Long-term management of chronic pain with transdermal buprenorphine: A multicenter, open-label, follow-up study in patients from three short-term clinical trials

Design of clinical trials for germline gene editing stretches current accepted standards for human subjects research. Among the challenges involved is a set of issues concerning intergenerational monitoring—long-term follow-up study of subjects and their descendants. Because changes made at the germline would be heritable, germline gene editing could have adverse effects on individuals’ health that can be passed on to future generations. Determining whether germline gene editing is safe and effective for clinical use thus may require intergenerational monitoring. The aim of this paper is to identify and argue for the significance of a set of ethical issues raised by intergenerational monitoring in future clinical trials of germline gene editing. Though long-term, multigenerational follow-up study of this kind is not without precedent, intergenerational monitoring in this context raises unique ethical challenges, challenges that go beyond existing protocols and standards for human subjects research. These challenges will need to be addressed if clinical trials of germline gene editing are ever pursued.

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Treatment of penile lichen sclerosus with topical corticosteroids for over 25 years’ duration: A case report

SAGE Open Medical Case Reports ◽

10.1177/2050313x18795047 ◽

2018 ◽

Vol 6 ◽

pp. 2050313X1879504 ◽

Cited By ~ 3

Author(s):

Matthew Howard ◽

Anthony Hall

Keyword(s):

Case Report ◽

Relevant Literature ◽

Lichen Sclerosus ◽

Short Review ◽

Short Term ◽

Topical Corticosteroids ◽

Long Term Follow Up ◽

Term Management

Topical corticosteroids are currently recommended only for short-term management of flares of lichen sclerosus, with efficacy in halting disease progression. Given the chronic nature of this condition, there is a lack of literature surrounding the chronic effects of topical corticosteroids on the male genitalia with many dermatologists avoiding prescribing long term. This case report aims to provide anecdotal observation for the long-term use of topical corticosteroids and details the long-term follow-up of an individual who used potent and superpotent topical corticosteroids for over 25 years without significant demonstrable side effects. A short review on relevant literature is provided.

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Changes in Visual Acuity and Refraction in the Exfoliation Syndrome. A Five-Year Follow-up Study

European Journal of Ophthalmology ◽

10.1177/112067210101100306 ◽

2001 ◽

Vol 11 (3) ◽

pp. 245-251 ◽

Cited By ~ 2

Author(s):

P.M. Puska ◽

A.H.A. Tarkkanen

Keyword(s):

Visual Acuity ◽

Main Type ◽

Exfoliation Syndrome ◽

Follow Up Study ◽

Exfoliative Glaucoma ◽

The Difference ◽

Term Management ◽

Fellow Eyes

Purpose To examine changes in visual acuity (VA) and refraction in non-glaucomatous patients with unilateral exfoliation syndrome (EXS). Methods The best corrected values for VA (Snellen acuity cards) subjectively adjusted for refraction, and IOP were measured, and the development of lens opacities was examined in 46 non-glaucomatous patients with unilateral EXS. Results After five years the rate of conversion to bilateral exfoliation was 22% and to exfoliative glaucoma 30%. There was a significant decrease in VA in the exfoliative (E) eyes (median; QI, QIII, range: 1; 0.8, 1, 0.4-1.3 vs. 0.55; 0.4, 1, 0.05-1.4, p<0.0001) and the fellow, initially non-exfoliative (NE), eyes (1; 0.9, 1, 0.3–1.3 vs. 0.7; 0.5, 0.9, 0.1–1.4, p<0.0001) and a significant myopic change in refraction in the E eyes (+1.02 ± 2.48 vs. +0.11 ± 3.06, p=0.0001) and the NE eyes (+0.99 ± 2.25 vs. +0.43 ± 2.55 D, p<0.01). At study entry the difference in refraction between the fellow eyes (refraction in the NE eye – refraction in the E eye) was −0.27 ± 1.00D. After five years it was +0.32 ± 1.44 (p 0.016), reflecting greater myopic changes in the E eyes. The main type of lens opacification was nuclear sclerosis. Conclusions In five years, significant decreases in VA and myopic shifts in refraction occurred in the E and fellow eyes. The E eyes showed significantly greater myopic changes than the fellow eyes; the cause was clearly nuclear sclerosis, which must be taken into account in the long-term management of patients with EXS.

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New Scheme of Intermittent Benznidazole Administration in Patients Chronically Infected with Trypanosoma cruzi: a Pilot Short-Term Follow-Up Study with Adult Patients

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.00745-15 ◽

2015 ◽

Vol 60 (2) ◽

pp. 833-837 ◽

Cited By ~ 49

Author(s):

María Gabriela Álvarez ◽

Yolanda Hernández ◽

Graciela Bertocchi ◽

Marisa Fernández ◽

Bruno Lococo ◽

...

Keyword(s):

Pilot Study ◽

Adverse Effects ◽

Liver Enzymes ◽

Main Criterion ◽

Short Term ◽

Follow Up Study ◽

End Of Treatment ◽

Chronic Chagas Disease

ABSTRACTThere is a clinical need to test new schemes of benznidazole administration that are expected to be at least as effective as the current therapeutic scheme but safer. This study assessed a new scheme of benznidazole administration in chronic Chagas disease patients. A pilot study with intermittent doses of benznidazole at 5 mg/kg/day in two daily doses every 5 days for a total of 60 days was designed. The main criterion of response was the comparison of quantitative PCR (qPCR) findings prior to and 1 week after the end of treatment. The safety profile was assessed by the rate of suspensions and severity of adverse effects. Twenty patients were analyzed for safety, while qPCR was tested for 17 of them. The average age was 43 ± 7.9 years; 55% were female. Sixty-five percent of treated subjects showed detectable qPCR results prior to treatment of 1.45 (0.63 to 2.81) and 2.1 (1.18 to 2.78) parasitic equivalents per milliliter of blood (par.eq/ml) for kinetoplastic DNA (kDNA) qPCR and nuclear repetitive sequence satellite DNA (SatDNA) qPCR, respectively. One patient showed detectable PCR at the end of treatment (1/17), corresponding to 6% treatment failure, compared with 11/17 (65%) patients pretreatment (P= 0.01). Adverse effects were present in 10/20 (50%) patients, but in only one case was treatment suspended. Eight patients showed mild adverse effects, whereas moderate reactions with increased liver enzymes were observed in two patients. The main accomplishment of this pilot study is the promising low rate of treatment suspension. Intermittent administration of benznidazole emerges a new potential therapeutic scheme, the efficacy of which should be confirmed by long-term assessment posttreatment.

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Quality of randomized clinical trials published by plastic surgeons: a long-term follow-up study

Revista Brasileira de Cirurgia Plástica (RBCP) – Brazilian Journal of Plastic Sugery ◽

10.5935/2177-1235.2019rbcp0013 ◽

2019 ◽

Vol 34 (1) ◽

pp. 96-103

Author(s):

THIAGO BEZERRA MORAIS ◽

DANIELA FRANCESCATO VEIGA ◽

MIGUEL SABINO NETO ◽

LYDIA MASAKO FERREIRA

Keyword(s):

Clinical Trials ◽

Randomized Clinical Trials ◽

Follow Up Study ◽

Long Term Follow Up

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Long-term safety, tolerability, and efficacy of OROS® hydromorphone in patients with chronic pain

Journal of Opioid Management ◽

10.5055/jom.2009.0011 ◽

2018 ◽

Vol 5 (2) ◽

pp. 97 ◽

Cited By ~ 20

Author(s):

Mark Wallace, MD ◽

Dwight E. Moulin, MD ◽

Richard L. Rauck, MD ◽

Sarita Khanna, PhD ◽

Iulia Cristina Tudor, PhD ◽

...

Keyword(s):

Chronic Pain ◽

Plasma Concentrations ◽

Brief Pain Inventory ◽

The United States ◽

Short Term ◽

Open Label ◽

Safety And Efficacy ◽

Analgesic Effects ◽

N 93

Objective: To assess the safety and efficacy of long-term repeated dosing of OROS® hydromorphone in chronic pain patients.Design: This multicenter, open-label extension trial enrolled patients from three short-term OROS® hydromorphone trials.Setting: Fifty-six centers in the United States and Canada.Patients: Adults with chronic cancer pain or chronic nonmalignant pain who were receiving stable doses of OROS® hydromorphone (≥8 mg/day). Three hundred and eighty-eight patients were enrolled, 106 patients completed at least 12 months of therapy.Interventions: OROS® hydromorphone (individualized doses) was administered once daily.Main outcome measures: Safety and efficacy (Brief Pain Inventory and patient and investigator global evaluations) were assessed at monthly visits.Results: The median duration of extended OROS® hydromorphone therapy was 274 days. The median daily dose of study medication was 32.0 mg at extension-study baseline, 40.0 mg at month 3, and 48.0 mg at months 6, 9, and 12, respectively. The most frequently reported adverse events were nausea (n = 93, 24.0 percent) and constipation (n = 75, 19.3 percent). The analgesic effects of OROS® hydromorphone, assessed using the Brief Pain Inventory, were maintained throughout the extension. At 12 months, 72.4 percent of patients and 75.9 percent of investigators rated overall treatment as good, very good, or excellent.Conclusions: Once-daily OROS® hydromorphone is an osmotically driven, controlled-release preparation that may be particularly well suited to long-term use, because it provides consistent plasma concentrations and sustained around-the-clock analgesia. In this study, the benefits of OROS® hydromorphone attained in short-term studies were maintained in the long-term when daily administration was continued.

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