptying and gastrointestinal motility in man
Digestive Diseases and Sciences, 1988
Nifedipine, a calcium-blocking agent, inhibits smooth muscle contractions in various organs including gastric muscle in vitro. Despite this, nifedipine has been found to have no effect on gastric emptying in man. We have investigated the effect of nifedipine on gastric emptying of liquids and solids and on gastrointestinal motility in six healthy subjects. For this, isotopic techniques and manometric methods were used. We confirm that nifedipine 30 mg per os does not modify gastric emptying of liquids or solids. By contrast, antral motility was significantly inhibited (P < 0.05) and duodenal motility increased. These results could be interpreted as (1) gastroduodenal motility changes are not severe enough to alter emptying or (2) isotopic techniques are not sensitive enough to detect subtle changes in gastric emptying.
Gastrointestinal Drug Interactions Affecting the Elderly
Clinics in Geriatric Medicine, 2014
This article investigates common interactions between drugs used to treat common geriatric primary care diseases and those used in common gastrointestinal diseases, including acid peptic disease, diarrhea, constipation, endoscopic procedural sedation, and inflammatory bowel disease. The predicted exponential growth of elderly patients will create challenging medical management and logistical problems for clinicians. This article emphasizes the need for physicians to be vigilant regarding potential drug interactions in a geriatric population burdened with polypharmacy and comorbid conditions.
Journal of Bioequivalence & Bioavailability, 2021
Purpose: The nifedipine immediate-release formulation has been associated with reflex sympathetic nervous system activation leading to several adverse effects such as flushing, tachycardia, worsening myocardial ischemia, and cerebrovascular ischemia. Development of a modified-release formulation represents a challenge, particularly the development of a once-daily formulation. Therefore, these studies evaluated the pharmacokinetic profile of a new 30-mg Extended-Release Nifedipine Tablets in Mexican population. The formulation [ANHITEN-A ® ] was manufactured by Ultra Laboratorios S.A. de C.V. [Jalisco, Mexico] with number of batch 9JN134A and expiration date September 2021. Methods: They were a single-center, single-dose, open-label, one-way trial. Study A was evaluated at a fasted state [at least 10 hours] and Study B was evaluated at a fed state [30 minutes before dosing]. The studies population were 14 [per study] healthy male and female adult [aged 18-55 year] Mexican volunteers. These trials comprised one day treatment period and a 7-day wash-out period before final evaluation. Serial blood samples were collected before and after dosing and evaluated by UPLC-MS/MS. The bioavailability of the 30-mg Extended-Release Nifedipine Tablets was assessed Non-Compartmental Pharmacokinetic analysis and in accordance with local law regulation. Tolerability and safety were evaluated throughout the research. Findings: The non-compartmental model [NCA] pharmacokinetic parameters obtained are mean [SD] C max 43.95 [16.082] ng/mL and 100.71 [42.441] ng/mL, t max 7.2 [3.326] h and 4.7 [2.343] h, AUC 0-∞ 739.100 [224.436] ng h/ mL and 676.605 [355.791] ng h/mL, t 1/2 8.1 h [2.081] and 5.6 [2.174] h, V d /F 526.46 [238.67] L and 434.35 [218.15] L and CL/F 44.49 [15.98] L/h and 56.97 [32.03] L/h for fasted [trial A] and fed [trial B] state, respectively. C max and t ½ values showed statistically significant differences [p<0.05] between studies, with the higher C max values for the fed state [trial B] and higher t ½ values for the fasted state [trial A], data correlated with dose-dumping effect. Only two Adverse Events [AEs] were reported in trial A, headache, in trial B, two AEs of headache were reported. Implications: The pharmacokinetic modifications observed in trial B [compared to trial A] may be therapeutically relevant; plasma concentrations at 24 hours in studies A and B show that dosing after food intake decreases the maintained time of the Minimum Effective plasma Concentration with a duration of 24 hours in trial A and 12 hours in trial B. Variations in plasmatic concentrations associated with the dosage condition; higher C max values for the fed state [trial B] and higher t½ values for the fasted state [trial A], did not impact the presence of adverse events, that was similar between studies.
Neurogastroenterology and Motility, 2009
Abstract Chronic constipation is common among nursing home residents. The aim of this study was to evaluate safety, tolerability and pharmacokinetics of the selective 5HT4 receptor agonist prucalopride in elderly, chronically constipated patients in nursing homes. A multicentre, phase II, randomized, double-blind dose-escalation study in 89 elderly constipated nursing home residents treated with placebo, 0.5, 1 or 2 mg prucalopride once daily for 28 days was analysed. Adverse events, vital signs, ECG, Holter monitor and pharmacokinetics were assessed (Clinicaltrials.gov identifier: NCT00627692). Patients’ mean age was 83 years; 88% had a history of cardiovascular diseases. Most frequent adverse events, at least possibly related to prucalopride, were diarrhoea and abdominal pain. Relative to placebo, there were no differences in vital signs, ECG corrected QT interval, ECG morphology parameters, or incidence of supraventricular or ventricular arrhythmias on Holter monitoring. Plasma prucalopride concentrations increased proportionally with administered dose. Prucalopride up to 2 mg once daily for 4 weeks was safe and well-tolerated by constipated elderly patients, with no differences vs placebo in ECG or a range of Holter-monitoring parameters.