Drugs online research references
Am J Ther. 2003 Sep-Oct;10(5):330-40.
Impact of cotherapy with some proton pump inhibitors on medical claims among HMO patients already using other common drugs also cleared by cytochrome P450.
McCarthy DM, McLaughlin TP, Griffis DL, Yazdani C.
VA Medical Center and University of New Mexico, Albuquerque, New Mexico, USA.
Adverse drug event (ADE) rates resulting from coadministration of proton pump inhibitors (PPIs) and other drugs with potential for interaction with PPIs (DPIs) are unknown. This retrospective study assesses the occurrence of such ADEs and their potential impact on medical care costs by reviewing integrated medical and pharmacy claims. Managed care patients receiving one or more DPIs were identified. Within this sample, those who were also prescribed omeprazole or lansoprazole (DPI + PPI) were included. A second cohort (DPI alone) was created, matching for age, gender, and DPI use. Rates of ADEs were followed for 6 months after entry. Among PPI users, 58% used one or more DPIs, whereas 7% of DPI subjects used a PPI. Among claims arising from ADEs occurring in more than 1% of patients, 14 occurred in the DPI + PPI group and 2 occurred in the DPI-alone cohort, respectively, a highly significant difference. Crude odds ratios for the risks of specific ADEs were significantly increased for cotherapy with a PPI and warfarin, clarithromycin, corticosteroids, carbamazepine, nifedipine, or diclofenac. After adjustment, the first three associations remained significant. Coprescription of a PPI with potentially interacting drugs was common in practice and associated with significantly increased claims for medical care.
online pharmacy ref source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12975717&dopt=Abstract
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tufts.edu
This article compares the Swedish Medical Products Agency's (MPA) decision to switch omeprazole from prescription (Rx) to over-the-counter (OTC) status with the US Food and Drug Administration (FDA) advisory panel's decision not to authorize the switch. The agencies' differing perspectives on efficacy, safety, labeling, and clinical trial requirements are evaluated with regard to the Rx-to-OTC switch process in general and omeprazole's case in particular. The FDA and MPA regulatory policies on switches are substantially divergent. The FDA maintains a stricter set of switch guidelines and requirements than the MPA. One could infer from this that the FDA is more risk-averse than the MPA. Nevertheless, the omeprazole switch in Sweden appears to be an exception in that it contrasts with the MPA's historical reluctance to switch the Rx status of medications. Cost considerations appear to have triggered the omeprazole switch, making it a special case. The lessons to be drawn from this case study are both specific and general. At the specific level, this case study suggests the MPA's decision to switch omeprazole was prompted by economic considerations, whereas the FDA's mandate did not allow cost to affect its decision on omeprazole. At a general level, this case study indicates that the differences between the FDA and MPA with respect to their regulatory policies on switches and their mandates apply not only to omeprazole but also to the dozens of switches currently under consideration by the respective regulatory agencies.
online pharmacy ref source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12975722&dopt=Abstract
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Gastroenterology. 2001 Jul;121(1):43-55.
Neuroendocrine-specific and gastrin-dependent expression of a chromogranin A-luciferase fusion gene in transgenic mice.
Hocker M, Cramer T, O'Connor DT, Rosewicz S, Wiedenmann B, Wang TC.
Medizinische Klink mit Schwerpunkt Hepatologie und Gastroenterologie, Universitatsklinikum Charite, Campus Virchow-Klinikum, Humboldt Universitat Berlin, Berlin, Germany.
BACKGROUND AND AIMS: Chromogranin A (CgA) is a multifunctional acidic protein specifically expressed in neuroendocrine cells. In the stomach, CgA is found predominantly in enterochromaffin-like (ECL) cells, where it is regulated by gastrin. We investigated the ability of a promoter fragment comprising 4.8 kb of 5'-flanking DNA of the mouse CgA (mCgA) gene to direct cell-specific expression as well as gastrin responsiveness in the gastroenteropancreatic neuroendocrine system. METHODS: Two independent lines of mCgA 4.8 kb-luc transgenic mice were created. Transgene expression was assessed by determination of luciferase activity and reverse-transcription polymerase chain reaction analysis of luciferase messenger RNA. Cell specificity of transgene expression was investigated by immunohistochemical analysis. The influence of hypergastrinemia on transgene expression was determined after repeated omeprazole injections. RESULTS: In both transgenic lines, mCgA 4.8 kb-luc expression paralleled the expression pattern of the endogenous CgA gene. ECL cells were identified as the major gastric cell population expressing the transgene. Omeprazole treatment stimulated expression of the transgene and the endogenous CgA gene selectivity in the gastric corpus (3-4-fold). CONCLUSIONS: mCgA 5'-flanking DNA (4.8 kb) contain the major cis-regulatory element(s) required for cell-specific CgA expression in the neuroendocrine system and gastrin-responsiveness in the gastric corpus. Further analysis of the CgA promoter in transgenic studies may elucidate the general molecular mechanisms underlying cell-specific gene expression in the gastroenteropancreatic neuroendocrine system.
online pharmacy ref source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11438493&dopt=Abstract
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