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Biomedical subjects

B Avouac

Publications and source records attributed to B Avouac.

At least 55 records · Page 3Linked to original sources

Ketoprofen: the European experience.

An overview of European experience with ketoprofen, a nonsteroidal anti-inflammatory drug (NSAID) with analgesic properties, from the time of its marketing in 1973 until the present is presented. Orally administered ketoprofen (200 mg/day) has been proven effective in treating rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. Furthermore, several alternate dosage forms, including intramuscular injection for relief of acutely painful conditions, suppositories, two slow-release forms (a sustained-release tablet [IBP 200] and a controlled-release capsule [Oruvail] ), and a topical gel for local treatment of certain superficial conditions and minor rheumatologic disease are available. The safety of ketoprofen has also been proven in several European postmarketing surveillance studies and more importantly, by French and British drug monitoring data. Ketoprofen was rated as one of the safest NSAIDs available in the United Kingdom (UK) by the Committee on the Safety of Medicine in 1986. For incidence of gastrointestinal complaints per million prescriptions, ketoprofen ranked seventh among 19 NSAIDs in its first five years of marketing in the UK. Ketoprofen has been associated with a very low incidence of serious renal, hepatic, or cutaneous reactions. Thus ketoprofen, in 15 years of marketed use in Europe, has proven to be an effective anti-inflammatory and analgesic agent with an excellent safety profile and several convenient dosage forms.

Europe↗

[Value of tomodensitometry in the diagnosis of lumbar disk hernias].

The authors relate their experiences concerning tomodensitometric examination to evaluate the herniation of a disk. 45 patients and 50 herniations of a disk have been studied. 39 herniations have sustained surgical procedures. The tomodensitometric examination and the radiculosaccography have been performed among these patients in order to compare the findings. The fact that there has only been 3 failures prove the reliability of tomodensitometric examination; among these failure there is 2 post-operative recurrences and one L4 L5 herniation. The radiculosaccography fails 5 times (1 L4 L5 herniation and 4 L5 S1 herniations). There is not any common negative in the two methods. Because of its total innocuity (no injection of any kind) the tomodensitometric examination seems to be the first exploration to prescribe when an herniation of a disk is resistant to clinical treatment and when a surgery is planned.

Diagnosis, Differential↗

Guidelines for clinical studies assessing the efficacy of drugs for the management of acute low back pain.

In this paper we propose guidelines for clinical trials aimed at assessing the efficacy of drugs for acute non-specific low back pain (LBP) with or without radicular pain, preliminary to their approval and registration. To this end, consensus statements were obtained from a group of experts in the fields of rheumatology, clinical medicine, public health and epidemiology. EBM resources were systematically used as references. Four diagnostic categories were defined: type 1--LBP with no radiation; type 2--LBP radiating no further than the knee; type 3--LBP radiating beyond the knee, but with no neurologic signs; and type 4--LBP radiating to a specific and entire leg dermatome, with or without neurologic signs. Studies should be designed on the basis of the claimed indications for the drug, but must be double-blinded whatever the indication. The duration of the study may be shorter for LBP type 1 or 2 (one week) than for LBP types 3 and 4 (up to one month), depending on the aim of the study and the indications for the drug. The comparator may be inactive (placebo) or active (for a superiority trial, e.g., versus paracetamol). Specific inclusion and exclusion criteria have been defined here for each category. An appropriate wash-out period for any drugs that could affect the pain status should be planned. Paracetamol may be allowed as rescue medication. The primary endpoint should be based on a validated pain assessment tool that may be either generic (type 1 or 2) or oriented (back and knee for types 3 and 4). Secondary endpoints could include the assessment of functional performance; the duration of any period of bed-rest; work limitation; a global assessment comprising pain at rest, standing and walking; the time elapsed before epidural injection, the prescription of other therapeutic agents, or surgery; and the use of rescue medication. Adverse events (AE) should be monitored systematically using a methodology that reflects the mode of action of the tested drug. With the application of these guidelines, LBP could serve as an appropriate disease for testing analgesic drugs. Rigorous evaluation may also help to improve the management of acute LBP.

Acute Disease↗

[Evaluation of the medical value of a drug. A necessity for the Transparency Commission].

The marketing approval (AMM) is based on criteria of pharmaceutical quality, efficacy and safety of use. Before marketing, the data are collected by means of double-blind, randomized, prospective clinical trials that compare the study product to a reference product. A post-AMM assessment is needed to define the increase of the medical benefit (ASMR) and the therapeutic value of the new drugs. The quantification of the ASMR is essential for registration on the list of drugs reimbursable for those who benefit from Social Security. The evaluation of the therapeutic value and the nature of the affection treated are the criteria upon which the reimbursement ratio is chosen. After marketing, the reevaluation of the medical benefit and the drugs' usefulness may be compared to the treatment's net medical cost (direct + indirect cost--avoided cost) in cost/utility or cost/benefit studies. The Transparency Commission has worked out a scale of assessment of the ASMR which will orient recommendation, or non-recommendation, of registration on the list of reimbursable drugs as well as price fixing proposals. In the future, the Transparency Commission is to strengthen its position regarding the good use of the drug through a better prescriber information system. Thanks to the pharmaco-epidemiology and the pharmaco-vigilance data, the Transparency Commission will be able to guarantee the post-marketing follow-up of the drugs. The examination of the products' conditions of use, the reevaluation of the treatment's advantages based on the utility studies and the epidemiological surveys, and the cost-benefit studies will contribute to a medical control of health spending linked to drug consumption.

Cost-Benefit Analysis↗

[Role of radiology in the diagnosis of joint chondrocalcinosis. The so-called atypical symptomatic aspects].

In a preceding article, we described "pseudogout" which is the expression of an episode of acute synovitis related to microcrystals of dehydrated calcium pyrophosphate invading the joint. This brutal episode of inflammation, predominantly occurring in the knee joint, is the most spectacular, most frequent and most characteristic manifestation of articular chondrocalcinosis. We attempted to demonstrate the important role of radiographs in the diagnosis, discovering in many cases the microcrystal impregnation of cartilage and fibrocartilage. But articular chondrocalcinosis, as has been shown by a large number of clinical and radiological surveys, may present a wide range of atypical or misleading forms, much different from the classic pseudogout. Among the different clinical presentations, some have no particularly special radiographic expression, showing only the common chondrocalcinosis lesions seen during the acute episodes of microcrystal related synovitis. This is the case in different situations of inflammation, notably subacute arthritis, purely algic forms and exsudative forms (chronic hydarthrosis, haemarthrosis). Complete clinical latency is also observed in certain cases. But many cases of articular chondrocalcinosis involve manifest radiological lesions which often appear to be secondary. This may occur in chronic inflammatory forms of chondrocalcinosis which can simulate rheumatoid polyarthritis. Careful analysis of the symptomatology should help to avoid confusion, especially when the radiograph reveals only degenerative lesions which often cause destructive damages. In other cases, a perfectly characteristic articular chondrocalcinosis is associated with typical polyarticular lesions of osteoarthritis. These cases often have the particularity of involving joints usually spared by the common arthrosic disease, especially in the upper limbs. They are also remarkable due to the amount of lytic damage. The deep destructive damage to joints during chondrocalcinosis may produced a particularly striking picture. Such damage is seen in approximately one-third of the cases. The onset is marked by sudden renewal of former arthrosic-type pain and by the development of major functional incapacity. Often, the radiograph is the only examination capable of revealing the diagnosis. The extent of bone destruction varies greatly. Sometimes it is limited to subchondral bone but in other cases underlying bony structures are also involved leading to extensive damage to the epiphysis. The distribution of lytic lesions varies. Damage may occur in the knee, the coxofemoral and the shoulder joints. Surgery is often absolutely indicated. In a number of cases of chondrocalcinosis, especially those involving the knee and the shoulder, true intraarticular foreign bodies may be encountered, opaque calcified or ossified formations simulating osteochondromatosis, existing along with destructive damages.(ABSTRACT TRUNCATED AT 400 WORDS)

Arthritis↗