A COMPARATIVE STUDY ON EFFICACY AND SAFETY OF DULOXETINE AND GABAPENTIN AMONG PATIENTS WITH DIABETIC POLYNEUROPATHY

Study of comparison of safety and efficacy of DULOXETINE and GABAPENTIN among patients with diabetic polyneuropathy at Rama Medical College Hospital & Research Centre, Kanpur.

In 2019, diabetes affected 9.3% of individuals aged 20–79 globally, with prevalence ranging from 4.7–12.2%. The countries with the highest diabetic populations were China (116.4 million), India (77 million), the United States (31 million), Pakistan (19.4 million), Brazil (16.8 million), and Mexico (12.8 million).

Diabetic peripheral neuropathy is identified by symptoms and signs of peripheral nerve damage in diabetes patients, excluding other potential causes. It ranks among the most common long-term complications of diabetes, impacting approximately 60% of diabetic individuals.

It stands as the primary cause of lower leg amputation in both the USA (50–75%) and India (76–78%) among amputations linked to diabetes or neuropathy. Neurological complications are equally prevalent in both Type 1 and Type 2 diabetes mellitus patients. Neuropathic pain is reported in 11–32% of individuals experiencing polyneuropathy.

Symptomatic relief for diabetic neuropathy, not effectively managed through glycemic control, involves using drugs such as amitriptyline, duloxetine, gabapentin, or pregabalin. According to National Institute for Health and Clinical Excellence guidelines, the choice among these drugs is based on assessing the risk and benefit for each patient. If there’s inadequate response or severe side effects with one drug, the treatment may be shifted to an alternative from the listed options.

Duloxetine and gabapentin, both FDA-approved oral agents, are typically the initial choices for addressing pain linked to diabetic neuropathy in the United States.

OBJECTIVES

• To monitor the adverse drug reactions for safety profile of the drugs.
• To monitor the efficacy of Duloxetine and Gabapentin.
• Comparison of compliance in patients treated with DULOXETINE and GABAPENTIN.

Materials and methods:

Place of Study: Department of Pharmacology with Department of Internal Medicine at Rama Medical College Hospital & Research Centre, Kanpur, UP.

Type of study: The study will be observational, comparative, computer randomized, open labelled parallel group study.

Study Duration: Research study will be 1 year(April 2024-March 2025).

Sample size: 150 patients of Type 2 diabetes mellitus with diabetic neuropathic pain

All the patients diagnosed with diabetic polyneuropathy pain attending outpatient department of Internal Medicine, fulfilling inclusion criteria and willing to give written informed consent will be included in the study.

An appropriate number of patients will be enrolled and  will be divided into two groups via computer generated, ramdomized method.

• Group I - will be administered Duloxetine 60mg OD for 12 weeks
• Group II - will be administered Gabapentin 300mg OD for 12 weeks

Patients unable to continue the prescribed treatment protocol will be cancelled to continue the treatment. Failure to which will be excluded from the study.

Patients will be assessed with the relief of symptoms at the interval through Visual Analogue Scale of 0-10 and other clinical evaluation at every 4 weeks interval at 0, 4, 8 and 12 weeks respectively.