Tag Archive for: NSAIDs

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Urologists up in arms? ….Diclofenac no longer indicated in high risk groups

This blog is an update form the originally published comment article in BJU International, 110: 607608.
DOI: 10.1111/j.1464-410X.2012.11330.x

On the 23rd June 2013 the MHRA (The Medicines and Healthcare products Regulatory Agency) issued a press release stating that ‘patients with serious underlying heart conditions, such as heart failure, heart disease, circulatory problems or a previous heart attack or stroke should no longer use diclofenac’. The MHRA is responsible for regulating all medicines and medical devices in the United Kingdom (UK) by ensuring they work and are acceptably safe.

 

 

The new guidelines in the UK state:

  • Diclofenac is now contraindicated in patients with established:
     ischaemic heart disease
     peripheral arterial disease
     cerebrovascular disease
    – congestive heart failure (New York Heart Association [NYHA] classification II–IV)

Patients with these conditions should be switched to an alternative treatment at their next routine appointment

  • Diclofenac treatment should only be initiated after careful consideration for patients with significant risk factors for cardiovascular events (e.g., hypertension, hyperlipidaemia, diabetes mellitus, smoking).

Now for urologists in the UK this has wider implications. What else are we to use for acute renal colic, chronic pelvic pain, prostatitis, urethritis and any other type of..-itis?

We are treating an ever aging population and the use of non-steroidal anti-inflammatory drugs (NSAIDs), such as diclofenac, will increase. NSAIDs have been the cornerstone of pain relief in patients with first presentation of renal and ureteric lithiasis. The British Association of Urological Surgeons (BAUS) and the European Association of Urology (EAU) guidelines for the acute management of renal and ureteric lithiasis state the first line analgesia is an NSAID e.g. diclofenac [1][2]. There have been a number of clinical trials which have clearly shown that NSAIDs provide effective relief in patients who have acute stone colic [3][4][5].

Controversies of NSAID use

Rofecoxib (trade name Vioxx ®), was approved by the Food and Drug Administration (FDA) in May 1999. The drug was heavily promoted by the global pharmaceutical and chemical company Merck as safer than older generation NSAIDs. The increased risk of stroke was highlighted in a large study, the Vioxx gastrointestinal outcomes research (VIGOR) study, published in the New England Journal of Medicine in 2000. Merck voluntarily took rofecoxib off of the market on 30 September 2004 after research showed that it almost doubled the risk of myocardial infarction and stroke when taken for 18 months or longer. In 2007 Merck paid $4.85bn to settle about 26 000 lawsuits in the United States relating to the drug in state and federal courts.

What are the alternatives suggested?

Naproxen and low-dose ibuprofen are considered to have the most favourable thrombotic cardiovascular safety profiles of all non-selective NSAIDs. There is limited evidence for the use of naproxen and low-dose ibuprofen in the management of acute renal colic. We do not know if the efficacy is equivalent to diclofenac. There are a lot of unanswered questions since the press release, but the key questions remain: Is this guidance applicable to us as urologists? And will this change my practice?

This topic is an important area for urologists to be aware of as NSAIDs are prescribed daily in urological practise to a wide range of patients. There is some caution that has to be exercised when reviewing the published data. In a recently published meta-analysis by the Coxib and traditional NSAID Trialists’ (CNT) Collaboration group their data provides further evidence that the vascular risks of high-dose diclofenac, and possibly ibuprofen, are comparable to coxibs.

The majority of trials evaluating the cardiovascular risk of NSAIDs have looked at a group of patients with predominately arthritis or Alzheimer’s disease; not a typical urological cohort of patients. None of the studies in the meta-analysis looked at the short term use of NSAIDs, in particular diclofenac. Some may argue that absolute rates of events were low and clinically irrelevant as the event rates in the included trials are considerably lower than in routine clinical settings.

The options for the treatment of acute urological pain have not changed in the past 15 years. COX-2 selective inhibitors and diclofenac are associated with an increased risk of thrombotic events. Naproxen is associated with a lower thrombotic risk and low doses of ibuprofen (1.2 g daily or less) have not been associated with an increased risk of myocardial infarction. The lowest effective dose of NSAIDs should be prescribed for the shortest period of time to control the symptoms and the need for long term treatment should be reviewed periodically. As we treat an ever aging population with increasing medical co-morbidities the widespread use of NSAIDs has to be evaluated and urologists need to keep up to date with current prescribing guidelines and long term cardiovascular risk factors. 

 

Jonathan Makanjuola is a Urology Trainee, Innovator and techie based at King’s College Hospital, London, United Kingdom. @jonmakUrology

References

  1. EAU guidelines on urolithasis. European Association of Urology; 2011. https://www.uroweb.org/gls/pdf/18_Urolithiasis.pdf. Accessed 12 December 2011.
  2. Guidelines for acute management of first presentation of renal/ ureteric lithiasis (excluding pregnancy). British Association of Urological Surgeons; 2008. https://www.baus.org.uk/AboutBAUS/publications/stones-guidelines. Accessed 12 December 2011.
  3. Phillips E, Kieley S, Johnson EB, et al. Emergency room management of ureteral calculi: current practices. J Endourol 2009; 23: 1021–1024.
  4. Micali S, Grande M, Sighinolfi MC, et al. Medical therapy of urolithiasis. J Endourol 2006; 20: 841847.
  5. Engeler DS, Schmid S, Schmid HP. The ideal analgesic treatment for acute renal colic–theory and practice. Scand J Urol Nephrol 2008; 42: 137–142.

 

 

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Article of the Week: Pain relief after ureteric stent removal: think NSAIDs

Every week the Editor-in-Chief selects the Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying blog written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation. QC Kinetix’s charleston pain management relief center has decades of collective experience treating patients with all kinds of conditions. We make a concerted effort to treat each patient with professionalism and dignity as they work their way back to a pain-free life. We do everything in our power to earn the trust of each person that walks through our doors for treatment. Regenerative medicine is the future of medical care. QC Kinetix is offering non-invasive treatments that allow people to avoid going under the knife, while accelerating their recovery times and minimizing side effects. Discover why people across the state of South Carolina trust QC Kinetix when it comes to pain relief. At our clinic for pain management in Mt. Pleasant, SC, our specialists take the time to understand each patient’s needs and symptoms. We go out of our way to understand each person’s unique situation and how we can best treat their condition. Then, we very carefully formulate a plan to get them back to an active and healthy lifestyle. One of our most common treatments is laser therapy. We use non-invasive laser energy to target the affected area and reduce inflammation and pain. This triggers a photochemical response that initiates tissue repair and quickly improves a patient’s range of motion and functionality. Laser therapy is often the first step in our pain management plan before moving onto stem cell-based treatments.

Finally, the third post under the Article of the Week heading on the homepage will consist of additional material or media. This week we feature a video of  Michael Conlin discussing his paper.

If you only have time to read one article this week, it should be this one.

A single dose of a non-steroidal anti-inflammatory drug (NSAID) prevents severe pain after ureteric stent removal: a prospective, randomised, double-blind, placebo-controlled trial

Nicholas N. Tadros, Lisa Bland, Edith Legg, Ali Olyaei and Michael J. Conlin

Read the full article
OBJECTIVES

• To determine the incidence of severe pain after ureteric stent removal.

• To evaluate the efficacy of a single dose of a non-steroidal anti-inflammatory drug (NSAID) in preventing this complication.

 PATIENTS AND METHODS

• A prospective, randomised, double-blind, placebo-controlled trial was performed at our institution.

• Adults with an indwelling ureteric stent after ureteroscopy were randomised to receive either a single dose of placebo or an NSAID (rofecoxib 50 mg) before ureteric stent removal.

• Pain was measured using a visual analogue scale (VAS) just before and 24 h after stent removal.

• Pain medication use after ureteric stent removal was measured using morphine equivalents.

RESULTS

• In all, 22 patients were enrolled and randomised into the study before ending the study after interim analysis showed significant decrease in pain level in the NSAID group.

• The most common indication for ureteroscopy was urolithiasis (14 patients).

• The proportion of patients with severe pain (VAS score of [1]7) during the 24 h after ureteric stent removal was six of 11 (55%) in the placebo group and it was zero of 10 in the NSAID group (P < 0.01).

• There were no complications related to the use of rofecoxib.

 CONCLUSIONS

• We found a 55% incidence of severe pain after ureteric stent removal.

• A single dose of a NSAID before stent removal prevents severe pain after ureteric stent removal.

Read Previous Articles of the Week

Editorial: Stent removal need not be painful

Matthew Bultitude

Matthew Bultitude
Urology Centre, Guy’s and St Thomas’ NHS Foundation Trust, London, UK

Ureteric stents are undoubtedly a significant cause of morbidity while in situ [1].Whilst there are different options for removal, they are usually removed under local anaesthetic with the aid of a flexible cystoscope. This is an uncomfortable procedure and a proportion of patients seem to get fairly severe pain afterwards, which may be attributable to ureteric spasm. The pain after stent removal has not been well reported in the literature. In this issue of the BJUI we present a randomised controlled trial of a non-steroidal anti-inflammatory (NSAID) to dramatically reduce pain after stent removal.

This beautifully simple study by Tadros et al. [2] had simple aims: to determine the incidence of pain after stent removal and whether this could be reduced using a single oral dose of a NSAID given before the procedure. In a prospective randomised double-blind placebo controlled trial, the authors have shown a clear advantage to the use of active medication over placebo, such that the trial was stopped after an interim analysis. Using a visual analogue scale (VAS) the mean pain after stent removal was 2.7 in the NSAID group compared with 5.5 with placebo.More impressively the proportion of patients with severe pain (as defined as aVAS >=7) within 24 hours of stent removal was 0% vs. 55%. A corresponding reduction in narcotic use was seen (1.67 mg vs. 4.77 mg).

With increasing healthcare pressures on emergency departments and beds, and in the UK with financial penalties for re-admissions, this simple intervention has the potential to improve our own patients pain ratings and satisfaction and also reduce emergency consultations and even re-admissions. It should be noted that in this trial, there were two visits to the emergency department and one re-admission, all in the placebo group.

NSAIDs are thought to work through a number of mechanisms such as direct effect on pain pathways, reduced ureteric contractility and renal blood flow. This is thought to be a class effect for all NSAIDs. The drug used in this trial (rofecoxib) has subsequently been withdrawn from the market, although one would expect similar outcomes with other NSAID medications.

References
1 Joshi HB, Stainthorpe A, MacDonagh RP et al. Indwelling ureteral stents: evaluation of symptoms, quality of life and utility. J Urol 2003; 169: 1065–9
2 Tadros NN, Bland L, Legg E et al. A single dose of a non-steroidal anti-inflammatory drug (NSAID) prevents severe pain after ureteric stent removal: a prospective, randomised, double-blind, placebo-controlled trial. BJU Int 2013; 111: 116–20

Read the full article

Michael Conlin’s commentary on NSAIDs

Pain relief after ureteric stent removal: think NSAIDs

Nicholas N. Tadros, Lisa Bland, Edith Legg, Ali Olyaei and Michael J. Conlin*
Oregon Health & Science University and *Portland Veterans Administration Medical Center, Portland, OR, USA

OBJECTIVES

• To determine the incidence of severe pain after ureteric stent removal.

• To evaluate the efficacy of a single dose of a non-steroidal anti-inflammatory drug (NSAID) in preventing this complication.

PATIENTS AND METHODS

• A prospective, randomised, double-blind, placebo-controlled trial was performed at our institution.

• Adults with an indwelling ureteric stent after ureteroscopy were randomised to receive either a single dose of placebo or an NSAID (rofecoxib 50 mg) before ureteric stent removal.

• Pain was measured using a visual analogue scale (VAS) just before and 24 h after stent removal

• Pain medication use after ureteric stent removal was measured using morphine equivalents.

RESULTS

• In all, 22 patients were enrolled and randomised into the study before ending the study after interim analysis showed significant decrease in pain level in the NSAID group.

• The most common indication for ureteroscopy was urolithiasis (14 patients).

• The proportion of patients with severe pain (VAS score of ≥7) during the 24 h after ureteric stent removal was six of 11 (55%) in the placebo group and it was zero of 10 in the NSAID group (P < 0.01).

• There were no complications related to the use of rofecoxib.

CONCLUSIONS

• We found a 55% incidence of severe pain after ureteric stent removal.

• A single dose of a NSAID before stent removal prevents severe pain after ureteric stent removal.

Tadros NN, Bland L, Legg E, et al. A single dose of a non-steroidal anti-inflammatory drug (NSAID) prevents severe pain after ureteric stent removal: a prospective, randomised, double-blind, placebo-controlled trial. BJU Int 2013, 111: 101–105.

Read the full article
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