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• W4236063035 abstract "Good adherence to medication is one of the cornerstones of successful management of chronic diseases. Unfortunately, such adherence is often difficult to achieve and estimates suggest that only 50% of all chronic disease patients are able to adhere to treatment. The adage that 50% of people with type 2 diabetes are diagnosed, 50% of those are prescribed suitable medications, and 50% of those are adherent might not be totally accurate, but the principle undoubtedly holds true. Adherence can even be tricky for patients who are reminded of their chronic disease by symptoms on a regular basis. However, for those with diseases with a more insidious course or where medications are used to prevent symptoms that may manifest years hence, adherence is notoriously difficult to maintain. Diabetes and its bedfellow, hypertension, are two such diseases. A variety of reasons account for poor treatment adherence, including side-effects, expense, inconvenience, psychological factors, and forgetfulness. Even in high-income settings with progressive health-care systems and patients who are well educated about health, adherence to treatment for diabetes is poor; for example, in the ENTRED study in France, good medication adherence was only found in 38% of participants. In areas where good health care is less widely available, and patients are perhaps less well educated about their disease, good medication adherence is a rarity; in one study of 600 patients in India, only 17% were adherent to treatment. The consequences of poor adherence to diabetes medications impact on individuals' health, health systems, and individual and country-wide economics. With an increasing global burden of diabetes and an earlier age at onset for many individuals, health systems are likely to suffer greatly from increasing rates of diabetes complications. Individuals who cannot work because of their condition are unable to contribute to the economies of their families or their countries. For diseases that require treatment with multiple drugs, safe and efficacious fixed-dose combination (FDC) therapy tantalisingly offers help in addressing some of the problems of adherence. FDCs are potentially more convenient for patients. For those who, reasonably, do not wish to take vast numbers of tablets, FDCs can be psychologically beneficial; they can also be less expensive to manufacture and easier to distribute than multiple single-dose formulations. FDCs have had most exposure in the HIV field, where they offer simplicity in the face of complex antiretroviral regimens. However, they are also gaining favour in primary and secondary prevention of cardiovascular disease. In these settings, they have been shown to improve adherence, even if the often small and short duration studies (including the IMPACT and UMPIRE studies) have not, as yet, been able to translate improved adherence into a large reduction in risk. The unfortunate necessity of many patients with type 2 diabetes to eventually require more than one drug—either oral or injectable—makes combining drugs into one product particularly attractive in this population, and several combinations are either in use or in development. FDCs' potential benefits of convenience apply to patients worldwide. For patients and health-care systems in lower-income and middle-income countries (LMICs), the benefits in terms of cost and distribution are potentially huge. The rising burden of diabetes in these countries may mean that health providers are increasingly looking towards FDCs as standard treatments for their patients with diabetes. The Comment by Allyson Pollock and Valerie Evans in this issue is therefore troubling. The authors have looked in depth at the Indian pharmaceutical industry's production of metformin-based FDCs and found that many of the formulations produced have little evidence supporting efficacy and safety. In the setting of a health system where regular monitoring of HbA1C may not be feasible, suboptimum efficacy could result in chronically poor glycaemic control and increased long-term complications. Lack of safety data could lead to increased risk of hypoglycaemia, with deleterious effects on patient adherence. Unfortunately, as India is one of the largest exporters of drugs to LMICs, the alleged misdemeanors of the Indian pharmaceutical industry could have wide-scale effects in countries whose nascent health systems can scarcely cope with the forecast of diabetes. The Indian pharmaceutical industry has proved its worth in the field of HIV generics; it is incumbent on them now to ensure that the drugs that they produce for diabetes care are of sufficient quality to help address the global epidemic of diabetes. The proliferation of irrational metformin fixed-dose combinations in IndiaIndia's pharmaceutical market, valued at more than US$12 billion in 2009 and projected to exceed $55 billion in 2020, is one of the largest markets in the world.1 The Indian generics industry manufactures drugs for use all over India and is also a major exporter, especially to low-income countries with scarce local manufacturing capacity. The Indian regulatory body, Central Drugs Standard Control Organization (CDSCO), is required by law to ensure that drugs are safe and effective.2 Full-Text PDF" @default.
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• W4236063035 date "2015-02-01" @default.
• W4236063035 modified "2023-09-30" @default.
• W4236063035 title "Treatment adherence: can fixed-dose combinations help?" @default.
• W4236063035 doi "https://doi.org/10.1016/s2213-8587(15)70011-2" @default.
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