Report on a Long-Term Tolerability Study of Up to Two Years with Diclofenac Sodium (Voltaren)

Ciccolunghi, S. N.; Chaudri, H. A.; Schubiger, B I; Reddrop, R.

doi:10.3109/03009747809097223

Cited by 41 publications

(15 citation statements)

References 4 publications

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“…Ciccolunghi et al 13 found that diclofenac sodium, which is not toxic to ocular cells, can damage the blood-aqueous barrier as well as inhibit synthesis of PGE 2. Nishi and Nishi 4 found that diclofenac sodium inhibits LEC proliferation and metaplasia.…”

Section: Discussionmentioning

confidence: 98%

Effect of diclofenac sodium combined with nuclear rotation on the prevention of posterior capsule opacification: Two-year follow-up

Yao

Shao

Tan

et al. 2011

Journal of Cataract and Refractive Surgery

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Section: Discussionmentioning

confidence: 98%

Effect of diclofenac sodium combined with nuclear rotation on the prevention of posterior capsule opacification: Two-year follow-up

Yao

Shao

Tan

et al. 2011

Journal of Cataract and Refractive Surgery

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“…Concurrent nonrheumatic medication is very often prescribed. For instance, in our longterm trials up to two-thirds of the patients received concomitant medication (Abrams et al, 1978;Ciccolunghi et al, 1978).…”

Section: Need For Concurrent Medicationmentioning

confidence: 94%

“…Even if one asks for patients with any rheumatological disease requiring long-term treatment, only 2 diagnoses occur with any frequency. Thus of the 155 370 patients entering our 24-month trial (Abrams et al, 1978;Ciccolunghi et al, 1978) all except 16 had either rheumatoid arthritis (RA with 171 patients) or osteoarthrosis (OA with 183 patients).…”

Section: Patient Selectionmentioning

confidence: 99%

See 1 more Smart Citation

How long should long be? Long-term trials in rheumatic diseases.

Ciccolunghi¹,

Chaudri²,

Schubiger³

1979

Annals of the Rheumatic Diseases

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SUMMARY In the interests of the safety of patients it is necessary to collect long-term clinical data. It is often assumed that the longer the trial the better. However, the longer the trial the more scientific compromises are necessary if it is to be carried out in a practical way. Because the therapeutic efficacy of and tolerance to the nonsteroidal anti-inflammatory drug diclofenac was established after 6 months' trial the optimal duration for a comparative long-term trial of this preparation is 6 months. The small amount of information gained from trials of diclofenac longer than this did not justify the reduction in quality of trial design and performance that they required. Thus it would appear that at least for 1 antirheumatic drug the assumption that 'the longer the trial the better' is not true.

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“…At least 6 studies before 41,42,[46][47][48][49] and several studies after [43][44][45] FDA approval demonstrated the effectiveness of a dosage of 75 mg/d (25 mg given 3 times daily), [41][42][43][44][45][46][47][48][49] as opposed to the *Dose values are given as milligrams per day unless otherwise indicated. PDR indicates Physicians' Desk Reference; BID, 2 times daily; HS, at bedtime; QID, 4 times daily; TID, 3 times daily; QD, daily; QHS, every night; and XL, extended release.…”

Section: Diclofenac Sodium (Voltaren)mentioning

confidence: 99%

Dose Discrepancies Between the Physicians' Desk Reference and the Medical Literature, and Their Possible Role in the High Incidence of Dose-Related Adverse Drug Events

Cohen¹

2001

Arch Intern Med

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Optimal therapeutics depends on the availability of comprehensive information. However, the PDR contains only the limited dose information from package inserts. Because the PDR was originally developed as a promotional device, there is no mechanism by which all clinically relevant dose-response data or important postrelease discoveries are regularly and rapidly incorporated into it. Thus, a gap exists in the availability of current and comprehensive dose information for physicians. This article provides information on lower, effective doses for 48 major medications, with an extensive reference list-a compilation of low-dose information not previously published, to our knowledge, in the medical literature. Physicians must have a readily accessible source of current and complete dose-response information to individualize drug therapy and minimize the risks of ADEs.

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Report on a Long-Term Tolerability Study of Up to Two Years with Diclofenac Sodium (Voltaren)

Cited by 41 publications

References 4 publications

Effect of diclofenac sodium combined with nuclear rotation on the prevention of posterior capsule opacification: Two-year follow-up

Effect of diclofenac sodium combined with nuclear rotation on the prevention of posterior capsule opacification: Two-year follow-up

How long should long be? Long-term trials in rheumatic diseases.

Dose Discrepancies Between the Physicians' Desk Reference and the Medical Literature, and Their Possible Role in the High Incidence of Dose-Related Adverse Drug Events

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