https://www.cghjournal.org/article/S1542-3565(04)00777-3/pdf

Nonsteroidal anti-inflammatory drugs and hepatic toxicity: a systematic review of randomized controlled trials in arthritis patients.

/pdf/nonopioid-pharmacologic-treatments-for-chronic-pain-488ow3myyj.pdf

Nonopioid Pharmacologic Treatments for Chronic Pain

The rationale for specialised oral formulations of drugs include prolongation of effect for increased patient convenience and reduction of adverse effects through lowered peak plasma concentrations. Local and systemic adverse effects due to high concentrations of drug can be minimised by the use of controlled release delivery systems. Local effects in the gastrointestinal (GI) tract from the release of irritant drug molecules can also be reduced, but the gastric damage caused by nonsteroidal anti-inflammatory drugs (NSAIDs) is only partially relieved by formulation approaches because of the involvement of systemic factors in the aetiology of GI adverse events. The advantages for each drug class must be examined. Newer dosage forms include: (i) osmotic pumps and zero order kinetics systems to control the release rate of the drug; (ii) bioadhesive systems and gastric retention devices to control GI transit; (iii) bioerodible hydrogels; (iv) molecular carrier systems (e.g. cyclodextrin-encapsulated drugs) to modulate local toxicity in the GI tract; (v) externally activated systems; and (vi) colloidal systems such as liposomes and microspheres. There is evidence for improved tolerability for a variety of drugs administered in novel delivery systems. However, the evidence for improved tolerability is complicated by the potential bias in adverse reaction reporting systems, and a lack of studies directly comparing conventional and modified release preparations. The technology now available to produce delivery systems which not only release drugs in a controlled and predetermined fashion, but which can also target to regions of the GI tract such as the colon, should allow greater control of therapy and potentially might minimise patient variables. However, the problem of variable GI transit times still eludes solution. Systems which rely on time to release drug might be more vulnerable to patient-to-patient variability than those which respond to local environments. The effect of food intake is more apparent on single-unit, nondisintegrating dosage forms, although of course none so far are immune from influence. The risk of new adverse effects resulting from such positional therapy with novel delivery devices must be considered. Understanding the mechanisms of induction of individual adverse effects can lead to advances in modes of delivery to decrease the potential for adverse reactions and events while maintaining therapeutic efficacy. Increased compliance can lead to increased therapeutic control and hence safety. Each system has to be considered on its merits. No generalisations can be made, although invariably the modulation of high peak plasma concentrations diminishes adverse effects due to rapid absorption.

Novel oral drug formulations : their potential in modulating adverse effects

In a randomized, double blind, multicentre study with 4 weeks follow-up of 290 patients with osteoarthritis of the knee joint, a topical NSAID (eltenac) was compared with oral diclofenac and placebo. The main outcome, Lequesne's Index and pain by VAS showed no statistically significant differences between neither of the active treatments and placebo for the total study population. However, in patients with more severe symptoms, both active groups showed statistically significant differences to placebo. No severe adverse drug reactions were seen but the number of GI reactions were three times higher in the diclofenac group compared to the topical treatment. Local skin reactions were twice as frequent in the eltenac than in the placebo group. Taking into account the nature of the treatment for a chronic disease like OA, our results indicate that eltenac gel could be a safe alternative to oral NSAIDs.

Local NSAID gel (eltenac) in the treatment of osteoarthritis of the knee : A double blind study comparing eltenac with oral diclofenac and placebo gel

Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for treatment of arthritis and many other painful conditions. These drugs may cause damage not only to the upper gastrointestinal tract but also to the small and large intestine. This prospective study aimed to determine the presence of colonic lesions among 24 patients who were receiving NSAIDs for more than 3 months, and presented with diarrhea, intractable abdominal pain, and lower GI bleeding. Colonoscopy was done and multiple biopsies from different sites in the colon were obtained. Colonoscopy was normal in 11 (45.8%), showed inflammation or superficial ulcers in 7 (29.1%) and solitary or multiple deep ulcers in 6 (25%). Histology showed erosions in 12 (50%) and lymphocytic colitis in 9 (37.5%); histology was normal in 4 (16.6%). NSAID-induced colonic damage may have clinically significant sequel.

Clinical, endoscopic and pathologic spectrum of non-steroidal anti-inflammatory drug-induced colitis.

A multicentre, twelve-week, double-blind, randomized trial was conducted to evaluate the efficacy and tolerability of diclofenac dispersible in patients suffering from osteoarthrosis of the knee and/or hip. Symptomatic adult patients (N=129) of either sex were treated with diclofenac dispersible or the conventional enteric-coated tablet of diclofenac sodium 50 mg orally, thrice daily. Both formulations of diclofenac led to comparable and clinically significant reductions in the intensities of pain at rest and during activity within 1 week of therapy initiation. More than 70% of patients in both treatment groups had no or mild pain on full passive movement by the end of the study with the Lequesne Index showing a reduction of around 50% from initial values. Overall assessments of efficacy by the patient and the investigator indicated a positive response rate for both diclofenac formulations ranging between 71% and 82%. The proportion of patients reporting adverse effects, predominantly gastro-intestinal, was slightly higher in the dispersible group, 40.3%, compared to 37.3% with enteric-coated diclofenac sodium.

Efficacy and tolerability of diclofenac dispersible in painful osteoarthrosis.

A 12-week, multicenter, double-blind, randomized trial was conducted to evaluate the efficacy and tolerability of diclofenac dispersible, a new drinkable form of diclofenac, in patients with osteoarthrosis of the knee or hip. Adult patients of either sex complaining of moderate or severe pain at rest or during activity were treated with 50 mg of diclofenac dispersible or conventional enteric-coated diclofenac sodium tablets orally three times daily. In the 134 patients eligible for efficacy analyses (67 in each treatment group), both formulations of diclofenac led to comparable and clinically significant reductions in the intensities of pain at rest and during activity within 2 weeks of treatment. Approximately 80% of patients in both treatment groups had no or mild pain on full passive movement by the end of 12 weeks of diclofenac therapy, with the Lequesne Index showing a reduction of 50% from initial values. Overall assessments of efficacy by the patients and the investigators indicated a positive response rate for the two diclofenac formulations ranging from 86% to 94%. The proportion of patients reporting one or more side effects was slightly higher in the dispersible group than in the enteric-coated group (20.9% versus 16.4%), but the difference was not statistically significant. All but one of the observed side effects were related to the gastrointestinal system. The results of this controlled study show that both diclofenac dispersible and enteric-coated diclofenac sodium are effective therapeutic agents for the treatment of osteoarthrosis.

Efficacy and tolerability of diclofenac dispersible in patients with osteoarthrosis

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Efficacy and tolerability of diclofenac dispersible in painful osteoarthrosis.

Efficacy and tolerability of diclofenac dispersible in patients with osteoarthrosis