scholarly journals Examination regarding the tolerability of the homochord Acidum L(+)-lacticum at a dosage of sixty drops three times daily

2021 ◽  
Vol 14 (4) ◽  
pp. 54-60
Author(s):  
Dieter Sonntag
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Adverse Drug Reactions ◽  
Regulatory Authority ◽  
Drug Reactions ◽  
Clinical Safety ◽  
Dosage Guidelines ◽  
Therapist Responses ◽  
Usual Dosage ◽  
Daily Application

In Germany, the commission D recommends in its current dosage guidelines from March 17, 2004, that homeopathic dilutions higher than 24x will be prescribed in a daily application of five drops once. This recommendation is decisive for the German Regulatory Authority. Even though the homochord Acidum L(+)-lacticum 4x/6x/12x/30x/200x contains dilutions above 24x, it is commonly used in clinical practice for over 30 years in a dosage of 60 drops three times daily. In order to explore the clinical safety and tolerability of Acidum L(+)-lacticum 4x/6x/12x/30x/200x at a dosage of 60 drops three times daily, as well as lower dosages, a therapist survey was designed to address the questions. Highly experienced and licensed therapists, including general and alternative practitioners, reported their usual dosage of homochord, incidences of drug reactions, initial homeopathic aggravations as well as the diagnoses that led to the prescription of Acidum L(+)-lacticum 4x/6x/12x/30x/200x. 167 therapist responses were analyzed. Only four therapists reported occurrences that classify as initial aggravation, (2.40 %), compared to 159 with no incidences (95.21 %). Four therapists made no statement. Nevertheless, there were no adverse drug reactions documented in the survey. Consequently, Acidum L(+)-lacticum 4x/6x/12x/30x/200x at a dosage of 60 drops three times daily or lower dosages may be construed to be clinically tolerable and safe. This evidence might lead to further re-evaluations of other homochords, and rigorous clinical trials for its safety and tolerability.

Efficacy and Safety of Lipegfilgrastim in Lung Cancer Patients Receiving Myelosuppressive Chemotherapy in a Real-World Setting: Results of an Analysis of Pooled Data from Two Non-Interventional European Studies

2021 ◽  
pp. 1-9
Author(s):  
Christian Gessner ◽  
Karin Potthoff ◽  
Nikolaj Frost
Keyword(s):  
Lung Cancer ◽  
Clinical Practice ◽  
Cancer Patients ◽  
Adverse Drug Reactions ◽  
Real World ◽  
Secondary Prophylaxis ◽  
Drug Reactions ◽  
Myelosuppressive Chemotherapy ◽  
Lung Cancer Patients ◽  
Chemotherapy Induced Neutropenia

<b><i>Background/Aim:</i></b> Chemotherapy-induced neutropenia is a common and serious complication in cancer patients receiving myelosuppressive chemotherapy. This analysis was undertaken to evaluate the effectiveness and safety of prophylaxis with lipegfilgrastim, a glycoPEGylated granulocyte colony-stimulating factor, in lung cancer patients undergoing chemotherapy in real-world clinical practice. <b><i>Methods:</i></b> Data from two European non-interventional studies (NIS NADIR and NIS LEOS) investigating lipegfilgrastim for primary and secondary prophylaxis were pooled. Outcomes included the incidence of chemotherapy-induced neutropenia and febrile neutropenia (FN), use of anti-infectives and antimycotics, and adverse events and their relationship to lipegfilgrastim. <b><i>Results:</i></b> The safety population included 361 patients with lung cancer (median age, 66 years [range, 36–88]), of whom 322 had received 2 or more consecutive cycles of lipegfilgrastim (efficacy population [primary prophylaxis, 75.5%; secondary prophylaxis, 16.5%]). Almost 40% of the patients were considered to have a high risk (&#x3e;20%) of FN, and around 60% had an intermediate risk (10–20%). For all cycles, FN was reported in 3 patients (0.9%), neutropenia in 14 (4.3%), and grade 4 neutropenia in 9 (2.8%). Anti-infectives were used in 27 patients (8.4%) and antimycotics in 6 (1.9%). The incidence rates were lower for the patients’ first cycle (FN, 0.4%; neutropenia, 0.8%; grade 4 neutropenia, 0.8%; anti-infectives, 0.6%; antimycotics, 0.6%). Adverse drug reactions considered lipegfilgrastim related were reported in 35 patients (9.7%), and serious adverse drug reactions in 10 (2.8%). None of the fatal events reported in 28 patients (7.8%) were lipegfilgrastim related. <b><i>Conclusion:</i></b> Lipegfilgrastim administered to patients with lung cancer undergoing chemotherapy in real-world clinical practice showed similar effectiveness and safety to that reported in published pivotal trials.

scholarly journals Adverse Drug Reactions during Real-Life Use of Direct Oral Anticoagulants in Italy: An Update Based on Data from the Italian National Pharmacovigilance Network

2020 ◽  
Vol 10 (4) ◽  
pp. 266-276 ◽  
Author(s):  
Carlo Lavalle ◽  
Luca Di Lullo ◽  
Antonio Bellasi ◽  
Claudio Ronco ◽  
Stefano Radicchia ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Market Share ◽  
Adverse Drug Reactions ◽  
Oral Anticoagulants ◽  
Risk Index ◽  
Direct Oral Anticoagulants ◽  
Real Life ◽  
Drug Reactions ◽  
Safety And Efficacy ◽  
Pharmacovigilance Database

Background: The availability of direct oral anticoagulants (DOAC) in clinical practice has transformed the health care provided to patients for the prevention and treatment of thromboembolism. Safety and efficacy data guide clinicians in the choice of the drug used. To date, no evidence is available from head-to-head trials comparing different DOAC with regard to safety and efficacy; information is mainly derived from several meta-analyses and real-life studies. Conclusions from these studies are inconsistent and unsatisfactory. The evaluation of self-reported adverse drug reactions (ADR) available from databases of drug-regulatory agencies such as the Italian Medicines Agency (AIFA) pharmacovigilance database represents a novel aid to guide decision-making. Objective: To analyze potential suspected ADR of DOAC using a previously described risk index (RI) in daily clinical practice in Italy. Methods: The National Pharmacovigilance Network database (from the AIFA website) was searched in order to retrieve information on all ADR related to oral anticoagulants occurring from 2013 to 2018. The ADR RI for each drug was calculated, where an RI = 1 indicates a balance between the percentage of ADR share and the percentage of market share for each DOAC; and an RI <1 indicates a rate of ADR lower than the rate of market share (safer DOAC). The following DOAC molecules were considered: dabigatran, rivaroxaban, apixaban, and edoxaban. Results: The results showed that rivaroxaban is the DOAC with the lowest RI among the 4 molecules available today in Italy. Conclusions: Based on the RI, we identified rivaroxaban as the DOAC having the best safety profile.

scholarly journals Precision dosing to avoid adverse drug reactions

2019 ◽  
Vol 10 ◽  
pp. 204209861989414 ◽  
Author(s):  
Thomas M. Polasek ◽  
Carl M. J. Kirkpatrick ◽  
Amin Rostami-Hodjegan
Keyword(s):  
Clinical Practice ◽  
Adverse Drug Reactions ◽  
Drug Response ◽  
Patient Characteristics ◽  
Trial And Error ◽  
Patient Harm ◽  
Drug Reactions ◽  
Dose Selection ◽  
Proactive Approach ◽  
Novel Biomarkers

Adverse drug reactions (ADRs) have traditionally been managed by trial and error, adjusting drug and dose selection reactively following patient harm. With an improved understanding of ADRs, and the patient characteristics that increase susceptibility, precision medicine technologies enable a proactive approach to ADRs and support clinicians to change prescribing accordingly. This commentary revisits the famous pharmacology–toxicology continuum first postulated by Paracelsus 500 years ago and explains why precision dosing is needed to help avoid ADRs in modern clinical practice. Strategies on how to improve precision dosing are given, including more research to establish better precision dosing targets in the cases of greatest need, easier access to dosing instructions via e-prescribing, improved monitoring of patients with novel biomarkers of drug response, and further application of model-informed precision dosing.

Adverse drug reactions with an immunological basis: from clinical practice to basic research

Allergy ◽  
2002 ◽  
Vol 57 (s72) ◽  
pp. 41-44 ◽  
Author(s):  
E. Sanchez ◽  
M. J. Torres ◽  
C. Mayorga ◽  
M. Reche ◽  
A. Padial ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Adverse Drug Reactions ◽  
Basic Research ◽  
Drug Reactions
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