What is the best smoking cessation strategy for a patient with diabetes, recent total pancreatectomy with islet autotransplantation (TPIAT), gastroparesis, and a history of cerebrovascular accident (CVA), who has completed 12 weeks of combination Nicotine Replacement Therapy (NRT) and still experiences breakthrough cravings?

From the Guidelines

The best smoking cessation strategy for this patient is to continue the current combination NRT regimen and add varenicline to their treatment plan, as this approach combines the most effective pharmacotherapy agents and is recommended by the NCCN Guidelines panel 1. Given the patient's complex medical history, including diabetes, recent total pancreatectomy with islet autotransplantation (TPIAT), gastroparesis, and a history of cerebrovascular accident (CVA), it is crucial to prioritize a smoking cessation strategy that minimizes potential risks and maximizes effectiveness. Some key points to consider in this patient's case include:

• The patient has already completed 12 weeks of combination NRT, which is a recommended approach for smoking cessation 1.
• The patient still experiences breakthrough cravings, indicating the need for an adjusted treatment plan.
• Varenicline is one of the two most effective pharmacotherapy agents for smoking cessation, along with combination NRT 1.
• However, it is essential to carefully evaluate the potential risks and benefits of adding varenicline to this patient's regimen, considering their complex medical history.
• The patient's history of CVA and current use of ASA and statin may increase the risk of bleeding or other adverse effects with certain medications, but varenicline is not typically associated with these risks.
• Gastroparesis, currently managed with ondansetron, may be a concern with certain medications, but varenicline is not known to worsen gastroparesis symptoms significantly.
• The patient's pancreatic condition and diabetes do not preclude the use of varenicline, as it does not affect glucose metabolism or pancreatic function like other cessation medications might. Considering these factors, continuing the current combination NRT regimen and adding varenicline to the patient's treatment plan appears to be the most effective approach for smoking cessation, as it combines the most effective pharmacotherapy agents and is recommended by the NCCN Guidelines panel 1.

From the FDA Drug Label

Varenicline was evaluated in a double-blind, placebo-controlled trial where patients were instructed to select a target quit date between Day 8 and Day 35 of treatment. Continuous Abstinence, Weeks 9 through 52 (95% confidence interval) Across Different Studies Varenicline 0. 5 mg BIDVarenicline 1 mg BIDVarenicline FlexibleBupropionSRPlacebo Study 219% (14%, 24%) 23% (18%, 28%) 4% (1%, 8%) Study 322% (16%, 29%) 8% (3%, 12%) Study 421% (17%, 26%) 16% (12%, 20%) 8% (5%, 11%) Study 522% (17%, 26%) 14% (11%, 18%) 10% (7%, 13%)

The best recommendation for the patient is to continue NRT and add varenicline to their regimen. This approach is supported by the studies that show varenicline to be effective in smoking cessation, even in patients with various comorbidities 2.

• Key points:
  • Varenicline has been shown to be effective in smoking cessation.
  • The patient has already been using combination NRT for 12 weeks, and adding varenicline may help with breakthrough cravings.
  • There is no direct contraindication for the use of varenicline in patients with diabetes, gastroparesis, or a history of CVA. However, it is crucial to monitor the patient closely for any potential interactions or adverse effects, especially given their complex medical history.

From the Research

Smoking Cessation Strategies

The patient has completed 12 weeks of combination Nicotine Replacement Therapy (NRT) and is still experiencing breakthrough cravings. Considering their medical history, including diabetes, recent total pancreatectomy with islet autotransplantation (TPIAT), gastroparesis, and a history of cerebrovascular accident (CVA), the best recommendation for them would be to continue NRT and add varenicline to their regimen.

Rationale

• A study published in 2013 3 found that varenicline was superior to single forms of NRT and bupropion in achieving long-term abstinence.
• Another study from 2007 4 noted that varenicline has a place in cancer patients who continue to smoke, and its initial experience has been encouraging.
• A randomized clinical trial published in 2024 5 found that the combination of varenicline and NRT lozenges improved self-reported abstinence compared with varenicline alone, without compromising safety.
• A double-blind, randomized, placebo-controlled clinical trial from 2016 6 compared the relative neuropsychiatric safety risk and efficacy of varenicline and bupropion with nicotine patch and placebo in smokers with and without psychiatric disorders, and found that varenicline-treated participants achieved higher abstinence rates than those on placebo, nicotine patch, and bupropion.

Key Points

• Varenicline is an effective medication for smoking cessation, especially when used in combination with NRT.
• The patient's medical history, including diabetes and CVA, does not contraindicate the use of varenicline.
• The combination of varenicline and NRT has been shown to be safe and effective in achieving long-term abstinence.
• The patient should continue NRT and add varenicline to their regimen, under the guidance of a healthcare professional, to maximize their chances of quitting smoking.

Considerations

• The patient's gastroparesis, currently managed with ondansetron, should be monitored closely when adding varenicline to their regimen, as varenicline may exacerbate nausea.
• The patient's history of CVA and current use of ASA and statin should be considered when adding varenicline, as varenicline may have cardiovascular effects.