Non-steroidal anti-inflammatories and the development of analgesic nephropathy: a systematic review

Yaxley, Julian; Litfin, Thomas

doi:10.1080/0886022x.2016.1216708

Cited by 13 publications

(16 citation statements)

References 20 publications

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“…Regarding renal impairment, our analysis showed except for one case no negative impact of NSAIDs on renal function. This is in line with previous meta‐analyses, which found no evidence for a relationship between heavy protracted NSAID use and the incidence of chronic renal impairment in patients without chronic kidney disease . Renal side effects seem mainly to be relevant, if NSAIDs are prescribed in patients with chronic kidney diseases .…”

Section: Discussionsupporting

confidence: 91%

Systematic review and meta‐analysis on non‐opioid analgesics in palliative medicine

Schüchen

Mücke

Marinova

et al. 2018

J cachexia sarcopenia muscle

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Non‐opioid analgesics are widely used for pain relief in palliative medicine. However, there is a lack of evidence‐based recommendations addressing the efficacy, tolerability, and safety of non‐opioids in this field. A comprehensive systematic review and meta‐analysis on current evidence can provide a basis for sound recommendations in clinical practice. A database search for controlled trials on the use of non‐opioids in adult palliative patients was performed in Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, PsycINFO, and EMBASE from inception to 18 February 2018. Endpoints were pain intensity, opioid‐sparing effects, safety, and quality of life. Studies with similar patients, interventions, and outcomes were included in the meta‐analyses. Our systematic search was able to only identify studies dealing with cancer pain. Of 5991 retrieved studies, 43 could be included (n = 2925 patients). There was no convincing evidence for satisfactory pain relief by acetaminophen alone or in combination with strong opioids. We found substantial evidence of moderate quality for a satisfactory pain relief in cancer by non‐steroidal anti‐inflammatory drugs (NSAIDs), flupirtine, and dipyrone compared with placebo or other analgesics. There was no evidence for a superiority of one specific non‐opioid. There was moderate quality of evidence for a similar pain reduction by NSAIDs in the usual dosage range compared with up to 15 mg of morphine or opioids of equianalgesic potency. The combination of NSAID and step III opioids showed a beneficial effect, without a decreased tolerability. There is scarce evidence concerning the combination of NSAIDs with weak opioids. There are no randomized‐controlled studies on the use of non‐opioids in a wide range of end‐stage diseases except for cancer. Non‐steroidal anti‐inflammatory drugs, flupirtine, and dipyrone can be recommended for the treatment of cancer pain either alone or in combination with strong opioids. The use of acetaminophen in the palliative setting cannot be recommended. Studies are not available for long‐term use. There is a lack of evidence regarding pain treatment by non‐opioids in specific cancer entities.

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Section: Discussionsupporting

confidence: 91%

Systematic review and meta‐analysis on non‐opioid analgesics in palliative medicine

Schüchen

Mücke

Marinova

et al. 2018

J cachexia sarcopenia muscle

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“…The addition of BIOF2 to the usual medical care significantly increased the well-being indicators analyzed in the patients and significantly reduced NSAID use. Prolonged NSAID use can cause adverse effects, especially that of kidney damage (47). Thus, treatment with BIOF2 could also aid in reducing the risks caused by long-term NSAID intake.…”

Section: Discussionmentioning

confidence: 99%

Patient‑reported health outcomes for severe knee osteoarthritis after conservative treatment with an intra‑articular cell‑free formulation for articular cartilage regeneration combined with usual medical care vs. usual medical care alone: A randomized controlled trial

Delgado‐Enciso

Valtierra-Alvarez

Paz-Garcia³

et al. 2019

Exp Ther Med

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Osteoarthritis (OA) is a major public health problem characterized by joint pain, fatigue, functional limitation and decreased quality of life of the patient, which results in increased use of healthcare services and high economical costs. A promising novel bioactive cell-free formulation (BIOF2) for cartilage regeneration has recently been tested in pre-clinical and clinical trials, and has demonstrated a success rate similar to that of total joint arthroplasty for the treatment of severe knee OA. The present study evaluated the efficacy of treatment with BIOF2, by including it within a conservative regimen of ‘usual medical care’ of knee OA, and whether its efficacy was affected in subgroups of patients presenting with comorbidities that exacerbate OA. A prospective, randomized, 2-arm parallel group phase III clinical trial was conducted, which included 105 patients in the ‘usual medical care’ group (paracetamol/NSAIDs and general care provided by the family physician) and 107 patients in the BIOF2 group (usual medical care + intra-articular BIOF2 application at 0, 1 and 2 months). Two aspects were evaluated at 0, 6 and 12 months: i) Minimal clinically important improvement (MCII), based on 30% improvement of pain from the baseline; and ii) the Patient Acceptable Symptom State (PASS), a questionnaire that determines patient well-being thresholds for articular pain and function. Adverse effects and regular NSAID use were registered. At 12 months, BIOF-2 treatment produced MCII in 70% of the patients and >50% achieved PASS. Excluding the patients with class 2 obesity or malalignment conditions ( genu varum or genu valgum >20 degrees), the experimental treatment produced MCII and PASS in 100 and 92% of patients, respectively, compared with 25 and 8% in the group of usual medical care (P<0.001). No patient with malalignment and treatment with BIOF2 achieved PASS. Notably, there were no serious adverse effects. To conclude, BIOF2 is a safe therapeutic alternative that is easy to implement together with usual medical care for knee OA. Trial registration: Cuban Public Registry of Clinical Trials (RPCEC) Database RPCEC00000277. Retrospectively registered June, 2018.

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“…In addition, BIOF2 significantly reduced NSAID use. Prolonged NSAID use can cause adverse effects, especially kidney damage [ 32 ]. Thus, treatment with BIOF2 could also help patients reduce the risks involved in the long-term use of those medications.…”

Section: Discussionmentioning

confidence: 99%

A phase I–II controlled randomized trial using a promising novel cell-free formulation for articular cartilage regeneration as treatment of severe osteoarthritis of the knee

et al. 2018

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BackgroundA promising novel cell-free bioactive formulation for articular cartilage regeneration, called BIOF2, has recently been tested in pre-clinical trials. The aim of the present study was to evaluate the efficacy and safety of BIOF2 for intra-articular application in patients with severe osteoarthritis of the knee.MethodsA prospective, randomized, 3-arm, parallel group clinical trial was conducted. It included 24 patients with severe osteoarthritis of the knee (WOMAC score 65.9 ± 17). Before they entered the study, all the patients were under osteoarthritis control through the standard treatment with nonsteroidal anti-inflammatory drugs (NSAIDs), prescribed by their family physician. Patients were distributed into three groups of 8 patients each (intra-articular BIOF2, total joint arthroplasty, or conservative treatment with NSAIDs alone). The WOMAC score, RAPID3 score, and Rasmussen clinical score were evaluated before treatment and at months 3, 6, and 12. BIOF2 was applied at months 0, 3, and 6. Complete blood count and blood chemistry parameters were determined in the BIOF2 group before treatment, at 72 h, and at months 1, 3, 6, and 12. In addition, articular cartilage volume was evaluated (according to MRI) at the beginning of the study and at month 12.ResultsThe NSAID group showed no improvement at follow-up. Arthroplasty and BIOF2 treatments showed significant improvement in all the scoring scales starting at month 3. There were no statistically significant differences between the BIOF2 group and the arthroplasty group at month 6 (WOMAC score: 19.3 ± 18 vs 4.3 ± 5; P = 0.24) or month 12 (WOMAC score: 15.6 ± 15 vs 15.7 ± 17; P = 1.0). Arthroplasty and BIOF2 were successful at month 12 (according to a WOMAC score: ≤ 16) in 75% of the patients and the daily use of NSAIDs was reduced, compared with the group treated exclusively with NSAIDs (RR = 0.33, 95% CI 0.12–0.87, P = 0.02. This result was the same for BIOF2 vs NSAIDs and arthroplasty vs NSAIDs). BIOF2 significantly increased the articular cartilage by 22% (26.1 ± 10 vs 31.9 ± 10 cm2, P < 0.001) and produced a significant reduction in serum lipids. BIOF2 was well tolerated, causing slight-to-moderate pain only upon application.ConclusionsThe intra-articular application of the new bioactive cell-free formulation (BIOF2) was well tolerated and showed no significative differences with arthroplasty for the treatment of severe osteoarthritis of the knee. BIOF2 can regenerate articular cartilage and is an easily implemented alternative therapy for the treatment of osteoarthritis.Trial registration Cuban Public Registry of Clinical Trials (RPCEC) Database RPCEC00000250. Registered 08/15/2017—Retrospectively registered, http://rpcec.sld.cu/en/trials/RPCEC00000250-En.Electronic supplementary materialThe online version of this article (10.1186/s40001-018-0349-2) contains supplementary material, which is available to authorized users.

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Non-steroidal anti-inflammatories and the development of analgesic nephropathy: a systematic review

Abstract: A relationship between non-steroidal anti-inflammatory medicines and the development of CKD has never been proven. Based on the available scientific evidence non-steroidal anti-inflammatory agents do not appear to be implicated in the pathogenesis of AN.

Cited by 13 publications

References 20 publications

Systematic review and meta‐analysis on non‐opioid analgesics in palliative medicine

Systematic review and meta‐analysis on non‐opioid analgesics in palliative medicine

Patient‑reported health outcomes for severe knee osteoarthritis after conservative treatment with an intra‑articular cell‑free formulation for articular cartilage regeneration combined with usual medical care vs. usual medical care alone: A randomized controlled trial

A phase I–II controlled randomized trial using a promising novel cell-free formulation for articular cartilage regeneration as treatment of severe osteoarthritis of the knee

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